WOODCLIFF LAKE, N.J., May 29 StrativaPharmaceuticals, the proprietary products division of Par PharmaceuticalCompanies, Inc. (NYSE: PRX) today announced that its development partner,Alfacell Corporation (Nasdaq: ACEL) reported that the preliminary statisticalanalysis of data from its confirmatory Phase IIIb clinical trial of its leadcompound, ONCONASE (ranpirnase), did not meet statistical significance for theprimary endpoint of survival in unresectable malignant mesothelioma (UMM).However, a statistically significant improvement in survival was seen in thetreatment of UMM patients who failed one prior chemotherapy regimen.
The preliminary results are based on 320 evaluable events that occurred inthe clinical trial out of a total of 428 patients randomized. The trial wasdesigned to show a statistically significant improvement in overall survival(p < 0.048) for UMM patients who were treated with a combination of ONCONASEplus doxorubicin as compared to patients who were treated with doxorubicin asa single agent. The analysis of the data did not show a statisticallysignificant improvement for evaluable patients receiving ONCONASE plusdoxorubicin (unadjusted log rank p=0.80). The median survival time (MST) forevaluable patients who received ONCONASE plus doxorubicin was 11.1 months ascompared to 10.7 months for patients who received doxorubicin as a singleagent.
Statistically significant results were achieved in evaluable UMM patientswho failed a prior chemotherapy regimen before entering this clinical trial.Patients who received ONCONASE plus doxorubicin experienced a MST of 10.5months 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 willcontinue with the planned submission of the remaining components of theONCONASE rolling NDA. Pending completion of the analysis of the data andfurther discussions with the FDA, the company currently estimates that the NDAsubmission will be completed by the end of calendar year 2008.
John MacPhee, president of Strativa Pharmaceuticals, said, "We remainoptimistic about the potential of ONCONASE for patients living withunresectable malignant mesothelioma. We are committed to collaborating withAlfacell as they continue with the planned submission of the NDA."
In January 2008, Strativa entered into an exclusive licensing agreementunder which Strativa received commercialization rights in the U.S. toAlfacell's ONCONASE (ranspirnase). In return for the commercialization rightsto ONCONASE, Strativa paid Alfacell an initial payment of $5 million, whichwas incurred as a research and development (R&D) expense in the first quarter2008. Strativa will also pay Alfacell a development milestone upon FDAapproval. In addition to royalties on sales, Alfacell may receive milestonepayments on future sales. Alfacell will also retain the right to co-promoteONCONASE in the future.
ONCONASE has been granted fast track status and orphan-drug designationfor the treatment of malignant mesothelioma by the FDA. Additionally,ONCONASE has been granted orphan-drug designation in the European Union andAustralia.
Strativa Pharmaceuticals is the proprietary products division of ParPharmaceutical, Inc. Strativa is committed to developing and marketing novelprescription drugs. Its initial focus is on supportive care therapeutics inHIV and oncology. Drawing on the specialty products expertise of its staff,Strativa possesses the resources to prepare products for introduction and tohelp ensure their success after launch. For additional information, pleasevisit www.strativapharma.com.
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Par Pharmaceutical, Inc. develops, manufactures and markets generic drugsand innovative branded pharmaceuticals for specialty markets. For pr