FDA Advisory Committees Set Meeting Dates
by Mark S. Senak
EyeOnFDA.com
Hi there. I know I was taking this week off for vacation, but it hasn’t worked out that way. After a quick trip to the family, a 14 hour return drive, instead of R&R, I’m working again. So here is a quick posting to let you know that the FDA today published its list of tentative advisory committee meeting dates for 2007.
There is nothing earth-shattering in a list of dates, but it is interesting to note where the action is. If a committee is scheduled for a slew of meetings, it is a good indication that the FDA is expecting to review a number of products in that therapeutic category. So which committees led the pack?
The real action is in devices. The Orthopaedic and Rehabilitation Devices Panel is scheduling 12 meeting days during 2007, followed by the Circulatory System Devices Panel and the Ear, Nose, and Throat Panel with 10 meeting days each. Trailing the pack slightly is the Obstetrics and Gynecology Devices Panel with 8 meeting days.
Next comes CDER, with more committees but a less active roster. The Cardiovascular and Renal Health Advisory Committee is leading there with 8 days of scheduled meetings, followed by the Oncologic Drugs Advisory Committee with 7 days and the Endocrinologic and Metabolic Drugs Advisory Committee with 6.
There is always a lot of talk that biologics are overtaking chemical compounds in development, but the schedule for CBER does not bear that out yet. There, the Vaccine and Related Biological Advisory Committee has scheduled 8 meeting days, followed by the Blood Products Advisory Committee and the Cellular Tissue and Gene Therapies Advisory Committee with 6 days each.
Of course, all of these dates, like my own dating life, is subject to change….
(The above article was re-published by BioHealth Investor with the exclusive permission of the author Mark S. Senak of EyeOnFDA.com)
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FDA Delay Reaffirms Shorting of Encysive Stock
by Andrew Vaino
I’ve written on a couple of occassions how I thought Encysive Pharmaceuticals (ENCY) was a good short. With announcement today that the FDA will delay any ruling on Thelin until June 15th, the stock dropped 25%. I still am mistrustful of the CEO for his lack of disclosure as to what the problem with their first two submissions was.
The stock may well drop further, but at this point I would look to cover tomorrow and take the ~25% profit the short I recomended (@ $5.76 week of Nov. 6) affords. My take is the stock will wind back up toward June, when it will time to reevaluate whether to go long or short. My initial guess is still short, but this is subject to change.
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Relted BHI articles:
- No Decisive Word on Encysive Pharmaceuticals
- Encysive: Despite TBC3711 Trial Resumption, Thelin is Key Factor
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VIVUS Looking to Profit from Obesity and Sexual Dysfunction
by H.S. Ayoub
BioHealthInvestor.com
Unless you have been under a rock, and not under a bed cover, you have probably heard of Pfizer’s (PFE) Viagra and ICOS’s (ICOS) Cialis, the erectile dysfunction blockbuster drugs that have been part of the prime time acts of many comedians. But it is not too late for small investors to jump in on the ground floor for the next line up of blockbuster drugs catering to sexual dysfunction and obesity in both men and women.
VIVUS Inc. (VVUS) is a small biopharmaceutical company focused on the growing need for sexual dysfunction and obesity drugs that have become a regular part of the lives of millions of baby boomers.
Back in 1997, VIVUS was granted marketing approval by the FDA for a novel treatment for erectile dysfunction in men, called MUSE, which is quite an interesting treatment to say the least.
While Viagra and Cialis are oral treatments, MUSE is a pellet smaller than a grain of rice that is administered through the penis! It is thus not surprising that MUSE has not garnered the attention necessary for huge profits.
VIVUS cleverly initiated a clinical program aimed at developing an oral therapy for erectile dysfunction in men, to compete with Viagra and Cialis. Avanafil is currently being readied for phase III clinical trials as an oral treatment for erectile dysfunction.
Previous phase II studies have shown that 84 percent of Avanafil doses resulted in erections, and Avanafil’s 20 minute onset of action was comparable to Sildenafil, the active ingredient in Viagra.
