Armed with a strong balance sheet including just under $175 million in cash, Savient Pharmaceuticals
Pivotal phase 3 data supporting FDA approval of Puricase -- to treat gout in patients who fail to respond to or do not tolerate standard treatments -- is expected by year's end. Puricase would join Savient's Oxandrin -- which combats severe weight loss caused by infection, surgery or trauma -- on the market.
In March, the company completed enrollment of about 200 patients in its phase 3 clinical trials for Puricase, and it remains on track to complete the trials and announce top-line results by the end of the year. Based on previous data for Puricase and its well-established mode of action, the phase 3 results have a high probability for success.
Puricase is a formulation of an enzyme not found in humans that breaks down the cause of gout -- the body's painful response to crystals that form due to elevated uric acid levels -- into harmless waste products that can be excreted in the urine.
Savient anticipates making a Biologics License Application submission to the FDA in early 2008, with a goal of bringing Puricase to the market in 2009.
In response to generic competition to the company's only marketed drug, Oxandrin, Savient eliminated its sales force and ceased all promotional activities in a proactive cost-cutting measure. The company reported that sales erosion in the first quarter was slightly lower than expected, and its generic version of Oxandrin -- which is sold and distributed through Watson Pharmaceuticals
I recommend biotech investors take a look at Savient and the market opportunity it has with Puricase ahead of the release of data at the end of this year.
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.