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Apricus Bio Moves Forward With Viagra Competitor Vitaros
June 15, 2011
http://seekingalpha.com/article/275006-apricus-bio-moves-forward-with-viagra-competitor-vitaros?source=feed
In November 2010, Health Canada gave marketing approval for Vitaros, Apricus Bio’s (APRI) first line therapy for erectile dysfunction (ED). Vitaros is an easy-to-use topical treatment that has been clinically approved and also proven to work faster, have a more attractive safety profile, and to work on a wider population compared to leading ED drugs, such as Viagra.
Partnerships for Vitaros have been announced for the Middle East and Gulf region, Israel, and Italy. A partnership for the Canadian market where the drug is approved, and potentially Europe, is expected in the near term.
Late last year, Apricus Bio announced that the company had selected Therapex, a division of Bracco Pharma, as the centralized manufacturer of Vitaros.
“Getting the manufacturing facility ready to produce is an important step in bringing Vitaros to market,” explained Apricus Bio CEO Bassam Damaj, in an exclusive interview. “We want to be as close to production as possible when we sign our Canadian partner,” he said.
According to the company, the new manufacturing facility is producing its first three batches of Vitaros. The analytical data from those batches will be submitted to Health Canada for inspection to approve the manufacturer before the drug becomes available to Canadian patients.
“Having the manufacturing facility prepared for production will cut the lag time between signing a partnership agreement and beginning production,” said Dr. Damaj. Because of the advanced stage of the manufacturing facility’s development, an announcement of a partnership will likely translate directly into sales, royalties, and revenues within a shorter period of time than without such development. Apricus Bio believes production of Vitaros could begin as early as October, with revenues coming in potentially by the end of the year.
In addition, the newly produced Vitaros samples will also allow Apricus Bio to issue the Certificate of Pharmaceutical Product (CPP) from Health Canada, which it plans to do in the coming months. The key here is that presenting a CPP with actual drug samples is usually sufficient for drug approval in many places around the world, such as the Middle East, the Gulf Countries and Israel where Apricus Bio has already established partnerships. A CPP may also help facilitate approval in developed countries with more stringent regulations. With partners already established in some of these geographies, revenue from these partnerships could be realized sooner.
The company is currently negotiating an agreement for a Canadian partner and aims to have a deal worked out in the near future. An agreement will likely have traditional structure, with upfront and milestone payments, royalties, as well as health agency filing reimbursements.
In an additional positive turn of events, the company indicated that it now believes a partnership could include both the Canadian and the European markets, which make up a combined billion-dollar-plus ED market. Dr. Damaj stated that “We received increased interest after filing for approval in Europe. The advantage for our commercial partner is that Vitaros can be sold in Canada, while we are waiting for European approval,” he explained. This development could result in a larger partnering deal for Apricus Bio. It appears that the terms in a European agreement may be at the level they would be if Vitaros was already approved on the continent.
But the company also sees further opportunities. “Within our Vitaros partnership discussions, there is interest in the use of the NexACT technology and building long term relationships,” Dr. Damaj noted. In fact, Apricus Bio is already in advanced discussions with companies for the use of its NexACT technology. NexACT allows for a more effective absorption of drug compounds into the body. Many companies have carried out studies with NexACT®, with some coming back to negotiate a license for the use of the technology within their own compounds. Apricus Bio believes that it may secure its first NexACT® license by year end.
The company also continues to work on a room temperature Vitaros® product. The new variation, which is currently undergoing stability testing, could create several exciting opportunities for the company.
“We believe our room temperature version of the product would likely be the only viable ED drug able to go from prescription-only to being available over-the-counter,” Dr. Damaj explained. The possibility of being the first and only OTC erectile dysfunction drug is a very exciting development. The hope is that no clinical data will be required for approval due to the similar properties that the new formulation shares with the original version of Vitaros. More importantly, Apricus Bio owns the full rights to this product’s dispenser, even in the United States.
The company also recently appointed an in-house general counsel. According to Apricus Bio, the move will help the company “transition into a commercial stage biopharmaceutical company and pursue numerous commercial partnership discussions and negotiations.”
The need for an in-house counsel is a response to the growing interest in the company’s products and technology. It is also indicative of the developments ongoing behind the scenes. The near-term looks full of positive events for this transitioning company, with its first approved drug set to hit shelves this year and significant revenues following. In addition, with the Vitaros manufacturing facility now producing the first batches of the drug, a pivotal Canadian and potentially European partnership should be announced in the near future.
CytoSorbents Corporation (OTC:CTSO) At a Technical Focal Point
http://www.hotstocked.com/article/11252/cytosorbents-corporation-otc-ctso-at-a-technical.html
Apricus Bio CEO to Present Commercialization Plans for Vitaros(R) at Jefferies 2011 Global Healthcare Conference
Date : 06/03/2011 @ 10:17AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47939875
Bassam Damaj, PhD., Chief Executive Officer of Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that he will discuss plans for the commercialization of Vitaros®, the Company's topical erectile dysfunction drug, during his presentation at the Jefferies 2011 Global Healthcare Conference. Dr. Damaj's presentation date and time have been changed, and will now take place on June 8, 2011 at 2:00pm, at the Grand Hyatt Hotel in New York.
Vitaros® is approved for sale in Canada and is expected to be on the market in that country during the second half of 2011. Dr. Damaj will also review the Company's recent marketing application filing for Vitaros® in Europe, as well as expectations for filing a marketing application in Switzerland. Vitaros® utilizes Apricus Bio's NexACT® drug delivery technology, which enables the rapid absorption of various active pharmaceutical ingredients through the skin, with the goal of improving patient outcomes and reducing side effects.
Dr. Damaj's presentation at the Jefferies conference will be webcast and accessible to the public online at http://www.wsw.com/webcast/jeff60/apri/ or via the Apricus Bio's web site at http://www.apricusbio.com. A replay will be available for 90 days after the presentation.
Other drugs in Apricus Bio's pipeline include: Femprox®, a treatment for female sexual arousal disorder; MycoVa™, for onychomycosis (nail fungus); PrevOnco™, a treatment for hepatocellular liver carcinoma; and RayVa™, for Raynaud's Syndrome.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further development products and product candidates, have such products and product candidates approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
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Keryx Biopharmaceuticals Announces Positive Final Data from Zerenex™ Short-Term Phase 3 Study
Date : 04/28/2011 @ 4:00PM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals, Inc. (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=47463060
Keryx Biopharmaceuticals (Nasdaq: KERX) today announced the final dataset from the Phase 3 short-term clinical trial of Zerenex™ (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. The Zerenex data was presented earlier today at the National Kidney Foundation Spring Clinical Meetings being held in Las Vegas, Nevada, in an oral presentation by David S. Goldfarb, M.D., Clinical Chief of Nephrology, NYU Langone Medical Center, Professor of Medicine & Physiology, NYU School of Medicine. On November 30, 2010, the Company issued a press release announcing positive top-line results from this Phase 3 short-term study.
Phase 3 short-term study design
This Phase 3 study was a multicenter, randomized, open-label trial with a two-week washout period, following which patients were randomized 1:1:1 to receive a fixed dose of Zerenex of either 1 gram, 6 grams or 8 grams per day for a treatment period of 28 days. Zerenex was administered using a 1 gram oral caplet formulation, hence, the fixed-dose arms of 1 gram, 6 grams and 8 grams per day represent 1, 6 and 8 pills per day, respectively.
One hundred fifty-one dialysis patients were enrolled into the study. The Intent-to-Treat (ITT) group included 146 patients, representing all patients who took at least one dose of Zerenex and provided a Baseline (at the end of washout) and at least one post-Baseline efficacy assessment. Efficacy assessments were taken weekly starting at Baseline and subsequently at days 7, 14, 21 and 28.
EFFICACY DATA ANALYSES
The primary endpoint of the study was to determine whether there was a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.
The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).
http://www.finanznachrichten.de/nachrichten-2011-04/20076999-keryx-biopharmaceuticals-announces-positive-final-data-from-zerenex-short-term-phase-3-study-008.htm
Additional highlights from Dr. Goldfarb''s presentation on Zerenex are as follows:
* Statistically significant dose response increase in serum bicarbonate suggests potential to address metabolic acidosis
* Statistically significant dose response reduction in calcium x phosphorus product
* Modest upward trends in Ferritin and TSAT in 6 grams/day and 8 grams/day dose groups further supports theory that Zerenex could reduce the need for intravenous iron and erythropoiesis-stimulating agent (ESA) use
* Zerenex appeared to be safe and well-tolerated in the study
* GI adverse events were mostly mild and transient in nature
* No SAEs were deemed to be drug-related by the Data Safety Monitoring Committee
Dr. Goldfarb concluded that Zerenex has the potential to become a viable alternative to the currently approved phosphate binders used to treat ESRD patients.
Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are encouraged by the final efficacy and safety data from the Phase 3 short term study presented earlier today, which confirm the top-line data previously reported." Â Mr. Bentsur continued, "We thank Dr. Goldfarb for his time and effort in preparing for and delivering this morning''s presentation."
In accordance with the Company''s Special Protocol Assessment (SPA) agreement with the FDA, the Phase 3 clinical program for Zerenex consists of two clinical studies, the completed short-term study, and a long-term safety and efficacy study that is currently ongoing.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with approved therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex'' (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner''s ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); uncertainties related to the regulatory process; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
© 2011 PR Newswire
Contrasting Opinions on Apricus Are to Be Expected
by: VFC's Stock House
April 28, 2011
http://seekingalpha.com/article/266134-contrasting-opinions-on-apricus-are-to-be-expected?source=feed
Apricus Biosciences to Present at the FSX Investor Conference in San Francisco on April 28, 2011
Date : 04/27/2011 @ 1:07PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47439728
Apricus Biosciences ("Apricus Bio") (Nasdaq:APRI) today announced that Ed Cox, Vice President Corporate Development and Investor Relations, will present at the FSX (Financial Services Exchange, Inc.) investors conference being held at the Ritz Carlton in San Francisco from April 28-30, 2011. Mr. Cox's presentation is scheduled for tomorrow, April 28, 2011 and will not be available in live webcast, but a replay will be available on the Company's website.
FSX is the premier investment conference organization in the United States, hosting quarterly investment conferences around the country, providing opportunities for networking and one-on-one communication between independent broker/dealers and companies seeking exposure or funding. FSX conferences also provide a forum for direct investment programs, mutual funds, and asset management companies. For more information visit: www.fsxone.com.
About Apricus Biosciences
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop products and product, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Bio Contacts:
Edward Cox, V.P. Investor Relations
Apricus Biosciences
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations:
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences Requests Approval of Vitaros(R) as a Treatment for Erectile Dysfunction in Europe
Date : 04/28/2011 @ 10:06AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47456409
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it has filed a marketing application in Europe for Vitaros® as a treatment for patients with erectile dysfunction ("ED"). Approval of the application would give Apricus the right to sell Vitaros® in multiple chosen countries in the European Union. "Our goal is to help millions of patients suffering with erectile dysfunction in Europe," said Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio.
Vitaros® has already been approved in Canada for the treatment of erectile dysfunction. Warner Chilcott, which owns the U.S. rights to Vitaros® for ED, has submitted a New Drug Application to the U.S. Food and Drug Administration, requesting approval in the U.S.
Before submitting the European application, Apricus Bio consulted with regulators in the United Kingdom, Germany and the Netherlands, and received positive guidance from each. The application includes positive data from the Company's two Phase III clinical studies of Vitaros® as a treatment for ED, as well as information about the chemistry, manufacturing and controls ("CMC") for the drug.
Under a European system called the "Decentralized Procedure" (DCP), a company files its application for marketing approval of a drug in just one European country, which is designated the Reference Member State (RMS). Apricus Bio has chosen The Netherlands as its RMS. The RMS then evaluates the application and prepares an assessment report that is submitted to other chosen European Union countries for their consideration and approval. The entire process takes approximately 240 days. One of the major advantages of the DCP is that a company may receive identical marketing authorizations for its product in multiple chosen European Member countries at the same time.
"This submission is another major milestone for the Company," said Damaj. "We look forward to working with the European regulatory authorities as they review our application."
About Vitaros® and the ED Market
According to IMS Health data, the annual ED market in Europe in 2010 was about $1.2 billion. The current leading drugs are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of being a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes -- much faster than the results achieved from the oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® was combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra. The side effects reported were localized and transient. "We believe that Vitaros® will be an attractive alternative to the oral PDE5 inhibitors for many patients with erectile dysfunction," noted Damaj.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further development products and product candidates, to have its products and product candidates approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Trades Higher on Long Term
April 18, 2011
http://seekingalpha.com/article/264072-apricus-trades-higher-on-long-term?source=feed
Apricus Biosciences Files for Orphan Drug Designation for RayVa(TM)
http://www.finanznachrichten.de/nachrichten-2011-04/19934210-apricus-biosciences-files-for-orphan-drug-designation-for-rayva-tm-016.htm
Drug Intended for the Treatment of Raynaud's Phenomena, Secondary to Systemic Sclerosis
SAN DIEGO, 2011-04-13 19:11 CEST (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today its filing with the U.S. Food&Drug Administration ('FDA') requesting orphan drug designation for RayVa?, the Company's drug candidate indicated for the treatment of Raynaud's phenomenon in patients with systemic sclerosis.
Raynaud's phenomenon is a condition in which the blood supply to fingers or toes is suddenly reduced. With less blood, the skin turns pale or white, and the fingers or toes become cold and numb.
The condition occurs in 4-15% of Americans, and is seven times more common in women than men. In many cases, Raynaud's phenomenon is caused by cold or emotional distress, and is mostly an inconvenience. However, it also can be caused by other diseases, such as systemic sclerosis, an autoimmune disorder. Patients who develop Raynaud's phenomenon as a consequence of systemic sclerosis can have severe complications. For example, the skin, subcutaneous tissues and muscles of the fingers and toes may weaken and shrivel, and in some cases, the fingers can develop ulcers. In extreme cases, the ulcers lead to gangrene, resulting in the loss of fingertips.
RayVa? is designed to treat the condition by increasing the blood flow to the fingers and toes. One component of RayVa? is the already approved drug, alprostadil, which has been clinically proven to boost blood flow. To create RayVa?, alprostadil is combined with Apricus Bio's clinically-validated, proprietary NexACT(r) technology?a substance that temporary loosens the space between cells, allowing drugs to penetrate the skin. RayVa? is designed to be applied as a cream to fingers or toes, delivering alprostadil directly to the area of need, in order to stimulate blood flow. Vitaros?, which also combines alprostadil with the NexACT(r) technology, has already been approved in Canada to treat erectile dysfunction.
'At Apricus Bio, we are continually expanding the potential uses for NexACT(r) and other active drugs such as alprostadil, while also attempting to bring new treatments to patients with unmet medical needs,' noted Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio. 'Our orphan drug filing for RayVa? is the second such orphan drug filing we have made in the last several years and represents another milestone for the Company.' In August 2008, the FDA granted orphan drug status for Apricus Bio's proprietary drug PrevOnco? for the treatment of liver cancer.
The FDA's Orphan Drug Designation Program is designed to spur the development of drugs to treat rare medical diseases. A company whose product is granted orphan drug status receives, among other benefits, seven years exclusive commercialization rights for the treatment of the disease and an expedited review process.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT(r) drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros(r), approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop products and product candidates such as RayVa?, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc. Edward Cox, V.P. Investor Relations&Corporate Development, Apricus Bio, Inc. (858) 848-4249 ecox@apricusbio.com
Apricus Bio Investor Relations Paula Schwartz Rx Communications Group, LLC (917) 322-2216 pschwartz@rxir.com News Source: NASDAQ OMX
13.04.2011 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: Apricus Biosciences, Inc.
United States Phone: Fax: E-mail: Internet: ISIN: US9901429525 WKN:
End of Announcement DGAP News-Service
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ISIN US9901429525
AXC0259 2011-04-13/19:12
© 2011 dpa-AFX
Apricus Biosciences Files for Orphan Drug Designation for RayVa(TM)
Date : 04/13/2011 @ 1:11PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47283337
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today its filing with the U.S. Food & Drug Administration ("FDA") requesting orphan drug designation for RayVa™, the Company's drug candidate indicated for the treatment of Raynaud's phenomenon in patients with systemic sclerosis.
Raynaud's phenomenon is a condition in which the blood supply to fingers or toes is suddenly reduced. With less blood, the skin turns pale or white, and the fingers or toes become cold and numb.
The condition occurs in 4-15% of Americans, and is seven times more common in women than men. In many cases, Raynaud's phenomenon is caused by cold or emotional distress, and is mostly an inconvenience. However, it also can be caused by other diseases, such as systemic sclerosis, an autoimmune disorder. Patients who develop Raynaud's phenomenon as a consequence of systemic sclerosis can have severe complications. For example, the skin, subcutaneous tissues and muscles of the fingers and toes may weaken and shrivel, and in some cases, the fingers can develop ulcers. In extreme cases, the ulcers lead to gangrene, resulting in the loss of fingertips.
