HIV Protection Trial Halted Due to Increase Risk of…HIV!
by H.S. Ayoub
BioHealth Investor.com
Shares of Canadian firm Polydex Pharmaceuticals (POLYXF) absolutely sank more than 50% on Wednesday as the company announced that phase III trials of Ushercell, a topical microbicide gel for the prevention of HIV infections in women, were halted internationally.
CONRAD, a reproductive health research organization dedicated to the prevention of AIDS and other sexually transmitted diseases in women and men, halted the trials of Ushercell in South Africa, Benin, Uganda, and India, after women taking part in the late stage trials exhibited an increased risk of HIV infection compared to the placebo group. Family Health International also halted a phase III trial of Ushercell in Nigeria following the preliminary data presented by the CONRAD trials.
This came as a surpise to Polydex officials as numerous earlier trials showed strong and positive data. Ushercell, which is a Cellulose Sulfate based topical gel, had consistently shown strong safety data through 11 trials and 500 total participants. The earlier trials mostly tested the gel’s safety profile and contraceptive potential however.
President and CEO George Usher declared that Polydex will continue to investigate Ushercell’s contraceptive potential, and will work together with CONRAD to determine the cause of the high incidence of HIV infection in the trials.
Polydex stock ended regular hours trading at $3 a share, down 55%. Shares dropped a further 14% to $2.59 in after-hours trading.
RELATED READING:
- Company Press Release
- VIVUS Looking to Profit from Obesity and Sexual Dysfunction
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The New FDA Drug Safety Initiative
by Mark S. Senak
EyeOnFDA.com
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report - The Future of Drug Safety - that soundly thrashed the FDA’s approach to safety issued in September of last year.
As a result, the FDA has entered some new chips into the game. One of them, per the FDA Fact Sheet on this new safety commitment, is the development of a new advisory committee on Risk Communications. We’ll leave that for later.
But another is that the agency is going to issue “report cards” in the words of ABC News. Following 18 months after the approval of a drug, the FDA is going to issue a report on that drug’s post-marketing safety issues. The actual description of these “report cards” contained in the FDA Report report seem somewhat vague on the details. The FDA report is titled The Future of Drug Safety — Promoting and Protecting the Health of the Public - FDA’s Response to the Institute of Medicine’s 2006 Report
Consider this passage:
In 2007, we plan to regularly publish a newsletter on the FDA Web site containing summaries of the results, including methods, of FDA post-marketing drug reviews. The summaries will not include confidential commercial or predecisional information. We believe it is important, particularly for healthcare professionals, for FDA to make readily available and easily accessible the results of our post-marketing reviews of adverse events. In addition, this regular newsletter will contain information on emerging safety issues, as well as provide information on recently approved products both to inform providers and to encourage reporting to the Agency.
But the preceding paragraph raises a caveat that makes it unclear what exactly is going to be in these newsletters:
FDA recognizes the importance of communicating information about the safety of drugs. However, many post-marketing assessments contain recommendations that are the subject of ongoing discussions within FDA and other information that is predecisional in nature. Release of such information could have adverse public health impacts. For example, release of information about a safety signal that is later determined to be erroneous could result in patients who could benefit from the drug not receiving it. Therefore, decisions to publicly disclose assessments of post-marketing safety studies have to be made on a case-by-case basis.
What ever these newsletters do or don’t exactly include nevertheless presents a whole new challenge to public relations supporting drug marketing. If there is to be a safety “report card”, however bold or timid, it becomes a new milestone to figure in to the existing mix of clinical and regulatory milestones.
Consider, for example, two new drugs in a new class are approved at or about the same point in time, such as was the case of Actos and Avandia. Their reports would then also come out at or near the same time. If this newsletter provides any insight at all, it could be a signal to patients, physicians, key opinion leaders and investors that one drug is better than the other. Unless the information to be contained in these newsletters is so vanilla as to be of no use at all, then with the advent of these newsletters, the FDA is adding an important new communications milestone in the life cycle of any new drug. Marketing and public relations teams, take note.
