Acquisitions /mergers/joint-ventures

January 16, 2015

Roche acquires Trophos and boosts its neuromuscular drug pipeline

Roche agreed to pay as much as $543 million to purchase Trophos, a Marseille (France) -based company funded by the French Muscular Dystrophy Association. The deal will give Roche access to Trophos' pipeline of neuromuscular disease drugs including the experimental spinal muscular atrophy treatment olesoxime. Olesoxime is the lead product in the company’s cholesterol-oxime family of compounds, designed to target and preserve mitochondrial integrity and function in stressed cells. Olesoxime has been granted the FDA’s orphan drug designation, as well as the ‘Orphan Medicinal Product’ designation by the European Medicines Agency. Roche will pay about $139 million to shareholders plus $404 million in milestone payments.

Chinese Giant Wuxi PharmaTech buys into NextCode

Wuxi is paying $65 million to access genomic company NextCode Health, a spinout of deCODE, to develop genomic sequencing and companion diagnostic tools.

Business

January 21, 2015

Johnson & Johnson's pharma unit 'fastest-growing' in the drug business

J&J, CEO Alex Gorsky was claiming that his company prescription drugs unit is the biggest in the U.S. and the fastest-growing pharma in the business.

January 23, 2015

Array BioPharma acquires rights to Novartis encorafenib cancer drug

Contingent to the closing of the Novartis/Glaxo transaction, in April 2014, Array BioPharma, a Colorado-based company, has acquired worldwide rights to Novartis' encorafenib, a BRAF inhibitor currently in Phase 3 development, for the treatment of melanoma. Under the terms of the agreement, Array will make a minimal payment to Novartis but no milestones or royalties will be paid by either party.

Approval of drugs

January 21, 2015

Cosentyx, Novartis' IL-17A inhibitor, gets EMA and FDA approval for psoriasis

On the heels of the EMA approval, Novartis has obtained the FDA's approval to market its monoclonal antibody drug Cosentyx, or secukinumab, for the treatment of moderate to severe plaque psoriasis. Secukinumab is the first interleukin-17A pathway inhibitor- known to play a crucial role in the development of the disease – cleared for this indication. The drug has the potential to become a blockbuster by 2020.

January 23, 2015

EMA approves Boehringer Ingelheim's OFEV for idiopathic pulmonary fibrosis

The European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Nintedanib is an oral pan-angiokinase inhibitor which inhibits endothelial growth factor receptors (VEGFR), platelet derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signaling pathways. The drug had earlier been approved for the same indication in the US and for the treatment of non-small cell lung cancer, in combination with docetaxel, in Europe.

Genzyme’s Eluglistat approved for Gaucher’s disease in Europe

The European Commission clears Genzyme's Cerdelga (eliglustat) for the long-term treatment of patients with Gaucher disease type 1. Eliglustat is a novel orally available glucosylceramide analog. It partially inhibits the enzyme glucosylceramide synthase which reduces the production of glucosylceramide, the substance that builds up in the cells and tissues of Gaucher patients. Cerdelga was approved by the FDA in August 2014.

January 25, 2015

FDA approves Novartis meningitis vaccine Bexsero

The FDA approves Novartis' Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals ages 10 through 25. This is the second vaccine the FDA has approved in three months for the prevention of serogroup B meningococcal disease.

International Regulators Closing Approval Time Gap with FDA

Global drug regulators have reduced drug approval times over the last 10 years. The FDA remains the fastest at approving new drugs, but other major regulators are closing the gap. According to a new report that tracks the time from submission to sign-off in six regulatory agencies over a 10-year period, the FDA reduced the median time required to approve new active substances to 304 days in 2013, from more than 400 days in 2004. Japan’s PMDA was the next fastest, with a median approval time of 342 days in 2013, down from around 600 in 2004. Health Canada, the European Medicines Agency, Swissmedic and Australia’s Therapeutic Goods Administration also markedly reduced their median approval times. Swissmedic was the slowest with a median approval time of 511 days in 2013. The report by the Centre for Innovation in Regulatory Science concluded the gap from fastest to slowest median approval time was about 500 in 2004. By 2013, that window had shrunk to 200 days. See the full report at www.fdanews.com/01-14-2015-International-Drug-Approvals.pdf

Drugs at clinical stage

January 23, 2015

EMA accepts AstraZeneca drug application for lesinurad, a new gout medication

The European Medicines Agency (EMA) accepts AstraZeneca's Marketing Authorization Application (MAA) for lesinurad for the treatment of patients with gout. Lesinurad is a selective uric acid reabsorption inhibitor that inhibits the URAT1 transporter, which is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen. Inhibiting URAT1 increases uric acid secretion and thereby lowers serum uric acid.

January 26, 2015

FDA accepts cholesterol-lowering drug BLA under priority review

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted, under priority review, the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia with a PDUFA date (deadlines for the FDA to approve new drugs) of July 24,2015. Alirocumab is a monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9) which is competing with Amgen's evolocumab in the post-statin anti-cholesterol market. The PDUFA date of evolocumab is August 27, 2015.

Ebola

January 18, 2015

Johnson & Johnson announces Ebola vaccine development consortium

A consortium of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals to accelerate the development of its Ebola vaccine that uses a booster from Bavarian Nordic. The European Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The new consortium includes the London School of Hygiene & Tropical Medicine, the University of Oxford and the Institut National de la Santé et de la Recherche Medicale (INSERM).

January 23, 2015

First Glaxo Ebola vaccine to arrive in Liberia

The first batch of GlaxoSmithKline's experimental Ebola vaccine has arrived in Liberia. The vaccine is already being tested in small phase I safety trials in Europe, and will now be used in the first large-scale trials in the coming weeks.

The World Health Organization (WHO) said that the Ebola outbreak in West Africa appears to be waning but still cautioned against its risks.

Miscellaneous

January 20, 2015

President Obama announces initiative to expedite development of personalized cures

During his State of the Union address, US President Obama claimed that “21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time”. President Obama then went on to say that “tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes and to give all of us access to the personalised information we need to keep ourselves and our families healthier”. President Obama is expected to share details of the initiative in his fiscal 2016 budget, which will be released next month.

MSF urges GSK, Pfizer to slash pneumococcal vaccine prices

The cost of vaccinating a child in the world's poorest countries is much higher than it was in 2001–68 times higher, according to the charity organization, Médecins Sans Frontières (MSF). MSF has encouraged the pharma giants Pfizer and GlaxoSmithKline to sink the prices on their pneumococcal disease blockers to $5 per child in poor countries, Reuters reports.

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

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