Acquisitions /mergers/joint-ventures

Mylan offers $29 billion to acquire Perrigo

Generic company Mylan (now located in Potters Bar, UK) offered almost $29 billion ($205 per-share) to acquire Perrigo (Dublin, Ireland), an over-the –counter drug company, in a cash and stock deal. Perrigo would bring a large number of over-the-counter brand drugs as well as Elan’s acquired share of Tysabri. Some analysts consider the Mylan bid as a defensive move to avoid a hostile takeover.

Business

April 2, 2015

Sanofi signs a computational partnership worth $120M with Schrödinger

Sanofi (Paris, France) announces that it signed a deal with Schrödinger (New York City, NY, USA) which will provide computational resources for up to 10 discovery programs under a multi-year collaboration deal worth $120 million for the software company.

…and teams up with VBI Vaccines

Sanofi Pasteur (Lyon France) and VBI Vaccine (Cambridge, MA, USA) enter into a R&D collaboration to use VBI’s Lipid Particle Vaccine formulation to improve the stability of a Sanofi vaccine candidate. Financial terms were not disclosed.

April 6, 2015

BMS and UniQure collaborate in gene therapy

Bristol-Meyers Squibb (New York City, NY, USA) and UniQure (Amsterdam, The Netherlands) enter into an exclusive strategic collaboration to develop gene therapies for cardiovascular diseases. The deal will give BMS an exclusive access to UniQure gene therapy technology platform for up to ten targets including S100A1, a calcium sensor to treat congestive heart failure. The deal is structured around a $100 million near-term payment, the acquisition of 4.9% stake in UniQure for at least $32 million, with further stake acquisition at a 10% premium, as well as milestone payments of up to $254 million for SA100A1 and milestone payments for each further development candidate.

Eli Lilly and OncoMed agree to combine some of their drugs in a cancer trial

To further continue a now well establish trend, companies agree to assess the combination of their drugs in cancer trials. This week Eli Lilly (Indianapolis, IN, USA) and OncoMed (Redwood, CA, USA) have announced that they will collaborate in a midstage trial to evaluate the combination of OncoMed’s Demcizumab (a DLL4 antibody) with Lilly’s Alimta (pemetrexed for injection) and carboplatin for the treatment of first-line advanced non- small cell lung cancer (NSCLC).

Aduro sets up for NASDAQ IPO

Aduro Biotech (Berkeley, CA, USA), a company specialising in the discovery and development of novel cancer treatments, which announced a week ago a strategic collaboration with Novartis worth up to $750 million, is now set up for its initial public offering (IPO) on the NASDAQ and expects to raise $93 million.

…. and Labco prepares its EuroNext IPO

Labco Group (Paris, France) a French medical diagnostic company prepares its IPO on the EuroNext exchange in Paris and hopes to raise €320 million in the offering. This constitutes the third IPO for diagnostic companies within the last weeks (RainDance in March and OpGen in April).

April 7, 2015

Roche and Foundation Medicine enter a strategic cancer agreement worth $1.2 billion

Roche (Basel, Switzerland) and Foundation Medicine (Cambridge, MA, USA) a cancer diagnostic company, announced a $1.2 billion deal aimed at building a cancer R&D agreement. Under the terms Roche will pay up to $150 million over the next five years into a broad R&D collaboration. Roche also purchased 5 million newly issued shares investing $250 million into the Massachusetts based company.

Approval of drugs, vaccines, diagnostics and devices

US FDA finalizes the accelerated approval pathway for critical devices

A year after the initial proposal, US FDA finalizes the approval for an accelerated review program for critical medical devices. The program applies to devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. To be accepted into the program, the device must treat a condition or diagnose a condition for which no appropriate means of diagnosis exists, provide a clinically meaningful advantage over existing technologies, or be in the best interest of patients”, the FDA says.

Drugs at clinical stage

March 25, 2015

US FDA grants Marinus ganaxolone orphan status for the treatment of rare epilepsy

Marinus Pharmaceuticals (Radnor, PA, USA) received an orphan status designation from the FDA for its investigational drug ganaxolone for the treatment of patients with protocadherin 19 gene family epilepsy, a rare syndrome affecting young females. Ganaxolone is a synthetic analog of allopregnanolone, an endogenous neurosteroid produced in the central nervous system.

…and to Curis for its lymphoma drug

Curis (Lexington, MA, USA) an oncology-focused company, announces that it has received orphan drug status from the FDA for its investigational drug CUDC-9O7, for the treatment for diffuse B-cell lymphoma.

US FDA accepts Novo’s reapplication for Tresiba

Novo Nordisk (Copenhagen, Denmark) announced that the US FDA has accepted the reapplication of its long-acting insulin Tresiba and hopes to launch the drug in the US before year end, six months ahead of earlier projections. Tresiba will be directly competing with Sanofi’s Toujeo which was launched earlier this month.

US FDA grants Clovis’ rucaparib breakthrough status for ovarian cancer

Clovis Oncology (Boulder, CO, USA) receives FDA breakthrough therapy designation for the use of rucaparib as monotherapy treatment of advanced ovarian cancer. Rucaparib is a potent orally active poly ADP Ribose polymerase PARP1 and PARP2 inhibitor.

