Biopharmaceutical News Week # 2016.26

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation,   jcm@btobioinnovation.com

Zika virus

New findings suggest that the list of possible Zika birth defects growth longer with seizures, joint problems and visions impairment and confirm that even when Zika-exposed babies are born without microcephaly, serious development delays may appear in the months following birth.

US scientists from the Walter Reed Army Institute of Research, from the Beth Israel Deaconess Medical Center and from the Harvard Medical School have completed a preclinical study of two Zika vaccine candidates that suggests that an effective human vaccine will be achievable in a rather short future.

Citizens in Florida start showing hints of the Zika threat: Mosquito season has started and anxious residents are looking for health experts to help them cope with the danger. Hillary Clinton calls the possibility of a US epidemic “deeply distressing” and recently sent two campaign advisers to Puerto Rico on a fact-finding mission.

US Senate has blocked a $1.1 billion proposal to fight the Zika virus. Democrats accused Republicans of sabotaging the legislation with provisions designed to deny new funding for Planned Parenthood Clinics in Puerto Rico and ease rules on pesticide spraying.

Just a few days after Rory McIlroy, Jason Day, the N°1-ranked golfer in the world, pulls out of the Rio 2016 Olympic Games because of concern over the Zika virus. “The reason for my decision is my concern about the possible transmission of the Zika virus and the potential risks that it may present to my wife’s future pregnancies and to future members of our family” he said in a statement.

Acquisitions /mergers/joint-ventures

Sanofi and Boehringer Ingelheim have signed their swap agreement to exchange their respective animal health and consumer healthcare businesses. Under the terms of the deal, Boehringer's CHC business, valued at €6.7 billion, will be transferred to Sanofi and Sanofi's Merial, valued at around €11.4 billion, will be transferred to Boehringer. The transaction also includes a cash payment to Sanofi of €4.7 billion, to reflect the difference in value of the two businesses.

Business

Novartis enters a strategic collaboration and a licensing deal with Xencor (Monrovia, CA, USA) to expand its immune-oncology portfolio in accessing and developing two bispecific antibodies in a deal worth up to $2.4 billion. . Bispecific antibodies are engineered to recognize and target two different antigens: a T-cell-engaging bispecific antibody is designed to bind an antigen on a tumor cell with one arm and engage T cells capable of their destruction with the other.  Under the terms of the deal Novartis gets global rights to XmAb1404, for the treatment of acute myeloid leukemia, and XmAb13676, for the treatment of B-cell malignancies, global rights to Xencor's bispecific technology to develop and commercialise four additional targets and a non-exclusive license to use Xencor's XmAb Fc technologies in up to ten molecules. Novartis will pay a $150 million upfront and contingent milestone payments as well as royalties for sales for the various developed products using Xencor’s XmAb FC technology

LEO Pharma (Ballerup, Denmak) enters biologics through a strategic partnership with AstraZeneca in licensing global rights to tralokinumab and European rights for bradalumab for various skin diseases. Tralokinumab is interleukin-13 (IL-13) monoclonal antibody that has completed a Phase 2 trial for the treatment of patients with atopic dermatitis. Brodalumab is an interleukin- 17 (IL-17) receptor monoclonal antibody under regulatory review for moderate-to-severe plaque psoriasis and in development for psoriatic arthritis. Under the terms of the deal, LEO will make an upfront payment of $115M for the exclusive, global rights to tralokinumab for skin diseases and up to $1B in commercially-related milestones and royalties on product sales.

Merck & Co enters a collaboration with Moderna Therapeutics (Cambridge, MA, USA) to develop and market novel messenger RNA-based personalized cancer vaccines and pays $200 million to support all R&D efforts through proof of concepts. The program will focus on various types of cancer and include combination therapies with Merck’s Keytruda or pembrolizumab.

Approval of drugs, vaccines, diagnostics and devices.

