Industry news: What happen last week?
By William Chin, PhD, Project Manager, EUCRAF
AbbVie goes full throttle into hematological oncology
AbbVie has announced that it will acquire Pharmacyclics, and its leading asset Imbruvica® (ibrutinib), a highly effective treatment for hematologic malignancies. The acquisition will position AbbVie as a leader in hematological oncology. Imbruvica® is a Bruton's tyrosine kinase (BTK) inhibitor approved for use in four indications to treat three different types of blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom's macroglobulinemia. It is foreseen that there will be significant opportunity for development with further Imbruvica® indications, including solid tumors. Did you know that Imbruvica® is the only therapy to have received 3 Breakthrough Therapy designations by the FDA?
AstraZeneca is spinning off its antibiotics division
In an effort to keep focus on key pipelines in cardio metabolic diseases, oncology, respiratory and inflammation thereapeutic areas, AstraZeneca has decided to decrease its overall investment in antibiotics. In-PharmaTechnologist reported that the pharma industry is loosing interest in antibiotics research because of low profitability.
Baxter acquires SuppreMol GmbH, a German based biopharmaceutical company
With the acquisition of SuppreMol, Baxter has garnered the early-stage development portfolio of a novel biologic that modulates the Fc receptor signaling pathways, for the treatment of autoimmune diseases such as idiopathic thrombocytopenic purpura. SuppreMol is a privately held biopharmaceutical company based in Martinsried. It was founded as a spin-off from the laboratory of Prof. Dr. Robert Huber, Nobel Prize Laureate in Chemistry 1988, at the Max Planck Institute for Biochemistry.
Boehringer Ingelheim pursues accelerated procedures for idarucizumab with 3 regulatory authorities
Boehringer Ingelheim announced that it has submitted application for approval of marketing authorization of idarucizumab to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada. Idorucizumab proposed indication is for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa®, in rare emergency situations. This is the first regulatory submissions for a specific reversal agent to a novel oral anticoagulant.
Bristol-Myers Squibb signs exclusive agreement with Bavarian Nordic
Bristol-Myers Squibb announced that it has secured an exclusive option to license and commercialize PROSTVAC®, Bavarian Nordic’s investigational Phase 3 development of prostate-specific antigen-targeting cancer immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Future study will investigate the combination of Bristol-Myers Squibb’s own prostate cancer drug, YERVOY (ipilimumab) and PROSTVAC. The companies have also agreed to conduct other exploratory combination studies of PROSTVAC and agents from Bristol-Myers Squibb’s immuno-oncology portfolio.
FDA approved first biosimilar of filgrastim, Zarxio(TM), in the US
Sandoz announced that the US FDA has approved Zarxio (filgrastim-sndz) for all indications included in the reference product's label. Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
1. AbbVie Press Releases, 4 March 2015, Abbvie to acquire pharmacyclics, including its blockbuster product imbruvica®, creating an industry leading hematological oncology franchise
2. Pharmatechnologist, 4 March 2015, AZ spins out antibiotics R&D biz to focus on key pipelines
3. Baxter Press Releases, 4 March 2015, Baxter's BioScience Business Acquires Biopharmaceutical Company SuppreMol
4. Boehringer Ingelheim, Press Release, 03 March 2015, Boehringer Ingelheim submits applications for approval of idarucizumab*, specific reversal agent to dabigatran etexilate (Pradaxa®), to EMA, FDA and Health Canada
5. Bristol-Myers Squibb Press Releases, 4 March 2015, Bristol-Myers Squibb Signs Exclusive Agreement with Bavarian Nordic for PROSTVAC®, a Prostate-Specific Antigen-Targeting Cancer Immunotherapy
6. Novartis, Media Releases, March 06, 2015, FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz