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RALLYY 1,5-2$++BY YEAR END
MSBT WILL BE THE NEXT VERMILLION WOOHOOHOOOO
TDLP.OB..Positive Phase 3 Data BOOOYAAAAHH
Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)
-- Primary Efficacy Endpoint Met
-- Excellent Safety and Tolerability Profile Demonstrated
-- Minimal Systemic Exposure Found in Pharmacokinetic Sub-Study
-- Company to Host Conference Call/Webcast Today at 9:00 a.m., (EDT)
Companies:Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel(®) is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company's innovative proprietary Transdel(TM) drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States.
The primary efficacy endpoint was the difference between Ketotransdel® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated instrument for pain measurement. The study achieved statistical significance in its primary endpoint in the per protocol analysis. The statistical analysis of those patients that complied with the study requirements (the per protocol (PP) population) included a total of 252 patients and showed a positive and statistically significant outcome in the primary efficacy endpoint between Ketotransdel® and placebo, reaching a p-value of less than 0.05.
Secondary endpoints included safety assessments and other efficacy parameters.
Ketotransdel® demonstrated an excellent safety and tolerability profile similar to the placebo cream. In particular, there were no Ketotransdel® treatment related gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the Company's previous clinical study findings.
Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).
"Based on these positive top-line clinical results and the excellent safety profile demonstrated, we believe Ketotransdel® is well-positioned to address a critical need in the pain management marketplace. We are committed to continue working closely with the FDA to bring this much needed drug to the marketplace as soon as possible," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximizing the medical and commercial potential of this technology to bring important therapies to patients."
"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."
Further detailed analyses are currently ongoing, and the Company intends to present the clinical trial results at upcoming medical conferences and in peer-reviewed journals.
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel®, and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
POSITIVEEEE DATAAAA WOHOOOOO
Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)
-- Primary Efficacy Endpoint Met
-- Excellent Safety and Tolerability Profile Demonstrated
-- Minimal Systemic Exposure Found in Pharmacokinetic Sub-Study
-- Company to Host Conference Call/Webcast Today at 9:00 a.m., (EDT)
Companies:Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel(®) is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company's innovative proprietary Transdel(TM) drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States.
The primary efficacy endpoint was the difference between Ketotransdel® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated instrument for pain measurement. The study achieved statistical significance in its primary endpoint in the per protocol analysis. The statistical analysis of those patients that complied with the study requirements (the per protocol (PP) population) included a total of 252 patients and showed a positive and statistically significant outcome in the primary efficacy endpoint between Ketotransdel® and placebo, reaching a p-value of less than 0.05.
Secondary endpoints included safety assessments and other efficacy parameters.
Ketotransdel® demonstrated an excellent safety and tolerability profile similar to the placebo cream. In particular, there were no Ketotransdel® treatment related gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the Company's previous clinical study findings.
Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).
"Based on these positive top-line clinical results and the excellent safety profile demonstrated, we believe Ketotransdel® is well-positioned to address a critical need in the pain management marketplace. We are committed to continue working closely with the FDA to bring this much needed drug to the marketplace as soon as possible," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximizing the medical and commercial potential of this technology to bring important therapies to patients."
"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."
Further detailed analyses are currently ongoing, and the Company intends to present the clinical trial results at upcoming medical conferences and in peer-reviewed journals.
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel®, and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
SENETEK IS MASSIVE UNDERVALUED !!!
Mcap 10 M$
Cash 13 M$
Fact Sheet ...Check Out
http://www.senetekplc.com/Senetek_Fact_Sheet-pdf.pdf
Senetek PLC Acquires Rights To Additional Anticancer RNAi Technology
Senetek PLC announced an agreement with the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznan, Poland for the exclusive rights to a new and promising tumor treatment using an RNAi based therapeutic technology for the potential use against a broad range of cancers. This technology, which specifically targets a cancer biomarker, was developed by the Institute in cooperation with Department of Neurosurgery and Neurotraumatology University of Medical Sciences in Poznan, Poland. Under the terms of the collaborative agreement, Senetek will have rights for all applications of the in-licensed technologies in exchange for undisclosed royalty payments to be paid to the Institute upon commercialization.
SENETEK IS SOOOO UNDERVALUED !!!
Mcap 10 M$
Cash 13 M$
Senetek PLC Acquires Rights To Additional Anticancer RNAi Technology
Senetek PLC announced an agreement with the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznan, Poland for the exclusive rights to a new and promising tumor treatment using an RNAi based therapeutic technology for the potential use against a broad range of cancers. This technology, which specifically targets a cancer biomarker, was developed by the Institute in cooperation with Department of Neurosurgery and Neurotraumatology University of Medical Sciences in Poznan, Poland. Under the terms of the collaborative agreement, Senetek will have rights for all applications of the in-licensed technologies in exchange for undisclosed royalty payments to be paid to the Institute upon commercialization.
RALLLLLYYYYYYYYYYYYYY
TDLP WILL OPEN AT 5$+++ TOMORROW
GOOD LUCK ALL
phase 3 data tomorrow
POSITIVE DATA = 6$++
Transdel Pharma (TDLP.OB)
MarketCap: 26 M$
Price: 1.67 $
Shares Out : 15,6 Mio
"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."
Transdel Pharmaceuticals is seeking a partner for Ketotransdel and is either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
"Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel."
TDLP.OB...Phase 3 Data Tomorrow !!
Transdel Pharma (TDLP.OB)
MarketCap: 26 M$
Price: 1.67 $
Shares Out : 15,6 Mio
"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."
Transdel Pharmaceuticals is seeking a partner for Ketotransdel and is either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
"Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel."
BIG NEWS COMING SOON
GET IN BEFORE ITS TOO LATE ..1$+ TGT very soon ..
