Acquisitions /mergers/joint-ventures

Mylan still active on the Perrigo bid

Analysts believe that the current offer of $75 per share in cash and 2.3 Mylan share for each Perrigo share is unlikely to change. Mylan says it still thinks it's possible to work something out directly with Perrigo and thus protect itself from a Teva takeover.

Novartis acquires Spinifex Pharma for $200 million

Novartis has acquired Spinifex Pharmaceuticals (Preston, Australia), a pain treatment specialist, for a $200 million upfront payment plus undisclosed milestones. Spinifex lead candidate EMA401, is an angiotensin II (AT2) receptor antagonist which could become a first in class oral treatment for chronic pain, such as neuropathic pain, without central nervous system side effects.

Qiagen forms a Joint Venture with Biotype Diagnostics

Qiagen (Hilden, Germany) is teaming up with Biotype Diagnostics (Dresden, Germany) to create a Joint Venture named Biotype Innovation geared towards companion diagnostics testing. Qiagen will provide technology and access to global markets and Biotype will contribute its test development know-how and scientific network. The Biotype Innovation JV will be headquartered on Biotype's Dresden campus.

Eurofins forms a Joint Venture with Emory University Genetics Laboratory

Eurofins (Nantes, France and Luxemburg) continues its business development activities through the creation of a joint venture with Emory University Genetics Laboratory (EGL). Under the terms of the deal Eurofins will acquire 75% stake in EGL and gain access to testing for rare and common genetic disorders. The formed JV named “EGL Genetic Diagnostics” will generate revenues of $15 million in 2015.

Business

Celgene and Juno enter a $1 billion immunotherapy collaboration

Celgene (Summit, NJ, USA) and Juno Therapeutics (Seattle, WA, USA) have signed a 10 year, 1 billion R&D collaboration agreement to treat cancer and autoimmune diseases. The initial work will be focusing on T cell therapeutic strategies such as Chimeric Antigen Receptor Technology (CAR-T) and T Cell Receptor (TCR) technologies including Juno’s CD19 and CD22 directed CAR-T products. Under the terms of the deal Juno will receive a $150 million upfront payment plus additional milestones and Celgene will acquire 9.1 million of Juno’s shares at $93 a piece with the option to increase its stake to up to 30%.

Incyte an Immunovaccine evaluate a new immunotherapy combination

Immunovacvine (Halifax, Nova Scotia, Canada) and Incyte (Wilmington, DL, USA) will collaborate to evaluate the combination of Immunovaccine’s T cell activating DPX-Survivac and Incyte’s epacadostat (INCB24360) for the treatment of platinum-sensitive ovarian cancer.

…..and Immunocore and Eli Lilly evaluate their own immuno-oncology combination

Immunocore (Oxford, UK) will collaborate with Eli Lilly to assess the potential of the combination of Immunocore's lead T cell receptor (TCR)-based therapy with galunisertib and merestinib in patients with metastatic cutaneous and uveal melanomas.

AstraZeneca gets into anti-addiction programme with Eolas for $145 million

AstraZeneca and EolaTherapeutics (Carlsbad, CA, USA) have entered into a global license and partnership to develop new therapies for smoking cessation and other addiction indications based on Eolas’ Orexin-1 Receptor Antagonist programme (EORA).  EORA compounds are highly specific orally active orexin-1 receptor antagonists, which block nicotine addiction and relapse. Under the deal Eolas will receive upfront and milestone payments as well as royalties on commercial sales of products from the collaboration.

3SBio acquires rights from Apexigen to develop an anti-TNF agent

3SBio, a China-based biopharmaceutical firm, has obtained the global rights to an anti-TNF monoclonal antibody, for autoimmune disease, including rheumatoid arthritis, which was discovered by Apexigen (San Carlos, CA, USA).

ViiV will produce dolutegravir an HIV drug in China

ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline, has entered a manufacturing agreement with Desano Pharmaceuticals (Shanghai, China) to produce dolutegravir in China. The deal will provide an additional source of the dolutegravir active pharmaceutical ingredient and will allow ViiV to offer a competitive supply of the drug in China and certain developing countries

Actelion creates Vaxxilon, a vaccine start up

Actelion (Allschwil, Switzerland) has invested €30 million to set up Vaxxilon, a synthetic carbohydrate vaccine-focused startup, with a mission to develop a programme licensed from the Max Planck Society. Vaxxilon will be led by Tom Monroe who has served in multiple roles at Actelion over the past 15 years.

Philips and Teva get their Israeli med tech incubator active

Royal Philips and Teva Pharmaceuticals had announced earlier this year that they would invest $26.5 million into early stage med tech companies in Israel through their Sanara Ventures joint venture. The company announced now that it has already invested into two companies: Kaleidoscope Medical, which developed a system for X-ray radiation shielding during catheterization; and MGD, which is developing a portable device for measuring lung function in patients with chronic obstructive pulmonary disease.

More Initial Public Offerings (IPOs)

• Shenzhen Kangtai Biological Products, a China-based vaccine products company, has filed its ChiNext IPO application with the Chinese SRC and plans to raise $90 million to fund its production and business expansion projects.
• Seres Therapeutics (Cambridge, MA, USA) who develops an oral treatment for Clostridium difficile, raised $134 million in its IPO while it had anticipated a $100 million debut.
• ConforMIS (Bedford, MA, USA) a custom knee implant company has priced its IPO at $135 million on NASDAQ. The company has already sold more than 30,000 of its customized knee implants in the U.S. and Europe.
• Natera (San Carlos, CA, USA) a genetic testing and diagnostic company is expecting to raise $175 million in its NASDAQ IPO.
• Cellnovo (Paris, France) expects to raise between €35 and €46.3 million on Euronext to develop its connected micro insulin pump.
• Biocorp (Issoire, France) launches its IPO on Alternext in Paris and expects to raise up to €12.2 million to further develop its DataPen, a smart injection pen that automatically transmits data to smartphone apps.

