Sciele Pharma Signs Exclusive License Agreement with LifeCycle Pharma A/S To Market a New Formulation of Fenofibrate in 120 mg and 40 mg Dosage Strengths
- Category: Small Molecules
- Published on Wednesday, 02 May 2007 04:00
- Hits: 1490
ATLANTA, GA, USA | May 01, 2007 | Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that it has signed an exclusive license agreement with LifeCycle Pharma A/S (OMX:LCP) to market fenofibrate in the U.S., Canada, and Mexico, in 120 milligram and 40 milligram strengths. Fenofibrate is prescribed for the treatment of hyperlipidemia and triglyceridemia. Under terms of the agreement, LifeCycle Pharma will receive an up-front payment of $5 million, milestone payments of up to $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 U.S. Food and Drug Administration (FDA) in October 2006 a New Drug Application (NDA) 505B2 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, President and Chief Executive Officer 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 $1 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 Copenhagen, 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.
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.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are unsuccessful in obtaining or renewing third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our future ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs;
We may encounter problems in the manufacture or supply of our products, for which we depend entirely on third parties. Strong competition exists in the sale of our promoted products, which could adversely affect expected growth of our promoted products' sales or increase our costs to sell our promoted products. We may not be able to protect our competitive position for our promoted products from patent infringers. If generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.
Certain of our products have experienced manufacturing issues. If the issues recur and cannot be resolved, our ability to acquire product for sale and sampling will be adversely affected. We may incur unexpected costs in integrating new products into our operations.
We may be unable to develop or market line extensions for our products including Prenate, Sular, Triglide, Nitrolingual, Altoprev and Fortamet, or, even if developed, obtain patent protection for our line extensions; further, introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our financial results could be adversely affected.
If we have difficulties acquiring new products or rights to market new products from third parties, our financial results could be adversely impacted. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60 dose size of this product has not yet met our expectation.
We depend on a small senior management group, the departure of any member of which would likely adversely affect our business if a suitable replacement member could not be retained.
An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. An adverse judgment in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our financial results and liquidity. Our business is subject to increasing government price controls and other healthcare cost containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market which would adversely affect our business. We may be found noncompliant with applicable federal, state or international laws, rules or regulations which could result in fines and/or product recalls or otherwise cause us to expend significant resources to correct such non-compliance.
A small number of customers accounts for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales, substantially and adversely impacting our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them.
We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels).
Our business and products are highly regulated; the regulatory status of some of our products makes these products subject to increased competition and other risks; and we run the risk that we, or third parties on whom we rely, could violate the governing regulations.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.
SOURCE: Sciele Pharma, Inc