Zika virus

French scientists have confirmed that the Zika virus can trigger Guillain-Barré syndrome, a rare disorder in which the body’s immune system attacks the nervous system and triggers paralysis. The study, co-authored by Arnaud Fontanet from the Institut Pasteur in Paris and published in the Lancet Medical Journal, is based on patients’ outcomes from a 2013-2014 Zika outbreak in French Polynesia.

American scientists have demonstrated a direct link between Zika virus infection and newborn microcephaly. The study, published in Cell Stem Cell and co-authored by Hengli Tang from the Department of Biological Science, Florida State University, used human induced pluripotent stem cells and showed that Zika virus infects human cortical neural progenitors and attenuates their growth.

French authorities have released new figures on the spreading of the Zika virus in the French West Indies: 9,240 cases in Martinique, 1,405 cases in Guyane, 474 cases in Guadeloupe with a slow but steady increase everywhere. Two patients have developed a Guillain-Barré syndrome.

The US FDA has approved the first Zika diagnostic under an emergency pathway.

Sanofi Pasteur announces that is committing 80 experts to Zika reseach and the “imminent start of preclinical studies on a potential Zika virus vaccine in order to launch a clinical trial next year” program head Nicholas Jackson told Reuters.

Novavax (Gaithersburg, MD, USA) is a new entrant in the vaccine companies and research organizations that are exploring Zika virus vaccines. The World Health Organization indicated that about 15 companies and organizations are participating in Zika vaccine R&D.

Acquisitions /mergers/joint-ventures

Centauri Therapeutics (Kent, UK) and Horizon Discovery (Cambridge, UK) form a joint-venture named Avvinity Therapeutics that will step into the immuno-oncology field, a market expected to reach $70 billion in 2020.Avvinity will combine Horizon’s gene editing, immunology, oncology and research capabilities with Centauri’s Alphamer technology, to create a proprietary platform for discovering novel immuno-oncology therapies. Alphamer technology is based on chemically synthesized molecules that redirect naturally occurring antibodies in the human immune system to selected pathogens or cancerous tissues.

Yuhan Corporation (Seoul, South Korea) partners with Sorrento Therapeutics (San Diego, CA, USA) to form a 51:49 joint-venture named ImmuneOncia Therapeutics aimed at developing oncology-focused immune checkpoint antibodies. The JV will be headed by Yuhan’s current Chief Scientific Officer Su Youn Nam. Under the terms of the deal Yuhan will invest $10 million and Sorrento Therapeutics will bring an unspecified immune checkpoint inhibitor, that excludes the US, Europe and Japan, as well as global rights to two additional antibodies that will be selected by ImmuneOncia from the current Sorrento portfolio.

Predictive Technology Group (Salt Lake City, UT, USA) acquires privately-held ReNovo Biotech (Salt Lake City, UT, USA), a cellular and regenerative medicine company, developing allograft stem cells and tissues to treat serious and debilitating conditions for undisclosed terms.

…. and at the same time ReNovo Biotech announces a partnership with Nexus CMF (Salt Lake City) to distribute Renovo’s allograft tissue products to craniomaxillofacial surgeons  in the US.

Business

AstraZeneca divests non-core business and products:

To China Medical System Holdings (Shenzhen, China) which acquires two heart drugs in two separate deals worth $500 million. The first one will give China Medical exclusive rights in China on Plendil, or felodipine, a calcium channel blocker, and AstraZeneca will a receive a license fee of $310 million. The second one will give China Medical and associate company Tibet Rodiola Pharmaceutical Holding (Lassa, China), global rights to Indur, or isosorbide mononitrate, a potent vasodilator, outside of the US and AstraZeneca will receive up to $190 million.

….To ProStrakan (a Kyowa Hakko Kirin unit based in Galashiels, Scotland, UK) which acquires European rights of Moventig, or naloxegol, to treat opoid-induced constipation (OIC). Moventig is a once-daily, oral peripherally-acting µ-opioid receptor antagonist approved for the treatment of OIC in adult patients who have had an inadequate response to laxatives. The drug is already launched in the UK, Ireland, Germany, the Nordic countries, Austria and Switzerland. Under the terms of the deal AstraZeneca will receive a $70 million upfront payment and additional payments contingent on market access decisions in other European markets, as well as sales milestones and double-digit royalties on sales.

