Zika virus

Inovio Pharmaceuticals (Plymouth Meeting, PA, USA) announced positive preclinical results for its Zika virus vaccine DNA construct. The synthetically candidate, generated with the company's SynCon vaccine technology, targeting multiple Zika virus antigens and administered using its CELLECTRA electroporation delivery technology, induced robust and durable immune responses. The company begins clinical manufacturing and expects to test its vaccine in humans in 2016.

World Health Organisation (WHO) said that Bharat Biotech (Hyderabad, India) and US National Institutes of Health (NIH) are farthest along in the development of a Zika virus vaccine. The NIH has been able to use past research on the West Nile and dengue viruses to create a hybrid Zika vaccine that should be ready for early stage trials this summer and broad trials at the beginning of next year. Bharat Biotech, already started working on a Zika vaccine in 2014; it now plans animal trials in the coming weeks, according to the Business Standard.

The US Centers for Disease Control and Prevention (CDC) confirmed that there have been two cases of Guillain-Barré Syndrome (GBS) in the US in people who also tested positive for Zika virus. “I think we can say that the link between Zika and Guillain-Barré looks strong and would not be at all surprising,” says Dr. Tom Frieden, director of the CDC. GBS is a rapid-onset (half a day to two weeks) muscle weakness as a result of damage to the peripheral nervous system. 

More than 15 companies have been in touch with the WHO about developing Zika virus vaccines, and about 20 are working on diagnostic tools.

Acquisitions /mergers/joint-ventures

Stryker (Kalamazoo, MI, USA) a former Medtronic unit, announced the acquisition of Physio-Control International (Redmond, WA, USA), from Bain Capital Private Equity for $1.28 billion. The acquisition will give Stryker a foothold in the automated external defibrillator and Cardio-Pulmonary Resuscitation (CPR)-assist device arenas and will add about $500 million in annual revenue. Physio-Control accessories and disposables include batteries, cables, sensors, cabinets and training tools associated with its AEDs, CPR devices and patient monitors.

IBM (Armonk, NY, USA) acquires Truven Health Analytics (Ann Arbor, MI, USA) in order to boost the healthcare capabilities of its Watson Health business cognitive computing system in adding 8,500 new clients which include hospitals, clinicians, health plans, employers, life science companies as well as state and federal government agencies. Watson uses machine-learning and natural-language skills to analyze and find trends in data from a wide variety of sources.

Merck & Co terminates its joint venture on generic drugs development, outside of India, with Sun Pharmaceutical Industries (Mumbai, India). Other agreements between the firms involving Merck’s diabetes drug Januvia (sitagliptin) and investigational psoriasis therapy tildrakizumab remain unaffected by the decision.

Business

Merck & Co acquires exclusive rights to market Daiichi Sankyo’s Lixiana, or edoxaban, in 13 European countries. Edoxaban is an oral, once-a day, factor Xa inhibitor which acts as an anti-coagulant. Financial terms were not disclosed

Synergy Pharmaceuticals (New York City, NY, USA) and BIND Therapeutics (Cambridge, MA, USA) enter a research deal to develop new gastrointestinal tumor drugs by engineering BIND’s Accurins to include uroguanylin analogs. Financial terms were not disclosed.

Eisai (Tokyo, Japan) enters a R&D collaboration with Charles River at Eisai’s research and development facilities in Hatfield (UK). The collaboration will involve Charles River supporting Eisai scientists from Japan, USA and the UK on medicinal chemistry projects, including treatments for neurological diseases and a project of new drugs to treat malaria effective against resistant strains.

…and with Sysmex (Kobe, Japan) to develop next-generation diagnostics for dementia.

Bristol-Myers Squibb enters into a collaboration with Dana-Farber to develop immuno-oncology products for rare cancers with poor prognoses. The agreement comes under the Bristol-Myers' multi-institutional Immuno-Oncology Rare Population Malignancy program (I-O RPM).

Effimune (Nantes, France) enters into a one-year collaboration with In-Cell-Art (Nantes, France) to develop cancer immunotherapy antibodies using in-Cell-Art’ Nanotaxi technology. The companies will compare the efficacy of that approach to traditional production of antibodies. Financial details of the deal were not disclosed.

Approval of drugs, vaccines, diagnostics and devices

The European Commission approves:

AstraZeneca’s Zurampic or lesinurad, in combination with a xanthine oxidase inhibitor, for the adjunctive treatment of hyperuricemia in adult gout patients. Lesinurad inhibits the function of transporter proteins involved in uric acid resorption in the kidneys. The drug was approved by the US FDA in December 2015.

And a new 60 mg dose of AstraZeneca’s Brilique or ticagrelor, for the once-daily treatment of patients who have experienced a heart attack at least one year prior and are at high risk of another atherothrombotic event.  Ticagrelor is an oral anti-platelet drug that works by inhibiting platelet activation acting as a P2Y12 receptor inhibitor.

US FDA expands:

Gilead Sciences’ Harvoni, a combination of ledipasvir and sofosbuvir, for the use in patients with HCV and advanced cirrhosis including the ones who had a liver transplant.

Pfizer’s Ibrance or palbociclib for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER-2) advanced metastatic breast cancer, in combination with fulvestrant, in women with disease progression following endocrine therapy. The drug had been approved for the first time in February 2015.

But rejects Merck & Co’ s request to extend the use of Zetia and Vytori, for the reduction of cardiovascular events, including non-fatal stroke and heart attacks, in patients with coronary disease. Details of the Complete Response Letter were not disclosed.

