Medgenics (MDGN) announced that Israel's Ministry of Health (MOH) has approved two Phase I/II clinical trials to assess the safety and efficacy of INFRADURE in patients with hepatitis C. One study will evaluate previously untreated patients with genotypes 1 and 3, and the other will study genotype 1 patients who have relapsed after initially responding to prior treatments.
These are the first approved clinical studies for the use of INFRADURE, a subcutaneous autologous tissue implant developed to continuously produce interferon alpha (IFNA). INFRADURE has been designed to be used in treating hepatitis B, C, and D, as well as other diseases. The first study will have up to 16 patients with hepatitis C and is expected to start in the fourth quarter of 2012 and to last approximately 24 months. The second study is planned to commence following initial results of the first study.
Many Hepatitis C (HCV) players have experienced multiple failures with their drugs in clinical trials lately. The Biopump Platform technology provides sustained protein therapy for the treatment of various chronic diseases and conditions, including anemia, hepatitis, hemophilia, multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity, diabetes, and other chronic diseases or conditions -- without drugs. Medgenics might be in an excellent position now to grab future market share -- if its platform ultimately is approved by the FDA.
Shares of Medgenics are currently trading around $13.25 , up $0.34 (2.59%).
Amarin (AMRN) announced today that additional data from its pivotal MARINE Phase 3 clinical trial are now available electronically through the Journal of Clinical Lipidology and are expected to be published in a future print issue of the journal before the end of 2012.
The MARINE trial was a Phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. The study enrolled 229 patients and investigated Vascepa as a treatment for severe (TG >=500 mg/dL) hypertriglyceridemia. The MARINE trial achieved its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a favorable safety profile.
Amarin has seen its stock price trade all over the place lately after Vascepa was approved on July 26, 2012.
On August 17, 2012, the FDA published the July 2012 cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book (the July Orange Book Supplement), in which, among other things, FDA listed new product approvals, issued patents related to such products and associated regulatory exclusivity grants made pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Vascepa. (icosapent ethyl) Capsules is expected to be included in the July Orange Book Supplement along with U.S. Patent No. 8,188,146.
However, Vascepa was not included on the Orange book listing as it was expected -- causing further strain on the stock price. Amarin shareholders now look to next month for the next possible NCE approval date.
It's important Vescepa receives New Chemical Entity (NCE) status along with getting all its patents approved in order to see a much higher stock price moving forward.
A new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act. Those who believe Vascepa will fail to gain NCE status refer to GlaxoSmithKline's (GSK) 1 billlion dollar drug Lovaza as having a similar makeup as Vescepa.
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 is my opinion that Amarin has a 70/30 chance to receive NCE status for Vescepa. If FDA wasn't prepared to provide Amarin with the eight or so years of market exclusivity that comes with NCE status, would the agency really demand the conduct of an 8,000-patient cardiovascular outcomes study that will cost $120 million?
Shares of Amarin are currently trading around $13, up $0.14 (1.05%).
Orexigen Therapeutics (OREX) shares are trading sharply higher at around $4.78, up $0.37 (8.35%) on a Paragon Financial Limited on a market wire report on anti Obesity drugs. The report also mentions Arena Pharma (ARNA) which is also trading slightly higher at $9.33, up $0.07 (0.76%).
The report remarks:
A recent data from the European Society of Cardiology conference showed that average weight people with "fat bellies" had a higher risk of death than people who were obese. Researchers stated that people with a normal body mass index (BMI) combined with a high waist-to-hip-ratio or "central obesity" had a 2.75 time higher risk of cardiovascular death when compared to a person with normal BMI and normal waist-to-hip-ratio. The risk death from all other causes was 2.08 times higher.
Obesity is a well known problem these days in the western world. We live in a "fast food" society where we collectively just do not eat right. While the drugs these companies are working on can help, a person must still engage in proper diet and exercise regiment to ensure optimal health. Regardless of this fact, anti-Obesity drug makes such as Arena and Orexigen should benefit because people will always look for an easier way out -- its western world human nature. Arena is in a much better position than Orexigen, because it already has a drug approved and ready for market, while Orexigen is at least 2 years away.
Shares of Peregrine Pharmaceuticals (PPHM) have rebounded sharply today after yesterday's selloff which might have been related to a negative article here on Seeking Alpha by Chimera Research Group. The article contends Peregrine's lead drug candidate, bavituximab is not as effective as many say, and the report also questions Peregrine's financial position.
According to the Peregrine website:
Currently in Phase II clinical development, bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated broad therapeutic potential across multiple oncology indications and represents a new approach to treating cancer. Bavituximab is currently being evaluated in three randomized Phase II clinical trials for non-small cell lung cancer (NSCLC) and pancreatic cancer.
On the surface this drug looks promising, so I encourage potential investors in Perigene to do careful and complete due diligence to consider both the bull and bear case -- for and against the company.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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.