ARNA - Arena Pharmaceuticals
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Arena Pharmaceuticals Announces European Medicines Agency's Acceptance of Lorcaserin Marketing Authorization Application for Weight Control
-- Company Also Receives FDA Confirmation of May 10th Lorcaserin Advisory Committee Meeting --
Press Release: Arena Pharmaceuticals, Inc. – 46 minutes ago.. .
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SAN DIEGO, March 26, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA - News) announced today that the European Medicines Agency (EMA) has accepted the filing of a Marketing Authorization Application (MAA) for lorcaserin, an investigational drug candidate intended for weight control, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. The acceptance of the MAA filing begins the EMA's review process.
In addition, Arena reported that the US Food and Drug Administration (FDA) has confirmed the scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission on May 10, 2012.
"Substantial evidence shows that being overweight or obese can have dire human health consequences coupled with tremendous economic burden," said Jack Lief, Arena's President and Chief Executive Officer. "With applications under review for approval in both the United States and European Union, lorcaserin has the potential to provide a new treatment for physicians to help patients lose weight and improve their overall cardiometabolic health."
Arena's preparations for the upcoming advisory committee meeting are being led by Craig M. Audet, Arena's Vice President of Global Regulatory Affairs, Dominic P. Behan, Ph.D., Arena's Chief Scientific Officer, and William R. Shanahan, Jr., M.D., Arena's Chief Medical Officer. Following the lorcaserin NDA resubmission and MAA filing, Christen M. Anderson, M.D., Ph.D., will be retiring from Arena at the end of the month.
"We are working diligently with Eisai Inc. to prepare for the FDA advisory committee meeting in May," said Mr. Audet. "We look forward to lorcaserin's PDUFA date in June as well as reporting on developments related to the MAA throughout the year."
About Lorcaserin
Lorcaserin 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 that cover lorcaserin in the United States, Europe and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena resubmitted the lorcaserin NDA to the FDA in December 2011, and the agency has assigned a new PDUFA target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA. An MAA for lorcaserin was accepted for filing by the EMA in March 2012. Arena currently owns rights to lorcaserin outside of the United States.
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.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
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 and use, safety, efficacy, mechanism of action and potential of lorcaserin; the regulatory review of the lorcaserin NDA resubmission and MAA, including the timing for the FDA to complete its review; the FDA advisory committee meeting, the discussion on the NDA resubmission and related preparations; developments related to the MAA; the Eisai collaboration and activities thereunder; the potential approval, commercialization and impact of lorcaserin; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to 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: the timing of regulatory review is uncertain and Arena's applications for regulatory approval of lorcaserin may not be reviewed when or as anticipated; the FDA may not complete its review of the lorcaserin NDA resubmission by the PDUFA date; the occurrence, timing and results of FDA advisory committee meetings relating to lorcaserin and other drug candidates; 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 lorcaserin and Arena's other research and development programs may not meet safety, efficacy or other regulatory requirements or otherwise be sufficient for regulatory review or approval; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's research and development programs; 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; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; 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.
Arena Pharmaceuticals, Inc.
Robert E. Hoffman, Vice President, Finance and Chief Financial Officer
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By Anna Edney - May 10, 2012 10:04 PM GMT+0200
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Arena Pharmaceuticals Inc. (ARNA) won the backing of advisers to U.S. regulators for the weight-loss medicine the company is developing in a race to bring the first obesity pill to market in 13 years.
Advisers voted 18-4 that the benefits of Arena’s pill outweigh the risks at a meeting today in Silver Spring, Maryland. The Food and Drug Administration is scheduled to decide by June 27 on the drug known chemically as lorcaserin and doesn’t have to follow the advisers’ recommendation. Arena licensed lorcaserin to Tokyo-based Eisai Co. (4523) to sell in the U.S.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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U.S.
Arena and Eisai Expand Marketing and Supply Agreement for Lorcaserin
New territories include Canada, Mexico and Brazil
Press Release: Arena Pharmaceuticals, Inc. – 1 hour 8 minutes ago.. .
