Montgomery, AL, April 14, 2009 – Kowa Pharmaceuticals America, Inc., (KPA) a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, has announced plans to divest its unique franchise of diclofenac products, including PRO-513 (proposed trade name: CAMBIATM) for the treatment of acute migraine headache pain and PRO 571 for the treatment of acute pain. KPA has appointed Robert W. Baird & Co. as its exclusive financial advisor with regard to a transaction involving these assets.
After a thorough review of its research & development portfolio, KPA (formerly known as ProEthic Pharmaceuticals, Inc.) has determined that the migraine and pain product candidates are not strategically aligned with KPA's long-term vision to become a leader in the cardiometabolic therapeutic arena.
"Although this novel diclofenac franchise represents an extremely compelling part of KPA's portfolio, our foremost priority is our company's extensive cardiometabolic pipeline. We will continue to focus our resources toward the successful sales and marketing of this pipeline, leveraging our current expertise with LIPOFEN®," said Ben Stakely, CEO and President of Kowa Pharmaceuticals America.
KPA's first new cardiovascular candidate is pitavastatin (proposed trade name: LIVALO®), a potent HMG Co-A reductase inhibitor for the primary treatment of hypercholesterolemia and combined (mixed) hyperlipidemia. A new drug application (NDA) for LIVALO® was filed with the Food & Drug Administration (FDA) in October 2008. Pending approval by FDA, KPA is responsible for the commercialization of LIVALO® in the United States.
The assets to be divested are patent protected diclofenac-based non-steroidal anti-inflammatory drugs (NSAIDs) that are combined with potassium bicarbonate, resulting in rapid and consistent absorption of diclofenac, leading to faster and higher peak blood concentrations than other approved dosage forms of diclofenac. KPA licensed rights to CAMBIATM and PRO-571 from Applied Pharma Research, S.A. (APR) of Balerna, Switzerland. The APR license provides KPA with exclusive rights to market, distribute and commercialize CAMBIATM and PRO-571, as well as other yet to be developed products in the U.S. and Canada.
CAMBIATM and PRO-571 will compete in two of the largest pain markets in the U.S. CAMBIATM is a powder for oral solution that will compete in the migraine pain market (estimated 2009 sales of approximately $4.1 billion), while PRO-571 is formulated as a tablet intended for use in the broader acute pain category (estimated 2009 sales of approximately $3.0 billion).
The NDA for CAMBIATM is currently being reviewed by the FDA. PRO-571 is currently entering into late-stage clinical trials.
KPA is a specialty pharmaceutical company focused primarily in the area of cardiology. The company, which was started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by Kowa Company, Ltd. in September of 2008. The privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. Its lead product, LIPOFEN®, 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 Kowa Company, Ltd.
Since its establishment in 1894, Kowa has grown into a multinational Japanese company actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science and information technology, textiles, machinery and various consumer products. During its long history, Kowa has consistently strived to meet the changing needs of the global market, and with its continuing entrepreneurial initiative, is determined to meet the needs of future generations. It is this commitment to consistency and initiative in an ever-changing world that Kowa vows to carry forward through each generation. For more information about Kowa, please visit www.kowa.com.
Baird is an employee-owned, international wealth management, capital markets, private equity and asset management firm with offices in the United States, Europe and Asia. Established in 1919, Baird has more than 2,300 associates serving the needs of individual, corporate, institutional and municipal clients. Baird oversees and manages client assets of $62 billion. Committed to being a great place to work, Baird ranked number 14 on FORTUNE's "100 Best Companies to Work For"® in 2009 -- its sixth consecutive year on the list. Baird's principal operating subsidiaries are Robert W. Baird & Co. in the United States and Robert W. Baird Group Ltd. in Europe. Baird also has an operating subsidiary in Asia supporting Baird's private equity operations. For more information, please visit Baird's Web site at www.rwbaird.com.
About Applied Pharma Research
APR Applied Pharma Research SA is a privately owned internationally oriented drug delivery company with registered offices in Switzerland and the U.S. It is focused in the research & development 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 about 35 countries worldwide and its sales are almost totally achieved abroad. For more information about APR, please visit www.apr.ch.