Teva-Mylan-Perrigo: An ongoing process

This week Abbott has indicated that it intends to vote its 14.5% stake in Mylan, acquired in late February through a 5.3 billion stock swap, in favor of a Perrigo buy. But OTC-focused Perrigo has so far repeatedly turned down Mylan’s offers indicating that they “substantially” undervalue the company.

Allergan acquires Kythera for $2.1 billion

Allergan (Dublin, Ireland) announced the acquisition of Kythera Biopharmaceuticals (Westlake Village, CA, USA) for $2.1 billion in a mix of cash and stocks, and increases its portfolio on the facial aesthetics scene. The acquisition gives Allergan access to Kythera’s lead product Kybella (deoxycholic acid) injection, the only FDA approved non-surgical treatment for severe submental fullness (or double chin) and to setitiprant (KYTH-105) a novel compound for the prevention of male baldness.

Hill-Rom acquires Welch Allyn for 2.05 billion

Hill-Rom (Chicago, IL, USA) acquires Welch Allyn (Skaneateles Falls, NY, USA) for 2.09 billion in cash and stocks to form a world leading healthcare technology company.

Anthem offers $54 billion to acquire Cigna

US Health insurer Anthem has publicly proposed to acquire Cigna in a deal valued at $53.8 billion. The move by Anthem marks the first step in what observers see as inevitable consolidation in the US health insurance industry. The transaction is not a done deal because of regulatory approvals and disagreement over the governance in particular the CEO appointment.

Business

IPOs successful all over the globe

Last week we had reported about Abivax, 3SBio and Pieris’ projects and successes. This week we saw abundant news from companies proposing to raise public funding or with successful IPOs on various stock markets:

• Biotie Therapies (Turku, Finland) share rise on NASDAQ as high as $20.84 after an original price at $14.88 and expects to accelerate its portfolio of drugs. Tozadenant its current lead is an orally administered inhibitor of the adenosine 2a (A2a) receptor initially developed for Parkinson disease with utility in other CNS disorders.
• Cynapsus Therapeutics (Toronto, Canada), currently traded at the Toronto Stock Exchange with a market value of $100 million, expects to raise $64 million on the US stock exchange to further develop its sublingual thin-film strip apomorphine for the turning ON of debilitating OFF episodes associated with Parkinson’s disease.
• IntecPharma (Jerusalem, Israel) aims to raise $46 million on its US IPO in order to develop its levodopa-delivering Accordion Pill against Parkinson’s disease. The Accordion Pill™ is a novel gastro-retentive delivery system which significantly improves the pharmacokinetics of drugs with either narrow absorption window or poorly soluble drugs. Cerecor (Baltimore, MD, USA) filed with the SEC to list on the NASDAQ and expects to raise $32 million to develop its portfolio of drugs for the treatment of neurological and psychiatric disorders.
• Celyad (Mont-Saint-Guibert, Belgium) announced terms of the NASDAQ listing and expects to raise $99 million to further develop its gene therapies to treat cancer and cardiovascular diseases.
• Nivalis Therapeutics (Boulder, CO, USA) secured $77 million in its IPO and will further develop its cystic fibrosis treatment.
• Aeglea Biotherapeutics (Austin, TX, USA) hopes to secure $86 million on NASDAQ to focus on the development of novel cancer therapies.
• Kiadis Pharma (Amsterdam, The Netherlands) provided more information on its IPO on the Amsterdam and Brussels Euronext exchanges where its new shares are to be priced between €11 and €13.75. Kiadis has developed a cell therapy called ATIR (allodepleted T lymphocytes for early immune reconstitution) that is being tested in patients with leukaemia as an adjunct to haematopoietic stem cell transplant. Raised funds will support the development of the lead product ATIR 101.  
• Navibra Therapeutics (Vienna, Austria) which develops a novel antibiotic for bacterial pneumonia, has filed with SEC to list on NASDAQ and expects to raise $92 million to support its development.

Janssen Pharmaceuticals collaborates with Arcturus on RNA-based drugs

Janssen Pharmaceuticals, a unit of Johnson and Johnson, and Arcturus Therapeutics (San Diego, CA, USA) have entered a research and development agreement on RNA-based drugs using Arcturus UNA Oligomer and LUNAR nanoparticle delivery technology. Under the deal, Arcturus will receive an upfront payment, R&D support, development and sales milestone payments, as well as royalty payments on any future licensed product sales.

GSK invests 95 million into Altius

GlaxoSmithKline is investing $95 million into Altius Institute for Biomedical Sciences (Seattle, WA, USA) to work on cell research. The partners have entered a 10-year collaboration supported by $95 million in cash and other resources from GSK to advance the Institute’s basic research and technology efforts.

Bayer and Johns Hopkins unite in ophthalmic research agreement

Bayer has signed a five-year agreement with Johns Hopkins University (Baltimore, MD, USA) to discover and develop new therapies for eye diseases. Under the terms of the pact, Bayer and the Wilmer Eye Institute of Johns Hopkins will jointly carry out research into new targets and disease mechanisms, drug delivery technologies and biomarkers for eye conditions with high unmet medical need. Bayer will have exclusive rights to option all drug candidates that emerge from the collaboration Financial terms of the deal were not disclosed. 

AstraZeneca enters diabetes and kidney disease deal with French INSERM

AstraZeneca has announced a three-year research agreement with French National Institute of Health and Medical Research (INSERM) to research into new therapeutic approaches to type II diabetes and chronic kidney diseases. Financial terms were not disclosed.

