Biopharmaceutical News Week 13-1016

Zika virus

According to a study by the Centers of Disease Control and Prevention (CDC), Zika may spread further north on the North America continent than previously thought. The Aedes aegypty species could reach as far north as San Francisco, Kansas City and New York City, the Aedes albopictus species could stretch across eastern US including New England.

The US FDA has cleared the use of Roche’s experimental diagnostic to test blood donations for the Zika virus. The diagnostic, a qualitative in vitro nucleic acid test that can detect the virus RNA in plasma specimens, will only be allowed for screening purposes.

Acquisitions /mergers/joint-ventures

The US Federal Trade Commission (FTC) asks for more information in a second request on the proposed merger conditions between Pfizer and Allergan. Both companies indicate that these requests were “fully anticipated as part of the regulatory process”. The deal’s completion remains subject to several closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, governmental and regulatory approvals in other jurisdictions, including the EU, approvals from both Pfizer and Allergan shareholders, and the pending divestiture of Allergan’s generics business, for $40.5 billion, to Teva which is now delayed from end-of-March to sometime in June.

Aclaris Therapeutics (Malvern, PA, USA) acquires Vixen Therapeutics for an undisclosed amount and boosts its portfolio of hair loss treatment with the access of Vixen’s experimental JAK inhibitor drug.

Business

Sun Pharma (Mumbai, India) acquires a portfolio of 14 prescription Novartis’ drugs marketed in Japan in a deal worth $293 million. The acquired brands have combined annualised revenues of around $160 million and address medical conditions across several therapeutic areas. Under the terms of the deal, Novartis will continue to distribute the brands until transfer of all marketing authorisations to a Sun Pharma subsidiary are completed.

Array BioPharma (Boulder, COL, USA) partners with Asahi Kasei Pharma (Tokyo, Japan) on the development and the marketing of ARR-954, a tropomyosin receptor kinase inhibitor, as a treatment of non-cancer indications such as chronic pain and inflammation within Asia. Array will retain rights for all indications outside of Asia. Financial terms were not disclosed.

Centrexion Therapeutics (Baltimore, MD, USA) expands its pain pipeline with the acquisition of three new analgesic candidate drugs from Boehringer Ingelheim for an undisclosed amount. Boehringer Ingelheim said it “is shifting its strategic focus to key CNS symptom domains with high medical need across a range of neuropsychiatric diseases, such as Alzheimer’s disease, schizophrenia and depression”.

Aduro Biotech (Berkeley, CA, USA) invests $7.5 million in University California Berkeley to investigate cyclic dinucleotides and natural killers, two new classes of immunotherapeutics for the treatment of cancers and infectious diseases.

Nestlé (Vevey, Switzerland) announced that it expands its research and innovation activities in Asia with the establishment of a Nestlé Research Centre Asia in Biopolis, the biomedical research hub of Singapore with a focus on Healthy Aging. Nestlé has identified a need to establish a footprint within Asia to study the role of nutrition and early development in health and disease in order to better address the needs of the Asian ageing population.

Approval of drugs, vaccines, diagnostics and devices.

The Japanese Ministry of Health, Labor and Welfare approves four new drugs:

GlaxoSmithKline’s Nucala or mepolizumab for the treatment of patients with refractory asthma. Nucula is a monoclonal antibody that binds to interleukin-5 (IL-5), which was approved by the US FDA in November 2015 and by the European Commission in December 2015.

AstraZeneca’s Tagrisso, or osimertinib, for the treatment of patients with epidermal growth factor (EGRF) T790M mutation non-small cell lung cancer (NSCLC) As many as 40% of Asian NSCLC patients have the EGFR mutation at diagnosis. Osimertinib is a third generation EGRF tyrosine kinase inhibitor which was approved by the US FDA in November 2015 and by the EU Commission in February 2016.

Bayer’s Kovaltri, a recombinant factor VIII, as a treatment for hemophilia A patients

and Bayer’s Xofigo, or radium-223 dichloride, as a treatment of castration-resistant prostate cancer. Kovaltri was approved in Europe and Canada in February and in the US earlier this month.

The European Medicines Agency approves Bio Products Laboratory’s (Elstree, UK) Coagadex, a coagulation factor X therapy, for the prevention and treatment of bleeding episodes and for perioperative management of patients with hereditary factor X deficiency. Coagadex is the first and only treatment licensed specifically for this rare bleeding disorder in Europe.

US FDA approves Jazz Pharmaceutcal’s (Dublin, Ireland) Defitelio, or defibrotide, an antithrombotic agent, for the treatment of hepatic veno-occlusive disease, a rare but life-threatening condition. The drug was approved in Europe in October 2013.

The Chinese Food and Drug Administration (CFDA) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules untitled Good Clinical Practices for Medical Devices which will become effective as of June 1, 2016. This ruling does not apply to in vitro diagnostic reagents that are classified as medical devices.

Drugs at clinical stage

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommends the approval of GlaxoSmithKline's Strimvelis for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) for whom no suitable human leukocyte antigen-matched related stem cell donor is available. ADA-SCID is a rare disorder caused by the lack of an enzyme called adenosine deaminase which leads to a compromised immune system. Stremvelis is a stem cell gene therapy created from the patient's own cells.

US FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-2 that the benefits of Acadia’s (San Diego, CA, USA) Nuplazid, or pimavaserin, an inverse agonist of the serotonin subtype 5-HT2A, outweigh the treatments risks for treating psychosis associated with Parkinson’s disease.

