Biopharmaceutical NewsWeek # 6
August 25, 2014
Roche buys InterMune for $8.3 billion
Roche is to acquire InterMune Inc, based in Brisbane, California, for $8.3 billion in cash to gain access to that company portfolio that includes pirfenidone, for the treatment of idiopathic pulmonary fibrosis. Pirfenidone is an already marketed product in the European Union and in Canada, The acquisition is the largest by Roche since 2009, when it bought out the remaining stake it did not already own in Genentech for $47 billion. The deal is a further step by Roche to diversify away from its reliance on cancer drugs, where it is the world leader. Roche already markets Pulmozyme for cystic fibrosis and Xolair for severe asthma in the United States. The FDA is to give its verdict on the approval of pirfernidone on November 23.
Medtronic Inc has paid €150 million in cash to acquire Sapiens Steering Brain Stimulation BV, a Dutch company developing deep brain stimulation technologies for the treatment of the movement symptoms of Parkinson’s disease.
August 26, 2014
Cilag GmbH International, an indirect affiliate of Johnson & Johnson Inc, has acquired Covagen AG from Covagen’s venture capital and other private investors for an undisclosed amount.
August 21, 2014
Illumina, based in San Diego, California, has inked deals with Astra Zeneca, Janssen and Sanofi with the goal of developing a universal gene-sequencing companion diagnostic test system focused on cancer.
Cancer immunotherapy combination therapies
For many years it has been known that combination therapy of cytotoxic agents is more efficient than monotherapy. Several companies are now testing this concept with immunotherapy agents and already established drugs.
August 25, 2014
Merck & Co has signed an immunotherapy pact with Advaxis for prostate cancer involving its high-profile PD-1 checkpoint inhibitor pembrolizumab. The collaboration will evaluate Advaxis' Lm (Listeria monocytogenes)-LLO cancer immunotherapy ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase I/II study of patients with previously treated metastatic, castration-resistant prostate cancer. No financial details have been disclosed.
August 26, 2014
Pfizer and Merck said they will explore, in a Phase 1b study, the safety and tolerability of a combination therapy in patients with anaplastic lymphoma kinase-positive (ALK-positive) advanced or metastatic non-small cell lung cancer. The combination consists of Pfizer's Xalkori (crizotinib) and Merck's investigational anti-PD-1 Ab pembrolizumab. Crizotinib inhibits an abnormally activated enzyme in patients with ALK-positive.
Approval of drugs
The Food and Drug Administration has approved a supplemental New Drug Application for the once-daily use of Promacta/Revolade (eltrombopag) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy. SAA is a disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.
Drugs at clinical stage
August 27, 2014
Amgen heart failure drug gets FDA priority review
The US Food and Drug Administration has granted Amgen a priority review for ivabradine, licensed from Servier, for the treatment of chronic heart failure. The latest designation comes some four months after the FDA granted fast track designation for ivabradine, which is already approved in Europe under the brand name Procoralan for stable angina and chronic heart failure. Amgen got US rights to sell the pill through a cross-licensing pact signed with Servier a year ago.
August 29, 2014
Amgen files cholesterol drug evolocumab in USA
Amgen has filed its cholesterol drug evolocumab in the USA, the first PCSK9 inhibitor to be submitted to regulators. The filing with the US Food and Drug Administration contains data from 6,800 patients, including more than 4,500 patients with high cholesterol in ten Phase III trials. Evolocumab has shown high levels of efficacy in patients with elevated cholesterol on statins with or without other lipid-lowerers, those who cannot tolerate statins and those patients with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder. Evolocumab belongs to the closely-watched PCSK9 class, a protein that reduces the liver's ability to remove bad cholesterol, from the blood. It is in a race with Sanofi/Regeneron’s alirocumab to see which will first get to market.
August 26, 2014
First Briton being treated for Ebola in London
Doctors at a London hospital have started treating the first confirmed case of a Briton with Ebola during the present outbreak. William Pooley, who contracted Ebola while working as a volunteer nurse in Sierra Leone, was flown to RAF Northolt at the weekend and taken under police escort to the Royal Free Hospital. He is being treated at the hospital’s high level isolation unit, the only one of its kind in Europe. Meantime the World Health Organisation (WHO) has commented on the “unprecedented number of medical staff infected with Ebola”. More than 240 healthcare workers have developed the disease in Guinea, Liberia, Nigeria, and Sierra Leone, and more than 120 have died. The agency notes that the loss of so many doctors and nurses “has made it difficult for WHO to secure support from sufficient numbers of foreign medical staff”. The World Health Organization says that the Ebola cases are accelerating. Forty percent of the infections have happened in the last 21 days. More than 20,000 people may be infected before the outbreak is contained.
Eight companies are working on Ebola vaccines/therapies:
- Tekmira Pharmaceuticals: TKM-Ebola in Phase 1
- Sarepta Therapeutics: AVI-7537 in Preclinicals
- NewLink Genetics: Ebola Vaccine in Preclinicals
- BioCryst Pharmaceuticals : BCX4430 in Preclinicals
- Nanoviricides: NV-INF-1 in Preclinicals
- FujiFilm: Favipiravir in Preclinicals
- Mapp Pharmaceuticals: ZMapp in Preclinicals.
- GlaxoSmithKline: Ebola Vaccine in Preclinicals
- Inovio Pharmaceuticals: SynCon DNA Vaccine in Preclinicals