FDA Approves Cambia for Migraine
MONTGOMERY, Ala. -- Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved CambiaTM, a diclofenac-based non-steroidal anti-inflammatory drug ("NSAID") combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
CambiaTM, formulated with KPA's patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, CambiaTM was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. CambiaTM was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.
"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, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. "Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe CambiaTM addresses these needs and will be a valuable addition to physicians' migraine armamentarium."
KPA obtained exclusive U.S. and Canadian marketing rights for CambiaTM from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover CambiaTM through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect CambiaTM to launch in 4th quarter 2009.
Migraine headaches affect an estimated 30 million people in the United States and disproportionately affect women 3 to 1. According to a recent peer reviewed publication authored by leading migraine researchers, more than 70 percent of patients indicated that they were less than completely satisfied with their current treatment. Over 85 percent complained that pain relief took too long and 25 percent decided to stop seeking treatment altogether.
About Kowa Company Ltd. and Kowa Pharmaceuticals America, Inc.
Kowa Company, Ltd. is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on cardiovascular therapeutics, with fiscal year 2008 sales of the company's flagship product, LIVALO® (pitavastatin) totaling ¥ 34 billion ($340 million) in Japan.
Kowa Pharmaceuticals America, Inc. is a specialty pharmaceutical company focused primarily in the area of cardiology. The company started in 2001 as ProEthic Pharmaceuticals, Inc., and a majority stake in the company was acquired by Kowa Company, Ltd. in September, 2008. A privately held company, KPA focuses its efforts on the acquisition, development, licensing and marketing of pharmaceutical products. Its lead product, LIPOFEN® (fenofibrate capsules), is indicated as adjunctive therapy to diet to reduce elevated triglycerides and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For more information about KPA, please visit www.kowapharma.com.
About Applied Pharma Research
APR Applied Pharma Research SA is an independent, international, vertically integrated drug delivery and drug development company in healthcare with registered offices in Switzerland and the U.S. It is focused in the R&D of innovative and patented drug delivery systems as well as innovative pharmaceutical products primarily for oral and topical administration. The APR products and technologies are licensed to third parties for distribution and marketing activities. R&D activities are carried out directly or under contract. APR has signed licensing agreements with pharmaceutical companies in 117 countries worldwide and its sales are almost totally achieved abroad. For more information about APR, please visit www.apr.ch.