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SAN DIEGO and WOODCLIFF LAKE, N.J., May 10, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. announced today the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management. In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US Food and Drug Administration (FDA).
"Obesity is a condition that transcends geographic boundaries," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. "Through this expanded agreement, we believe Eisai has an opportunity to help address the significant and growing need for medical obesity treatments by bringing a potential new option to physicians and patients throughout the Americas."
As in the original agreement, Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution, subject to applicable regulatory approvals in the territories. Under the expanded agreement, Arena is eligible to receive increased payments based upon Eisai's net sales of lorcaserin in the United States and expanded North and South American territories. Additionally, Arena will receive an upfront payment and is eligible to receive regulatory and development milestone payments.
"We believe in Eisai's human health care mission to help satisfy unmet medical needs and increase benefits to patients and their families," said Jack Lief, Arena's President and Chief Executive Officer. "The expanded commercialization agreement further supports our belief in the medical potential of lorcaserin in the United States and beyond."
Conference Call & Webcast
Arena will host a conference call and webcast tomorrow, May 11, 2012, at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to provide a business update. The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "Lorcaserin" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
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.
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.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-25 US pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the US pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes US-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunologic
Ein externer Beraterausschuss (Endocrinologic and Metabolic Drugs Advisory Committee) der US-Arzneimittelbehörde FDA hat mit großer Mehrheit die Zulassung des Wirkstoffs Lorcaserin zur Adipositas-Behandlung befürwortet.
Nach einem negativen Votum im Jahr 2010 hat die Substanz damit zumindest diese Hürde im zweiten Anlauf genommen.
Beim ersten Anlauf hatte die Behörde die Zulassung von Lorcaserin wegen Sicherheitsbedenken abgelehnt. Dabei ging es um Bedenken wegen eines möglicherweise erhöhten Risikos für Krebserkrankungen.
Diese Bedenken hat der Hersteller (Arena Pharmaceuticals) anscheinend mit inzwischen eingereichten neuen Daten zerstreuen können. Lorcaserin wirkt serotoninerg und appetitmindernd.
By Brian Orelli | More Articles
June 15, 2012 | Comments (1)
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Arena Pharmaceuticals' (Nasdaq: ARNA ) obesity drug lorcaserin is currently under review, with a Food and Drug Administration decision expected on or around June 27. Buying in front of such binary events can provide substantial gains, as witnessed by the post-approval jumps following the FDA decisions on Amylin Pharmaceuticals' (Nasdaq: AMLN ) Bydureon and Discovery Laboratories' (Nasdaq: DSCO ) Surfaxin. Here are three reasons you might want to buy Arena.
FDA advisory committee vote
Last month, a panel of outside experts reviewed the drug and recommended approving it by an 18 to four margin. The advisory panel vote is important, but the FDA doesn’t have to follow the panel’s advice. Orexigen, for example, received a positive advisory committee vote for its obesity drug, Contrave, but was ultimately rejected by the agency. But Orexigen’s smaller margin of victory, at 11 to eight, should give investors confidence that Arena won't follow in its footsteps.
In addition to getting outside expert's options, the advisory committee provides an opportunity for investors to sneak a peek at what the agency is thinking in public briefing documents provided for the panel. Based on those documents, it seems the FDA is no longer worried about issues around cancer risk. As long as the agency buys the advisory committee’s view that heart risks can be dealt with post-approval, lorcaserin should be approved.
Potential market
In case you haven't noticed, Americans are getting fatter, and most people are too lazy to do anything about it. If empirical observations aren't good enough, check out the graphs in this article, with cold hard data to prove we're getting fatter. Now, of course, we could shed those pounds with diet and exercise, but we won’t. When given the choice, most people will take the easy way out, opting to pop a pill daily rather than suffering to shed the pounds.
It’s hard to know what the potential market size for obesity drugs is, because earlier offerings have been hampered by poor risk-to-benefit ratios, which led to Abbott Labs' (NYSE: ABT ) Meridia and Wyeth's Fen-Phen getting pulled off the market.
