The Burrill Report


Dendreon said it will eliminate 500 positions or roughly 25 percent of its workforce as part of a restructuring plan unveiled in response to disappointing sales of its prostate cancer vaccine Provenge. The cost of the job cuts is expected to be approximately $21 million, about $5 million of which are non-cash charges related to stock-based compensation. The company said it expects modest quarter-over-quarter growth as it works to educate physicians on an improved reimbursement model under the Centers for Medicaid and Medicare Services recently established National Coverage Decision and issuance of a product specific code for Provenge. Dendreon said it expects to have sufficient cash to enable the company to achieve a cash flow break even position in the United States at an annual run rate of approximately $500 million in revenue.

Genzyme, the biotech unit of Sanofi, issued an apology to doctors and patients over its failure to make expected shipments in August of Fabrazyme, a drug for the rare condition Fabry disease. The apology was made in a letter to patients and healthcare providers that the U.S. Food and Drug Administration made public. In July, the company had stated in a letter to healthcare providers and patients that it would begin shipping the August allocation of the drug August 1. The company said soon after issuing the July letter it experienced unexpected delays related to its quality release process and was not able to ship the drug as expected. The most recent problem continues production difficulties for Genzyme that date back to 2009 when it suffered a viral contamination at a production plant that resulted in shortages of the drug.

SANE Vax said it notified the U.S. Food and Drug Administration that all of 13 samples of Merck’s HPV 4 Quadrivalent vaccine, Gardasil have been found to be contaminated with recombinant HPV DNA. The vaccine vials were from different lots currently marketed in the United States, Australia, New Zealand, Spain, France and Poland. Medical consumers from these countries asked SANE Vax to help determine if there is residual recombinant HPV DNA in the Gardasil vaccine currently used by their doctors. They are concerned that the recombinant DNA, if present, may have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children and young women after receiving Gardasil vaccinations. Both the FDA and the vaccine manufacturer assumed that there was no HPV DNA in Gardasil when the vaccine was approved for marketing, according to SANE Vax. “Because one hundred percent of the samples tested were positive for HPV DNA contamination, SANE Vax requests the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments,” the letter said.

San Diego County Sheriff Bill Gore said investigators have ruled the death of the girlfriend of Medicis Pharmaceutical CEO Jonah Shacknai a suicide, Reuters reported. Rebecca Zahau, 32, was found hanged, bound, and naked in July at the Shacknai estate. The suicide occurred two days after the accidental fatal fall from a staircase of his 6-year-old son while he was in the care of Zahau. The sheriff said Zahau had left a message scrawled in black paint on the inside door to the bedroom leading to the balcony from which she was found hanged. Details of the message were not made public. The sheriff said there were no signs of a struggle, sexual assault or drugs in her system, and no indication of foul play.

Eisai said it will discontinue global development of an extended-release version of its acid reflux drug Aciphex following a letter from the U.S. Food and Drug Administration in February that the agency would not approve the drug without additional information. The company said after full consideration of the discussion with the FDA regarding its concerns, Eisai determined that an additional study would be required to support approval. As a result, Eisai has decided to discontinue the global development of the product. The company said it remains committed to marketing Aciphex delayed-release tablet, which is marketed as a treatment of various acid-related gastrointestinal diseases in more than 90 countries including Japan, Europe, and the United States.


September 08, 2011
http://www.burrillreport.com/article-dendreon_to_slash_500_jobs_as_part_of_restructuring.html