Drug Pipeline Pulse Check: Human Genome in the Spotlight
Major pharmaceutical companies are awaiting FDA approval for the next potential big cash generator and Human Genome Sciences Inc. (HGSI) has definitely been on the “to watch” list of analysts lately.
But the Maryland-based company received a setback this week when announcements came out that its new lupus drug missed extended study goals. After 76 weeks of therapy, 38.5 percent of lupus patients responded to high doses of “Benlysta”, compared to 32.4 percent who responded on a placebo. The difference was not wide enough for a secondary endpoint, but the product could still gain FDA approval.
According to TheStreet’s Adam Feuerstein, doctors could shorten the treatment stage for patients if the drug’s effects decrease after a year of therapy and that could take a bite out of Benlysta’s expected lucrative revenue.
RBC Capital Markets analyst Michael Yee said a drop in the stock of Human Genome presents a buying opportunity in the long-term, “because we expect the drug will still be FDA approved and remain a significant blockbuster.” (BusinessWeek)
Leerink Swann analyst Joseph Schwartz agrees. “We view this as a very minor disappointment since Human Genome Sciences has already met the primary endpoint in both Phase III studies, along with many other important secondary endpoints,” he wrote in a note to investors. Both analysts agree that the companies will probably seek approval in the second quarter and will face the FDA before the end of the year. The drug has the potential to reach sales of $4 billion. (Minyanville)
In other developments regarding Humane Genome, the Marketing Authorization Application for its hepatitis C drug “Joulferon” was withdrawn by its partner Novartis AG (NOVN).
The drug is under review in the U.S. and the company submitted a Biologics License Application to the FDA November last year. Humane Genome expects the FDA to approve the drug in the fourth quarter of 2010 - target date: October 4, 2010. Analysts noted that the drug will face tough competition from both Merck (MRK) and Roche (RO) products. (Zacks)
The FDA has approved Novartis’s Zortress (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunoligic risk. Under the brand name Certican, everolimus is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the US. (StreetInsider)
GlaxoSmithKline (GSK) sees significant progress with its late-stage pipeline drugs and biopharmaceuticals are playing a big part in the company’s future business prospects.
According to equity research analysts on Zacks.com, (they have a “neutral” rating on the stock), Glaxo intends to stop pursuing research activity in certain areas including depression and pain. Instead, the company will focus on higher growth areas such as neurodegenerative and neuro-inflammatory diseases like Alzheimer’s, multiple sclerosis and Parkinson’s.
The company is working on growing its biopharmaceutical pipeline through in-house research, the acquisition of Domantis and by licensing late-stage products. Glaxo has several clinical research programs underway including nine of them in late-stage development.
Both Glaxo and Denmark-based Genmab AS (GEN) received marketing authorization for “Arzerra” from the European Commission. The drug is for patients with chronic lymphocytic leukemia, a cancer of the blood and bone marrow. The approval resulted in an approximately $16 million payment to Genmab. (BioSpace)
But positive news aside, the FDA is deciding whether to halt a safety study involving thousands of patients taking Glaxo’s “Avandia” diabetes drug, a decision that could determine whether the product stays on the U.S. market. In the past three years, studies have tied the medicine to increased risk of heart attacks.
BioMarin Pharma Inc. (BMRN) announced recently that its product “Firdapse” for treating Lambert Eaton Myasthenic Syndrome is commercially available in the European Union. The drug received marketing approval from the European Commission in December last year and it is the first drug in Europe for treating the rare autoimmune disease.
The product is already selling in Germany and in the U.K., and is expected to reach other European markets by the end of the year. “Firdapse” has been granted an orphan drug designation by the U.S. FDA and enjoys market exclusivity in Europe.
The drug has the potential to be used for other diseases as well, including multiple sclerosis. However, the market for multiple sclerosis is already dominated by big players such as Biogen Idec (BIIB), Pfizer (PFE) and Teva Pharmaceutical Industries (TEVA). (Zacks)
Pfizer has discontinued the Phase III study of Sutent (sunitinib malate) in advanced liver cancer. The decision follows a review by the independent Data Monitoring Committee (DMC) that showed a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm. Also, sunitinib did not demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced liver cancer.
Sheena Lee
This post was based on an Advanced Search of Alacra Pulse:
Industry: pharmaceuticals, biotech
Street Pulse: include any analyst comment
Keywords: FDA OR pipeline (select Boolean)
Date: past 7 days
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