Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
aschoff is a smart guy. he brought out parts of the data regarding the way the two companies track anemia that was very important for the people that follow ymi or incy.
the analysis shouldn't be used for tissue paper
if you wish to use it for that you may
why is mnta raising money when it appears that they are printing money
ymi vs. Incy from jonathan Aschoff
We primarily wanted to point out some differences between INCB18424 and CYT387, as these drugs are often directly compared. We emphasize that data for CYT387 comes from 60 patients followed for a median of two months and that data for INCB18424 comes from 153 patients followed for a median of 20 months, and thus drawing useful comparisons best wait for more mature data from YM Boisciences, but by which time we will already have Phase 3 data from Incyte. We also wanted to point out that transfusion independence was in fact measured differently in the INCB18424 NEJM paper than it was in the ongoing YM trial, and thus conclusions about CYT387’s superiority in reversing anemia are premature. Later this month, should INCB18424 succeed in Phase 3 with spleen size reductions in the Phase 1/2 ballpark and acceptable safety, it is in our view way too early to consider CYT387 a serious future threat about four years from now. We also discuss Incyte’s updated PV and ET results.
Discussion
§Concerning anemia and transfusion independence, there appears to be a real difference between the definitions that both companies are using to define the transfusion independence. Incyte was trying to use a more inclusive definition of transfusion independence in order to describe patients that are freer of transfusions than the less stringent IWG criteria. Incyte’s definition describes a patient that is transfusion free for 12 consecutive weeks or at least during the last 8 weeks on study (or the last 8 weeks prior to database closure for Incyte’s published NEJM paper), whereas the more standard IWG definition used by YM less stringently requires a patient to go any 8 weeks without a transfusion. The confusion lay in the fact that the NEJM paper describing Incyte’s Phase 1/2 did not accurately describe the actual criteria used. This statement in the paper “After a median treatment duration of 12 weeks, four patients (14%) had transfusion independence (clinical improvement according to the International Working Group) for a median duration of 20 months.” inaccurately describes the criteria used. In fact, the Phase 2 median transfusion free period of 20 months for INCB18424 patients that qualified as being transfusion independent was defined under Incyte’s stricter definition described above.
If a patient in YM’s trial had a transfusion right before enrolling in the trial, and several transfusions more than two months after dosing started, they would have been considered to be transfusion free. Due to the different definitions used for transfusion independence, and what we view to be unfair comparisons drawn by YM, Incyte calculated its data using the more forgiving standard IWG definition used by YM in order to directly and more fairly compare these results. Using this more proper comparison, one can see a comparable anemia response between the two drugs, with INCB18424 showing a 45% response, and CYT387 showing a 50% response. Furthermore, given the numerical similarity between these measurements, that fewer patients (n=60) were reported on from the CYT387 trial than in Incyte''s trial (n=153), and that median follow up was two months for YM versus 20 months for Incyte, we view YM''s findings as far less robust at present and in need of much maturation prior to drawing any definitive comparisons regarding transfusion independence.
Stent maker paid notorious cardiologist to use device
December 6, 2010 — 1:40pm ET | By Dan Bowman
St. Joseph Medical Center
Sen. Max Baucus
Dr. Mark Midei
Looks like the case against Dr. Mark Midei--the Maryland surgeon accused of implanting hundreds of unnecessary cardiac stents in patients since at least 2007--has become a lot more interesting, with ties to the top of Chicago-based pharma outfit Abbott Laboratories. According to a 170-page report compiled by the U.S. Senate Committee on Finance, Abbott's desire to push their drug-coated stent--Xience V--proved a catalyst in their relationship with Midei, reports the Baltimore Sun.
The skinny? In 2007, Abbott execs allegedly knew Midei had a reputation as a "top-volume stent doctor," and recruited him to be a "stent ambassador" to give their yet-to-be-FDA-approved Xience V market credibility. Soon after, Midei was touting the benefits of using stents at an Abbott sponsored dinner at a Ruth's Chris Steak House, and the relationship was off and running.
Sign up for our FREE newsletter for more news like this sent to your inbox!
Lavish trips around the world and expensive barbecues at Midei's mansion followed, all funded by Abbott, allegedly, for Midei's use of the stent. From 2007 through 2009, the Xience V was the only drug-eluting stent used by Midei, the Sun reports. Prior to one of those barbecues--and shortly after Midei implanted 30 Xience stents in patients in a single day--Abbott executive vice president John M. Cepak sent the doctor a note saying: "I heard thru the grapevine that you had a truly outstanding day with Xience in the labs on Friday, perhaps setting the single day implant record....[S]tay in touch and thanks for your support."
Once investigations against Midei went public, Abbott, it appears, went full swing into cover-up mode. The same day this story broke in the Sun, Abbott sent the doctor to Japan. One executive wrote in an email to Chuck Simonton, the company's chief medical officer, that the press was getting "too hot." And after a commentary in which a Sun columnist talked about stent overuse, another Abbott exec, vice president of global marketing David Pacitti, sent a note to a company official saying: "Don't you have connections in Baltimore????? Someone needs to take this writer outside and kick his ass! Do I need to send the Philly mob?"
St. Joseph Medical Center, where Midei practiced, billed the government and private insurers roughly $6.6 million for the doctor's work, the report showed. Medicare, according to the Sun, paid $3.8 million of that amount. Sen. Max Baucus (D-Mont.), the Committee's chairman, called the findings "shocking, disturbing and shameful."
Abbott, which gave no comment to the Sun, released a statement calling Midei a "highly regarded physician" with whom it had worked in the past. "Our affiliation with Dr. Midei ended early this year," the statement read.
Stephen Snyder, Midei's lawyer, doesn't seem concerned with any of the allegations, calling them all "speculation."
"Big deal....There's no news here," he told the Sun.
To learn more:
- here's the Sun's article
Read more: Stent maker paid notorious cardiologist to use device - FierceHealthcare http://www.fiercehealthcare.com/story/stent-maker-paid-notorious-cardiologist-use-device/2010-12-06?utm_medium=nl&utm_source=internal#ixzz17MoAFcCH
Subscribe: http://www.fiercehealthcare.com/signup?sourceform=Viral-Tynt-FierceHealthcare-FierceHealthcare
I have taken the Neptune product.
It reduced my triglycerides with no effect on my HDL. I was taking it to increase my HDL.
The fda is getting very concerned about companies not doing phase 4 studies.
What if they ask amarin for an outcome study?
