Zika virus

The European Medicines Agency sets up a task force offering advice on scientific and regulatory matters for the research and development of medicines or vaccines against the Zika virus. The Agency has put together a group of experts with specialized knowledge in vaccines, infectious diseases and other relevant expertise to contribute to the global response to the threat of ZKV infection.

President Barack Obama is asking US Congress for more than $1.8 billion in emergency funding to fight the Zika virus.  The new request comes as the Centers for Disease Control and Prevention announced that its emergency operations center has been put on a “Level 1” status, its highest level of activation. The spending proposal includes $355 million in foreign aid to South America, Central America, the Caribbean, where the Zika virus is spreading most rapidly.

A group of 30 funders, research institutions and scientific journals have pledged the sharing of free research data sharing in a push to develop vaccines and treatments against the Zika virus. Signatories of the agreement include the US Centers for Disease Control and Prevention, the Bill & Melinda Gates Foundation, The World Health Organization, the Institut Pasteur, the UK academy of Medical Sciences, the Welcome Trust as well as the New England Journal of Medicine, Nature, Science and The Lancet.

On the fourth-quarter earnings press conference, Sanofi’s CEO Olivier Brandicourt said “in a year from now we should be ready to start a clinical trial with a Zika vaccine”.

Acquisitions /mergers/joint-ventures

Mylan (Hertfordshire, UK and Pittsburgh, PA, USA) acquires Meda AB (Stockholm, Sweden) in a cash and stock deal valued at around $7.2 billion (9.9 billion including debts). The offer values Meda at a 92% premium. The acquisition provides Mylan an entry into a number of new emerging markets, such China, Southeast Asia, Russia, the Middle East and Mexico.  The deal follows Mylan’s unsuccessful attempt to acquire rival Perrigo in a hostile takeover last year.

Hikma Pharmaceuticals (London, UK) has lowered its offer to acquire Boehringer’s US generic unit Roxane Laboratories (Columbus, OH, USA) by some $535 million after due diligence revealed lower expected revenue performance and forecasts. The revised offer is now worth around $2.1 billion.

Cofactor Genomics (Saint Louis, MS, USA) acquires Narus Biotechnologies (San Francisco, CA, USA) a company developing biomarkers associated with neurological diseases for use in RNA-based diagnostics for an undisclosed amount. Cofactor Genomics offers a whole suite of RNA and DNA sequencing capabilities including using RNA to diagnose disease.

Business

Sandoz, the generic division of Novartis, enters an agreement with MedinCell (Jacou, near Montpellier, France) to develop controlled-released drugs with a focus on cancer drugs. Sandoz intends to use MedinCell‘s BEPO platform, which is a semi-solid polymer designed to release drugs at a controlled rate, mainly for its line of subcutaneous drugs.

…. and acquires rights to Pfizer’s PF-06438179, a biosimilar of MSD’s Remicade (infliximab) in the 28 countries that form the European Economic Area (EEA). "Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis" said Richard Francis, Global Head of Sandoz. Pfizer had to stick to its commitments to the European Commission in connection with its acquisition of Hospira to divest the programme, but it retains rights to the biosimilar in all countries outside of the EEA.

GlaxoSmithKline and VBI Vaccines enter into a research collaboration to evaluate VBI’s proprietary liquid particle vaccine (LPV) formulation. LPV uses a mixture of synthetic lipids to encapsulate vaccines and biologics to stabilize and protect them from damaging temperature fluctuations. Sanofi Pasteur is already testing the LPV technology with some of its own vaccines. Financial terms were not disclosed.

…and enters a research and development agreement with Valneva to produce flu vaccine based on Valneva’s EB66^® cell line, derived from duck embryonic stem cells,. Under the terms of the deal GSK will pay undisclosed research and milestone payments and royalties on future sales.

RedHill Biopharma (Tel Aviv, Israël) partners with Fraunhofer Institute for Cell Therapy and Immunology or IZI (Leipzig, Germany) to evaluate RedHill’s RP101, a first-in-class, orally-administered, heat shock protein 27 (Hsp27) inhibitor intended to prevent the induction of resistance to chemotherapy and maintaining sensitivity of the tumour to chemotherapy and potentially enhancing patient survival.

