Biopharmaceutical News Week 4- 2016


Aedes aegypti mosquito

Zika Virus (Aedes aegypti mosquito)


The Zika virus, which has been linked to brain damage in thousands of babies, in now more than 20 countries in Latin America and mainly in Brazil, is “spreading explosively” World Health Organization chief Margaret Chan said while calling for an emergency meeting, on February 1, to determine if the outbreak qualifies as an international public health emergency. "The level of alarm is extremely high” she said. During previous outbreaks the virus, which was first discovered in a monkey in Uganda in 1947, "occasionally caused a mild disease of low concern. The situation today is dramatically different. A causal relationship between Zika virus infection and birth malformations and neurological syndromes has not yet been established, but is strongly suspected," Chan said. The Zika virus, transmitted by the Aedes aegypti mosquito, which is also known to carry the dengue, yellow fever and Chikungunya viruses, may infect 3-4 million people in the Americas, including 1.5 million in Brazil, according to World Health Organization expert Marcos Espinal (see Newsweek #2015.52). 

French Health Minister, Mrs. Marisol Touraine, strongly recommends pregnant women to postpone their eventual trip to the French Indies (Martinique and Guadeloupe) and French Guyane where Zika virus infected cases have been identified earlier this week.

A first case of an infected Danish tourist traveling back from South America has also been identified in Europe this week.

GlaxoSmithKline and Sanofi are evaluating the possibility of using their current vaccine technology for developing a vaccine for Zika rather quickly. “We can be fairly confident that we can make a good vaccine for Zika quickly,” said, Scott Weaver, the head of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in Galveston, because scientists have learned how to attenuate, or weaken, similar viruses for the purposes of inclusion in a safe vaccine. It will nevertheless take a long time before a vaccine will be ready and by no means before the start of the Olympics Games hosted in Rio de Janeiro in August (winter months with dryer and cooler climate) when Brazil will see the arrival of thousands of athletes and hundreds of thousands of spectators from all over the world. For the time being officials are not considering postponing or cancelling the Olympics.


Acquisitions /mergers/joint-ventures


The list of companies bidding for the acquisition of Toshiba Medical systems is steadily growing.  According to Reuters, Konica Minolta is making a joint bid with investment firm Permira, so is Sony with Carlyle, an equity firm, while Mitsui is allying with KKR. Other potential bidders such as Fujifilm and Canon may also declare interest before the deadline of January 29th. Toshiba Medical Systems consists of imaging devices for CT scans, MRIs, ultrasounds and X-rays. It leads the Japanese market with a 30% share, and is fourth worldwide, with a global market share of 10%. The sale of the medical device unit which is expected at around $3 billion will help Toshiba to recover from a recent accounting scandal forecasted to induce a $4.6 billion annual loss.


Adicet Bio (Menlo Park, CA, USA) acquires Applied Immune Technologies (Haifa, Israel), a biotechnology company which specializes in the development of T-cell receptor-like antibodies for an undisclosed amount.





AstraZeneca and Allergan enter a global agreement to develop and commercialize ATM-AV1, an investigational fixed-dosed combination antibiotic, aztreonam and avibactam, for the treatment of serious infections caused by metallo-beta-lactamase (MBL)-producing Gram-negative bacteria, a resistant Enterobacteriaceae for which there are limited treatment options. Under the terms of the agreement, Allergan owns commercialization rights in the US and Canada and AstraZeneca owns commercialization rights elsewhere.


Merck & Co enters and agreement with UK Cancer Research Technology (CRT) to develop new treatments targeting blood disorders and cancer. The deal focuses on a new class of drugs that inhibit protein arginine methyltransferase 5 (PRMT5), developed by the Australian Cooperative Research Centre for Cancer Therapeutics (CTx).The PRMT5 protein plays a role in many cellular processes, including the epigenetic control of genes such as p53 – which protects the cell against cancer-causing mutations. PRMT5 inhibitors also switch on important genes in the development of blood, which could provide disease-modifying treatment options for patients with blood disorders like sickle cell disease and beta thalassaemia. Under the terms of the deal, negotiated by CRT on behalf of CTx, Merck will make an upfront payment of $15 million and potential milestone payments of up to $500 million, as well as royalties on any sales.


AstraZeneca, GlaxoSmithKline and Johnson & Johnson are joining forces with Imperial College London, University College London and the University of Cambridge to create Apollo Therapeutics Fund, a new £40 million fund supporting early drug research. Each company will contribute £10 million to the fund over six years, as well as R&D expertise and additional resources to assist with the development and the commercialization of future projects, while the technology transfer offices of each university  will add £3.3 million each. For successful projects, the originating university and tech office will receive a percentage of future commercial revenues or out-licensing fees and the remainder will be divided amongst all the Apollo partners.


The French government is planning to triple the size of the “Fonds d’Accélération Biotech Santé" its biotech investment fund. Officials now intend to set aside €340 million for the fund when at the time of the announcement the Government had spoken of €100 million to invest in local biotechs. “It is a very good initiative," France Biotech President Pierre-Olivier Goineau told La Tribune. Goineau is among those concerned that without more local VC money, French biotech companies will target US cash sooner. It is still unclear when the fund will start operating.



