Business

March 20, 2015

Eli Lilly and China Innovent Biologics sign a 10-year cancer deal

Elli Lilly has entered into a 10-year collaboration with Innovent Biologics (Suzhou, China) to develop, manufacture and commercialize three cancer drugs. Lilly will contribute its cMet monoclonal antibody and Innovent will contribute its CD 20 monoclonal antibody targeting protein and a pre-clinical immune-oncology product. Under the terms of the deal Innovent Biologics will lead the development and manufacturing of the three drugs while Lilly be responsible of the commercialization. Innovent will receive a $56 million upfront payment and $400 million in regulatory and sales milestones, Lilly will gain the rights to sell the three products outside of China.

March 23, 2015

Takeda and Immunogen strike a cancer drug deal for conjugate antibody products

Takeda signs a licensing deal with Immunogen (Waltham, MA, USA) to develop anti-cancer products using the antibody-drug conjugate (ADC) technology platform. Under the agreement Immunogen shall receive an upfront fee of $20 million for each new target and milestones payments of up to $210 million plus royalties on each developed product. Immunogen has already completed licensing deals with Genentech, Sanofi, Novartis and Bayer in the past.

March 24, 2015

Bristol-MyersSquibb acquires Novo’s autoimmune disease assets

Bristol-MyersSquibb acquires an exclusive global license to a Novo Nordisk (Copenhagen, Denmark) research programme focused on modulation of the innate immune system. In November of 2014, Novo had announced that is was stopping all inflammatory R&D programmes and focus on diabetes and obesity diseases.

March 25, 2015

AstraZeneca collaborates with Harvard in diabetes research

AstraZeneca has contracted a five-year research agreement with the Harvard Stem Cell Institute (HSCI) (Cambridge, MA, USA) to convert stem cells into human beta cells for use in the research and development of new diabetes treatments. Financial specifics were not revealed, but AstraZeneca said it will fund a team of investigators at HSCI and establish an in-house team in Mölndal (Sweden), dedicated to the collaboration.

Janssen and Philips partner to develop a blood test for brain disorders

Royal Philips (Amsterdam, the Netherlands) and Janssen Pharmaceutica, a Johnson & Johnson company, have entered a deal to develop a blood–based diagnostic device, based on the Minicare system developed by Philips, to improve the care of patients with neuropsychiatric disorders.

French Biotech companies successful with their IPOs

• Cellectis (Paris, France) raises $212 million at NASDAQ in its US IPO
• Ose Pharma (Paris, France) raises €21.1 million on EuroNext IPO in Paris

March 26,

Industry and academia join to form the GENE Consortium

Genomics England announces the launch of the GENE (Genomics Network for Enterprises) Consortium. Ten companies* have already joined the consortium which aims at mapping 100,000 genomes from patients with rare diseases or cancer, by 2017, in bringing industry expertise into the project.

* Members of the GENE Consortium are: AbbVie, Alexion, AstraZeneca, Biogen, Dimension Therapeutics, GSK, Helomics, Roche, Takeda and UCB

Approval of drugs, vaccines, diagnostics and devices

March 23, 2015

Boehringer and partner Lilly launch combo Glyxamin in the US

One month after the US FDA has approved the drug, Boehringer Ingelheim (Ingelheim, Germany) and Eli Lilly are launching Glyxami, the new diabetes combination therapy, across the US. Glyxami is a combination of Jardiance or empagliflozin – a sodium glucose co-transporter-2 inhibitor and Trajenta or linagliptin- a dipeptidyl peptidase-4 inhibitor, in an orally once a day pill.

March 24, 2015

EU Commission approves Novo Nordisk’s liraglutide for obesity

Novo Nordisk (Copenhagen, Denmark) has gained the European Commission’s approval to market an injectable formulation of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, as a treatment for obesity.

March 25, 2014

US FDA approves Sanofi Pasteur Quadracel pediatric vaccine

Sanofi Pasteur (Lyon, France) gets US approval for its Quadracel vaccine to protect children 4 to 6 years old against diphtheria, tetanus, pertussis and poliomyelitis.

Japan approves Gilead’s Sovaldi and Actelion Opsumit

Japan Ministry of Health Labor and Welfare (MHLW) approves Gilead’s Sovaldi (sofosbuvir) for the suppression of viremia chronic hepatitis C virus (HCV). Japan has one of the highest rates of liver cancer in the world. According to Gilead up to 30% of the chronically infected Japanese patients with HCV have the genotype 2 strain of the virus.

… and on March 26,

approves Actelion’s (Allschwil/Basle, Switerland) Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH).

Opsumit is a novel dual endothelin receptor antagonist (ERA) which has already been approved in the US in October 2013 and in the EU in December 2013. Actelion Pharmaceuticals Japan will co-promote Opsumit with Nippon Shinyaku (Kyoto, Japan).