Halozyme Therapeutics Realigns Management
- Gregory I. Frost, Ph.D., appointed president and CEO -
- Jonathan E. Lim, M.D., resigns as president, CEO and director -
- H. Michael Shepard, Ph.D., promoted to chief scientific officer -
I believe that Jonathan Lim started this company in a garage. The stock hasn't reacted well over the last couple of years but I have not seen any missteps by management. I believe it has been more a function of things taking longer than people like, but you can't rush good science or a partner like Roche. It appears to be a lousy ending for the guy. The success that will probably come for the company will be because of him and the deals he has made but he will not be there to benefit. I hope he has a lot of options that won't expire.
Press Release Source: Halozyme Therapeutics, Inc. On Friday December 3, 2010, 7:30 am
SAN DIEGO, Dec. 3, 2010 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq:HALO - News), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced the appointment of Gregory I. Frost, Ph.D., to serve as president and CEO, effective immediately. Jonathan E. Lim, M.D., has resigned as president, CEO and member of the board of directors to pursue other opportunities. H. Michael Shepard, Ph.D., has been promoted to chief scientific officer after having joined the company as vice president of discovery research. The board has also accepted the resignation of Robert J. Little as vice president and chief commercial officer effective immediately.
(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)
"On behalf of the entire board I want to express our gratitude for the excellent job that Jonathan Lim has done since joining the company. He has been instrumental in transforming Halozyme from a research company to one with a rich development pipeline and lucrative partnerships. Dr. Lim has served Halozyme well, beginning in 2003, and the board appreciates his contributions to the company's success," stated Kenneth J. Kelley, chairman of the board of directors.
"I am pleased by this new role for Dr. Greg Frost. Greg's scientific experience and integrated understanding of the biological systems at Halozyme's core combined with his business acumen provide the right leadership for Halozyme's product strategy," stated R.J. Kirk, member of the Halozyme board of directors and largest shareholder.
"I am passionate about Halozyme's future, our proven technology platform, and have confidence in our team to achieve our goals," stated Gregory I. Frost, Ph.D., Halozyme's president and CEO. "With the promotion of Mike Shepard to chief scientific officer, our scientific leadership has been placed in the capable hands of a proven biotechnology product innovator."
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning our potential opportunities and implementation of our strategy) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
Halozyme Contact
Robert H. Uhl
Senior Director, Investor Relations
(858) 704-8264
ruhl@halozyme.com
From Alex To -- EXEL: Betting the House on XL-184
•At the re-strategized Exelixis, "the single focus is on XL-184". This was
the message from its annual R&D day yesterday. The following is our take:
•The positive attribute on XL-184 is the recently observed data from the randomized
discontinuation trials that the drug has efficacy signals in a number of solid tumors:
liver cancer, prostate cancer, ovarian cancer, breast cancer, melanoma, etc - the fact
that the company has just found out the drug has efficacy signals in these common cancers
after the drug has been in development for so many years is baffling, but we won't go
there. It is intriguing that XL-184 is particular good in reducing, and sometimes
completely wiping out, bone metastasis in prostate cancers. It makes some sense since met
oncogene plays a heavy role in bone metastasis growth and XL-184 is a met inhibitor.
Therefore, developing XL-184 for castration resistant prostate cancer (CRPC) is now the
new found focus within the single focus.
•The risk for the single horse bet is that one would have to be darn sure that the
horse you are betting on is a winner. We don't have a clear answer for the question and
are open minded about it. A potential source for worry is the side effects XL-184 has so
far exhibited. Recall in previous trials, 175 mg was an intolerable dose and there had to
be dose reductions. The current 100 mg in the new formulation is equivalent to the old
125 mg dose. There are still many side effects. There were 4 drug related death in the
randomized discontinuation trial: the causes were pulmonary embolism, respiratory
failure, hemorrhage, and GI-hemorrhage. While GI side effects are widely experienced
though potentially manageable, thrombosis, hypertension, stomatitis and increased liver
enzyme are meaningful concerns. While we tolerate a lot of side effects for cancer drugs,
especially if the drug is highly efficacious, one has to put XL-184 in the category of
the more toxic cancer drug candidates in development. That might partially be the reason
why both Glaxo (GSK) and Bristol (BMY) gave the drug back to EXEL. For CRPC, the patients
have relatively long life expectancy, compared to other more deadly cancers. Therefore,
the life threatening adverse effects will be a consideration.
•The other concern is manmade error. The management spoke about going into an initial
Phase 3 with a composite end point other than a survival end point. (It is premature to
speak of Phase 3 at any rate since the drug is effectively just entering Phase 2, but
anyway.) It might be possible if the company can convince the regulatory agencies that
XL-184 is a cancer supportive care drug, for the treatment of bone pain and bone
metastasis. In that case an end point other than survival could be acceptable. But
regulatory standards for cancer supportive agents consist of much higher hurdles on side
effect profile. As a direct cancer fighting agent, on the other side, an overall survival
end point would be the only safe bet, especially all the other recently approved or
likely to be approved drugs for treatment of CRPC (Jevtana, Provenge, and abiraterone)
are all based on overall survival.
•As for XL-184 in medullary thyroid cancer, there are so few patients it is not going
to be financially meaningful for the company. For the couple thousand patients with MTC,
there is also competition. Just yesterday, the FDA advisory panel recommended approval of
AstraZeneca's (AZN) Zictifa (vandetanib).
•So, for investors' sake, maybe some hedging on the single focus bet can be helpful.
EXEL has a number of early stage molecules from the days when the company had a more
diverse focus. Perhaps EXEL can spin those molecules into different companies, while
retain significant equity stakes. We suspect many of these molecules have not been fully
characterized and in the hands of some savvy venture capitalists and through different
management perspectives, something valuable may come out of it and generate value for
EXEL shareholders. This approach is different from out-licensing the molecules to drug
companies. In the out-licensing approach, the upfront and milestone payments will likely
be ploughed right into XL-184 development. If XL-184 turns out to be the wrong horse,
there will be nothing.
•Although EXEL is projecting to have $250 million cash by end of 2010, it only has
enough funding to get through 2011. The earliest timeline for XL-184 to be commercialized
for CRPC is 2016. Getting from point A to point B would require very patient investors
who are willing to put up with lots of dilutions.