The European Commission approves AstraZeneca’s combination antibiotic Zavicefta for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation. Zavicefta is a fixed combination of avibactam, a new beta-lactamase inhibitor, and ceftazidime, a third generation cephalosporin antibiotic already approved in Europe. The approval includes intravenous use of Zavicefta for the treatment patients suffering from complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired pneumonia and the treatment of aerobic Gram-negative infections. Zavicefta is being jointly developed by AstraZeneca and Allergan.

US FDA approves Gilead Sciences’ combination drug Epclusa, or sosfosbuvir and velpatasvir for the treatment of all six forms of hepatitis C virus infection and eliminating the need for genotyping testing. Epclusa is a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (approved as Sovaldi) and the pan-genotypic NS5A inhibitor velpatasvir. Epclusa is the first and only all-oral, pan-genotypic, single tablet regimen cleared for the treatment of adults with genotype 1-6 chronic HCV. Gilead indicated that the drug will be priced, in the US, at $74,760 for a 12-week regimen.

Drugs at clinical stage

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of six new treatments: MolMed's Zalmoxis, a cell-based therapy , as an add-on treatment to support hematopoietic stem cell transplantation; Teva Pharmaceutical Industries' Cinqaero, or reslizumab, an interleukin-5 antibody, as an adjunctive therapy for severe eosinophilic asthma; Teva's Aerivio Spiromax and Airexar Spiromax, both indicated to treat asthma and chronic obstructive pulmonary disorder; Mylan's generic atazanavir to treat HIV-1 infections and Nordic Group's Nordimet, or methotrexate, designed to manage three types of arthritis.

US FDA grants breakthrough status to:

Ultragenyx Pharmaceutical’s (Novato, CA, USA) KRN23 for the treatment of X-linked hypophosphatemia in pediatric patients.

Bristol-Myers Squibb’s Opdivo or nivolumab, for the treatment of unresectable locally advanced or metastatic urothelial carcinoma. Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year; urothelial carcinoma is the most common bladder cancer type, accounting for around 90 percent of cases. Opdivo is already marketed to treat patients with melanoma, non-small cell lung cancer, renal cell carcinoma and classical Hodgkin lymphoma.

Janssen and AbbVie’s Imbruvica, or ibrutinib, a Bruton’s tyrosine kinase inhibitor, as treatment of chronic graft-versus-host disease (cGVHD) in previously treated patients with corticosteroid. Last week the US FDA had granted breakthrough status to Incyte’s (Wilmington, Del, USA) Jakafi, or ruxolitinib, for the treatment of acute graft-versus-host disease.

US FDA grants fast-track status to Cascadian Therapeutics’ (Seattle, WA, USA) ONT-380, an oral selective small-molecule inhibitor of HER2 to treat advanced HER2-positive breast cancer. ONT-380 is currently being evaluated in combination with capecitabine and Roche's Herceptin or trastuzumab, in HER2 positive metastatic breast cancer patients

US FDA grants priority review to Roche/Genentech's Ocrevus (ocrelizumab), a new experimental multiple sclerosis therapy. Ocrevus is a humanised monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage, leading to disability in people with MS.

US FDA Endocrinology and Metabolic Drugs Advisory Committee supports the approval of Eli Lilly and Boehringer Ingelheim’s Jardiance, or empagliflozin, an establsihed antidiabetic drug, to include that the drug reduces the risk of cardiovascular death.

Miscellaneous

Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) following “serious breaches” of its Code of Practice. Astellas is accused of breaking Clause 2 of the Code, after its conduct in organising an advisory board meeting in 2014, in Milan, where it presented the benefits of its medicine enzalutamide in an unlicensed indication. The complainant alleged that the firm was not truthful as to why delegates had been invited to the meeting, and that the company promoted something it should not have done.

Sanofi Pasteur doubles is vaccine Stamaril production facility in Val de Rueil (France) in order to alleviate a potential shortage of the vaccine in the wake of recent yellow fever outbreaks in Angola, Democratic Republic of Congo and Uganda.

Pfizer will invests $350 million to build a biotech center in Hangzou (China) to produce biologics and biosimilars and “help support China's aim to increase the complexity and value of its manufacturing sector by 2025".

Bioevents

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.