Needless to say, the issue of safety is not going to go away during the post-COX-2 issues and the emphasis of risk over benefit is going to continue.
By the way, this FDA action comes pre-emptively before a re-introduction of the well known Kennedy Enzi bill on drug safety, which, when it appears, will be carried at www.eyeonfda.com.
(This article was published by BioHealth Investor with permission of Mark S. Senak, author of EyeOnFDA.com)
RELATED READING:
- Eurpoean Medicines Agency Lagging Behind FDA
- FDA Warning Letters on the Decline
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Wednesday’s Top Biotech and Medical Stocks
Biotechnology
IDERA PHARMACEUTICAL [IDP] +9.90%
BIONOVO INC [BNVI.OB] +9.20%
CHELSEA THERAPEUTICS [CHTP] +9.00%
CURIS INC [CRIS] +7.58%
MICROMET INC [MITI] +5.78%
Diagnostic Substances
PALATIN TECH INC [PTN] +13.66%
AVALON PHARMACEUTIC [AVRX] +9.30%
SURMODICS INC [SRDX] +7.99%
SYNOVICS PHARMACEUTL [SYVC.OB] +7.69%
ADEZA BIOMEDICAL COR [ADZA] +5.19%
Drug Delivery
QUIGLEY CORP THE [QGLY] +3.62%
MATRIXX INITIATVS [MTXX] +3.12%
EMISPHERE TECH [EMIS] +2.83%
NOVEN PHARMACEUTIC [NOVN] +1.63%
DELCATH SYSTEMS INC [DCTH] +1.36%
Drug Manufacturers
ARQULE INC [ARQL] +7.97%
UNIGENE LABS INC [UGNE.OB] +6.35%
SIGA TECH INC [SIGA] +5.04%
NOVOGEN LTD ADS [NVGN] +4.81%
MARSHALL EDWARDS [MSHL] +4.73%
Medical Appliances & Equipment
HOLOGIC INC [HOLX] +13.84%
RESTORE MEDICAL INC [REST] +12.90%
THERAGENICS CORP [TGX] +12.50%
MEDICAL SOLUTION MGT [MSMT.OB] +10.00%
HANSEN MEDICAL, INC. [HNSN] +9.45%
Medical Instruments & Supplies
IMMUNOCELLULAR THERA [IMUC.OB] +73.91%
NEPHROS INC. [NEP] +19.51%
MILESTONE SCIENTIFIC [MLSS.OB] +15.15%
MICROMED CARDIOVASCU [MMCV.OB] +7.50%
ATRICURE, INC. [ATRC] +5.95%
Medical Laboratories & Research
ARRAY BIOPHARMA IN [ARRY] +3.07%
GENOMIC HEALTH, INC. [GHDX] +1.20%
ERESEARCHTECHNOLOG [ERES] +1.01%
RADNET INC [RDNT.OB] +1.01%
BIO-REFERENCE LAB [BRLI] +0.75%
RELATED ARTICLES:
- Tuesday’s Top Biotech and Medical Stocks
- Monday’s Top Biotech and Medical Stocks
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Companies Banking on Anti-Smoking Trend
by H.S. Ayoub
BioHealth Investor.com
During the November elections three states, Ohio, Arizona and Nevada, passed tight smoking bans. Arizona’s anti-smoking laws will be enforced in May, Ohio is proceeding through the final legal drafts, while Nevada has been challenged in the courts after the state exempted Casinos from the recent regulations (no surprise there!). The three states have now joined 12 other states in banning smoking in all restaurants and bars.
The recent tightening of anti-smoking regulations has given momentum to a brand new industry. Large Pharmaceuticals and smaller firms alike have jumped on this health conscious trend. The National Bureau of Economic Research Inc. suggested in a report issued last year that companies selling smoking cessation products saw total annual sales almost reach the $1 billion mark, with total advertising spending exceeding $100 million.
