Biopharmaceutical News Week16
Recro acquires Alkermes’ assets
Recro Pharma (Malvern, PA, USA) acquires Alkermes’ (Dublin, Ireland) manufacturing facility in Gainesville (GA, USA). The facility will manufacture several products including Meloxicam iv/im, a proprietary Phase III long acting COX-2 NSAID designed for the treatment of moderate to severe acute pain. Under the terms of the agreement Alkermes will receive an initial cash payment of $50 million, development and commercialization milestones of up to $120 million and low double-digit royalties related to Meloxicam sales.
April 13, 2015
Roche acquires CAPP Medical
Roche Holdings acquires CAPP Medical (Palo Alto, CA, USA), a privately held genomic research company, to expand its cancer screening and monitoring foot print. CAPP Medical is a spin off from Stanford University which has developed technology to locate cancer cells and monitor them by detecting circulating tumor DNA (ctDNA) in blood. Financial terms of the acquisition were not disclosed.
April 13, 2015
Eisai enters drug development deal with Genomics
Eisai (Tokyo, Japan) announces an agreement with Genomics plc (Oxford, UK) to accelerate its drug discovery process in using Genomics analyses of genetic association data. Eisai’s Human Genetics Research unit will use Genomics genetic information to speed up the discovery and development of “impactful new medicines”.
Medivir and Cancer Research enter into cancer development deal
Medivir AB (Stockholm, Sweden) and Cancer Research Technology (UK) have announced a two year agreement to work on an new approach to discover an innovative class of anti-cancer drugs targeting the cell surface protein ADAM8 which is associated with tumor survival and cell invasion.
AstraZeneca partners with PatientsLikeMe
AstraZeneca announces a five-year partnership with PatientsLikeMe (Cambridge, MA, USA) to access its patient-generated information database and support research and development activities in the oncology, diabetes, lupus and respiratory fields. PatientsLikeMe is a patient-generated data community in which individuals can connect with others who have the same medical condition.
Boehringer Ingelheim partners with Hydra Biosciences to focus on renal diseases
Boehringer Ingelheim (Ingelheim, Germany) has announced a research collaboration with Hydra Biosciences (Cambridge, MA, USA) to focus on transient receptor potential (TRP) channel modulation and identify small molecule TRP inhibitors for the treatment of renal disease and related disorders. Boehringer had already established an earlier partnership with Hydra Biosciences aimed at discovery of TRPC4/5 inhibitors for the treatment of central nervous system diseases. Details of the financial terms were not disclosed.
Sanofi stops TransCon Insulin development with Ascendis
Ascendis Pharma (Copenhagen, Denmark) disclosed that Sanofi has stopped the development of TransCon Insulin, but continues ongoing programs with TransCon peptides. The TransCon technology is used to generate prodrugs yielding improved versions of high value existing drugs.
…. and enters in an antibody drug conjugate agreement with Innate Pharma
Sanofi and Innate Pharma (Marseille, France) agreed to start a program to develop new antibody drug conjugates (“ADC”). Under the terms of the deal Sanofi will be responsible for assessing the payload conjugation and get option to license Innate’s technology. Innate Pharma is a first in class therapeutic antibody company which has developed site-specific conjugation technology to generate homogeneous ADCs in two steps with and exact antibody/toxin ratio. Details of the agreement were not disclosed.
Approval of drugs, vaccines, diagnostics and devices
US FDA approves Amgen’s heart drug Corlanor
Amgen (Thousand Oaks, CA, USA) has won the US FDA approval for the heart drug Corlanor (ivabridine), a first approval for a new class of drugs aimed at preventing heart failure. Corlanor is a bradycardia agent which decreases heart rate by blocking the heart’s natural pacemaker cells. Amgen acquired US commercial rights to Corlanor from Servier (Paris, France) which sells the medicine in Europe and in Australia.
Drugs at clinical stage
US FDA grants fast track to Horizon’s Actimmune
US FDA has placed Actimmune from Horizon Pharma (Deerfield, IL, USA) on a fast track pathway to speed up its development for the degenerative neuro-muscular disorder Friedreich’s ataxia. Actimmune (interferon gamma-1b) a biologically manufactured protein which helps preventing infection, has already been approved in the US for use in chronic granulomatous disease and severe malignant osteopetrosis.
