Biopharmaceutical NewsWeek # 40

Acquisitions /Mergers/Joint-ventures

September 29, 2014 

Daiichi Sankyo agreed to buy Ambit Biosciences

Daiichi Sankyo agreed to buy Ambit Biosciences, a US-based company, for $410 million and thus hopes to increase its pipeline of cancer treatments. The Japanese company will pay $15 in cash per share. Ambit shareholders will have the right to receive an additional payment of as much as $4.50 if certain milestones are achieved. The acquisition will give Daiichi Sankyo the access to quizartinib, an experimental drug, to treat the most common type of acute leukemia.

September 30, 2014 

Johnson & Johnson acquires Alios for $1.75 billion

Johnson & Johnson is buying viral disease company Alios BioPharma for $1.75 billion in cash. The acquisition includes Alios’ portfolio of various therapeutics for viral infections including AL-8176, an orally active antiviral therapy, currently in Phase II for the treatment of infants with respiratory syncytial virus (RSV).

Business

October 2, 2014 

Novartis stops its collaboration with Enanta on hepatitis C virus

Novartis has stopped its current collaboration with Enanta Pharmaceuticals and will focus its research efforts in other therapeutic areas. The company has returned the rights to EDP-239, an NS5A inhibitor currently in Phase I for Hepatitis C virus. Enanta’s CEO, Jay Luly indicated that “as part of an ongoing portfolio transformation, HCV research would no longer be a strategic focus for Novartis”.

Approval of drugs

September 26, 2014

Alimera, pSivida eye implant wins U.S. approval

After three rejections, the US FDA has finally approved Alimera Sciences and pSivida Corp’s vision-loss treatment Iluvien. The eye implant will treat a condition known as diabetic macular edema (DME) which can lead to blindness. Iluvien, which will compete with Regeneron’s Eylea and Roche’s Lucentis, is expected to be launched in the US in early 2015.

US FDA approves Gilead’s Vitekta and Tybost

Gilead Sciences' integrase inhibitor drug Vitekta and protease-inhibitor booster Tybost have been approved. Both drugs are used as part of multidrug regimens to treat patients with HIV.

Drugs at clinical stage

September 29, 2014 

Perjeta, from Roche, a novel drug "unprecedented" in extending lives for cancer breast patients

Patients with HER2 positive breast cancer, who were treated with Perjeta on top of Herceptin and chemotherapy, lived 15.7 months longer than those on Herceptin and chemotherapy alone. That is the longest extension to survival ever seen for a drug studied in metastatic breast cancer. Perjeta, a monoclonal antibody, developed by Roche, is designed to block HER2, a protein produced by a cancer-linked gene. This outstanding result is a further evidence that combination of therapies that fight cancer cells through several pathways is more beneficial than monotherapy.

Important survival for BRAF melanoma patients treated with Tafinlar.

At the ESMO Congress in Madrid, GlaxoSmithKline presented overall survival data from a Phase 3 study of Tafinlar (dabrafenib) as a treatment for patients with BRAF mutant metastatic melanoma. The proportion of survival in patients treated for two years with Tafinlar was 45% compared to 32% of patients treated with dacarbazine.

September 30, 2014 

Regeneron and Sanofi announce successful phase 2 results for Duplimab.

Dupilumab, a humanized monoclonal antibody that blocks IL-4 and IL-13 signaling, co-developed by Regeneron and Sanofi, met all primary and secondary endpoints in a Phase 2a study in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids.

October 2, 2014

Ariad cancer drug AP2611 gets Breakthrough Therapy Label

Phase I/II clinical trials demonstrated sufficient significant outcomes for the US FDA to designate Ariad investigational cancer drug, AP26113, a Breakthrough Therapy for the treatment of patients with anaplastic lymphoma kinase positive (ALK) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Are combination therapies the best way forward for cancer vaccines?

An increasing number of experts believe that appropriate combination between immunotherapy cancer vaccines and checkpoint inhibitors may be the most suitable approach to help current or once-failed vaccines to realize their real potential.

Miscellaneous

September 25, 2014 

Pneumonia bacterium leaves tiny lesions in the heart

There has been a long-observed association between pneumonia and heart diseases. Recent scientific progress has now shown that Streptococcus pneumonia physically damages the heart. The bacterium leaves tiny lesions which were detected in human autopsy tissues.

September 30, 2014 

Officials confirm first Ebola case diagnosed in the United States.

The Centers for Disease Control and Prevention (CDC) Director, Thomas Frieden, announced that a patient treated at a Dallas hospital has tested positive for Ebola. This is the first case diagnosed in the United States.

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

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