Cristiana Bernini

Bristol-Myers Squibb and Transgene have closed a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with BMS’s nivolumab and standard chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1. The phase 2 trial will evaluate objective tumor responses, and disease control in patients whose tumors express low and undetectable levels of PD-L1.

The first initiative within the broader Project Baseline has just began: the longitudinal study will collect broad phenotypic health data from approximately 10 thousands participants, who will each be followed over the course of at least four years. The project is managed under a partnership between Verily Life Sciences, an Alphabet company, Duke University School of Medicine and Stanford Medicine. Project Baseline represents an effort designed to develop a well-defined reference, or “baseline,” of health as well as a rich data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease.

The exclusive, global collaboration and license agreement for the development and commercialization of gene therapy programs for Haemophilia A has been signed between Sangamo Therapeutics and Pfizer. It will include SB-525, one of Sangamo’s four lead product candidates, which has been granted orphan drug designation by the FDA and is expected to soon enter human clinical trials. Sangamo will receive a $70 million upfront payment from Pfizer and it will be responsible for conducting the SB-525 Phase 1/2 clinical study and certain manufacturing activities. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525 and additional products, if any.

Novartis and Allergan have entered a clinical trial agreement to conduct a phase IIb study for the treatment of non-alcoholic steatohepatitis (NASH). The study will focus on a combination of a Novartis FXR agonist and Allergan’s cenicriviroc (CVC). This last one is a once-daily, oral, phase III-ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. Novartis’ farnesoid X receptor (FXR) agonists include a potent, non-bile acid FXR agonist, which recently received Fast Track designation from the FDA and is in a Phase II clinical trial.

The agreement will cover the commercial rights to  metoprolol tartrate and metoprolol succinate respectively and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) treatments in Europe. Recordati will pay AstraZeneca $300 million upon completion of the agreement. AstraZeneca will manufacture and supply the medicines under a supply agreement. The drug product is a beta-blocker indicated for the control of a range of conditions including hypertension, angina pectoris, disturbances of cardiac rhythm, maintenance treatment after myocardial infarction and functional heart disorders with palpitations.

The new joint Process Scale-Up Lab is located in Bengaluru, India, within the Stelis Biopharma R&D Facility in the Jigani industrial estate. Merck will use the new Lab to provide end-to-end solutions from process development to scale-up manufacturing for pre-clinical, clinical and commercial supply. The collaboration brings together Stelis’ end-to-end capabilities in high-yield bioprocess development from cell line to commercial manufacturing scale and Merck’s industry leading technological expertise in bioprocessing. The Lab, together with a soon-to-be-completed cGMP manufacturing facility, will house Merck’s portfolio of Mobius bioprocessing equipment and single-use manufacturing components.

Ipsen has completed the acquisition of five consumer healthcare products from Sanofi, among which there are an analgesic for the treatment of moderate to severe pain, only sold in France, an antispasmodic (sold in the Czech Republic, Estonia, Hungary, Latvia, Poland and Slovakia), a laxative (sold in the Czech Republic), as well as two expectorants for cough and flu, sold respectively in Greece and the Republic of Ireland. This operation aims to strengthen Ipsen Consumer Healthcare portfolio in France and Central Europe with the strategic intent to further develop the OTx model in most geographies.

Teva’s investigational drug candidate fremanezumab (TEV-48125), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of migraine, is administered monthly as a subcutaneous injection. The company has signed an agreement with Otsuka Pharmaceutical to develop and commercialize the product in Japan. Otsuka will pay Teva a lump-sum payment of $50 million. Milestone payments will be made upon filing and regulatory approval in Japan and then upon achievement of specified revenue targets. Future clinical trials in Japan will be carried out and funded by Otsuka.