Biopharmaceutical News Week 33
Roche acquires GeneWEAVE Biosciences (USA), a privately held diagnostic company, and extends its footprint in the antibiotic field. Under the terms of the agreement, Roche will pay $190 million upfront and up to $235 million in contingent product related milestones. The acquisition provides Roche with GeneWEAVE’s Smarticles technology, an innovative class of molecular diagnostics that quickly identifies multidrug-resistant organisms and assesses antibiotic susceptibility directly from clinical samples. The Swiss company who used to be a major player in the field of antibiotics is making a strong come back with five major deals signed over the last two years.
Mallinckrodt Pharmaceuticals (UK) acquires Therakos (USA), a developer of devices for immunotherapy, in a deal worth $1.33 billion. The deal gives Mallinckrodt access to Therakos’ cell therapy platform approved for the treatment of the skin manifestations of cutaneous T-cell lymphoma. The CELLEX Photopheresis System is already installed in 350 academic medical centres and hospitals in 25 countries around the globe.
MedImmune inks a deal with Inovio Pharmaceuticals (USA), the third one for AstraZeneca within a few days, aimed at bolstering its immune-oncology portfolio. The agreement includes clinical-stage INO-3112, a HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates. Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as development and commercial milestones totaling up to $700 million.
Sanofi extends again its collaboration with Evotec (Germany) and simultaneously enters into a strategic collaboration with Apeiron Biologics (Austria), a company with a focus on immunological approaches, to develop small molecule cancer immunotherapy treatments. Under the terms of the deal Evotec and Apeiron will receive up to €200 million in various milestones and royalties on commercial sales.
Synairgen (UK), a drug company focused on severe respiratory diseases, partners with Pharmaxis (Australia) to develop a lysyl oxidase type 2 enzyme (LOXL2) inhibitor as a treatment for idiopathic pulmonary fibrosis.
Boehringer Ingelheim and Circuit Therapeutics (USA) expand their current collaboration to the cardiometabolic field with the aim to discover potential new obesity treatments. Both companies will use Circuit’s optogenetics technology platform to explore the role central and peripheral nervous circuits play in the coordination of food intake. Details on the deal structure and terms were not revealed.
Roche discontinues its partnership with Heidelberg Pharma, a Wilex subsidiary, which was focusing on the development of antibody-targeted amanitin conjugates based on Roche-Genentech antibodies. The decision stemmed from Swiss drug giant to prioritize its efforts on cancer immunotherapies.
Drugs at clinical stage
Clovis Oncology and Roche’s Genentech have established a collaboration to investigate the value of the combination of some of their cancer therapies. Under the agreement both companies will assess the clinical benefit of the combination of Genentech's investigational PDL1 inhibitor atezolizumab (MPDL3280A) and Clovis’ rociletinib, a tyrosine kinase inhibitor, in advanced EGFR-mutant non-small cell lung cancer.
Roche announces that its Pharma Research & Early Development unit has developed a smart-phone application and a monitoring system to measure Parkinson’s disease and the severity of the symptoms. The application will enable continuous measurement of Parkinson’s disease fluctuation throughout the day over several days.
Medical Devices and Diagnosis News
Google collaborates with Dexcom (USA) to develop miniaturized glucose monitors combining its electronics platform with Dexcom’s sensor technology.
Last month US FDA has approved Praluent, co-developed by Sanofi and Regeneron, as the first PCSK9 inhibitor for the treatment of high level of cholesterol. Amgen expects its own PCSK9 drug, Repatha, already approved in Europe, to be approved in the US by the end of this month. CVS Health, the number two pharmacy benefit manager, says it will wait until both drugs are approved before adding either one to its list of covered drugs. In a letter published in the Journal of American Medical Association, CVS urges cardiovascular experts to revamp guidelines for treating patients with high cholesterol and provide clarity on how to best choose the most effective treatment. The issue is also on pricing. Generic statins, which have proven effective and safe, are priced at ~$50 per month when PCSK9 inhibitors will cost ~$1200 per month before discounts.
Amarin wins an injunction against US FDA, in a First Amendment free speech victory for a drugmaker. The federal court said the FDA cannot bar Amarin from discussing off-label use for its fish-oil Vascepa for a wider group of patients than it is approved for. It is not clear how big this victory will impact the off-label use by drugmakers. Off-label use of drugs is permitted and often happens, but the FDA gets really concerned when education becomes pure marketing and risks get downplayed in the process. Several federal litigations resulting in multibillion-dollar settlements have pointed to biopharmaceutical companies using these kinds of tactics.
GlaxoSmithKline was forced to temporarily close its Zebulon manufacturing site (North Carolina) after the company detected the bacteria for Legionnaire’s disease in one of its cooling tower. The site produces several major GSK brands including its multi-billion inhaled respiratory drug Advair and Elipta inhaler products. According to The New York Times an outbreak of Legionnaire’s diseases has occurred in the South Bronx (New York City) and has infected 113 people since early July, 12 of whom died.
Daiichi Sankyo completes a new building for some $80 million at its Kitasato Daiichi Sankyo Vaccine’s production site in Saitama Prefecture in order to manufacture new vaccines.
- 3rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
- Pharma Competitive Intelligence Conference on September 10-11 in Parsippany (USA)
- BioPharm America 2015 on September 15-17 in Boston (USA)
- Innovation Days on October 5-6 in Paris (France)
- BIO Japan on October 13-16 in Yokohama (Japan)
- BIO Latin America on October 14-16 in Rio de Janeiro (Brazil).
- 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
- BIO Europe 2015 on November 2-4 in Munich (Germany)
- Biofit 2015 on December 1-2 in Strasbourg (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, email@example.com
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