Alex To, MD
look at the great data that Aradigm has exhibited in both CF and and Bronchiectasis. They could have gotten that entire platform for a lot less then they paid for this one.
http://finance.yahoo.com/news/Aradigm-Reports-Successful-bw-667874049.html?x=0&.v=1
insmed wastes the hundred million dollars by giving away half the company for a product I do not think much of.
where is read this now.
http://finance.yahoo.com/news/Insmed-Incorporated-and-prnews-3038473745.html?x=0&.v=1
I am taking finasteride for bph.
of course part of the reason for me to take it is that I have elevated psa levels which the drug reduces, and I believe there is a chance that if I may have a higher risk of prostate cancer that the drug may reduce. I am also aware of the fact that it probably doesn't reduce the chance of getting an aggressive form.
I think what the drug may do is delay the non aggressive forms so the ones that are diagnosed would tend to be the more aggressive type.
but who knows.
I also have regrown hair in a place that I had a bald spot so it isn't all bad.
fwiw, if I didn't have bph I wouldn't take the drug. I agree that if you have no disease it shouldn't be taken for cancer prevention. The fact that it can regrow hair means that it may be doing something else to my body that I don't care for, but haven't figured out what it is.
Friday, November 26, 2010
Termeer Touts Campath-Linked CVRs
It is funny to see that one of the main assets of Genzyme is Campath for MS. I owned Ilex when it was bought out by Genzyme because I saw the early results of the drug. The main side effect was some kind of thyroid issue which I thought was an acceptable safety issue. It has certainly taken them a lot longer than I thought it would to get it where it is now. I would have thought there would have been off label use.
While the US digests its Thanksgiving turkeys, life, work and...yes, pre-takeover posturing continues on this side of the pond. We're talking Sanofi-Aventis' attempt -- thus far too cheap -- to buy Genzyme, naturellement.
Speaking to French national daily Le Figaro (in his first interview with the French press), Genzyme chief Henri Termeer confirmed a report in the Wall Street Journal a couple of weeks ago that he's willing to explore Campath-linked contingent value rights (CVRs) in any future negotiations with Sanofi-Aventis. (We say 'future' coz they haven't started yet; "we have nothing on which to base a discussion," as Termeer insists).
Having CVRs pop up is not much of a surprise, though, is it. They're becoming part of the deal-making landscape, after all; soon enough they'll be as unremarkable as option-based structures. And wind-turbines.
You see, Termeer isn't opposed to selling Genzyme (shareholder value 'n all that). He's just opposed to selling it at $69/share (shareholder value 'n all that). It's all about price, he confirmed to the French newspaper.
The fact that Termeer is the one suggesting Campath-linked ways out of this stalemate hints that he's keen to squeeze more money out of his predator and get things sorted (so do the recent sales of the genetic testing and diagostics units); after all, he doesn't want his shareholders (particularly the newer ones) getting fed up and just turning over. He may say (he did say) that "we have time on our side, because our production issues are resolving themselves." But perhaps not that much time. Not more than Sanofi does, anyway.
So while Termeer sketches down his list of poison pills to buy time while the company rights itself, the valuation battle-ground may shift to Campath, and just what that drug could be worth.
There's a huge difference (surprise!) between what Sanofi thinks ($700m) and what Genzmye thinks ($3.5 billion). In Termeer's view, "this will be the most effective, cheapest and most convenient treatment for MS patients."
The Phase III trials, due next June and next autumn, may show who's right. They may also be the trigger-points for Campath-linked contingent value notes/rights/widgets to ex-Genzyme shareholders....if Genzyme is to become "a Sanofi-Aventis Rare Disease Company" by next Thanksgiving...
image by flikrer Chuck Coker, with permission
Email this • Twit This! • Digg This! • Share on Facebook • Save to del.icio.us • Technorati Links
By Melanie Senior at 5:09 AM 1 comments Links to this post
If you don't check their site everyday I guess it isn't important.
he can post it on a mnta board. it isn't a part of biotech values.
It doesn't mean anything.
anyone that wants to see the open positions only has to look at their website.
If I am on the dole then we are all in a lot of trouble
why do you post these open positions at mnta.
do you use these figures to adjust the unemployment numbers the government issues
According to a GlaxoSmithKline spokesperson, an internal analysis of the kidney failure cases has concluded that they “most likely were due to the underlying disease … However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute [kidney] failure.”
from those side effects it appears that it should be inlicensed by a small biotech company and put immediately in obesity trials.
Stem Cell Institute (Cellmedicine) Successfully Treats Spinal Cord Injury Patient With Adult Stem Cells
Peer-Reviewed Joint Publication Between Stem Cell Clinic and American Researchers
Press Release Source: Stem Cell Institute On Thursday November 25, 2010, 1:59 pm EST
PANAMA CITY--(Marketwire - 11/25/10) - The Stem Cell Institute (www.cellmedicine.com) reported today recovery of a spinal cord injury patient that was treated with a unique combination stem cell treatment. The patient suffered a crush fracture of the L1 vertebral body on May 13th, 2008 after a single propeller engine airplane crash. As a result of the spinal cord injury, the patient had severe neuropathic pain, loss of sexual and bladder function, as well as loss of movement and sensation in the legs.
He was treated on Oct 31-Nov 20, 2008, Jan 21-30, 2009, and July 1-10, 2009 with an adult stem cell protocol. The patient underwent a progressive recovery of sensation, mobility, and sexual and bladder function subsequent to each cycle of stem cell administration. Currently the patient is capable of walking and neuropathic pain diminished substantially.
"The doctors at the Stem Cell Institute have changed my life. After the accident there was no hope. Now I have a new lease on life," said Juan Carlos Murillo Rodriguez, the patient who was treated. "I have recently passed my physical and am flying again as a commercial pilot."
Details of the scientific rationale for the treatment, as well as protocols and outcomes may be found in the peer-reviewed paper "Feasibility of combination allogeneic stem cell therapy for spinal cord injury: a case report" which was published in the International Archives of Medicine and is available online at http://www.intarchmed.com/content/pdf/1755-7682-3-30.pdf.
"It is my honor that such a team of internationally recognized opinion leaders in the area of stem cells such as Doctors Amit Patel, Michael Murphy and Thomas Ichim have co-authored this publication," said Dr. Jorge Paz Rodriguez, Medical Director of the Stem Cell Institute and co-author of the publication. "By combining our clinical experience with cutting-edge advances in molecular and cellular biology, we believe we have put forth a very innovative protocol that we anticipate will be attempted by other groups."
About Stem Cell Institute
Stem Cell Institute is one of the leading adult stem cell research and treatment centers in the world. Using our pioneering treatment methods and utilizing partnerships with universities and physicians across the world, Stem Cell Institute has already treated over 800 patients with stem cell therapy and the company continues to expand. Stem Cell Institute is located in Panama City, Panama.
