|BioMed News Bytes: Angiotech, BioSante, HGSI|
|Tuesday, 20 October 2009 08:07|
On 10/19/09, Angiotech Pharma (NASDAQ: ANPI) received notice from the FDA that Bio-Seal is a Class III medical device that requires Pre-Market Approval (PMA) for marketing clearance by the Agency.
As a result, ANPI is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydro-gel plug.
On 10/20/09, BioSante Pharma (NASDAQ: BPAX) announced positive safety data in its ongoing LibiGel Phase 3 clinical development program. For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study and the DMC unanimously recommended continuation of the study based on this review with no modifications, including a review of all “serious adverse events” and all “adverse cardiovascular / breast cancer events” in 1,055 women with 883 women-years of exposure.
BPAX stated that based on blinded data the rates of adverse events in the study are lower than expected in women at the higher end of cardiovascular risk for the intended population so the DMC review based on un-blinded data validates the safety of LibiGel to date (which includes no deaths, one myocardial infarction and three cases of breast cancer reported). BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011. The Phase 3 Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll 2,400-3,100 women, exposed to LibiGel or placebo for 12 months. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.
In addition to the Phase 3 Safety Study, BPAX is conducting two Phase 3 efficacy trials with about 500 surgically menopausal women each for a six-month clinical trial under an FDA approved SPA (special protocol assessment). Antares (AMEX:AIS) will receive mid-single digit royalties, milestone sharing rights in U.S. and exclusive marketing rights elsewhere for its Advanced Transdermal Delivery gel technology.
On 10/20/09, Human Genome Sciences (NASDAQ: HGSI) and GlaxoSmithKline (NYSE: GSK) announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The data demonstrate that, in BLISS-52, belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.
Study results also show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. HGSI stated that these data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points and included a greater percentage of patients receiving BENLYSTA that were able to reduce their use of steroids. Belimumab is an experimental drug and the first in a new class of drugs called BLyS-specific inhibitors being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
Results from BLISS-76, the second Phase 3 trial of belimumab, will be announced on 11/2/09. Assuming the results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the United States, Europe and other regions during 1H10.
Disclosure: Long BPAX
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