Arena Pharmaceuticals Announces Third Quarter 2010 Financial Results and Reviews Recent Developments
"We believe the BLOOM-DM top-line results provide additional support for lorcaserin's benefit-to-risk profile," said Jack Lief, Arena's President and Chief Executive Officer. "We remain focused on addressing the recommendations outlined by the
Arena reported a net loss in the third quarter of 2010 of
As expected, research and development expenses declined to
Arena's Recent and Third Quarter Developments
- Announced top-line results from the lorcaserin BLOOM-DM trial that demonstrate statistically significant weight loss and improved HbA1c in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three primary efficacy endpoints.
The US Food and Drug Administration( FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. In the CRL, the FDAstated that it has completed its review of the NDA and determined that it cannot approve the application in its present form. The FDAalso outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. Prior to issuance of the CRL, the FDA Endocrinologic and Metabolic Drugs Advisory Committeevoted nine to five that the available data do not demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long term in a population of overweight and obese individuals to allow marketing approval.
- Results from a lorcaserin mechanism of action study conducted at the
Pennington Biomedical Research Centerwere presented at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society. The data presented showed that lorcaserin reduces energy intake and appetite, and causes weight loss without stimulating energy expenditure.
FDAcompleted the Pre-Approval Inspection of Arena's drug product manufacturing facility in Switzerlandand classified the inspection as No Action Indicated.
- Results from Arena's two-year, pivotal Phase 3 BLOOM
(Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial were published in the
July 15, 2010, issue of the New England Journal of Medicine. The data presented in the article show that lorcaserin used in conjunction with behavioral modification caused significantly greater weight loss and improved maintenance of weight loss compared to placebo. The data also indicated that lorcaserin improved values for biomarkers that may be predictive of future cardiovascular events, including lipid levels, insulin resistance, levels of inflammatory markers and blood pressure.
- Arena's wholly owned subsidiary,
Arena Pharmaceuticals GmbH, entered into a marketing and supply agreement with Eisai Inc.for the commercialization of lorcaserin in the United Statesfollowing FDAapproval of the NDA for lorcaserin. Under the terms of the agreement, Arena received a non-refundable, upfront payment of $50.0 millionfrom Eisai.
- Announced that following the completion of a Phase 1 clinical trial program for APD597,
Ortho-McNeil-Janssen Pharmaceuticals, Inc., decided not to advance APD597 and notified Arena that it is terminating their collaboration, effective December 28, 2010. APD597 is a GPR119 agonist intended for the treatment of type 2 diabetes, which, along with other compounds and intellectual property, will revert to Arena upon termination of the collaboration. The Phase 1 program provided evidence for incretin stimulation (GLP-1, GIP and PYY) and reductions in post-meal glucose increases with APD597 alone and in combination with sitagliptin, a DPP-4 inhibitor.
- Announced results from a Phase 1 clinical trial of APD916, a novel drug candidate Arena discovered that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy. In this randomized, double-blind, placebo-controlled trial in 24 healthy volunteers, APD916 demonstrated dose-proportional pharmacokinetic exposure over the tested dose range.
- Received gross proceeds of approximately
$60.0 millionfrom the sale of 8,955,224 shares of its common stock to certain Deerfieldentities at a price of $6.70per share. As part of the transaction, Arena amended its June 2009Facility Agreement with Deerfieldpursuant to which $30.0 millionof the proceeds from this transaction was used to prepay the portion of the principal amount that Arena otherwise would have been required to repay in July 2012.
Conference Call & Webcast
Arena will host both a conference call and webcast to discuss top-line results from the BLOOM-DM trial and third quarter 2010 financial results today,
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 "
Upcoming Corporate Presentations
Arena is planning to present at upcoming investment and industry conferences, including:
Piper Jaffray22nd Annual Health Care Conference, November 30-December 1, 2010, New York, New York
- 29th Annual
J.P. Morgan Healthcare Conference, January 10-13, 2011, San Francisco, California
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's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary,
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 BLOOM-DM, including providing support for lorcaserin's profile; addressing recommendations in the complete response letter for lorcaserin; the advancement, therapeutic indication and use, safety, efficacy, tolerability, mechanism of action, scheduling and regulatory review, approval, commercialization and potential of lorcaserin; the termination of the Ortho-McNeil-Janssen collaboration and related expectations and future activities; the therapeutic indication and use, safety, efficacy, tolerability, mechanism of action and potential of APD597 alone and in combination; the therapeutic indication and use, mechanism of action and exposures of APD916; the
Contact: Arena Pharmaceuticals, Inc.
Media Contact: Russo Partners
David Schull, President
President and CEO
Manager, IR and Corporate Communications
Anthony J. Russo, Ph.D., CEO
858.453.7200, ext. 1479
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended
Nine months ended
Cost of manufacturing services
Research and development
General and administrative
Amortization of acquired technology & other intangibles
Total operating expenses
Interest and Other Income (Expense)
Gain from valuation of derivative liabilities
Loss on extinguishment of debt
Total interest and other expense, net
Net loss per share, basic & diluted
Shares used in calculating net loss per share, basic & diluted
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
September 30, 2010
December 31, 2009
Cash, cash equivalents & short-term investments
Other current assets
Land, property & equipment, net
Acquired technology & other non-current assets
Liabilities and Stockholders' Equity
Accounts payable and accrued liabilities
Total deferred revenues
Total derivative liabilities
Total note payable to Siegfried
Total note payable to Deerfield**
Total lease financing obligations & other long-term liabilities
Total stockholders' equity
Total liabilities & stockholders' equity
* The condensed consolidated balance sheet data as of
** The outstanding principal balance of the note payable to
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