H0RSHOLM, Denmark, October 11 /PRNewswire/ -- LifeCycle Pharma A/S today announced that it has entered into three strategic collaboration agreements with leading players in the pharmaceutical industry. These companies are Sandoz Inc. (an affiliate of Novartis AG), Merck Generics (a subsidiary of Merck KGaA of Darmstadt, Germany) and H. Lundbeck A/S.
“We are delighted to be able to announce strategic collaboration agreements with three such prominent global pharmaceutical companies”, said Dr. Flemming 0rnskov, President and CEO of LifeCycle Pharma. “These new partnerships provide a strong validation of our innovative MeltDose(R) technology which improves the bioavailability of drugs with low water solubility. They also validate our business model; a model based on identifying and developing products which represent significant business opportunities for big pharmaceutical companies. We are now also a significant step closer to the first commercial launch of a product derived from LifeCycle Pharma’s strong research and development pipeline”, said Dr. Flemming 0rnskov.
Details of the three strategic collaboration agreements include:
Sandoz
Sandoz and LifeCycle Pharma have entered into an exclusive development and commercialization agreement regarding the US market with respect to an undisclosed fenofibrate product developed by LifeCycle Pharma. The parties will be jointly responsible for the future development and Sandoz will be solely responsible for later commercialization of the product in the US. LifeCycle Pharma will receive milestone payments and a significant double-digit royalty rate of future sales. In 2005, the US market for fenofibrate products exceeded USD 1 billion.
Merck Generics
Merck Generics and LifeCycle Pharma have entered into an exclusive development and commercialization agreement regarding the European markets with respect to an undisclosed fenofibrate product developed by LifeCycle Pharma. Merck Generics is currently considering when to initiate the pivotal studies in Europe with the fenofibrate product. Merck Generics will conduct the future development and commercialization of the fenofibrate product, and will be responsible for all costs associated with these activities. LifeCycle Pharma will receive milestone payments in addition to a significant double-digit royalty rate of future sales. In 2005, the European market for fenofibrate products amounted to USD 235 million.
Lundbeck
Lundbeck and LifeCycle Pharma have entered into an agreement by which Lundbeck is granted rights to LifeCycle Pharma’s MeltDose(R) technology in connection with Lundbeck’s further development of two internal pre-clinical CNS-related projects. LifeCycle Pharma will receive milestone payments related to achieved results in the future developments of these projects. Due to the nature of an existing agreement between Lundbeck and LifeCycle Pharma, LifeCycle Pharma will not receive royalties on future possible revenues of these two CNS-related projects.
About fenofibrate:
According to the American Heart Association, up to 34.5 million people in the United States alone suffer from high cholesterol in the blood, and some of the biggest sub-populations have too high triglycerides levels, including patients with metabolic syndrome, mixed dyslipidemia and diabetes. Fenofibrate has proven to be very effective at lowering triglyceride (“TG”) concentrations and increasing high density lipoprotein (“HDL” or good cholesterol).
In 2005, sales of all fenofibrate drugs were approximately EUR1.2 billion world-wide. To address this market segment, LifeCycle Pharma has developed a franchise of 3 fenofibrate products - LCP-Feno, LCP-FenoChol and LCP-AtorFen. LCP-FenoChol is being developed as branded product candidates that will address selective sub-populations within the fenofibrate market while LCP-AtorFen is being developed as a powerful and safe treatment of high cholesterol, addressing three primary cardiovascular risk factors: low density lipoprotein (“LDL”), HDL and TG.
About LifeCycle Pharma A/S:
LifeCycle Pharma A/S was founded in June, 2002 as a spin-off from H. Lundbeck A/S. Its investors include H. Lundbeck A/S, Novo A/S, Nordic Biotech K/S, Alta Partners (USA), and Lacuna SICAV - Lacuna APO Biotech Subfund as well as LifeCycle Pharma executives. The company is based in H0rsholm, Denmark, and currently employs a staff of 42.
The company utilizes its proprietary MeltDose(R) technology to improve the bioavailability of known and established compounds so that patients can absorb them better and more effectively. LifeCycle Pharma’s pipeline contains six products in clinical trials within the areas of immunosuppression and cardiovascular diseases. LifeCycle Pharma expects to file an application to the FDA during the second half of 2006 to market its first product within its fenofibrate franchise - LCP-FenoChol in the US.
LifeCycle Pharma believes that its core competence is its ability to select appropriate drugs, improve their formulation, conduct clinical tests and obtain regulatory approvals within a short time frame, thus substantially reducing the financial risk and time to market compared with other pharmaceutical or biotechnology companies.
For more information about LifeCycle Pharma A/S, please visit www.lcpharma.com
LifeCycle Pharma A/S
CONTACT: For further information, please contact: Flemming 0rnskov,President & CEO, tel. +4-70-33-33-00 or +45-24-20-03-68, Michael WolffJensen, Executive VP & CFO, tel. +45-70-33-33-00 or +45-40-74-62-44
