Acquisitions /mergers/joint-ventures

Cigna rejects Anthem’s offer

US Health insurer Cigna sharply rejected Anthem’s bid proposal worth nearly $54 billion including debt in saying the terms of the bid are inadequate and “woefully skewed in favor of Anthem’s shareholders. Nothing of this size and scale has been attempted in our sector," the Cigna officials said of the merger.  Anthem has been in talks with Cigna since last summer.

Teva continues to buy more Mylan shares

Teva has now raised its stake in Mylan to 4.6%. Under Dutch law the owning of this amount of shares allows Teva to legally challenge the rejections of the takeover offer.

Medtronic acquires Aptus and CardioInsight for around $203 million

Medtronic (Dublin, Ireland) will acquire Aptus Endosystems (Sunnyvale, CA, USA) and CardioInsight Technologies (Cleveland, OH, USA), two medical device companies for $203 million. Aptus is developing advanced technology for endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). CardioInsight has developed Ecvue, a novel, non-invasive advanced cardiac mapping system to map electrical disorders of the heart.

Eurofins gets frenetic about acquisitions and buys French Biomnis for €220 million

Eurofins Scientific (Nantes, France and Luxemburg) announced plans to acquire Biomnis (Paris and Lyon, France), a testing company for €220 million. The news follows Eurofin’s investment in French clinical diagnostic company Bio-Access and US-based testing service company Diateherix Laboratories within the last month and six months after the acquisition of Boston Heart Diagnostic and just one year after it bought ViraCor-IBT Laboratories.

Business

Chris Viehbacher appointed managing partner of Gurnet Point Capital

Chris Viehbacher, the former chief executive of Sanofi, was named managing partner of Cambridge (MA, USA) based Gurnet Point Capital (GPC) fund, a $2 billion healthcare fund. The GPC fund, which is part of Switzerland’s Bertarelli family Waypoint Capital Group, will be used to build new companies not only in biotech but also medical devices and technology. Mr. Viehbacher had previously taken a role as director of PureTech, a London-based life science investment company.

Pfizer acquires two meningitis vaccines from Glaxo for €115 million

Pfizer acquires quadrivalent meningitis vaccine Nimenrix and Mencevax from GlaxoSmithKline for €115 million. Nimenrix is a single-dose meningococcal conjugated vaccine to protect against Neisseria meningitidis. Mencevax is a single-dose meningococcal unconjugated vaccine used to control outbreak of the infection and for travelers use.

Biophytis files for IPO in Paris

Biophytis (Romainville, France) a company focusing on age-related diseases has filed with Paris stock exchange to finance its two lead candidates, BIO201 for the treatment of age-related macular degeneration (AMD) and BIO101 for the treatment of sarcopenia.

Mayor of London proposes a £10 billion fund to support biotech

London Mayor Boris Johnson has invited biopharma investors and stakeholders to discuss its proposal to launch a £10 billion ($15 billion) fund intended to support drug discovery and development and position London and the East of England “golden triangle”, anchored by London, Oxford, and Cambridge, as a leading global hub. The megafund which consists of debt and equity financing is designed to close the gap between the UK and other leading science hubs such as the San Francisco Bay area and Boston. "London is one of the most powerful scientific discovery engines in the world. We hope to harness our role as a global financial center that will bring more lifesaving drugs to market and deliver a huge boost to the economy," Johnson said. The fund could also take advantage of the InnovFin programme set up by the European Commission and the European Investment Bank, which is expected to provide more than £17 billion of new financing for research and innovation over the next five years.

Oxford Science Innovation raises $320 million

Oxford University, through its investment fund Oxford Science Innovation, raises $320 million ($475 million) with the backing of Google Ventures and the Woodford Patient Capital Trust.

Approval of drugs, vaccines, diagnostics and devices 

Europe approves BMS’ Opdivo for the treatment of melanoma

European Commission approves Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for the treatment of unresectable or metastatic melanoma, after an accelerated assessment. Opdivo is the first PD-1 inhibitor to win approval in Europe, it was already approved last year in the US and in Japan.

… and Daiichi Sankyo’s Lixiana for the prevention of stroke

The European Commission has approved Daiichi Sankyo’s Lixiana or edoxaban, a once- a- day orally active factor Xa inhibitor, for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is already approved in the US, Japan and Switzerland.

US FDA approves Medicines Company’s Cangrelor for the treatment of PCI

After several setbacks The Medicines Company (Parsippany, NJ, USA) received FDA approval for Kengreal (Cangrelor) as an intravenous therapy aimed at preventing blood clots in patients who need percutaneous coronary intervention (PCI) or angioplasty. In a large clinical trial Cangrelor, a P2Y12 inhibitor, was compared to Plavix (clopidogrel) and showed significant reduced heart attack occurrence. The Medicines Company had licensed the drug from AstraZeneca back in 2003.

