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

Mergers, Acquisitions and Joint Venture

Abbott Laboratories has reached new terms for the acquisition of Alere (Waltham, MA, USA), a competing diagnostic company, for $5.3 billion and both companies have dismissed their respective lawsuits. The agreement comes more than a year after Abbott first agreed to acquire Alere which was highly active at exiting the deal.

Business

Bristol-Myers Squibb licenses two of its early stage drugs and cashes $470 million. Biogen gets control of BMS-986168, an anti-eTau compound, in clinical development for Progressive Supranuclear Palsy, for $300 million upfront and $410 million in milestones. Biogen is assuming the obligations BMS took on when it acquired iPierian in 2014 for $175 million in cash and $550 million in milestones. Roche gets control of BMS-986089, an anti-myostatin Adnectin in development for Duchenne muscular dystrophy and is paying $170 million upfront plus $205 million in milestones. BMS originally accessed the product in 2007 with the $505 million acquisition of Adnexus.

Ferring Pharmaceuticals (Saint Prex, Switzerland) enters a partnership with Alrise Biosystems (Berlin, Germany) to evaluate its Imsus microparticle drug-delivery technology for use with injectable peptide formulation acting over several months. Alrise’s ImSus platform has been developed as a high-throughput approach to manufacture drug-loaded polymeric microparticles, including capsules, sponges, and spheres that can be used to encapsulate hydrophobic and hydrophilic drugs, including small molecules, peptides, and proteins. Financial terms of the deal were not disclosed. Last month Ferring announced an agreement with Instituto de Ciênas Farmacêuticals in Brazil to develop mucoadhesive rectal delivery for treating anal fissures.

Janssen Pharmaceuticals enters a collaboration with PeptidDream (Tokyo, Japan) to use the Peptide Discovery Platform System (PDPS) to discover and develop macrocyclic constrained peptides for metabolic and cardiovascular disease targets in a deal worth up to $1.15 billion.

Gedeon Richter (Budapest, Hungary) gets non US commercialization rights to a female urological product from Evestra (San Antonio, TX, USA). Financial terms of the deal were not disclosed but are linked to an upfront payment, milestone s and sales on royalties.

Takeda enters an agreement with NuBiyota’s (Teaneck, NJ, USA) Microbial Ecosystem Therapeutic platform to develop oral microbiome drugs for the treatment of gastrointestinal diseases. The deal represents Takeda’s second microbiome deal this month after the agreement with Finch Therapeutics. Under the terms of the deal, Takeda will make upfront and milestone payments as well as royalties tied to future sales.

GE Healthcare partners with Cellular Biomedicine Group or CBMG (Shanghai, China) to develop CAR-T and stem cell production technologies to support its aim to produce 10,000 cancer cell therapies per year. The agreement is set for two years with option to extend. Under the agreement, GE CAR-T cell and stem cells technologies such as Sefia, Sepax 2, Xuri, SmartMax, as well as Asymptote, VIA Freeze product lines, will be installed in Shanghai, Beijing and Wuxi where CBMG has a total 70,000 square feet of manufacturing space.

Novigenix (Lausanne, Switzerland) enters an agreement with Dr. Risch Medical Laboratory to distribute Colox, its PCR-based colorectal cancer blood test in the Swiss German market and Lichtenstein. In 2014, Novigenix closed a similar agreement with Unilabs to target the French Swiss market.

Approval of drugs and vaccines

The US FDA approves Neurocrine Biosciences’ (San Diego, CA, USA) Ingrezza, or valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, as the first drug approved for the treatment of tardive dyskinesia. Tardive dyskinesia is characterised by repetitive involuntary movements, usually of the jaw, lips and tongue, and sometimes involuntary movement of the extremities or difficulty breathing. The condition is an irreversible serious side effect often seen in patients who have been treated with antipsychotics for long periods to treat chronic conditions such as schizophrenia and bipolar disorder. The approval comes one week after Teva’s, Austedo, or deutetetabenzanine, a similar drug was approved for the treatment of Huntington chorea. Un­like Teva, Neu­ro­crine Ingrezza’s label does not carry a black box warn­ing on de­pres­sion and sui­ci­dal ideation.

The US FDA rejects Eli Lilly’s baracitinib, a JAK 1 and 2 kinase inhibitor, as a treatment for rheumatoid arthritis and requests more effective dose and safety data. Eli Lilly and partner Incyte disagree with the FDA’s conclusions, indicating they might be able to speed the resubmission with more discussion.

The European Medicines Agency Pharmacovigilance Risk Assessment Committee backs the continued use of Actelion’s Uptravi, or selexipag, for the treatment of patients with pulmonary arterial hypertension after conducting a safety review of the drug, following the death of five patients in France. As a result, no changes to the prescribing information are considered necessary by the regulator. However, the safety of Uptravi will continue to be monitored, and emerging data from ongoing and planned studies will be carefully evaluated, it stressed.

Drugs at clinical stage

The US FDA grants orphan status to Active Biotech’s (Lund, Sweden) tasquinimod, a once-daily oral, investigational, small molecule immunomodulatory drug with a novel mechanism of action, as a treatment for patients with multiple myeloma. The drug had been in development by Active Biotech and Ipsen for the treatment of prostate cancer but was stopped in 2015.

The US FDA grants fast-track status to Relmada’s (New York, NY, USA) d-methadone ( REL-1017 dextromethadone), and investigational, rapid-acting, oral N-methyl-D-aspartate (NMDA) receptor antagonist as an adjunctive treatment of major depression.

Takeda has finished the enrolment of 20,100 children, aged 4 to 16, in eight endemic countries to test the efficacy and safety of TAK-003, its dengue vaccine candidate.