Eli Lilly announced two cancer research collaborations

Eli Lilly enters into two separate research collaborations with the Dana-Farber Cancer Institute (Boston, MA, USA) and the Sarah Cannon Research Institute (Nashville, TE, USA) to increase its discovery oncology efforts. The partnership between Lilly and the Sarah Cannon Research Institute will focus on the development LY3023414, a PI3K/mTOR dual inhibitor.

Philips and Siemens establish large contracts with North-American hospitals

Royal Philips, which now focusses on HealthTech, has announced a $500 million, 15-year contract with WMC Health, a 7-hospital health system based in Valhalla, New York which has almost 300 healthcare partners. The deal includes the provision of a range of clinical and business consulting services, as well as technologies such as imaging systems, patient monitoring, telehealth and clinical informatics solutions.

Siemens Healthcare also announced a 15-year contact with Canada's William Osler Health System, worth $124 million. The conglomerate will provide management services and solutions for its medical imaging equipment, which includes over 190 diagnostic imaging devices across radiology and cardiology.

WuXi AppTec partners with University of Pennsylvania to develop gene therapy products

WuXi App Tec (Wuxi, China) and University of Pennsylvania announced a collaboration agreement to work on viral vectors for the delivery of gene products. The Chinese company had already announced, in March, the opening of a 145,000-square-foot gene therapy facility at the Philadelphia Navy Yard Corporate Center.

Approval of drugs, vaccines, diagnostics and devices  

European regulator approves Sanofi-Pasteur MSD’s new Gardasil 9 vaccine

Gardasil 9, a new version of Sanofi Pasteur MSD’s Gardasil vaccine, has been approved by European regulators for protection of nine strains of the human papillomavirus (HPV). The new jab induced immunization against premalignant lesions and cancers affecting the cervix, vulva, vagina or anus and also against genital warts caused by the 9HPV strains covered by the vaccine.

US FDA approves St Jude’s neurostimulator

St Jude Medical (Saint Paul, MINN, USA) received FDA approval for its Brio Neurostimulator System to treat the symptoms of Parkinson’s and essential tremor. Brio is implanted under the skin of the upper chest and consists of a small battery-powered electrical pulse generator and leads (or wires) that attach to electrodes placed at specific locations within the brain. The continuous low-intensity electrical pulses block signals that can cause symptoms like tremoring hands. The device received a CE mark in 2009.

Europe approves Alcon’s trifocal intraocular lens

Alcon (Basel, Switzerland) received CE mark clearance for its AcrySof IQ PanOptix trifocal intraocular lens (IOL) for patients undergoing cataracts surgery with or without presbyopia. AcrySof enables the patients to satisfy his near, intermediate and distance vision needs with a single lens without the need of glasses or contact lenses.

Drugs at clinical stage

US FDA grants breakthrough status to Serus for its Clostridium difficile microbiome-base therapy

Seres Therapeutics (Cambridge, MA, USA) received FDA breakthrough status for SER-109, for the prevention of recurrent Clostridium difficile. SER-109 which consists of purified and encapsulated firmacute eubacterial spores, is the lead Seres Ecobiotic microbiome therapeutic currently under investigation for treating recurrent C. difficile infection.

US FDA grants orphan status to Protalex’s blood disease drug

Protalex (Florham Park, NJ, USA) received orphan drug status from the FDA for PRTX-100 as a treatment for immune thrombocytopenia. PRTX-100 is a highly purified form of Staphylococcal Protein A which has the ability, at very low concentration, to bind to human B-lymphocytes and macrophages and to modulate immune processes.

High dose of AstraZeneca’s lesirunad in combination hit primary goal in gout treatment

AstraZeneca reported positive Phase III results for investigational gout drug lesinurad. The combination of lesirunad (400 mg) and Takeda’s Uloric (febuxostat) lowered serum uric acid to a significantly higher level than Uloric or lesinurad alone. Lesinurad is a one daily Urate Anion Exchanger Transporter 1 (URAT-1) inhibitor.

Technology

Sequential immunizations could be solution to HIV vaccine

For some time scientists have proposed to use multiple immunizations, each tailored to a specific stage of the immune response, to generate a special class of HIV-fighting antibodies called neutralizing antibodies. New findings provide solid evidence supporting this approach.

Miscellaneous

MERS coronavirus contamination in Europe & in Asia

Health authorities have announced the first death of a 65 years old Western citizen from MERS coronavirus contamination probably contracted in the United Arab Emirates. The case was reported in a hospital of Ostercappeln (Germany)

….and the WHO announced the first case of a contaminated patient, originating from the Middle East, in Bangkok (Thaïland).

Risk of hepatitis E outbreak very high in Nepal

According to infectious disease experts, there is a “very high risk” of a hepatitis E outbreak for survivors of earthquake-ravaged Nepal during the upcoming monsoon season. Pregnant women are at particular risk.

Chinese official that probed the GSK bribery arrested for corruption

Sun Hongzi, Chinese former vice minister and deputy head of State Administration for Industry and Commerce (SAIC) has been arrested for corruption. The agency was at the center of the GlaxoSmithKline scandal and its bribery probe. The UK company had been fined $490 million, in 2014, after a Chinese court had found it guilty of bribery.

Bio and Business Events

BIO changes its name

BIO announced its name change from Biotechnology Industry Organization to Biotechnology Innovation Organization. "This is a great move that will help clarify for policymakers and the public the heart of our industry — scientific innovation that will help to heal, feed and fuel the world. Each day, our members use cutting-edge science and technology to deliver game-changing products, therapies and cures to improve the human condition," BIO President and CEO Jim Greenwood said. The new name will be introduced next year.

• 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)
• 15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)

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

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