RayVa™ is designed to treat the condition by increasing the blood flow to the fingers and toes. One component of RayVa™ is the already approved drug, alprostadil, which has been clinically proven to boost blood flow. To create RayVa™, alprostadil is combined with Apricus Bio's clinically-validated, proprietary NexACT® technology—a substance that temporary loosens the space between cells, allowing drugs to penetrate the skin. RayVa™ is designed to be applied as a cream to fingers or toes, delivering alprostadil directly to the area of need, in order to stimulate blood flow. Vitaros™, which also combines alprostadil with the NexACT® technology, has already been approved in Canada to treat erectile dysfunction.
"At Apricus Bio, we are continually expanding the potential uses for NexACT® and other active drugs such as alprostadil, while also attempting to bring new treatments to patients with unmet medical needs," noted Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio. "Our orphan drug filing for RayVa™ is the second such orphan drug filing we have made in the last several years and represents another milestone for the Company." In August 2008, the FDA granted orphan drug status for Apricus Bio's proprietary drug PrevOnco™ for the treatment of liver cancer.
The FDA's Orphan Drug Designation Program is designed to spur the development of drugs to treat rare medical diseases. A company whose product is granted orphan drug status receives, among other benefits, seven years exclusive commercialization rights for the treatment of the disease and an expedited review process.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop products and product candidates such as RayVa™, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences' CEO Interviewed by WallStreetCorner.com
Date : 04/05/2011 @ 12:16PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47174907&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Chairman, President and Chief Executive Officer, Dr. Bassam Damaj, was recently interviewed by WallStreetCorner.com, a New York-based financial publication. The interview is available at http://wallstreetcorner.com/daily.html.
In the interview, Dr. Damaj provided an update on Apricus Bio's recent developments and plans. He noted that, based in San Diego, Apricus Bio is a revenue-generating pharmaceutical company. Its clinically-validated NexACT® drug delivery technology enables multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of its technology for the development and commercialization of those compounds to pharmaceutical and biotechnology companies worldwide.
Apricus is also monetizing its existing product pipeline, including its lead product, Vitaros®, approved in Canada in November 2010 for the topical treatment of erectile dysfunction, and which is expected to be available on the Canadian market later this year. The company's pipeline also includes compounds in development from the pre-clinical stage through Phase III. These drugs are focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes, cosmaceuticals, and others.
Dr. Damaj noted that the company is in late-stage discussions with several major pharmaceutical companies in Canada to commercialize its lead product, Vitaros®, in that market, and currently expects to sign a commercial partnership for Canada in Q2 2011. Apricus Bio expects to sign additional commercialization partnership deals in the second half of 2011 and anticipates receiving royalty revenues from sales of the product possibly during the second half of 2011 or the first half of 2012, Dr. Damaj said.
"We also plan to file for approval for Vitaros® in Europe in the first half of 2011," said Dr. Damaj. "Further, our expectation is to sign a commercialization partnership similar to Canada for a number of the major European countries in 2011. We have already signed a partnership in Italy with Bracco, whereby we expect to receive €750,000 before the end of Q2 2011. We believe that if Vitaros® is approved in Europe in late 2012, we will begin to receive royalty revenues beginning in 2013 for the major markets described above," he added.
In the interview, Dr. Damaj pointed out that Apricus Bio also holds the worldwide rights to Femprox®, a topical treatment for female sexual dysfunction. Like Vitaros®, it contains a previously approved sexual dysfunction drug, alprostadil. Apicus Bio's proprietary NexACT® technology allows medication to be delivered topically, through the skin, for fast efficacy and fewer side effects than oral medications.
Regarding Femprox®, Dr. Damaj said, "We have already completed one Phase II trial in the U.S. and one Phase III study in close to 400 women in outside the U.S., which achieved a 44% positive response rate as compared to a placebo. We plan to meet with the U.S. Food & Drug Administration in order to agree on the planned Phase III clinical program required for marketing approval in the U.S. We are also planning to meet with Canadian agency officials to seek guidance as to whether the current Phase III trial will be sufficient for filing a New Drug Submission ("NDS") in Canada."
As for the size of the market for Femprox®, Dr. Damaj stated, "To our knowledge, there aren't any approved products in any major market to treat female sexual arousal disorder, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. It is estimated that there are approximately 50 million potential sufferers in the U.S. alone, according to Fitzheny and Sandberg in 2005. The market value in the U.S. could exceed $4 billion, with only 15% of patients captured on therapy."
Asked to provide an overview of Apricus Bio, Dr. Damaj said, "We currently focus our efforts on new and patented pharmaceutical products. They are mostly based on our patented drug delivery technology known as NexACT®. We leverage the know-how of our CRO (Clinical Research Organization) business to assist in our product and NexACT® technology development. In 2010, through the acquisition of Bio-Quant, we expanded our R&D capabilities with NexACT® into the areas of oncology, inflammation, immunology, and metabolic diseases."
In addition, Dr. Damaj said, "We intend to continue our efforts developing topical treatments based on the application of the NexACT® technology to drugs: (1) previously approved by the U.S. Food and Drug Administration; (2) with proven efficacy and safety profiles; (3) with patents expiring in the near term, or expired; and, (4) with proven market track records and potential."
"Other products in the Apricus Bio pipeline include PrevOnco™, for liver cancer and MycoVa™ for the treatment of fungal nail infection (onychomycosis)," Dr. Damaj noted.
In addition, Dr. Damaj said that Apricus Bio has recently appointed a Sexual Dysfunction Clinical Advisory Board. "It consists of such key opinion leaders as Irwin Goldstein, M.D., Jed Kaminetsky, M.D., and Ajay Nehra, M.D. We are pleased that Drs. Goldstein, Kaminetsky and Nehra have agreed to serve on this new Board. Their expertise will be key to helping us move forward with our Femprox® program as well as in the development of other products in the male and female sexual dysfunction field," Dr. Damaj added.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to obtain and/or develop products from its patented technology and to successfully enter into partnership, licensing or commercialization agreements for its Vitaros® product for erectile dysfunction and its NexACT™ platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Positron Seeks To Grow Share in Molecular Imaging Market
Saturday, April 02, 2011
by Jason Chew
http://www.proactiveinvestors.com.au/companies/news/15158/positron-seeks-to-grow-share-in-molecular-imaging-market-15158.html
CytoSorbents Corporation (OTC:CTSO) Reaches a Corporate Milestone
By Martin Tsvetkov
Date: Apr 1, 2011
http://www.hotstocked.com/article/4378/cytosorbents-corporation-otc-ctso-reaches-a.html
Apricus Biosciences Expands Patent Coverage in Mexico for Its Erectile Dysfunction Drug, Vitaros(R)
Date : 03/31/2011 @ 10:41AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=47106143
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that the Mexican Patent Office ("MPO") will grant an additional patent for Vitaros®, the Company's topical alprostadil-based cream for the treatment of erectile dysfunction ("ED").
The MPO issued a "notice of allowance" for the patent entitled, "Topical Stabilized Prostaglandin E Compound Dosage Forms," which is expected to be granted within a few months. Upon receipt, the new patent will provide Apricus Bio patent protection for Vitaros® for ED until 2026. It will be the sixth patent that Apricus has received in Mexico for the technology underlying the product for this indication.
"The issuance of this patent provides strong intellectual property protection for Vitaros® for erectile dysfunction and we believe it enhances our product's present value," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "Vitaros® for ED is now protected in multiple countries by issued patents and we are continuing our efforts to expand our patent portfolio for this important medical innovation. We are also engaged in discussions with potential partners in Latin America to license and commercialize Vitaros® for ED in certain countries in that region."
About Vitaros® for Erectile Dysfunction
Vitaros®, for ED, has been approved by Health Canada for marketing and sales in that country and Apricus Bio is currently in discussions with major pharmaceutical companies to license and commercialize the product in Canada. In addition, the Company has licensing and commercialization agreements with companies for future marketing and sales of Vitaros® for this indication in Italy, the Gulf Countries and parts of the Middle East and also Israel and the Palestinian territories and is in discussions with potential partners in other international markets.
The Vitaros® product for ED incorporates Apricus Bio's proprietary postdermal and permeation enhancer using its NexACT® technology. It is a topically-applied cream that the Company believes may be one of the fastest acting drugs currently approved for ED.
