ipilimumab

Ipilimumab - Next gen biotech blockbusters

Maureen Martino — Tue, 08 Jul 2008 16:02:05 -0400

Drug: Ipilimumab
Company: Bristol-Myers Squibb, Medarex

Scoop: Ipilimumab is a fully human anti CTLA-4 monoclonal antibody that BMS is testing as a treatment for metastatic melanoma and other cancers, including prostate and lung cancers. The drug was originally slated for submission this year, but BMS and Medarex announced in April that they would delay filing a BLA for the drug after the FDA requested additional overall survival data on the drug. Pfizer is also developing an anti CTLA-4 monoclonal antibody--called tremelimumab--but the company recently halted a Phase III trial of the drug after researchers concluded it was no more effective than standard chemotherapy. Analysts say either ipilimumab or tremelimumab could have a significant impact on the melanoma market if approved.

The next generation of biotech blockbusters

Maureen Martino — Tue, 08 Jul 2008 15:51:25 -0400

The 2007 rate of new biologic approvals was slow, with only a handful of drugs squeaking through FDA review. But the pace is set to pick up in 2008. According to IMS Health, these biologics could receive FDA approval this year if they don't hit any stumbling blocks. Each of the drugs on this list has the potential for over a billion dollars in sales if all goes according to plan. These four drugs are the next generation of biologic blockbusters that could offer real breakthroughs for patients--and add significant cash to their developers' bottom lines.

Motavizumab - AstraZeneca's MedImmune

Denosumab - Amgen

Golimumab - Johnson & Johnson's Centocor

Ipilimumab - Bristol-Myers Squibb, Medarex

Data courtesy of IMS Health

Medarex shares dented on analysts' skepticism

Tue, 03 Jun 2008 06:59:56 -0400

Investors dented the value of Medarex shares after analysts doused its recent claims concerning its late-stage cancer drug ipilimumab with cold water. BMO Capital Market's Jason Zhang says that Medarex doesn't have the data to back up claims that a combination of ipilimumab and dacarbazine work better than ipilimumab alone. Its shares slipped seven percent on the news.

"There is no randomized data with a chemotherapy control supporting ipilimumab's survival-prolonging abilities," said Zhang in a note. Mid-stage study data demonstrated median overall survival of 449 days on the combo therapy compared to 351 days with ipilimumab alone. That was not a statistically significant difference in survival.

- read the AP story

Medarex shares slide on news of drug app delay

Mon, 28 Apr 2008 06:59:55 -0400

Shares of Medarex slipped seven percent this morning as investors digested Friday's announcement that its application for a new cancer drug will be delayed into 2009. The developer says that the FDA wants more data on ipilimumab, which is in late-stage trials. Bristol-Myers Squibb is partnered on the therapy, which is being investigated as a new treatment for metastatic melanoma. The agency is looking for more data on overall survival rates. That left the analysts scrambling to calculate the revenue the company will lose as a result of the delay. Medarex shares have lost more than half of their value since last summer.

- see Medarex's release
- read the AP report