5 BioPharmas To Watch For Wednesday, September 5

by: StockMatusow

Today, I list 5 bio pharmas I believe could be on the move for today and into the next few weeks. Investors and traders might want to keep a close eye on these stocks for consideration to either trade in and out of, or buy and hold for the longer term. These companies all have potential upcoming anticipated catalyst events which could provide traders with a good opportunity to make some decent gains, if traded correctly.

Amarin Corp. (NASDAQ:AMRN) $14.64, up $0.95 (6.94%).

Amarin announced yesterday that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for U.S. Patent Application Serial Number 13/282,145, titled "Method of Treating Hypertriglyceridemia." The application includes claims intended to protect the Vascepa (TM) (icosapent ethyl) indication approved in July 2012 by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results. The Patent Office issues NOAs after deciding that a patent can be granted.

Amarin is also expecting an FDA orange book decision on New Chemical Entity (NCE) status soon for its recently FDA approved Vescepa -- a prescription-only omega-3 fatty acid comprising icosapent ethyl, or ethyl-EPA for the treatment of patients with moderately to extreme elevated levels of high triglyceride levels or hypertriglyceridemia.

Vascepa hopes to compete with GlaxoSmithKline's (NYSE:GSK) 1 billlion dollar drug Lovaza. Both Vascepa are Lovaza are essentially pharmaceuticalized fish oil drugs that went through the full phase 1-to-phase 3 process, and are now approved by the U.S. Food and Drug Administration (FDA) for treating very high triglyceride levels.

It's my personal opinion it's likely that the company will be acquired for the Vascepa assest by a larger pharma soon -- if NCE status is granted.

What to watch for: Upcoming NCE status for Vescepa

Santarus (NASDAQ:SNTS) $7.05, up $0.88 (14.16%).

The company announced yesterday that the U.S. Court of Appeals for the Federal Circuit reversed in part a lower court decision of invalidity involving certain asserted patent claims covering ZEGERID Capsules and ZEGERID Powder for Oral Suspension. The Federal Circuit found that certain claims of asserted U.S. Patent numbers 6,780,882 and 7,399,772, which Par Pharmaceutical, Inc. had been found to infringe, were not invalid due to obviousness. The Federal Circuit also upheld the District Court's finding that there was no inequitable conduct. The case will be remanded back to the U.S. District Court for the District of Delaware for further proceedings consistent with the appellate decision.

These patents were the subject of lawsuits brought by Santarus in 2007 against Par for patent infringement associated with Par's submission of Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA). The patents at issue expire in July 2016. In July 2010, following the District Court decision that five patents covering ZEGERID were invalid due to obviousness, Prasco, LLC, under a distribution and supply agreement with Santarus, and Par launched generic versions of ZEGERID Capsules.

Santarus also has a Prescription Drug User Fee Act (PDUFA) target action date of January 16, 2013 for the review of its New Drug Application for UCERIS (budesonide) 9 mg tablets.

UCERIS is designed for the induction of remission of mild to moderate active ulcerative colitis.

What to watch for: Traders might want to consider Satarus for a good catalyst trade as we get close to the PDUFA target date in January of next year.

Sarepta Therapeutics (NASDAQ:SRPT) $14.92, down $0.90 (5.69%).

The company announced yesterday that it entered into an At-the-Market (ATM) equity offering sales agreement with Citadel Securities LLC on September 4, 2012, under which Sarepta may, from time to time, offer and sell shares of its common stock having an aggregate value of up to $40 million through Citadel. Sarepta expects to use any proceeds from this offering for general corporate purposes, including the continued development of Eteplirsen and other product candidates.

Eteplirsen, formerly known as AVI-4658, is Sarepta's lead therapeutic candidate currently in Phase 1b/2 for Duchenne Muscular Dystrophy (DMD) and uses the company's core PMO chemistry applied as a splice switching oligomer (SSO). The drug is intended to skip exon 51 of the dystrophin gene. By skipping exon 51, eteplirsen may restore the gene's ability to make a shorter - but still functional - form of dystrophin. DMD is one of the most common fatal genetic disorders to affect children around the world. Approximately one in every 3,500 boys worldwide is affected with DMD. Girls are rarely affected by the disorder. DMD is a devastating and incurable muscle-wasting disease associated with specific inborn errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function.

After a reverse 1: 6 Stock Split on July 12th 2012, the stock has rallied from $3.30 to a 52 week high of $16.40 on September 4th -- roughly a 500% gain in just under 2 months.

