Announcement no. 8/2007
To OMX Nordic Exchange Hørsholm, Denmark, 1 May 2007
LIFECYCLE PHARMA SIGNS EXCLUSIVE LICENSE AGREEMENT WITH SCIELE PHARMA
TO MARKET A NEW FORMULATION OF FENOFIBRATE
IN 120MG AND 40MG DOSAGE STRENGTHS
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®
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.”
For further information please contact:
LifeCycle Pharma A/S
Flemming Ornskov
President & CEO
DK Tel. +45 24 20 03 68
US Tel. +1 917 288 6446
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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® 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.
LIFECYCLE PHARMA SIGNS EXCLUSIVE LICENSE AGREEMENT WITH SCIELE PHARMA TO MARKET A NEW FORMULATION OF FENOFIBRATE IN 120MG AND 40MG DOSAGE STRENGTHS - ADDITIONAL AGREEMENT FOR TECHNOLOGY PARTNERSHIP
| Quelle: Veloxis Pharmaceuticals A/S