FDA Votes in Favor of Human Genome's Lupus Drug
Human Genome Sciences (HGSI) shares have been quite the volatile over the last few trading days as investors geared up for a Food and Drug Administration advisory panel vote on its lupus drug, Benlysta, which finally came late Tuesday. In a 13-2 favorable vote the panel of outside experts recommended to approve the drug -- the first new lupus treatment in decades.
Lupus is a chronic autoimmune inflammatory disease in which the patient's own immune system attacks healthy tissue, causing inflammation and tissue damage. If approved -- and the panel's recommendation is a strong step toward approval -- Benlysta has potential to be a blockbuster, with estimates of peak annual worldwide sales reaching $3 billion.
Shares of the small biotech fell last week after the FDA raised tough questions about Benlysta's benefits and adverse events. After being halted Tuesday, shares started the morning down 7% in premarket trading on worries that label warnings listing the potential side effects -- among them increased risks of suicide and depression -- might curb Benlysta sales, and because of two downgrades from Citigroup and Bank of America. Shares pared their losses in the regular session.
The panel also voted 14-1 that the drug is safe, and 10-5 that it is effective. A decision from FDA is expected by Dec. 9. Meanwhile, shares of Human Genome' partner, GlaxoSmithKline (GSK), were up 3%.
Merck Heart Drug Improves Cholesterol Levels
Pharmaceutical giant Merck & Co (MRK) reported its experimental heart drug positively affected both good and bad cholesterol levels substantially, according to data from a clinical trial.
It will likely be at least five years before Merck can begin selling the drug, Reuters reported. Other potential treatments from this class of drugs have failed in the past, exhibiting adverse side effects in studies, including higher death rates. But researchers found no evidence of these side effects in anacetrapib, which increases the good cholesterol considerably more than other therapies.
While researchers observed lower rates of cardiovascular death, heart attack, stroke and hospitalization for unstable angina in patients taking anacetrapib, Merck will have to conduct a large "outcomes" trial to prove the drug reduces heart attacks and deaths rather than merely impacting cholesterol levels. On Wednesday, it announced a four-year, 30,000 patient trial. Merck shares were up 1.5% in late afternoon trading.
Novartis Presents New Strategic Plan
Novartis (NVS) shares rose fractionally Wednesday after it unveiled an accelerated cost-cutting and efficiency improvement plan with the goals of improving profitability and securing long-term growth. The company plans to cut costs in supply chain, marketing, sales and procurement, while diverting assets to innovation, specialty medicines and emerging markets.
The Swiss drugmaker will have to deal with a number of key drugs losing patent protection in the coming years, including multi-billion dollar blood pressure drug Diovan. "Key to offsetting patent expirations is converting the innovation into sales growth," Novartis said.
Basel-based Novartis said it has 142 pipeline projects, of which more than 35% are in Phase III or registration, and that it is planning for 30 regulatory submissions before the end of 2012. It also plans to increase "the percentage of specialty and oncology products in its portfolio, from currently over 65% to more than 75% of expected pharmaceuticals sales in 2015."
Novartis is also banking on its eye-care unit, its Sandoz generic division, consumer health, vaccines and diagnostics to drive growth. In addition, it plans to strengthen its operations in the fast-growing emerging markets of China, Russia, Brazil and India.