Migraine medicine gets the OK from FDA
MONTGOMERY, Ala. The Food and Drug Administration has approved Cambia for the treatment of acute migraine with or without aura in adults.
The privately held specialty pharmaceutical company, Kowa Pharmaceuticals America, developed the drug with its patented Dynamic Buffering Technology to provide patients with fast and effective relief for migraine pain. Clinical trials showed Cambia also helped ease photophobia, phonophobia and nausea, all commonly associated with migraine attacks.
“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, COO of Kowa Pharmaceuticals America. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”
KPA holds exclusive U.S. and Canadian marketing rights for Cambia from Applied Pharma Research. In conjunction with Novartis Pharma AG, the current European marketer, KPA and APR are in the final stages of negotiations with a marketing partner and anticipate the drug will launch in the fourth quarter 2009.
NAMI releases PSA initiative regarding psychological disorders
ARLINGTON, Va. A nonprofit organization hopes that a new series of public service announcements it has released will encourage people to connect with each other to help themselves, their families and friends who live with psychological disorders.
The National Alliance on Mental Illness announced this week that it had released a PSA initiative called “Puzzle Pieces” that includes four 60-second and three 30-second radio PSAs featuring testimonials from individuals and families that describe their experiences with mental illnesses and the role NAMI played in their recovery.
“We know that with early detection, appropriate treatment and support from family and friends, people with mental illness can lead healthy, rewarding lives,” NAMI executive director Michael Fitzpatrick said. “NAMI members connect to educate each other and encourage their loved ones during their personal journeys to wellness.”
The organization said that an estimated 1-in-5 American families is affected by mental illnesses, including major depression, bipolar disorder, schizophrenia and post-traumatic stress disorder.
KV Pharmaceutical, Gedeon Richter announce licensing agreement
BUDAPEST, Hungary An American drug maker has signed a licensing agreement with a Hungarian pharmaceutical company.
KV Pharmaceutical Co. announced that it had entered into an agreement with Budapest, Hungary-based Gedeon Richter and its American subsidiary for licensing rights to KV technologies and products in the women’s health category.
Under the agreement, Gedeon Richter will have the right to manufacture and distribute certain proprietary technologies and products from KV in the European Union and other areas where it does business, while KV will receive undisclosed milestones and royalties for products that the two companies develop. KV will retain U.S. rights.
“KV Pharmaceutical and Gedeon Richter have for many years enjoyed an excellent relationship and business collaboration, and we are very pleased to extend it in this fashion,” KV Pharmaceutical Co. interim CEO David Van Vliet stated. “We believe this agreement allows both Richter and KV to offer additional enhanced products to more completely serve physicians and their patients.”