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

Mergers, Acquisitions and Joint Ventures

Eli Lilly acquires CoLucid (Cambridge, MA, USA) and increases its migraine pain management with lasmiditan in a deal worth $960 million. Lasmiditan has completed the first of two pivotal phase 3 trials, a second one is expected later this year and a US FDA filling in 2018. Lasmiditan is a first in class 5HT-1F receptor agonist, which acts through a novel mechanism of action without vasoconstriction. The acquisition of Colucid will boost Eli Lilly’s own migraine pain management portfolio, such as glacanezumab which is competing with Amgen and Teva Pharmaceuticals to capture the 13 million patient population affected with a severe form of the condition.

Boehringer Ingelheim’s acquisition of Merial, Sanofi’s animal health business makes it the number two player in the veterinary medicine industry, which is now dominated by four major companies: Zoetis, Boehringer Ingelheim, Merck and Eli Lilly. According to Handelsblatt Global's (Francfort, Germany) Siegfried Hofman, the concentration of market heft makes further consolidation unlikely, although Bayer is considering divesting its own animal health business.

Biogen is now very close of spinning off Bioverativ, its hemophilia business, and make it a publicly traded company.

Business

Sanofi’s approval of Suliqua (see below) has triggered a $10 million payment to Zealand Pharma (Copenhagen, Denmark) as per the terms of a license agreement between the two firms for lixisenatide. Zealand is also eligible to receive remaining milestone payments of up to $100 million as well as low double-digit percentages on global sales in royalty income.

Approval of drugs and vaccines

The European Commission has granted marketing authorization to Sanofi’s Suliqua for the treatment of type 2 diabetes. Suliqua is a fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist, in-lincensed from Zeland Pharma. Suliqua has been authorised for use in combination with metformin to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

US FDA approves AbbVie’s Imbruvica, or ibrutinib, a Bruton kinase inhibitor, for the treatment of marginal zone lymphoma in patients who need therapy after receiving anti-CD20-based treatments.

US FDA has issued a draft guidance on biosimilar interchangeability recommending that sponsors conduct at least one switching study to demonstrate the interchangeability of a proposed biosimilar with its reference product without reducing safety and efficacy. This draft guidance appears to be more stringent than expected and make switching studies more complicated than those now in the works.

Drugs at clinical stage

US FDA grants fast-tack and qualified infection disease product (QIDP) status to Starpharma Holding’s (Melbourne, Australia) Vivagel’s BV, or astodrimer sodium, for the prevention and treatement of bacterial vaginosis QIDP status allows for accelerated review of the marketing application and an additional five-year period of market exclusivity for the indication, if approved.

US FDA has granted Pulmatrix’s (Lexington, MA, USA) PU1900 a qualified infection disease product (QIDP) status to treat fungal respiratory infections in patients with cystic fibrosis.

US FDA grants orphan status to Remedy Pharmaceutical’s (New York City, NY, USA) Cirara, for the treatment of severe cerebral edema in patients with acute ischemic stroke. Cirara, is an injectable drug which inhibits Sur1-Trpm4 channels in the capillary endothelium.

US FDA grants rare pediatric disease status to Tarix Orphan’s (Cambridge, MA, USA) TXA127 for the treatment against recessive dystrophic epidermolysis bullosa, a rare genetic disease that causes skin blistering.

US FDA grants fast-track status:

to TapImmunne’s (Jackonsville, Fl, USA) TPIV 200, a T-cell therapy that targets the folate receptor alpha protein, as a treatment for platinum-sensitive ovarian cancer, in combination with chemotherapy.

…and to Atyr Pharma’s (San Diego, CA, USA) Resolaris for the treatment for limb girdle muscular dystrophy and removes a partial clinical hold.

Allergan (Dublin, Ireland) and partner Gedeon Richter (Budapest, Hungary) report that uliprislatl acetate met all the co-primary and secondary endpoints with significant improved rates of an absence of bleeding as a treatment of uterine fibroids. A US FDA application is expected in Q2 2017.

Alcobra (Tel Aviv, Israel) reports that its pivotal phase 3 study of Methadoxine (MDX) missed it primary endpoint, and showed no superiority over a placebo, in the treatment of Attention-Deficit/Hyperactivity (ADHD).

Medical Devices and Diagnosis News.

Bio-Rad announced the acquisition of RianDance Technologies (Billerica, MA, USA), a genetic analysis company for an undisclosed amount. RainDance specializes in droplet-based genomic tools to investigate genetic variations in a range of diseases as well as to research liquid biopsy. It markets the low-cost NGS target-enriching system, ThunderBolts, as well as the RainDrop Plus Digital PCR system.

Science & Technology

Many vaccines contain viruses that are inactivated to prevent them from harming recipients, generally by adding certain types of chemicals. Scientists are now taking a different approach, using low-energy-electrons to irradiate the pathogens. The advantages of this new method are that it produces no toxic waste and provides a faster and less aggressive way of rendering pathogens inactive.

Cost, Pricing and Market Access

A recent report by QintilesIMS indicates that the oncology market is set to reach unprecedented heights by 2022, whereby the top 15 cancer drugs are expected to collectively represent $90 billion in sales. Among the top six, three will be representatives from the PD-1/PD-L1 or checkpoint inhibitor class

US Acthar pricing, a corticotrophin for the treatment of various autoimmune diseases, has gone up 85,000% over the last 15 years, according to the Federal Trade Commission (FTC). The FTC has won a $100 million settlement from Mallinckrodt (Staims-upon-Thame, UK) from illegally maintaining drug monopoly on Acthar. Mallinckrodt got access to the drug through the acquisition of Questcor for $5.6 billion in 2014.

Miscellaneous

Allergan, AstraZeneca, Biogen, GlaxoSmithKline, Novartis and Pfizer have formed Align Biopharma to address common technology standards to facilitate communication between health care professionals and drugmakers. The group will initially focus on two issues: identity management and preferences for consent and communications.

Biogen and Forward Pharma (Copenhagen, Denmark) have entered into settlement and a license agreement on patent fight on Tecfidera in a $1.25 billion in upfront cash as well as on royalties of 10 to 20% on future sales of the multiple sclerosis drug.

People on the move:

Abbas Hussain, the global head of pharmaceuticals at GlaxoSmithKline, who had been considered as a potential contender to take over from CEO Andrew Witty, is leaving the company and will be replaced by Luke Miels from AstraZeneca.

Friday, was supposed to be Francis Collins’ last day as NIH director. According to a spokesperson he will be “held over” by the Trump Administration.

Bioevents

3^rdAnnual Biotech and Money London on February 7-8, in London (UK)

BIO CEO & Investor Conference on February 13-17, in New York City (USA)

European Life Sciences CEO Forum & Exhibition on March 6-7, Zurich (Switzerland)

BIO Asia on March 14-15, in Tokyo (Japan)

BIO-Europe Spring on March 20-22, in Barcelona (Spain)

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

9^th Annual China BIO Partnering Forum on May 10-11 in Shunde (China)

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

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

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

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

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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