Biopharmaceutical News week42 2014

 

 Ebola outbreak

Acquisitions /Mergers/Joint-ventures

October 16, 2014 

AbbVie stops its plans to acquire Shire 

The company said it was recommending shareholders to vote against the $54 billion takeover deal it had signed on July 18 in light of new tax rules from the U.S. Treasury Department. “Although the strategic rationale of combining our two companies remains strong, the agreed-upon valuation is no longer supported as a result of the changes to the tax rules and we did not believe it was in the best interests of our stockholders to proceed,” AbbVie CEO Richard A. Gonzalez said in a statement.

…..termination fees will be hefty

If AbbVie walks away from the deal it will have to pay a $1.635 billion breakup fee which corresponds to almost 3% of the deal’s value. ….. but AbbVie can take a tax write-off for the full amount of the fees

 

Business

October 13, 2014 

Oxford Biomedica (UK) extends its agreement with Novartis

Oxford Biomedica has extended its collaboration with Novartis to supply it with greater quantities of lentiviral vector to be used to engineer T cells for an autologous undisclosed therapy.

Combination Therapies

For several years we have been advocating that combination therapies will progressively become the standard care in many complex diseases. Targeting several targets, within a pathway rather than tackling a single one, will be more effective in many diseases where complexity is the rule. This is particularly true in infectious diseases, cancer, inflammation, immune diseases, cardiovascular and CNS diseases. Recently the industry has shown that it now adopts this strategy not just with drugs which are already marketed but with also with drugs which are not yet approved but where combining drugs with different mechanisms of action makes sense. Several announcements, this week, support this increasingly new paradigm.

Sanofi Pasteur and Immune Design Enter a Collaboration for Herpes Simplex Virus

Immune Design, today announced that it has entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy with Sanofi Pasteur. Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration. The collaboration will explore the potential of various combinations of agents, with the goal to select the best potential immune therapy for patients.

October 17, 2014

New drug to treate hypercholesterolemia

Sanofi and Regeneron are in a race with Amgen to be the first to launch a PCSK9 inhibitor for the treatment of severe hypercholesterolemia. But now the game is changing, Amgen filed a suit, in the U.S. District Court of Delaware, against Regeneron alleging infringements of three of its patents.

Approval of drugs

FDA approves Gilead combination therapy, Harvoni, for chronic hepatitis C infections

The daily fixed combination of ledipasvir and sofosbuvir, labelled as Harvoni, has been approved by the FDA. The approval was based on three clinical trials in which at least 94% of patients achieved complete and sustained virological response. ….but as with Sovaldi, the price of Harvoni ($94,500 for a 12 week supply) has caused uproar. John Rother, chief executive of the National Coalition on Health Care, claimed that the company’s “refusal to take a more reasonable and moderate approach to pricing cements its status as the foster child for everything that is wrong with pharmaceutical industry pricing”.

 

Drugs at clinical stage

October 14, 2014 

Bristol-Myers Squibb, Pharmacyclics, and Janssen are teaming up to test cancer immunotherapy combinations for patients with non-Hodgkin lymphoma 

The three parties have signed a clinical trials agreement under which they will assess BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

October 17, 2014

Theravance and its partner GSK in competition with Boehringer Ingelheim for best treatment in Chronic obstructive pulmonary disease (COPD)

In a randomized 905- patients 24-week multicenter study Anoro Ellipta from Theravance/GSK demonstrated superiority over Spiriva HandiHaler from Boehringer Ingelheim.

 

Ebola

October 14, 2014 

Canada's Ebola vaccine enters human trial

NewLink Genetics started a clinical trial, in Maryland (USA), to assess the safety and efficacy of an experimental Ebola vaccine, according to Canada's health minister. The vaccine, licensed to NewLink Genetics, was developed by Canada's health agency. Results are expected in December 2014.

Donation to fight Ebola

Centers for Disease Control and Prevention (CDC) Foundation Received $25 Million Donation from Mark Zuckerberg and Dr. Priscilla Chan for Ebola Response.

 

October 15, 2014

A second healthcare worker, has contracted Ebola in Texas

A second healthcare worker, has contracted Ebola at Texas Health Presbyterian Hospital where Thomas Ducan, who died of the virus earlier this month, was treated. She traveled on plane just before reporting fewer. There is now great fear in travelers who were on the same plane that day.

 

WHO estimates that the toll of Ebola will increase from 1,000 deaths per week to 10,000 deaths per week in a very near future

 

A New Peptide against Ebola

Researchers have developed a synthetic peptide that mimics a critical region of the Ebola virus protein which is universally conserved in all known strains and who plays a role in the entry of the virus in the host cell.The study was reported in the journal Protein Science.

 

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

 

 

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