While GlaxoSmithKline Consumer Healthcare, a division of GlaxoSmithKline (GSK), has been selling its popular Nicorette gum and NicoDerm CQ patch for many years, sales have especially surged lately in states where tighter anti-smoking regulations have passed into law. GSK has also seen a surge in sales of Zyban, the prescription drug of choice for smokers looking to kick the habit.
Laser Innovations, a provider of laser systems, has been receiving more interest lately according to company president Ray Tucke. The company utilizes laser beams on various parts of the body to help smokers quit. It seems that this company is betting big on both the anti-smoking and medical laser health trends
No one could better gauge this recent trend than QuitSmoking.com, a company dedicated to selling all kinds of smoking cessation products, including “No Smoking” signs, nicotine reduction filters, and artificial cigarettes. The company’s president declared that sales of the above mentioned products have increased tremendously during the previous year.
The trend is surely to increase, as MarketResearch.com estimates that products designed to aid smokers in quitting will grow to $809 million in the U.S. alone.
It is not clear if that estimate includes the recent surge in hypnotherapy sessions designed to help smokers quit.
RELATED READING:
- Smoking Bans Spur Business Opportunities (Palm Beach Post)
- The National Bureau of Economic Research Report
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Tuesday’s Top Biotech and Medical Stocks
Biotechnology
PIPEX PHARMACEUTICAL [PPXP.OB] +42.50%
BIONOVO INC [BNVI.OB] +15.87%
NEUROBIOLOGICAL TECH [NTII] +13.93%
REPROS THERAPEUTICS [RPRX] +10.24%
OBAGI MEDICAL [OMPI] +9.90%
Diagnostic Substances
LEXICON GENETICS I [LEXG] +8.50%
GENELABS TECH INC [GNLB] +6.21%
EZ EM INC [EZEM] +5.59%
SURMODICS INC [SRDX] +4.06%
OSTEOLOGIX INC [OLGX.OB] +4.00%
Drug Delivery
COLUMBIA LABS INC [CBRX] +4.57%
FLAMEL TECH SA ADR [FLML] +3.14%
DELCATH SYSTEMS INC [DCTH] +2.79%
EMISPHERE TECH [EMIS] +2.12%
K V PHARMA CL A [KV-A] +1.73%
Drug Manufacturers
ATHEROGENICS INC [AGIX] +13.77%
EXEGENICS INC [EXEG.OB] +9.38%
NITROMED, INC. [NTMD] +7.69%
ALTAIR NANOTECH INC [ALTI] +6.54%
REGENERX BIOPHARM IN [RGN] +6.19%
Medical Appliances & Equipment
THERAGENICS CORP [TGX] +27.17%
ALIGN TECHNOLOGY I [ALGN] +21.21%
REGENERATION TECH [RTIX] +7.88%
EDAP TMS SA ADR [EDAP] +7.88%
ZIMMER HOLDINGS INC [ZMH] +5.92%
Medical Instruments & Supplies
BIOFORCE NANOSCIENCE [BFNH.OB] +12.50%
HEMOSENSE INC. [HEM] +5.70%
UROPLASTY INC [UPI] +5.43%
KENSEY NASH CP [KNSY] +4.00%
VASCULAR SOLUTIONS [VASC] +3.97%
Medical Laboratories & Research
PREMD INC [PME] +4.79%
MEDTOX SCIENTFIC INC [MTOX] +4.00%
ERESEARCHTECHNOLOG [ERES] +1.91%
NATL DENTEX CP [NADX] +1.80%
OSI PHARMACEUTIC [OSIP] +1.55%
RELATED ARTICLES:
- Monday’s Top Biotech and Medical Stocks
- Friday’s Top Biotech and Medical Stocks
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Biotechs Ahead of Pharmas after All?
by H.S. Ayoub
BioHealth Investor.com
In an earlier article, I reviewed Pisano’s book Science Business: the Promise, the Reality, and the Future of Biotech
But a recent report by the Government Accountability Office (GAO) paints a different picture all together. In the report, for which data was collected from the Pharmaceutical Research and Manufacturers of America, the GAO found that the pharmaceutical industry was in fact losing to the biotech industry in the number of new molecular entities (NMEs) approved by the FDA over the last few years.