BREAK OUT SOON
http://quote.barchart.com/texpert.asp?sym=SNKTY
RALLY WILL START SOON :::
PARTNER NEWS FOR INVICORP SOON
Now a great buying Opportunity eom
Bought more today ---
PIII RESULTS WILL BE POSITIVE ..
5$ + VERY SOON ----
RALLLYYYYY WOHHOOHOOO
STILL A GREAT OPPORTUNITY
US-Partner for Invicorp soon
Big news coming soon !!!
glta
Up again
2$ very soon ---
More EU Approvals coming soon ::
Market Cap of 10 M$ is a Joke ...
Cash 13 M$
The Company reported that there continues to be great interest in Invicorp® for the European Market and that the Company is diligently working to restore an out-of-stock situation due to its former licensee, Ardana BioScience Limited, entering receivership. Senetek expects to have finished product manufactured in the fourth quarter of 2009 and, thus, to begin receiving corresponding revenues for Named Patient Supplies in the UK and commercial sales in Denmark. The Company noted a recent addition to the general approval process in Europe that could impact future sales of Invicorp, creating a potential opportunity to accelerate approval in some countries such as Turkey, a country with a population of more than 36 million males. Invicorp is a highly safe and effective treatment for erectile dysfunction ("ED") that has received marketing authorization in Denmark and authorization for Named Patient Supply in the UK.
"The second quarter saw the Company take a variety of actions aimed at preparing for sales growth as we initiated the rollout of clinically-proven PyratineXR, our next generation Cytokinin-based skincare technology, into the marketplace," said Frank Massino, Chairman and CEO, Senetek PLC. "We enter the second half of the year with focus and momentum as we launch our first marketing campaign for PyratineXR, which has been shown to be highly beneficial for all skin types, while being ideal for sensitive skin caused by inflammatory skin conditions such as rosacea and acne, which result in facial redness in millions of people."
On July 22, 2009, the Company announced that PyratineXR is now available nationwide through select dermatologists and other physicians. The launch is being supported by conventional and new line media advertising in select markets nationwide. To view copies of the ads, visit http://www.senetekplc.com/ads. The Company expects to launch a comprehensive new website for PyratineXR, incorporating product information, educational resources and e-commerce capabilities among other features, during the third quarter at www.PyratineXR.com.
During the second quarter, a clinical study entitled "Topical PRK-124 (0.125%) Lotion for Improving the Signs and Symptoms of Rosacea," was published in the Journal of Drugs in Dermatology, a prestigious peer-reviewed dermatological publication (May 2009). The 12-week, open-label study concludes that PyratineXR (0.125% furfuryl tetrahydropyranyladenine) improved skin barrier function and the appearance of erythema (redness) and lesions (pustules and papules) associated with mild-to-moderate rosacea during 12 weeks of treatment.
In the latter stages of the quarter, Senetek opened its new Customer Care Center in Brentwood, TN to support the national rollout of PyratineXR as well as Pyratine-6. The Customer Care Center, located outside of Nashville, provides doctors (dermatologists, plastic surgeons, etc.) and others who provide PyratineXR and Pyratine-6 to consumers an on-call resource to answer any questions related to the products and for sales, distribution and fulfillment. Consumers can call the Customer Care Center to find Pyratine products in their hometowns, to have questions answered and to place orders. The Customer Care Center is led by Mark Ryals, Director of Customer Service, who brings nearly 25 years of pharmaceutical and related customer service and sales experience to Senetek. Ryals spent 12 years working with GlaxoSmithKline's dermatology portfolio.
In early June, Senetek announced a six year extension of existing rights under its agreement with the Czech Republic Institute of Experimental Botany to receive exclusive global licenses, for all applications, to any cytokinin developed, in-licensed or otherwise acquired by the Institute and the right to co-exploit with the Institute any cytokinins that Senetek does not elect to in-license. Senetek also has a right of first refusal before the Institute can license any of its non-cytokinin compounds to any third party for cosmeceutical or anti-aging dermatological applications. In addition, a new group of compounds, "supercytokin plus", has been added to the agreement. The Institute will also perform enhanced research activities in the areas of pre-selective assay, development of analytical methods, stability testing, large scale synthesis and molecular mechanism of action. Visit the Institute's website at www.ueb.cas.cz.
Clinical studies demonstrate that PyratineXR is an anti-aging compound that can help "Beat Red" with 67% less redness, 84% smoother skin and 41% more moisture. Physician-strength PyratineXR is clinically proven to relieve redness (erythema), soothe irritation, increase moisture and repair damaged skin quickly and effectively. Clinical studies have demonstrated that PyratineXR significantly reduces the appearance of lesions (papules and pustules), spider veins and dark spots. In addition, PyratineXR improves skin texture in just days while improving dry, flaky skin by restoring the skin's barrier function and increasing moisture retention. PyratineXR offers an option for inflammatory skin conditions such as rosacea, acne, sunburn and razor burn.
PyratineXR is available as a Lotion or Creme through select physicians throughout North America. Senetek plans to introduce three new products for PyratineXR later this year. For more information or to find a PyratineXR Physicians Network doctor, call 1-888-467-9728 or visit www.PyratineXR.com. To watch a brief video news segment about PyratineXR, visit www.youtube.com/watch?v=i8oa3N99e_o.
THIS UNDERVALUED STOCK IS FLYING UNDER RADAR !!!
