FDA accepts Satraplatin NDA for priority review

Apr 17 2007

Spectrum Pharmaceuticals has announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the U.S. Food & Drug Administration (FDA).

A Prescription Drug User Fee Act (PDUFA) date of August 15, 2007 has been established by the FDA for a decision regarding the approval of the satraplatin application. Satraplatin is an investigational drug for the treatment of hormone refractory prostate cancer (HRPC) for those patients who have failed prior chemotherapy.

"The acceptance by the FDA of the satraplatin NDA represents an important milestone for Spectrum as it validates our risk-reduced business model," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We identified satraplatin as a promising treatment for hormone refractory prostate cancer patients and moved the product through development without incurring major development expenses or diluting our shareholders. The regulatory and sales-related milestone payments as well as the royalties we expect to receive related to satraplatin will serve as a non- dilutive source of funding for the advancement of our pipeline of nine other drugs including EOquin(TM) for non-invasive bladder cancer in Phase 3 clinical trials, ozarelix for benign prostatic hypertrophy, expected to enter Phase 3 clinical trials by year end and SPI-1620 a novel adjunct to chemotherapy, expected to enter clinical testing this year."

The FDA's acceptance of the NDA triggers a $4 million milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the U.S., Europe, Japan and other countries. Further payments are due on achieving certain sales targets. In addition to milestones, Spectrum is entitled to receive royalties on worldwide sales of satraplatin. The company also has co-promotion rights in the U.S., now that the partner has announced its decision to market satraplatin in the U.S.

A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission. A PDUFA date typically occurs ten months following the submission of an NDA. However, a PDUFA date for an NDA that is granted priority review typically occurs six months following the submission of the NDA. The FDA grants priority review status to products that, if approved, would address an unmet medical need or are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. On the August 15, 2007 PDUFA date set for satraplatin, the FDA is expected to notify the Company whether satraplatin will be approved for marketing in the US, or not.

Prostate cancer is the most common cancer among men in the U.S. and Europe. According to the American Cancer Society, approximately 219,000 men in the U.S. are expected to be diagnosed and over 27,000 men are expected to die from the disease in 2007. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.

Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones -- or "hormone-refractory" -- and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for hormone-refractory prostate cancer. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed.

Satraplatin, a fourth-generation, oral investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum- based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an oral compound and is given as capsules that patients can take at home.

In addition to HRPC, satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.

In 2002, Spectrum licensed the global rights to GPC Biotech. GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.

Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC. Spectrum is required to pay to Johnson Matthey $500,000 in cash upon acceptance of the NDA by the FDA.

http://www.spectrumpharm.com/