2003 was the first time that biotechs had a higher number of NMEs approved, and the gap has widened since then. Pharma companies had 16 approvals that year, compared to biotechs’ 18.
According to the report, only one third of pharma’s approvals were new entities, the rest were variations of existing drugs. In fact, the top 100 drugs since 1980 treated only 50 conditions. Big pharmas are thought to have a ‘blockbuster mentality’, a term suggested by many critics as the reason for the industry’s short fall over the last few years.
Big pharmas continue to concentrate on a very small number of target conditions that bring in billions of dollars in revenue. This tactic however has backfired. There are a multitude of other disease conditions being studied by many little biotechs. While singularly unattractive financially, taken all together drugs aimed at those ailments can bring a hefty return on investment capital to the biotech industry as a whole. The big pharmas realize the missed opportunities; hence, the sudden jump in acquisitions of smaller companies over the last couple of years.
One major finding of the GAO report however had nothing to do with competition from the biotech industry. From 1993 to 2004, the report found that while R&D spending by the pharmaceutical industry increased by 147%, drug approvals only increased by 38%.
This finding might not have much to do with the industry’s shortcomings as much as it is the rising cost of medical research, and it will not get cheaper. As the science head at Eli Lilly (LLY) predicts; a new drug could cost as much as $2 billion to develop by the year 2010. This price tag does not guarantee a drug’s approval, as Pfizer (PFE) learned the hard way back in December. The company cancelled its next blockbuster drug torcetrapid after spending $1 billion on the program.
Pharmas also continue to research new drugs the old fashioned way, through a hit-and-miss tactic. Pharmas will have to initiate the utilization of novel techniques, including the use of DNA based research.
But the coming few years might turn things around for the industry, as a changing political environment could provide positive regulatory changes. Under a democratic majority the FDA could prove less restrictive. Pharmas could also be provided with 10 years of market exclusivity. Currently, companies are awarded 20 year patent protection, of which as many as 12 years are dedicated to research and development.
While debates rage on as to which industry is winning, pharmas will continue to gobble up smaller biotechs. It would not be too surprising to see the merging of the two industries over the next couple of decades, eventually forming the singular Biopharma Indsutry.
RELATED READING:
- GAO Report: New Drug Development
- Pharma Industry Lags On Research Efficiencies-IBD
- The Biotech Industry: 30 Years of Failure
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Ranbaxy Appeals Lipitor Case to Supreme Court
Lipitor (atorvastatin calcium), indicated for the reduction of cholesterol, is the world’s best-selling pharmaceutical. Ranbaxy has applied to market a generic version of Lipitor and has challenged Pfizer’s (PFE) patents on Lipitor in many countries around the world–usually without success. For instance, in August 2006 the Federal Circuit upheld the validity of Pfizer’s U.S. Patent No. 4,681,893. (In the same decision the Federal Circuit invalidated Pfizer’s U.S. Patent No. 5,273,995, but Pfizer has vowed to correct the defect through a re-issue.) Now, Ranbaxy has appealed the case to the Supreme Court, on somewhat unconventional grounds.
The Federal Circuit’s August 2006 decision affirmed the district court’s claim construction and found that Ranbaxy’s generic Lipitor infringed the ‘893 patent claims. In addition, the Federal Circuit upheld the validity of Pfizer’s patent term extension on the ‘893 patent, rejecting (in just a couple paragraphs) Ranbaxy’s argument that the extension was invalid due to Pfizer’s failure to disclose material information to the patent office. Ranbaxy is appealing only this latter finding to the Supreme Court.
According to Ranbaxy’s cert petition:
This case presents an important federal question: In seeking a patent term extension under 35 U.S.C. 156 on the basis that the patent claims an approved drug, do the controlling statute and regulation require a pharmaceutical company to disclose (1) its own prior, inconsistent representations made before the United States Patent and Trademark Office that the patent does not cover the approved drug, (2) a patent office Board of Patent Appeals and Interferences decision adopting those representations, and (3) a later patent claiming the drug on which the patent term extension application is premised, or is this information per se irrelevant to the patent term extension proceedings?
