BioSante completes FDA required studies of LibiGel
LINCOLNSHIRE, Ill. BioSante Pharmaceuticals has completed validation studies of its new drug LibiGel, which is used for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, as required by the Food and Drug Administration as part of the clinical development program for the drug.
The validation studies included keeping patient diaries to measure the number of satisfying sexual events and desire. The BioSante inventory of Sexual Events and Desire was able to differentiate between women with HSDD and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire.
The company has started a Phase III trial of the drug and hopes to start another by early 2008. In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. An application can be filed and reviewed by the FDA, possibly leading to the approval of LibiGel, at that time.
McKesson announces plans to acquire Oncology Therapeutics for $575 million
SAN FRANCISCO McKesson Corp. announced plans Thursday to buy fellow cancer drug distributor Oncology Therapeutics network for $575 million, according to the Associated Press.
Based on IMS health data, McKesson expects annual sales of oncology drugs to double in the next four years to $60 billion. Oncology Therapeutics also distributes drugs for rheumatoid arthritis and hepatitis C, seeing about $3 billion in annual sales.
The acquisition would be McKesson’s second major purchase this year, the first being a $1.1 billion takeover of Per-Se Technologies, a health care administrator. Both purchases indicate an upswing for the company, which in January 2005 had to set aside more than $1 billion to resolve shareholder lawsuits revolving around a $12 billion acquisition of health-services software maker HBO & Co., which revealed only after the sale that it had been highly overvalued.
To help boost its stock price, the Associated Press reported, McKesson unveiled plans to spend an additional $1 billion in buying back its own shares. The company has already burned through $684 million of the $1 billion authorized in an earlier stock repurchase program announced in May.
Pfizer hires two scientists to boost research operations
NEW YORK Pfizer has hired two senior scientists and promoted a third to help rejuvenate its lackluster research operations.
Briggs Morrison, M.D., a senior vice president of research at Merck, Pfizer’s rival, will become chief of clinical development. Corey S. Goodman, M.D., who recently stepped down as chief executive of Renovis, a biotech company, will become the head of a new biotech center based in San Francisco. Martin Mackay, M.D., the former deputy head of research at Pfizer will become chief of global research and development.
The company is trying to establish a new drug pipeline after having a disappointing couple of years in its research and development departments, which saw very few products, hit the market, while Merck saw a boom in product development.