|ArQule Announces Tivantinib Meets Primary Endpoint; XOMA Acquires U.S. Rights to Perindopril Franchise|
|By Staff and Wire Reports|
|Tuesday, 17 January 2012 19:51|
ArQule, Inc. (NASDAQ:ARQL) announced treatment with tivantinib as single agent therapy produced a statistically significant 56% improvement in time-to-progression (TTP) in the intent-to-treat (ITT) population, the primary endpoint in a randomized, controlled Phase 2 clinical trial in previously treated patients with hepatocellular carcinoma (HCC) (hazard ratio = 0.64; log rank p-value = 0.04).
Adverse events were reported at similar rates in the treatment and placebo arms, except for a higher incidence of fatigue and hematologic events, including neutropenia and anemia, in tivantinib-treated patients. The incidence of hematologic events declined following dose reduction of tivantinib from 360 milligrams twice daily (BID) to 240 milligrams BID.
These findings represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC, said Dr. Brian Schwartz, chief medical officer of ArQule. Second line treatment for HCC remains a challenge, lacking an approved agent. We look forward to presenting complete data from this trial at a peer-reviewed forum later this year, including secondary endpoint, sub-group and biomarker analyses.
XOMA Corporation (Nasdaq:XOMA) announced it has acquired U.S. rights to the perindopril franchise from Les Laboratoires Servier, XOMA's partner for its lead product candidate, gevokizumab (formerly XOMA 052). The agreement includes the branded product ACEON® (perindopril erbumine), a currently marketed angiotensin converting enzyme (ACE) inhibitor, and a portfolio of three fixed-dose combination product candidates where perindopril is combined with other active ingredient(s), such as a calcium channel blocker. The proprietary form of perindopril in each of the combination products provides patent protection until 2023. XOMA plans to assume commercialization activities for ACEON on January 23, 2012, following the transfer from Servier's previous licensee.
"We have been consistent in articulating our commitment to establishing a commercial capability in order to derive appropriate value from XOMA's products. By acquiring the U.S. rights to ACEON, we meet that objective immediately, and we further deepen our relationship with Servier. The capabilities and components required to sell $2 to $3 million worth of ACEON currently are not significantly different than what is required to sell a substantially greater volume of product(s)," stated John Varian, Chief Executive Officer of XOMA. "We have the commercial infrastructure in place that allows us to continue to deliver ACEON to patients, with a margin to XOMA. We do not intend to actively promote ACEON.
"With our partner, we will evaluate the best plan forward for the development of the fixed-dose combination products in the U.S., including financial arrangements to support such development," Mr. Varian added. "Servier's clinical and commercial expertise has made perindopril a highly successful franchise outside the U.S. with sales of over $1.2 billion in 2011. Perindopril is used widely in the treatment of hypertension, with significant clinical outcomes evidence generated by numerous positive morbidity and mortality trials. We intend to work closely with Servier to create new commercial opportunities within the U.S. market."
The Company reaffirmed its guidance that XOMA anticipates that its cash utilization from ongoing activities will be approximately $35 million in 2012.
Abaxis, Inc. (NasdaqGS: ABAX), a medical products company manufacturing point-of-care blood analysis systems, has scheduled a conference call to discuss its financial results for the third quarter of fiscal year 2012, ended December 31, 2011.
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced that the Wills Eye Institute in Philadelphia has received institutional review board (IRB) approval as a site for the Phase 1/2 clinical trial for dry age-related macular degeneration (dry AMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE)cells.
Agilent Technologies Inc. (NYSE:A) today announced that it has listed its Infinity Series 1200 liquid chromatography systems and 6000 Series mass spectrometry systems as Class I medical devices with the U.S. Food and Drug Administration.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has filed a patent infringement lawsuit against Tekmira Pharmaceuticals Corporation in the U.S. District Court of the District of Massachusetts.
ArQule, Inc. (NASDAQ: ARQL) today announced that treatment with tivantinib as single agent therapy produced a statistically significant 56 percent improvement in time-to-progression (TTP) in the intent-to-treat (ITT) population, the primary endpoint in a randomized, controlled Phase 2 clinical trial in previously treated patients with hepatocellular carcinoma (HCC) (hazard ratio = 0.64; log rank p-value = 0.04).
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, announced today a new agreement with Harrison Clinical Research (HCR), an international full-service contract research organization.
HP (NYSE: HPQ) Enterprise Services and Blue Shield of California today announced they have signed an agreement designed to enable Blue Shield to deliver new services that enhance efficiencies and improve affordability of health care for its customers.
Intellect Neurosciences, Inc. (OTCPK: ILNS) announces that Dr. Daniel G. Chain, chairman and CEO will be presenting at the 9th Annual BIO Asia International Conference.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), and Geisinger Health System today announced a research collaboration to conduct a preclinical study using InVivo’s injectable biocompatible hydrogel for the treatment of chronic pain caused by peripheral nerve compression.
Johnson & Johnson (NYSE: JNJ) will host an analyst meeting at 8:30 a.m. (Eastern Time) on Tuesday, Jan. 24, to discuss fourth-quarter and full-year 2011 financial results.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced the appointment of W. James O'Shea to its Board of Directors.
Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) today announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s disease.
Nano Mask, Inc. (NMI) (Pink Sheets: NANM), a healthcare product development and distribution company focused on emergency and critical care as well as infection control markets, today announced that it has opened a sales, marketing and distribution office in Riyadh, Saudi Arabia to service its customers in the Middle East and to tap into the strong demand for its products in the region.
PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global consultancy serving the biopharmaceutical and medical device industries, today announced that David Elder, formerly a senior official of the U.S. Food and Drug Administration (FDA), has been appointed as a Vice President to its Strategic Compliance Services team.
Palatin Technologies, Inc. (NYSE Amex: PTN) announced today it has received net proceeds of approximately $1.1 million of non-dilutive funding through the New Jersey Economic Development Authority's tax credit transfer program.
Positron Corporation (OTCBB: POSC), a leading molecular imaging company specializing in the field of nuclear cardiology is pleased to announce the acquisition of Manhattan Isotope Technology, LLC (MIT).
When Rainbow Coral Corp. (OTCBB:RBCC) moved its biosciences division to Houston, Texas, it tapped into an economic hot bed. According to local economists, Houston’s biotechnology sector outpaced every other sector of the city’s economy last year.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its fourth quarter and full year 2011 financial results on Thursday, February 2, 2012 after the financial markets close. The company will host a conference call at 5:00 p.m. EST.
VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the REVIVE study were published in The Journal of Sexual Medicine (JSM),a peer-reviewed journal with broad, multidisciplinary readership. REVIVE (TA-301) was a randomized, placebo-controlled, phase 3 study evaluating the safety and efficacy of avanafil, an investigational drug currently under review by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).