Biopharmaceutical News Week # 2016.43

Biopharmaceutical News Week # 2016.43

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, jcm9144@gmail.com

Zika Virus

Sanofi enters into a collaboration with Brazil’s Fiocruz public health center in order to speed up the development of its Zika vaccine.

Heat Biologics (Durham, NC, USA) has entered into an agreement with the University of Miami to develop vaccines for several infectious diseases including the Zika virus, in using Heat's gp96 vaccine platform, to induce an immune response in the placenta to protect the fetus from Zika infection.

Mergers, Acquisitions and Joint Ventures

Evotec (Hamburg, Germany) acquires Cyprotex (Macclesfield, UK) to extend its preclinical capabilities in particular its ADME-Tox services (absorption, distribution, metabolism, excretion and toxicity) and strengthens is leadership in drug discovery. Under the terms of the deal Evotec would pay $62 million in cash.

Allergan has exercised its option to acquire Motus Therapeutics (Boston, MA, USA), formerly Rhythm Health, and boosts its gastrointestinal disease portfolio just after the announcement of robust topline Phase 2 results assessing remalorin, or RM-131, a ghrelin antagonist aimed at treating gastroparesis. Under the terms of the deal Allegan will make a $200 million upfront payment and undisclosed contingent milestone tied to the sales of relamorelin.

Business

GlaxoSmithKline partners with Fimbrion Therapeutics (St Louis, MO, USA) to develop new drugs aimed at treating and preventing urinary tract infections (UTI). The joint project will see Fimbrion and the Discovery Partnerships with Academia (DPAc) team at GSK focus on the development of mannosides, a class of mannose-containing small molecule compounds, and explore whether this new class of drugs may be able to treat and prevent UTIs without inducing antibiotic resistance. The deal is the first between a start-up biotech and GSK's DPAc, which was established to bring together researchers at the GSK’s facility "to establish truly integrated partnerships”.

Approval of drugs and vaccines

European authorities approve Martindale Pharma’s (Wooburn Green, UK) clobazam for the treatment of epilepsy. Clobazam is used principally as an adjunctive therapy for epilepsy with an oral formulation particularly suitable for children and young adults

US FDA approves:

Merck’s immunotherapy Keytruda (pembrolizumab) as the only anti-PD-1 therapy to be cleared in the first-line setting of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

Merck’s Zinplava, or bezlotoxumab to reduce the recurence of Clostridium difficile (CDI) in patients who are already receiving antibacterial drug treatment and are at high risk for recurrence. The drug is not an antibacterial and is not indicated to actually treat the infection, but is designed to neutralise C. difficile toxin B, which can damage the gut wall and cause inflammation, leading to diarrhoea.

US FDA rejects

Sanofi/Regeneron’s Sarilumab. In its Q3 2016 report Sanofi announces that “Manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility, which conducts fill and finish activities. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies. Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab on its PDUFA date of October 30, 2016”. Citing the above mentioned manufacturing issues US FDA has issued a complete response letter ahead of the PDUFA date, to Regeneron and Sanofi rejecting the approval of Sarilumab.

Drugs at clinical stage

The European Medicines Agency's Committee grants orphan status to La Jolla Pharmaceutical's (San Diego, CA, USA) LJPC-401, a synthetic human hepcidin, as a treatment for sickle cell disease.

US FDA’ s Bone, Reproductive and Urologic Drugs Advisory Committee has voted in favor of approving Allergan's low-dose nasal formula SER120, or desmopressin, for treating nocturia but asks to restrict its use to patients who have nocturnal polyuria.

US FDA grants fast track status to:

SELLAS Life Sciences (Zug, Switzerland) for its WT1 cancer vaccine galinpepimut-S as a treatment for patients with malignant pleural mesothelioma. The vaccine is under late-stage clinical development for hematologic cancers and solid tumors.

… and to aTyr Pharma (San Diego, CA, USA) Resolaris an experimental treatment for facioscapulohumeral muscular dystrophy (FSHD), a rare and severe genetic disorder characterized by muscle weakness and wasting.

