Biopharmaceutical News Week 3- 2016



Greetings from Singapore



Acquisitions /mergers/joint-ventures:


Acorda Therapeutics acquires Biotie Therapies (Finland) for $362 million and gets global rights to tozadenant, an oral adenosine A2a receptor antagonist that is in late-stage clinical development for Parkinson's disease.


BioMerieux (Lyon France) spins off bioTheranostics (San Diego, CA, USA), a cancer diagnostic company, for $32 million in a private equity financing from MVM Life Science Partners, Canepa Advanced Healthcare Fund and HealthQuest Capital. bioMérieux, will remain a minority shareholder,




Merck receives $5 million from GAVI, in an advance purchase commitment to help the Ebola vaccine to move through late-stage trials and to submit the vaccine for regulatory approval by the end of 2017.


Roche will pay up to a $618 million in milestone payments to Catalent under its research collaboration centered around the SMARTag platform for the creation of antibody-drug candidates.


Takeda enters a collaboration with enGene (Montreal, Canada) to develop gastrointestinal gene therapies using enGene’s DNA and RNAi mucosal delivery. Financial terms were not disclosed.


At the World Economic Forum in Davos (Switzerland) more than 80 drug and diagnostic companies have committed to a common set of principles to fight the antimicrobial resistance crisis. The Declaration also asks that governments help develop new and alternative market structures providing more dependable and sustainable models for antibiotics. The Declaration will be updated every two years.



Approval of drugs, vaccines, diagnostics and devices:


European Commission approves Samsung Bioepis' Benepali, the first biosimilar version of Amgen's arthritis drug Enbrel, or etanercept. Biogen will market the drug in all European Union member states as well as in Norway, Iceland and Liechtenstein.


US FDA approves Novartis’ Cosentryx, the first IL-17 inhibitor approved in the US, for the treatment of ankylosing spondylitis and psoriatic arthritis, two life-long, painful and debilitating inflammatory diseases affecting the joints and/or the spine.


US FDA approves Amgen’s Kyprolis in tandem with dexamethasone or with dexamethasone plus Revlimid to treat patients with relapsed or refractory multiple myeloma. The drug was acquired for nearly $10 billion from Onyx Pharmaceuticals back in 2013.


The Japanese Ministry of Health, Labour and Welfare approves Amgen's Repatha (evolocumab), as the first PCSK9 inhibitor in Japan, for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have a high risk of cardiovascular events.


Drugs at clinical stage:


US FDA grants priority review status for Eisai’s supplemental new drug application for the use of lenvatinib in combination with erolimus for the treatment of renal cell carcinoma patients.


US FDA grants orphan status to Nivalis Therapeutic’s N91115 for the treatment of cystic fibrosis.


US FDA grants breakthrough therapy status to AbbVie’s venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein in combination with Roche’s rituximab as a treatment for patients with relapsed/refractory chronic lymphocytic leukaemia.


Medical Devices and Diagnosis News:


Johnson & Johnson’s restructures its medical device business which sales are lagging behind its fast-growing biopharmaceutical business and the company wishes to get back on track with an approximately 3,000 job cuts in an effort to save up to $1 billion in 2018. The cuts comprise up to 6% of its medical device segment, and will apply to J&J's orthopedics, surgery and cardiovascular businesses but not the other medical device units, vision care and diabetes care businesses.


Cost, Pricing and Market Access:


The UK National Institute for Health and Care Excellence (NICE) has recommended Bristol-Myers Squibb’s Opdivo (nivolumab) as a monotherapy for adult patients with advanced (unresectable or metastatic) melanoma, after the Institute concluded that the most plausible incremental cost-effectiveness ratio for the drug was likely to be less than £30,000 per QALY gained. Opdivo became the first medicine to be cleared for the UK’s Early Access to Medicines Scheme in March last year, and the first PD-L1 checkpoint inhibitor approved in Europe last June





After the death of one volunteer in a phase 1 trial with Bia 10-2474, a fatty acid amide hydrolase (FAAH) inhibitors, from Bial Laboratories (Portugal) last week in Rennes (France), this class of drugs will be looked very closely by all regulatory bodies although it is too early to say if the death is due to a class safety effect or an error in the clinical protocol. 




  • BIO CEO Investor Conference on February 8-9 in New York City (USA)
  • BIO Asia 2016 on March 15-16 in Tokyo (Japan)
  • 9th European Life Science CEO Forum and Exhibition on March 15-16 in Zürich (Switzerland)
  • Global Healthcare Forum on March 16-17 in Singapore (Singapore)
  • BIOPharma Asia Convention on March 22-24 in Singapore (Singapore)
  • BIO Europe Spring on April 4-6 in Stockholm (Sweden)
  • BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
  • BIO Vision on April 13-14 in Lyon (France)
  • BIO Trinity on April 25-27 in London (UK)
  • BIOEquity Europe 2016 on May 10-11 in Copenhagen (Denmark)
  • Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
  • China BIO Partnering on May 18-19 in Suzhou (China)
  • BIO International Convention on June 6-9 in San Francisco (USA)


  • BIO Pharm America on September 13-15 in Boston (USA)
  • 7th Innovation Days on October 3-4 in Paris (France)
  • Biofit 2016 on November 30-December 1 in Lille (France)


IMPORTANT NOTICE: This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.


Author: Jean-Claude Muller, Special Advisor at I&IR,


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