Senetek (SNKTY.OB)
Market Cap : 9 M$
Cash : 13 M$ (NO DEBT)
Price : 1,20 $
Shares Out : 7,65 Mio
Pipeline
http://www.senetekplc.com/view_our_pipeline.asp
Analyst Report ..Read
http://www.senetekplc.com/SenetekPLC-IntelligenceDynamicsResearchReport.pdf
Senetek PLC
(OTC Bulletin Board: SNKTY.OB)
Senetek is a Life Sciences company engaged in the development of technologies
that target the science of healthy aging. The Company’s extensive research
collaborations have resulted in a strong pipeline of patented compounds and
products with broad therapeutic applications and a leading presence in
dermatology. Senetek collaborates with established specialty pharmaceutical
companies in the final development and marketing of its proprietary products, most
recently resulting in the development of the best-selling anti-aging product sold in
the North American physician market.
Lead Products
Pyratine-6™
(0.1% Furfuryl Tetrahydropyranyladenine)
The first in Senetek’s new generation cytokinin pipeline to complete development,
Pyratine-6™ has demonstrated, through clinical trials, superior results and faster
onset of action in treating photodamaged skin when compared to Senetek’s highly
successful predecessor compounds.
In September 2008, Senetek launched the Pyratine-6™ family of products in the
North America Physician market.
The Company is actively seeking marketing collaboration agreements for other
geographies.
Pyratine XR™
(0.125% Furfuryl Tetrahydropyranyladenine)
Based on positive results demonstrated in Pyratine-6™ clinical evaluations,
Senetek initiated a clinical trial of 0.125% Furfuryl Tetrahydropyranyladenine for
the reduction of visible signs and symptoms associated with various conditions
such as rosacea, eczema, contact dermatitis and menopause. Rosacea is a chronic
dermatosis afflicting more than 14 million people in North America and 45 million
people worldwide.
An overall clinical improvement was noted in 80% of subjects, including reduction
of erythema and papules. The investigators saw continual, statistically significant
mean improvement with Pyratine XR™ treatment, including a 90% improvement
in lesions, 45% improvement in erythema and a 28% improvement in
telangiectasia
Pyratine XR™ Crème and Lotion were launched in the North American Physician
market in March 2009.
The Company is actively seeking marketing collaboration agreements for other
geographies
Kinetin
Senetek scientists developed and patented the cytokinin Kinetin as an anti-aging
compound. Senetek commercialized Kinetin under the Kinerase® trademark, which
is now owned by Valeant Pharmaceuticals Inc. Kinerase® is currently the leading
anti-aging compound sold in the North American physician market. In early 2007,
Senetek sold Valeant a perpetual use license for Kinetin for $21 million,
forgiveness of a $6 million prepaid royalty credit reimbursement obligation that
Senetek otherwise would have owed to Valeant, and a right to share in future
royalties due to Valeant from other Kinetin licensees through 2011.
Invicorp®
Senetek has entered into a partnership agreement with Plethora Solutions
Limited (LSE-AIM: PLE), for the commercialization of Invicorp® in North
America. Under this agreement, Plethora assumes full financial responsibility
for all future development, regulatory approvals, and sales and marketing of the
product. Senetek will participate in the success of Invicorp® through milestone
payments and royalties based on net sales. The European marketing rights,
previously licensed to Ardana Biosciences Ltd, were returned to Senetek when
Ardana entered receivership in June 2008. An evaluation of the Company’s
options regarding redeployment of the European marketing rights as well as
rights for the rest of the world is currently underway.
Reliaject®
Reliaject® is an advanced drug delivery system for self-administration of
parenteral drugs, including epinephrine for emergency treatment of anaphylaxis,
a severe allergic reaction that occurs in response to food, insect venom or
medication – currently a $250 million market in North American alone.
Reliaject® is also well suited to other injectable therapies including Senetek’s
Invicorp® for the treatment of ED. The company entered an agreement with
Ranbaxy Pharmaceuticals, through which Senetek will receive future milestone
payments, as well as royalties paid out over 15 years on all products introduced
in the Reliaject® drug delivery system.
Research & Development
Senetek’s scientific research collaborations form the basis for a continuous,
interactive flow of new product identification, evaluation and testing activity
between the University of Aarhus, Senetek’s dedicated laboratory in Denmark,
the Institute of Experimental Botany in the Czech Republic, the University of
California-Irvine, and the Institute of Bioorganic Chemistry of the Polish
Academy of Sciences among others. Through these collaborations the Company
has greatly expanded its IP portfolio, adding many vital technologies, while
accelerating product development.
Pipeline
Senetek’s partnerships with leading research and academic institutions have
placed the Company at the forefront of technological advancements in the
science of aging. The Company’s large and growing IP portfolio features new
models in treatment that span a range of therapeutic areas including
dermatology, nutrition, wound healing and erectile dysfunction.
Market Opportunity
Owing to an increase in health awareness and continued progress in the field of
science and medicine, the average global life span has seen a steady rise over the
past several decades, a trend that is only expected to become more pronounced
in the decades to come. According to the United Nations, the percentage of the
world’s population over the age of 60 is expected to rise from 10.0% in 2000 to
22.1% in 2050. In more developed regions, such as Europe and North America,
these percentages are anticipated to be even higher, estimated at approximately
35.0% and 27.0%, respectively, by 2050. The aging of society is likely to create
increased opportunity for treatments and therapies such as those based on
Senetek’s patented compounds.
Business Model
With a strong balance sheet in place, the Company has transitioned from a
licensing model to a sales and marketing model, delivering an increased revenue
stream with higher margin potential and creating long-term value for its
shareholders.
re P3 results next Week..Under Radar
Lead Drug In Phase 3 Trial Has Potential To Be First FDA-Approved Prescription Topical NSAID Cream Product
LA JOLLA, Calif.--Freud’s pleasure principle dictates that humans continuously drive to seek pleasure and avoid pain. And our daily lives provide proof: we pop Tylenol for headaches, take non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen for pain, and use stronger but riskier analgesics—including narcotic drugs such as morphine, synthetic drugs with narcotic properties such as tramadol, and various others—to relieve very severe pain.