UCB and Baylor College of Medicine (Houston, TX, USA) have entered a strategic research collaboration to discover new therapeutics for neurodegenerative diseases. Financial terms were not disclosed.

Sanofi Genzyme enters into a strategic collaboration, worth $845 million, with Voyager Therapeutics (Cambridge, MA, USA) to develop and commercialize novel adeno-associated virus (AAV) gene therapies for patients with severe CNS disorders. Genzyme will make an upfront commitment of $100 million to Voyager, including $65 million in cash, a $30 million equity investment in Voyager, future potential development and sales milestone payments of up to $745 million, as well as tiered royalties on product sales.  “Through our combined efforts, Voyager and Genzyme are at the forefront of converting the promise of gene therapy into innovative therapies for CNS disorders that make a meaningful difference in patients’ lives,” said Steven Paul, M.D., President & CEO of Voyager.

Bavarian Nordic (Copenhagen, Denmark) enters into a collaboration with Evaxion Biotech (Copenhagen, Denmark) and the Technical University of Denmark to develop an MVA-BN-bases vaccine against methicillin-resistant Staphylococcus aureus. Financial terms were not disclosed.

AstraZeneca, through its MedImmune Biological unit, Eli Lilly are joining with University of Michigan to form a Renal Pre-Competitive Consortium project aimed at identifying new therapeutic targets for the treatment of chronic kidney disease.

Approval of drugs, vaccines, diagnostics and devices

US FDA expands Bristol-Myers Squibb Daklinza or daclatasvir hepatitis C label. The drug, along with Sovaldi (sofosbuvir)  with or without ribavirin, can now be used in chronic hepatitis C patients with genotypes 1 and 3, patients who also have HIV or advanced cirrhosis and those with post-transplant recurrence.

…and issues a complete response letter refusing the extension of Vertex’s Kalydeco or ivaclafor to market the therapy for cystic fibrosis patients carrying one of 23 residual function mutations, concluding that it “cannot approve the application in its current form”. Kalydeco is already cleared for use in cystic fibrosis patients aged two and older who have one of 10 mutations in the CFTR gene.

Drugs at clinical stage

US FDA grants breakthrough therapy status to Adaptimmune Therapeutics’ (Philadelphia, PA, USA and Oxford, UK,) affinity enhanced T-cell therapy for use in pretreated inoperable or metastatic synovial sarcoma patients with NY-ESO-1 antigen-expressing tumors who carry certain types of HLA-A alleles. According to the American Cancer Society, synovial sarcoma is more common in children and young adults than elderly patients, and is most frequently located in the hip, knee, ankle, and shoulder. NY-ESO-1 is one of the best-characterized and most immunogenic cancer antigens and is highly expressed in the majority of synovial sarcomas (see newsletter 5-2016).

US FDA grants orphan status

• to Atara Biotherapeutics’ EBV-CTL, a T lymphocyte product investigational drug as a treatment of Epstein-Barr virus associated post-ransplant lymphoproliferative disorders amongst patients receiving hematopoietic cell or solid organ transplant.
• to Epizyme’s (Orlando, FL, USA) tazemetostat, an inhibitor of EZH2 gene expression, as a treatment for highly aggressive rhabdoid tumors and other genetically defined solid tumors.
• And to Amarantus Bioscience’s (San Francisco, CA, USA) eltoprazine, a 5HT1a/1b receptor agonist and 5HT2c receptor antagonist, as a treatment for levodopa-induced dyskinesia associated with Parkinson’s disease treatment. The drug is also developed for the treatment of attention-deficit/hyperactivity disorders in adults.

US FDA grants fast-track status to Conatus Pharmaceutical’s (San Diego, CA, USA) emricasan, a potent irreversible pan-caspase inhibitor, as a treatment of patients with nonalcoholic steatohepatitis-associate (NASH) liver cirrhosis. Conatus plans to focus first on patients with NASH cirrhosis and will develop the drug in parallel for patients with NASH fibrosis.

