October 2008

Elite Announces Drug Application Filing For Synthetic Narcotic Analgesic Accepted by FDA

Globes News Wire Source

Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX:ELI) in collaboration with ThePharmaNetwork, LLC., announced today the acceptance by the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for a generic equivalent of a synthetic narcotic analgesic drug product. The product had annual sales of approximately $36 million in 2007. Elite will manufacture the product and will receive a share of the profits from the sale of the product upon commercialization.

"We are pleased to reach this milestone and look forward to working with ThePharmaNetwork in this venture," commented Bernard Berk, Chairman and CEO for Elite. "With the revenue generated from the Lodrane(r) products along with the proceeds of our recent capital raise, Elite continues to move forward with the development of our two lead pain products, ELI-216, our abuse resistant oxycodone, and ELI-154, our once daily oxycodone product and will complete the work necessary for initiating Phase III clinical studies. Prescription drug abuse is a national crisis and abuse resistant drugs, like those being developed by Elite, are aimed at making a significant impact on this problem. ELI-216 is differentiated from other abuse resistant products in development by being the only once daily oxycodone using a pharmacological approach for abuse resistance. The pharmacological approach, we believe, compared to other technologies can provide a higher barrier for those recreational drug users trying to use these prescription drugs inappropriately to achieve a euphoric high and the once daily delivery provides a more consistent blood levels of the drug for these chronic indications as compared to the current sustained release oxycodone products. Elite will continue to prosecute the patents it has filed for this product and is preparing to file additional patents to strengthen our intellectual patent estate. Elite has also improved its financial condition by restructuring its workforce which, together with the growth in Elite's Lodrane revenues (approximately $1.3 million in last 6 months), is expected to significantly reduce Elite's operating losses. Lodrane 24(r) and Lodrane 24D(r) are products manufactured by Elite and sold and distributed by our partner ECR Pharmaceuticals. We will continue to seek out additional partnering prospects and other venture opportunities to leverage our proprietary opioid abuse technology and our unique drug delivery systems."

FDA Offers Advice on End of Phase IIa Meetings

FDA Source

The FDA is recommending that IND sponsors meet with the agency at the end of Phase IIa clinical trials to discuss dose estimation and selection for late-stage efficacy trials and whether novel trial designs would be useful, according to a new CDER draft guidance. The meeting also would allow sponsors to discuss critical data on drug interactions, studies in special populations defined by genetic characteristics or other biomarkers, and other pharmacokinetic or pharmacodynamic relationships.

The FDA is also recommending that IND sponsors meet with the agency at the end of Phase IIa clinical trials to discuss dose estimation and selection for late-stage efficacy trials and whether novel trial designs would be useful, according to a draft guidance from the Center for Drug Evaluation and Research.

Comments on the draft are due Nov. 25.

U.S. Food & Drug Administration Approved the use of REYATAZ® (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Business Wire Source

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food & Drug Administration (FDA) approved the use of REYATAZ® (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients. REYATAZ boosted with ritonavir (REYATAZ/r) taken once daily with food is recognized by the U.S. Department of Health and Human Services (DHHS) as a preferred component of combination HIV therapy for treatment-naive patients1.

For treatment-naive patients who are unable to tolerate ritonavir, REYATAZ 400 mg (without ritonavir), taken once daily with food, is recommended.

This use of once-daily REYATAZ/r in HIV-1 infected treatment-naive adult patients is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of REYATAZ/r to twice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIV combination therapy, in treatment-naive HIV-1 infected adult patients.

Within the CASTLE study, the REYATAZ/r arm was associated with low increases from baseline in total cholesterol (13 percent), LDL cholesterol (14 percent), HDL cholesterol (29 percent), and triglycerides (15 percent). The lopinavir arm was associated with 25 percent increase in total cholesterol, 19 percent increase in LDL cholesterol, 37 percent increase in HDL cholesterol, and 52 percent increase in triglycerides. Two percent of patients in the REYATAZ® (atazanavir sulfate)arm and eight percent of patients in the lopinavir arm required lipid-lowering therapy in the study, compared to 1 percent in each arm at baseline.

Safety events in this study were consistent with prior experience. Grade 2-4 treatment-related adverse events that occurred in two percent or greater of patients in the CASTLE study included jaundice (4 percent and zero percent), nausea (4 percent and 8 percent), diarrhea (2 percent and 11 percent) and rash (3 percent and 2 percent) in the REYATAZ/r and lopinavir/r arms, respectively. Grade 3–4 increases in total bilirubin were seen in 34 percent of patients in the REYATAZ/r arm and in less than 1 percent of patients in the lopinavir/r arm.

"Bristol-Myers Squibb is committed to developing medicines that enhance the care of people living with HIV and AIDS," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Boosted REYATAZ provides health care professionals a newly approved, once-daily dosing option as part of combination therapy for patients naive to HIV therapy."