Happy Friday morning everyone! Let’s jump right into today’s biotech news.
DRUG CEOS UNDER PRESSURE–Newspapers across the country have featured stories of biotech and pharma CEOs who explain the difficulties that today’s economy and the issue of health care reform are posing.
In a separate article, Dow Jones Newswires/The Wall Street Journal reports on a high and “generational” turnover among pharmaceutical CEOs. “The new leaders are taking over an industry under pressure. The past decade has brought heightened scrutiny of drug safety, government probes of sales and marketing practices, and greater pricing pressure from drug-benefit plans and generic competitors. Drug makers feel compelled to control costs and do more to get results from the billions of dollars they pour into their research labs” (Loftus, 2/2).
BIOTECHNOLOGY GROUP OBJECTS TO U.S. STANCE ON GENE PATENTS–The Biotechnology Industry Organization recently issued a letter to the U.S. Department of Health and Human Services opposing certain provisions within a policy that would make it more difficult for scientists and companies to uphold gene patents.
“It is not the time to undertake or recommend policy changes that would undermine the foundations of American life science innovation,” said the letter signed by the chief executive officers of the biotechnology group and companies including Genzyme Corp. of Cambridge, Massachusetts, Monsanto Co. of St. Louis, Bayer AG of Germany and Human Genome Sciences Inc. of Rockville, Maryland.
A companion letter from the presidents of the Council on Governmental Relations, an association of research universities, and the Association of American Universities also objected to the proposals, saying they “will harm rather than advance the interests of patients and the public by impeding the development of effective genetic tests and patient access to them.”
THE ECONOMICS OF BIOLOGICS–Today, Portfolio.com reports on the issues involved in data exclusivity, the development of biosimilars and the recent developments in health care reform.
The threat: the White House’s move to reduce the amount of protection brand-name drug companies would have for groundbreaking biologic drugs before their generic competitors can use their data to produce cheaper, similar versions. Considering that the average single biologic takes 10 to 15 years and $1.2 billion to research and develop (and that’s not including any new special facility costs or other capital costs that a firm may incur), big money is clearly at stake for the industry.
Compared to traditional, small-molecule chemical drugs, biologics—drugs that offer the best hope for finding new cures and treatments to debilitating diseases such as cancer, AIDS, Alzheimer’s, and rheumatoid arthritis—are highly complex and made of larger living molecules. Their composition makes them virtually impossible to replicate. Attempts to produce generic, yet not-quite-the-same, versions are referred to as “follow-on biologics,” or “biosimilars.”
GLAXO TO SHUTTER NEUROLOGICAL PROGRAMS, CREATE RARE DISEASES UNIT–GlaxoSmithKline yesterday announced yet another cut to R&D, this time at the cost of almost $800 million.
Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer’s, Parkinson’s and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.
“We are allocating capital to areas where we can get the best return on investment,” the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company’s workforce that would amount to the “hundreds rather than thousands” in the U.K.

Leave a reply