US FDA approves the Mako robot for hip replacement 

Mako's Rio robot-assisted surgery system

Styker Orthopaedics (Mahwah, NJ, USA) gets US approval to use its Mako surgery system for total hip replacement. The first total hip surgery procedure with the Mako system was conducted in 2010, since then over 7,000 hip procedures have been performed with this system.

Drugs at clinical stage

March 22, 2015

US FDA grants AB Science orphan status for masitinib

US FDA grants AB Science (Paris, France) an orphan status for masitinib for the treatment of a rare degenerative disorder amyotrophic lateral sclerosis which induces progressive muscle paralysis. The prognosis of affected patients is poor with 10% of people surviving five years after diagnosis. Masitinib is a tyrosine kinase inhibitor which blocks mast cell-mediated release of cytotoxic substances that damage motor nerve cells. The drug is already approved for veterinary indications as Masivet in Europe since 2009 and in the U.S. as Kinavet since 2011.

March 24, 2015

… and Agios for AG-348

US FDA grants Agios Pharmaceuticals (Cambridge, MA, USA), an orphan drug status for AG-348 to treat pyruvate kinase (PK) deficiency, a rare and severe genetic form of hemolytic anemia with no approved disease modifying treatment. AG-348 is a first-in-class orally activator of pyruvate kinase-R (PKR) enzyme.

March 24, 2015

Merck’s Keytruda with spectacular results in first-line melanoma trial

Merck’s Keytruda (pembrolizumab) has been approved by US FDA last year for the treatments of patients with advanced unresectable melanoma who were not responding to other drugs. The company has now stopped an ongoing Phase III study, after the drug had demonstrated “a statistically significant and clinically meaningful improvement in overall survival and progression-free survival” in untreated patients compared to Yervoy. Keytruda is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma.

March 26, 2015

Genfit disappoints with the phase 2 results of GFT505 for NASH

Genfit (Lille, France) announces topline results of a one-year phase 2 trial with GTF505 in Non-Alcoholic Steato-Hepatitis (NASH) where the study did not meet the primary end points. The company explains that these results are due to an unexpected high rate of responders in the placebo group along with a high number of sites with a limited sample size. Nevertheless the evaluation of various biomarkers confirms the biological activity and the safety assessment of GFT505 and Genfit intends to start a phase 3 study by the end of the year.

Ebola

US FDA approves Cepheid rapid Ebola test for emergency use

Cepheid (Sunnyvale, CA, USA) has received US approval for its Xpert Ebola testing for emergency use.

First Ebola vaccine based on 2014 virus strain provokes an immune response

Until now all tested Ebola virus vaccines have been based on the virus strain from the disease outbreak at the Ebola river in Zaire in 1976. Researchers now have shown that a vaccine based on the current strain of Ebola virus was triggering an immune response and was safe in a phase I study.

A Chinese Ebola vaccine in Phase I trial shows immune response

A Chinese candidate recombinant adenovirus type-5 vaccine developed by Beijing Institute of Biotechnology and Tianjin CanSino Biotechnology, showed immune responses in a phase I study conducted in Jiangsu Province (China)

GSK and NewLink Ebola vaccine are safe

The experimental Ebola vaccines from GSK and NewLinks genetics are safe in an interim mid-stage trial performed in Liberia on more than 600 patients.

Miscellaneous

March 24, 2015

Gilead warns of fatal reactions to Sovaldi or Harvoni and Amiodarone

Gilead has send to healthcare professionals a letter indicating the potential harmful effect of interactions between Sovaldi or Harvoni (two antiviral treatment of hepatitis C) and amiodarone (an anti-arrhythmic agent). Gilead said in its letter that, "The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA (direct antiviral agent) is unknown." It said it is recommended that patients who need amiodarone and Sovaldi be monitored in an inpatient setting for the first 48 hours, followed by daily outpatient or self-monitoring of their heart rate for at least the first two weeks of treatment. It said that because amiodarone has a "long half-life," patients who have just gone off of amiodarone ahead of starting Harvoni or Sovaldi along with a DAA should also be monitored.

Type 1 diabetes market will increase from $6.6B in 2013 to $13.6B by 2023

According to a report from GlobalData, type 1 diabetes market will expand from $6.6 billion to an estimated $13.6 billion by 2023 with the US remaining the biggest market mainly because of an average insulin pricing five to six time higher than in other western countries.

2015: The year of the blockbusters?

According to the Thomson Reuter’s “2015 Drugs to Watch” report, as many as 11 drugs, with blockbuster potential, are expected to be approved by the regulatory bodies in 2015. As stated by us previously the emergence of these novel therapeutic approaches is inducing several consequences: a substantial increase in classical as well as innovative deal transactions, an in depth analysis and study on how payers are going to handle the issue of pricing and paying for innovation, an overall reflection how sponsors of innovation and payers will interact to make sure innovation does not get restricted by pricing issues.

Bio and Business Events

• China Bio Partnering Forum on April 22-23 in Shanghai (China)
• Biotrinity 2015 on May 11-13, London (UK)
• 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)

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

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