The problems associated with these drugs are not insignificant. Apart from the risk of painkiller abuse and addiction, over one hundred thousand patients are hospitalized each year due to orally administered NSAID-related gastro-intestinal (GI) complications. That is because when one takes a pill, it passes from the GI tract into the bloodstream and organs, exposing one to cardiovascular, renal, and hepatic systemic effects. It is to a patient’s great advantage, therefore, to use topical drugs that can be applied locally for pain thereby potentially allowing just a small fraction of the dosage to enter the body systemically and resulting in fewer medical complications.
Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically delivered medications. The Company’s lead topical drug, Ketotransdel®, utilizes the company’s innovative proprietary Transdel™ cream formulation to facilitate the passage of ketoprofen, considered one of the best NSAIDs for topical application, through the skin barrier to reach targeted underlying tissue where the drug exerts its localized anti-inflammatory and analgesic effect.
The company’s Phase 3 clinical program for Ketotransdel® is currently in progress and they are working with Cato Research Ltd. as their CRO and strategic partner to conduct the trial. If approved by the FDA, Ketotransdel® has the potential to be the first topical NSAID cream product available in the U.S. for acute pain management. The commercial opportunity for such a topical, potentially safer and more effective NSAID treatment is enormous as more than thirty million people worldwide take NSAIDs daily. In the U.S., annual sales of NSAIDs and Cox-2 inhibitors exceed $6 billion (pain medications being the third most commonly prescribed class of drugs in the U.S.).
The Transdel™ platform technology has the potential to create a deep and rich product pipeline as it offers an effective cream based delivery system capable of delivering a variety of drugs, sizes and dosages. These include a number of generic and proprietary drugs, cosmetic/cosmeceutical and nutritional co-development opportunities.
Proprietary Transdel™ Technology
* Proprietary transdermal cream drug delivery platform enables the avoidance of first pass metabolism by the liver and minimizes systemic exposure
* Facilitates effective dissolution and delivery of drug across the skin barrier to reach targeted underlying tissues
* Ideal drug delivery system
o Biocompatible with human skin
o High skin penetrating qualities
o Delivers sufficient quantities and sizes of drugs
o Strong safety profile associated with the delivery system
Ketotransdel® Lead Topical Drug
* Phase 3 clinical program in progress for treatment of acute pain
* Comprised of a transdermal formulation of ketoprofen, an NSAID
o Ketoprofen selected as active ingredient for its proven clinical, safety, and efficacy track record
* Effectively penetrates skin barrier to reach the targeted underlying tissue where it exerts its localized anti-inflammatory and analgesic effect
* The topical delivery of the drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, renal, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs
* If approved, Ketotransdel® could be the first topical NSAID cream in the U.S. for pain
Market Opportunity
* Withdrawal of Cox-2 inhibitors Bextra and Vioxx leaves multi-billion dollar market void largely replaced by oral NSAIDs
* NSAIDs and Cox-2 inhibitors market > $6B
o More than thirty million people worldwide using prescription and over the counter NSAIDs daily, making this one of the most prescribed class of drugs in the pain management market
* Recent recognition of cardiovascular, gastrointestinal and other risks associated with orally administered NSAIDs and decline in use of Cox-2 inhibitors related to safety concerns provides market opportunity for topical pain management products
Sales and Marketing
* Company is in discussions with commercial partners for future sales and marketing strategies related to Ketotransdel® and other co-development opportunities.
* In addition, the Company is discussing with potential pharma partners licensing opportunities related to the TransdelTM delivery system.
Intellectual Property
* Over five hundred different drugs are specifically listed in more than sixty therapeutic areas
* Transdel Pharmaceuticals owns U.S. patented proprietary Transdel™ technology
* Broad technology platform that is patent protected
o Patent specifically covers composition of matter, methods of manufacture and methods of use
o Patent covers novel formulation with any medication capable of being administered transdermally
Clinical Results of Ketotransdel® Phase 1/2 Trial
* Double blind, randomized placebo-controlled
* Assessed efficacy, safety and systemic levels for treatment of acute pain and soreness
* Demonstrated effective local delivery of ketoprofen resulting in statistically significant relief of pain and soreness
* Low serum concentrations of drug enhanced safety profile
* No significant adverse reactions reported
Market Research Study
* Market research study conducted by an independent consulting firm concluded that Ketotransdel®:
o Will be well accepted by physicians and patients
o Could be used for a variety of acute and chronic pain conditions
* Potential drug utilization frequency of Ketotransdel® by physicians and patients could be high
Senetek PLC Rated 'Strong Buy' by Wharton Capital Management
Senetek PLC (Nasdaq: SNTKY) that New York City-based Wharton Capital Management Inc., has initiated coverage of Senetek with a "strong buy" rating on the company.
"Our price target is $10," said Wharton Capital Management analyst Rick Joshi. "We believe that Senetek is grossly undervalued at current levels.
"Senetek has a profitable Cosmeticals business with substantial and rapidly growing sales," Joshi continued. "It has in the late stages of development a novel biopharmaceutical for treating ED (Erectile Dysfunction) with a proprietary, advanced drug delivery system that targets
P3 results next Week..Under Radar
If positive this stock will skyrocket
Transdel Pharma (TDLP.OB)
MarketCap: 23,4 M$
Price: 1.50 $
Shares Out : 15,6 Mio
"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."
Transdel Pharmaceuticals is seeking a partner for Ketotransdel and is either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
"Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel."
Senetek will be the next Psivida !!!!
THIS UNDERVALUED STOCK IS FLYING UNDER RADAR !!!