US FDA grants fast-track status to OXiGENE’s (South San Francisco, CA, USA) CA4P, or fosbretabulin, for the treatment of platinum resistant ovarian cancer. Fosbretabulin, or combrestatin-A4 phosphate, is a vascular disrupting agent which compromises the blood vessels to feed the tumors and causing massive ischemia and necrosis of the cancer cells.

US FDA grants orphan status to Actinium Pharmaceuticals’ (New York, NY, USA) Iomab-B, a radioimmunotherapeutic, as a treatment for patients with relapsed and refractory acute myeloid leukemia who will undergo hematopoietic stem cell transplants. Iomab-B consists of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope which targets CD45, a pan-leukocytic antigen widely expressed on white blood cells.

Regeneron Pharmaceuticals and Sanofi announce successful outcomes from two Phase 3 pivotal studies of dupilumab, in adults with inadequately controlled moderate-to-severe atopic dermatitis. Dupilumab is a dual human antibody which binds to interleukin-4 (IL-4) and interleukin-13 (IL-13) which had received breakthrough status by the US FDA in November 2014. A New Drug Application (NDA) should be submitted in the second part of the year.

Pfizer reports positive results with bococizumab, its PCSK9 inhibitor, in a phase 3 clinical study assessing the effects of the drug in patients with hyperlipidemia versus a standard statin therapy.

Array Biopharma (Boulder, COL, USA) announces its decision to discontinue the development of binimetinib for the treatment in ovarian cancer. Binimetinib is a protein kinase inhibitor in the RAS/RAF/MEK/ERK pathway.

Science and Technology

A team led by Graig Venter has described the synthetic creation of a “minimal bacterial genome” containing just 473 genes necessary for a living cell. In order to get down to a truly minimal genome, scientists had to take an existing genetic sequence and pare it down, cutting away all the nonessential genes until they end up with only the ones that are absolutely essential, then make a synthetic version and prove it can live.

Sanofi Pasteur and the University of Georgia (USA) announced that through the use of novel computationally optimized broadly reactive antigen (COBRA) technology, they have elicited a response against multiple seasonal and pandemic H1N1 influenza virus strains in mice. The new vaccine technology focuses on the hemagglutinin protein, found in all licensed flu vaccines. A universal flu vaccine would be a complete paradigm-shifting development, Sanofi Pasteur VP of R&D John Shiver has said "we believe that a broader-spectrum vaccine could be available first to replace the current seasonal flu vaccine given annually."

Medical Devices and Diagnosis News

A research team from North Carolina State University has developed a microneedle patch which delivers nanoparticles of a PD-1 antibody directly into the melanoma cancer cells of the skin. The microneedles consist of biocompatible hyaluronic acid which hold the nanoparticles and glucose oxidase. As the glucose oxidase reaches the blood, it converts to an acid, which then breaks down the nanoparticles, releasing the antibodies directly into the cells.

Microneedle patch designed to release nanoparticles to melanoma cells–Courtesy of NC State

Cost, Pricing and Market Access

The UK National Institute for Health and Care Excellence (NICE) has issued new guidance designed at improving the treatment of multimorbidities. “This draft guideline is designed to help health-care professionals, especially GPs and acute physicians, to make complex decisions more simple and to offer the best advice on maintaining people’s health and wellbeing,” noted Mark Baker, director of clinical practice at NICE.

Miscellaneous

GlaxoSmithKline adopts a new approach to intellectual property where it intends to improve access health challenges in developing countries. Under the new approach, whether the firm will seek IP protection will depend on a country’s economic maturity. For Least Developed Countries and Low Income Countries, GSK will not file patents for drugs, so as to give clarity to various companies seeking to manufacture and supply generic versions of GSK medicines in those countries. For Lower Middle Income Countries, GSK will file for patents but will offer and agree licences to allow supplies of generic versions of its medicines for 10 years, seeking a small royalty on sales in those countries. For High Income Countries, Upper Middle Income Countries and G20 countries, GSK will continue to seek full patent protection.

Sanofi appoints Dr. Yong-Jun Liu, a specialist in immunology, as Head of Research, Global R&D. Since 2014 Dr. Liu was leading the research organization of MedImmune. He was the founding director of the Cancer Immunology Research Institute at the University of Texas MD Anderson Cancer Center and later joined the Baylor Research Institute in Dallas where he became the director of the Baylor Institute for Immunology Research.

Merck & Co versus Gilead Sciences in hepatitis C patent litigation: Round 2. A California jury awarded Merck and Ionis a $200 million damage award. Analysts had theorized a royalty for plain stiffs of around 5%. Merck had asked 10%, and expected as much as $2.3 billion for sales through December 2015.

The Manhattan US Attorney asks Novartis to provide 80,000 records of doctor events considered as bogus educational programs at restaurants and sports bars, the prosecutor calls “shams”. “The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place,” it said in the prosecutor’s filing. In 2015, Novartis agreed to pay $390M to settle a lawsuit in which the US government claimed it paid kickbacks to pharmacies to boost sales of some of its prescription drugs.

Bioevents

BIO Europe Spring on April 4-6 in Stockholm (Sweden)

Small Midcap Event on April 11-12 in Paris (France)

BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)

BIO Vision on April 13-14 in Lyon (France)

The Health Industry Summit on April 17-20 in Shanghai (China)

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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