Six Trades on FDA, Clinical Trial Binary Events

by: Mike Havrilla

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

BioSante Pharma (NASDAQ:BPAX)

LibiGel (testosterone) - Pivotal Phase 3 Clinical Trials under SPA

- expected NDA filing in 2011, Phase 3 long-term safety study plus two Phase 3 efficacy trials ongoing for sexual dysfunction post-menopausal women, expects to make decision during 4Q10 on enrollment status safety study, on 7/13/10 initiated six-month study to evaluate effect on cognitive function


ENMD-2076 (a selective angiogenic kinase inhibitor anti-cancer agent) - Phase 2 Clinical Trial, Preclinical Data

On 4/13/10, initiated Phase 2 study in patients with platinum-resistant ovarian cancer with ID NCT01104675 and results expected during 1Q11, six sites are actively recruiting patients, reported anti-cancer effect in preclinical multiple myeloma (MM) models on 7/13/10

Protalix Biotherapeutics (AMEX:PLX)

UPLYSO (taliglucerase alfa) (a plant-cell expressed form of the enzyme, gluco-cerebrosidase) received a temporary authorization for use in France today, following news on Monday that the FDA accepted the Company's NDA with a standard 10-month review and PDUFA action goal data in late February 2011.

Lorillard (NYSE:LO) - Newport Brand of Menthol Cigarettes

FDA Tobacco Products Scientific Advisory Panel Ruling, FDA Decision on Menthol Cigarettes

- An initial recommendation to FDA is expected March 2011 with final FDA ruling expected by March 2012, reviewing health effects of menthol cigarettes (which account for approx. 25% smokers and 33% of the $70 billion US cigarette market), a second FDA Tobacco Advisory Panel Meeting is scheduled for July 15-16 (first panel meeting was held March 2010)

Vivus (NASDAQ:VVUS) - QNEXA (phentermine plus topiramate) (once-daily combo weight loss / obesity drug candidate)

- Five potential safety concerns (neuro-psychiatric) outlined in briefing docs ahead of 7/15/10 Endocrinologic and Metabolic Drugs Advisory Panel Meeting, no efficacy concerns based on weight loss observed in pivotal studies, PDUFA action goal date 10/28/10 under standard 10-month review

Immunovaccine [IMV.V] - EMD 640744 (surviving-based therapeutic cancer vaccine) formulated with DepoVax delivery system

- On 7/12/10, announced in-licensing from Merck KGaA (OTCPK:MKGAY), pending Phase I/II clinical trial estimated to begin by year-end 2010 targeting multiple solid tumors and blood-based cancers (melanoma, prostate, pancreatic, colon and multiple myeloma.

Disclosure: No positions

Disclosure: No positions