Senetek (SNKTY.OB)
Market Cap : 9 M$
Cash : 13 M$ (NO DEBT)
Price : 1,20 $
Shares Out : 7,65 Mio
Pipeline
http://www.senetekplc.com/view_our_pipeline.asp
Analyst Report ..Read
http://www.senetekplc.com/SenetekPLC-IntelligenceDynamicsResearchReport.pdf
Senetek PLC
(OTC Bulletin Board: SNKTY.OB)
Senetek is a Life Sciences company engaged in the development of technologies
that target the science of healthy aging. The Company’s extensive research
collaborations have resulted in a strong pipeline of patented compounds and
products with broad therapeutic applications and a leading presence in
dermatology. Senetek collaborates with established specialty pharmaceutical
companies in the final development and marketing of its proprietary products, most
recently resulting in the development of the best-selling anti-aging product sold in
the North American physician market.
Lead Products
Pyratine-6™
(0.1% Furfuryl Tetrahydropyranyladenine)
The first in Senetek’s new generation cytokinin pipeline to complete development,
Pyratine-6™ has demonstrated, through clinical trials, superior results and faster
onset of action in treating photodamaged skin when compared to Senetek’s highly
successful predecessor compounds.
In September 2008, Senetek launched the Pyratine-6™ family of products in the
North America Physician market.
The Company is actively seeking marketing collaboration agreements for other
geographies.
Pyratine XR™
(0.125% Furfuryl Tetrahydropyranyladenine)
Based on positive results demonstrated in Pyratine-6™ clinical evaluations,
Senetek initiated a clinical trial of 0.125% Furfuryl Tetrahydropyranyladenine for
the reduction of visible signs and symptoms associated with various conditions
such as rosacea, eczema, contact dermatitis and menopause. Rosacea is a chronic
dermatosis afflicting more than 14 million people in North America and 45 million
people worldwide.
An overall clinical improvement was noted in 80% of subjects, including reduction
of erythema and papules. The investigators saw continual, statistically significant
mean improvement with Pyratine XR™ treatment, including a 90% improvement
in lesions, 45% improvement in erythema and a 28% improvement in
telangiectasia
Pyratine XR™ Crème and Lotion were launched in the North American Physician
market in March 2009.
The Company is actively seeking marketing collaboration agreements for other
geographies
Kinetin
Senetek scientists developed and patented the cytokinin Kinetin as an anti-aging
compound. Senetek commercialized Kinetin under the Kinerase® trademark, which
is now owned by Valeant Pharmaceuticals Inc. Kinerase® is currently the leading
anti-aging compound sold in the North American physician market. In early 2007,
Senetek sold Valeant a perpetual use license for Kinetin for $21 million,
forgiveness of a $6 million prepaid royalty credit reimbursement obligation that
Senetek otherwise would have owed to Valeant, and a right to share in future
royalties due to Valeant from other Kinetin licensees through 2011.
Invicorp®
Senetek has entered into a partnership agreement with Plethora Solutions
Limited (LSE-AIM: PLE), for the commercialization of Invicorp® in North
America. Under this agreement, Plethora assumes full financial responsibility
for all future development, regulatory approvals, and sales and marketing of the
product. Senetek will participate in the success of Invicorp® through milestone
payments and royalties based on net sales. The European marketing rights,
previously licensed to Ardana Biosciences Ltd, were returned to Senetek when
Ardana entered receivership in June 2008. An evaluation of the Company’s
options regarding redeployment of the European marketing rights as well as
rights for the rest of the world is currently underway.
Reliaject®
Reliaject® is an advanced drug delivery system for self-administration of
parenteral drugs, including epinephrine for emergency treatment of anaphylaxis,
a severe allergic reaction that occurs in response to food, insect venom or
medication – currently a $250 million market in North American alone.
Reliaject® is also well suited to other injectable therapies including Senetek’s
Invicorp® for the treatment of ED. The company entered an agreement with
Ranbaxy Pharmaceuticals, through which Senetek will receive future milestone
payments, as well as royalties paid out over 15 years on all products introduced
in the Reliaject® drug delivery system.
Research & Development
Senetek’s scientific research collaborations form the basis for a continuous,
interactive flow of new product identification, evaluation and testing activity
between the University of Aarhus, Senetek’s dedicated laboratory in Denmark,
the Institute of Experimental Botany in the Czech Republic, the University of
California-Irvine, and the Institute of Bioorganic Chemistry of the Polish
Academy of Sciences among others. Through these collaborations the Company
has greatly expanded its IP portfolio, adding many vital technologies, while
accelerating product development.
Pipeline
Senetek’s partnerships with leading research and academic institutions have
placed the Company at the forefront of technological advancements in the
science of aging. The Company’s large and growing IP portfolio features new
models in treatment that span a range of therapeutic areas including
dermatology, nutrition, wound healing and erectile dysfunction.
Market Opportunity
Owing to an increase in health awareness and continued progress in the field of
science and medicine, the average global life span has seen a steady rise over the
past several decades, a trend that is only expected to become more pronounced
in the decades to come. According to the United Nations, the percentage of the
world’s population over the age of 60 is expected to rise from 10.0% in 2000 to
22.1% in 2050. In more developed regions, such as Europe and North America,
these percentages are anticipated to be even higher, estimated at approximately
35.0% and 27.0%, respectively, by 2050. The aging of society is likely to create
increased opportunity for treatments and therapies such as those based on
Senetek’s patented compounds.
Business Model
With a strong balance sheet in place, the Company has transitioned from a
licensing model to a sales and marketing model, delivering an increased revenue
stream with higher margin potential and creating long-term value for its
shareholders.
RALLLLLLLYYYYYYYYYYYYY
Market Cap of 5 M$ is joke lol
Get in before its too late ...
RALLLYYYYYYYYYYY
A lot of upside potential here eom
PSDV IST STILL THE CHEAP BIO-STOCK
A lot of Potential here !!!!