US FDA approves Siemens’ HIV combination test

Siemens received FDA approval for its HIV combination test “ADVIA Centaur Ag/Ab Combo” assay. The ADVIA combination test can simultaneously screen blood samples for HIV viral protein and antibodies produced in response to HIV viral infection. The test, which has already been on the market in Europe since 2010, can check for both acute and established HIV-1/HIV-2.

Drugs at clinical stage

US FDA grants breakthrough therapy status to Aimmun’s peanut allergy therapy

Aimmune Therapeutics (Brisbane, CA, USA) received FDA breakthrough status for AR101, an oral immunotherapy for peanut-allergic children and adolescents. The investigational drug, which had been granted FDA fast track designation in September 2014, will be competing with French DBV Technologies epicutaneous immunotherapy.  DBV has exited its end-of-Phase II meeting with FDA with an approved development plan and now expects its pivotal trial to be initiated before the end of the year.

The European Medicines Agency grants orphan status to Avexis’ gene therapy for spinal muscular atrophy

The European Medicines Agency (EMA) has granted Avexis’ (Dallas, TX, USA) ChariSMA, a gene therapy, orphan drug designation for the treatment of Spinal Muscular Atrophy (SMA). SMA is a disease which is characterized by motor neuron loss and progressive muscle weakness and is caused by a genetic defect in the SMN1 gene that codes for the survival motor neuron (SMN), a protein necessary for survival of motor neurons. There are between 25,000 and 50,000 spinal muscular atrophy patients in the western world.  ChariSMA had been granted orphan status by the FDA in October 2014.

Technology

Google unveils its new health-monitoring wristband

Google Life Sciences group has unveiled an experimental health-monitoring wristband for use in clinical trials and drug testing. The device is equipped with sensors which can incessantly produce an electrocardiogram and is expected to be used for tracking cardiac signals in heart attack patients after their release from hospital. Google indicated that it does not intend to market the product as a consumer device and will therefore not need stringent regulatory approval.

Medical Devices and Diagnosis News

Teva partners with Microchips Biotech to develop electronic drug delivery

Drug-delivering chip from Microchips–Courtesy of Microchips

Teva announced a $35 million investment into a partnership with Microchips Biotech (Lexington, MA, USA) to develop an electronic drug delivery implant for long term administration of drugs. Teva will pay additional milestone payments based on development and commercial milestones, as well as royalties on future products. The microchip-based implant comprises hundreds of tiny airtight reservoirs, each of which can store 1 milligram worth of medication. Each reservoir is sealed with a titanium and platinum seal, which melts temporarily when hit with a wirelessly transmitted electrical current, allowing the release of the drug. Delivery can occur according to a preprogrammed dosing schedule.

Miscellaneous

South Korea spends $9 billion to manage MERS outbreak

South Korea has decided to spend an additional $9 billion to handle the Middle East Respiratory Syndrome (MERS) outbreak that has afflicted 180 subjects and caused 27 deaths since May.  South Korea's MERS outbreak has been traced to a businessman who returned from the Middle East. The outbreak in South Korea has led to a scramble by regional government to screen at airports and other border crossing points and for novel detection methods and adequate treatment options.

MERS coronavirus vaccine candidate

Scientists have demonstrated the protective effect of a clinical vaccine candidate directed against MERS coronavirus.

Alexion Pharmaceuticals (Cheshire, CT, USA) settles in Europe

Alexion Pharmaceuticals (Cheshire, CT, USA) settles its first non-European R&D facility at the Imagine Institute in the Necker Hospital (Paris, France).The Institute specializes in genetic and rare diseases.

China rejects Gilead’s patent for Solvadi

China’s State Intellectual Property Office rejected Gilead’s prodrug patent for the inactive form of hepatitis C Solvadi which is converted in the body to sofosbuvir the active form of the drug.  Gilead continues to hold the China patent to the active ingredient sofosbuvir.  The Chinese denial of the patent paves the way for cheap generic versions to be produced in the country. Médecins Sans Frontières (MSF), a non-governmental organisation, said in a statement that "China's rejection of a key patent on sofosbuvir goes to show that there are serious questions about whether this drug merits patenting, and sends a strong signal to other countries that are currently reviewing patent applications for the drug."

Bio and Business Events  

• Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
• 3^rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
• BioPharm America 2015 on September 15-17 in Boston (USA)
• Innovation Days on October 5-6 in Paris (France)
• 15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
• BIO Europe 2015 on November 2-4 in Munich (Germany)
• Biofit 2015 on December 1-2 in Strasbourg (France)

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

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