Arena Pharmaceuticals 8-K 2006
WASHINGTON, D.C. 20549
Date of Report (Date of earliest event reported): March 29, 2006
Arena Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
6166 Nancy Ridge Drive, San Diego, California 92121
(Address of Principal Executive Offices) (Zip Code)
(Registrants telephone number, including area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On March 29, 2006, Arena Pharmaceuticals, Inc. (the Company) issued a press release announcing updates on its clinical programs for APD356, being developed for the treatment of obesity, and APD125, being developed for the treatment of insomnia.
APD356 (Obesity) Clinical Program Update
The Company received results from its chronic twelve and six-month pre-clinical toxicology studies of APD356, its orally administered, internally discovered drug candidate for the treatment of obesity. The toxicology studies did not demonstrate any apparent drug effect on heart valves or pulmonary vasculature, and the Company continues to expect to initiate the APD356 Phase 3 program in the second half of 2006.
APD125 (Insomnia) Clinical Program Update
The Company also received correspondence from the FDA seeking clarification of certain nonclinical issues in its IND application for APD125, which seeks approval to conduct a Phase 2 clinical trial in patients with chronic insomnia. The Company believes that the issues raised by the FDA may be resolvable using available data, but the FDA may require the Company to generate additional data. If no additional data are required, the Company believes it will be able to initiate the Phase 2 trial around mid-year. If additional data are required, the Company expects the initiation of the trial will be delayed until the fourth quarter of this year. The initiation of the Phase 2 trial is subject to the FDAs further review and allowance.
Certain statements in this Form 8-K are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the expected clinical trials of APD356 and APD125, and whether the FDAs comments regarding APD125 are resolvable, and, if so, the time and effort it may require to resolve. For such statements, the Company claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from the Companys expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the FDA may not allow the Companys planned clinical trials to proceed at the time the Company expects or at all, the results of preclinical studies or clinical trials may not be predictive of future results, the Companys ability to partner APD356, APD125 or other of its compounds or programs, the timing, success and cost of the Companys research, out-licensing endeavors and clinical trials, the Companys ability to obtain additional financing, the Companys ability to obtain and defend its patents, and the timing and receipt of payments and fees, if any, from the Companys collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by the Companys forward-looking statements are disclosed in the Companys filings with the Securities and Exchange Commission. These forward-looking statements represent the Companys judgment as of the time of the filing of this Form 8-K. the Company
disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.