Contact:
Contact InfoDr. Jorge Paz Rodriguez800 980 STEM (7836) Email Contactwww.cellmedicine.com
the doctor is incentivised to treat patients monthly
Provenge is part of a paradigm shift, not as a cancer treatment but in the amount of money the healthcare system will have to pay for very little benefit.
I was at a prostate cancer panel session at the Lazard conference, the docs were saying that patients are not that interested in using Provenge because if they are going to be on a drug they want to see their PSA counts go down and their tumors shrink. Provenge does neither.
Then I asked the question, if abiraterone which decreases PSA and reduces tumors gets approved, will it get used ahead of Provenge. Sadly they said, probably not because doctors will get paid 5 to 10 thousand a patient to hang IV bags containing Provenge, they will not get paid anything to prescribe abiraterone.
If this doesn't exhibit a sick medical system, I do not know what does.
Cracked vials force Anthera to suspend PhIIb lupus study
Hgsi must have done this
By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn
Hayward, CA-based Anthera Pharmaceuticals ($ANTH) announced this morning that it is suspending dosing and enrollment in a Phase IIb study of its experimental lupus drug after a clinical investigator discovered that some of the vials containing the drug were cracked. A visit to the drug store room led researchers to conclude that the cracking was "not an isolated problem."
"The safety of our patients and the trust of the healthcare professionals involved in our clinical trials are of the utmost importance to Anthera so we have voluntarily placed PEARL-SC on hold until we can satisfactorily address the vial cracking that has been reported," said Paul Truex, CEO of Anthera Pharmaceuticals. "Getting to the root of this issue and resuming the clinical program for A-623 is a top priority. We believe that A-623 represents a promising therapeutic option for patients with autoimmune diseases and remain committed to working as quickly as possible to resolve this issue and discuss our plans with the FDA. We intend to provide a further update once those plans are in place."
As Xconomy reports this morning, Anthera has had its ups and downs over its five-year history. This week was intended to end on a high note as Truex and other company officials journeyed to the AHA meeting in Chicago to make their case for the potential of the developer's lead drug, A002, which is designed to prevent heart attacks and strokes by tamping down on excess inflammation.
Anthera is at the AHA meeting to tout plans for a pivotal trial of A002--their lead drug licensed from Eli Lilly and Shionogi--which will need up to 6,500 patients to provide the data it needs for an approval
they have formulation deals with companies. we shall see if they turn to product deals.
It pays to be skeptical but I guess it pays to get the poster that is being presented
Access Pharmaceuticals Presents CobOral Insulin Research at 10th Annual Diabetes Technology Meeting on November 11-13, 2010
Related Quotes
Symbol Price Change
ACCP.OB 3.0800 0.0000
Press Release Source: Access Pharmaceuticals, Inc. On Thursday November 11, 2010, 8:00 am
DALLAS and NEW YORK, Nov. 11, 2010 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob - News), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that it will be presenting a poster today at the 10th Annual Diabetes Technology Meeting, entitled, "Preclinical Studies with Cobalamin™ Nanoparticles for Oral Drug Delivery of Insulin." The poster reviews the progress made by Access scientists in developing its proprietary oral insulin formulation. Access recently rebranded its oral drug delivery technology as CobOral™ to reflect the advances made with the technology platform.
"We are delighted to share our recent findings from our CobOral insulin research at this year's Diabetes Technology Meeting," said David Nowotnik, Senior VP of Research and Development, Access Pharmaceuticals, Inc. He continued, "Our team has made significant advancements with our CobOral drug delivery technology, particularly in the diabetes area. We are continuing to explore additional collaborations to further the technology's promise in providing an effective and convenient method to control glucose levels in diabetic patients, and in treating other indications."
The 10th Annual Diabetes Technology Meeting is being held at the Marriott Bethesda North in Bethesda, Maryland. For more information, visit http://www.diabetestechnology.org/.
Last week, Access received a $245,000 grant for the Cobalamin Insulin program as one of several awards under the Qualifying Therapeutic Discovery Project (QTDP). Access recently announced agreements with a biopharmaceutical and biotechnology company to develop oral formulations of their widely-marketed injectables. Access' CobOral product development program initially focused on the oral delivery of insulin and human growth hormone (hGH), two peptides which currently can only be given by injection. Since presenting promising results at a major conference in mid-2008, Access has made substantial improvements to the formulation technology. An improved CobOral insulin-containing nanoparticle formulation delivered orally provided a pharmacological response (lowering of blood glucose levels in an animal model of diabetes) equivalent to greater than 80% of that achieved by insulin delivered subcutaneously. This represents a substantial oral bioavailability, indicating that this formulation has potential for clinical development and ultimate commercialization. Adaptation of this technology has provided a CobOral hGH formulation that has demonstrated good efficacy, represented by more than 25% improvement in weight gain, when given orally in an established animal model.
About Access:
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), for the management of patients with mucositis, ProLindac™, currently in Phase II clinical testing of patients with ovarian cancer, and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.
The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Contact: Company
Contact: Investor Relations
Christine Berni
Donald C. Weinberger/Diana Bittner (media)
Director of Investor Relations
Wolfe Axelrod Weinberger Assoc. LLC
Access Pharmaceuticals, Inc.
(212) 370-4500
(212) 786-6208
Painful bladder syndrome
take a look at the movement of this company's SLXCF.OB stock price since the financing announcement on 10/05/10 until their data was released today.
just because they can't use the old batches that expired does not mean the would be able to make new batches using a different formulation and keep the same anda in place.
if they change the formulation they would need to file a new anda
So, has Teva attempted to meet the criteria with a different process (drug) since then? Or is it simply going to pretend, amid growing skepticism as the months roll by, that their application will be approved any day, which would make them look like idiots? In the end, does Teva lose more credibility in this fashion, or by publicly admitting they cannot do it? Teva filed their drug about seven years ago. Let us say that they now the technology to characterise the product as well as momenta. they would have to go to the batches that they used in their filing seven years ago. What are the chances that those batches, after being characterised would fall into the ranges of the Sanofi product?
For that to happen they would have to be very lucky. That is why Momenta feels confident. If Teva does have the road map on what they need, they will probably have to reformulate the drug based on the criteria ranges of the Sanofi product, so the new batches would have to be manufactured, go through stability before the fda two year ANDA review process could even begin
dovp went to zero.
that doesn't mean he didn't get out in one of the spikes.
