Biopharmaceutical NewsWeek 46 

Acquisitions /Mergers/Joint-ventures

November 12, 2014 

Actavis in talks with Allergan for $60 billion merger

According to a Bloomberg report, Actavis would acquire Allergan for $60 billion. Allergan has spent the past few months in trying to avoid the hostile take-over by Valeant.

Business

November 6, 2014 

Aegerion acquires a Rare Disease Drug from AstraZeneca for $325 million

AstraZeneca is selling its treatment for the rare disease generalized lipodystrophy Myalept™ (metreleptin for injection) to Aegerion Pharmaceuticals for $325 million. AstraZeneca acquired the drug from Bristol-Myers Squibb (BMS). Myalept is a recombinant analog of human leptin and is the first approved product in the U.S. for the treatment of generalized lipodystrophy.

November 10, 2014

Dendreon to file for bankruptcy

Ever since the failure of Provenge’s launch, the first (prostate) cancer vaccine to win FDA approval, Dedreon has been in trouble. A $620 million debt forced Dendreon to file for Chapter 11 bankruptcy protection last Monday. As part of its bankruptcy strategy, the company plans to sell itself via auction, with qualifying bids beginning at $275 million.

Roche sets up a new diagnostic manufacturing facility in Suzhou (China)

Roche will invest 450 million Swiss francs over the next three years, into a manufacturing site at Suzhou Industrial Park in Suzhou, China, addressing an increased demand for diagnostic tests in the Asia Pacific region and expanding its global footprint. Roche plans to build a workforce of 600 employees at the site. The facility will be fully operational by 2018.

November 11, 2014

QIAGEN the Key Player in companion diagnostics

Qiagen signs 9 master collaboration agreement for companion diagnostics and beats the 2014 Q3 expectations with strong sales of companion diagnostics and next generation tuberculosis blood test. A few days after the announcement of its master collaboration agreement with Astelllas, Qiagen announces that it entered into a similar agreement with Novartis.

November 12, 2014

Servier agrees to pay up to $1 billion on Intarcia's Ph III diabetes drug/device

Servier (France) has finalized a deal with Intarcia, a Boston based company, to get access to ITCA 650, a subcutaneous implant that administers exenatide to control blood sugar levels. Servier agreed to pay a hefty $171 million upfront and committed to three “early stage” regulatory milestones worth $230 million and up to $650 million in accumulated development and sales milestones.

GlaxoSmithKline intends to divest its mature drugs portfolio

In order to improve its growth prospects, GlaxoSmithKline plans to sell its portfolio of older prescription medicines (Paxil, Imitrex; Zantac and Zofran) sold in North America and Western Europe.

November 14, 2014

Geron licenses myelofibrosis drug to Janssen in potential $935M deal

Geron granted Janssen, a Johnson & Johnson's company, the licensing rights to co-develop its myelofibrosis drug candidate imetelstat. The deal entitles Geron to $35 million upfront and up to $900 million in milestone fees plus sales royalties.

Approval of drugs

November 14, 2014

Genzyme's Lemtrada approved by the FDA

Lemtrada was originally rejected by the FDA at the end of last year, but the Sanofi subsidiary resubmitted the application several months ago. With the FDA's action today, the U.S. joins many other countries in approving Lemtrada for treating relapsing forms of multiple sclerosis. The approval will trigger the payment of a contingent value right.

Drugs at clinical stage

November 12, 2014 

Polyphor’s lead antibiotic POL7080 receives Qualified Infectious Disease Product (QIDP) designation from the FDA

Polyphor, a Swiss based company, reports that its lead antibiotic product POL7080 received QIDP designation from the U.S. FDA for the treatment of Ventilator-Associated Bacterial Pneumonia caused by Pseudomonas aeruginosa. QIDP designation provides priority review and eligibility for the FDA fast-track status. QIDP also extends statutory exclusivity of POL7080 for five years if the product is ultimately approved by the FDA.

November 13, 2014

Amgen's cholesterol drug application accepted by FDA.

The FDA has agreed to review Amgen's biologics license application to use its PCSK9 inhibitor evolocumab for the treatment of high LDL cholesterol levels. A decision is expected by Aug. 27, 2015.

November 14, 2014

Sanofi/Regeneron asthma drug successful in Phase 2 trial

Dupilumab, a fully-human monoclonal antibody which blocks IL-4 and IL-13, being co-developed by Sanofi and Regeneron Pharmaceuticals, showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.

Ebola

November 13, 2014 

A Severe Attack from World Health Organisation Director On Pharma

Ebola Efforts Last week, WHO Director-General, Margaret Chan assaulted the industry for not taking an interest in developing an Ebola vaccine. “Ebola has historically been confined to poor African nations. The R&D incentive (for Pharma) is virtually non-existent. A profit driven industry does not invest in markets that cannot pay."

November 13, 2014

Aethlon to begin U.S. testing for its Ebola treatment device by year end

Aethlon Medical said it will begin U.S. clinical trials of its Hemopurifier device following news a German patient suffering from Ebola was declared free of the virus. The device is a blood-filtering cartridge containing "affinity" agents that attract and capture specific viruses and immunosuppressive proteins, the company said in a press release.

November 15, 2014

Ebola discussed at G-20 meeting in Brisbane

World leaders who gathered at the G-20 meeting in Brisbane (Australia) have warned Ebola outbreak could have a serious impact on the global economy, as well as being a humanitarian disaster. They are calling for greater international efforts to combat the spread of the virus now blamed for more than 5,000 deaths.

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

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