Malaysia is requesting a phase 4 testing of Sanofi Pasteur’s Dengvaxia, in order to fully approve the dengue vaccine.

Roche’s late-stage Alecensa, or alectinib, showed superiority over Pfizer’s Xalkori, or crizotinib, in patients with anaplastic lymphoma kinase (ALK)-positive advanced non –small cell lung cancer (NSCLC). Alecensa was first approved in 2015 to treat patients with advanced ALK-positive NSCLC who have failed on Xalkori.

Medical Devices and Diagnosis News.

The US FDA authorizes Nanobiosym’s (Cambridge, MA, USA) portable diagnostic platform to qualitatively detect Zika RNA in human serum.

The US FDA approves Inari Medical’s (Irvine, CA, USA) ClotTriever peripheral thrombectomy device to remove blood clots from large vessels in the peripheral vasculature.

Several security offices are warning that the medical devices with wireless capabilities are expected to become a primary target for hackers. In the past year, J&J and St. Jude Medical have dealt with cybersecurity vulnerabilities linked to insulin pumps and cardiac devices. Although both companies said hackers did not successfully access the devices, the industry is likely to face mounting pressure when hackers figure out how to monetize an attack, perhaps with a form of ransomware that has already been used against hospitals. As the threat of hacking intensifies, so too will the liability risks, according to Melissa Markey, a technology and cybersecurity lawyer at Hall Render (Indianapolis, IN, USA).

Science & Technology

Scientists at New York University’s Langone Medical Center reported data from a study showing that deep brain stimulation (DBS) decreased the severity of tics for patients with severe Tourette syndrome. Tourette is characterized by motor and vocal tics, or sudden, involuntary sounds or movements. The FDA has already approved DBS systems, such as those from Medtronic and St. Jude Medical, to treat Parkinson’s disease but not for treating Tourette. DBS involves the implantation of a neurostimulator that sends electrical impulses via lead wires to specific parts of the brain. The NYU team investigated an experimental treatment called thalamic DBS in inserting two electrodes in patients’ medial thalamus, the part of the brain that “functions abnormally” in people with Tourette.

The first live-attenuated Zika vaccine, still in the development stage, completely protected mice against the virus after a single vaccination dose, according to new research performed at the University of Texas Medical Branch in Galveston. One injection with 10 live-attenuated vaccine particles triggered full immune response and completely prevented mice from Zika virus infection

Cost, Pricing and Market Access

The UK National Institute for Health & Care Excellence (NICE) has issued a draft guidance rejecting Bristol-Myers Squibb’s Opdivo as a treatment of squamous cell carcinoma of the head and neck indicating that the drug was too expensive. NICE calculated the drug’s incremental cost effectiveness ratios (ICERs) would be above the range of £66,000 to £75,000 per QALY gained compared to other treatments, and thus far above the normal £20,000 to £30,000 per QALY value for money threshold or £50,000 bar for life-extending therapies.

Miscellaneous

The European Medicines Agency has set up an email inbox for whistle-blowers along with details how it will manage and investigate allegations of improper practices provided by drug company employees. The EMA said it aim is “to create an environment where individuals from outside the agency fell confident to raise their concerns on improprieties in their area of work”. The agency revealed that it has received 43 reports of improper practices relating to manufacturing and clinical assessment since 2013

The European Medicines Agency released a 15-page draft guidance on controlling false positives in clinical trials that involve multiple treatment groups and endpoints. Among the situations covered in the guidance are when adjustments for multiplicity must be made, when additional claims can be made based on success against secondary endpoints and how composite endpoints should be handled.

Bristol-Myers Squibb announces major restructuring of its US West Coast operations. The Hopewell (NJ) site will be closed by 2020 and the Lake Union Steam Plant site in Seat­tle will close in 2019. BMS has al­ready announced the closing of its op­er­a­tions in Walling­ford, CT next year. New buildings include an R&D build­ing at the com­pany’s Lawrenceville (NJ) cam­pus that will co-lo­cate lab-based Dis­cov­ery and Trans­la­tional Med­i­cine ac­tiv­i­ties, con­struc­tion at its New Brunswick (NJ) fa­cil­ity to sup­port bi­o­log­ics de­vel­op­ment, and con­struc­tion to con­tinue ex­pan­sion of its bi­o­log­ics cam­pus in De­vens (MA).

People on the move:

David Meeker, who recently announced his retirement from Sanofi Genzyme, has been appointed chairman at Rhythm (Boston, MA, USA) a start-up company developing peptide therapies for rare genetic diseases.

Bioevents

Strategic Alliance Management Congress on May 1-3, in Philadelphia (USA)

BIOTrinity on May 8-10, in London (UK)

China BIO Partnering Forum on May 10-11 in Suzhou (China)

9^thAnnual China BIO International Partnering Forum on May 31-June 1 in Zhuhai (China)

The Health Industry Sumitt (tHIS) 2017 on May 15-18 in Shanghai (China)

2017 BIO-IT World Conference & Expo on May 23-25 in Boston (USA)

BIO International Convention on June 19-22 in San Diego (USA)

5^thAntibody Industrial Symposium, on June 27-28, in Tours (France)

MedFIT on June 28-29 in Grenoble (France)

Nordic Life Science Days (NLS) 2017 on September 12-14 in Malmö-Copenhagen (Sweden and Denmark)

BIOPharm America on September 26-27 in Boston (USA)

BIO Latin America on October 26-28 in Sao Paulo (Brazil)

BIO Europe on November 6-8 in Berlin (Germany)

World Congress on Biomedical Engineering 2017 on November 9-11 in Xian (China)

BIOFIT on November 28-29 in Strasbourg (France)

http://btobioinnovation.com/events/pharma-biotech-events/

http://btobioinnovation.com/events/in-vitro-diagnostic-events/

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