Roche, Cipla trade jabs on Tarceva

Mon, 21 Apr 2008 06:59:55 -0400

We turn to India for updates on another cancer-drug battle, this one between Roche's brand-name Tarceva and Cipla's copycat version, Erlocip. A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its version for an unapproved use. Taksal Pharma alleged that Cipla is touting Erlocip for head and neck cancer and colorectal cancer, as well as for the approved uses in non small-cell lung cancer and pancreatic cancer. One source close to the situation said, "They are selling it for uses that even the innovator hasn't discovered."

This is just the latest skirmish between Roche and Cipla. The two companies have been wrangling over Tarceva's patent for some time now: Cipla launched a generic even though Roche had a patent on the med, so Roche sued to keep Cipla's drug off the market. Then Cipla countersued, alleging that Tarceva didn't deserve a patent anyway because it's a tweaked version of an older med. Delhi high court denied Roche's injunction, saying that it's in patients' best interest to have Cipla's cheaper version available. Roche appealed. And the beat goes on: hearings are continuing in the patent revocation case. Stay tuned.

- see the item at Pharmalot
- check out LiveMint's coverage

Related Articles:
European committee gives negative ruling on Tarceva. Tarceva report
FDA panel endorses Tarceva for pancreatic cancer. FDA report
The specter of generic competition grows. Report

Lancet: Glaxo HIV med boosts cardiac risk

Wed, 02 Apr 2008 07:59:56 -0400

A leading AIDS med made by GlaxoSmithKline carries nearly double the risk of heart attack compared with other anti-HIV meds, according to a new study published by the Lancet. Abacavir--which recently was anointed a "preferred choice" for first-time AIDS treatment--stepped up heart attack risk by 90 percent, the 33,000-patient study showed. EU drug regulators asked GSK for more data on the drug so they might better analyze the potential risk.

AIDS treatment experts said that, because the study didn't identify a biological cause for the increased risk, they might not choose to switch patients off the med. Plus, the patients most likely to develop heart problems with abacavir are those with underlying medical problems such as diabetes and high blood pressure--but the alternative drug can cause kidney problems in those patients.

GSK sped out a statement in response, saying that analysis of its own data on 9,600 patients show no increased risks (But the EMEA notes that these studies weren't designed to check for cardiac risks). Even if the heart attack risk were doubled, it would still be quite low, the company said: 6 per 1,000 patients versus 3 per 1,000.

- see GSK's statement
- read the European Medicines Agency release
- get more from the BBC
- find this story from the San Francisco Chronicle
- check out the MarketWatch news on the EU

ALSO: India's Cipla makes its anti-HIV meds by circumventing other companies' patents, making it the largest AIDS drug supplier in the world. Supporters say CEO Yusuf Hamied has saved countless lives by making meds affordable; critics call him a pirate and opportunist. Report | Report

Related Articles:
Feds steering funds back to basic AIDS vax research. Report
Merck halts study of "ineffective" HIV vaccine. Report
GSK allows generic AIDS drug. Report