Chinese FDA grants fast track review or “green pass” to AstraZeneca and Fibrogen’s (San Francisco, CA, USA) roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, as a treatment of chronic kidney associated anemia. The drug is now being considered as a local product after AstraZeneca reformulated roxadustat using materials sourced in China.

Chugai’s Alecensa or alectinib was stopped after early successful primary endpoint was met in a Phase III clinical trial assessing the drug versus Pfizer’s crizotinib in patients with anaplastic lymphoma kinase positive non-small cell lung cancer (NSCLC). The drug was approved in the US in December 2015 for NSCLC 2015, and in Japan in July 2014.

Alkermes (Dublin, Ireland) has started a second Phase III trial with ALKS 3831 its investigational antipsychotic drug and evaluate its effect on weight against Eli Lilly’s Zyprex or olanzapine.ALKS 3831 is a novel, oral atypical antipsychotic drug candidate consisting of the combination of ALKS 33, a potent opioid modulator acting as an agonist or antagonist at multiple receptor sites and of olanzapine.

Incyte terminates its Phase III trial assessing Jakafi or ruxolitinb, a first-in-class JAK1/JAK2 inhibitor- in combination with capecitabin, as a treatment for advanced or metastatic cancer after an interim analysis failed to show efficacy. Based on these data and the interim analysis of another phase II study, in patients with metastatic colorectal cancer, the company will stop all Jakafi studies in solid tumors, including trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.Ruxolitinib is already approved by the US FDA for treatment of people with polycythemia vera. 

Science and Technology

Aurélien Bancaud, a CNRS researcher based in Toulouse (France) received the instrumentation award from the French Chemical Society for its µLAS invention related to a fast DNA sequencing technology. The technology does not need any matrix or gel preparation and runs on a microfluidic chip. According to Aurélien Bancaud, the technique is a 100 to a 1,000 more sensitive than a gel matrix and provides sequencing results in minutes rather than in hours.

Medical Devices and Diagnosis News

The Sensimed Triggerfish system, a smart contact lens already approved in Europe but not in the US, was used by Columbia University Medical Center (New York City, USA) researchers to monitor and track the progression of glaucoma. The data collected through the contact lens and sent to a portable device indicated that pressure peaks in the evening and that more peaks indicate a faster rate of disease progression.

Novartis teams up with Microsoft to develop an intelligent camera system called Assess MS. The system, using Microsoft's Kinect motion camera and machine-learning software to track multiple sclerosis (MS) patients' movements. MS is often difficult to monitor because some individuals' symptoms progress quickly, while others' symptoms appear and disappear over time.

Cost, Pricing and Market Access

After a revised appraisal, The National Institute for Health and Care Excellence (NICE) is now backing Amgen’s Repatha (evolucumab), a PCSK9 inhibitor, alone or in combination with other lipid-lowering therapies, as an option in various scenarios, but only at a dosage of 140mg every two weeks and as long as the company continues to offer discount agreed in the patient access scheme.

And rejects Sanofi’s own PCSK9 inhibitor Praluent (alirocumab), largely because of a lack of comparison data. NICE considers the drug was as clinically effective in reducing LDL-c levels when compared with reference drugs in people with hypercholesterolaemia. The Institute is nevertheless concerned that Praluent “had not been compared with the combination therapy of ezetimibe plus a statin, in the large population of people with non-familial hypercholesterolaemia”.

Novartis agrees to “performance and value-based” pricing deals with US key insurers Cigna and Aetna for its heart drug Entresto (a combination of sacubitril and valsartan). The drug will be prices at $12.50 per day. Under the terms of the agreements Cigna's payments to Novartis will depend on results linked to the rate of hospitalization among patients on the Entreso treatment. Aetna said the deal is based on the drug delivering real-world results similar to those seen in clinical trials. This pricing approach precisely corresponds to what we have described in a recent article in the November 2015 issue of MedNous (www.mednous.com) namely that “value-based” pricing, where drugs are priced on the basis on measurable outcomes, will progressively become the norm.

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, jcm@btobioinnovation.com

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