Biotech Day In Review: Novartis Pulls Zelnorm Off The Market

Novartis (NVS) suspended sales of Zelnorm, a treatment for irritable bowel syndrome with constipation, at the request of the FDA. The agency noticed a statistically significant number of cases of angina pectoris in patients taking the drug.

Zelnorm has been approved since 2002. The news took a 4% bite out of Novartis, which fell $2.26 to $54.63.

An FDA advisory panel recommended approval for Provenge, the cancer vaccine from Dendreon (DNDN). In its Phase III trial, Provenge did not meet its primary endpoint of extending the time-to-progression in prostate cancer patients, but it did increase median survival by a median 4.5 months to 25.9 months. The vote of the panel was 13-4 in favor of approving the drug.

The drug was given to patients whose prostate cancer was not responding to hormone therapy. The FDA will render its decision on Provenge on May 15. Because the news was not widely expected, Dendreon soared. After trading as high as $18, Dendreon ended the day at $12.93, a gain of $7.71 or 148%.

Vivus (VVUS) sold the rights to EvaMist, a transdermal estradiol spray for menopause, to KV Therapeutics. EvaMist is currently awaiting an FDA final marketing decision, which is expected July 29, 2007. KV will pay $10 million upfront and $140 million if the drug is approved. Another $30 million is available for sales milestones. The spray delivery device contains a meter that measures the amount of estradiol that is delivered. Vivus was 40 cents higher at $5.13.

Progenics (PGNX) and Wyeth (WYE) asked the FDA to approve their treatment for opioid-induced constipation. Methylnaltrexone is aimed at treating OIC without interfering with the pain relief that opioids produce. If the drug is approved, Wyeth will own the worldwide rights, while Progenics has the option of co-promoting the drug in the U.S. Progenics was up 4 cents at $23.68, and Wyeth added on 13 cents to close at $50.03.

Wyeth also reported that bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia, while maintaining stability is patients with stable disease. Also the drug did not increase weight or lipid levels, as other treatments are prone to do. The drug is under review at the FDA.

Astellas Pharma of Japan will pay up to $120 million for a non-exclusive license to the VelocImmune technology developed by Regeneron (REGN). Astellas paid $20 million upfront, and it will make up to five additional $20 million payments in the next five years. The technology is used to discover human monoclonal antibody product candidates. Regeneron moved up 37 cents to $21.62.

Galapagos NV received 3.2 million euros in milestones from GlaxoSmithKline (GSK) in their osteoarthritis partnership. The partnership attained two milestones in their collaboration, which began in June 2006. Galapagos is responsible for identifying molecules and developing them through Phase IIa trials. At that point, GSK has the option of doing the rest of the development work.

GlaxoSmithKline also submitted its Biologics License Application to the FDA for Cervarix, its vaccine for human papillomavirus which causes cervical cancer. GlaxoSmithKline climbed 71 cents to $55.26.

Quark Biotech (QURK) filed to raise $86 million in its IPO. Quark, a company that uses gene silencing mechanisms in its drugs, has out-licensed a drug for wet age-related macular degeneration to Pfizer (PFE). The drug, which is in Phase I/II trials, uses a different mechanism than the anti-VEGF drugs currently approved for wet AMG. Quark has a second drug that is about to start a Phase I trial for acute renal failure.

NovaCardia (NCAR), a company focused on treatments for cardiovascular diseases, will seek to raise $86 million in its IPO. It has a drug for congestive heart failure that has completed three Phase II trials and a Phase III test. NovaCardia also has an atrial fibrillation drug that will soon begin a Phase II study.

Biotech booked a decent gain in the last session of the week. The Centient Biotech 200™ rose 15 points to 3879, an increase of .40%. The S&P 500 was down .12% in today’s session, but Nasdaq was higher by .16%.

Disclosure: none.

Comments

[marcel.tony]

Astellas is quite right : REGN has fantastic monoclonal technology. Rather than manipulate the Fc fragment, they know how to manipulate the moieties of the receptors linked to it. This is unique.
Have a look at a picture that hopefully makes this a bit more simple to understand :
www.healthvalue.net/VE...