Biopharmaceutical NewsWeek # 5

Acquisitions /Mergers/Joint-ventures

May 26, 2014
As expected Pfizer has abandoned its desire to acquire AstraZeneca for $116B saying that “it does not intend to make an offer” fort the Bristish-Swedish company after the board rejected its latest offer. Under British law Pfizer cannot make another bid for AstraZeneca for three-to-six months.

May 29, 2014
Evotec acquires, for as much as $5.3 million, UK-based contact research company Euprotec which specialized in infectious disease and respiratory biology services.

Business

May 28, 2014
Nestlé will pay $1.4B for several skin care products from Valeant Pharmaceuticals. This acquisition will boost its new division: Nestlé Skin Health. Nestlé has recently expanded its business in the medical and the health field.

The medical device market is one of the largest one in the global healthcare industry and is worth $28B. This market is expected to grow at a Compound annual growth rate (CAGR) of 5.5% mainly due to an increase in prevalence of many diseases worldwide as well as a fast growing aging population.

May 29, 2014
Biogen signs a deal with Array BioPharm to discover and develop kinase inhibitors for the treatment of autoimmune and anti-inflammatory diseases.

May 30, 2014
QIAGEN and Lilly collaborate to co-develop diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers. This is the fourth oncology project whereby Lilly and QIAGEN collaborate to develop innovative therapies.

Three months after a first fine of $251 million, Roche and Novartis face $1.6 billion damages on charges they colluded to protect sales in Italy of the eye drug Lucentis. Last month, French authorities began their own probe in raiding local offices of both companies.

Johnson & Johnson announces a global licensing deal with Aduro Biotech for developing new therapies to treat prostate cancer. The candidates are based on Aduro’s proprietary live-attenuated double-deleted (LADD) immunotherapy platform.

Approval of drugs

May 23, 2014
The European Commission CHMP has granted a conditional marketing authorization on PTC Therapeutics Translara (antaluren) for the first ever drug for Duchenne muscular dystrophy (DMD), a rare genetic disease affecting 18,000 people in Europe.

May 24, 2014
The European Commission CHMP has granted marketing authorization for Takeda’s bowel drug Entyvio (vedolizumab) for use of the gut-selective monoclonal antibody to treat active ulcerative colitis and active Crohn’s disease.

May 27, 2014
The US FDA approves Durata’s antibacterial Dalvance (dalbavancin) to treat acute bacterial skin ad skin structure infections caused by bacteria such as Staphylococcus aureus. Dalvance is the only intravenous approved drug for this indication with a two dose regimen of 1,000mg on day one followed by a 500mg doses one week later.

The US FDA approved Amgen's Vectibix as a frontline treatment for metastatic colorectal cancer (CRC) alongside Qiagen's Therascreen KRAS test as companion diagnostic that can determine which patients are most likely to benefit from the drug. These simultaneous Rx/Dx approvals are the result of regulatory actions that began five years ago, showing that CRC patients with KRAS gene mutations in codons 12 or 13 would not respond to EGFR-inhibiting monoclonal antibodies, such as Vectibix and Erbitux (cetuximab).

May 30, 2014
Sanofi annouces that Lemtrada (resubmission), was accepted by the FDA for the treatment of relapsing forms of multiple sclerosis.

Bayer gest European CHMP approval for Nexavar (sorafenib) for the most common form of thyroid cancer.

Drugs at clinical stage

May 27, 2014
Biocryst Pharmaceutical’s experimental oral drug BCX4161 was better than placebo in reducing attacks among patients with hereditary angioedema in a phase II trial

May 30, 2014
Newron Pharmaceuticals and Italian partner Zambon, have filed their new Parkinson’s drug safinamide with US FDA.

Technology

Bioserenity, a French start-up company, has invented connected clothes allowing continuous surveillance of epileptic patients. The crisis events of patients are downloaded on a smartphone and shared through the cloud with family members and physicians. The commercial product should become available at the end of 2015.

Miscellaneous

May 27, 2014
UK fraud police launch GSK probe in wake of China corruption charges. Since China began investigating GSK’s business practices last year other countries have considered running similar probes. In the UK, the Serious Fraud Office (SFO) said that it has opened a criminal investigation into GSK which confirmed the investigation saying it “is committed to operating business in the highest ethical standards and will continue to cooperate with the SFO.

May 29, 2014
China fines Johnson & Johnson, Bausch & Lomb and other major companies more than 19 million yuan ($3 million) for fixing prices in China’s eye glasses and contact lens market.

The ASCO's meeting will take place in Chicago from Friday May 30, 2014 until Thursday June 3, 2014

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

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