2007-05-01 09:47:24 -
HØRSHOLM, Denmark, May 1 /PRNewswire/ --
- Additional Agreement for Technology Partnership
Summary: LifeCycle Pharma announces US partnership with Sciele Pharma for
LCP-FenoChol and also enters into Technology Partnership for MeltDose(R)
Technology
LifeCycle Pharma A/S (OMX: LCP) today announced that it has signed an
exclusive license agreement with Sciele Pharma, Inc. (NASDAQ:SCRX) to market
fenofibrate in the US, Canada, and Mexico, in 120 milligram and 40 milligram
strengths. Fenofibrate is prescribed for the treatment of hyperlipidemia and
triglyceridemia. Under the terms of
the agreement, LifeCycle Pharma will
receive an up-front payment of US$5 million, milestone payments of up to
US$12 million upon FDA approval and meeting certain sales targets, and tiered
mid-teen to high-teen royalty payments on product sales.
LifeCycle Pharma filed with the US Food and Drug Administration (FDA) in
October 2006 a New Drug Application (NDA) 505(b)(2) for this new formulation
of fenofibrate (LCP-FenoChol). Upon FDA approval, this new formulation of
fenofibrate in 120 mg. and 40 mg. dosage strengths are expected to be the
lowest doses of fenofibrate available for patients.
Sciele has also entered into a technology collaboration with LifeCycle
Pharma utilizing LifeCyle's MeltDose Technology for the life-cycle management
of its products. Under the terms of this agreement, LifeCycle Pharma will be
responsible for the development of the product and in return, LifeCycle
Pharma will be entitled to receive R&D reimbursement, development milestones
and mid-single digit royalties on eventual sales.
Patrick Fourteau, Chief Executive Officer and President of Sciele,
said, "This agreement, coupled with our existing Triglide product line and
our pravastatin/fenofibrate combination in phase III clinical trials, will
help us to build a strong position in the fast growing fenofibrate market.
Furthermore, this collaboration will enable us to capitalize on LifeCycle
Pharma's proprietary MeltDose technology to further expand our product
pipeline through life-cycle management."
Dr. Flemming Ornskov, CEO of LifeCycle Pharma stated, "We are extremely
pleased with both of these agreements, and look forward to Sciele helping us
capitalize on LCP-FenoChol's (fenofibrate) significant commercial opportunity
of being the lowest dose fenofibrate product in the US$1.3 billion US
fenofibrate market. Sciele has a proven track record in the cardiovascular
market with its Primary Care sales force."
About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in Hørsholm, Denmark, is an emerging
pharmaceutical company with a broad and late stage product pipeline in
therapeutic areas of cholesterol management, hypertension and organ
transplant. LifeCycle Pharma's product candidates are proprietary and
designed to improve the quality of existing drugs by enhancing the release
and absorption of drugs in the human body. LifeCycle Pharma's proprietary
technology platform, MeltDose(R) technology, offers lower dosing, reduced
side effects and improved safety and patient compliance, as well as reduced
product development time and production costs. LifeCycle Pharma is listed on
the OMX Nordic Exchange under the trading symbol (LCP). Please visit
www.lcpharma.com for further information about LifeCycle Pharma A/S.
About Sciele Pharma, Inc. :
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales,
marketing and development of branded prescription products focused on
Cardiovascular/Diabetes and Women's Health. The Company's
Cardiovascular/Diabetes products treat patients with high cholesterol,
hypertension, high triglycerides, unstable angina and Type 2 diabetes, and
its Women's Health products are designed to improve the health and well-being
of women and mothers and their babies. Founded in 1992 and headquartered in
Atlanta, Georgia, Sciele Pharma employs more than 800 people. The Company's
success is based on placing the needs of patients first, improving health and
quality of life, and implementing its business platform - an Entrepreneurial
Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork. For more
information about Sciele Pharma and its products, visit www.sciele.com.
Source: Lifecycle Pharma A/S