1.) Auxilium Pharma (AUXL): 3/2/09 BLA submission with priority review request for XIAFLEX (clostridial collagenase for injection), a novel, first-in-class, orphan-designated biologic for the treatment of Dupuytren's contracture. 5/2/09 is the date for FDA to accept the filing for review and decide on priority review (6-month) status. Dupuytren's contracture is a progressive condition that affects the connective tissue that lies beneath the skin in the palm, resulting in collagen deposits which impair normal hand function.
2.) Bovie Medical (BVX): 510(k) pre-market notification application (PMA) for regulatory clearance of ICON GS electrosurgical generator and handpiece (J-Plasma system). The technology utilizes a gas ionization process producing a stable thin focused beam of ionized gas that can be controlled in a wide range of temperatures and intensities, providing the surgeon greater precision, minimal invasiveness and an absence of conductive currents during surgery.
3.) Eli Lilly (LLY) + Bristol-Myers (BMY): Erbitux sBLA to expand label as a first-line treatment for head and neck cancer – an animal study in the U.S. must be conducted since Eli Lilly (LLY) and Bristol-Myers (BMY) are using clinical data from Merck KGaA (OTC:MKGAY), which markets the drug in Europe. The animal study will be used to determine if both batches of the drug are absorbed into the bloodstream in a similar fashion and drug levels are comparable.
LLY + BMY also withdrew their sBLA to market Erbitux for advanced non-small cell lung cancer (NSCLC) because of the same requirement to verify comparability of different batches of the drug. LLY expects to re-file the sBLA for NSCLC during 2H09 and will not be required to re-file the sBLA for head and neck cancer since it is considered a standing application. LLY did not provide guidance for the FDA review timeline for the head and neck indication.
4.) AstraZeneca (AZN): Seroquel (quetiapine) XR sNDA - to expand label to treat adults with major depressive disorder and generalized anxiety disorder -- complete response letter from FDA on 2/27/09 and 4/8/09 FDA advisory panel meeting to address concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects (e.g. high blood sugar/diabetes) and a possible risk of tardive dyskinesia (which causes involuntary, repetitive movement of the limbs and lip smacking, grimacing and other symptoms that can be permanent).
Seroquel is AZN's second best-selling drug, with $4.5B in 2008 sales. Seroquel XR is an extended-release version of the medicine with a longer patent life than the original formulation. Seroquel is already sold for treatment of schizophrenia and bipolar disorder, which are not a part of the advisory committee review
The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 97 entries as of 3/4/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 133 entries as of 3/4/09 and 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.
BioMedReports.com offers free and premium subscription options, with a $120 annual fee for access to over 200 entries for pending FDA decisions, clinical trial results, and pending re-submissions or new filings for FDA approval. The monthly average cost of just $10 is the same as an average online stock trading commission and compares favorably to competing reports at sites such as Revere Data, which charges $125 and $100 each per month for their FDA Approval and Biotech Pipeline research reports, respectively.
Aside from our much lower cost (at less than one-twentieth the cost of the two similar Revere Data monthly research reports), the FDA and Clinical Trial Calendars at BioMedReports.com feature daily updates to the database and users have access on a dynamic basis through the website platform rather than a static PDF report which is issued on a monthly basis.
Please note that many of the entries on these two calendars involve small and micro-cap stocks which represent high risk, high reward trades so it is prudent to avoid the temptation of going all-in, no matter how bullish you may be on the prospects for a company or new product. Also, many stocks begin to rise in price in anticipation of their PDUFA decision date or clinical trial results, presenting an opportunity to take profits ahead of the binary event.
This risk-reduction strategy could involve selling out completely or just letting your profits ride through the binary event so your original investment is no longer at risk. Trading binary events (FDA decisions and clinical trial results) should be limited to the portion of your portfolio that is allocated for speculation and that you can afford to lose.
Disclosure: no positions