I agree that genes were not invented by man the reason the court and now the department of justice doesn't want to validate gene patents is because of the following
"human and other genes should not be eligible for patents because they are part of nature"
and I agains state that most biologics are a part of nature. Where do you make the distinction.
Isn't almost every biotech drug derived from a product of nature?
It isn't neccessarily traders, there are many bonifide investors waiting on the sidelines thinking teva will be approved shortly.
Many of these people would be long term holders
If this is verified, do you think it is something mnta should mention on their conference call?
Sanofi Aventis cfo video interview
http://www.eurobusinessmedia.com/Sanofi-aventis-video-Q-A-CFO-Jerome-Contamine-comments-on-Q3-2010-results
for the last few years I have not understood why everyone thought it was so obvious that the drug would be approved. The twice a day has side effects and the weekly drug was only tested in about 200 patients. I do not think the safety database was large enough.
then again why did the fda give them guidance that such a small trial would be acceptable?
HEDGEYE
EARLY LOOK: ISOLATED CURIOSITIES
"Clouds are not spheres, mountains are not cones, coastlines are not circles, and bark is not smooth, nor does lightning travel in a straight line."
-Benoît Mandelbrot
To say Benoît Mandelbrot lived a great life would be an understatement. The recently deceased Sterling Professor of Mathematial Sciences at Yale University had the opportunity to follow and study his passion his entire life and, as a result, his contributions to the field of mathematics were vast.
Most interesting to our Hedgeyes was Mandelbrot's work on fractals, which underscore many of our own market models. In fact, Mandelbrot actually coined the term fractal in his consummate work, The Fracatal Geometry of Nature. He also did what many academics actually have a hard time doing, he extended his academic studies into the more practical areas. According to our friends at Wikipedia:
"Although Mandelbrot coined the term fractal, some of the mathematical objects he presented in The Fractal Geometry of Nature had been described by other mathematicians. Before Mandelbrot, they had been regarded as isolated curiosities with unnatural and non-intuitive properties. Mandelbrot brought these objects together for the first time and turned them into essential tools for the long-stalled effort to extend the scope of science to non-smooth objects in the real world. He highlighted their common properties, such as self-similarity (linear, non-linear, or statistical), scale invariance, and a (usually) non-integer Hausdorff dimension."
Mandelobrot passed away at the age of 84 years after more than 60 years of pursuing his passion. He was one of the most celebrated mathematicians of the last 50 years and won innumerable awards for his work, including: the Wolf Prize for Physics in 1993, the Lewis Fry Richardson Prize of the European Geophysical Society in 2000, the Japan Prize in 2003, and the Einstein Lectureship of the American Mathematical Society in 2006. Most interestingly of his awards was perhaps that fact that he has an asteroid named after him: 27,500 Mandelbrot.
As it relates to financial markets, his primary contribution was determining that price changes in "financial markets did not follow a Gaussian distribution, but rather Lévy stable distributions having theoretically infinite variance." In addition to his study of financial markets, he also had an idiosyncratic character that was near and dear to our hearts. So much so in fact, that he actually gave himself his own middle initial, "B", which actually did not stand for anything.
So in memory of Professor Mandelbrot and chaos theorists everywhere (especially our Harvard friend at a well known money management firm in Canada), we are going to focus on only 3 important global macro events this morning as it relates to managing risk, which are as follows:
1. The Election - As many of our subscribers know elections are near and dear to our hearts and the upcoming midterm election is one we've been very focused on. (If you would like to trial our research and to see some of proprietary election analysis, please email sales@hedgeye.com.) In fact, we are on record saying that we are more bullish for Republican chances than our friend Karl Rove. For us, though, it is not about politics, but is simply math. As the math stands now, and excluding races that are "too close to call", the Republicans will win 233 seats in the house (a majority) and will win 45 seats in the Senate. We believe that turnout could be the wildcard and slide many of the "too close to calls" to the Republicans as many poll internals show a highly motivated Republican base. The primary implication of this is that the Republicans will likely implement immediate budget cuts, which, according to reports this morning, could be as much as $100BN as soon as January. While in the short term a decline in government spending may hurt GDP, in the longer term deficit reductions will put the U.S. economy on a more stable path of growth.
2. Greek Deficits - If you don't think that government numbers can be wrong or revised lower, well now you know. Greek deficits this morning were revised higher to 15% of GDP as, shockingly, tax revenues were worse than expected. As we've been saying for months, sovereign debt issues in Europe will rear their ugly heads again and obviously Greece is at the forefront of that again this morning. We've highlighted this point of Interconnected Global Risk in the Chart of the Day below, which highlights that credit default swaps in Europe are making higher lows. As these CDS spreads increase, we are likely to see equity markets act inversely to those spreads widening.
3. U.S. Dollar - The U.S. dollar is appreciating this morning (not a sentence we have been used to typing over the last few months) on the back of Wall Street Journal reports that while Quantitative Guessing will likely be implemented on some level, it won't be the "shock and awe" type that many proponents of Krugman Kryptonite were hoping would be implemented. It seems Chairman Bernanke may actually be listening to some of his colleagues at the Fed like Thomas Hoenig, president of the Federal Reserve Bank of Kansas City, who said Monday that more expansive monetary policy was a "bargain with the devil." Indeed. The most immediate term impact of a stronger dollar is likely a correction in those commodities that are priced in dollars.
Just like Mandelbrot, many of the fine folks at Hedgeye have left higher paying jobs to pursue their passion. This passion is the art and process of producing objective and real-time investment research, which we believe is Hedgeye's core competency. We aren't always right and we aren't always popular, but we passionately believe in what we do and we thank you for your support.
Yours in risk management,
Daryl G. Jones
Managing Director
stock is halted
hard to believe amln isn't down more
Copaxone Highlights. Teva had a big presence at ECTRIMS, with
a centrally located booth touting a "Think Thin" campaign (lower
gauge needle) and Copaxone's long-term efficacy and safety. Foot
traffic was high, seemingly reflective of physician loyalty. Data-wise,
we were encouraged by SONG trial results, which found a lower
volume dose (20mg in 0.5ml, 1/1/11 PDUFA) effective in reducing
pain and injection site reactions vs. the current 20mg in 1.0ml dose.
Curiously, AEs were higher for the lower volume dose (18.1% vs.
