Cristiana Bernini

Shire and the Foundation Fighting Blindness have announced a new agreement focused on furthering research for a novel treatment for autosomal dominant retinitis pigmentosa (adRP), a rare genetic disease that usually first occurs in late childhood or adolescence and is followed by the progressive loss of peripheral vision. There are no currently approved treatment options for adRP.

The Foundation Fighting Blindness and its research partners will provide Shire with expert knowledge and scientific background, as well as pertinent clinical information that could be useful in the development of a drug to treat adRP. Backed by its scientific advisory board, the Foundation Fighting Blindness will also provide counsel as requested on the pre-clinical and/or clinical development of Shire compounds in development for the treatment of adRP.

Lexicon Pharmaceuticals and Bristol-Myers Squibb have selected a development candidate for neuropathic pain as part of their neuroscience drug discovery and development alliance. Lexicon and Bristol-Myers Squibb are proceeding with plans to progress the development candidate through IND-enabling studies in preparation for the commencement of clinical trials. Bristol-Myers Squibb has the first option under the alliance to obtain exclusive clinical development and commercialization rights upon the initiation of Phase 1 clinical studies, subject to the payment of milestone.

Germany-based Merck and Pfizer announced the finalization of a co-promotion agreement allowing the companies to jointly co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor crizotinib, the first ALK inhibitor approved in the United States, Japan and the European Union (EU).

The agreement reinforces the alliance’s commitment to establishing a combined oncology sales organization in key markets. In 2015, Merck will receive a reimbursement associated with its promotion of crizotinib, followed by an 80 percent (Pfizer), 20 percent (Merck) profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the United States, Canada, Japan, France, Germany, Italy, Spain and the United Kingdom and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of the drug in countries where it is co-promoted with Merck.

Bayer HealthCare has expanded its collaboration with the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University to include cardiovascular genomics and drug discovery. The goal of this new part of the alliance is to leverage insights from human genetics to help create new cardiovascular therapies. Governance for this alliance will be comprised of a joint steering committee and joint research committee that will oversee research progress and direction. Financial terms of the agreement were not disclosed.

Cardiovascular genomics is an emerging field of cardiology that uses genomic information to characterize disease risk and identify new therapeutic targets for drug discovery.

Arvinas has announced a multi-year strategic collaboration with Merck Sharp & Dohme encompassing multiple disease targets across several therapeutic areas. Arvina’s novel proteolysis-targeting chimeras (PROTAC) technology, bifunctional small molecules that target proteins for degradation and removal from a cell

Arvinas will receive an up-front payment and funding to support Merck-related research. Additionally, Arvinas could earn up to $434 million if all research, development, regulatory and commercial milestone payments are successfully paid for products against all the targets initially selected by Merck, as well as tiered royalties. Merck may, at its discretion, elect to expand the collaboration to include additional disease targets.

Acting on behalf of the Wisequity III closed-end fund, Italy-based Wise SGR has finalised the acquisition of the entire share capital of NTC, an Italian pharmaceuticals company operating in the generic pharmaceuticals, medications and nutraceuticals sectors. The company exports more than 85% of its output to around 55 different countries. This operation forms part of a plan to create an Italian pharmaceuticals group with a strong focus on exports that was set in motion in January 2015 with the acquisition of PH&T. Both companies have interesting “stand alone” development plans that will be accelerated by pooling the international distribution and product development platforms that the companies have developed over the years.

US-based Formula Pharmaceuticals announced the acquisition of worldwide exclusive rights to an allogeneic, non-viral chimeric antigen receptor (CAR) technology platform which leverages cytokine-induced killer (C.I.K.) cells as immune effector cells. The platform has been developed at the Research Center Fondazione M. Tettamanti, a University of Milano-Bicocca affiliate.

“Formula’s C.I.K. CAR represents a proprietary, next-generation technology platform that is significantly differentiated from existing CAR-T approaches” said President and CEO, Maurits W. Geerlings. “In addition, Formula’s technology platform leverages non-viral transfection, which could make scale-up manufacturing significantly more practical and cost-effective as compared to viral transfection methods”.

Baxter International has announced the signature of the definitive agreement to acquire the pegaspargase product portfolio from Sigma-Tau Finanziaria. By mid-year, Baxter expects to establish the BioScience business as a separate, publicly traded, innovation-oriented biopharmaceutical company, Baxalta Incorporated.

The acquisition further accelerates the innovation capabilities and the commercial presence of Baxter BioScience in growing oncology markets for rare and orphan diseases. The company gains the leading marketed biologic treatment pegaspargase, the investigational biologic calaspargase pegol, and an established oncology infrastructure with clinical and sales resources.

Pegaspargase is a first-line biologic used as part of a multi-agent chemotherapy regimen to treat acute lymphoblastic leukemia (ALL). It is currently marketed in the United States, Germany, Poland and certain other countries and has approximately USD $100 million in annual sales.

Bristol-Myers Squibb has announced the completion of the planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries.

A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.

Sweden-based Medivir and UK’s Cancer Research Technology (CRT) have announced a partnership to conduct a two-year research programme to optimize and develop small molecules targeting the cell surface protein ADAM8, which has been linked to tumour survival, cell invasion and metastasis. Under the terms of the agreement, Medivir receives an exclusive, global license to research, develop, manufacture and commercialize ADAM8 inhibitor drugs resulting from development. CRT receives an upfront payment and future success milestones as well as royalties on sales which are shared with the academic collaborators.

The research will be led by Professor Jörg Bartsch as head of the TransMIT-Project Division for Research in Neuro-Oncology at TransMIT GmbH, Marburg University, in collaboration with Medivir. Prof. Bartsch previously worked at King’s College London where the initial patent application was filed. Further proof of concept studies were funded by Cancer Research UK at King’s College.