Senetek will be the next Psivida !!!!
THIS UNDERVALUED STOCK IS FLYING UNDER RADAR !!!
Senetek (SNKTY.OB)
Market Cap : 9 M$
Cash : 13 M$ (NO DEBT)
Price : 1,20 $
Shares Out : 7,65 Mio
Pipeline
http://www.senetekplc.com/view_our_pipeline.asp
Analyst Report ..Read
http://www.senetekplc.com/SenetekPLC-IntelligenceDynamicsResearchReport.pdf
Senetek PLC
(OTC Bulletin Board: SNKTY.OB)
Senetek is a Life Sciences company engaged in the development of technologies
that target the science of healthy aging. The Company’s extensive research
collaborations have resulted in a strong pipeline of patented compounds and
products with broad therapeutic applications and a leading presence in
dermatology. Senetek collaborates with established specialty pharmaceutical
companies in the final development and marketing of its proprietary products, most
recently resulting in the development of the best-selling anti-aging product sold in
the North American physician market.
Lead Products
Pyratine-6™
(0.1% Furfuryl Tetrahydropyranyladenine)
The first in Senetek’s new generation cytokinin pipeline to complete development,
Pyratine-6™ has demonstrated, through clinical trials, superior results and faster
onset of action in treating photodamaged skin when compared to Senetek’s highly
successful predecessor compounds.
In September 2008, Senetek launched the Pyratine-6™ family of products in the
North America Physician market.
The Company is actively seeking marketing collaboration agreements for other
geographies.
Pyratine XR™
(0.125% Furfuryl Tetrahydropyranyladenine)
Based on positive results demonstrated in Pyratine-6™ clinical evaluations,
Senetek initiated a clinical trial of 0.125% Furfuryl Tetrahydropyranyladenine for
the reduction of visible signs and symptoms associated with various conditions
such as rosacea, eczema, contact dermatitis and menopause. Rosacea is a chronic
dermatosis afflicting more than 14 million people in North America and 45 million
people worldwide.
An overall clinical improvement was noted in 80% of subjects, including reduction
of erythema and papules. The investigators saw continual, statistically significant
mean improvement with Pyratine XR™ treatment, including a 90% improvement
in lesions, 45% improvement in erythema and a 28% improvement in
telangiectasia
Pyratine XR™ Crème and Lotion were launched in the North American Physician
market in March 2009.
The Company is actively seeking marketing collaboration agreements for other
geographies
Kinetin
Senetek scientists developed and patented the cytokinin Kinetin as an anti-aging
compound. Senetek commercialized Kinetin under the Kinerase® trademark, which
is now owned by Valeant Pharmaceuticals Inc. Kinerase® is currently the leading
anti-aging compound sold in the North American physician market. In early 2007,
Senetek sold Valeant a perpetual use license for Kinetin for $21 million,
forgiveness of a $6 million prepaid royalty credit reimbursement obligation that
Senetek otherwise would have owed to Valeant, and a right to share in future
royalties due to Valeant from other Kinetin licensees through 2011.
Invicorp®
Senetek has entered into a partnership agreement with Plethora Solutions
Limited (LSE-AIM: PLE), for the commercialization of Invicorp® in North
America. Under this agreement, Plethora assumes full financial responsibility
for all future development, regulatory approvals, and sales and marketing of the
product. Senetek will participate in the success of Invicorp® through milestone
payments and royalties based on net sales. The European marketing rights,
previously licensed to Ardana Biosciences Ltd, were returned to Senetek when
Ardana entered receivership in June 2008. An evaluation of the Company’s
options regarding redeployment of the European marketing rights as well as
rights for the rest of the world is currently underway.
Reliaject®
Reliaject® is an advanced drug delivery system for self-administration of
parenteral drugs, including epinephrine for emergency treatment of anaphylaxis,
a severe allergic reaction that occurs in response to food, insect venom or
medication – currently a $250 million market in North American alone.
Reliaject® is also well suited to other injectable therapies including Senetek’s
Invicorp® for the treatment of ED. The company entered an agreement with
Ranbaxy Pharmaceuticals, through which Senetek will receive future milestone
payments, as well as royalties paid out over 15 years on all products introduced
in the Reliaject® drug delivery system.
Research & Development
Senetek’s scientific research collaborations form the basis for a continuous,
interactive flow of new product identification, evaluation and testing activity
between the University of Aarhus, Senetek’s dedicated laboratory in Denmark,
the Institute of Experimental Botany in the Czech Republic, the University of
California-Irvine, and the Institute of Bioorganic Chemistry of the Polish
Academy of Sciences among others. Through these collaborations the Company
has greatly expanded its IP portfolio, adding many vital technologies, while
accelerating product development.
Pipeline
Senetek’s partnerships with leading research and academic institutions have
placed the Company at the forefront of technological advancements in the
science of aging. The Company’s large and growing IP portfolio features new
models in treatment that span a range of therapeutic areas including
dermatology, nutrition, wound healing and erectile dysfunction.
Market Opportunity
Owing to an increase in health awareness and continued progress in the field of
science and medicine, the average global life span has seen a steady rise over the
past several decades, a trend that is only expected to become more pronounced
in the decades to come. According to the United Nations, the percentage of the
world’s population over the age of 60 is expected to rise from 10.0% in 2000 to
22.1% in 2050. In more developed regions, such as Europe and North America,
these percentages are anticipated to be even higher, estimated at approximately
35.0% and 27.0%, respectively, by 2050. The aging of society is likely to create
increased opportunity for treatments and therapies such as those based on
Senetek’s patented compounds.
Business Model
With a strong balance sheet in place, the Company has transitioned from a
licensing model to a sales and marketing model, delivering an increased revenue
stream with higher margin potential and creating long-term value for its
shareholders.