Ipsen (Boulogne-Billancourt, France) secures exclusive commercialization rights for current and future indications, out of the USA, Canada and Japan, to Exelixis’ (South San Francisco, CA, USA) oncology drug cabozantinib in a deal worth up to $855 million. In 2014, cabozantinib, a tyrosine kinase c-Met and VEGFR2 inhibitor, had missed its primary endpoint in a large prostate cancer study but has since been approved in Europe as a treatment of severe medullary thyroid cancer, a rare disease. Both companies expect that the drug can be approved in larger indications such as kidney and liver cancers. Under the terms of the deal Ipsen will make a $200 million upfront payment and $110 million contingent on European approval for advanced renal cell carcinoma and advanced hepatocellular carcinoma indications, as well as up to $545 million in commercial milestone fees plus sales royalties.

Merck KGaA enters a three-year research collaboration with European Molecular Biology Department (EMBL), to investigate mechanisms by which cancer cells generate energy and growth enabling pathways, in order to discover new therapies that target metabolic pathways in cancer as well as novel biomarkers. Financial terms were not disclosed.

…and teams up with Pfizer and Verastem (Needham, MA, USA) to assess the efficacy and tolerance of the combination of avelumab and VS-6063 in advanced ovarian cancer patients. Avelumab, is a fully human anti-PD-L1 IgG1 monoclonal antibody, co-developed by Merck KGaA and Pfizer, for the treatment of a range of cancers. VS-6063 inhibits an enzyme called focal adhesion kinase which plays a key role in the development and survival of cancer stem cells.

Merck & Co partners with NanoString Technologies (Seattle, WA, USA) to design and commercialize diagnostic tests for Merck’s Keytruda, its PD-1 inhibitor. Under the terms of the deal NanoString could get up to $24 million in technology access and short-term milestones, as well as development funding and regulatory milestones.

PeptiMimesis (Strasbourg, France), a new company exploiting peptide technology to discover and develop drugs for immune-oncology disorders has been launched by three scientists from the University of Strasbourg and the French Institute of Health and Medical Research (Inserm).

Approval of drugs, vaccines, diagnostics and devices

US FDA approves:

Genentech’s Gaziva or obinituzumab, as a treatment for follicular lymphoma patients who are refractory to rituximab or patients which relapsed after treatment. Obinituzumab is indicated along with bendsmustine followed by monotherapy and is already approved by the US FDA for use in combination with chlorambucil as a first-line treatment for patients with chronic lymphocytic leukemia.

Gilead’s Odefsey for the treatment of certain patients with HIV-1 infection. Odfesey is a combination therapy of emtricitabine/rilpivirine/tenofovir alafenamide or TAF and is the second Gilead’s TAF-based regimen to receive US FDA approval.

….and a new indication for AstraZeneca’s Faslodex or fulvestrant– an estrogen receptor antagonist-, in combination with Pfizer’s Ibrance or palbociclib – a selective inhibitor of cyclin-dependent kinases CDK4 and CDK6-, for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Faslodex was first approved by US FDA in 2002 as monotherapy for the treatment of postmenopausal women with HR+ MBC.

US FDA extends Novartis’ Afinitor or everolimus, an mTOR inhibitor, for endocrine tumors that originate in the lungs or in the gastrointestinal system. Everolimus was previously approved for pancreatic neuroendocrine tumors, advanced breast and kidney malignancies, and nonmalignant tumors of the kidney and brain.

China FDA Commissioner Bi Jingquan follows President Xi Jingping’s directives for the "most stringent standards" for food, drug and device safety along with the "most severe punishment" for fraud. He said that CFDA will "crackdown on all kinds of food and drug safety crimes."  He also indicated that clearing a backlog of thousands of pending drug applications remains a work-in-progress, with a case load which peaked at 32,000 applications at a time, without specifying the time period or current backlog status. Figures published late last month showed the CFDA approved 241 drugs in 2015, 470 drugs in 2014 and 374 in 2013. The breakdown for 2015 showed 24 biologic drugs approved of the 241 and 76 in traditional Chinese medicine.

Drugs at clinical stage

US FDA grants breakthrough status to Trevena’s (King of Prussia, PA, USA) oliceridine, the first μ receptor G protein pathway selective modulator, a biased μ opioid receptor ligand, as a treatment of moderate to severe acute pain.

US FDA grants fast-track status to Aurinia Pharmaceuticals’ (Victoria, BC, Canada) voclosporin as a treatment for lupus nephritis and kidney inflammation caused by autoimmune disorder systemic lupus erythematosus (SLE). Voclosporin has similar effectiveness with other calcineurin inhibitors, such as cyclosporine and tacrolimus, with less serious deleterious side effects.

