Annoucement

December 10, 2014 

A New President at the European Federation of Pharmaceutical Industries and Associations (EFPIA)

Sanofi head Chris Viehbacher resigned as EFPIA boss at the end of October. Joe Jimenez, Novartis’ CEO, has been officially unveiled as President of EFPIA until June 2017

Acquisitions /Mergers/Joint-ventures

December 8, 2014 

Merck  acquires Cubist for $9.5 billion

Merck(MSD) has agreed to acquire antibiotics maker Cubist Pharmaceuticals (USA) for $8.4 billion or about $102 per share plus 1.1 billion in net debt. The acquisition will give Merck access to Cubist's drugs used mainly in hospitals to treat infectious diseases and other illnesses, including Cubicin which targets treatment-resistant S. aureus infections.

Business

December 9, 2014 

Pfizer agrees to collaborate with Spark Therapeutic and moves into gene therapy

Pfizer and Spark Therapeutics (USA) agreed to collaborate in the development of treatments for hemophilia B based on Spark’s gene therapy technology. Spark will handle the Phase I and II trials, while Pfizer will be in charge of late-stage trials, regulatory filings and product sales. The deal entitles Spark to $20 million upfront and up to $260 million in milestone fees plus sales royalties. Pfizer has tasked Professor Michael Linden from King's College London to create a gene therapy group within the company's rare disease unit.

Approval of drugs

December 10, 2014

FDA clears Sanofi's four-strain flu vaccine

The FDA approves Sanofi Pasteur's Fluzone Intradermal Quadrivalent influenza vaccine. The new product helps protect adult patients from four strains of influenza virus which is an improvement over the trivalent version that has been available for last three years.

…and Merck's 9-valent HPV vaccine

The FDA approves Merck's nine-valent human papillomavirus vaccine Gardasil 9 for use in females ages 9 to 26 and males ages 9 to 15. The new vaccine offers protection against nine strains of the virus that causes cervical and other cancers. "Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers," the FDA said

Drugs at clinical stage

December 8, 2014 

Novartis Chimeric Antigen Receptor Therapy, CTL019 highly efficacious in Acute Lymphoblastic Leukemia (ALL)

Novartis' investigational drug CTL019, a chimeric antigen receptor (CAR), demonstrates remarkable efficacy in a 39-patient study in young patients with relapsed/refractory acute lymphoblastic leukemia (ALL). 36 of the 39 patients (92%) experienced complete remissions. The FDA designated CTL019 a Breakthrough Therapy in July 2014.

December 10, 2014

Anti PD-1 checkpoint inhibitors show remarkable efficacy in Hodgkin lymphoma patients.

Two studies reported at the American Society of Hematology meeting in San Francisco, show that the anti-PD-1 checkpoint inhibitors from Bristol-Myers Squibb, Opdivo (nivolumab) and Merck & Co, Keytruda (pembrolizumab) have shown remarkable efficacy in classical Hodgkin lymphoma (cHL) patients who relapsed after failing all prior treatments.“PD1 therapies target the immune system and enable it to respond to cancer as it is supposed to,” said Philippe Armand of the Dana-Farber Cancer Center.

December 12, 2014

Novartis' Cosentyx superior to Stelara in Phase 3 trial

Novartis' recently approved Cosentyx (secukinumab), a IL-17A inhibitor, demonstrated superiority to Janssen's Stelara (ustekinumab) in psoriasis patients. The study met its primary endpoint at week 16 as well as its secondary endpoint at week 4.

Ebola

December 8, 2014 

Qiagen joins up with Altona to distribute Ebola testing kit

Qiagen (Germany) has agreed to distribute Altona Diagnostics' RealStar Ebolavirus RT-PCR Kit 1.0, a testing kit capable of detecting all four known strains of Ebola viruses. The diagnostic kit was granted emergency-use authorization by the FDA on November 10, 2014.

The Global Alliance for Vaccines and Immunisation (GAVI) gives Ebola vaccine developers extra incentives.

GAVI plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. Gavi is funded by governments and the Bill & Melinda Gates Foundation.

December 12, 2014

FDA grants orphan status to Arca's experimental Ebola drug

Arca Biopharma's rNAPc2, an investigational drug to treat viral hemorrhagic fever following Ebola virus exposure, obtained orphan drug designation from the FDA.

Miscellaneous

December 10, 2014 

Pierre Fabre cuts 550 jobs in R&D and sales 

Pierre Fabre (France) is reducing its pharma headcounts in R&D and sale forces. Pierre Fabre will shrink its pharma division by 551 jobs. The cuts will mainly affect its French operations, in R&D, which will lose 272 jobs and 279 on the sales side. The remaining will come from the closure of an R&D site in Barcelona.

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

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