FDA Dislikes Novartis on Facebook: Biotech's Latest Mishaps

by: The Burrill Report

The U.S. Food and Drug Administration notified Novartis (NYSE:NVS) that information the drug maker has on Facebook about its cancer drug Tasigna is misleading because it makes claims of its efficacy, but fails to note any risks. The agency also said in a letter to the company that the content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products. The FDA noted that Novartis failed to submit the marketing material as required under regulations. Tasigna is indicated for certain forms of chronic myelogenous leukemia in adult patients resistant or intolerant to prior therapy that includes imatinib. The FDA also approved Tasigna for second line treatment of chronic or accelerated phase Ph+ CML. The agency told the company to cease the dissemination of the problematic promotional materials and provide a written response.

Cypress Bioscience (CYPB) said it was cutting 123 employees or 86 percent of its workforce as part of an effort to cut operating costs by about $10 million a year. The announcement came as part of broader steps being taken by the company that includes plans to discontinue or sell its personalized medicine services business by the end of the third quarter and discontinuing its rights under its agreement with Forest Laboratories to co-promote Savella, its drug for fibromyalgia. Forest has agreed to pay Cypress a one-time payment of $2.0 million to help facilitate with this transition. Cypress will retain all other rights under its agreement with Forest including its royalty on Savella sales and may pursue the opportunity to re-activate the co-promotion right through discussions with Forest in the future. Forest will maintain promotional levels behind Savella.

Illumina (NASDAQ:ILMN) has filed suit against Complete Genomics claiming the Mountain View-based company is infringing on three its sequencing patents, GenomeWeb reported. The suit, filed in the U.S. District Court for the District of Delaware, seeks to enjoin Complete Genomics from infringing on the patents either directly or indirectly, and seeks damages as well as attorneys' fees and costs associated with the suit. Complete Genomics filed an $86.3 million IPO on July 30.

AstraZeneca (NYSE:AZN) agreed to pay about $55 million to resolve around 5,500 lawsuits related to side effects of the antipsychotic Seroquel, Bloomberg said in a report attributed to people familiar with the settlements. The settlements represent an average payout of about $10,000 per case and resolve some 26,000 lawsuits over the drug. AstraZeneca previously agreed to pay $2 million to resolve more than 200 allegations that Seroquel causes diabetes in some users. Seroquel, the company’s second- biggest seller, produced sales of nearly $4.9 billion last year, about 15 percent of AstraZeneca’s total revenue. The company has not disclosed financial terms of the settlements.

Thoratec (NASDAQ:THOR) said it mutually terminated the previously announced agreement to sell its International Technidyne Corporation division to Danaher Corporation. The termination came about as the result of the failure of the two companies to agree on the status of certain aspects of ITC's quality system and regulatory filings. In addition, during the period since the agreement was signed, the ProTime InRhythm launch in the United States has been delayed because the FDA did not clear the product's initial 510(k) submission. As a result, the parties were unable to reach agreement as to whether closing conditions had been met and thus determined to terminate the transaction agreement.

Thoratec plans to account for the ITC division as “held for sale,” and its results will be displayed in discontinued operations in the company's financial statements beginning in the second quarter of 2010. Thoratec's board of directors currently expects that a sale of ITC will occur in the next twelve months.