12.5%, with more infections seen), but there were no deaths, SAEs
or AEs that lead to discontinuation.
the above was written in a Jefferies report by Corey Davis
This is what I call saving the best for last
Phase II Study with Ocrelizumab Shows Significant Reduction in Disease Activity for Multiple Sclerosis Patients
Press Release Source: Genentech On Friday October 15, 2010, 9:30 am EDT
GOTHENBURG, Sweden--(BUSINESS WIRE)-- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (NASDAQ:BIIB - News) today announced 24-week results1 from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form2 of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate. Patients with RRMS suffer from relapses and disabling symptoms caused by nerve damage which can significantly affect their quality of life.
Reductions in total number of brain lesions detected by magnetic resonance imaging (MRI) scans (the primary endpoint of the study) were highly significant at 96% for 2000mg ocrelizumab and 89% for 600mg ocrelizumab compared to placeboi. Disease activity was also measured by reduction in annualized relapse rate (ARR), the rate of attacks or flare-ups per patient-year. At week 24, ARR was significantly lowered versus placebo with a reduction of 73% for ocrelizumab 2000mg and 80% for ocrelizumab 600mgii.
“These efficacy results are amongst the most remarkable seen in a phase II RRMS study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease,” said Professor Ludwig Kappos, lead investigator of the study, from the Department of Neurology, University Hospital Basel, Switzerland.
“We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with MS,” commented Hal Barron, M.D., executive vice president, Product Development and chief medical officer. “We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development.”
Both ocrelizumab doses were generally well tolerated and no opportunistic infections were reported. Serious adverse events (SAEs) were similar in all treatment groups. Infusion-related events during first infusion, predominantly mild to moderate, were more common with ocrelizumab (34.5% and 43.6%) than placebo (9.3%). However, these reports decreased during the second ocrelizumab infusion and were comparable to those initially reported with placebo.
About the Study
A phase II randomized, multicenter, 220-patient study investigating ocrelizumab compared to placebo in patients with RRMS. Open-label, rater-blinded, interferon beta-1a (30 mcg IM) was also included as a study arm.
Efficacy and safety profile of two dose regimens of ocrelizumab (600mg and 2000mg) were evaluated. Patients were treated for 24 weeks and received two ocrelizumab intravenous infusions of 300mg or two intravenous infusions of 1000mg given at day 1 and day 15.
Primary endpoint was efficacy measured by gadolinium-enhancing T1 lesions observed by magnetic resonance imaging (MRI) scans of the brain at weeks 12, 16, 20 and 24 compared with placebo.
Secondary endpoints included ARR at week 24; total number of new gadolinium-enhancing T1 lesions at four-weekly intervals; safety and tolerability of the two ocrelizumab dose regimens compared to placebo and interferon beta-1a.
In the double-blinded treatment groups (ocrelizumab 600mg, ocrelizumab 2000mg vs. placebo) SAEs included: systemic inflammatory response syndrome [SIRS] (0.0%, 1.8% vs. 0.0%), hypersensitivity (1.8%, 0.0% vs. 0.0%), oral herpes (0.0%, 0.0% vs. 1.9%), squamous cell carcinoma of the skin (pre-existing lesion) (0.0%, 1.8% vs. 0.0%) and anxiety (0.0%, 1.8% vs. 0.0%). One death related to the consequences of a systemic acute inflammatory reaction was recorded in the 2000mg ocrelizumab treatment arm. A causal relationship with ocrelizumab has not been established.
Patients will be treated according to study protocol for up to 96 weeks, receiving ocrelizumab infusions every 24 weeks.
About Ocrelizumab
Ocrelizumab is an investigational humanized monoclonal antibody designed to selectively target CD20-positive B-cells, which are believed to play a critical role in multiple sclerosis (MS). It then interacts with the body’s immune system to eliminate CD20-positive B-cells.
About Multiple Sclerosis
Multiple sclerosis (MS) is a highly debilitating autoimmune disease of the central nervous system (CNS) and is one of the leading causes of neurological disability in young adults3,4. The immune system incorrectly attacks healthy nerve tissue in the CNS which affects the transfer of messages from the CNS to the rest of the body5. Symptoms are unpredictable and vary between patients, but include tingling, numbness, pain, slurred speech, and blurred or double vision. Some patients may experience muscle weakness, poor balance or coordination and tremors as well as altered sensation, memory and concentration problems. In severe MS, patients have permanent symptoms, including partial or complete paralysis and difficulties with vision, speech and memory. According to estimates of the World Health Organization, approximately 1.3 million people worldwide have been diagnosed with multiple sclerosis6. Most people experience their first symptoms between the ages of 20 and 40 years7. Relapsing-remitting multiple sclerosis (RRMS) is the most common form of MS and accounts for around 85% of all cases2. RRMS is characterized by acute exacerbations with full or partial recovery between attacks.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
All trademarks used or mentioned in this release are protected by law.
References
1) ‘Efficacy and Safety of Ocrelizumab in Patients with Relapsing-Remitting Multiple Sclerosis: Results of a Phase II Randomized Placebo-Controlled Multicenter Trial’, Kappos et al., ECTRIMS 2010
2) Multiple Sclerosis Society (MSS) UK’s information page, What is relapsing and remitting MS? http://www.mssociety.org.uk/about_ms/types_of_ms/what_is_rrms.html#
3) Ford HL, Gerry E, Johnson M, et al. A prospective study of the incidence, prevalence and mortality of multiple sclerosis in Leeds. J Neurol 2002; 249:260–265
4) Sloka JS, Pryse-Phillips WE, Stefanelli M. Incidence and prevalence of multiple sclerosis in Newfoundland and Labrador. Can J Neurol Sci 2005; 32:37–42
5) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 10/30/09
6) MS Atlas, World Health Organization, 2008
7) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 10/30/09
-----------------------------
i p-value <0.0001 and <0.0001
ii p-value 0.0014 and 0.0005
Contact:
GenentechJoe St. Martin, 650-467-6800 (Media)Karl Mahler, 011 41 61 68785 03 (Investor)orBiogen IdecAmy Reilly, 617-914-6524 (Media)John Applegate, 617-679-2812 (Investor)
Windhover Announces the 2011 "Top Biopharma Projects to Watch"
Listed Companies to Present at Therapeutic Area Partnerships Conference, November 2-4 in Boston
ShareretweetEmailPrintPress Release Source: Elsevier Business Intelligence On Thursday October 14, 2010, 11:15 am EDT
NORWALK, CT--(Marketwire - 10/14/10) - Elsevier Business Intelligence and Windhover Conferences today announced the 2011 Top Projects to Watch list. The list delivers projects and companies with high-value assets for partnership. Winners exhibit the potential to create future growth through investments in deals.