What to watch for: Any potential treatment for DMD if ultimately approved by the FDA, would constitute a major life changing break-thru for many who suffer from this terrible disease.

NovaBay Pharmaceuticals (NYSEMKT:NBY) $1.20, up $0.02 (1.69%).

NovaBay announced last week that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market NeutroPhase(NYSE:R) Skin and Wound Cleanser under widened indications including the moistening and debriding of graft and donor sites. Concurrently, the FDA cleared NeutroPhase to be administered through a new convenient spray pump.

Ron Najafi, PhD, Chief Executive Officer and Chairman of NovaBay Pharmaceuticals commented,

This new FDA clearance is a major milestone in the recognition of NeutroPhase as an effective wound cleanser and significantly strengthens and enhances its use throughout the surgical community. We believe surgeons will be attracted to the flexibility it offers in the grafting and donor arena and its availability in a new easy-to-use spray pump.

Another potential catalyst for the company is the beginning of a global Phase 2b trial in Q3 2012 for NVC-422, designed for the treatment of impetigo, which its partner in the drug, Galderma is conducting and fully funding. If approved, Galderma's worldwide manufacturing, distribution, and marketing infrastructure should expedite the process of reaching the global market for this highly contagious skin infection, for which approximately 13 million prescriptions were written in 2009 in developed countries which includes the U.S., Europe, Japan and Brazil.

The company has also relayed to me its belief that there is the potential for another 13 million prescriptions for India, China and emerging markets

From clinicaltrials.gov:





Drug: Experimental: CD07223 1.5 % Topical Gel BID
Drug: Experimental: CD07223 1.5% Topical Gel TID
Drug: Placebo Comparator: CD07223 vehicle gel BID
Drug: Placebo Comparator: CD07223 vehicle gel TID

Phase 2
Phase 3

In a recent phone conversation I had with Dr. Najafi, I asked him if CD07223 is in fact NVC-422, which he confirmed it is. As mentioned prior, this trial is scheduled to get underway in the current quarter -- which ends this month.

What to watch for: Catalyst trade potential in NovaBay here, notwithstanding the company has been floating under the biotech catalyst trade radar.

BioSante Pharmaceuticals (BPAX) $1.62, up $0.14 (10%).

Biosante announced yesterday that the independent Data Monitoring Committee (DMC) has completed the ninth unblinded review of the LibiGel Phase III cardiovascular events and breast cancer safety study. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (NYSE:FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.

In December of 2011, the company announced top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials failed to meet the co-primary or secondary endpoint.

At the time, BioSante's stock plunged $1.62, (76%) to $0.50 after the release of the failed trial results. On June 4th of this year, Biosante engaged a 1: 6 Stock Split, hitting a high of $3.45 on June 5th, before once again selling off to around $1.20 a share.

It is my opinion that although Libigel might be shown to be safe, the drug will never see FDA approval.

Well known biotech writer Adam Feuerstein remarked in an article on June 6th, 2012 for the street.com:

Biosante's plan to start two, new phase III clinical trials of Libigel for female sexual dysfunction has very little to do with medicine or improving the lives of women. What it's really about is greed and the legal but unconscionable transfer of cash from investors into the pockets of BioSante executives. Libigel, a low-dose testosterone gel, has already proven to be an expensive placebo following the failure of two, large phase III studies completed last December. The studies demonstrated quite convincingly that Libigel does not improve the sex lives of post-menopausal women compared to a placebo.

Adam further stated:

Chief executive Stephen Simes makes $500,000 per year in salary -- a princely sum considering under his watch, BioSante has flushed tens of millions of dollars down the toilet. The company's stock price trades at an all-time low.

By taking a mulligan on Libigel and pushing ahead foolishly with another set of clinical trials, BioSante is merely guaranteeing that its executive team, led by Simes, will continue to collect massive paychecks for the next five years or so.

I agree 100% with Adam here concerning Biosante. While the recent news might seem positive, in my opinion it's nothing more than a ploy designed to keep Biosante executives on the job. Furthermore, I tried to warn investors in an article I wrote in February of this year that Biosante was likely to engage in toxic financing which would result in a reverse split, causing massive shareholder loss of equity -- sadly to say, my prediction proved correct.

It's my strongest opinion that investors should stay far away from Biosante.

What to watch for: Potential short play as other traders realize what myself and Feurestein already clearly see -- Biosante is being kept alive for executives to continue to receive their good pay.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.