Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. 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 categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 7/21/09, STAAR Surgical (NASDAQ:STAA) announced that it has been informed by the FDA Division of Bioresearch Monitoring that the restrictions of the integrity hold put in place by the Agency on 8/3/07 have been removed. The removal of the integrity hold enables the FDA to resume scientific review of the Company's application for the Toric Implantable Collamer Lens (TICL) for Myopic/Astigmatic patients. This application is a PMA Supplement to the Visian ICL which the FDA approved on 12/22/05. Pursuant to the terms of the integrity hold, between September 2007 and May 2009, STAA initiated and completed the following actions required by the FDA. The Company retained Promedica International (PMI) to perform a comprehensive systems audit and data audit related to the TICL application.
PMI performed the required audits of 100% of data of patient records at all seven clinical sites and a systems audit of the Company from December 2007 to October 2008. PMI prepared a systems audit report dated 10/8/08 and submitted the report to the FDA. In addition, PMI prepared a final field audit report dated 3/13/09 and submitted it to the FDA. Based on these reports, STAA submitted a Corrective Action Plan to the FDA on 5/22/09 to address the findings included in the PMI audit reports and provide assurances that all future studies would be conducted in accordance with applicable laws, regulations and good clinical practices.
On 7/21/09, Spectrum Pharma (NASDAQ:SPPI) and Allergan (NYSE:AGN) announced that the FDA has granted Fast Track Designation for the investigation of apaziquone (EOquin) for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer. Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer (affecting an estimate of more than 1 million patients in the U.S. and Europe ). EOquin has two Phase 3 trials underway with a primary endpoint of tumor recurrence at Year 2 under defined registration paths for the U.S. and Europe . EOquin is expected to complete enrollment in ongoing Phase 3 pivotal trials by the end of 2009 with more than 1,000 patients enrolled at more than 120 sites. SPPI also expects to initiate trials for EOquin in BCG-Failure bladder cancer patients by the end of 2009.
EOquin is a targeted pro-drug that is bio-activated by enzymes which are over-expressed in bladder tumors to focus the drug activity at the site of the bladder cancer. On 11/6/08 , SPPI announced a licensing deal with AGN for $41.5 million upfront additional milestone payments possible for up to $304 million. SPPI retained exclusive rights in Asia ( Japan , China , India ) while AGN received exclusive rights to apaziquone in the rest of the world ( U.S. , Canada , Europe ). In the U.S. , the two companies will co-promote apaziquone and share in its profits and expenses. AGN will pay royalties to SPPI on EOquin sales outside of U.S. SPPI agreed to conduct EOquin clinical trials with AGN bearing 65% of these expenses.
On 7/21/09, Incyte Corp. (NASDAQ:INCY) announced that it reached agreement with the FDA on a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The SPA provides agreement that the study design and planned analysis of the Phase 3 trial adequately address objectives in support of a regulatory submission.
COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment), is a double-blind, placebo-controlled Phase 3 trial comparing the efficacy and safety of INCB18424 to placebo in approximately 240 patients with PMF, PPV-MF or PET-MF.. COMFORT-I is expected to begin in August while COMFORT-II (a second Phase 3 trial being conducted in Europe ) began patient enrollment in July. INCY expects to file a New Drug Application for INCB18424's use in MF in late 2010 or early 2011, assuming that results from the pivotal study are positive.
On 7/20/09, Ardea Biosciences (NASDAQ:RDEA) announced that it has initiated a Phase 2b clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a next-generation URAT1 inhibitor, as a development candidate for the same indication. The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more).
The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (marketed as Uloric by Takeda Pharma and Adenuric by Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
CSL Limited (ASX:CSL) (PINK:CMXHY) is expected to begin the first human trials for a swine influenza (flu) vaccine on 7/22/09 in Australia. The seven-week trial will inject healthy volunteers age 18-64 as deaths, infections, and media coverage of the H1N1 virus gain momentum across the globe. The seven-week study will be closely monitored to measure the immune responses of the subjects in order to determine the optimal antigen (the substance which elicits an immune response and thus protection from the virus) dosing for the flu vaccine.
The World Health Organization (WHO) reported that a total of 94,512 confirmed cases of swine flu resulted in 429 deaths through 7/6/09. Analysts expect CSL may post sales of $244 million (U.S. Dollars) for the Company's swine flu vaccine, which may require two shots in order to fully protect people from the pandemic influenza virus. In the trial by CSL starting tomorrow, each volunteer will be given two shots of the vaccine at three weeks apart in order to determine the optimal dosing that generates an immune response and protection in the subjects.
Other companies which are expected to begin trials of flu vaccines in the coming weeks include Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), Baxter (NYSE:BAX), and Sinovac Biotech (AMEX:SVA). Also, Hemispherx Biopharma (AMEX:HEB) is scheduled to provide an update on its flu research initiatives via a teleconference on 7/22/09 at 10am (ET). There has been much discussion about the role of the Company's Ampligen (poly I: poly C12U) in the flu pandemic as a possible adjuvant (to boost the immune response of people receiving the vaccine) to a vaccine.
Disclosure: Long SPPI