One more very important and potentially lucrative observation was that Avanafil had less effect on blood pressure and heart rate than did Viagra.
But VIVUS is also very aware of the health needs of women. How about Female Sexual Dysfunction, or FSD? Could drugs tailored to FSD be the next round of blockbuster treatments?
According to the American Urological Association about 40 million women in one way or another suffer from FSD in the United States. That could make a very large and lucrative pool of consumers for VIVUS which is tackling the problem with Testosterone MDTS, a transdermal spray that delivers a dose of the hormone through the skin.
Testosterone MDTS is being investigated through late stage clinical trials for the treatment of hypoactive sexual desire disorder (HSDD), a condition in women characterized by low sexual desire.
Just recently VIVUS announced that the FDA had accepted its New Drug Application (NDA) for EvaMist, a transdermal spray treatment for menopause. If accepted for marketability this could at least provide a confidence booster for the spray technology used in Testosterone MDTS, and EvaMist itself could also bring in substantial revenue for the company.
VIVUS’s true blockbuster potential could rely on Qnexa, a two drug formulation that could potentially supress the apetite and burn fat through a once-a-day tablet! The size of the potential consumer market cannot be over-exaggerated.
Phase II trial results of Qnexa showed an average weight loss of 20 pounds by 24 weeks of treatment. To put this data in perspective, patients taking Sanofi-Aventis’s (SNY) Acomplia lost only about 10 pounds after 52 weeks!
Also, the weight loss did not reach its peak after 24 weeks, which has been shown in studies of other drugs.
VIVUS continues to show lower sales and revenue year after year for the last few years. The company also carries cash of only $26 million and debt of more than $10 million as last reported by Yahoo!Finance. But the company did sell shares back in November of 2006, generating more than $30 million in additional fundings. The company burned more than $20 million in cash last fiscal year. So the more than $50 million in cash the company currently holds should be more than enough for VIVUS to continue the development of its strong pipeline through 2007, and to launch EvaMist following the expected FDA approval.
Being a small company, with a market cap of less than $200 million and a strong pipeline filled with late stage candidates tailored towards billion dollar markets, VIVUS could very well end up being acquired by a larger drug company keen on competing with Viagra and Cialis.
2007 looks to be a very promising year for VIVUS.
VIVUS is now a BioHealth Investor Stock Pick.
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Tuesday's Top Biotech and Medical Stocks
Biotechnology
NEURALSTEM INC [NRLS.OB] +19.05%
REPROS THERAPEUTICS [RPRX] +16.52%
CYTORI THERAPEUTICS [CYTX] +13.83%
ADVENTRX PHARMACTL [ANX] +10.98%
ARTES MEDICAL, INC. [ARTE] +9.83%
Diagnostic Substances
ASPENBIO PHARMA INC [APNB.OB] +7.66%
EPICEPT CORPORATION [EPCT] +7.19%
ISTA PHARMACTLS [ISTA] +6.54%
THRESHOLD PHARMACEUT [THLD] +5.08%
TORREYPINES THERAPEU [TPTX] +4.69%
Drug Delivery
IOMED INC [IOX] +3.67%
COLUMBIA LABS INC [CBRX] +2.78%
MATRIXX INITIATVS [MTXX] +1.91%
BIOVAIL CORP [BVF] +1.89%
NOVADEL PHARMA INC [NVD] +1.84%
Drug Manufacturers
QUICK-MED TECHNOLOG [QMDT.OB] +20.19%
JAVELIN PHARMACEUTIC [JAV] +11.83%
NITROMED, INC. [NTMD] +5.04%
DUSA PHARM INC [DUSA] +3.55%
BRADLEY PHARMACTCL [BDY] +3.25%
Medical Appliances & Equipment
ESCALON MED CP [ESMC] +7.36%
RESTORE MEDICAL INC [REST] +5.05%
SYMMETRY MEDICAL INC [SMA] +4.81%
SPECTRASCIENCE NEW [SCIE.OB] +4.48%
INVACARE CORP [IVC] +3.47%
Medical Instruments & Supplies
MINDRAY MEDICAL INTL [MR] +6.63%
ENDOLOGIX INC [ELGX] +5.67%
ENPATH MED INC [NPTH] +5.38%
MEMRY CORPORATION [MRY] +4.84%
RETRACTABLE TECH INC [RVP] +3.99%
Medical Laboratories & Research
PREMD INC [PME] +6.08%
BIO-IMAGING TECH [BITI] +2.21%
ALLIANCE IMAGING INC [AIQ] +2.15%
NEOGENOMICS INC [NGNM.OB] +2.07%
SPHERIX INC [SPEX] +2.00%
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ADVENTRX Cleared to Initiate New Cancer Drug Study
by H.S. Ayoub
BioHealthInvestor.com
ADVENTRX Pharmaceuticals (ANX) announced early Tuesday that the FDA has accepted its Investigational New Drug (IND) application for a bioequivalence study of its cancer drug candidate ANX-530.
