Sanofi US and POZEN Sign Exclusive License Agreement for the Commercialization of PA8140/PA32540 Tablets in the U.S.

BRIDGEWATER, N.J. and CHAPEL HILL, N.J., Sept. 4, 2013 /PRNewswire/ -- Sanofi US (NYSE: SNY) and POZEN Inc. (NASDAQ: POZN) announced the signing of an exclusive license agreement for the commercialization of POZEN's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet ("PA"), PA8140 and PA32540. Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15MM and will be eligible for pre-commercial milestone payments of up to $20MM and other future milestone payments and royalties on product sales.

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"Sanofi has a strong heritage and expertise in the cardiovascular space, with Lovenox, Plavix, and most recently Multaq, and the PA products are an important addition to our already strong CV portfolio," said Anne Whitaker, President, North America Pharmaceuticals at Sanofi US. "The PA products have the potential to be an effective solution for the millions of patients at risk for gastric ulcers from chronic aspirin use in the prevention of secondary cardiovascular disease. We look forward to bringing this therapy to patients and healthcare providers."

Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S.  POZEN will retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZEN will transfer the NDA to Sanofi US.  The NDA was submitted in March 2013 and accepted for filing in May 2013 by the U.S. Food and Drug Administration (FDA). 

John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN Inc. said, "We are pleased to have Sanofi US commercialize PA8140 and PA32540 in the US.  We have been excited about the results of our Phase 3 clinical trials and look forward to the prospect of making this product available to cardiovascular patients at risk for gastric ulcers. Sanofi's dominant CV heritage and strong commitment to PA, make them the right partner for these products."

About PA 

POZEN has created a portfolio of investigational integrated aspirin therapies - the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.

The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

About Cardiovascular Disease

Patients with established coronary heart disease or cerebrovascular disease have a high risk of a subsequent cardiovascular event including myocardial infarction (MI), stroke and death from cardiovascular disease. For such patients, lifestyle changes and drug therapy are of proven benefit and may improve outcomes. Heart disease is the leading cause of death for both men and women in America today[i]. Coronary artery disease is the most common type of heart disease and is caused by atherosclerosis and often develops into angina pectoris and MI. This condition can lead to angina pectoris and MI and caused more than 405,000 deaths in 2008[ii]. Roughly 16.8 million people have a history of MI and/or angina[iii]. An estimated 24 million have been identified as secondary prevention patients (post-event)[iv]. It is estimated that cardiovascular disease causes one in every three deaths in the United States[v]. Every 25 seconds, someone in the United States will suffer a coronary event[vi]. About every minute, someone will die from one[vii].

About POZEN

POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestones/royalty streams, POZEN is creating a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.

POZEN continues to seek strategic partners to help maximize the opportunities for its portfolio assets.

The Company's common stock is traded under the symbol "POZN" on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.

About Sanofi

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

POZEN Forward-Looking Statements

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to license our PA product candidates on terms and timing acceptable to us, our inability to file a new drug application with the FDA for our PA product candidates in the timeframe we anticipate, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca for the sales and marketing of VIMOVO^®; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended March 31, 2013. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

[i] American Heart Association, "Heart Disease and Stroke Statistics – 2009 Update" (2009): e32

[ii] American Heart Association, "Heart Disease and Stroke Statistics – 2012 Update" (2012): e3

[iii] American Heart Association, "Heart Disease and Stroke Statistics – 2009 Update" (2009): e175

[iv] American Heart Association, "Heart Disease and Stroke Statistics – 2010 Update" (2010): e46

[v] American Heart Association, "Heart Disease and Stroke Statistics – 2012 Update" (2012): e21

[vi] American Heart Association, "Heart Disease and Stroke Statistics – 2012 Update" (2012): e3

[vii] American Heart Association, "Heart Disease and Stroke Statistics – 2012 Update" (2012): e3

SOURCE Sanofi US