FDA Calendar Updates: Trinity Biotech Awaiting Two Responses

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (NYSE:CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

SkyePharma [UK: SKP.L] (OTC:SKYEF) has a pending NDA for a new asthma drug, Flutiform, which is the Company's most important pipeline product. On 5/22/09, SkyePharma announced that the NDA was accepted for review by the FDA and noted that the regulatory review timeline for asthma treatments is typically longer than the standard 10-month PDUFA decision deadline of 1/23/10.
On 6/9/09, SkyePharma provided info on FDA communication in the form of a 74-day letter which confirmed that the NDA is sufficiently complete to permit a review. However, the FDA has given preliminary notice of potential review issues which the Company stated will likely require additional clinical work to provide more data on Flutiform dosing. The potential FDA review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan.
Par Pharma (NYSE: PRX): On 6/10/09, MonoSol Rx, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the FDA with an expected PDUFA action date during 1Q10. Ondansetron ODFS was developed using MonoSol Rx's proprietary PharmFilm technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue. MonoSol Rx and its partner Strativa Pharma (the proprietary products division of PRX) are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.
On 6/10/09, Watson Pharma (NYSE:WPI) announced that it filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its guaifenesin/pseudoephedrine extended-release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by Reckitt Benckiser [LON:RB] (OTCPK:RBGPF) for Mucinex D. Reckitt Benckiser filed suit seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent numbers 6,372,252 and 6,955,821.
Reckitt's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, WPI believes it is the first applicant to file an ANDA for a generic version of Mucinex D and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
NeurogesX (NASDAQ:NGSX): On 6/10/09, NGSX announced that the FDA agreed to its proposed study to evaluate Qutenza in patients with post-herpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing NDA review, the FDA wants to determine whether pretreatment with an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. The NDA is supported by clinical studies of Qutenza which was applied after a 60-minute pre-treatment with an over-the-counter (OTC) topical anesthetic.
The study protocol involves enrolling about 20 patients with PHN to receive the Qutenza patch application after a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine). Based on the expected short-term nature of the study, NGSX believes that it could potentially complete enrollment, analyze the data, and submit an NDA amendment prior to the assigned PDUFA date. Submission of this amendment during the review cycle may result in an extension of the PDUFA date (likely to be a minor three-month delay from the current PDUFA action date of 8/16/09).
Trinity Biotech (NASDAQ:TRIB): On 3/10/09, TRIB provided the following update on the Company's new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08. TRIB expects to receive clearance and launch the Destiny Max high throughput coagulation analyzer in the US market toward the end of 2Q09.
On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.
Disclosure: Long TRIB.

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