Arena Pharmaceuticals, Inc. Issued Composition Of Matter Patent By United States Patent And Trademark Office For Ralinepag And Related Compounds

SAN DIEGO, Nov. 25, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the US Patent and Trademark Office granted Arena U.S. Patent No. 8,895,776, entitled "Modulators of the Prostacyclin (PGI2) Receptor Useful for the Treatment of Disorders Related Thereto," covering ralinepag (formerly APD811), an orally available agonist of the prostacyclin (IP) receptor. Ralinepag is an investigational drug candidate being developed by Arena for the treatment of vasospastic diseases such as pulmonary arterial hypertension (PAH).

"We believe that ralinepag, a lead development compound discovered and developed at Arena, could provide physicians and patients an improved treatment option for PAH compared to currently available therapy," said Jack Lief, Arena's President and Chief Executive Officer. "The issuance of this patent increases the value of this important asset by providing duration of coverage in the United States to at least August 2031. The FDA recently granted ralinepag orphan drug status for the treatment of PAH, and we plan to initiate a Phase 2 trial with the compound before the end of this year."

Arena owns patents and pending patent applications covering compositions of matter for ralinepag and related compounds, as well as methods of treatment utilizing ralinepag and related compounds. Patent applications for ralinepag have been filed in 19 jurisdictions, including the United States, Europe, Japan and China.

About Pulmonary Arterial Hypertension

PAH is a progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure and reduce life expectancy. Based on data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the United States, there is an estimated five-year survival rate of 57% from diagnosis.

About Ralinepag

Ralinepag, an orally available agonist of the IP receptor, is an investigational drug candidate internally discovered and developed by Arena and intended for the treatment of vasospastic diseases, including PAH. In Phase 1 trials, ralinepag showed an approximate 25-hour half-life, indicating that the compound could be dosed orally, once or twice daily. Arena believes that an orally available, non-prostanoid IP receptor agonist that provides clinical benefits similar to currently available IP receptor agonists has the potential to improve treatment for patients with PAH.

About Arena Pharmaceuticals

Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's internally discovered drug, BELVIQ® (lorcaserin HCl), is approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of ralinepag; patents, patent applications and patent protection, including their significance, coverage, duration and exclusivity provided thereby; the increase in value and importance of ralinepag; providing an improved treatment option for PAH; initiation of a Phase 2 trial of ralinepag, including related timing; potential of an orally available, non-prostanoid IP receptor agonist that provides clinical benefits similar to available IP receptor agonists to improve the standard of care for PAH; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: Arena's patent protection and ability to obtain and defend patents; ralinepag may not be developed or approved for marketing for any disease or condition; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena's revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; the timing, success and cost of Arena's research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc.

Media Contact: Russo Partners





Craig M. Audet, Ph.D., Senior Vice President,

David Schull, President


Operations & Head of Global Regulatory Affairs

david.schull@russopartnersllc.com


caudet@arenapharm.com  

858.717.2310


858.453.7200, ext. 1612






www.arenapharm.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-issued-composition-of-matter-patent-by-united-states-patent-and-trademark-office-for-ralinepag-and-related-compounds-300000865.html



SOURCE Arena Pharmaceuticals, Inc.

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