Apricus Bio feels that Vitaros® has many advantages over other currently marketed products for the treatment of ED. First, the Company believes that it is 'on-demand,' in that patients normally see results more quickly than with oral drugs such as Viagra®, Cialis® and Levitra®. Second, there are no known restrictions on use of Vitaros® for ED by patients with cardiac, hypertension or prostectomy issues, as there appear to be with the oral drugs for erectile dysfunction such as Viagra®, Cialis® and Levitra® for example, for patients who have cardiac risk and are taking drugs that contain nitrates or alpha blockers. Thus, it is the Company's belief that patients who have prostectomies or with hypertension are not allowed to use those drugs. Third, the oral drugs appear to have a lesser effect with patients who take satomines or drink alcohol. With Vitaros®, there are no restrictions as to what a patient can eat or drink while using the product. Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lily USA, LLC; and Levitra® is a registered trademark of Bayer Corporation.
Erectile dysfunction is estimated to affect approximately 50% of the male population between the ages of 18 and 49 in Latin America increasing to 70% among men aged 50 years or older (Becher and Glina 2002). According to 2010 data from IMS, the size of the market for ED drugs in Mexico is currently estimated as being between $175 million to $200 million per year.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to obtain and/or develop products from its patented technology and to successfully enter into partnership, licensing or commercialization agreements for its Vitaros® product for erectile dysfunction and its NexACT® platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
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Apricus Biosciences Announces Poster Presentations on Progress of PrevOnco(TM) in Combination With NexACT(R) Technology at the American Association for Cancer Research 2011 Annual Meeting
http://ih.advfn.com/p.php?pid=nmona&article=46973506&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it will present two posters at the American Association for Cancer Research ("AACR") 102nd Annual Meeting to be held April 2-6, 2011 in Orlando, Florida.
The presentations will include one poster discussing how the Company's NexACT® technology, involving a small molecule permeation enhancer called Dodecyl 2-(N,N dimethylamino) propionate ("DDAIP"), improves the pharmacokinetic profile of PrevOnco™, Apricus Bio's proprietary drug for human hepatocellular carcinoma ("HCC") or liver cancer, in different species in mice, beagle dogs and cynomolgus monkeys. The second poster discusses the anti-tumor activity of PrevOnco™ in in vitro and in vivo human tumor models using a combination therapy of PrevOnco™ and Doxorubicin that resulted in a better efficacy profile with enhanced survival rate in a liver cancer model.
PrevOnco™ Posters
Title: DDAIP improves the pharmacokinetic profile of PrevOnco® in different species: Comparison of DDAIP, CMC and PEG-300/400 formulations in mice, beagle dogs and cynomolgus monkeys.
Abstract Number: 1297
April 4, 2011: 8:00 am to 12:00 pm ET
Session Title: Pharmacokinetics and Metabolism
Session Category: Clinical Research 5
Poster Section: 13
Board Number: 9
Title: PrevOnco™ exhibits anti-tumor activity in in vitro and in vivo human tumor models: Combination therapy (PrevOnco™/Doxorubicin) demonstrates a better efficacy profile with enhanced survival rate in a liver cancer model.
Abstract Number: 2535
April 4, 2011: 1:00 pm to 5:00 pm ET
Session Title: Chemotherapeutic Agents
Session Category: Experimental and Molecular Therapeutics 15
Poster Section: 26
Board Number 20
About PrevOnco™
PrevOnco™ is Apricus Bio's proprietary treatment for HCC or liver cancer. The product incorporates lansoprazole, a commonly marketed anti-ulcer compound which has shown strong anti-cancer activity in mice bearing human liver tumors. The U.S. Food & Drug Administration ("FDA") granted PrevOnco™ Orphan Drug status in August 2008. The Company is currently in discussions with the FDA regarding a Special Protocol Assessment ("SPA") Phase III protocol which was submitted in November 2011, and expects to have a final protocol agreed upon within eight to 12 months.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes and cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also find out more about the company by visiting http://twitter.com/apricusbio, http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, the FDA and other countries' regulatory approval of PrevOnco™ and other of its products and product candidates, its ability to commercialize such products and to enter into license agreements with potential pharmaceutical partners and obtain upfront and milestone payments as well as royalties and to achieve other of its financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development
Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences: Great Pipeline at a Good Price
by: Chemistfrog
March 07, 2011
http://seekingalpha.com/article/256835-apricus-biosciences-great-pipeline-at-a-good-price?source=feed
Apricus Biosciences Announces Removal of Auditor's "Going Concern" Opinion From Its 2010 Form 10-K and Increased Cash Reserves
Date : 03/08/2011 @ 9:57AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46782491&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that the going concern paragraph has been removed from its audit opinion contained in its upcoming filing of Form 10-K for the year ended December 31, 2010 and the Company has increased cash reserves in 2010 compared to the previous year. Apricus Bio will file its Form 10-K for the year ended December 31, 2010 by the close of business on Thursday, March 10, 2011.
The going concern assumption in the Generally Accepted Auditing Standards (SAS 59, The Auditor's Consideration of an Entity's Ability to Continue as a Going Concern) requires an auditor to evaluate conditions or events that raise questions about an entity's ability to continue as a going concern. Typically, if an auditor has concerns about a firm's ability to continue as a going concern, the audit opinion will contain a paragraph outlining issues with this assumption. In its to-be-filed 10-K report for the year ended December 31, 2010, the Company's auditors did not include any such going concern paragraph in their audit opinion.
"Having the going concern issue removed from our audit opinion for the first time in nine years is a significant accomplishment for our relatively new management team, further affirming our continued success in the execution of the Company's goals," noted Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "Having the going concern opinion removed not only validates our business strategy but also instills further trust in our management team by our shareholders, as well as, with the numerous pharmaceutical companies, which we are in active partnership discussions with at this present time."
Dr. Damaj continued, "At December 31, 2010, the Company had approximately $9.1 million in cash reserves and our current cash reserves of approximately $11 million should provide us with sufficient cash to fund our operations into the second half of 2012. In addition, we will receive upfront payments and we may receive milestone payments and royalties in 2011 from existing and future licensing deals. We would expect such payments to extend our cash runway even further."
For the year ended December 31, 2010, the Company reported a net loss per share of $2.49, which includes a non-cash impairment charge of approximately $10 million for the write down of goodwill and intangible assets and non-cash interest charges of approximately $8.7 million, as compared to a net loss per share of $5.43 in 2009 which also included non-cash interest charges of approximately $28.3 million.
"Having laid a solid financial foundation in 2010 we remain focused on continuing to execute our long term strategy to continue to move the company towards eventual profitability," noted Dr. Damaj.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes and cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also find out more about the company by visiting http://twitter.com/apricusbio http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to enter into license agreements with potential pharmaceutical partners and obtain upfront and milestone payments as well as royalties and to achieve other of its financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development
Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences Announces Expanded European Patent Coverage for MycoVa(TM) for Nail Fungus
Date : 03/01/2011 @ 9:14AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46676626&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that the European Patent Office ("EPO") will grant a patent for the company's MycoVa™ product for treating onychomycosis (commonly referred to as nail fungus).
The European Patent Office recently issued a "notice of allowance" for the Company's patent entitled "Antifungal Nail Coat and Method of Use." Once issued, this will be the second patent that Apricus has received in Europe for MycoVa and onychomychosis.
The patent will give Apricus Bio patent protection for MycoVa™ and its use for nail fungus in Europe until 2024. "This expanded patent coverage will enable us to move forward with our plans to seek regulatory approval for MycoVa™, and to potentially market the product as a treatment for mild nail fungus in Europe," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "We are also seeking similar patents worldwide."
The Company currently holds 16 patents related to the treatment of nail fungus, with 13 patent applications pending and has patent protection for its underlying NexACT® technology used in the nail fungus treatment in Europe, and well as in a number of other countries.
MycoVa™combines an existing, approved drug for nail fungus, terbinafine, with the NexACT® technology that enhances the absorption of the drug through the skin. In January 2011, the Company announced that an additional analysis showed that MycoVa™ is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl® (an ointment made by Galderma). Those results convinced the Company to seek regulatory guidance meetings from certain health agencies in Europe.
The advantage of Apricus Bio's MycoVa™ is that it is easy to apply, thus improving patient compliance. MycoVa™ is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.
