TRIALS AND TRIBULATIONS

Shire Surprisingly Pulls Biologics License Application

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

Shire said that it is pulling its application with the U.S. Food and Drug Administration to begin marketing its experimental drug to treat Fabry disease, Reprigel, after the agency indicated that Shire may need to run new clinical studies before it would approve the treatment. The news was an unexpected turn of events for Shire, considering that the FDA had actually pushed the company to submit its BLA. “Shire has had a close partnership with the global Fabry patient community for over 10 years, and we are extremely disappointed that we feel compelled to make this decision,” said Sylvie Gregoire, president of Shire Human Genetic Therapies. The company also stated that a new trial would take at least two years to complete and wouldn’t be economically justifiable.

Bionovo has decided to slash 90 percent of its remaining workforce after failing to secure the fresh funds its needs to pay its bills. Bionovo had set out to develop orphan treatments for women’s health, and settled on developing a drug for menopause. Its lead drug, Meberba, is in late-stage trials for hot flashes but Bionovo no longer has the necessary capital to continue operations. “[We] do not currently have the adequate internal liquidity to meet our cash needs,” the biotech company said in a statement. Bionovo’s shares are currently trading at 4 cents a share on the Pink Sheets after it said in January that it would voluntarily delist from the Nasdaq.

Sanofi said it would cut 450 jobs and close down a U.K. drug manufacturing plant by mid-2015. The company blamed the closure and job cuts on the growing use of low-cost generic drugs and the European economic downturn. “The proposal is being considered in the context of an adverse economic climate and the challenging pharmaceutical market in Europe,” the company said in a statement. “The products manufactured at the Newcastle, England site have been adversely impacted by other factors, including generic competition, resulting in a fall in demand and required production volumes.

After an independent data and safety monitoring board recommended that Anthera Pharmaceuticals halt its late-stage trial on its lead heart disease drug, the company took action to reduce its operating expenses by eliminating 45 percent of its staff and reducing or eliminating vendor activities. According to a statement released by the company, these “actions will allow for the reallocation of resources to other potential development programs and product portfolio efforts.” Shares of Anthera are down more than 50 percent since its late-stage trial was halted.

Nabi Pharmaceuticals will further reduce its head count after posting a $2 million loss in the fourth quarter. After Nabi’s once-promising vaccine to help smokers quite failed a late-stage clinical trial in late 2011, it hired Piper Jaffrey to help it explore strategic alternative for the future. The outcome of those efforts will soon be announced and options may include the sale or possible liquidation of the company. “This has been an intense effort and we have made significant progress,” says CEO Raafat Fahim. “We expect to announce the outcome of the strategic alternatives process in the second quarter of 2012.”













March 16, 2012
http://www.burrillreport.com/article-shire_surprisingly_pulls_biologics_license_application.html