US FDA grants orphan drug status to:

Yisheng Biopharma's (Ji’an City, China) YS-ON-001, a treatment for hepatocellular carcinoma. YS-ON-001 is a multi-component complex with broad immunomodulating properties such as promoting Th1-biased immunity, inducing the activation and proliferation of dendritic cell, B and natural killer c promoting macrophage M1 polarization and downregulating regulatory T cells.

to Opsona Therapeutics'(Dublin, Ireland) OPN-305, a humanized IgG4 monoclonal antibody that targets toll-like receptor 2, as a treatment for myelodysplastic syndromes, a cancer disease where blood cells do not fully mature in the bone marrow.

…and to Taiwan Liposome’s TLC178 as a treatment for cutaneous T-cell lymphoma. TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX nanotechnology platform to decrease the toxicity of the drug.

US FDA grants priority review to Bristol-Myers Squibb’s Opdivo, or nivolumab, for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in patients whose condition progressed after receiving a platinum-based therapy.

US FDA suspends recruitment in AstraZeneca’s clinical trials of durvalumab, in head and neck cancer following severe bleeding events.

AstraZeneca reports positive benefits for Lynparza or olaparib in a late-stage study in treatment-resistant ovarian cancer. Olaparib is the first PARP (poly ADP-ribose polymerase) inhibitor approved in the US for patients with deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Medical Devices and Diagnosis News

US FDA approves Roche and Ventana’s PDL-1 Assay (SP142) to be used as a complementary diagnostic in conjunction with Tecentric or atezolizumab for the treatment of metastatic non-small cell lung cancer.

Baxter is launching Theranova a new type of hemodialysis which uses a new dialyzer that filters a greater range of molecules from the blood. Expanded hemodialysis, or HDx, is enabled by Baxter’s new dialyzer, which is indicated for the treatment of acute and chronic renal failure.

St Jude is facing more pushback after it has released a report showing its cardiac device was vulnerable and open to hacking such as turning off the devic or sending shocks to a patient’s heart

Science & Technology

A new type of nanoparticles has been designed by researchers from the University of Carolina in Chapel Hill, to create a vaccine which effectively immunizes against all four serotypes of the dengue virus.

Cost, Pricing and Market Access

The UK National Institute for Health and Care is recommending:

Merck's Zepatier, or elbasvir and grazoprevir, as a treatment option for adults with chronic hepatitis genotypes 1a, 1b or 4,

….and UCB Pharma's Cimzia, or certolizumab pegol, to be taken along with methotrexate as a treatment option for certain adults with active, severe rheumatoid arthritis.

The UK National Institute for Health and Care Excellence is recommending that everyone diagnosed with colorectal cancer should be screened for an inherited genetic condition called Lynch syndrome (LS). LS is the most common cause of hereditary bowel cancer and people with it also have an increased risk of developing other cancers such as womb, ovarian and stomach. Tests for LS are already widely available, but "there is currently wide variation" in their provision, says Professor Carole Longson, director of the centre for health technology assessment at NICE. "

Miscellaneous

Last year, the China Food and Drug Administration (CFDA) ordered companies behind 1,622 regulatory applications for new drugs–mainly generics–to carry out "self-examination on the authenticity, integrity and compliance of clinical trial data." In June, reports showed that companies had pulled 1,193 applications, which led to "reports in some media that '80% of China’s clinical trial data are fraudulent'," according to a CFDA official, who insisted that those assertions "are not fact-based." Some applications may have been retrieved because of deliberate data fraud. But many may have been withdrawn for other reasons, such as non-compliance with Good Clinical Practice (GCP), incomplete data or data which failed to "demonstrate the safety and effectiveness for the drug in application," the statement said. The official insisted, citing problems that, while severe, don't constitute fakery. CFDA director Bi Jingquan recently described falsified clinical data as a "cancer" on the development of Chinese-made medicines that threatened to undermine the credibility of the domestic drug industry.

Bioevents

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)

9^th Biotech Showcase Investor Conference on January 9-11, 2017 in San Francisco (USA)

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.

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