Thank you CTS
Great job
PSDV..A great Opportunity ..Newbies Read !!
MarketCap only 94 Mio$ is way too Cheap
Shares Out 18,2 M ..Listed in USA,Australia and Germany
Rodman Slide Presentation Sep 2009
http://www.wsw.com/webcast/rrshq15/psdv/
Pipeline
http://www.psivida.com/products.html
Major Shareholder
http://phx.corporate-ir.net/phoenix.zhtml?c=168274&p=irol-ownershipSummary
pSivida is a leader in the development of miniaturized, injectable, drug delivery systems. We develop products to treat serious or life threatening diseases alone or in partnership with other companies. We have developed devices that are so small they are FDA approved to be administered into the eye and once administered they release their drug for months and years.
pSivida’s lead development product, Iluvien™, delivers fluocinolone acetonide (FA). Formerly known as Medidur™ FA for DME, Iluvien is in fully recruited Phase III clinical trials for the treatment of diabetic macular edema (DME), one of the leading causes of blindness in the developed world. Iluvien is designed to provide sustained release of drug for up to three years after a single injection. It is also in Phase II clinical trials for the treatment of dry age-related macular degeneration (dry-AMD) and wet age- related macular degeneration (wet-AMD). These studies are being conducted and fully funded by our licensee, Alimera Sciences.
pSivida’s two FDA approved sustained release products to treat chronic back of the eye diseases are Retisert® for the treatment of posterior uveitis and Vitrasert® for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. Vitrasert and Retisert provide sustained release for six to nine months and two and a half years, respectively.
pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. to develop additional ophthalmic products.
pSivida is developing a series of additional miniaturized, bioerodible technologies designed to provide long term (months and years) release to virtually any site in the body. One of these technologies is BioSilicon™, a bioerodible form of silicon. The most advanced BioSilicon product candidate, BrachySil™, is in a dose ranging clinical trial to treat pancreatic cancer. BrachySil is designed to deliver a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors to minimize side effects and maximize efficacy. pSivida has completed an initial safety study of BrachySil for the treatment of pancreatic cancer and a dose ranging study has completed enrollment.
pSivida’s intellectual property portfolio consists of over 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
STILL A BIG BARGAIN
7-8$ by next week !!
PSDV IS A REAL BIG OPPORTUNITY .NO PUMP AND DUMP CRAP
CRXX ON THE MOVE
STILL WAY UNDERVALUED --
3-4$ BY TUESDAY
FDA-MEETING NEXT WEEK
ON THE MOVE AGAIN ..
MARKETCAP OF 94 M$ IS WAY UNDERVALUED ...
RALLYYY AGAIN..STILL VERY UNDERVALUED
Psivida (PSDV)
MarketCap : 60 M$
Cash : 8,02 M$
Price : 3,40 $
Shares Out : 18,26 M .... Pfizer is largest Shareholder (1,9 million shares )
Pipeline
http://psivida.com/products.html
Ownership Summary
http://phx.corporate-ir.net/phoenix.zhtml?c=168274&p=irol-ownershipSummary
Iluvien™ NDA filing remains on schedule for early calendar 2010
Positive 12 month interim safety and efficacy data from Iluvien PK study
PDSV has two ophthalmic sustained delivery products approved by the FDA for treatment of back of the eye diseases
With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
“We are confident in our strategy to capitalize on our core strength of developing drug delivery systems and bringing products to a point where they can be partnered or further developed by the Company,” stated Dr. Paul Ashton, President and CEO of pSivida. “Following the independent Data Safety Monitoring Board’s final review recommending the continuation of the Iluvien Study for the treatment of DME, an NDA filing remains on schedule for early calendar 2010.”
Dr. Ashton noted that the Company’s net cash burn has averaged $1.5 million per quarter during the past six months. “With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
An ongoing PK study running concurrently with the pivotal Phase III clinical trials is also designed to provide information on the safety and efficacy of Iluvien in the DME population. Twelve month data from this study was recently presented at the ARVO annual meeting. “We were extremely pleased with the safety and efficacy data from the 12 month PK study readout,” said Dr. Ashton. “There were no adverse events related to IOP (intra ocular pressure) in the low dose patients and even the high dose patients had a lower incidence of IOP compared to the published Retisert DME data. Additionally, the efficacy data continues to be consistent with our expectations.” pSivida’s partner, Alimera Sciences, has worldwide marketing rights to Iluvien.
DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.
re PSDV ..The NEXT HGSI
Special delivery looks good
THE human eye is a truly amazing instrument. But one of its great strengths - its relative isolation from the rest of the body - is also a real problem for the treatment of eye diseases.
Delivering drugs that can treat problems at the back of the eye, such as macular degeneration, is particularly difficult.
Large and possibly toxic doses are needed when they are delivered through eye drops or intravenously.
Which is where Australian listed drug delivery company pSivida comes in.
Chief executive Dr Paul Ashton said he was "very encouraged" by a recent 12-month safety and efficacy study of its Iluvien product.
The key point about Iluvien is not the drug it contains -- well-known corticosteroid FA (fluocinolone acetonide) -- but in the manner of delivery.
The drug is contained in a tiny, slow-release device that can fit inside a needle. It is injected into the eye where it releases a very low dose of the drug over several years.
The 12-month study produced no adverse effects for low-dose patients while 23.5 per cent of high-dose patients recorded a rise in intraocular pressure.
Those figures are an improvement on earlier results recorded by Retisert, a larger insert developed by pSivida which is surgically implanted into the eye.
pSivida is also working on a nanotechnology delivery system which would be even smaller again.
Reducing side-effects is one thing, but it is treating the debilitating effect of diseases such as diabetic macular edema that is the very positive flip side.
