LAVAL, Jan. 11 /PRNewswire-FirstCall/ - LAB International Inc. (“LAB”), an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services, today announced that its drug development subsidiary, LAB Pharma Ltd., and Teikoku Seiyaku Co. Ltd. have entered into a licensing and development agreement for Fentanyl TAIFUN(R), LAB’s fast-acting Fentanyl formulation, for the Japanese market.
Teikoku Seiyaku will be responsible for the further development of Fentanyl TAIFUN(R) in Japan, building on LAB’s global development plan for European and North American markets. Under the terms of the agreement, LAB will receive a signing fee, development milestones payments and R&D reimbursements for development activities conducted by LAB in support of the development in Japan. In addition, Teikoku Seiyaku will pay LAB royalties on sales and manufacturing revenues for supplying the finished product.
“With Teikoku Seiyaku’s commitment to building a world-class franchise in the pain management area, we are now well positioned to move forward the development of our lead product into another major market,” said Dr. Halvor Jaeger, Chief Executive Officer of LAB International Inc. “Teikoku Seiyaku, with its experience in opiate products and drug delivery differentiated products, represents an ideal partner for LAB to bring Fentanyl TAIFUN(R) through clinical development and regulatory submissions in the Japanese market.
“This agreement with LAB Pharma is a perfect fit with our strategy to become a world leader in a selected sector of drug delivery differentiated pain-relief products. LAB’s Fentanyl TAIFUN(R) will be a key element in our pain-relief prescription pharmaceuticals portfolio” said Mr. Shosaku Murayama, President and Chief Executive Officer of Teikoku Seiyaku. “LAB has a well constructed development program for a product with excellent attributes for cancer patients suffering from breakthrough pain. We are looking forward to contribute to and share in the success of this product.”
Fentanyl is an opiate analgesic commonly used for the treatment of moderate to severe chronic pain associated with conditions such as cancer. Fentanyl TAIFUN(R) consists of a dry powder formulation of Fentanyl delivered by LAB’s proprietary TAIFUN(R) dry powder inhaler. In recently presented clinical results, absorption of Fentanyl after a single inhalation of Fentanyl TAIFUN(R) (200 (micro)g) was shown to be very rapid, with an average peak concentration reached in one minute. The development program of Fentanyl TAIFUN(R) is currently in clinical Phase II in cancer patients in Europe. In Japan, there are no Fentanyl breakthrough pain products on the market, and Fentanyl TAIFUN(R) is expected to obtain a substantial share of this emerging market.
“We look forward to a very productive operational collaboration between LAB and Teikoku Seiyaku. We highly appreciate the commitment of the Teikoku Seiyaku team to integrate the Japanese development activities into the LAB global development plan to ensure fast time to market”, commented Dr. Taneli Jouhikainen, President of LAB Pharma, on the relationship between the companies.
About Teikoku Seiyaku
Teikoku Seiyaku Co., Ltd. headquartered in Sanbonmatsu, Kagawa, Japan, is the world leader of manufacturing medicated plasters and a pioneer in the field of anti-inflammatory and analgesic plasters. Lidoderm(R), Lidocaine Patch distributed by its American partner in the US market place is developed and manufactured by Teikoku Seiyaku. Teikoku Seiyaku is mainly proceeding in two directions. One is for products based on its innovative TTS technology. The other is for products for pain-relief.
Teikoku group companies are innovating high quality drug delivery systems, and developing and manufacturing the final products. Its product range is therefore very varied from the medicated patches to unit-dose jellies and liquids, creams, ointments and other delivery products for numerous conditions and applications. Teikoku Seiyaku was founded in 1848 and has been in the pharmaceutical business for nearly 160 years. Further information about Teikoku Seiyaku is available at www.teikoku.co.jp
About LAB International
LAB International (LAB Pharma and LAB Research) is an integrated drug development company. LAB Pharma is focused on the growing multi-billion dollar inhalation market. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company’s TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, and growth hormone deficiencies. LAB Research is a profitable and growing contract research services division supporting its clients base from state-of-the-art facilities in Canada, the US, Denmark and Hungary.
LAB’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “LAB”, on the Frankfurt Regulated Unofficial Market under the symbol “LD9.F” and on XETRA under the symbol “LD9.DE” with 70.0 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of LAB International Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
LAB INTERNATIONAL INC.
CONTACT: visit LAB’s website at www.labinc.ca, or contact: Luc Mainville,Chief Operating Officer, (450) 973-2240 ext. 1206, Fax: (450) 973-2259,mainvillel@labinc.ca; Frederic Dumais, Director, Communication and InvestorRelations, (450) 973-2240 ext. 1207, Fax: (450) 973-2259,dumaisf@labinc.ca; Kim Sutton Golodetz, Investor Relations (U.S.A), (212)838-3777, Fax: (212) 838-4568, kgolodetz@lhai.com