The study will aim to compare ANX-530, a generic anti-cancer drug, to Navelbine, already approved for small cell cancers.
The new study is to be initiated in 2007, and the company expects to file a New Drug Application (NDA) by end of 2007.
Preclinical studies of ANX-530 have shown the following conclusions:
- Pharmacokinetics were unchanged between ANX-530 and Navelbine
- No Difference in anti-tumor activity was found between the two formulations
- ANX-530 showed less irritation of of the vein and site of injection
Shares of ADVENTRX were trading at $2.75 a share, up more than 4% in pre-market action.
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Has Wal-Mart's $4 Drug Program Begun To Lose Gas?
Walgreeen (WAG) and Rite Aid (RAD) both turned in excellent results for the last quarter. Part fo the message sent by both companies is that Wal-Mart’s (WMT) $4 generic drug program is not hurting them. But, Wal-Mart said its November pharmacy sales were up sharply.
Some part of this does not make sense. Some analysts say that the Wal-Mart drug buyers as consumers without insurance who were not going to any store while the mainstream pharmacies cater to patient who are insured. Rite Aid and its large competitiors keep more generic drugs stocked in its stores, and their prices are not very different from Wal-Mart’s.
If there is a surge in the purchase of generic drugs that is fueling growth at both Wal-Mart and Walgreen, there has to be a problem a Big Pharma company’s who patent drug sales are being eroded by generics already.
Again, that answer would be too simple. Some data still appears to be missing.
While the mystery of both Wal-Mart and Walgreen both doing well is still open, one piece of data does appear to be clear. CostCo (COST) took a shot at $4 generics and lost money. They moved the price point to $10.
Lost money? Can Wal-Mart be making any at $4? If not, one of Wal-Mart’s biggest initiatives could be a bust.
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IBD Weekly Top Ranked Medical Stocks
The following list represents the top ten medical stocks ranked according to Earnings Per Share and Relative Strength by Investor’s Business Daily (12/23/06)
scores out of 100 (last week’s rank, change in score):
1(1) Arrhythmia Research (HRT) EPS=95 RS=99
2(4) Celgene Corp (CELG) EPS=98 RS=95(+2)
3(2) LHC (LHCG) EPS=98 RS=95(+1)
4(6) Immucor (BLUD) EPS=95 RS=95(+1)
5(7) West Pharmaceutical (WST) EPS=94 RS=95(+1)
6(-) Nighthawk Radiology (NHWK) EPS=99 RS=90
7(8) Wellcare (WCG) EPS=95 RS=93(+1)
8(3) Mindray Medical (MR) EPS=99 RS=89(-4)
9(5) Palomar Med Tech (PMTI) EPS=99 RS=87
10(9) American Oriental Bio (AOB) EPS=87 RS=99
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Three FDA Approvable Letters Issued This Week
by Mark S. Senak
EyeOnFDA.com
Not all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to three companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued. These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.
New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder (ADHD). The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.