Pfizer obtained a patent term extension of more than three years for the ‘893 patent, due to the lengthy FDA approval process for Lipitor. Without the extension, the patent would have expired on May 30, 2006. Ranbaxy unsuccessfully argued in the Federal Circuit that the extension is invalid. Chances are that the Supreme Court will take the case seem remote.
(This article was published by BioHealth Investor with permission of Aaron F. Barkoff, author of OrangeBookBlog.com)
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Eurpoean Medicines Agency Lagging Behind FDA
by Mark S. Senak
EyeOnFDA.com
Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) - the European Union’s FDA equivalent - had met its performance goals, it was nevertheless lagging behind the FDA in approval times.
In terms of review times, the average in the EU was 15.8 months compared to 15.7 months in the US during the period of 2000-2005. According to the report, the agencies approved 71 drugs, but 47 of those were approved more quickly by the FDA than by the EMEA.
That said, if you compare the EMEA to the FDA for the matter of transparency, the FDA also wins hands down. The FDA Web site, for instance, not only lists the meetings of advisory committees, but also posts the transcript of the meeting as well as the slides and supportive materials. The FDA also posts the Warning Letters and has a vast Web site that provides information and therefore, an opportunity for learning. The EMEA provides far fewer such opportunities and the Web site is not exactly consumer-friendly.
One aspect where EMEA is ahead, is that all of the CVs of advisory members are posted on the site, while with FDA, the CVs of most, though not all, committee members are posted by FDA, though often not in a timely manner.
(This article was published by the BioHealth Investor with permission of Mark S. Senak, author of EyeOnFDA.com)
RELATED READING:
- FDA Warning Letters on the Decline
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Monday’s Top Biotech and Medical Stocks
Biotechnology
NEURO-HITECH INC [NHPI.OB] +17.36%
LEV PHARMACEUTICALS [LEVP.OB] +11.18%
OBAGI MEDICAL [OMPI] +9.16%
GENVEC INC [GNVC] +7.84%
ACHILLION PHARMACEUT [ACHN] +6.71%
Diagnostic Substances
SCOLR PHARMA INC [DDD] +8.00%
LEXICON GENETICS I [LEXG] +6.97%
ASPENBIO PHARMA INC [APNB.OB] +6.12%
ABAXIS INC [ABAX] +5.98%
ICAGEN, INC. [ICGN] +5.32%
Drug Delivery
FLAMEL TECH SA ADR [FLML] +11.22%
INSITE VISION INC [ISV] +7.55%
QUIGLEY CORP THE [QGLY] +3.79%
DELCATH SYSTEMS INC [DCTH] +3.77%
K V PHARMA CL A [KV-A] +2.85%
Drug Manufacturers
PHARMAXIS LTD ADR [PXSL] +9.69%
NITROMED, INC. [NTMD] +7.99%
ADVANCIS PHARMA CP [AVNC] +5.95%
BRADLEY PHARMACTCL [BDY] +5.70%
ATHEROGENICS INC [AGIX] +5.56%
Medical Appliances & Equipment
SYNOVIS LIFE TECH [SYNO] +5.76%
ROCKWELL MED TECHS [RMTI] +4.97%
ALPHA PRO TECH [APT] +4.91%
NORTH AMERN SCI [NASI] +4.85%
SPECTRASCIENCE NEW [SCIE.OB] +4.72%
Medical Instruments & Supplies
NEPHROS INC. [NEP] +22.85%
OCCULOGIX, INC. [OCCX] +21.33%
MICROMED CARDIOVASCU [MMCV.OB] +14.29%
IMMUNOCELLULAR THERA [IMUC.OB] +13.04%
BIOMIMETIC THERAPEUT [BMTI] +9.97%
Medical Laboratories & Research
MEDTOX SCIENTFIC INC [MTOX] +6.38%
RADNET INC [RDNT.OB] +3.68%
ERESEARCHTECHNOLOG [ERES] +2.87%
GENOMIC HEALTH, INC. [GHDX] +2.83%
QUEST DIAGNOSTC [DGX] +1.61%
RELATED ARTICLES:
- Friday’s Top Biotech and Medical Stocks
- Thursday’s Top Biotech and Medical Stocks
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Government Contract Could Set Hollis-Eden Stock Soaring
by Andrew Vaino
The upcoming week will be a big one for Hollis Eden Pharmaceuticals (HEPH), a company I’ve written about previously. The company was founded in 1992 and they’ve not advanced a single drug to a Phase 3 clinical trial.