Onychomycosis is a chronic persistent fungal infection of the nail bed that causes thickening and discoloration of the nail. The infection sometimes causes serious pain and disability. According to the Merck Manual, about 10% of people around the world suffer from onychomycosis. Recent studies (such as one by Iorizzo and Piraccini in 2007) show that the incidence is rising due to diabetes, immunosuppression and an aging population. The infection may hit as much as 90% of the elderly (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma estimated that the worldwide market is approximately $2.8 billion per year, and predicted that the market would grow to approximately $2.9 billion by 2014.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to obtain and/or develop products from its patented technology and to successfully enter into partnership, licensing or commercialization agreements for MycoVa™ and other of its product candidates, its Vitaros® product and its NexACT™ platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Bio Seeks to Penetrate Untapped Sexual Dysfunction Market
http://seekingalpha.com/article/254438-apricus-bio-seeks-to-penetrate-untapped-sexual-dysfunction-market?source=feed
Chart ( daily / weekly ) >>> LINK back
A Plethora of Pipeline Products With Market Moving Potential
http://seekingalpha.com/article/253930-apricus-bioscience-a-plethora-of-pipeline-products-with-market-moving-potential?source=feed
Undervalued Apricus Bio Poised to Follow Threshold Pharma in Receiving SPA Approval
http://seekingalpha.com/article/253430-undervalued-apricus-bio-poised-to-follow-threshold-pharma-in-receiving-spa-approval?source=feed
CytoSorbents Corporation Broadens Its Intellectual Property Portfolio
Date : 02/17/2011 @ 7:30AM
Source : MarketWire
Stock : CytoSorbents Corporation (CTSO)
http://ih.advfn.com/p.php?pid=nmona&article=46509341&symbol=CTSO
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced the issuance of two additional U.S. patents, bringing its total patent portfolio to 29 issued patents.
U.S. Patent 7,846,650 is titled "Methods for reducing levels of pro-inflammatory or anti-inflammatory stimulators or mediators in the blood" and covers a number of different hemocompatible device configurations to treat a variety of acute and chronic disorders including sepsis, trauma, myocardial ischemia and reperfusion injury, biologic or chemical warfare, renal disease, and others.
U.S. Patent 7,875,182 titled "Size-selective hemoperfusion polymeric adsorbents" describes the production of polymer beads ideally suited for the treatment of chronic diseases such as renal failure and auto-immune diseases.
Dr. Phillip Chan, Chief Executive Officer, stated, "These awarded patents add to an already substantial patent portfolio that broadly covers the use of our biocompatible porous polymer beads to treat a variety of conditions and diseases. We continue to invest significantly in research and development, expanding the potential applications of our purification technology, and increasing our pipeline of licensable products. Our long-term goal is to maximize the value of our technology and create lasting shareholder value."
About CytoSorbents and CytoSorb™
CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a critical care focused therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb™. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to severe inflammation and the unregulated, massive production of cytokines, often called "cytokine storm," that then causes multi-organ failure and often death. CytoSorb™ is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped repeatedly through the CytoSorb™ cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb™ to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. Importantly, cytokine reduction via CytoSorb™ has broad applicability to a number of other critical care diseases where cytokine storm plays a detrimental role, including burn and smoke inhalation injury, trauma, acute respiratory distress syndrome, advanced influenza, acute pancreatitis and others. CytoSorb™ is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc. believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 9, 2010, and subsequent quarterly reports on Form 10-Q, which are available at http://www.sec.gov.
Contact:
CytoSorbents Corporation
David Lamadrid
(732) 329-8885 ext. 816
DavidL@cytosorbents.com
Apricus Clinical Pipeline Nearing Groundbreaking FDA Catalysts
http://seekingalpha.com/article/253237-apricus-clinical-pipeline-nearing-groundbreaking-fda-catalysts?source=feed
Apricus Biosciences and FDA Initiate PrevOnco(TM) SPA Phase III Clinical Protocol Discussion
Date : 02/17/2011 @ 9:11AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46511797
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.
In the first response received by Apricus Bio relating to this SPA, the FDA accepted some of the questions submitted by the Company and commented on the rest. The Company's Clinical Advisory Board, formed to focus on the clinical development of PrevOnco™, Apricus Bio's first oncology compound, will meet in late February to discuss the FDA response and comments, and the Company will prepare a response according to feedback from the Clinical Advisory Board. In addition, the Company may request a meeting with the FDA to accelerate the FDA's SPA Phase III protocol review process.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted, "We will continue to work diligently with the FDA and respond to their comments as expeditiously as possible."
PrevOnco™ is Apricus Bio's proprietary treatment for hepatocellular carcinoma (liver cancer). The Company announced in late November 2010 that it intended to file the protocol for a proposed Phase III clinical trial of PrevOnco™ with the FDA. Pursuant to the FDA's SPA program, the agency provides approval for the trial's design, clinical endpoints and statistical analysis. A company's SPA is not considered accepted until the FDA comments and agrees to all of the questions and protocol design submitted therein. Once the SPA is accepted, the PrevOnco™ Phase III study is expected to take about 12-24 months, depending on patient recruitment. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug Application for marketing approval of PrevOnco™ for the treatment of liver cancer in the U.S.
The FDA granted PrevOnco™ Orphan Drug status in August 2008. The product incorporates lansoprazole, a commonly marketed anti-ulcer compound which has shown strong anti-cancer activity in mice bearing human liver tumors. Upon acceptance of the SPA, the Company expects that the Phase III study will enroll up to 218 patients who have advanced, unresectable hepatocellular carcinoma who no longer respond to Nexavar® (the currently marketed first-line anti-cancer treatment for patients with this type of liver cancer). The subjects will receive Nexavar® and doxorubicin (the widely used chemotherapy anti-cancer drug), plus either PrevOnco™ or a placebo. Nexavar® is marketed in the U.S. by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., with close to $1 billion in sales, and is approved in more than 90 countries for the treatment of patients with hepatocellular carcinoma.
About Special Protocol Assessment
The FDA's Special Protocol Assessment process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. The SPA process is normally a multi-step negotiation process with the FDA which may take up to a year pending FDA review.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, FDA review of the PrevOnco™ SPA Phase III protocol FDA approval of the marketing of PrevOnco™ and commercialization of PrevOnco™, timing for seeking approvals for Vitaros® for erectile dysfunction and for a chemical formulation similar to Vitaros® for premature ejaculation, timing and success of the commercial launch of Vitaros® in Italy, The Gulf Countries and part of the Middle East and in Israel and the Palestinian Territories, the potential size of the market, the ability to develop and commercialize the Company's products on its own and with partners and the ability to meet its milestones. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Sunesis Announces 1-for-6 Reverse Stock Split
Company Is Well Capitalized and Positioned for the Future
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 02/14/11 -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a 1-for-6 reverse stock split, effective as of 5 p.m. Eastern time today. The reverse stock split was effected by Sunesis in accordance with the authorization, and within the split ratio range, adopted by Sunesis stockholders at the 2010 Annual Meeting of Stockholders held on June 2, 2010.
The reverse stock split is intended to better enable Sunesis to meet and maintain the $1.00 minimum bid price required for continued listing on the NASDAQ Capital Market and attract additional shareholder interest. Sunesis' common stock will begin trading on a post-split basis on the NASDAQ Capital Market when the market opens on February 15, 2011. Beginning on that date, Sunesis' common stock will trade for 20 trading days under ticker symbol "SNSSD" to provide notice of the reverse stock split. After this period, the symbol will revert back to "SNSS."
"Sunesis is well capitalized with $53.4 million in cash and investments as of December 31, 2010. After careful consideration, we determined that the reverse stock split announced today was an important step to better position Sunesis for the future," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We believe that this action will result in better shareholder and corporate recognition of the value and importance of our future milestones."
At the effective time of the reverse stock split, every six shares of Sunesis' pre-split capital stock, par value $0.0001 per share, including shares subject to outstanding stock options and warrants and shares available for grant under Sunesis' equity benefit plans, will automatically be combined into one share of Sunesis' post-split capital stock. The reverse stock split will affect all stockholders uniformly and will not affect any stockholder's ownership percentage of Sunesis' shares (except to the extent that the reverse stock split would result in some of the stockholders receiving cash in lieu of fractional shares). Stockholders will receive cash in lieu of fractional shares based on today's closing sales price of Sunesis' common stock as quoted on the NASDAQ Capital Market. American Stock Transfer and Trust Company, Sunesis' transfer agent, will provide instructions to stockholders regarding the process for exchanging their shares and stock certificates. Upon completion of the reverse stock split, there will be approximately 46 million shares of Sunesis' common stock outstanding, excluding outstanding and unexercised stock options and warrants, subject to adjustment for fractional shares.