Allergan (AGN) Receives Approvable Letter – Allergan of Irvine, California, announced an approvable letter for its product for COMBIGAN, a treatment for patients with glaucoma experiencing elevated intraocular pressure. The release states that an additional confirmatory study is being requested by the agency and a quote from the Executive Vice President of Research and Development states that the study has already been underway.
Generic Omeprazole Delayed – Perrigo (PRGO) announced that it received an approvable letter for a generic version of omeprazole. There was no word on the cause of the approvable letter or what conditions the FDA is seeking prior to approval. If eventually approved, however, the generic version of omeprazole, a compound now marketed by Procter & Gamble (PG) as Prilosec OTC, would be the first.
I did say yesterday, Eye on FDA would be on hiatus. But I woke up to see 3 new approvable letters this morning and felt compelled to let you know about them.
(This article was re-posted with exclusive permission from the author Mark S. Senak of EyeOnFDA.com)
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Friday's Top Biotech and Medical Stocks
Biotechnology
REPROS THERAPEUTICS [RPRX] +30.18%
INTERMUNE INC [ITMN] +29.03%
EXACT SCIENCES COR [EXAS] +24.59%
LA JOLLA PHARMA [LJPC] +10.32%
IDM PHARMA INC [IDMI] +9.16%
Diagnostic Substances
REMOTEMDX INC [RMDX.OB] +12.95%
IMMUNOMEDICS INC [IMMU] +7.98%
GENE LOGIC INC [GLGC] +4.64%
ASPENBIO PHARMA INC [APNB.OB] +4.44%
MONOGRAM BIOSCIENCES [MGRM] +2.87%
Drug Delivery
BENTLEY PHARMACEUTIC [BNT] +11.38%
EMISPHERE TECH [EMIS] +4.94%
IOMED INC [IOX] +4.26%
ELAN CP PLC ADR [ELN] +4.16%
PENWEST PHARM CO [PPCO] +3.82%
Drug Manufacturers
SCICLONE PHARMA [SCLN] +38.59%
INSPIRE PHARMACEUT [ISPH] +7.04%
ARENA PHARMACEUTIC [ARNA] +6.06%
DEPOMED INC [DEPO] +5.59%
INYX INC [IYXI.OB] +5.56%
Medical Appliances & Equipment
ALPHA INNOTECH [APNO.OB] +33.66%
QMED INC [QMED] +11.14%
RESTORE MEDICAL INC [REST] +6.82%
SYNERGETICS USA INC [SURG] +5.30%
SOMANETICS CORP [SMTS] +3.72%
Medical Instruments & Supplies
IMMUNOCELLULAR THERA [IMUC.OB] +66.67%
LEMAITRE VASCULAR [LMAT] +6.49%
VIVUS INC [VVUS] +5.83%
ENPATH MED INC [NPTH] +5.52%
QUANTRX BIOMEDICAL [QTXB.OB] +5.51%
Medical Laboratories & Research
PREMD INC [PME] +11.28%
MEDASORB TECHNOLOGS [MSBT.OB] +5.00%
PACIFIC BIOMETRICS N [PBME.OB] +2.94%
MEDTOX SCIENTFIC INC [MTOX] +2.86%
ARRAY BIOPHARMA IN [ARRY] +2.24%
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Bentley Up on FDA Approval of Generic Zocor
by H.S. Ayoub
BioHealthInvestor.com
Shares of Bentley Pharmaceuticals (BNT) are up more than 13% early Friday as the company announced that its U.S. marketing partner, Perrigo Company, has received marketing approval for simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets.
The FDA also determined that these formulations are equivalent to Merck’s (MRK) Zocor. Simvastatin will be manufactured at Bentley’s Facility in Spain.
The company has already initiated the manufacturing process for fast introduction into the U.S. market.
Shares of Bentley were trading abover $11 at one point during morning trading hours.
The company’s total stock worth is just under $250 million. Bentley holds cash of just over $20 million with a debt of $380 thousand as last reported on Yahoo!Finance.
Annual sales and net profit have been increasing substantially over the last few years.
On November 9 a company director purchased almost $50 thousand worth of stock at $9.85 a share.
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