R&D budget

Development chief outlines strategy at Genentech

John Carroll — Thu, 12 Jun 2008 10:55:43 -0400

Genentech's Susan Desmond-Hellmann, president of product development, outlined the biotech giant's development strategy to a group at the Goldman Sachs healthcare conference. In addition to testing new uses of its cancer blockbusters, Desmond-Hellman says the company will push hard to advance new therapies in the neuroscience and infectious disease areas. Genentech also has 14 new molecules in development for cancer indications.

The research chief also told the group that the blockbuster drugs of the past may never be duplicated. Future drugs will cater to a smaller, better defined group of patients. "The days of big cholesterol-lowering drugs for millions of people may be behind us."

- read the report in the Wall Street Journal

ALSO: Genentech announced that it had settled a patent dispute with MedImmune over basic production methods. Report

Deloitte sees 'fundamental shift' in drug dev. strategies

Tue, 13 May 2008 06:59:58 -0400

Deloitte sees a major shakeup going on in clinical research strategies at the large pharma companies. Instead of focusing on the development of a small portfolio of blockbuster meds, pharma pipelines are shifting to create a host of new therapies that will have higher efficacy in smaller groups--the genotype-basing approach that's been so much discussed in biotechnology. By targeting smaller populations with promises of greater efficacy, says the accounting firm, the pharma industry can still rely on bigger per-treatment revenues.

The shakeup in R&D strategies is coming after the industry marks only mixed results from outsourcing and other efforts aimed at improving efficiency. And it marks a period of high stress for the companies, as they transition from blockbusters to targeted meds. A "fundamental shift in the industry's operating environment is under way."

- check out the report from Seeking Alpha

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

U.S. R&D headcount tumbles in key categories

Wed, 09 Apr 2008 06:59:57 -0400

Pharmalot has been crunching the numbers for R&D jobs and concludes that the U.S. is seeing a considerable amount of shrinkage in the field. Looking at new numbers from PhRMA for 2006, R&D employment among its members dropped 3.9 percent. And there were a number of sizable reductions last year, with the axe expected to drop again over the course of 2008.

RPM concludes that the biggest cutbacks in R&D are occurring in the approval and post-marketing phases. The money spent on R&D in the U.S. continues to rise, but after an 11.3 percent hike in 2006 budgets rose only 2.7 percent to a still considerable $35.4 billion.

- read the report from Pharmalot
- see the PhRMA report (.pdf)

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