Their lead compound, called Neumune, prevents loss of white blood cells (neutropenia), loss of platelets (thrombocytopenia), and loss of red blood cells (anemia). This drug has been demonstrated safe in several Phase 1 clinical trials. The biggest indication for Neumune is protection against acute radiation syndrome (ARS).
Project Bioshield, a response to potential terrorist attacks, was signed into law in July 2004. One of the purviews of Project Bioshield is to develop and stockpile drugs to protect Americans from biological, chemical, and nuclear attacks. The anthrax scares in Washington DC are a chilling reminder of why this may be important: I’ll leave comments about feasibility aside.
Sensing opportunity, Hollis Eden has been seeking to provide the Government (specifically the Department of Health and Human Services, HHS) with Neumune to protect against a radiation attack. At first glance, this was a smart strategy. Implementation, however, has not been so easy.
HEPH has been trading wildly (according to Yahoo Finance beta = 5.42) over the past 
few years, due in large part to their attempts to secure a contract for Project Bioshield. In my opinion Hollis Eden has an extremely weak pipeline, and this procurement is their last hope. Trouble is, much like Lucy pulling the football away before Charlie Brown can ever kick it, HHS keeps moving the deadline back. Initially a target date of September 30th 2006 was set, which was pushed back to November 30th, which was pushed back to January 31st—next Wednesday.
So, while I would never recommend HEPH as an investment, I think it will be a fun stock next week for day traders (take a look at Friday afternoon’s minute-by-minute chart) and those looking to speculate next week. If HHS awards a contract to Hollis Eden the stock will take a nice spike. If they don’t deliver on a contract, or delay it a third time, I think the stock will take a substantial dive.
There are a couple of ways to play this. A good volatility play is a straddle with March $5 options: open interest on February options is very low, and March options, while still illiquid have a higher open interest.
Now, Project Bioshield has hit some hiccups. A debacle in which a $1B contract was cancelled sent Vaxgen’s stock (VXGN.PK) to the Pink Sheets. There have also been calls, by Senators Collins and Lieberman, for a congressional investigation into Project Bioshield.
But here’s another twist. A week after announcing the November delay in the HHS procurement, Hollis Eden announced it was selling $26M worth of shares at $6.50, a substantial discount then. The company had $48M in cash at the end of Q3, and were burning on average $6M per quarter: there certainly was danger of running out before the January 31st tentative date set by HHS. Waiting until after a contract award would have meant a higher share price, and a bigger infusion of cash.
One can speculate endlessly about what the secondary offering of stock means about management’s confidence in obtaining the contract. To be clear, according to a November press release, Hollis Eden is “not aware of any other company that remains in the competitive range for this contract award”.
Whether or not HEPH gets a contract next week is pure speculation. The stock is trading near $6, so shorting it can be risky—shorts I recommended on Avanir Pharmaceuticals (AVNR) and Encysive Pharmaceuticals (ENCY) were both in this range, and both paid off very well! This is a situation where I like to buy puts, and I have purchased some. To be clear, this is highly speculative, but I like the odds of betting on government inaction. Should be a fun week!
RELATED READING:
- Project BioShield Has Given Biotechs Little Motivation to Protect Americans
- Three Biotech Drugs Have Potential to Treat Polonium-210 Radiation
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