This year's list includes a Top 10 in each of six therapeutic areas: cardiovascular/metabolic, oncology, neuroscience, infectious diseases and inflammatory/autoimmune, plus a "hot space" category, including ophthalmology, orphan diseases, and women's health. The selected companies have been screened using a strict set of judging criteria, including unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications, and corporate stability.
The complete list of all projects to date is available at www.windhover.com/taprojects.
Each project has been hand-selected by Windhover's elite selection panel to ensure a high-quality slate of presenters.
Oncology companies on the list to date are MolMed S.p.A. (NGR-hNTF for mesothelioma), MethylGene Inc. (MGCD265 for solid tumors), Astex Therapeutics (AT9283 for hematologic malignancies including AML), AVEO Pharmaceuticals Inc. (Tivozanib for renal cell carcinoma), Synta Pharmaceuticals Corp. (STA-9090 for multiple solid tumor and hematologic cancers), Oxford Biomedica (TroVax, cancer vaccine), Alexion Pharmaceuticals Inc.(samalizumab which is in Phase I/II development for B-CLL and MM), Tracon Pharma (TRC105 for solid tumors and prostate cancer) and Calistoga Pharmaceuticals (CAL-101 for hematologic malignancies).
Cardiovascular/metabolic companies are NormOxys (OXY 111A for hypoxia), Spherix (Tagatose for Type 2 diabetes mellitus), Resverlogix Corp. (RVX 208 for Acute coronary syndromes, Alzheimer's disease, Atherosclerosis), Genfit (GFT 505 for lipid metabolism disorders), Halozyme Therapeutics (Hyaluronidase/insulin), Lexicon Pharmaceuticals (LX4211 for Type 2 diabetes), Rhythm (RM-493 for obesity and insulin resistance), Momenta Pharmaceuticals (M 118 for acute coronary syndromes), Viron Therapeutics (VT 111 for Acute coronary syndromes, Atherosclerosis, Coronary artery restenosis, Myocardial reperfusion injury, Rheumatoid arthritis, Transplant rejection) and Stealth Peptides (MTP131 for Myocardial infarction and aschemia reperfusion injury).
Neuroscience companies are Naurex Inc. (GlyX-13, MRX1051 for treatment-resistant depression), NeurAxon Inc. (NXN-188 for migraine), PsychoGenics Inc. (eltoprazine for ADHD), Seaside Therapeutics (STX209 (arbaclofen) for Fragile X Syndrome), BrainCells (BCI-540, BCI-952 for depression), AgeneBio (levetiracetam for MCI, Alzheimer's), BioAxone (Cethrin for spinal cord injury) and CeNeRx (TriRIma, the antidepressant).
Inflammatory/autoimmune companies are Hutchison MediPharma (HMPL 004 for Crohn's disease, ulcerative colitis), SunTen Phytotech (STA 36 for allergic asthma), Yaupon Therapeutics (Clearazide for cutaneous T-cell lymphoma/psoriasis), Agennix (Talactoferrin alfa for allergic contact dermatitis, asthma, psoriasis, etc.); Biofrontera AG (aminolevulini acid for actinic keratosis, basal cell cancer, condylomata acuminate); Neovacs (TNFa Kinoid immunotherapy), Anthera Pharmaceuticals Inc. (A-623 for lupus), Kineta Inc. (Kv1.3 potassium channel blockers for MS, rheumatoid arthritis, type 1 diabetes and other autoimmune diseases), Idera Pharmaceuticals (IMO-3100 for inflammatory disease) and Alvine Pharmaceuticals (ALV003 for celiac disease).
Companies with top infectious diseases projects are Progenics Pharmaceuticals Inc. ) PRO 140 for HIV/AIDS), Vaxinnate (VAX125 for flu), SCYNEXIS Inc. (SCY-635 for Hepatitis C), GlobeImmune Inc. (GI-5005 for Hepatitis C), Optimer Pharma (Fiaxomicin, antibiotic), Sangamo Biosciences (SB-728-T for HIV/AIDS), Achillion (ACH-1625 for HCV), Theravance (TD-1792 for MRSA), Argos Therapeutics (AGS-004 for HIV/AIDS) and Dynavax (HEPLISAV for hepatitis B).
Top Hot Space companies are Vital Therapies (ELAD for liver failure), Lithera (LIPO-102 for exopthalmia of Graves Disease), CoDa Therapeutics (Nexagon for leg ulcers), Inspire Pharmaceuticals (Denufosol for cystic fibrosis), Radius Pharmaceuticals (RAD1901 for hot flashes), Cytokinetics (CK-2017357 for ALS and other indications), Lux Biosciences (LX214 for dry eye and blepharitis), Osteologix (strontium malonate for post-menopausal osteoporosis), and Tranzyme Pharma (novel compounds for gastric emptying and motility).
All companies are listed in random order.
"This year's list is handpicked in the six hottest therapeutic areas", said David Cassak, VP, Content, for Elsevier Business Intelligence's publications. "Many of our past winners have gone on to do big deals, and we expect the same from this years' companies."
A major partnering event
'Top Projects' companies will present at Therapeutic Area Partnerships, the Pharma's most targeted and efficient partnering meeting for life science companies seeking partnerships in the top therapeutic areas, November 2-4 in Boston.
Companies will present the product's target and first indication(s); other compounds addressing the same target; the relative advantage of the compound; the clinical results to date and general clinical plan for the future; IP on the compound or target; and any partnerships the company currently holds on the compound. Registered attendees will have pre-conference access to a database that includes detailed technical, non-confidential information on projects available for partnering (pre-clinical and clinical stage).
Industry analysts will open each Top Projects session with therapy area-specific discussions on Matchmaking in Drug Partnering: Identifying the Right Drugs and the Right Partners. Leading industry executives will discuss timely issues, including Therapeutic Area Challenges and Opportunities: Who Will Win, Who Won't, and Where Are You in the Mix; Scientific Innovation and Industry Barriers: Rethinking the Business Development Model for Hard Times; Leveraging Insights to Pick Targets and Deal Models that are Likely to Succeed; Rainmaking in a Drought: Financing Innovation, Innovating Finance; and Creative Risk Sharing and Alternative Funding Strategies for Today's Biotech.
To register, contact Pat Cardone at (203) 838-4401 ext. 124 or pcardone@windhover.com.; or register on the Therapeutic Area Partnerships 2010 website at www.tapartnerships.com.
