MONTREAL, June 21 /PRNewswire-FirstCall/ - LAB International Inc. (“LAB”), a drug development company focused on developing inhalation therapies for pain treatments, today announced that it has signed a licensing and development agreement with Janssen Pharmaceutica NV for Fentanyl TAIFUN(R), its fast-acting Fentanyl formulation using the company’s TAIFUN(R) dry powder inhaler, for the treatment of breakthrough cancer pain.
The licensing agreement covers the European Union, Eastern Europe, Russia, the Middle-East and Africa. LAB and Janssen Pharmaceutica will collaborate to develop the product for the initial indication of breakthrough cancer pain. Janssen Pharmaceutica NV will be marketing authorization holder in the territories covered by the agreement and will also be responsible for developing any additional indications. LAB will manufacture the product for all territories. The Janssen-Cilag companies will market and distribute the product. Under the terms of the agreement, LAB will receive a signing fee of US $10.8 million ((euro) 8.0 million), up to US $33.6 million ((euro) 25.0 million) in development and regulatory milestones as well as payments of commercial sales milestones. LAB could receive significant royalty income on sales of the product as well as manufacturing profit.
“We are extremely pleased to have partnered our lead product, Fentanyl TAIFUN(R), with the originator of fentanyl that was successfully marketed by Janssen-Cilag companies as DUROGESIC(R), the Fentanyl transdermal patch. The company’s world class product development and marketing expertise combined with Fentanyl TAIFUN(R)'s superior formulation and therapeutic profile should make it an important therapeutic option for many patients.”, said Dr. Halvor Jaeger, Chief Executive Officer of LAB International.
Janssen Pharmaceutica NV is a Belgium based worldwide pharmaceutical center of excellence for integrated R&D, production and general services. With a track record consisting of more than 80 medicines, the company is among the most innovative in the world and its products are available all over the globe.
The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Leading products include Concerta(R) (ADHD), Durogesic(R) (pain management), Eprex(R) (anemia), Pariet(R) (gastroenterology), Topamax(R) (epilepsy, migraine prevention), Reminyl(R) (Alzheimer’s disease), Risperdal(R) (schizophrenia, bipolar disorders, disruptive behavior), Risperdal(R) Consta(R) (schizophrenia) and Velcade (multiple myeloma).
Conference call information:
LAB will host a conference call at 2:00 pm, on Thursday June 21, 2007. Interested parties may also access the conference call by webcast at www.labinc.ca.
The telephone numbers to access the conference call are 416-644-3414 or 1-800-732-9303. A replay of the call will be available until Thursday June 28, 2007. The telephone numbers to access the replay are 416-640-1917 and 1-877-289-8525 with code number 21237175#.
About Breakthrough Pain
Chronic pain associated with advanced cancer is commonly treated with opioid analgesics, such as fentanyl. Breakthrough pain episodes are sudden and intense flares of pain that “break through” a long-acting continuous treatment, such as a transdermal patch or sustained release oral formulations. Break-through pain episodes are common in cancer patients, often occurring several times a day.
About LAB International
LAB International is an integrated drug development company 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’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 82.3 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: Frederic Dumais, Vice-President, Investor Relations, (514)315-3330 ext. 106, Fax: (514) 315-3325, dumaisf@labinc.ca; www.labinc.ca