The only remaining prescription obesity drug on the market, Roche’s Xenical, hasn’t been a big seller, because it works by blocking the absorption of fat, which then passes through the body. As you can imagine, adding fat to excrement creates an undesirable side effect.
Even if Arena has immediate competition from VIVUS's (Nasdaq: VVUS ) Qnexa, the market still appears large enough to support both drugs. Vivus is scheduled to hear back from the FDA next month. Neither drug is going to be able to help all patients, leaving plenty of market share for Arena to feast on. And even when the drugs help patients lose weight, there’s often a plateau. We may see patients yo-yoing back and forth between the two drugs.
Pharma backer
Arena isn't in this alone. Japanese drug maker Eisai Pharmaceuticals is backing it, and will be in charge of marketing the drug in North and South America.
I wouldn’t put much emphasis on Eisai licensing the drug as an endorsement of the product. The pharma only paid $50 million for the U.S. rights back in 2010 and is only on the hook for $90 million when the drug is approved. Eisai set up the deal so that Arena gets paid well if the drug sells well. In addition to earning a percentage of net sales, there are $1.2 billion in potential milestone payments that are triggered if the drug is a commercial success.
Getting there will be a lot easier with the marketing muscle that Eisai will provide. Having a partner in place should allow the company to hit the ground running once it launches, something VIVUS might have trouble doing because it doesn't have a big-pharma partner.
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Arena Pharmaceuticals (Nasdaq: ARNA ) Fettleibigkeit Medikament Lorcaserin wird derzeit geprüft, mit einem Food and Drug Administration Entscheidung am oder um den 27. Juni erwartet. Kaufen Sie vor solchen binären Ereignisse können erhebliche Gewinne, wie sie von den nach der Zulassung Sprünge erlebt nach den FDA-Entscheidungen über Amylin Pharmaceuticals "bieten (Nasdaq: AMLN ) Bydureon und Discovery Laboratories (Nasdaq: DSCO ) Surfaxin . Hier sind drei Gründe, weshalb Sie Arena kaufen könnte.
FDA-Beratungsausschuss Abstimmung
Im vergangenen Monat bewertet ein Gremium von Experten außerhalb der Droge und empfahl dessen Genehmigung durch eine 18-Marge auf vier. Der Beirat Stimme ist wichtig, aber die FDA nicht an das Gremium um Rat zu folgen. Orexigen zum Beispiel erhielt eine positive Bewertung Beratenden Ausschusses für seine Fettleibigkeit Medikament, Contrave, wurde aber letztlich verworfen durch die Agentur. Aber Orexigen die geringere Marge des Sieges, bei 11 bis acht, sollte den Anlegern Vertrauen, dass Arena nicht in seine Fußstapfen zu treten.
Zusätzlich zu bekommen externen Sachverständigen vor Optionen bietet der Beratende Ausschuss eine Chance für Investoren, einen Blick auf, was die Agentur wird in der Öffentlichkeit Briefing-Dokumente für das Panel zur Verfügung gestellt Denken zu schleichen. Basierend auf diesen Dokumenten, so scheint es die FDA ist nicht mehr über Themen rund um das Krebsrisiko besorgt. Solange die Agentur kauft der Beratende Ausschuss der Ansicht, dass Risiken, die mit Herz nach der Zulassung behandelt werden können, sollten Lorcaserin genehmigt werden.
Potenzielle Markt
Falls Sie noch nicht bemerkt haben, sind die Amerikaner immer dicker, und die meisten Leute sind zu faul, um etwas dagegen zu tun. Wenn empirische Beobachtungen nicht gut genug sind, sehen Sie sich die Grafiken in diesem Artikel , mit kalten, harten Daten zu beweisen, werden wir immer dicker. Nun, natürlich könnte man die Pfunde mit Diät und Bewegung zu vergießen, aber wir nicht. Wenn sie die Wahl, die meisten Leute nehmen den einfachen Weg und entschied sich, eine Pille täglich knallen anstatt leiden, um die Pfunde loszuwerden.
