Biotech: Genetech and Biogen fail in phase II & III

Just thought this was a fairly interesting look at failures in Biotech land.

My understanding of the Biotech industry is that they're generally concerned with all possible applications of combinations of biology and technology. Some firms create products very similar in nature to what pharmaceuticals produce in terms of use/purpose, while others might be more concerned with genetically modified organisms for agricultural purposes. In the case of companies making products to cure human ailments, instead of general compounds or substances, the product appears to generally be far more complex (such as antibodies in the case of Genetech's Lupus product).

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Biotech Drug Fails Crucial Lupus Study
By REUTERS

Two biotechnology companies, Genentech and Biogen Idec, said on Tuesday that a crucial study of Rituxan did not meet its main goal of a response in patients with systemic lupus erythematosus, commonly called lupus.

The Phase II/III study also did not meet any of the six secondary endpoints, the companies said.

Shares of Genentech fell more than 6 percent Tuesday, while Biogen stock fell more than 4 percent.

“We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,” Dr. Hal Barron, Genentech chief medical officer, said in a statement.

Lupus is an autoimmune disease characterized by inflammation of the joints, skin, major organs and central nervous system as the immune system attacks healthy tissues and cells.

The 257 patients in the study were evaluated for effectiveness every four weeks for 52 weeks using a measure of lupus disease activity known as the British Isles Lupus Assessment Group.

An analyst at JP Morgan, Geoffrey Meacham, said Wall Street had been optimistic about Rituxan for lupus because of favorable data in smaller studies.

“That said, our model and most Street models did not include lupus sales, so we don’t expect large downward revisions to estimates on the news,” Mr. Meacham said in a note.

Rituxan, an antibody that is approved to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, is also being studied in a Phase III trial in a different set of patients who have lupus nephritis. Results of that trial are expected in the first quarter of 2009.

The results are a blow to Genentech, which was riding high after another drug, Avastin, was approved for breast cancer in February. Now Rituxan has failed twice for new uses — multiple sclerosis and lupus — dealing a blow to expand uses of the drug.
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