BioMed News Bytes: Novadel, Hemispherx Biopharma and GTx, Inc. Print E-mail
By M.E.Garza   
Monday, 02 November 2009 11:56

Shares of Novadel Pharma Inc. (AMEX:NVD) shot up in reaction to Friday's news that it had entered into a licensing agreement with privately held Mist Acquisition to manufacture and commercialize the NitroMist lingual spray version of nitroglycerine, a prescribed short-acting nitrate for the treatment of angina pectoris.

Under terms of the agreement, Mist will pay NovaDel a $1,000,000 licensing fee upon execution of the agreement, milestone payments totaling an additional $1,000,000 over the next twelve months and ongoing performance payments of seventeen percent (17 percent) of net sales. In a release, the Company also noted that through a separate license agreement with Mist, Akrimax Pharmaceuticals will receive the exclusive right to manufacture, distribute, market and sell NitroMist in North America. NitroMist provides acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

NovaDel develops oral spray formulations for a range of marketed pharmaceuticals. The Company has six product candidates in its pipeline, but before investors get too excited, chart technicians like James E. Brumley warn that "shares are dealing with a truckload of horizontal resistance. And yes, there is a layer of it around today's high of $0.32. Even if NVD does break through it once and for all though, there's still another ceiling around $0.41. Bottom line? Novadel Pharma may be impressive today, but don't be fooled. We've seen the same setup go nowhere over the last several months. NVD only belongs on your watchlist, and will only be interesting above $0.41."

On the other side of the spectrum, shares of Hemispherx Biopharma (AMEX:HEB) reacted negatively after officials said that the company plans to finally complete all outstanding queries from the FDA regarding their application for Ampligen as a treatment for Chronic Fatigue Syndrome by December of 2009. This was confirmed by Dr. William A. Carter during an exclusive interview with BioMedReports regarding the status of the NDA for Ampligen in October.

On May 26, 2009, the company announced a delay on the Ampligen N.D.A. which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the company at that time, but several outstanding items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009 and September 15, 2009, the company issued six new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The company now believes that these reports may fully retire all Agency queries in these particular areas.

News that the company plans to widen its ongoing clinical programs in C.F.S. by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome did not seem to impress investors as shares fell.

Shares of GTx, Inc. (NASDAQ: GTXI) dropped in value (nearly 50%) after the company today announced that it had received a Complete Response Letter issued by the FDA regarding its New Drug Application for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).The company said the U.S. health regulators did not approve its experimental drug to reduce fractures in men with prostate cancer citing clinical deficiencies and asked the company to conduct a second late-stage study.

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to prevent and treat cancer, fractures and bone loss, muscle loss and other serious medical conditions.

The good news for biomed investors is that over all, biotech stocks continued to see notable strength in trading on Monday. This news comes as we see a bounce coming off of Friday's three month closing low for the NYSE Arca Biotechnology Index.

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