|BioSante Announces Results from LibiGel® Efficacy Trials; ARIAD Announces Proposed Public Offering of Common Stock|
|By Staff and Wire Reports|
|Wednesday, 14 December 2011 20:57|
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials. Initial analysis of the data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences in the endpoints, all results were in the appropriate directions. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
Subjects in the first trial, called BLOOM-1, who were treated with LibiGel showed an increase of 1.47 days with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline. The difference between these increases demonstrated a p value of 0.463. In BLOOM 1 there was an increase in the total number of satisfying sexual events of 3.87 from baseline (an increase of 83 percent) in the LibiGel group and in the placebo group there was an increase of 3.52 satisfying sexual events from baseline (an increase of 65 percent) for a p value of 0.698. Subjects in BLOOM-1 showed an increase in mean sexual desire of 0.03 over placebo, a p value of 0.672, while subjects in BLOOM-2 demonstrated an increase in mean sexual desire of 0.03 compared to placebo, a p value of 0.48. Subjects in both trials demonstrated a decrease in sexual distress when treated with LibiGel (p=0.569 and p=0.26) compared to baseline.
Subjects in BLOOM-2 who were treated with LibiGel showed an increase of 1.0 day with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.28 days with a satisfying sexual event compared to baseline. The difference between these increases demonstrated a p value of 0.214.
The trials demonstrated that LibiGel was generally well tolerated with a safety profile that appears to be comparable to placebo.
"We obviously are very disappointed by the Phase III LibiGel efficacy trial results. We have been committed to LibiGel for many years and we are committed to determining the future of LibiGel," stated Stephen M. Simes, BioSante's president & CEO. "We will continue to analyze the efficacy trial data fully and determine plans for our next steps in the LibiGel development plan, and provide an update at a later time. While the LibiGel Phase III cardiovascular and breast cancer safety study currently continues as planned, we will be analyzing the best path forward for the study given the results reported today. I want to thank our entire BioSante clinical team and the clinical investigators for their tireless efforts in these trials, and I also want to thank the women enrolled in the BLOOM trials for their participation."
The two completed Phase III efficacy trials were randomized, double-blind, placebo-controlled trials which enrolled 597 and 575 surgically menopausal women, respectively, for six-months of therapy. These trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. The co-primary endpoints of both LibiGel efficacy trials were the change in the total number of days with a satisfying sexual event from baseline, and the change in mean sexual desire from baseline. The secondary endpoint for both trials was the change in sexual distress from baseline. Subjects recorded their sexually satisfying events in a validated daily diary, during a baseline period and during the full six months of therapy.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced it has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by ARIAD.
J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies & Company, Inc. are acting as joint book-running managers and underwriters for the proposed offering. ARIAD intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the amount sold to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
This funding is expected to enable ARIAD to continue treatment and follow-up of patients in the pivotal PACE trial of its investigational pan BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) and, subject to further patient follow-up and data analysis in this trial, to file for marketing approval of ponatinib in the United States and Europe in the middle of 2012. ARIAD anticipates that this funding will also enable it to continue preparations for commercial launch of ponatinib in the United States and Europe and, if approved, to sell, market and distribute ponatinib in these and other markets on its own, allowing ARIAD to retain the substantial potential commercial value of ponatinib. ARIAD also expects that this funding will allow it to conduct additional clinical trials of ponatinib, including a Phase 3 clinical trial in newly diagnosed CML patients and clinical trials of ponatinib in Japan, as well as to complete the Phase 1/2 trial of AP26113, its investigational dual inhibitor of anaplastic lymphoma kinase and epidermal growth factor receptor, and, depending on the results of this trial, conduct a pivotal trial of AP26113 in patients with non-small cell lung cancer and to fund additional trials in the United States, Europe and Asia.
Financing to support filings for regulatory approval and global commercialization of ponatinib in patients with resistant or intolerant CML and additional clinical development of its investigational targeted cancer medicines.
AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque has established a clear development plan, including Phase I and Phase II protocol outlines, based on the recently finalized minutes of its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) for its AHRO-001, a compound for the treatment of atherosclerosis.
NeurOp, Inc. today announced that Bristol-Myers Squibb (NYSE: BMY) has agreed to fund an additional year of research for NeurOp’s proprietary small molecules for the treatment of major depression and neuropathic pain.
Celgene International Sàrl (Nasdaq: CELG) and the Groupe d’Etude des Lymphomes de l’Adulte (GELA) today announced the organizations have initiated an international, Phase III, open-label, randomized study to evaluate the therapeutic potential of a novel chemotherapy-free approach for the treatment of follicular lymphoma (FL).
Charles River Laboratories International, Inc. (NYSE: CRL) today provided guidance for 2012 and updated guidance for 2011.
Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today that a meta-analysis of data from five double-blind, placebo-controlled trials of vaginal progesterone, including the PREGNANT study, Columbia's pivotal clinical trial of progesterone vaginal gel 8% to reduce the risk of preterm birth in women with premature cervical shortening, found that administering vaginal progesterone to asymptomatic women with a sonographic short cervix in the mid-trimester of pregnancy significantly reduces the risk of preterm birth and neonatal morbidity.
Intellect Neurosciences, Inc. (OTCPK: ILNS) announces that Dr. Daniel G. Chain, chairman and CEO will be presenting at the 10TH Annual BIO Investor Forum.
Interleukin Genetics, Inc. (OTCQB: ILIU) today announced the appointment of Lynn Doucette-Stamm, Ph.D., as Vice President of Development.
Metiscan, Inc. (PINKSHEETS: MTIZ) today announced its settlement with the China Trust Bank (CTB).
Nanostart (OTCQX: NASRY), holding MagForce AG (XETRA: MF6), a leading medical technology company focusing on nanomedicine in oncology and Delrus Inc., a leading Russian medical product distribution company, announced today the signing of a Letter of Intent (LOI) between the two companies.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea.
ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it will present at J.P. Morgan's 30th Annual Healthcare Conference, to be held in San Francisco from January 9-12, 2012.