Acquisitions /mergers/joint-ventures

Shire acquires Dyax (Burlington, MA, USA) for $6.5 billion and gets access to DX-2930, an investigational hereditary angioedema drug (HEA), considered as a strong competitor to Shire’s own HEA portfolio such as Cinryze and Firazyr. HEA is a debilitating and potentially life-threatening rare genetic disease that causes swelling in the face, extremities and gastro-intestinal tract. Under the terms of the agreement, Dyax will receive an initial payment of $5.9 billion and an additional $646 million contingent on approval of DX-2930, expected sometime in 2018.

Bristol-Myers Squibb acquires Cardioxyl (Chapel Hill, NC, USA) for $2 billion and extends its cardiovascular franchise with the access of CXL-1427, a novel nitroxyl donor produg, for the treatment of acute decompensated heart failure. Under the terms of the agreement B-MS is paying $300 million upfront and a further $1.775 billion upon development, regulatory and sales based milestones.

AstraZeneca acquires ZS Pharma (San Mateo, CA, USA) for $2.7 billion in cash, extends its cardiovascular franchise and stops rival bidder Swiss Actelion. The company has been developing novel treatments for hyperkalemia, or high potassium levels, which is typically associated with chronic kidney disease and chronic heart disease with its lead compound ZS-9 currently under review by the US FDA.

Johnson & Johnson acquires privately held Novira Therapeutics (Doylestown, PA, USA), a biopharmaceutical company developing novel treatments for chronic hepatitis B virus (HBV) infection.  Novira‘s lead product NVR 3-778, an orally available small molecule, disrupts the HBV lifecycle by inducing the assembly of defective capsids and is a potent inhibitor of HBV cell replication. Financial terms of the deal were not disclosed.

Mylan has cleared one more step to acquire Perrigo for $27 billion with the approval of the Federal Trade Commission on the condition that Mylan divests seven of its generic drugs before the completion of the deal. Mylan is now waiting for the reply from Perrigo’s shareholders on whether they will or not accept the offer which was tendered on September 14.

Business

Sanofi presents its strategic roadmap for the period 2015-2020 and strengthens its R&D portfolio in diabetes with two major license agreements through:

An agreement with Hanmi Pharmaceuticals (Seoul, Korea) to develop a portfolio of experimental long-acting diabetes treatment worth $3.9 billion. Sanofi will receive an exclusive worldwide license to develop and commercialize three drugs: efpeglenatide, a late stage long-acting glucagon-like peptide receptor agonist (GLP1-RA); a weekly insulin and a fixed dosed-weekly GLP1-RA/insulin drug combination. Under the terms of the agreement Hamni will receive an upfront payment of $400 million and up to $3.5 billion in contingent development, regulatory and sales milestones as well as double digit royalties on net sales. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China.

A collaboration and license agreement with Lexicon Pharmaceuticals (The Woodlands, TX, USA) worth $1.7 billion for the development and commercialization of sotagliflozin (SX4211), an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1, SGLT-2) for the treatment of diabetes. Under the terms of the agreement Sanofi will make an upfront payment of $300 million an up to $1.4 billion in development, regulatory and sales milestones as well as tiered, escalating double digit percentage royalties on net sales.

Sanofi enters into an exclusive collaboration and license agreement with BioNtech (Mainz, Germany) to develop up to five novel cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs. Under the terms of the deal Sanofi will pay an upfront payment of $60 million, near-term development milestones of $300 million and additional other payments as well as tiered royalties on net sales. BioNTech has the option to co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the European Union and the United States.

…..and stops its licensing deal with Glenmark (India) after its monoclonal antibody Vatelizumab (GBR 500) failed to meet its efficacy endpoint in multiple sclerosis. Glenmark initially licensed the drug in May 2011 in a deal worth $613 million.

GlaxoSmithKline has entered a pact with Merck & Co to assess GSK’s investigational GSK317998, a humanized IgG1 anti-OX40 monoclonal antibody, with Merck’s Keytruda, a humanized monoclonal antibody acting as a checkpoint inhibitor, to treat various cancers.

….and teams up with Regulus Therapeutics (La Jolla, CA, USA) to evaluate a combination and formulation study of RG-101, a microRNA therapeutic, with GSK2878175, a non-nucleoside NS5B polymerase inhibitor, for the treatment of patients with chronic Hepatitis C Virus infection.

Allergan partners with Mimetogen Pharmaceuticals (Montreal, Canada) to develop and commercialize MIM-D3 or tavilermide for the treatment of the dry eye. Tavilermide, an investigational drug, is a small cyclic peptidomimetic of Nerve Growth Factor (NGF), a naturally occurring protein responsible for the maintenance of corneal nerves and epithelium in the eye. Tavilermide induces the production of mucin, a naturally occurring component of the tear film. Under the terms of the agreement, Allergan will pay a $50 million upfront payment plus undisclosed milestone fees and sales royalties and provide funding for late-stage development of the drug.

Pfizer has entered a five-year technology transfer agreement with Biovac Institute (Cape Town, South Africa), a Public Private Partnership established to manufacture vaccines in South Africa, to locally produce Prevnar 13, a life-saving pneumonia vaccine for infants.

Takeda has taken a stake in Univercells (Gosselies, Belgium) a bioprocessing company as part of a programme aimed at supplying low-cost vaccines to lower-income countries. The first step for this collaboration will be “to revamp and optimize the manufacturing process for current vaccines” using Univercell’s cell culture platform. Terms of the deal were not disclosed but Takeda has closed a €3 million investment in Univercells which gives it a 19.9% stake in the Belgian company.