Dr Ashton said many macular degeneration sufferers got a marked improvement.
A larger Phase 3 trial produced an improvement of 15 letters or better on a standard eye chart for 27.3 per cent on a higher dose and 23.1 per cent for the lower dose.
That sort of marked eyesight improvement is particularly important in treating patients with diabetes, who can be quite young when their vision is first affected.
One early trial patient, a young diabetic, went from being close to legally blind to getting back 20/40 eyesight.
"The main alternative treatment is with a laser and this delivery method produces much better results than that," said Dr Ashton.
The company hopes to file a new drug application with the US Food and Drug Administration next year.
Despite its innovative drug delivery technology, like most life sciences companies pSivida has come through a rocky patch on the ASX.
It licensed the only two FDA-approved, back-of-the-eye treatments for chronic eye disease to Bausch & Lomb while licensing partner Alimera Sciences is progressing the diabetic macular edema treatment.
Major shareholder Pfizer has the rights for all other opthalmic applications, which could be significant given the potential to treat other back-of-the-eye diseases.
Dr Ashton said the company was fortunate to have no debt with the prospect of significant royalty income in the short to medium term.
Last year pSivida raised $82 million from partner Alimera in exchange for increasing its equity stake in future treatment profits to 80 per cent.
New article ..10$ very soon
Special delivery looks good
THE human eye is a truly amazing instrument. But one of its great strengths - its relative isolation from the rest of the body - is also a real problem for the treatment of eye diseases.
Delivering drugs that can treat problems at the back of the eye, such as macular degeneration, is particularly difficult.
Large and possibly toxic doses are needed when they are delivered through eye drops or intravenously.
Which is where Australian listed drug delivery company pSivida comes in.
Chief executive Dr Paul Ashton said he was "very encouraged" by a recent 12-month safety and efficacy study of its Iluvien product.
The key point about Iluvien is not the drug it contains -- well-known corticosteroid FA (fluocinolone acetonide) -- but in the manner of delivery.
The drug is contained in a tiny, slow-release device that can fit inside a needle. It is injected into the eye where it releases a very low dose of the drug over several years.
The 12-month study produced no adverse effects for low-dose patients while 23.5 per cent of high-dose patients recorded a rise in intraocular pressure.
Those figures are an improvement on earlier results recorded by Retisert, a larger insert developed by pSivida which is surgically implanted into the eye.
pSivida is also working on a nanotechnology delivery system which would be even smaller again.
Reducing side-effects is one thing, but it is treating the debilitating effect of diseases such as diabetic macular edema that is the very positive flip side.
Dr Ashton said many macular degeneration sufferers got a marked improvement.
A larger Phase 3 trial produced an improvement of 15 letters or better on a standard eye chart for 27.3 per cent on a higher dose and 23.1 per cent for the lower dose.
That sort of marked eyesight improvement is particularly important in treating patients with diabetes, who can be quite young when their vision is first affected.
One early trial patient, a young diabetic, went from being close to legally blind to getting back 20/40 eyesight.
"The main alternative treatment is with a laser and this delivery method produces much better results than that," said Dr Ashton.
The company hopes to file a new drug application with the US Food and Drug Administration next year.
Despite its innovative drug delivery technology, like most life sciences companies pSivida has come through a rocky patch on the ASX.
It licensed the only two FDA-approved, back-of-the-eye treatments for chronic eye disease to Bausch & Lomb while licensing partner Alimera Sciences is progressing the diabetic macular edema treatment.
Major shareholder Pfizer has the rights for all other opthalmic applications, which could be significant given the potential to treat other back-of-the-eye diseases.
Dr Ashton said the company was fortunate to have no debt with the prospect of significant royalty income in the short to medium term.
Last year pSivida raised $82 million from partner Alimera in exchange for increasing its equity stake in future treatment profits to 80 per cent.
PSDV HITS NEW 52W HIGH !!
For Newbies
If you do your Homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed ..
GLTA .. A real Lifetime Opportunity !!
Psivida (PSDV)
MarketCap : 57 M$
Cash : 8,02 M$
Price : 3,15 $
Shares Out : 18,26 M .... Pfizer is largest Shareholder (1,9 million shares )
Iluvien™ NDA filing remains on schedule for early calendar 2010
Positive 12 month interim safety and efficacy data from Iluvien PK study
PDSV has two ophthalmic sustained delivery products approved by the FDA for treatment of back of the eye diseases
With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
“We are confident in our strategy to capitalize on our core strength of developing drug delivery systems and bringing products to a point where they can be partnered or further developed by the Company,” stated Dr. Paul Ashton, President and CEO of pSivida. “Following the independent Data Safety Monitoring Board’s final review recommending the continuation of the Iluvien Study for the treatment of DME, an NDA filing remains on schedule for early calendar 2010.”
Dr. Ashton noted that the Company’s net cash burn has averaged $1.5 million per quarter during the past six months. “With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
An ongoing PK study running concurrently with the pivotal Phase III clinical trials is also designed to provide information on the safety and efficacy of Iluvien in the DME population. Twelve month data from this study was recently presented at the ARVO annual meeting. “We were extremely pleased with the safety and efficacy data from the 12 month PK study readout,” said Dr. Ashton. “There were no adverse events related to IOP (intra ocular pressure) in the low dose patients and even the high dose patients had a lower incidence of IOP compared to the published Retisert DME data. Additionally, the efficacy data continues to be consistent with our expectations.” pSivida’s partner, Alimera Sciences, has worldwide marketing rights to Iluvien.
DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.
RALLYYYYYYYYYY
New 52W high eom .. Still significantly undervalued
See you at 15$ by year end !!
NEXT RALLY STARTS HERE !!!
PSDV is a real big Opportunity !!
NICE DAY AGAIN WOHHOHOOO