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Collegium Pharmaceutical Obtains U.S. Patent Allowance for Bupropion Patch-Nicotine Kit to Treat Smoking Cessation
HINGHAM, MA--(BUSINESS WIRE)-June 5, 2003-Collegium Pharmaceutical, Inc., a closely held specialty pharmaceutical company, today announced it has received notification from the U.S. Patent and Trademark Office (PTO) allowing the Company's patent application #09/962,927, "Pharmaceutical Composition Containing Two Active Ingredients for Smoking Cessation." The invention describes a kit combining two active ingredients (nicotine and bupropion) with the potential for alleviating symptoms of depression and smoking cessation. The kit includes a therapeutically effective amount of nicotine (any existing dosage form) and a transdermal system delivering a therapeutically effective amount of bupropion base. Bupropion HCl is available commercially in tablet form to treat depression (Wellbutrin(R), Glaxo SmithKline) and as an aid for smoking cessation treatment (Zyban(R), Glaxo SmithKline). Annual sales of oral forms of Bupropion HCl presently exceed $1 billion. Bupropion is currently the only antidepressant approved as an aid for smoking cessation. Titrated forms of nicotine (gum, patches, nasal spray) are also used to treat this problem. Collegium anticipates that the combined use of the two compounds may better target the range of symptoms associated with smoking cessation. A transdermal delivery system could also provide more consistent drug levels, helping to reduce the incidence of “break through” cravings. Collegium's Bupropion portfolio includes two U.S. patents (U.S. 6,280,763 B1; U.S. 6,312,716) for the development of transdermal bupropion base using a patch. The Company has successfully completed in vitro diffusion studies and is in the process of developing a prototype transdermal system for in vivo studies. Collegium expects to begin bioavailability studies in late 2003-early 2004. “We are extremely pleased with the continued growth of our bupropion patent portfolio. Smoking cessation remains a substantial chronic health problem and withdrawal symptoms are especially troublesome. We are optimistic that targeting a spectrum of symptoms with a patch delivery system would offer important benefits for people struggling with this problem,” said Jessica Wolfe, PhD, Vice President, Collegium Pharmaceutical.
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