CSE no. 04/2008: LifeCycle Pharma Launches Its First Product in the U.S.
It will be marketed under the brand name Fenoglide(TM) by Sciele Pharma, Inc.
HORSHOLM, Denmark--(BUSINESS WIRE)--Feb. 21, 2008--LifeCycle Pharma A/S (OMX: LCP), an emerging specialty pharmaceutical company, announced today that its first product, the cholesterol lowering Fenoglide(TM) (formerly LCP-FenoChol) for the treatment of hyperlipidemia and hypertriglyceridemia, was launched today under the name Fenoglide(TM) as approved by the U.S. Food and Drug Administration (FDA). Fenoglide will be marketed by its partner Sciele Pharma Inc.
Fenoglide will be the lowest dose of fenofibrate available for patients. Fenoglide will be offered in 40 mg and 120 mg strength tablets. Fenoglide utilizes LCP's unique MeltDose(R) technology, a clinically validated reformulation technology, designed to provide enhanced absorption and greater bioavailability of the drug.
Fenoglide will be marketed by Sciele Pharma's more than 400 sales representatives across its diabetes and cardiovascular sales force teams.
"Fenoglide is our first marketed product and we are extremely pleased to launch it in the United States - and proud to be one of the very few Danish specialty pharmaceuticals companies to take a product to the U.S. primary care market," said Dr. Flemming 0rnskov, President and Chief Executive Officer of LCP. "It is a significant step forward in our strategy of becoming a fully integrated specialty pharmaceuticals company. Sciele Pharma has a proven track record in the cardiovascular market and we are excited about our collaboration with them."
According to the American Heart Association (AHA), over 140 million American adults have excessive total blood cholesterol values. Sales of fenofibrate have increased significantly in the last few years, and in 2006, fenofibrate sales totaled USD 1.7 billion worldwide, an increase of 16% over 2005. In the U.S. alone, fenofibrate sales totaled USD 1.3 billion in 2006. In 2007, the fibrate segment is estimated to increase around 14% over 2006 with estimated gross sales of USD 1.6 billion.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "We are enthusiastic about introducing LCP's Fenoglide in 40-milligram and 120-milligram dosage strengths. We expect the launch of Fenoglide, the lowest dose fenofibrate available to patients, will enable us to increase our share of the fenofibrate market, which is one of the fastest growing areas of the cardiovascular market."
According to the agreement with Sciele Pharma, LCP will receive tiered royalty payments on product sales and may also receive milestone payments of up to USD 8 million when certain sales targets are met.
The launch of Fenoglide demonstrates one of LCP's key strengths; the short time span from idea to commercialization thanks to the proprietary MeltDose technology and strong research and development capabilities. FenoGlide was developed from pre-clinical trials to FDA approval for sale in the U.S. within five years as compared with a traditional drug development time of around 8-11 years.
About LifeCycle Pharma A/S ("LCP")
LCP is an emerging specialty pharmaceuticals company that, through innovative technologies, is able to rapidly develop a portfolio of differentiated products to meet the unique needs of key therapeutic markets and patient populations. This includes products for immunosuppression, specifically organ transplantation, and to combat certain cardiovascular diseases. By using its unique and patented delivery technology, MeltDose, LCP is able to develop drugs with enhanced absorption and thereby increased bioavailability. The company has one product ready for US commercialization, seven clinical development programs covering five product candidates and three product candidates in preclinical development. LCP is listed on the OMX Nordic Exchange Copenhagen under the trading symbol