LAUSANNE, SWITZERLAND and RESEARCH TRIANGLE PARK, NORTH CAROLINA – December 20, 2004 – Debiopharm S.A., the independent drug-development company specializing in oncology, endocrinology, CNS and niche diseases, announced today that it has entered into an exclusive licensing agreement with Rowfarma S. de R.L. de C.V., a subsidiary of Quintiles Transnational Corp., to market Decapeptyl® Depot 3.75mg and Decapeptyl ® LA 11.25mg in Mexico. Under the terms of this agreement, Debiopharm will supply Decapeptyl® from its FDA-inspected plant in Switzerland exclusively to Rowfarma for distribution and sale in Mexico. Debiopharm will also receive royalties on the sales of Decapeptyl® in Mexico.
In Mexico, Decapeptyl® is registered for prostate cancer, endometriosis, precocious puberty and breast cancer. Decapeptyl® is an intramuscular injectable formulation of triptorelin pamoate, a luteinizing hormone releasing hormone (LHRH or GnRH) agonist. Triptorelin products have been marketed for the last 18 years in Europe, Asia and South America as Decapeptyl®, which is the market leader in Southern Europe. In the United States, Decapeptyl® is marketed as Trelstar®.
“Rowfarma and Debiopharm recognized the good fit between the market potential in Mexico for Decapeptyl® and Quintiles’ ability to market and sell the product there. Rowfarma is familiar with the local prescribing habits and cultural environment in Mexico and is an ideal partner in this agreement,” said Rolland-Yves Mauvernay, President and CEO of Debiopharm.
David Hodgson, General Manager of Rowfarma, said: “Current LHRH use in Mexico is principally in the management of prostate cancer. I believe there is much scope for strong future growth as the disease is largely under-reported. Awareness campaigns are already having a positive effect on men in susceptible age groups presenting for prostate examination. The other main indications also provide opportunities for future growth. The Mexican medical community already is aware of Decapeptyl® from its widespread use in other countries and is ready to welcome its introduction.”
About Decapeptyl ®
Decapeptyl® Depot 3.75mg and Decapeptyl® LA 11.25mg products, formulated using the Debio® PLGA proprietary technology, are controlled-release one- and three-month intramuscular injectable formulations of triptorelin pamoate, a luteinizing hormone releasing hormone (LHRH or GnRH) agonist. They have a greater potency than naturally occurring LHRH and are approved for the palliative treatment of advanced prostate cancer in the US and Europe. In clinical trials, the most common adverse events were hot flushes, bone pain and headache. Decapeptyl® is contraindicated for use in women who are or may become pregnant and should not be administered to patients who are hypersensitive to triptorelin or other LHRH agonists.
About Debiopharm
Debio is an established group of four complementary companies, Debiopharm, Debioinnovation, Debio R.P. and Debioclinic. Debiopharm, founded in 1979 in Lausanne, Switzerland, focuses on evaluating compounds with promising in-vivo results in animals to in-license, develop for global registration, and out-license to sales and marketing pharmaceutical partners. Debiopharm has proven expertise in drug development, having registered three products: Eloxatin®, one of Sanofi-Aventis’ leading marketed products, Decapeptyl®, the leading product of Ipsen, and Trelstar® (1-and 3-month). Together, their combined sales are in excess of $ 1.8 bn in 2004. Debioinnovation was set up to complement the core business objectives of Debiopharm through addressing the financing and partnering needs of biotechnology, pharmaceutical start-up companies and life science incubators. Debio R.P. is a leader in polymer-based controlled release technologies that allow certain drugs like proteins, peptides and anti-cancers to be delivered in customized, sustained-release formulation. From its FDA-inspected manufacturing facility in Martigny, Switzerland, Debio R.P. also conducts feasibility studies, formulation selection, optimization, scale-up and cGMP manufacturing from clinical trial supplies to commercial scale. Debioclinic is a contract research organization, specialized in oncology and dedicated to clinical development, providing regulatory, biometric and clinical support in line with cGCP.
For more information on Debiopharm, please visit our website at www.debio.com
About Rowfarma and Quintiles Transnational Corp.
Rowfarma is a Quintiles subsidiary established in Mexico to help pharmaceutical companies expand the sale of their products in the Mexican market. Operating independently of the Quintiles’ services business, Rowfarma’s mission is to provide the research-based pharmaceutical industry with incremental sales opportunities in markets outside the US, Europe and Japan. Quintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, Quintiles has offices in 50 countries and is the world’s leading pharmaceutical services organization. For more information visit the company’s Web site at www.quintiles.com.
Information in this press release contains “forward-looking statements” about Quintiles that involve risks and uncertainties that could cause actual results to differ materially, including without limitation, uncertain demand for the primary indication or other indications, the possibility that growth in the market will take longer than anticipated, and the possibility that competing products will affect demand. Additional factors that could cause actual results to differ materially, are discussed in Quintiles’ recent filings with the U.S. Securities and Exchange Commission, including but not limited to its annual report on Form 10-K, its quarterly reports on Form 10-Q and its current reports on Form 8-K.