Additional information regarding the reverse stock split approved by stockholders can be found in Sunesis' definitive proxy statement filed with the Securities and Exchange Commission on April 29, 2010.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including statements related to Sunesis' ability to meet and maintain the $1.00 minimum bid price required for continued listing on the NASDAQ Capital Market following the reverse stock split and any effect of the reverse stock split on future market and shareholder interest in Sunesis and its common stock. Words such as "is intended to," "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties related to Sunesis' ability to comply with the continued listing requirements of and maintain its listing on the NASDAQ Capital Market, need for substantial additional funding to complete the development and commercialization of vosaroxin, the risk that unfavorable economic and market conditions may make it more difficult and costly to raise additional capital, the risk that Sunesis' development activities for vosaroxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of vosaroxin, and the risk that Sunesis' proprietary rights may not adequately protect vosaroxin. Risk factors related to Sunesis and its business are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
© 2011 MarketWire
Apricus Biosciences and Neopharm Group Sign Licensing Agreement for Vitaros(R) in Israel for up to $4.35 Million, Plus Royalties
Date : 02/14/2011 @ 10:14AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46446728&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that it has entered into a licensing agreement granting Neopharm Group ("Neopharm") the exclusive rights to market and sell Vitaros®, Apricus Bio's treatment for erectile dysfunction ("ED") and, when and if available, its formulation for the treatment of premature ejaculation ("PE"), in Israel and the Palestinian Territories of the Gaza Strip and the West Bank.
On November 12, 2010, Apricus Bio announced that Health Canada had approved Vitaros® for marketing as the first topical treatment for ED in that country. The application for approval to market Vitaros® for ED in Israel is scheduled to be filed in the first half of 2011 and later, in the Palestinian Territories.
Under the terms of the licensing agreement, Neopharm has been granted exclusive rights in Israel and the Palestinian Territories to commercialize and market Vitaros® under the Vitaros® trademark for ED and, when and if available, Apricus Bio's formulation for PE. In return, Apricus Bio is entitled to receive up to a total of $4.35 million in up-front, regulatory and sales milestone payments for the products. Further, over the life of the agreement, Apricus Bio will receive tiered, double-digit royalties based on Neopharm's sales of the products.
Commenting on today's announcement, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are delighted to be able to announce yet another licensing and commercialization agreement for our first product, Vitaros®, that utilizes our proprietary NexACT® technology. Since December 22, 2010, we have closed three licensing and commercialization transactions covering 14 countries. We also continue to talk with numerous other potential partners to increase the number of these transactions and to broaden the potential market for Vitaros®."
David Fuhrer, Chairman of the Neopharm Group, commented, "I am confident that our well established expertise and heritage in partnership with innovative biopharmaceutical companies will make Vitaros® a success in Israel. We see Vitaros® as an excellent addition to our group's strong and growing portfolio of innovative products."
About Vitaros® and the ED Market
According to Neopharm, the ED market in Israel and the Palestinian Territories is dominated by oral PDE5 treatments. However, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from oral PDE5 drugs like Viagra®, Cialis® and Levitra® in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications, and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros® contains a previously marketed ED drug, known by the chemical name of alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros® works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.
Alprostadil is currently marketed as an injectable drug. Apricus Bio incorporated alprostadil with its NexACT® delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®. Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; Vitaros® is a registered trademark in Israel held by Apricus Bio through its subsidiary NexMed International Limited, and in the U.S. held by Warner Chilcott Company.
About Neopharm Group
Established in 1941, Neopharm Group is one of Israel's leading providers of innovative integrated solutions across the pharmaceutical, medical and healthcare markets. Neopharm has a long heritage of collaboration with leading multinational corporations and is positioned as the partner-of-choice and one-stop-shop for multinational corporations seeking to enter or expend their business in the Israeli healthcare market. The group has expertise and strengths in marketing of pharmaceuticals and biological products including niche and orphan drugs, hospital products, vaccines, medical devices, diagnostic products, medical and scientific equipment, OTC/CH products, medical services and home therapy – all of which enabled the group to grow and become the second largest provider to the Israeli healthcare market with annual revenues exceeding $300M, and 600 employees. The Neopharm Group is headquartered in Petach Tiqva, Israel. www.neopharmisrael.com
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide, as well as by monetizing its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, in addition to compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, timing for seeking foreign approvals for Vitaros® for erectile dysfunction and for a chemical formulation similar to Vitaros® for premature ejaculation, timing and success of the commercial launch of Vitaros® in Italy, The Gulf Countries and part of the Middle East and in Israel and the Palestinian Territories, the potential size of the market, the ability to develop and commercialize the Company's products on its own and with partners and the ability to meet its milestones. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Neopharm Group, Israel
bd@neopharmisrael.com
+972 3 9373783
Uri Goren,
Spokesman and PR Manager
uri.g@neopharmgroup.com
+972-52-7444680
Apricus Biosciences to Present Review of Commercialization Plans for Vitaros(R) and Development of Product Pipeline at BioPartnering North America Conference(TM)
Date : 02/10/2011 @ 10:14AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46396078
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), (http://www.apricusbio.com) today announced that Linda Smibert, Vice President, Business Development at the Company's NexMed, USA, Inc. ("NexMed, USA") subsidiary, will present at the BioPartnering North America Conference™ in Vancouver, Canada, on Tuesday, March 1, 2011, at 10:15 am PST. The presentation will include an overview of the Company's commercialization plans for Vitaros®, its first approved product, as well as development of the Company's 12 other products and compounds utilizing its proprietary NexACT® technology.
On November 12, 2010, Apricus Bio announced that Health Canada had approved Vitaros® for marketing as the first topical treatment for ED in that country. The Company announced on December 22, 2010 a licensing agreement with Bracco SpA for the commercialization of Vitaros® in Italy, and on January 4, 2011, announced the signing of a licensing agreement with Elis Pharmaceuticals for the Gulf Countries and certain countries in the Middle East. Apricus Bio is currently in proactive discussions to expand the commercialization of Vitaros® to certain other international markets.
Commenting on the upcoming presentation, Dr. Bassam Damaj, President and Chief Executive Officer of the Company, noted, "We are very excited to have this opportunity to present a review of our commercialization progress for Vitaros® at such a key industry event. Our business development group at NexMed USA has been very proactive in seeking appropriate licensing and commercialization partners throughout the world in order to potentially make this promising drug available to patients in many different countries. In addition to this review, Ms. Smibert will be presenting an update on our 12 other products and compounds in development, including later stage products, such as MycoVa™ for onychomycosis (nail fungus), PrevOnco™ for liver cancer, Femprox® for female sexual arousal disorder, and RayVa™ for Raynauld's Syndrome, as well as our pre-clinical products in development, in the areas of sexual dysfunction, oncology, autoimmune disease, anti-inflammatory, pain, anti-infectives, diabetes and cosmeceuticals. We are enthusiastic about the opportunity to discuss these products, as well as the underlying NexACT® technology, and how it may help other companies achieve better results from their own compounds and products."
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide, as well as monetizing its existing product pipeline, including its approved drug, Vitaros®, for treatment of erectile dysfunction, in addition to compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, timing for seeking foreign approvals for Vitaros®, timing and success of the commercial launch of Vitaros® in Italy, The Gulf Countries and part of the Middle East and in Israel and the Palestinian Territories, the potential size of the markets in each of these countries, the ability to develop and commercialize the Company's products on its own and with partners and the ability to meet its milestones. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox
VP, Investor Relations & Corporate Development
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Chart ( daily / weekly ) >>> LINK back
Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin(R) U.S. Marketing Authorization
Date : 02/01/2011 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=46250012
Discovery Laboratories, Inc. (Nasdaq:DSCO) is providing an expanded update regarding ongoing efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization for Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants. On January 10, 2011, Discovery Labs issued a press release reporting that the FDA had recently provided detailed, written direction in response to an earlier submitted proposal by Discovery Labs relating to its ongoing comprehensive preclinical program intended to gain Surfaxin approval. Throughout the conduct of the program, Discovery Labs has been interacting with the FDA and incorporating the FDA's guidance into its efforts to complete the program and file the Surfaxin Complete Response. The filing of the Complete Response is currently targeted for early third quarter 2011 and anticipated to lead to a potential approval early in the first quarter 2012.
The Company will host a conference call this morning at 10:00 AM EST to provide an update regarding certain activities relating to the Surfaxin Complete Response. The call-in number is 866-332-5218 (additional call-in information below).
If approved, Surfaxin would become the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine. The safety and efficacy of Surfaxin for neonatal RDS has previously been demonstrated in a large, multinational Phase 3 clinical program.