According to Francesco De Rubertis, a partner at Medicxi Ventures (London, Jersey and Geneva), one third of US FDA approved drugs were discovered in European university laboratories.

Drugs at clinical stage

US FDA grants breakthrough status

• to AstraZeneca’s durvalumab, an investigational PDl-1 immunotherapy, for the treatment of urothelial bladder cancer.
• to Roche’s ocrelizumab as a treatment for progressive multiple sclerosis.
•  to Novartis’s PKC412 or midostaurin, an investigational kinase inhibitor, for the treatment of newly-diagnosed acute myeloid leukemia (AML) who are positive for the FLT3 gene mutation.

US FDA grants Biota Pharmaceuticals (Atlanta, Geo, USA) fast-track status for its antiviral BTA585, as a treatment for patients with syncytial virus infections. BTA585 is an oral RSV fusion inhibitor that fights RSV infection by interfering with the fusion of the viral envelope to the cell membrane of the host cell.

US FDA grants orphan status to ONL Therapeutics (Ann Arbor, MI, USA) ONL 1204 for the treatment of patients with retinal detachment. ONL 1204 protects retinal cells from death resulting from disease or conditions.

US FDA Arthritis Advisory Committee voted a 21-3 in favour of recommending Celtrion CT-P13 biosimilar of Johnson & Johnson’s Remicad. CT-P13 will be the first monoclonal antibody biosimilar to be approved in the US and will be marketed by Pfizer in the US.

In 2015 US FDA received 472 requests for orphan drug designations and granted 354, an increase of 22% over 2014. In terms of approval the US FDA endorsed 41 orphan medicines, seven fewer than in 2014.

Science and Technology

Researchers at the Massachusetts Institute of Technology are considering using a modified malaria parasite for use as a tool for drug delivery to take advantage of the parasite ability to survive in the blood stream. The engineered parasites would carry gene sequences that code for the production of certain molecules.

Huge Hype on T-Cell cancer therapies. The media widely reported recent results from scientists after a small clinical trial showed that engineered T-cells induced complete remission in 94% of terminally ill patients with acute lymphoblastic leukaemia. The potentially “unprecedented medicine”, is a form of immunotherapy that involves extracting a patient's own T-cells, engineering them to fight cancer, and then re-introducing them into the body. Experts have now cautioned that the hype surrounding T-cell cancer therapies could be too optimistic and overlooks costs and safety concerns surrounding the treatment.  “The cost of T-cell therapy is currently estimated at $300,000 per patient” said Cai Xuan, GlobalData’s Analyst. “The aggressive nature of T-cell therapy’s side effects means it is highly unlikely to replace current frontline therapy options. On top of this, the lack of long-term follow-up data presents the danger of additional long-term toxicities being revealed in the future” said Cai.

Short shelf-life of cell therapy poses manufacturing and logistics problems. Holoclar, a therapy based on autologous stems cells for restoring eyesight, which was approved last year by the European Medicines Agency, “has a shelf-life of 36 hours which means we had to take the decision to either have the patients from all over Europe come to our clinical centers, or to have the product shipped within 36 hours to all members states” said Chiesi’s Diego Ardigo. Chiesi chose the latter.

Medical Devices and Diagnosis News

New saliva tests for identifying cancer and Parkinson’s disease are soon to be trialed in patients.

Prof. David Wong, of the School of Dentistry at the University of California-Los Angeles (UCLA) and colleagues have been working on a method called "liquid biopsy" that detects circulating tumor DNA in bodily fluids such as saliva and blood. The device uses electric field-induced release and measurement (EFIRM) to detect non-small cell lung cancer (NSCLC) biomarkers in saliva. The EFIRM device analyzes the contents of exosomes – tiny bags of molecules that cells release. The device forces the exosomes to release their full contents and carries out bio-recognition of the released biomolecules at the same time. The study is a collaboration between UCLA and West China Hospital of Sichuan University. The test takes only 10 minutes to give a result and could be done in the doctor's office.

The announcement followed another report by Researchers from the Mayo Clinic in Phoenix, AZ, and Banner Sun Health Research Institute in Sun City, AZ, about the development of a salivary gland test for early Parkinson’s disease. The team found an abnormal protein in 9 out of 12 patients with Parkinson’s disease in a first study and 14 out of 19 patients in a second study.

Miscellaneous

The Hollywood Presbyterian Medical Center (HPMD) in Los Angeles has paid hackers roughly $17,000 (40 bitcoins) after a ransomware attack left the hospital networks disabled for several days "The quickest and most efficient way to restore our systems and administrative functions was to pay the ransom and obtain the decryption key," HPMD’s CEO Allen Stefanek said in a statement.

Ipsen (Boulogne, France) modifies its Corporate Governance and announces a management change. Marc de Garidel, former Chairman of the Board and CEO, steps aside and sees his role limited to nonexecutive Chairman, while Deputy CEO Christel Bories leaves the company following “disagreements with the board of directors over the strategy”. Ipsen is now in search of an external person to occupy the CEO position.

Bioevents

• BIOCOM Global Life Science Partnering Conference on February 24-25 in Torrey Pines (USA)
• BIO Asia 2016 on March 15-16 in Tokyo (Japan)
• 9^th 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)
• Annual China Healthcare Investment Conference on March 29-31 in Shanghai (China)
• 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)
• 7^th 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, 穆卓Special Advisor at I&IR and Executive Editor at BtoBioInnovation, jcm@btobioinnovation.com

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