Biopharmaceutical News # 2

April 30, 2014 

GSK reported pharmaceutical and vaccines turnover in the USA was down 10% to £1.13 billion, as sales across of Advair (salmeterol and fluticasone) for asthma and chronic obstructive pulmonary disease, fell 30% to £455 million. Also the launch of its new COPD drug Breo (fluticasone furoate/vilanterol) has been disappointing and it contributed just £1 million. European turnover for its pharmaceutical business grew 3% to just over £1 billion, while emerging markets pharma/vaccines sales were up 2% to £691 million. Sir Andrew added that with around 40 new molecular entities currently in late-stage development GSK’s late-stage pipeline "remains attractive and we expect the next wave of innovative R&D opportunities to become more visible as this year progresses".

Transgene SA announced that Novartis has informed the Company that it will not exercise its option for the global development and commercialization rights to TG4010 MUC1 targeted cancer immunotherapy. As a result, Transgene retains all rights to the advanced lung cancer program.

Otsuka Pharmaceutical has gained European Commission approval of its tuberculosis drug Deltyba for use as part of an appropriate combination regimen for pulmonary multidrug-resistant (MDR-TB) tuberculosis.

The World Health Organisation reports that antibiotic resistance is going to have devastating implications and the “global threat is no longer for the future, it is happening right now in every region and has the potential to affect anyone, of any age, in any country” says Keiji Fukuda, the WHO’s assistant director-general for health security. “Without urgent and coordinated action by many stakeholders, the world is headed for a post-antibiotic era, in which common infections and minor injuries which have been treatable for decades can once again kill". He added that without "significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics…the implications will be devastating".

May 2, 2014

Pfizer is prepared to increase its offer for AstraZeneca to $106B with a larger cash component than previously. The board of AstraZeneca meet on May 2nd and turned down the new proposal.

A new experimental vaccine produces an immune response against Severe Acute Respiratory Syndrome (SARS) Coronavirus as well as Middle East Respiratory Syndrome CoronaVirus. The study was performed by scientists at the University of Maryland School of Medicine and Novavax Inc.

Novo Nordisk expects lower sales growth in 2014 due to generic competition and currency impact.

May 6, 2014

FDA approves EPANOVA (omega-3 carboxylic acid) from AstraZeneca for the treatment of Adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL)

Merck (MSD outside the USA) agreed to sell its consumer healthcare (OTC) business to German company Bayer for $14.2 billion. This announced deal is a continuation of recent big deals in the pharmaceutical industry. The two companies also announced a collaboration to develop and market Bayer’s treatment for pulmonary hypertension including Adempas, the recently approved new drug in the US.

Regeneron Pharmaceuticals acquires Avalanche Biotechnologies’ adeno –associated virus (AAV) technology platform to discover and develop, gene therapy vectors for ophthalmology products. The collaboration could bring as much as $640 million to Avalanche Biotechnologies.

Yellow fever is an acute viral disease which has been responsible for 78,000 deaths in Africa in 2013. Mass vaccination campaigns led to a 27% reduction in the burden of the disease across Africa in 2013.

May 7, 2014

AstraZeneca has turned down the offer by Pfizer to acquire the Anglo-Swedish company. Pascal Soriot, the CEO of AstraZeneca said that the company is completing the transformation of the pipeline and “now has the right size, focus and team to deliver one of the most exciting pipelines in the pharmaceutical industry”. He added that forecast for 2023 were highly promising and that “our independent strategy will create significant value for patients and our shareholders”.

FDA approved Alexion Pharmaceuticals’ Soris (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS). aHUS is an ultra-rare genetic and chronic disorder defined by lifelong risk of thrombotic microangiopathy in the smallest vessels found in the brain and the kidney.

Qiagen announces clearance by the FDA of its diagnostic kit which is associated with the presence of Toxins A and B in Clostridium difficile infections.

Veracyte, a California based company, has scored a partnership deal that will help expand the reach of its thyroid cancer diagnostic technology throughout Brazil.

Enterome, a French start-up company, has raised $13.8 million in a Series B round in order to accelerate the development of biomarkers and companion diagnostics in the field of inflammatory bowel and metabolic disorders. The “Metagenotyping” technology is meant to improve the analysis of the gut microbiome in order to better understand the associated diseases.

May 8, 2014

FDA has approved vorapaxar, an antiplatelet drug, developed by Merck & Co for the treatment of patients with heart attacks or who suffer from arteries blockage of the legs. The drug is not approved for use in patients who had suffered a stroke, as those patients were found to be at particular high risk of massive bleeding.

May 9, 2014

Brodalumab, an antibody drug developed by Amgen and AstraZeneca meets all the primary and secondary endpoints of a Phase 3 study in patients with moderate-to-severe psoriasis. The drug acts by blocking the interaction of interleukin-17 to cell receptors.

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

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