Alkermes Inc., of Cambridge, Mass., said its new drug application for Vivitrex (naltrexone long-acting injection) has been granted priority review by the FDA. The PFUFA date for completion of the review is Sept. 30. Vivitrex, for alcohol dependence (in conjunction with counseling), is administered once every four weeks by injection. The NDA was filed in April. (See BioWorld Today, April 4, 2005.)
Biopure Corp., of Cambridge, Mass., said its previously announced 1-for-6 reverse stock split became effective Friday. The company s stockholders authorized the reverse stock split last month in an effort to broaden Biopure s investor base and help the company regain compliance with Nasdaq s $1 minimum bid price listing requirement by increasing the share price and decreasing the number of shares, warrants and options outstanding. The company had 146 million shares of Class A stock outstanding before the split, and after, will have 24 million shares outstanding.
Celgene Corp., of Summit, N.J., said its partner, Novartis Pharma AG, of Basel, Switzerland, received FDA approval for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention deficit hyperactivity disorder in adults, adolescents and children. Celgene said it stands to receive a milestone payment in connection to the FDA approval. The company licensed worldwide rights, excluding Canada, to Focalin and Focalin XR to Novartis in exchange for milestone payments and royalties on Focalin, as well as for the entire Ritalin family of drugs.
Cellegy Pharmaceuticals Inc., of Brisbane, Calif., said Cellegesic (nitroglycerin ointment) was launched in the UK by ProStrakan Group plc, of Galashiels, UK. Branded Rectogesic outside the U.S., the product is a 0.4 percent topical ointment for the treatment of pain associated with chronic anal fissure. The Medicines and Healthcare Products Regulatory Agency approved the product for sale in the UK in August, and Cellegy said it will work with ProStrakan in filing submissions for marketing approval for the rest of the European Union.
Elite Pharmaceuticals Inc., of Northvale, N.J., said the FDA approved its investigational new drug application for an abuse-resistant oxycodone product designed using Elite s abuse-resistant technology, ART. The product incorporates an opioid antagonist aimed at discouraging and reducing abuse of narcotic analgesic medications by making the product more difficult to abuse when crushed, damaged or otherwise manipulated. Under the IND, the company will conduct studies to evaluate the extent of naltrexone and oxycodone absorption from extended-release oxycodone HCl and 25-mg naltrexone HCl capsules administered unaltered vs. crushed.
Exiqon A/S, of Copenhagen, Denmark, said a paper published in Science described the temporal and spatial expression patterns of 115 conserved vertebrate microRNAs in zebrafish embryos by in situ hybridizations, using Exiqon s mercury detection probes. MicroRNAs are a recently discovered class of small RNA molecules that have demonstrated regulatory effects on gene expression.
InSite Vision Inc., of Alameda, Calif., completed its previously announced $9 million private financing of common stock and warrants. New York-based Paramount BioCapital Inc. served as the placement agent. Terms of the agreements provided for the sale of about 16.4 million shares at 55 cents per share, and the issuance of warrants to purchase 4.9 million shares at an exercise price of 63 cents per share. InSite said the financing will allow the company to focus on Phase III pivotal trials with AzaSite, an antibiotic targeting infections of the eye, and other programs.
Neurocrine Biosciences Inc., of San Diego, completed submission of a new drug application for indiplon tablets for the treatment of insomnia in both adult and elderly patients. The NDA for indiplon capsules was submitted in April. Those filings are based on clinical data demonstrating that both capsules and tablets show significant improvement in sleep onset, sleep maintenance and sleep quality parameters. Indiplon is a non-narcotic, non-benzodiazapine agent designed to act on a specific site of the GABA-A receptor.
NovaDel Pharma Inc., of Flemington, N.J., completed the sale of common stock and warrants in a private placement, raising $7 million in gross proceeds. The company sold about 6.7 million shares at $1.05 per share, and granted investors warrants to purchase about 2.4 million shares at an exercise price equal to $1.30 per share. NovaDel said net proceeds of $6.3 million will be used to advance its unpartnered lingual spray products toward pivotal trials and new drug application submissions. The financing was led by ProQuest, of San Diego, and included the Caisse de depot et placement du Quebec.
ProMetic Life Sciences Inc., of Montreal, has filed a short form prospectus to issue subordinate voting shares in Canada, with Paradigm Capital Inc., of Ontario, to act as lead agent in connection with the proposed offering. ProMetic said the transaction could generate proceeds of $10 million to $15 million that would be used to advance clinical trials for its lead therapeutic drugs, PBI-1402 and PBI-1393, accelerate the scale-up and commercialization of the Cascade process and fund development and product marking of a prior reduction device. The closing is expected to occur on or about June 20.
SemBioSys Genetics Inc., of Calgary, Alberta, received the second and final license payment from its royalty-bearing license and sales agreement with Lonza Inc., of Basel, Switzerland. The agreement provides Lonza with the global rights to SemBioSys DermaSphere Oleosome Technology for use in personal care markets. Lonza launched its first DermaSphere-based product under its Natrulon line of natural ingredients in 2004. SemBioSys expects to receive its first royalty payment in the last half of 2005, and the early revenues will be used to fund the development of the company s other products, including insulin and Apo AI, a product candidate aimed at the atherosclerosis market.