This is one of a continuous series of articles that will highlight selected recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.
Alkermes (NASDAQ:ALKS) released top line results from a phase 1b study of ALKS 9070 in patients with schizophrenia. This compound is a once-monthly formulation that converts in the body to aripiprazole which is commercially available as Abilify (click here). Abilify is currently used for Bipolar Disorder, Schizophrenia and as an add-on treatment for depression when conventional anti-depressants are not effective. Abilify sales exceeded $3.5 billion in 2010 in the U.S. alone (click here). ALKS 9070 was well tolerated, safe and achieved relevant concentrations of aripiprazole in patients. Once monthly dosing offers a significant convenience to patients over the once daily administration of Abilify. Initial indications for the ALKS product are for schizophrenia but are expected to expanded with successful trial results. ALKS expects to move development forward before the end of 2011.
Novartis (NYSE:NVS) announced the early termination of a Phase 3 study of Afinitor, a drug already approved for several indications and generating $243 million in sales in 2010. An interim analysis showed that Afinitor tablets, in combination with exemestane, a drug used to treat breast cancer (click here). Afinitor significantly extended progression-free survival (click here), a common measure of Phase 3 trials, in the over 700 patients that participated in an advanced breast cancer trial. It was deemed not necessary to allow the trial to run to conclusion as the primary endpoint had already been met. This is generally a very positive development for a new drug. Novartis plans to submit NDAs in various countries by the end of 2011. Analysts expect sales to exceed $1 billion if approved and reach peak sales of as much as $1.8 billion (click here).
Pharmasset (VRUS) announced that it has entered into a collaboration agreement with Tibotec Pharmaceuticals for a Phase 2 trial of PSI-7977, in combination with Tibotec's TMC435, for treatment of chronic hepatitis C. The study will enroll patients who had no response to treatment with peginterferon alfa and ribavirin. VRUS is focused on the treatment of hepatitis C virus. PSI-7977 is currently being studied in three Phase 2b trials, one of which is in combination with Bristol-Meyers Squibb's compound, BMS-790052 (click here). VRUS has a market cap of $4.3 billion with a float of 29 million shares, just over 900,000 of which are sold short.
These clinical updates are short summaries and should be used as a basis for further research. You should always perform your own due diligence. Many factors can determine whether a particular drug candidate will ever come to market or be profitable and biotech investing should be considered very high risk.