Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Celgene-CELG -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (321)	7/13/1999 8:54:00 AM
From: LLCF	Respond to of 804

Some patent news on d-methylphenidate: biz.yahoo.com DAK

To: Miljenko Zuanic who wrote (321)	7/13/1999 9:49:00 AM
From: lwd	Read Replies (1) \| Respond to of 804

Tuesday July 13, 8:03 am Eastern Time Company Press Release SOURCE: Celgene Corporation Celgene Awarded Key Patent for Single-Dose Administration of Chiral Version of ADHD Pharmaceutical WARREN, N.J., July 13 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) announced today the company had been awarded U.S. Patent No. 5,922,736 for the once daily administration of d-methylphenidate, the chirally pure version of RITALIN® (dl-methylphenidate) for the treatment of attention deficit-hyperactivity disorder (ADHD). Current RITALIN® regimens require multiple daily dosages, a major inconvenience for young ADHD patients; pending scientific and regulatory reviews, the single dose administration of d-methylphenidate may help many ADHD patients better comply with their treatment. The patent, covers both methods and formulations for the pharmaceutical, which is being evaluated in pivotal clinical trials in the United States and Canada. ''The Celgene formulations of this important pharmaceutical targets major unmet medical needs of millions of patients in this country. Our comprehensive patent estate -- which includes pulsed release dosage forms, the compound, methods of treatment, and now once-daily oral dosing -- helps ensure that Celgene and its partners will derive maximum commercial benefit from this important product,'' said Sol Barer, Ph.D., President and COO of Celgene. Jerome Zeldis, M.D., Ph.D., Vice President for Medical Affairs at Celgene and co-author of the patent, noted that simplifying the dosage regimen for ADHD patients could be expected to afford substantial benefits for ADHD patients and their healthcare providers, particularly at school. ''If demonstrated clinically, administration of d-methylphenidate for ADHD outside of the school setting would eliminate the need for children to report to their school nurse's offices for treatment, easing the visibility and stigma of their condition and easing the burden on the school,'' Dr. Zeldis noted. Celgene is evaluating earlier study data which suggested the chirally pure formulation has a longer therapeutic effect than the racemic formulation, Dr. Zeldis said. Celgene recently announced that a pivotal clinical trial for d-methylphenidate had been fully enrolled at 18 centers throughout the United States, and would be completed this year. Clinical studies are underway to evaluate different dosages, as well as the therapeutic benefits and the potential for reduced side effects of d-methylphenidate. As reported in the Journal of the American Medical Association* 3-6% of the school-age population (elementary to high school) have ADHD. The Journal reported that 1-1.5 million children in the US are now being treated for this condition. Total North American sales of dl-MPH are estimated to exceed $400 million per year. Celgene Corporation, headquartered in Warren, NJ, is engaged in the development of pharmaceuticals and agrochemicals. This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q, and 8K reports. JAMA April 8, 1998 (Vol 279, No. 14) SOURCE: Celgene Corporation