Strativa Pharmaceuticals Announces Preliminary Results From ONCONASE Phase IIIb Clinical Trial

Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. recently announced that its development partner, Alfacell Corporation reported that the preliminary statistical analysis of data from its confirmatory Phase IIIb clinical trial of its lead compound, ONCONASE (ranpirnase), did not meet statistical significance for the primary endpoint of survival in unresectable malignant mesothelioma (UMM). However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen.

The preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The trial was designed to show a statistically significant improvement in overall survival (p < 0.048) for UMM patients who were treated with a combination of ONCONASE plus doxorubicin as compared to patients who were treated with doxorubicin as a single agent. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving ONCONASE plus doxorubicin (unadjusted log rank p=0.80). The median survival time (MST) for evaluable patients who received ONCONASE plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

Statistically significant results were achieved in evaluable UMM patients who failed a prior chemotherapy regimen before entering this clinical trial. Patients who received ONCONASE plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin (unadjusted log rank p=0.016).

Based on the preliminary statistical analysis of the data, Alfacell will continue with the planned submission of the remaining components of the ONCONASE rolling NDA. Pending completion of the analysis of the data and further discussions with the FDA, the company currently estimates that the NDA submission will be completed by the end of calendar year 2008.

John MacPhee, president of Strativa Pharmaceuticals, said, "We remain optimistic about the potential of ONCONASE for patients living with unresectable malignant mesothelioma. We are committed to collaborating with Alfacell as they continue with the planned submission of the NDA."

In January 2008, Strativa entered into an exclusive licensing agreement under which Strativa received commercialization rights in the U.S. to Alfacell's ONCONASE (ranspirnase). In return for the commercialization rights to ONCONASE, Strativa paid Alfacell an initial payment of $5 million, which was incurred as a research and development (R&D) expense in the first quarter 2008. Strativa will also pay Alfacell a development milestone upon FDA approval. In addition to royalties on sales, Alfacell may receive milestone payments on future sales. Alfacell will also retain the right to co-promote ONCONASE in the future.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.

About Strativa
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.

About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com .

About Alfacell
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com .

SOURCE: Par Pharmaceutical Companies, Inc.