Biopharmaceutical NewsWeek #7
September 01, 2014
Ablynx signs a deal with China's Eddingpharm
Ablynx of Belgium has signed a deal to license one of its investigational rheumatoid arthritis drug ozoralizumab to China's Eddingpharm. Ozoralizumab is a next-generation nanobody TNF-alpha. Eddingpharm is getting rights to the compound and will be responsible for the clinical development, registration and commercialisation in Greater China. Ablynx will receive an upfront fee of 2 million euros, plus development and commercial milestones plus tiered, double-digit royalties of up to 20%. This is the second deal the two firms have signed within the last twelve months.
September 03, 2014
AbbVie signs a $800 million cancer deal with Infinity
AbbVie has acquired rights from Infinity Pharmaceuticals’ for its blood cancer drug duvelisib in a deal that could be worth over $800 million. Duvelisib, also known as IPI-145, is an oral inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma. It is in Phase II for indolent non-Hodgkin lymphoma and Phase III for chronic lymphocytic leukaemia. Abbvie is paying $ 275 million upfront cash and up to $530 million in development, regulatory and commercial milestones. In the USA, the firms will co-market and split profits while elsewhere, Infinity will receive royalties ranging from 23.5% to 30.5%.
Calico, the Google new life sciences unit, links up with AbbVie for $1.5 billion aging project
AbbVie and Google’s new life sciences unit, Calico, are putting in $250 million each to collaborate on drugs for age-related diseases, helping the latter “establish a world-class R&D facility” in San Francisco. Each partner may contribute an additional $500 million to the collaboration which will look at areas such as neurodegeneration and cancer. Calico will be responsible for research and early development during the first five years and advance projects through Phase IIa for a ten-year period, with the support of AbbVie. Following completion of Phase IIa studies, AbbVie will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally.
Approval of drugs
September 04, 2014
Merck & Co's Keytruda first FDA approved PD-1 inhibitor
The US Food and Drug Administration has granted accelerated approval to Merck & Co’s Keytruda for patients with advanced or unresectable melanoma who are not responding to other drugs. Keytruda (pembrolizumab) is the first FDA approved drug that blocks the PD-1 (programmed death receptor-1) cellular pathway, which restricts the body’s immune system from attacking melanoma cells. This new checkpoint inhibitor is intended for use following treatment with Bristol-Myers Squibb's immunotherapy Yervoy (ipilimumab). Keytruda can be also be used after Yervoy and a BRAF inhibitor, like Roche’s Zelboraf (vemurafenib) and GlaxoSmithKline’s Tafinlar (dabrafenib).
But this melanoma “game-changer” is likely to bolster another drug pricing debate
Keytruda, the latest of new cancer therapies from Meck would cost $12,550 per patient per month, or $150,000 per year. These new approved drugs are helping push the overall market for oncology drugs to $100 billion a year. Thanks to previously approved high-priced blockbusters such as Pfizer's Xalkori for lung cancer and Roche's melanoma drug Zelboraf, global oncology spending hit $91 billion last year and it's growing 5% a year, according to the IMS Institute. Every new entry seems to revive the pricing debate. When Novartis's Zykadia hit the market in April, competing directly with Xalkori, its price raised plenty of eyebrows: Zykadia costs $13,200 per month, versus Xalkori's $11,500 per month price. Based on data collected by EvaluatePharma in 2013, Keytruda's price would make it the 6th most expensive drug on the market. Analysts expect the drug to generate about $1.5 billion in sales for Merck in 2017
Drugs at clinical stage
August 31, 2014
Novartis new drug LCZ696 could revolutionise heart failure treatment
Novartis has presented its new and complete data on heart failure drug LCZ696 at the European Society of Cardiology meeting in Barcelona, showing its clear superiority over the ACE inhibitor enalapril. The 8,442-patient PARADIGM-HF trial was stopped early, on evidence of the “overwhelming benefit” of LCZ696 compared to enalapril. The results, published in the New England Journal of Medicine, show that LCZ696, a dual angiotensin receptor- neprilysin inhibitor, reduced the risk of death from cardiovascular causes by 20%, heart failure hospitalisations by 21% but also reduced the risk of all-cause mortally by 16%.
September 01, 2014
Sanofi/Regeneron's alirocumab reduces Cardiovascular events in Phase III trials
Just a few days after Amgen filed evolocumab in the USA, Sanofi and Regeneron have presented data of their PCSK9 inhibitor cholesterol-lowerer alirocumab at the European Cardiology Society meeting in Barcelona. The companies presented results from four ongoing Phase III trials of alirocumab in people with hypercholesterolemia, all of which met their primary efficacy endpoint. Sanofi and Regeneron are in a race with Amgen’s evolocumab. Alirocumab has not been filed yet, but last month, Sanofi and Regeneron paid $67.5 million to buy a US priority review voucher from BioMarin that can be used for the drug.
September 03, 2014
Sanofi’s dengue vaccine shows benefits in new clinical trial conducted in Latin America
Sanofi's vaccine division, Sanofi Pasteur, reports that its dengue vaccine candidate achieved its primary endpoint in a Phase III clinical trial conducted in Latin America. The vaccine demonstrated a 60.8% reduction in dengue disease cases in children and adolescents ages 9 – 16 years after a three-dose vaccination regimen. It also demonstrated improvement in efficacy across the four dengue serotypes. Vaccinated patients experienced an 80.3% reduction in the risk of hospitalization.
September 02, 2014
Novo Nordisk ends inflammatory R&D and sticks to diabetes
Novo Nordisk is stopping inflammatory disorder R&D to increase its diabetes and obesity efforts, following the failure of its investigational rheumatoid arthritis drug NN8226, which targeted interleukin-20 (IL-20).
Roche plans to reduce Spanish jobs in response to price controls
Roche has disclosed a restructuring of its pharmaceuticals business in Spain which will affect 100 jobs, prompted by the challenging Spanish market and price controls. The cuts will mainly affect support staff and sales reps, claiming that the current environment “requires a transformation of the company”.
September 04, 2014
J&J joins race for Ebola vaccine
Johnson & Johnson is accelerating the development of a combination vaccine regimen against Ebola. The regimen consists of two components from J&J unit Crucell NV and Bavarian Nordic, and the programme has received funding and preclinical support from the US National Institutes of Health. The decision to fast-track the combination is in response to the current outbreak in West Africa and is aligned with the WHO Ebola Response Roadmap.