Approval of drugs, vaccines, diagnostics and devices


US FDA approves:

Eisai’s Halaven as a treatment of liposarcoma, a rare type of soft tissue sarcoma that occurs in fat cells. Clinical trials showed that the median overall survival for patients with liposarcoma receiving Halaven (eribulin mesylate) was 15.6 months compared to 8.4 months for those who received dacarbazine. Harlaven, a halichondrin antineoplastic agent, is derived from the marine sponge Halichondria okadai, was approved for breast cancer in the US in 2010 and in the EU in 2011.

….and Merck & Co’s Zepatier (elbasvir/grazopevir) single pill, fixed-combination hepatitis C drug for patients with genotype 1 and 4 infections. Zepatier carries a warning alerting patients and healthcare providers that elevations of liver enzymes to greater than five times the upper limit of normal were observed and that liver-related blood tests should be performed prior to starting therapy and at certain times during treatment.


European Commission expands:

Eli Lilly’s Cyramza (ramucirumab), as a combination treatment with docetaxel for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC), with disease progression after platinum-based chemotherapy and for patients with metastatic colorectal cancer, can be administered alongside the FOLFIRI regimen (irinotecan, folinic acid and 5 floururacil) if there is disease progression on or after treatment with Roche’s Avastin (bevacizumab), oxaliplatin and a flouropyrimidine. Cyramza was approved in Europe as a treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma in December 2014.

….and Bristol-Myers Squibb’s Daklinza (daclatasvir) for the treatment of chronic hepatitis C in three new patient populations.  The drug’s expanded label includes use of the drug in combination with sofosbuvir (Gilead’s Sovaldi, with or without ribavirin) in hepatitis C (HCV) patients with decompensated cirrhosis, HIV-1 co-infection, and post-liver transplant recurrence. Daklinza is already approved in Europe for use in combination with other therapies for the treatment of chronic HCV infection in adults, and the Daklinza/sofosbuvir regimen is the only approved 12-week, all-oral treatment for HCV patients without cirrhosis. 


The Ministry of Health of the Russian Federation approves Biocad’s (Saint Petersburg, Russia) HERtiCAD, a biosimilar version of Roche’s trastuzumab, which will be priced 10% cheaper than Herceptin.



Drugs at clinical stage


US FDA grants breakthrough status:

to AstraZeneca’s Lynparza, as a monotherapy treatment for certain forms of prostate cancer. Lynparza’s (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.  The drug is being developed for BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).  Lynparza is already approved as a maintenance treatment of women with BRCA-mutated ovarian cancer.  

…and to AbbVie’s venetoclax as a treatment for acute myeloid leukemia (AML). Venetoclax, an inhibitor of the B-cell lymphoma-2 protein being developed by AbbVie in partnership with Genentech and Roche has as a single agent for chronic lymphocytic leukaemia in previously treated patients with the 17p deletion genetic mutation, as well as in combination with rituximab for the same patient subset.


US FDA grants orphan status to Immunocore’s (Oxford, UK) IMCgp100 an immune-mobilizing drug for the use in patients with uveal melanoma. Immunocore's ImmTACs (Immune mobilising mTCR Against Cancer), are a new class of drug with ultra-high affinity for intracellular cancer targets, which enable the immune system to recognise and kill cancerous or bacterially/virally infected cells. 


US FDA has accepted Merck & Co’s biologics license application for its human monoclonal antibody bezlotoxumab as a preventive treatment against recurrent Clostridium difficile infection. A final decision from the agency is expected by July 23.


Akashi Therapeutics (Cambridge, MA, USA) suspends enrollment in its clinical trial with investigational fast-track and orphan drug tagged HT-100 in patients with Duchenne muscular dystrophy (DMD) after one patient developed life-threatening health issues while receiving a high dose of 60 μg/kg/day. HT-100 (a delayed-release of halofuginone) is an orally available small molecule designed to reduce fibrosis and inflammation and promote healthy muscle fiber regeneration in patients with DMD. Earlier this month, the company has announced a $100M global agreement with Germany's Grünenthal to develop HT-100 for DMD.



Science and Technology


St. Jude Children's Research Hospital scientists have identified a molecular property of the hemagglutinin protein that contributed to the emergence of the 2009 H1N1 pandemic influenza virus. Hemagglutinin is carried on the surface of the flu virus. The virus needs the protein for binding to and infecting host cells. The researchers showed that hemagglutinin became more stable in an acidic environment as the H1N1 virus shifted from swine to humans. The adaptation increased the protein's stability in the acidic conditions of the human respiratory tract and lowered the pH at which hemagglutinin was activated. Activation triggers an irreversible change in the protein's molecular shape that fuses the virus and target cell.

