ARNA - Arena Pharmaceuticals Inc - NASDAQ GS

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ARNA - Arena Pharmaceuticals Inc




About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.

For Clinical Trial inquiries, please contact us at [e-mail]

Contact Info
6166 Nancy Ridge Drive
San Diego, CA 92121
United States
Phone: [phone]
Fax: [phone]
www.arenapharm.com

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Jack Lief
Co-Founder, Chairman, President and CEO
Jack Lief is a co-founder of Arena and has served as a director and our President and Chief Executive Officer since April 1997. Mr. Lief has also served as the Chairman of our Board of Directors since October 2007. Mr. Lief served as an advisor and consultant to numerous biopharmaceutical organizations from 1995 to April 1997; as Senior Vice President, Corporate Development and Secretary of Cephalon, Inc., a biopharmaceutical company, from 1989 to 1994; as Director of Business Development and Strategic Planning for Alpha Therapeutic Corporation, a manufacturer of biological products, from 1983 to 1989; and in various positions at Abbott Laboratories, a pharmaceutical company, from 1972 to 1983, most recently as the head of International Marketing Research. Mr. Lief serves as the Chairman of the board of directors of ADVENTRX Pharmaceuticals, Inc., a company focused on pharmaceuticals for cancer and infectious disease. Mr. Lief is also an Executive Board Member of BIOCOM, a life science association representing more than 550 member companies in Southern California, and was the Chair of the board of directors of BIOCOM from March 2005 to March 2006. Mr. Lief holds a B.A. from Rutgers University and an M.S. in Psychology (Experimental and Neurobiology) from Lehigh University.

E-mail: [e-mail]

www.arenapharm.com/Officers.aspx

About Lorcaserin

Lorcaserin, an investigational drug candidate intended for weight management, is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents or patent applications that cover lorcaserin in the United States, Europe, Canada, Mexico, Brazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

Arena submitted the original New Drug Application (NDA) for lorcaserin to the FDA in December 2009, and the agency issued a Complete Response Letter (CRL) in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011, and the agency assigned a Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute lorcaserin in most of North and South America, including the United States, Canada, Mexico and Brazil, subject to approval by the applicable regulatory authorities. In addition, the European Medicines Agency accepted the lorcaserin marketing authorization application for filing in March 2012. Arena owns rights to market and distribute lorcaserin in Europe and other territories.

Our Focus
We are a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.

Our Research & Development Pipeline
Lorcaserin is our most advanced investigational drug candidate and is intended for weight management, including weight loss and maintenance of weight loss. In October 2010, the US Food and Drug Administration, or FDA, issued a Complete Response Letter, or CRL, with respect to the lorcaserin New Drug Application, or NDA, we submitted in December 2009. In the CRL, the FDA stated that it completed its review of the NDA and determined that it could not approve the application in its then present form.
After completing various studies, analyses and other activities in response to the lorcaserin CRL, in December 2011, we resubmitted the lorcaserin NDA. The FDA accepted the resubmission for filing and review and assigned a new Prescription Drug User Fee Act, or PDUFA, target date of June 27, 2012.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met on May 10, 2012, to discuss the lorcaserin NDA. The advisory committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

We are also seeking regulatory approval for lorcaserin in the European Union. On March 2, 2012, we filed a marketing authorization application, or MAA, for lorcaserin through the centralized procedure with the European Medicines Agency, or EMA, and the EMA subsequently accepted the filing. The acceptance of the MAA filing begins the EMA’s review process.
In addition to lorcaserin, our prioritized earlier-stage programs include APD811, an internally discovered, orally available agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension; APD334, an internally discovered, orally available agonist of the S1P1 receptor intended for the treatment of a number of conditions related to autoimmune diseases, including multiple sclerosis; APD371, an internally discovered, orally available agonist of the cannabinoid receptor 2 intended for the treatment of pain; and GPR119 agonists, intended for the treatment of type 2 diabetes. Our internally discovered, oral drug candidates also include temanogrel, which was formerly called APD791 and is intended for the treatment of arterial thrombosis and other related conditions, and nelotanserin, which we previously studied for insomnia and was formerly called APD125.

Our Strategy
The key elements of our general strategy are as follows:
Focus on lorcaserin. We intend to focus our efforts on seeking approval for lorcaserin in the United States, the European Union and other select markets outside of the United States. Pending regulatory approvals, we intend to commercialize lorcaserin in the United States under our marketing and supply agreement with Eisai and in other markets with one or more collaborators or independently.

Selectively advance our other lead candidates. We intend to selectively advance our pipeline of drug candidates independently or through licensing, collaborations or other opportunities.
Maintain research and development capabilities to advance our pipeline. Our technologies, our drug discovery infrastructure and the integrated approach to research used by our scientists have allowed us to identify and develop a number of GPCR targets and novel compounds, and our development infrastructure has allowed us to develop compounds through NDA filing. We expect that our research and development capabilities will continue to play an important role in the support of the further development and potential commercialization of lorcaserin. We intend to maintain our research and development capabilities to selectively advance our programs and to discover additional drug candidates.
Our drug candidates have not been approved by the U.S. Food and Drug Administration or any other regulatory agency.



