Ardea Biosciences has announced that it has earned a $7.5 million milestone from Bayer HealthCare under the terms of their April 2009 global license agreement to develop and commercialize Ardea’s mitogen-activated ERK kinase inhibitor compounds for cancer and other indications. The milestone was triggered by the initiation of the Phase 2 part of a previously reported Phase 1/2 clinical study evaluating the investigational agent BAY 86-9766 in combination with gemcitabine for the treatment of advanced pancreatic cancer.
Monthly Archives: May 2012
Bristol-Myers Squibb has announced the formation of the International Immuno-Oncology Network, a collaboration with 10 academic institutions that aims to further the scientific understanding of immuno-oncology. Immuno-oncology focuses on the potential of harnessing the intelligence of the body’s own immune system to fight cancer. An objective of this collaborative forum is to facilitate the translation of scientific research findings into clinical trials and, eventually, clinical practice. It will also work to further advance innovation in drug discovery and development.
In a forthright statement Immune Response BioPharma has announced that it has terminated its partnership discussions with GlaxoSmithKline to develop NeuroVax, its multiple sclerosis vaccine.
A new collaboration has been launched with the objective of improving the underlying scientific understanding of antibiotic resistance, design and implement efficient clinical trials and take novel drug candidates through clinical development. The programme is part of the European Commission’s Action Plan Against the Rising Threats from Antimicrobial Resistance, launched in November last year. Supported by the Innovative Medicines Initiative, the research programme’s first projects will be funded by a joint budget of up to €224 million – €109 million provided by IMI and €114.7 million in-kind contributions from the pharmaceutical and biotechnology companies involved. GlaxoSmithKline, AstraZeneca, Janssen, Sanofi and Basilea Pharmaceutica will work alongside public research organisations and scientific experts to address several aspects of resistance and stimulate new antibiotic research. Further projects within the programme, with additional funding, are expected to launch later in the year.
Accuray has announced the signing of a research and collaboration agreement with the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) a research institution located in Heidelberg, Germany. Under the agreement Accuray and DKFZ will collaborate on research in radiation oncology.
Bayer and Onyx Pharmaceuticals have announced that a Phase 3 trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival was observed. The study compared Nexavar plus best supportive care to placebo plus best supportive care.
Lundbeck and CHDI Foundation have announced a research collaboration to investigate candidate therapies for Huntington’s Disease. As part of the collaboration CHDI will conduct pre-clinical studies on a Lundbeck investigative compound. Research will focus on the compound’s effect on P2X receptors that may be involved in HD.3 The study results will influence future research into this and other compounds for HD.
BioDelivery Sciences has announced that it has received a $2.5 million prelaunch milestone payment from Meda, triggered by the first national regulatory clearance and pricing approval for Breakyl/Onsolis (fentanyl buccal soluble film) in the EU. Breakyl is indicated for the management of breakthrough pain in opioid-tolerant adult cancer patients. BioDelivery will receive another, final $2.5 million EU-related milestone when the drug is launched commercially in Europe by Meda, which the firm anticipates before the end of 2012.
Auxilium Pharmaceuticals and GlaxoSmithKline have announced that they have entered into an agreement for the co-promotion of Testim 1% (testosterone gel), which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. Under the terms of the agreement, Auxilium has granted GSK the exclusive right to co-promote the sale of Testim with Auxilium in the US until September 2015. Auxilium and GSK have agreed on a baseline revenue forecast for Testim through September 30, 2015, and GSK will be compensated to the extent that Testim net sales exceed this baseline. In addition, in certain circumstances, Auxilium will pay GSK specified tail payments following the term of the agreement. The GSK sales force is expected to begin promoting Testim to physicians early in the third quarter 2012. Auxilium will remain responsible for all Testim commercial drug manufacturing, supply, and regulatory activities.
Bloomberg reports that Human Genome Sciences has said it’s in talks with major pharmaceutical and biotechnology companies about a potential transaction and adopted measures to avoid a hostile takeover by GlaxoSmithKline. According to the reports HGS has entered into confidentiality agreements with certain parties and is providing an opportunity to engage in due diligence reviews. Its board of directors said shareholders should reject GSK’s $2.6 billion offer.