Es ist schwer zu wissen, was die potenzielle Marktgröße für Fettleibigkeit ist, weil frühere Angebote von armen Risiko-Nutzen-Verhältnisse, die zu Abbott Labs 'geführt (NYSE behindert worden: ABT ) Meridia und Wyeth Fen-Phen bekommen gezogen vom Markt.
Die einzige verbleibende Rezept Fettleibigkeit Medikament auf dem Markt, Roche Xenical, war nicht ein Verkaufsschlager, weil es durch die Blockierung der Aufnahme von Fett, das geht dann durch den Körper arbeitet. Wie Sie sich vorstellen können, Zugabe von Fett an Exkrementen entsteht ein unerwünschter Nebeneffekt.
Auch wenn Arena hat unmittelbare Konkurrenz aus VIVUS 's (Nasdaq: VVUS ) Qnexa, der Markt scheint immer noch groß genug, um beide Medikamente zu unterstützen. Vivus soll hören wieder von der FDA im nächsten Monat. Weder Medikament ist in der Lage sein, alle Patienten zu helfen, so dass viel Marktanteil für Arena am Fest. Und selbst wenn die Medikamente den Patienten helfen, Gewicht zu verlieren, gibt es oft ein Plateau. Wir können sehen, Patienten Jo-Yoing hin und her zwischen den beiden Medikamenten.
Pharma Backer
Arena ist noch nicht in diesem allein. Japanische Pharmakonzern Eisai Pharma setzt auf ihn, und ist verantwortlich für die Vermarktung des Medikaments in Nord-und Südamerika sein.
Ich würde das nicht viel Wert auf Eisai die Lizenzierung der Droge als eine Billigung des Produktes. Der Pharma nur bezahlt 50 Millionen Dollar für die US-Rechte wieder im Jahr 2010 und ist nur an den Haken für 90.000.000 $, wenn das Medikament zugelassen ist. Eisai richten Sie den Deal so dass Arena wird gut, wenn das Medikament verkauft sich gut bezahlt. Zusätzlich zu verdienen, einen Prozentsatz des Nettoumsatzes, gibt es 1,2 Milliarden Dollar in potenzielle Meilensteinzahlungen, die ausgelöst werden, wenn die Droge ist ein kommerzieller Erfolg werden.
Anreise wird viel einfacher mit der Marketing-Muskel, der Eisai zur Verfügung stellt. Einen Partner an Ort und Stelle sollte es dem Unternehmen ermöglichen, den Boden zu laufen, sobald es startet getroffen, vielleicht etwas VIVUS Schwierigkeiten haben, zu tun, weil es nicht habe ein großes Pharma-Partner.
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Narr Beitragszahler Brian Orelli , wenn Sie in die Turnhalle nach der Einreichung dieser Geschichte. Er hat keine Position in jedem Unternehmen erwähnt. Klicken Sie hier , um seine Bestände und eine kurze Biographie zu sehen. Das Motley Fool hält Aktien von Abbott Laboratories. Der Schatz zum Veröffentlichungs-und Informationspolitik ist dünn, aber oho.
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Jefferies Boosts Arena (ARNA) Target to $20
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ARNA Hot Sheet
Rating Summary:
3 Buy, 8 Hold, 4 Sell
Rating Trend: Up
Today's Overall Ratings:
Up: 6 | Down: 0 | New: 12 Jefferies lifted its price target on Arena Pharma (NASDAQ: ARNA) from $9 to $20 following FDA approval for Belviq.
"We believe the Belviq label is a major positive for ARNA, as it lacks a restrictive REMS or cardiovascular monitoring requirements. We remain buyers of ARNA and are raising our price target from $9 to $20."
The firm lifted FY12 EPS from $0.09 to $0.11 and FY13 EPS down from $0.10 to ($0.10).
For an analyst ratings summary and ratings history on Arena Pharma click here. For more ratings news on Arena Pharma click here.
Shares of Arena Pharma closed at $11.39 yesterday, with a 52 week range of $1.23-$13.50.
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