The Burrill Report

Marina Biotech said that it no longer has enough funding to continue implementing its business plan and will conserve its available cash by laying off approximately 90 percent of its workforce and discontinuing most of its day-to-day operations. The decision halts Marina’s early-stage trial in familial adonomatous polyposis but, for now, the company will stick to two preclinical programs in bladder cancer and carcinoma. Although Marina signed several licensing agreements in 2011, the company was still forced to shutter its Cambridge offices and had to consolidate all R&D efforts at its headquarters in Bothell, Washington to reduce cash utilization. Marina’s shares were down 29 cents, or 42 percent, in mid-day trading shortly after it made the announcement.

Chelsea Therapeutics said its rheumatoid arthritis candidate CH-4051 failed to outperform the standard of care, methotrexate, for the disease in a mid-stage study, leading Chelsea to quit development of the compound. The announcement follows a string of bad news for Chelsea and contributed to a 27 percent drop in its share price. “The outcome of the trial was confounded by the unexpectedly robust response reported by patients treated with methotrexate,” said Chelsea Therapeutics’ CEO Simon Pedder. In March the U.S. Food and Drug Administration rejected marketing approval of its experimental treatment for hypotension, Northera. The company has lost more than 47 percent of its value since then.

Vertex Pharmaceuticals has revised previously announced interim results from a mid-stage study of a combination cystic fibrosis treatment because it had misinterpreted data from a contract research organization. The blunder sent Vertex’s shares spiraling down more than 21 percent but it has since rebounded and is trading near its pre-announcement price. The bungled data had first been reported by Vertex on May 7 when it said that 46 percent of patients taking its combination cystic fibrosis drug experienced an improvement in lung function of 5 percent or greater while 30 percent of patients on the combo-pill saw an improvement in lung function of 10 percent of more. The revised data found, instead, that only 35 percent of patients improved 5 percent while only 19 percent of patients improved 10 percent or more. In the same week, the company received a letter from the U.S. Food and Drug Administration suggesting it had provided misleading material in its promotion of the company’s FDA-approved hepatitis C drug, Incivek.

Johnson & Johnson said federal drug regulators have not approved its application to market a once-per-day version of its HIV pill, Prezista, and are seeking more information. The company said it is reviewing the Food and Drug Administration's response to its marketing application for an 800-milligram Prezista pill, and it plans to respond as quickly as possible. The company said it does not expect to have to run any new clinical trials of the drug. Regulators approved the 400-milligram version of Prezista in 2006.

One of Alnylam’s leading RNAi drug programs failed a mid-stage trial testing for efficacy in treating a respiratory infection caused by respiratory syncytial virus. The drug, ALN-RSV01, targets and silences a gene that is required for the replication of the virus. Despite the bad news and the fact that its stock price has dropped 24 percent over the past three months, the company still sees potential for the drug and has plans to discuss the results of the study with both U.S. and European regulators later this year to determine appropriate next steps for the ALN-RSV program.


May 31, 2012
http://www.burrillreport.com/article-marina_biotech_slashes_90_percent_of_workforce.html