Acquisitions /mergers/joint-ventures
March 30, 2015
Fujifilm acquires Cellular Dynamics for $307M
In recent previous newsweeks we had indicated that Canon and Nikon had entered the biomedical field. We now see that Fujifilm Holdings (Tokyo, Japan) acquires Cellular Dynamics International (CDI, Madison, Wis, USA) in a deal worth $307 million in buying all issued and outstanding shares for $16.5 each. The offer represents a premium of 108% of CDI’s closing price of March 27. Fujifilm which intends to strengthen its presence in the biopharmaceutical field will now have access to CDI’s platform and be able to produce, on an industrial scale, high-quality functional human cells including pluripotent stem cells. CDI will continue to run its operations in Madison, Wisconsin and Novato California as a consolidated subsidiary of Fujifilm.
March 31, 2015
Teva acquires Auspex for $3.5Bn
Teva (Jerusalem, Israel) acquires neurology group Auspex Pharmaceuticals (La Jolla, CA, USA) for $ 3.5Bn, in buying in cash all outstanding shares for $101 each. The deal will strengthen Teva’s pipeline in the CNS. Auspex is a biopharmaceutical company specializing in applying deuterium chemistry to know molecules. Its lead product, SD-809, or deutetrabenazine, is being developed for the treatment of chorea associated with Huntington’s disease, tardive dyskinesia and Tourette syndrome.
Business
March 30, 2015
Novartis partners with Aduro in an immunotherapy deal worth up to $750M
Novartis and privately-held Aduro Biotech (Berkeley, CA, USA) announce an agreement to partner in the research and development of novel cancer immunotherapies in a deal worth up to $750 million. The deal is structured around an upfront payment of $200 million and development and regulatory milestones of up to $500 million as well a first 2.7% equity investment from Novartis worth $25 million followed by a second one of the same amount sometime in the future. Aduro’s proprietary cyclic nucleotide technology resides in synthetic small molecule immune modulators that target the Stimulation Interferon Gene (STING) receptor. Products arising from the collaboration will be commercialized by Aduro in the US and by Novartis outside of the US.
Bayer extends its collaboration with MIT and Harvard
Germany’s Bayer which already partners with MIT and Harvard (both in Cambridge, MA, USA) in oncology research now extends its partnership to include cardiovascular genomics and drug discovery. The alliance will search for genetic biomarkers of patient risks to drugs that treat cardiovascular diseases.
Merck Serono signs a $941M cancer immunotherapy deal with Intrexon
Merck Serono (Darmstadt, Germany) and Intrexon (Germantown, Md, USA) enter a licensing deal worth $941 million aiming at developing new Chimeric Antigen T (CAR-T) based cancer immunotherapy treatments. The deal is structured around a $115 million upfront, research funding and development and regulatory milestones of up to $826 million. Under the agreement Merck will get exclusive access to Intrexon’s platform technologies.
….and with MMV in the antimalarial field
Merck Serono signs an agreement with Medicines for Malaria Venture (MMV) – a non-profit public-private foundation based in Switzerland- to obtain rights to develop DDD107498, an investigational antimalarial compound. Details of the business agreement were not disclosed.
March 31, 2015
Merck and Syndax collaborate to combine their cancer drugs
Merck & Co (Kenilworth, NJ, USA) and Syndax Pharmaceuticals (Waltham, MA, USA) agree to assess the effects of the combination of Merck’s Keytruda or pembrozuliumab – a programmed death receptor checkpoint (PD-1) inhibitor- and Syndax’s entinostat- an oral histone deacetylase (HDAC) inhibitor- in a Phase II clinical clinical trial as a treatment for advanced non-small cancer lung cancer with the hope to identify a synergistic effect.
Quintiles and Quest form a laboratory service joint venture company
Quintiles (Research Triangle, NC, USA) and Quest Diagnostics (Madison, NJ, USA) form a joint venture that will offer worldwide clinical trials laboratory services. The transaction is expected to close in Q3, 2015 after which Quintiles will own 60% and Quest 40% of the new joint venture.
Redx Pharma raises £15 M in UK IPO
Redx Pharma (Liverpool, UK) has raised £15 million in an initial public offering (IPO) on the Alternative Investment Market (AMI) London stock exchange market in order to strengthen its pipeline in the infectious diseases and oncology area.
Sensorion prepares for its IPO on AlterNext in Paris
Sensorion (Montpellier, France), an inner ear disease specialist, has set terms for its IPO and represents the fourth biotech IPO on the Parisian stock exchange market since the beginning of the year. The company expects to raise €12 million.