Approval of drugs, vaccines, diagnostics and devices

Boehringer Ingelheim’s combination drug Spiolto approved in Europe for COPD treatment

European Commission has approved Boehringer Ingelheim’s combination lung drug Spiolto for the treatment of chronic obstructive pulmonary disease (COPD). The drug combines Spiriva, a long acting muscarinic antagonist with Striverdi (olodaterol) a long-acting β2-adrenergic. The drug is delivered through the Respimat mist inhaler, which is designed to allow for more natural inhalation than standard devices. The combination drug was already approved by the US FDA in May.

US FDA approves Vertex’s new cystic fibrosis drug Orkambi

Vertex Pharmaceuticals (Boston, MA, USA) got FD approval for its first in class cystic fibrosis (CF) drug Orkambi (lumacaflor/ivicaflor) directed at treating the cause of the disease in people who have two copies of the F508del mutation. The FDA had previously granted the drug breakthrough therapy designation and priority review as studies have demonstrated a “substantial” improvement over other therapies. Cystic fibrosis is a serious genetic disorder that results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems.

US FDA approves Proteus ingestible sensor for measuring medical compliance

Proteus Digital Health (Redwood City, CA, USA) had already received FDA approval for its ingestible sensor back in 2012. But now the US health agency has expanded the label for the product to be used to measure medication adherence which makes it the first device to have received this particular indication. The Proteus system includes an ingestible sensor that communicates with an adhesive patch worn on the patient torso. The patch records time of ingestion along with steps, rest and heart rate communicate to a mobile app via Bluetooth.

US FDA approves TVU as alternative confirmation of Bayer’s Essure permanent birth control

Bayer Healthcare Pharmaceuticals has received FDA approval for its transvaginal ultrasound (TVU) as an alternate confirmation for its Essure permanent birth control. TVU is a test which uses sound waves to look into a woman's reproductive organs. The sound waves are emitted via a probe placed in the vagina.

Drugs at clinical stage

Roche‘s multiple Sslerosis with positive Phase 3 results

Roches’ multiple sclerosis (MS) investigational drug ocrelizumab meets its clinical end points in two phase 3 studies. The Swiss company announces that the drug significantly reduced the annualized rate of multiple sclerosis over a two-year period when compared to interferon beta-1a. The humanized monoclonal antibody also significantly reduced the progression of clinical disability and the number of lesions in the brain versus interferon beta-1a. These results should put the drug on regulatory filing for early 2016.

Boehringer/Vitae diabetes investigational drug misses clinical endpoint

An investigational diabetes drug co-developed by Boehringer Ingelheim and Vitae Pharmaceuticals (Fort Washington, PA, USA) has failed to reach its clinical endpoints in reducing blood sugar levels in a phase 2 trial. The trial was testing VTP-34072 – an HSD1 inhibitor, also known as BI187004 ­– as an add-on to metformin in overweight type 2 diabetics. This is the second setback for the Boehringer/Viatea partnership after the announcement of the hold of their Alzheimer’s drug BI1181181 in February.

Technology

Blackberry working on a bacteria-free smartphone for health professionals

Blackberry (Waterloo, Ontario, Canada) is considering building a new device specific to healthcare industry that would feature bacteria-fighting technology. "Healthcare workers have to be worried about one less thing to wipe down" with a bacteria-free handset, BlackBerry CEO John Chen stated .The Canadian mobile manufacturer is partnering with ThoughtWire and Cisco Systems to provide nurses and doctors in a Mackenzie Richmond Hill Hospital (Canada) unit with a portable messaging and alert system. BlackBerry will be providing the software and devices.

Miscellaneous

New case of Ebola

Two months after Liberia had been declared Ebola free, one new case has been identified in the province of Margibi where the patient died.

Novo stops supply of Tresiba in Germany

Novo Nordisk (Copenhagen, Denmark) will cease supplying Tresiba (insulin degludec) in Germany after September 2015 following a disagreement over pricing. “If we were to accept the price set by the GKV-Spitzenverband, which refuses a premium price for the product, we would undermine our ability to research and develop medical innovations for people with diabetes” the company said.

Biogen builds a $1billion plant and adds 400 jobs in Switzerland

Thanks to a very promising pipeline of drug candidates Biogen (Cambridge, MA, USA) has decided to increase its biologics manufacturing capacity in adding a new $1 billion facility in Lüterbach (Switzerland) The new facility will add 400 new jobs and should be fully operational by 2021.

Novasep invest €10 million in its production facility in France

Novasep (Lyon, France), a CMO company, announces the expansion of its Le Mans (France) facility which will be producing antibody-drug conjugates (ADC) in 2016.

US Department of Justice is demanding Novartis a fine of $3.4 billion

The US Department of Justice and 11 US states want Novartis to cough up $3.4 billion in civil fines and damages as restitution for its alleged misconduct in promoting some of its drugs to federal healthcare programs that resulted in over-payments. The Justice Department has identified 166,011 Medicare and Medicaid claims related to the alleged kickbacks, and more than $500 million in government payments for those scripts. It's asking for triple that amount in damages and it is demanding as much as $1.83 billion in fines for those 116,011 allegedly false claims. The case stems from a whistleblower lawsuit filed in 2011 by a former sales manager.

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)
• BIO Japan on October 13-16 in Yokohama (Japan)
• 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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