Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Bristol-Myers (NYSE: BMY): On 5/26/09, BMY announced that the FDA granted full approval for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate). Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML.
Hemispherx Biopharma (AMEX: HEB): Investors and chronic fatigue syndrome patients eagerly anticipating approval from the FDA on the Company's Ampligen may have to wait as much as 1-2 additional weeks for a decision according to the company's latest news release and Form 8K filing. Late-day trading has shares of HEB trading up 25% on the news as investors interpreted the development as a positive sign that approval for the drug may be coming. Read the full feature story here.
iCAD Inc. (NASDAQ: ICAD): On 5/26/09, ICAD submitted data to the FDA seeking 510(k) clearance of its VeraLook computer-aided detection technology for CT colonography (CTC), or “virtual” colonoscopy. CTC employs cutting-edge, advanced visualization technology to produce three-dimensional images that permit a thorough and minimally invasive evaluation of the entire colorectal structure. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist.
MAP Pharma (NASDAQ: MAPP): Shares of MAPP were surging by nearly 200% in late-day trading on 5/26/09 after the Company reported that the efficacy portion of its first Phase 3 clinical trial evaluating its novel Levadex orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that Levadex provided rapid and sustained pain relief for up to 48 hours after dosing. A total of 792 patients were included in the primary data analysis as specified in the protocol of the FREEDOM-301 study, which was conducted under a Special Protocol Assessment agreement with the FDA.
There were no drug-related serious adverse events reported in the trial. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at six percent, with two percent of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as chest discomfort (one percent) or chest pain (0 percent), were rare and comparable to placebo. There were no changes in lung function, as measured by spirometry, between the active and placebo groups.
Cytokinetics (NASDAQ: CYTK): Shares of CYTK were advancing by 27% in late-day trading on 5/26/09 after announcing that Amgen (NASDAQ: AMGN) exercised its option to obtain an exclusive worldwide license (excluding Japan) to the Company's cardiac contractility drug development program after reviewing clinical trial data for CK-1827452, which is a novel cardiac myosin activator being developed for the treatment of heart failure. Amgen has agreed to pay CYTK a non-refundable exercise fee of $50 million and has assumed responsibility for development and commercialization of CK-1827452 and related compounds, at its expense, subject to the specified participation rights of Cytokinetics.
Allos Therapeutics (NASDAQ:ALTH) received a priority review (six-month) designation for its experimental anti-cancer drug on 5/26/09. NDA was filed in late March with the FDA for marketing approval of pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
United Therapeutics (NASDAQ: UTHR): UTHR announced on 5/26/09 that the FDA approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). UTHR licensed the rights to develop, market, promote, and commercialize Adcirca for PAH in the U.S. and Puerto Rico from Eli Lilly (NYSE: LLY) in November 2008. Adcirca contains the same active ingredient as the erectile dysfunction drug Cialis (tadalafil), which is marketed by LLY on a global basis.
Disclosure: No positions.