… to two Merck’s hepatitis C drugs

Merck & Co (Kenilworth, NJ, USA) received FDA breakthrough status for grazoprevir and elbasvir. The drugs cured at least 90% of infected patients. Both drugs had already been granted breakthrough status in 2013 for their use in patients with hepatitis C genotype. The new designation is for use in patients with chronic hepatitis C genotype 4 and patients with hepatitis C genotype 1 who have end-stage kidney disease and are undergoing haemodialysis.

…. and to DBV’s peanut allergy patch

DBV Therapeutics (Bagneux, France) has also been awarded breakthrough status by US FDA for its Viaskin electrostatic peanut allergy patch, making it the first such designation with the food allergy field. This patch delivers peanut protein directly into the upper layer of the skin and activates the immune system without entering the bloodstream and thus significantly reduces the risk of anaphylaxis in children eating peanuts. The FDA’s breakthrough designation “highlights the urgent need to find a treatment for this life-threatening disease,” noted DBV’s chairman and chief executive Pierre-Henri Benhamou.

 Regulus and partner AstraZeneca advance RG-125 for the treatment of NASH

Regulus Therapeutics (La Jolla, CA, USA) and development partner AstraZeneca will proceed with the clinical development of RG-125 for the treatment of nonalcoholic steatohepatitis (NASH) in type diabetic patients and will pay Regulus a $2.5 million milestone. RG-125 is an N-acetylgalactosamine conjugated anti-miR targeting microRNA-103/107.

Technology

Merck accesses Arvinas PROTAC technology

Arvinas (New Haven CT, USA) has developed a new technology named PROTAC for proteolysis-targeting chimeras and creates bifunctional small molecules to target proteins and remove them from cells. The technology allows specific targeting of uncontrolled proteins and eliminates them through the Ubiquitin/Proteasome system. Merck & Co has entered a collaboration with Arvinas to assess the potential of this novel approach of designing new drugs.

Ebola

US DARPA selects Inovio to lead an Ebola collaborative research program

The US Defense Advanced Research Projects Agency (DARPA) selected Inovio Pharmaceuticals (Plymouth Meeting, PA, USA) a $45 million program to lead a development collaboration aimed at finding multiple treatment and prevention approaches to treat Ebola. Other partners are GeneOne Life Sciences, MedImmunne, and Pennsylvania, Emory and Vanderbilt Universities. Development programs include monoclonal antibodies as well as vaccines.

Asian Events

Chinese FDA issues stem cell research guidelines

China has issued a draft proposed guidance on stem cell research which merges two existing regulations that separated approvals for companies conducting therapies and those for patients.

Japan promoting “sakigake” its fast-track innovative approval

Japan Ministry of Health, Labor and Welfare (MHLW) wants companies to offer innovative drug, medical devices and regenerative medicine candidates for its accelerated approval “sakigake designation system”. The selected product must display a novel approach, show high efficacy and developed for Japan ahead of any western country. Under the “sakigake system”, consultation of submitted files will be reduced from two to one month and the review period from twelve to six months, and is expected to be implemented in 2015.

Riken’s new president intends to increase partnerships and fix scandal over stem cell research

Hiroshi Matsumoto, previous president of Kyoto University and recently appointed as new president of the Riken Research Institute (Japan), pushes institutional reforms and shift the focus from publishing articles to build new partnerships. Riken, regarded as the Japanese research flagship institute, had recently to deal with a scandal about a stem cell research fraud.

South Korea names Seunghee Kim as first women to lead the Food and Drug Ministry

South Korea President Cheong Wa Dae appointed Seunghee Kim head of Ministry of Food and Drug Safety to become the first female in a ministry position. Kim had been the first head of the National Food and Safety Evaluation agency. Asian device market could reach $15 billion in 2017 A survey of the top 10 medical devices makers forecasts that the Asian market will reach the $15 billion mark in 2017, a fantastic increase from just $2 billion in 2012.

Miscellaneous

Sanofi Pasteur “flipping the model” for its dengue vaccine

Sanofi Pasteur (Lyon, France) will not use its traditional model to launch its dengue vaccine. According to Guillaume Leroy, head of the Dengue programme, the company is “flipping its model” to favor wide access and look for highly endemic and middle-income countries first. The dengue vaccine project is the largest investment Sanofi Pasteur ever made with 20 years of research and development efforts and about 1.5 billion investment including $300 million in the transformation of a manufacturing facility in Neuville-sur-Saône (France).

GSK moves its US vaccine R&D hub to Maryland

Just a few weeks after the multi-billion business swap with Novartis has been completed, GSK announces the relocation of its US vaccine R&D global center to Rockville (Maryland, USA). The facility, which currently houses a manufacturing plant, will open by the end of the year and will consolidate existing locations in Philadelphia (PA) and Cambridge (MA). With the consolidation complete, Rockville will become one of the three GSK global vaccines R&D centers including Rixensart in Belgium and Siena in Italy.

Bio and Business Events

• China Bio Partnering Forum on April 22-23 in Shanghai (China)
• Biotrinity 2015 on May 11-13 in London (UK)
• MedTech Partnering Forum on May 28-29 in Tokyo (Japan)
• IIR’s IN3 EuroMedtech 2015 on June 10-11 in Vienna (Austria)
• BIO International Convention on June 15-18 in Philadelphia (USA)
• Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
• BioPharm America 2015 on September 15-17 in Boston (USA)

Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)

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