Top industry executives and strategists to speak at Therapeutic Area Partnerships include Dr. Stephen Friend, former Senior Vice President and Franchise Head for Oncology Research, Merck & Co.; David H. Donabedian, PhD, MBA, Vice President, Strategic Alliances, US CEEDD, GlaxoSmithkline; Polly Murphy, VP, R&D Business Development, Pfizer Inc.; Sridaran Natesan, PhD, Scientific Site Head, R and D (Cambridge), Head of External Innovation and Partnering, Sanofi-Aventis; Ulrik Spork, Managing Partner, Novo Growth Equity; and Lauren Silverman, Ph.D., Managing Director, Novartis Option Fund.
About Windhover Conferences
Windhover Conferences is an Elsevier Business Intelligence company, the leading provider of business intelligence and analysis to senior executives in the medical device, pharmaceutical, and biotechnology industries. Publishers of "The Pink Sheet," PharmAsia News, "The Tan Sheet", IN VIVO: The Business & Medicine Report, Start-Up: Emerging Medical Ventures, and The RPM Report: Regulation -- Policy -- Market Access, Elsevier and Windhover also host a variety of industry meetings and webinars in both medical device and pharma/biotech, and produce a wide array of market research reports. For more on the companies' products and services, please visit www.ElsevierBI.com.
Contact:
Contact:Pat Cardone(203) 838-4401 ext. 124Email Contactor register at www.tapartnerships.com
Will Access Pharmaceuticals keep trending higher? PDF
Written by M.E.Garza
Monday, 11 October 2010 17:14
1retweet0As we told our subscribers this past weekend, the stock for Access Pharmaceuticals (OTC: ACCP) has been acting very bullishly. During the past two weeks the company the press releases have caught our attention and the stock has been pushing higher. Our advice was for investors, just as it was back in September, was to put the stock on their watch lists.
While candle stick analysis shows some uncertainty in the market direction at the end of Columbus Day trading, shares of ACCP broke through resistance on Friday and closed up at $2.63+0.13 (5.20%) with the next 2 levels of minor resistance showing at $2.69 and $2.75 respectively. In addition to everything else that is shaping up for them, Greg Zeng of Zacks recently reconfirmed his $8.00 price target for ACCP and stated his belief that "third quarter financials are expected to be better than our estimates."
This morning, the company announced some highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.:
MuGard provided a significant improvement and/or stabilization of oral mucositis lesions and symptoms of oral mucositis (OM) in more than 75% of cancer patients treated with radiotherapy/chemotherapy;
Patients reported a 52% significant reduction in oral discomfort (oral pain and swallowing ability) in patients with pre-existing lesions of OM, and reported a substantial reduction in the use of pain medication;
MuGard has a ready-to-use formulation that is well accepted by 86% of patients, as reported in this assessment program;
No MuGard-related adverse reactions have been identified in clinical practice;
MuGard represents a valuable therapeutic option in the treatment and prevention of OM in cancer patients undergoing radio/chemotherapy.
In an interview with BioMedReports Access Pharmaceuticals, CEO Jeff Davis said: “As we continue our extensive outreach to top oncology networks, we are reminded constantly of the dire need for something that works to treat oral mucositis. We are pleased to learn the additional European clinical experience data strongly supports MuGard as a curative treatment for Oral Mucositis. This curative data coupled with the previously announced impressive prophylactic (preventative) data, further positions MuGard as the leading treatment for Oral Mucositis currently available today.”
See the today's ACCP candlestick chart
ACCP's Equities Research Report
Access Pharmaceuticals, Inc.
2.63 - (0.00%)
Intraday |
3 Month |
6 Month |
1 Year
Quotes delayed at least 20 mins.
Access also announced recently that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies. As a result, Access rebranded the targeted-drug delivery technology as CobaCyte™; and submitted additional patent applications for its improved CobaCyte formulations, including siRNA compositions.
According to the company, the siRNA application has shown significant promise. There are several diseases for which this targeting approach holds promise; for example, cancer, rheumatoid arthritis, psoriasis, acute leukemia, lymphomas, Crohn’s disease, ulcerative colitis, and multiple sclerosis. Access Pharmaceuticals is developing applications of this technology in the area of oncology, while seeking collaborations and partnerships for development of this technology for other diseases.
Additionally, Access has initiated a program whereby proprietary formulations of currently marketed chemotherapies will be developed and tested to assess CobaCyte's ability to enhance drug pharmacokinetics and pharmacodynamics.
In a previous press release issued in late September, the company announced that signed a $30 million supply agreement for it's novel; ready-to-use mucoadhesive oral wound rinse and coating MuGard with RHEI Pharmaceuticals, Inc. ("RHEI"), a specialty pharmaceutical company focused on bringing proprietary medicines to the China market. Access will ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
At the time, BioMedReports reached out to Access Pharmaceuticals, CEO Jeff Davis to ask about that agreement and this is what he had to say:
"Central to the announcement is both the sublicense agreement between RHEI and Jian An, and the $30M MuGard supply agreement. Jian An is a large, well-established pharma company in China with over 150 branch offices and 1400 sales reps calling on hospitals, clinics, etc. It was the expectation of a larger, more significant commercial launch in China that triggered the agreement and necessitated the need to secure some manufacturing capacity through the supply agreement with Access Pharmaceuticals. We are certain that Access, through our third-party manufacturer Accupac, can meet the near-term needs of RHEI/Jian An for its launch of MuGard. Additionally, this relationship allows Access to explore additional collaborative opportunities with Jian An on our other programs."
We are told that Jian An is responsible for finalizing marketing approval of MuGard and though they remain on-track with the finalizing the regulatory process in each area, they wanted to ensure adequate supply of MuGard to push through its promotion channels for when marketing approval is finalized.
See the today's ACCP chart here:
http://stockcharts.com/h-sc/ui?s=ACCP&p=D&b=5&g=0&id=p64573069591
Research Report here:
http://biomedreports.com/Download-document/141-Equity-Report-for-Access-Pharmaceuticals-ACCP.html
More information about ACCP's Cobalamin-targeted drug-delivery program can be found here:
http://www.accesspharma.com/product-programs/cobalamin-targeted-delivery/
Disclosure: No positions
Read the full report: http://biomedreports.com/2010101157747/chances-are-access-pharmaceuticals-will-keep-trending-higher.html#ixzz127KPTwNA
I am sure biovail had access to anything they wanted before they shelled over 40 million