Key Developments For MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals, Inc. (MAPP.O) (Consolidated Issue listed on NASDAQ Global Market)
MAP Pharmaceuticals Inc. Secures $60 Million Committed Equity Financing Facility
MAP Pharmaceuticals Inc. announced that it has secured a committed equity financing facility under which it may sell up to $60 million of its registered common stock to Azimuth Opportunity Ltd. MAP Pharmaceuticals is not obligated to utilize any of the $60 million facility, which has a term of 24 months. During the term of the purchase agreement, at its sole discretion and subject to certain conditions, MAP Pharmaceuticals may present Azimuth with draw down notices requiring Azimuth to purchase a specified dollar amount of shares of its common stock at pre-defined terms. Any shares sold under this facility will be registered on MAP Pharmaceuticals' effective shelf registration statement on Form S-3 (File No. 333-157339) filed with the Securities and Exchange Commission.
MAP Pharmaceuticals Inc. Comments On FY 2009 Earnings Guidance
MAP Pharmaceuticals Inc. announced that for fiscal 2009, it expects to have a net loss. According to Reuters Estimates, analysts were expecting the Company to report net income of $(9.15) million for the same period.
MAP Pharmaceuticals Inc. Completes Interim Safety Review Of LEVADEX Open-Label Safety Extension in More Than 400 Patients
MAP Pharmaceuticals Inc. announced that it has completed a planned interim safety review of the open-label, long-term safety extension of the Company's Phase 3 FREEDOM 301 clinical trial with its LEVADEX orally inhaled migraine therapy. To date, more than 400 patients have completed at least six months of treatment and over 7,800 headaches have been treated in the safety extension. No drug-related serious adverse events have been reported. The goal of the ongoing open-label, long-term safety extension is to evaluate overall safety, including pulmonary and cardiovascular safety, of LEVADEX in 300 patients for six months and 150 patients, including asthmatics, for 12 months as part of a potential New Drug Application. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration. The interim review of the data was conducted after a pre-specified number of patients had completed six months of exposure to LEVADEX and was also reviewed by an independent Data Monitoring Committee. The DMC is an independent group of clinical trial experts, including physicians, formed to critically review and evaluate patient safety data generated in the FREEDOM 301 trial with the objective of ensuring clinical trial patient safety, quality of the data collected and continued scientific validity of the trial design.
MAP Pharmaceuticals Inc. Announces 'Headache' Publication Describes Potential Mechanistic Rationale For LEVADEX Favorable Adverse Event Profile
MAP Pharmaceuticals Inc. announced publication of results from an in vitro study of its novel LEVADEX (MAP0004) orally inhaled migraine therapy in development exploring the potential mechanism by which the pharmacokinetics (PK) and pharmacodynamics of LEVADEX may produce fewer adverse events than those seen with intravenous dihydroergotamine (DHE). Results will be published in a manuscript titled Reduced Adverse Event Profile of Orally Inhaled DHE (MAP0004) vs IV DHE: Potential Mechanism in an upcoming issue of Headache: The Journal of Head and Face Pain and are available currently in the online version. LEVADEX, a novel formulation of DHE that is administered via oral inhalation using the company's proprietary TEMPO inhaler, recently met all four primary endpoints in the efficacy portion of a Phase three clinical trial.
MAP Pharmaceuticals Inc. Announces Analysis of Positive Phase 3 LEVADEX Data
MAP Pharmaceuticals Inc. announced the data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, in development. Data from this Phase 3 trial show the potential of LEVADEX to be effective in treating acute migraine as well as a broad spectrum of migraine, including migraine subpopulations that are often resistant to current therapies such as triptans, migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura.