We are focusing our resources and activities on the following programs:
Program (Indication) Development Status
Lorcaserin (weight management) Resubmitted NDA
APD811 (pulmonary arterial hypertension) Phase 1
APD334 (autoimmune diseases) Preclinical
APD371 (pain) Preclinical
GPR119 agonists (type 2 diabetes) Research

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Arena Weight-Loss Drug Wins Over FDA Advisers
Published: Friday, 11 May 2012 | 8:21 AM ET Text Size
By: CNBC

An experimental obesity pill from Arena Pharmaceuticals won the support of U.S. advisers on Thursday, as public health advocates push for new solutions to the nation's growing obesity epidemic.


A panel of outside experts to the U.S. Food and Drug Administration voted 18 to 4 to recommend approval of lorcaserin, bringing the drug a step closer to U.S. approval as one of the first new weight-loss treatments in over a decade.

Lorcaserin is Arena's most important product.

Shares of Arena [ARNA 6.36 2.70 (+73.77%) ], which were halted pending the panel vote, nearly doubled in value to $6.92 after closing at $3.66 on Wednesday.

Arena's pill is one of three new potential obesity treatments vying to gain U.S. approval and be the first new weight-loss treatment on the market after initial rejections over safety issues.

The FDA first rejected lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co., in October 2010, citing potential cancer risks.

Arena resubmitted its application with more data after the 2010 rejection to show that the previous findings of tumors in rats did not apply to people, which seemed to soothe some of the FDA's concerns.

The advisory committee members still had some concerns about side effects, especially uncertainty about heart valve problems, but most said these concerns could be addressed in post-approval studies.

The panelists were also concerned about the drug's modest weight loss, but said overweight and obese patients needed more options.

"Currently the options available to obese patients are very limited, and severely obese patients are willing to accept a high degree of risk," said panel member Dr. Daniel Bessesen, chief of endocrinology at the Denver Health Medical Center. "And while it isn't an ideal drug... I think it will be a useful adjunct."

The FDA often follows panel recommendations, although it is not required to. It is due to make a final decision by June 27.

After the panel vote, Arena and Eisai said they were expanding their partnership.

If the drug is approved, Arena will manufacture lorcaserin at its facility in Switzerland, then pass it to Eisai for distribution in most of North and South America, including Canada, Mexico, and Brazil.

Obesity, a leading cause of diabetes, heart disease, and other serious health problems, has reached epidemic proportions in the U.S. with nearly a third of the population falling into the category.

The pricetag of obesity has also soared, with the condition contributing an additional $190 billion a year in health-care costs, or one-fifth of all health-care spending.

But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.

Focus on Safety

Vivus [VVUS 24.70 2.01 (+8.86%) ] and Orexigen Therapeutics have also tried to get obesity pills approved in the last two years but have been rejected because of safety.

Vivus resubmitted its pill Qnexa, and won the backing in February of the same advisory panel that voted in favor of lorcaserin. The FDA has pushed back its final decision on Qnexa by three months to July 17 in order to review the company's risk evaluation plan for the drug.

Vivus shares closed down 0.3 percent on Nasdaq on Thursday, while shares of Orexigen [OREX 3.99 0.64 (+19.1%) ], which is still testing the heart safety of its obesity drug Contrave, closed down 6.4 percent.


RELATED LINKS
One Nation Overweight: Fighting Obesity in AmericaFDA Backs Vivus Drug Regulators Mull Heart Safety Trials for Obesity Drugs
In a review earlier this week, staff from the FDA said Arena's pill appeared to help people lose weight and was unlikely to cause tumors in humans, but questioned if the company had provided enough data to rule out heart valve problems.

Heart problems have dogged the obesity field for decades, making the FDA especially cautious about any potential issues.

Arena's lorcaserin was designed to block appetite signals in the brain in a similar way to "fen-phen," an infamous diet pill that was pulled from the market in 1997 after reports of sometimes fatal heart-valve problems.

Another diet pill, Meridia, was withdrawn in 2010 after also being linked to heart problems.

Some FDA advisers questioned whether the smaller weight loss of Arena's pill, compared to the drugs from Vivus and Orexigen, justified its uncertain heart risks.

Lorcaserin helped people lose at least 5 percent of their weight compared to placebo, meeting the FDA's threshold, according to a combined analysis of three clinical trials for the drug. But if any of the trials were analyzed alone, the drug did not meet the bar, FDA staff said earlier.

"There remains a lingering uncertainty regarding potential (heart valve disorder) associated with lorcaserin, especially given the weight loss that's observed," said Dr. Sanjay Kaul, an influential cardiologist from Cedars Sinai Medical Center in Los Angeles, who voted against lorcaserin.

Most panel members suggested the company should study the risk of heart valve disorder after lorcaserin is approved, and make people who take it get regular echocardiograms.