Surfaxin® for Neonatal RDS – Status of Comprehensive Preclinical Program for Filing Complete Response to Gain FDA Marketing Authorization
Discovery Labs believes that a key remaining step to potentially gain FDA marketing approval for Surfaxin is to satisfy the FDA as to the final validation of the fetal rabbit biological activity test (BAT). The BAT is an important quality control release and stability test for Surfaxin. Final BAT validation is intended to satisfy the FDA with respect to the ability of the BAT to adequately reflect the biological activity of Surfaxin throughout its shelf life and to discriminate biologically active from inactive Surfaxin drug product. Discovery Labs has been conducting a comprehensive preclinical program with regard to this key remaining step. The BAT has undergone a number of method refinements intended to optimize its performance and reduce assay variability. The optimized BAT has subsequently been used to generate data to support BAT validation as well as to demonstrate concordance between the BAT and the well-established preterm lamb model of RDS by performing a series of prospectively-designed, side-by-side preclinical studies (i.e., concordance studies). Data from the preterm lamb model and BAT concordance studies are intended to support final BAT validation and to demonstrate comparability of drug product used in the Phase 3 clinical program with Surfaxin drug product to be manufactured for commercial use.
Discovery Labs has been interacting with the FDA in an effort to ensure that the comprehensive preclinical program (and the Surfaxin Complete Response) will ultimately satisfy the FDA as to the final validation of the BAT. The FDA's most recent communication clearly indicates that several aspects of Discovery Labs' proposed approach to the BAT validation are reasonable and provides detailed, written direction regarding certain components of Discovery Labs' comprehensive pre-clinical program. Discovery Labs believes that it can incorporate the FDA's direction into its ongoing efforts to complete the comprehensive preclinical program and be in a position to file a Surfaxin Complete Response by early third quarter 2011, which, after an anticipated six-month FDA review cycle, could lead to potential Surfaxin approval early in the first quarter 2012.
BAT Optimization and Final Validation: Before undertaking steps to optimize the BAT, Discovery Labs submitted a proposal to FDA outlining several specific method refinements intended to improve BAT performance and reduce assay variability. After taking into account the FDA's response, Discovery Labs incorporated the proposed method refinements into the BAT and conducted testing that demonstrates that all pre-specified acceptance criteria were met and that BAT optimization has resulted in a greater-than-40% reduction in assay variability relative to the BAT methodology that was employed prior to 2010.
Following BAT optimization, at the FDA's suggestion, Discovery Labs submitted an additional proposal regarding specific and detailed aspects of final BAT validation. With respect to certain technical criteria relating to final BAT validation, the recent communication directs Discovery Labs to increase the sample size of specified data sets by testing additional Surfaxin batches. Discovery Labs currently has data from several batches that have previously been manufactured and analyzed. To be responsive to FDA's direction, Discovery Labs has initiated and anticipates completing manufacture of additional Surfaxin batches in the first quarter of this year. The additional batches will be tested using the optimized BAT and the additional data will be incorporated into the Complete Response.
Concordance Studies – Throughout the conduct of the comprehensive preclinical program, Discovery Labs has interacted with the FDA on certain aspects of the concordance studies. Multiple Surfaxin batches have been used to assess the biological activity of Surfaxin via measurement of respiratory compliance at various time points across the proposed shelf-life in both the preterm lamb model and the optimized BAT. The FDA has previously indicated that, to gain Surfaxin approval, data generated in the concordance studies must demonstrate the same relative changes in biological activity over time in both models using both regression analysis as well as a point-to-point comparison. Discovery Labs has evaluated the concordance data generated to date by these models using both regression analysis and point-to-point comparisons. Discovery Labs believes that these data demonstrate the same relative changes in biological activity over time in both the optimized BAT and the preterm lamb models and support the comparability of drug product used in the phase 3 clinical program and Surfaxin drug product to be manufactured for commercial use.
The most recent proposal submitted by Discovery Labs to the FDA also requested clarification with respect to certain limited technical aspects of the concordance study. The FDA's response includes detailed direction with respect to generating limited additional confirmatory data through further concordance testing. Discovery Labs plans to generate these additional data for inclusion in the Complete Response, which data must be consistent with the concordance data generated to date.
DISCLOSURE NOTICE:
The information in this press release includes certain "forward-looking" statements relating, among other things, to Discovery Labs' understanding of the recently-received written guidance from the FDA and the remaining questions identified in the FDA's April 2009 Complete Response Letter that must be addressed to gain FDA approval of Surfaxin. Discovery Labs has interacted with the FDA in an effort to ensure that the comprehensive preclinical program (and the Surfaxin Complete Response) will ultimately satisfy the FDA. In addition, Discovery Labs is presently assessing whether to request further clarification from the FDA on certain technical aspects of the comprehensive preclinical program. There can be no assurances, however, that the FDA will be satisfied with all aspects of the comprehensive preclinical program or that, should Discovery Labs request further clarification, that the FDA will provide further direction prior to the planned filing of the Complete Response. In any event, such potential interactions with the FDA or lack thereof could affect the ultimate timing, conduct and outcomes of remaining steps necessary to gain Surfaxin approval, including the potential filing of the Complete Response. In addition to uncertainties related to the FDA's review of the Complete Response, Discovery Labs presently anticipates that the FDA will likely inspect and otherwise assess the manufacturing and quality assurance/quality control facilities for Surfaxin including those of third-party raw material suppliers and testing laboratories. The outcomes of such FDA activities could also affect the ultimate timing and remaining steps necessary to gain Surfaxin approval.
The completion of the aforementioned activities will require Discovery Labs to raise significant amounts of additional capital and, notwithstanding, the ultimate outcomes remain subject to a variety of risks and uncertainties that could cause actual results to be materially different. These risks and uncertainties include, but are not limited to, risks that (i) the FDA may not approve Surfaxin or may subject the marketing of Surfaxin to onerous requirements that significantly impair marketing activities; (ii) Discovery Labs may be unable to complete the manufacture of additional Surfaxin batches within the time frame set forth above, (iii) Discovery Labs may identify unforeseen problems that have not yet been discovered or the FDA could in the future impose additional requirements to gain approval of Surfaxin; and (iv) Discovery Labs may be unable to raise sufficient additional capital, through financings, strategic collaborations, or otherwise. Any failure to satisfy the issues raised by the FDA, in the Complete Response letter or in related discussions, could significantly delay, or preclude outright, gaining approval of Surfaxin, which could potentially delay or prevent the approval of Discovery Labs' other products.
Surfaxin is an investigational drug product and is not approved by the FDA or any other world health regulatory authority for use in humans.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol and lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
Conference Call Details
Discovery Labs will hold a conference call today, February 1, 2011, at 10:00 AM EST to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. An audio webcast will be available through a live broadcast on the Internet at http://us.meeting-stream.com/discoverylaboratories_020111 and www.discoverylabs.com. A replay of the conference call will be available two hours after the call's completion and remain available through February 8, 2011. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 40660551.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the Company's comprehensive preclinical program, development and manufacturing activities and related regulatory efforts, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
CONTACT: John G. Cooper, President and
Chief Financial Officer
215-488-9490
Apricus Biosciences Presents Data on Oral Use of Nexact(R) Technology at the Controlled Release Society Conference
Date : 01/28/2011 @ 9:52AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46210298
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), (http://www.apricusbio.com) today announced that its research and development team at its NexMed, USA, Inc. ("NexMed, USA") subsidiary is presenting data demonstrating the use of the Company's proprietary NexACT® technology to improve less permeable or less soluable drugs, at the Controlled Release Society ("CRS") Product Development Forum for Poorly Soluble Drugs, being held January 27 to 29, 2011, in Miami, Florida. The presentation, entitled, "Improved Oral Absorption of BCS 2-4 Compounds Using the NexACT® Technology" is scheduled to be presented by Richard Martin, Ph.D., Vice President, Chemistry at NexMed, USA on Thursday, January 27, 2011 from 4:30 pm to 5:45 pm EST and also on Friday January 28, 2011 from 10:50 am to 2:15 pm EST.
The BCS, developed by Professor Gordon L. Amidon from the College of Pharmacy at the University of Michigan, separates drugs into four quadrants depending on their solubility and permeability. Class 1 drugs are high solubility and high permeability, Class 2 low solubility and high permeability, Class 3 high solubility and low permeability, and Class 4 low solubility and low permeability. In the NexMed studies, the compounds that showed the most improvement when formulated with the NexACT® technology was in Classes 2 and 4, where solubility is a determining factor.
Dr. Bassam Damaj, Apricus Bio's Chief Executive Officer commented on these results, "We are very pleased with the research and development efforts of our NexMed, USA team. This data demonstrates to us that the NexACT® technology may be used to enhance the oral bioavailability of some of the less permeable and less soluble drugs on the market today. We believe this is another application for our NexACT® technology, which could be used by us with any of our future proprietary drug candidates, or it may be applied to a broader range of generic drugs and proprietary drugs owned by others. These results continue to validate our strategy of evaluating our NexACT® technology for additional indications beyond improving the topical delivery of products and to also offer partners the ability to potentially improve the convenience and bioavailability of their oral drugs."
