12 Extreme FDA Trades on New Product Decisions

by: Mike Havrilla

Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

See the BioMedReports.com FDA Calendar.
1.) Vion Pharma (OTC:VION): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). 4/17/09 is date for FDA to accept the filing and rule on priority review request – if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.
2.) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October with an expected decision date of 4/17/09. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded sharply since that time and is up over 30% in the past few days and closed today at $1.72 per share.
3.) Northfield Labs (NFLD): PolyHeme BLA (priority review) for life-threatening red blood cell loss. The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09.
4.) Vanda Pharma (NASDAQ:VNDA): The Company's iloperidone (formerly Fanapta) NDA resubmission is in response to a previous not approvable ruling by the FDA on 7/25/08. The PDUFA decision date for iloperidone as an atypical anti-psychotic treatment for schizophrenia is 5/6/09.
5.) Hemispherx Biopharma (NYSEMKT:HEB): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09.
6.) Acusphere (OTCPK:ACUS): Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.
7.) Arca biopharma (NASDAQ:ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
8.) BioDelivery Sciences (NASDAQ:BDSI): Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision date of 6/15/09 and a $27M milestone payment if approved from partner Meda AB (OTC:MDABF). Onsolis is a small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the cheek.
BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis last December based on the feedback it received from a complete response ruling by the FDA in August 2008. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission.
9.) Spectrum Pharma (NASDAQ:SPPI): Zevalin sBLA (priority review) as consolidation therapy follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved. Cell Therapeutics (NASDAQ:CTIC) recently sold its 50% interest in a joint venture between the two companies to market Zevalin so SPPI owns a 100% stake in the cancer drug. A three-month delay in the PDUFA decision date to 7/2/09 was announced on 2/23/09 as SPPI submitted additional data to the FDA, which was classified as a major amendment to the sBLA filing
SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.
10.) Labopharm (DDSS): A decision date of 7/18/09 is looming for the Company's rapid-onset formulation of trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market.
11.) Transcept Pharma (TSPT): The decision date for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed for insomnia from middle of night awakenings is 7/30/09.
12.) Advanced Life Sciences (OTC:ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP) with a decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of the FDA is tentatively scheduled to meet on 6/2/09 to discuss the NDA for cethromycin.

Disclosure: no positions