A four-year collaboration to identify novel drug targets, tackle new subsets of disease and enable rapid progression of clinical programmes has been signed between GSK and 23andMe, a leading consumer genetics company with more than 5 million customers and a portfolio of early stage therapeutic research programmes across a wide range of disease indications. Both companies shall bring existing early stage programmes within the collaboration; GSK will contribute its LRRK2 inhibitor, which is currently in preclinical development as a potential treatment for Parkinson’s disease. All activities will initially be co-funded (50%/50%). GSK has also made a $300 million equity investment in 23andMe, and it will have the right to analyse its database for validation of GSK’s existing therapeutic portfolio as well as leverage 23andMe’s capabilities for clinical trial recruitment. 23andMe customers voluntary and affirmatively consented to participate to research and mantain the control of their data, which are used after de-identification, so no individual will be identifiable to GSK.
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New partnerships for Gilead
Gilead closed a strategic collaboration with Precision BioSciences to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) using Precision’s proprietary genome editing platform, Arcus. According to the company, Precision will be primarily responsible for the development, formulation, and preclinical evaluation of the investigational nucleases, and Gilead will be responsible for the clinical development and commercialization of potential therapies. R&D activities will be funded by Gilead, while Precision is eligible to receive milestone payments up to $445 million, plus tiered royalties.
Gilead also closed a license agreement with Trianni to use its transgenic human monoclonal antibody discovery platform to support the Gilead’s drug discovery efforts.
Merck rescinds mandatory CEO retirement policy
Merck‘s current Chief executive officer, Kenneth C. Frazier, shall rest in his position beyond December 2019, when he turns 65. The announcement followed the decision of Merck’s Board of Directors that rescinded the CEO’s mandatory retirement at age 65. “CEO succession has been our top priority, and removing the mandatory retirement policy enables the Board to make the best decision concerning the timing of that transition,” said Leslie A. Brun, lead director, speaking on behalf of the Board of Directors.
A new licensing agreement for Ferring
Ferring Pharmaceuticals (https://www.ferring.com/) signed an agreement for the global commercialisation rights to nadofaragene firadenovec/Syn3 (rAd-IFN/Syn3), a novel gene therapy developed by Finnish gene therapy specialists FKD Therapies Oy as a treatment for patients with high-grade non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG) therapy. rAd-IFN/Syn3 is currently undergoing Phase 3 development in the US under the sponsorship of FKD.
A new Japanese consortium for R&D
Ono Pharmaceutical (https://www.ono.co.jp/eng/) announced the establishment of the new Immune-mediated Inflammatory Diseases Consortium for Drug Development to run drug discovery research targeting immune-mediated inflammatory diseases. Other participants to the initiative include Keio University, Kochi University, National Institutes of Biomedical Innovation, Health and Nutrition, Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo. The consortium will work to overcome challenges due to limitations on clinical samples from immune-mediated inflammatory diseases and further increases in research costs.
A new high containment facility for Aspen
South African Aspen Pharmacare (APN) (https://www.aspenpharma.com/) officially opened its new high containment facility in Port Elizabeth. The 23,000m² facility has been audited by the South African Health Products Regulatory Authority and the German regulator, Landesamt für soziale Dienste des Landes Schleswig-Holstein (LAsD) both of which have granted the requested approval. At full capacity, the high containment facility is expected to produce approximately 3.6 billion tablets annually and package some 3 million bottles per month. The establishment of a new Training Academy is also ongoing in order to train employees.
UCB expanded its epilepsy portfolio
The acquisition of Midazolam Nasal Spray (USL261) from Proximagen allowed UCB (https://www.ucb.com/) to pursue the consolidation of its epilepsy portfolio. The product is a nasally administered investigational midazolam formulation intended as a rescue treatment of acute repetitive seizures (ARS) in patients with epilepsy, which has completed Phase 3 clinical development. USL2611 already granted orphan drug and fast track designation by the FDA and is ready to be filed as a New Drug Application (NDA) in the course of 2018.
Valeant to become Bausch Health Companies
At the end of two years of profound restructuring and disinvestures, Valeant (http://www.valeant.com/) will change its name to Bausch Health Companies Inc. starting July 2018. According to the company, all entities that have separate established brands will continue to operate under the corporate umbrella using their existing names. As part of the name change, the Company will roll out a new corporate brand identity in July 2018, which will include new imagery and web site, and will trade under a new symbol, BHC.
Expansion of the licensing agreement for Daiichi Sankyo
The licensing agreement between Zymeworks and Daiichi Sankyo (https://www.daiichi-sankyo.ch/de/), started in 2016, has been expanded to allow Daiichi Sankyo to acquire licenses to Azymetric and Efect technology platforms in order to develop two additional bispecific antibody therapeutics. Zymeworks will receive an upfront technology access fee of US$18 million and may receive up to US$466.7 million in potential clinical, regulatory and commercial milestone payments.
Restructuration for Astellas
Japanese’s pharma company Astellas Pharma https://www.astellas.com/announced its “Strategic Plan 2018”, comprehensive of the restructuring of operations in Japan and of the introduction of an early retirement incentive program. The goal is to optimise the organisational capabilities of the company, according to which all operations will be restructured, including R&D and Sales & Marketing, and its group companies in Japan.