…. to MEDI8897 from MedImmune to prevent lower respiratory tract illness
US FDA has granted fast track designation to MedImmune (Gaithersburgh, MD, US) for the development of MEI8897, a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody designed to prevent lower respiratory tract illness associated with respiratory syncytial virus (RSV) in babies and children.
….to Gencaro from ARCA to prevent atrial fibrillation
US FDA grants fast track designation to ARCA Biopharma (Broomfield, CO, USA) for the development of Gencaro (bucindolol) to prevent atrial fibrillation flutter in genetically modified heart failure patients who have reduced ventricular ejection fraction. Bucindolol is a non-selective beta-blocker with additional weak vasodilator activity, which has been rejected, in 2009, by the FDA for the treatment of heart failure.
…. and to cabozantinib from Exelixis to treat renal carcinoma
US FDA grants fast-track status for Exelexis’ (South Francisco, CA, USA) drug cabozantinib for the treatment of advanced renal cell carcinoma patients. Cabozantinib is a pan-kinase inhibitor which tackles MET, VEGFRs and RET receptors, which has already been approved in the US, in November 2012, for the treatment of medullary thyroid cancer.
US FDA grants orphan-status to Reata’s pulmonary arterial hypertension drug
US FDA grants Reata’s (Irving, TX, USA) bardoxolone methyl orphan-drug status for the treatment of arterial pulmonary hypertension. Bardoxolone methyl is an experimental and orally-available semi-synthetic triterpenoid, called antioxidant inflammation modulators (AIMs) which acts as a potent activator of the transcription factor Nrf2 and a potent inhibitor of the transcription factor NF κB. Bardoxolone methyl is being investigated by Reata Pharmaceuticals in a partnership with Abbvie and Kyowa Hakko Kirin.
… and to AstraZeneca’s tremelimumab for the treatment of mesothelioma
US FDA designates AstraZeneca tremelimumab, an anti-CTLA-4 monoclonal antibody, an orphan drug status for the treatment of malignant mesothelioma an aggressive cancer affecting the lining of the lungs and abdomen often associated with asbestos exposure.
Pfizer stops early Ibrance Phase 3 study after reaching primary efficacy endpoint Based on the assessment by the Data Monitoring Committee
Pfizer stopped early a phase 3 trial of Ibrance (palbociclib), after reaching primary efficacy endpoints. The study was performed in a specific breast cancer study which compared the combination of palbociclib and fulvestrant to fulvestrant plus placebo in women with hormone positive, human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer. Palbociclib is a selective inhibitor of the cyclin-dependent kinase CDK4 and CDK6 which has already been approved in the US, in February 2015, in combination with letrozole for the treatment of estrogen positive, HER2 negative breast cancer.
Merck, NewLink Ebola vaccine enters third trial
Merck & Co and NewLink Genetics (Ames, Iowa, USA) have confirmed that the third, late-stage, clinical trial of their Ebola vaccine candidate rVSV-ZEBOV-GP (V920) has begun in Sierra Leone.
US spent record amount on prescription drugs in 2014
According to the IMS Health report Medicine Use and Spending Shifts: A Review of the Use of Medicines in the US in 2014, a record volume of 4.3 billion prescriptions were filled during the year. Spending on prescription drugs reached a record high to $373.9 billion in 2014, an increase of 13.1% over the previous year. New drugs contributed $20.3 billion to growth, including $11.3 billion from four new hepatitis C treatments.
GSK closes its Pittsburgh office
Just a few days after GSK announced the relocation of its US vaccine R&D global center to Rockville (Maryland, USA) it now announces the closing of its Pittsburgh office where it has 275 employees working for its consumer health unit. The plan is to relocate the current GSK office in Pittsburgh (PA) and the Novartis operations currently located in the Parsippany area in a new space in New Jersey.
Bio and Business Events
- China Bio Partnering Forum on April 22-23 in Shanghai (China)
- Swiss Italian Healthcare Licensing Groups, on May 7-8 in Lugano (Switzerland)
- Biotrinity 2015 on May 11-13 in London (UK)
- MedTech Partnering Forum on May 28-29 in Tokyo (Japan)
- IIR’s IN3 EuroMedtech 2015 on June 10-11 in Vienna (Austria)
- BIO International Convention on June 15-18 in Philadelphia (USA)
- Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
- BioPharm America 2015 on September 15-17 in Boston (USA)
Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)
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