The European Medicines Agency (EMA) grants orphan status to True North Therapeutics (South San Francisco, CA, USA) TNT009 for the treatment of autoimmune hemolytic anemia including cold agglutinin disease (CAD). CAD is a form of autoimmune hemolytic anemia in which antibodies mistakenly attack red blood cells, causing anemia, fatigue and sometimes fatal thrombosis. TNT009 is an antibody which blocks the classical complement pathway by targeting serine protease within the C1-complex.

Novo Nordisk announces that Victoza, its GLP-1 agonist drug, significantly reduced the combined incidence of heart attack, stroke and cardiovascular death in high-risk Type 2 diabetes patients. Full results of the LEADER trial, tracking more than 9,000 patients, over a period of up to five years, will be unveiled in June at the American Diabetes Association meeting in New Orleans.

GlaxoSmithKline’s Benlysta, a human monoclonal antibody belonging to the BLyS-specific inhibitor class, which has been approved in Europe as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), has shown low rates of organ damage progression in patients with moderate-to-severe SLE taking the drug for five years.

AstraZeneca’s tremelimumab, an orphan drug tagged drug, failed to achieve the primary endpoint of a statistically valid improvement in overall survival as a treatment for the second- or third-line treatment of unresectable malignant mesothelioma.Tremelimumab is a selective human antibody that binds to cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), acting as "releasing the brakes" on T cell activation and boosting the immune system's ability to kill cancer cells.

VMP 001, a vaccine developed by US Army’s Walter Reed Army Institute of research and formulated with GlaxoSmithKline’s AS01B adjuvant failed to protect volunteers against Plasmodium vivax the world most prevalent malaria parasite.GlaxoSmithKline's Mosquirix, the world's first approved malaria vaccine, protects against the Plasmodium falciparum parasite, which causes the most malaria deaths worldwide but is not the most prevalent species.

Medical Devices and Diagnosis News

The UK National Institute for Health Research (NIHR) links with Novartis to study which asthma patients would most benefit from Xolair, or omalizumab. Xolair is already approved for people who do not respond to taking steroid treatment with long-acting reliever medication. The study, being run by the NIHR Translational Research Partnership, aims at identifying which biomarkers are changed by the treatment, and thus make it possible to quickly identify those patients most likely to benefit of the drug.

Cost, Pricing and Market Access

The National Institute for Health and Care Excellence (NICE) has published preliminary guidelines rejecting Janssen’s Imbruvica, or ibrutinib, as a treatment of chronic lymphocytic leukemia (CLL) because of doubts whether the drug is a cost-effective use of NHS resources for this indication. The cost of a year’s course of Imbruvica treatment is £55,954.50 (excluding VAT), but the company has agreed a patients access scheme with the Department of Health which provides discounts. Janssen said it is “extremely disappointed” with NICE’s position which, it argues, is “in stark contrast to the recommendations of 48 countries globally which have opted to fund or reimburse the medicine including 27 European countries”. 

US Democratic Presidential candidate Hillary Clinton has turned on pharma again with a new ad, dubbed "Predatory," that features a Valeant Pharmaceuticals price hike. The TV commercial includes footage from a Jan. 28 town hall meeting, where a woman in the audience complained of an enormous increase in the cost of her migraine treatment. When she began taking the shots in the early 1980s, they ran $18 each; now, she said, they cost $1,473.

Miscellaneous

Olympus Corporation of the Americas has agreed to pay a record $623 million to resolve civil and criminal allegations that it paid kickbacks to US hospitals and doctors in exchange for purchasing its endoscopes.

French regulators have raised serious concerns about heparin made by Dongying Tiandong Pharmaceutical (Dongying City, China) and called the European Medicines Agency to revoke its GMP certificate.  French inspectors who visited Donging’s facility in December observed ten deviations from GMP standards and indicated that the firm had used seven batches out of specification to make heparin sodium and enoxaparin sodium Active Principle Ingredients (APIs). The firm has passed an US FDA inspection in 2013 and was cleared at the time.      

Bayer is spending $2.7 billion in manufacturing capacity expansion. Outgoing CEO Marijn Dekkers explained "we are continuing to build up new production capacity for our products." That includes $2.7 billion in fixed assets, and another $437 million in tangible assets. Some of that is going to expansions in Bayer's crop sciences operations, but a significant amount is also directed at pharma projects including building out a $213 million plant in Majinpu in the Yunan province of China. Bayer is also investing $115 million to expand another plant in Beijing. Also on the list, is a $100 million investment to upgrade its Berkeley (California) facility that is focused on developing new treatments for hemophilia  and a $700 million project for new hemophilia-focused manufacturing operations in Germany.

Bioevents

• 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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