Research led by Dr Mario Weick of the School of Psychology at the University of Kent has for the first time linked the activation of the brain's two hemispheres with lateral shifts in people's walking trajectories. People experiencing anxiety and inhibition have more activity in the right side of the brain, causing them to walk in a leftward trajectory.



Medical Devices and Diagnosis News


A new MRI imaging technique could reduce the need for amputation in patients with critical limb ischemia, according to a new study. The technique uses a new way of mapping blood delivered to the leg muscle immediately after operations on people with severely reduced blood flow to their limbs. Currently surgeons may need to wait days or weeks to see how successful the surgery has been.


Two studies, one from The Cancer Research UK and one from KU Leuven in Belgium, relating to ovarian cancer have yielded information about the genetic background to the disease, as well as evidence that improving a test linked to ultrasound diagnosis can produce a better classification of ovarian tumors.



Cost, Pricing and Market Access


Novo Nordisk finally launches its new diabetes treatment Tresiba in the US approved by the FDA in September. The Danish company which has high expectations for the drug will face strong competition from Sanofi’s Lantus and newly launched Toujeo, plus as of December, from Lilly and Boehringer Ingelheim’s Basaglar, a Lantus biosimilar. Payers’ contracts will be key in the market share battle of these new drugs.


UK National Institute for Health and Care Excellence (NICE):

has issued final guidelines recommending seven biological disease modifying drugs for severe rheumatoid arthritis which has not responded to conventional therapy such as methotrexate. The guidance recommends: AbbVie’s Humira (adalimumab); Pfizer’s Enbrel (etanercept); Merck Sharp & Dohme’s (MSD) Remicade (infliximab) and biosimilars by Hospira UK (Inflectra) and Napp Pharmaceuticals (Remsima); UCB Pharma’s Cimzia (certolizumab);  MSD’s Simponi (golimumab); Roche’s RoActemra (tocilizumab); and Bristol-Myers Squibb’s Orencia (abatacept), each in combination with methotrexate.  Humira, Enbrel, Cimzia or RoActemra are also recommended as monotherapy for people who cannot take methotrexate.

…and approves the routine use of Boehringer Ingelheim’s Ofev (nintedanib, a pan kinase inhibitor) as a treatment for patients with lung-scarring disease pulmonary fibrosis but only if it is provided with the discount agreed in the patient access scheme.

The Massachusetts Attorney General, Maurey Healy, is warning Gilead that it will take legal action if the company doesn’t cut the price of Sovaldi and Harvoni. According to the Boston Globe she wrote to Gilead’s CEO John Martin saying that Sovaldi's list price of $84,000 and Harvoni's $94,500 "may constitute unfair trade practice" that violates state law. John Martin, who has led Gilead Sciences through two decades and more recently through intense controversy over its pricing policies of hepatitis C cures, is stepping up and out of the CEO role. President John Milligan has been named CEO as Martin moves up to the executive chairman of the board.





The Euro Health Consumer Index (EHCI) 2015 reports its ninth study made by Health Consumer Powerhouse Ltd. (HCP) on healthcare systems in 35 European countries. Since 2006 this comparison of key values in healthcare, taking the patient and consumer point of view, has improved the understanding of European healthcare, empowered patients and helped addressing weaknesses. EHCI, and a wide range of disease-specific studies produced by HCP set standards for what could and should be achieved by modern, well-serving healthcare. The report authored by Professor Arne Björnberg, Ph.D states:

European healthcare – a success story?

In the European public healthcare industry nurturing a self-image of continuous budget-cuts, recruitment problems and patient dissatisfaction it is easy to forget that the last ten years – according to the repeated Euro Health Consumer Indexes – can be described as a major success. The EHCI 2006 had France as the champion with 768 points out of 1000. In the EHCI 2015, the Czech Republic at that level of achievement is 13th among 35 countries. Top performance ten years ago has today become European average! This has happened in spite of financial tensions, integration challenges and political turmoil in many countries. For once, reality stands out somewhat better than fiction. Treatment results have been improving in essentially all European countries over the nine years.

In the 2015 ranking, The Netherland stays the European Champion with 916 points as the only country reaching above the 900 points level of the maximum 1000.  Seven countries Switzerland, Norway, Finland, Belgium, Luxemburg, Germany and Iceland, are scoring above 800 points and are followed at some little distance by four counties: Denmark, Sweden, France and Austria “not quite making the 800 mark”. The first CEE country, the Czech Republic, is closing in 14 points behind Austria but 24 points ahead of the UK which is now ranking 14th.


The full report is available on


Novartis announces major changes to its operating structure in moving most of Alcon’s prescription eye drug business into its pharma division and appoints former Hospira CEO Michael Ball to run the new Alcon eye division.  Some mature drugs worth around $1 billion in sales will be transferred from pharma to Sandoz, Novartis’ generic unit.





  • 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)
  • Bio€quity Europe 2016 on May 10-11 in Copenhagen (Denmark)
  • Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
  • China BIO Partnering Forum 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)
  • BIO Europe on November 7-9 in Cologne (Germany)
  • BIO Latam on November 29-30 in San Juan (Puerto Rico)
  • 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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