Gilead Sciences and WuXi PharmaTech (Wuxi, China) enter into partnership to conduct stability and analytical studies of small-molecule new chemical entities to support global marketing applications and commercial products. Under the agreement, WuXi will equip and operate a dedicated, fully cGMP-compliant 12,500-square-foot facility in Shanghai.

Approval of drugs, vaccines, diagnostics and devices

The European Commission extends Bayer Healthcare’s Eylea (an injectable aflibercept solution) to the treatment of myopic choroidal neovascularization, a visual impairment affecting the retina. Eylea is already approved for the treatment of patients with wet age-related macular degeneration and for the treatment of visual impairment due to diabetic macular oedema. Bayer HealthCare and Regeneron are collaborating on the global development of Eylea.

US FDA approves:

• GlaxoSmithKline’s Nucala, or mepolizumab as an add-on treatment of severe asthma. Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), the main promoter of eosinophil growth. Over-production of eosinophils causes inflammation that can affect the airways, limiting breathing and increasing asthma attacks. Around 60% of patients with severe asthma are thought to have eosinophilic airway inflammation.
• Gilead’s HIV drug Genvoya, a combination of elvitegravir, cobicistat, emtricitabine and tenovir alafenamide. A warning will be included stating that the drug is not intended for patients with chronic hepatitis B.

Drugs at clinical stage

US FDA grants breakthrough status:

to Daiichi Sankyo’s pexidartinib for the treatment of patients with tenosynovial giant cell tumor where surgical removal is not appropriate. Pexidartinib is a pan kinase inhibitor that selectively inhibits a grow factor of abnormal cells in the synovium.

to Merck’s Keytruda or pembrolizumab for the treatment of microsatellite instability-high metastatic colorectal cancer, representing its third breakthrough designation in the US.

European Medicine Agency (EMA) grants orphan status to Stemline Therapeutics’ (New York, NY, USA) SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm, (BPDCN) a rare form of myeloid leukemia. SL-401 is a targeted therapy directed to the interleukin-3 receptor present on cancer stem cells and tumor bulk of BPDCN. The drug holds orphan drug designation in the US for the same indication and orphan status in the US and in Europe for acute myeloid leukemia.

Science and Technology

A report in the journal Sleep lead by Patrick Finan, from the Johns Hopkins University School of Medicine, shows that interrupted sleep affects one’s mood rating far more than short sleep. Previous data already linked poor sleep and depression, and Finan says “it may be worth delving deeper into understanding whether depression is associated with more interrupted sleep or shorter sleep”.

Medical Devices and Diagnosis News

Roche launches three rapid diagnostic test for HIV, hepatitis C and hep C in Europe.  In a statement the company said these tests can run simultaneously on its cobas 4800 system speeding up processing times while streamlining workflow.

Miscellaneous

At an R&D Day held in New York City on November 3, GlaxoSmithKline presented its long-term pipeline of new medicines across six core areas of its business. The company believes that 80% of the investigational drugs presented have the potential to be “first in class” and that it can potentially file for up to 20 new drugs by 2020. 

Highlights of Sanofi’s Investor Relations event for the period 2015-2020,held on November 6. Annual sales growth expected to be 3-4%.  Six major product launches to generate aggregate peak sales of €12-14 billion. Targeted costs savings of €1.5 billion. R&D investment to increase to up to €6 billion. Strategic options explored for Merial Animal Health and European generic business.

Q3 Results from European Companies

• AstraZeneca: Total Revenues down 9%, net sales up by 203%
• Lundbeck:  Total revenues increase by 15.2%, operating loss of DDK 1.5 billion compared to profit of DDK 21 million in Q3 2014

At a briefing session for the National People's Congress Standing Committee, China Food and Drug Administration head BI Jingquan said that the current approval process in China “does not suit the development drug making industry and that the quality of some generic drugs lags far behind their international counterparts”, and that the problem could be fixed by changing the approval system. Reforms being considered would allow research agencies and researchers themselves to apply for drug approvals where previously they were required to transfer their findings to drug producers.

US FDA warns Novartis on manufacturing violations at Turbhe and Kalwa (India), two Sandoz’s generic drugs sites. Novartis did not specify details of the warning. The FDA has banned more than 30 drug manufacturing plants in India since 2013, as it ramps up inspections of foreign facilities that supply to the United States.

US FDA has released a guidance on drug development for safe and effective therapeutic biologics and antiretroviral medications for the treatment of HIV.

According to market analysis Biocom, European Biotechnology companies raised more than €1 billion through Initial Public Offerings (IPOs) in the first 9 months of 2015, an increase of 18% over the same period of last year but expectations for the final quarter are less promising.

Bioevents

• BIO Latam on November 16-17 in Santiago (Chile)
• Medica and Compamed on November 16-19 in Düsseldorf (Germany)
• Biofit 2015 on December 1-2 in Strasbourg (France)

Early events in 2016

• BIOTech ShowCase 2016 on January 11-13 in San Francisco (USA)
• JP Morgan 33^rd Annual Healthcare Conference on January 12-16 in San Francisco (USA)
• BIO CEO Investor Conference on February 8-9 in New York City (USA)
• BIO Asia 2016 on March 15-16 in Tokyo (Japan)
• Global Healthcare Forum on March 16-17 in Singapore (Singapore)
• BIO Europe Spring on April 4-6 in Stockholm (Sweden)
• BIO Vision on April 13-14 in Lyon (France)
• BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
• Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
• China BIO Partnering on May 18-19 in Suzhou (China)
• BIO International Convention on June 6-9 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.

Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com

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