April 2, 2015
US Movantik launch by AstraZeneca triggers a $100 M milestone payment to Nektar
Nektar Pharmaceuticals (San Francisco, CA, USA) announces receipt of a $100 million milestone payment from AstraZeneca upon the launch of Movantik (naloxegol) and will receive an initial royalty rate of 20% on net sales. Movantik, is indicated for the treatment of opioid-induced constipation in adults with chronic, non-cancer pain and was approved by US FDA in September 2014. AstraZeneca and Daiichi Sankyo will jointly commercialise Movantik in the US.
Medtronic acquires Diabeter and enters the healthcare solution provider business
Medtronic (Dublin, Ireland) is expanding into the healthcare business with the acquisition of Diabeter, an innovative Netherlands-based diabetes clinic and research center. "This acquisition marks Medtronic's first entry into a diabetes integrated care model approach and signifies that Medtronic Diabetes is more than pumps and sensors, we are a holistic diabetes management company focused on making a real difference in outcomes and cost," Hooman Hakami, Medtronic's diabetes group president, said in a statement. Diabeter manages more than 1,500 patients using innovative technologies such as the Diabeter Dashboard for connecting patients and physicians in order to improve self-management of the disease, Medtronic says.
Approval of drugs, vaccines, diagnostics and devices
March 29, 2015
Sanofi’s Genzyme gets Japanese approval for Eliglustat
The Japanese Ministry of Health, Labour and Welfare (MHLW) approves Genzyme’s Cerdelga (Eliglustat) for the treatment of patients with Gaucher disease. The drug was already approved by the FDA in August 2014, by the European Commission in January 2015 and the Australian Therapeutics Goods Administration in February 2015
The European Committee for Medicinal Products for Human Use recommends the approval for five new drugs – Levatinib from Eisa, a tyroisine kinase inhibitor for the treatment of thyroid cancer – Gardasil 9 from Sanofi Pasteur for the prevention of certain diseases linked to human papillomavirus – Akynzeo (netupitant/palonosetron) from Helsinn, for the prevention of chemotherapy induced nausea and vomiting – Synjardy (empaglifozin/metformin) from Boehringer Ingelheim, for the treatment of type 2 diabetes – Voriconazole from Hospira for the treatment of fungal infections.
April 1, 2015
US FDA approves Teva’s new asthma inhaler
Teva (Jerusalem, Israel) has obtained US FDA approval for its breath-actuated dry-powder inhaler ProAir RespiClick to treat reversible obstructive airway diseases.
… and Novartis’ iron overload drug
Novartis has obtained an accelerated US FDA approval for Jadenu (desefasirox) for the treatment of chronic iron overload in blood transfusion recipients who have non-transfusion- dependent thalassemia syndromes.
China FDA has a backlog of 18,500 drugs
According to the China FDA’s Center for Drug Evaluation the regulator has efficiency issues with a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% over 2013.
Drugs at clinical stage
Wuxi MedImmunne gets a CFDA approval to review its rheumatoid arthritis mAb drug
China FDA accept a New Investigational Drug (IND) application for MED15117, submitted by WuXi MedImmunne Biopharmaceutical, a Chinese joint venture formed by WuXi AppTec and MedImmunne in 2012. MED15117 is a novel anti-IL6 monoclonal antibody (mAb) developed by the JV to treat rheumatoid arthritis.
April 1, 2015
US FDA grants orphan drug status to lymphoma drug from Idera
Idera Pharmaceuticals (Cambridge, MA and Exton, PA, USA) experimental drug IMO-8400 was granted orphan drug status from the FDA as a treatment for diffuse large B-cell lymphoma. IMO-8400 is a first in class synthetic oligonucleotide-based antagonist of endosomal Toll-like receptor (TLR) TLRs 7, 8 and 9.
Technology
March 29, 2015
An oral hepatitis B vaccine: a reality soon to come?
In a recent study researchers report progress toward a new method producing vaccines using genetically modified corn. The approach could rapidly lead to an oral hepatitis B vaccine that would cost less than $1 per dose to manufacture.
Ebola
April 1, 2015
VSB-ZEBOV, an experimental Ebola vaccine is safe and prompts immune response in an early stage clinical trial
Miscellaneous
Sanofi’s new CEO Olivier Brandicourt took office on April 2, 2015
Pfizer stops Prevnar vaccine sales in China
In response to the Chinese government refusal to renew its import license for the pneumococcal vaccine Prevnar, Pfizer decides to stop all sales operation for the vaccine. No explanation was given why the import license was not renewed.
Bio and Business Events
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Swiss-China Life Science Events on April 8 in Basle (Switzerland)
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China Bio Partnering Forum on April 22-23 in Shanghai (China)
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Biotrinity 2015 on May 11-13, London (UK)
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MedTech Partnering Forum on May 28-29, in Tokyo (Japan)
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IIR’s IN3 EuroMedtech 2015 on June 10-11 in Vienna (Austria)
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BIO International Convention on June 15-18 in Philadelphia (USA)
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Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
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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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