About Apricus Biosciences, Inc.
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, as well as compounds in development from pre-clinical through Phase III, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to replicate its research results with various drugs, to develop such drugs utilizing the NexACT® technology that have been demonstrated in clinical trials, to receive approval of its products from the US FDA and other regulatory authorities, and to successfully enter into partnership agreements for its product candidates, its Vitaros® product and its NexACT® platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox
VP, Investor Relations & Corporate Development
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Cardium's Exchange Listing Compliance Plan Accepted by NYSE Amex
Date : 01/24/2011 @ 9:00AM
Source : PR Newswire
Stock : Cardium Therapeutics, (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=46138690
Cardium Therapeutics (NYSE Amex: CXM) reported that its exchange listing compliance plan submitted on December 2, 2010 has been accepted by the NYSE Amex LLC.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
As previously reported, a communication from the staff of the company's current listing exchange indicated that the company was considered to be noncompliant with one of the exchange's listing requirements based on its quarterly report for the period ended September 30, 2010, and provided that the company should submit a plan that would reestablish compliance with the listing requirement by August 26, 2011. On December 2, 2010, the company reported that it had submitted a plan designed to reestablish compliance with the exchange's requirement in advance of the August 26, 2011 timeframe, and that plan has now been accepted by the listing exchange.
The notification received from the listing exchange had no current effect on the listing of the company's shares on the exchange. Rather, the company was afforded the opportunity to submit a plan pursuant to which the company would seek to establish compliance with the requirements of section 1003(a)(iii) with respect to minimum "stockholders' equity" of $6.0 Million by August 26, 2011. The company will be subject to periodic review by the exchange staff during the period covered by the plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the applicable extension periods could result in the company's shares being delisted from the exchange. If the company's common stock was ultimately delisted from the exchange, it would be expected to trade on the OTC Bulletin Board, a regulated quotation service that provides quotes, sale prices and volume information in over-the-counter equity securities. The company's common stock was traded on the OTC Bulletin Board until July 2007, when the company elected to instead list its shares on the American Stock Exchange.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium healthy lifestyle product platform. The Company's lead product candidates include Excellagen™ topical gel for wound care management, and Generx® DNA-based angiogenic biologic for patients with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the company can achieve and maintain compliance with the requirements of its listing exchange or that its shares can continue to be listed on national exchange, that results observed in one study or using one type of product or procedure will be replicated in subsequent studies or in studies using newly-developed products or procedures, that planned product development efforts and clinical studies can be performed in an efficient and effective manner, that regulatory approvals can be obtained in a timely manner or at all, that partnering, distribution or other commercialization efforts can be achieved, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that results or trends observed in one clinical study will be reproduced in subsequent studies, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of therapeutic hypothermia devices and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new devices and systems and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2011 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics™ Generx® and MedPodium™ are trademarks of Cardium Therapeutics, Inc.
Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen™, Excellarate™,
Osteorate™, Appexium™ and Linee™ are trademarks of Tissue Repair Company.
SOURCE Cardium Therapeutics
Discovery Labs to Host a Conference Call to Provide an Overview of Its Program for Surfaxin(R) U.S. Marketing Authorization
Date : 01/27/2011 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=46190024
Discovery Laboratories, Inc. (Nasdaq:DSCO) will host a conference call on Tuesday, February 1, 2011, at 10:00 AM EST. Management will provide an overview of Discovery Labs' efforts to gain U.S. Food and Drug Administration (FDA) marketing approval of Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants.
Discovery Labs believes that a key remaining issue necessary to potentially gain FDA marketing approval for Surfaxin is to satisfy the FDA as to the validation of the fetal rabbit biological activity test (BAT), an important quality control release and stability test for Surfaxin. On January 10, 2011, Discovery Labs issued a press release announcing that the FDA had recently provided detailed, written direction regarding certain components of Discovery Labs' comprehensive pre-clinical program, which is intended to potentially satisfy the FDA as to the validation of the BAT. As indicated in that press release, in the upcoming conference call, management will provide an overview of the program and review its progress.
Participants are encouraged to access this audio webcast through a live broadcast on the Company's website at www.discoverylabs.com. It is recommended that participants log onto the audio webcast at least 15 minutes prior to the call. The Internet broadcast will be available for up to 90 days after the call at the Company's website.
The call in number is 866-332-5218. The international call in number is 706-679-3237. A replay of the conference call will be available two hours after the call's completion and remain available through February 8, 2011. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 40660551.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol and lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
CONTACT: John G. Cooper, President and Chief Financial Officer
215-488-9490
Apricus Biosciences Reports Additional Analysis Showing That MycoVa(TM) is as Effective for the Treatment of Nail Fungus as the Current European Standard of Care for Topical Therapy, Loceryl(R)
http://www.finanznachrichten.de/nachrichten-2011-01/19121148-apricus-biosciences-inc-apricus-biosciences-inc-press-release-252.htm
SAN DIEGO, Jan. 19, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) today announced that an additional analysis conducted on behalf of the Company has shown that MycoVa' has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis (commonly referred to as nail fungus), compared to the current standard of care in Europe for topical therapy, Loceryl®.
'Non-inferiority' means that the experimental treatment worked well enough, compared to the effective existing drug, to support the conclusion that the new test drug is also effective. With this new analysis, Apricus Bio intends to request regulatory guidance from certain European agencies for the continued development of MycoVa' and hopes to eventually file for approval in certain European countries to market the drug for onychomycosis. "We are very pleased with this new analysis," says Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "We believe it may allow us to move forward towards eventual approval of the drug."
MycoVa'(formally known as NM100060) combines an existing, approved drug for nail fungus, terbinafine, with Apricus' NexACT® technology that enhances the absorption of the drug through the skin. Clinical trials on the drug started after 2005, when NexMed (now known as Apricus Bio) signed an agreement with Novartis, under which Novartis assumed responsibility to develop and commercialize the drug.
The first clinical trials did not show clear-cut efficacy, and in 2008, NexMed announced that the results were not strong enough to support filing for new drug approval with the U.S. Food&Drug Administration. Novartis declined to continue to develop the drug in 2009, and NexMed acquired the worldwide rights to the drug, subject to certain payments to be made to Novartis.
A later trial conducted by Novartis in Europe between 2007 and 2009, comparing MycoVa' with Loceryl® over 48 weeks, was more promising. The reanalysis of the comparator trial data announced today shows that MycoVa' is no less effective than Loceryl®in curing nail fungus. The percentage of patients with an adverse event that was suspected to be related to study drug was low for both drugs with no serious adverse events attributed to the drugs. There also were no safety concerns.
"We were disappointed that Novartis did not move forward with the drug in 2009, but we were excited when we regained worldwide rights, subject to certain payments to Novartis," explained Dr. Damaj. "We were convinced at that time, and remain so today, that MycoVa' had, and has, the potential to treat patients with mild onychomycosis. The analysis that we have recently performed has convinced us to move forward and request regulatory guidance meetings from health agencies in the United Kingdom, the Netherlands and Germany."
In the study, 1,029 patients with mild to moderate nail fungus were given either MycoVa' (a topical 10% terbinafine hydrogen chloride formulation) or Loceryl® (5% amorolfine nail lacquer) for 48 weeks of treatment. The primary objective endpoint was a complete cure. The secondary endpoints were killing the fungus and improving the appearance of the nail.
The reanalysis of the results showed no significant difference in either the primary or secondary endpoints between MycoVa' and Loceryl®,which is a registered trademark of Galderma.
The advantage of Apricus Bio's MycoVa' is that it is easy to apply, thus improving patient compliance. MycoVa' is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located. By contrast, Loceryl® requires more patient care before applying the lacquer. For Loceryl®, this includes filing the affected areas of nail, including the nail surfaces, as thoroughly as possible. The surface of the nail should then be cleansed using disposable swabs. The nail lacquer should be applied onto the entire surface of the infected nail(s) using reusable applicators. Before repeat application of Loceryl®, the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any residual lacquer.
Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma has stated that the worldwide market is approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.
About Apricus Biosciences, Inc.
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: With the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to obtain and/or enforce patent coverage in major markets, to develop products that have been demonstrated in clinical trials and to successfully enter into partnership agreements for its product candidates, its Vitaros® product and its NexACT® platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc. Edward Cox VP, Investor Relations&Corporate Development (858) 848-4249 ecox@apricusbio.com
Apricus Bio Investor Relations Paula Schwartz Rx Communications Group, LLC (917) 322-2216 pschwartz@rxir.com
© 2011 GlobeNewswire