Biopharmaceutical News Week 39
Aduro Biotech (Berkeley, CA, USA) acquires BioNovion (Oss, The Netherlands), a company dedicated to antibodies and checkpoint inhibitors for $32.5 million: about $16 million in cash and $16 million in stock as well as subsequent regulatory milestones.
Regeneron Pharma will receive $17 million funding from US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture a monoclonal antibody treatment for Ebola infection.
Merck KGaA and Pfizer have entered a three party agreement with Dako (Glostrup,Denmark) to discover and develop companion diagnostic for avelumab. Avelumab is a checkpoint inhibitor that blocks the interaction of PD-L1 with its receptor PD-1, potentially restoring effective anti-tumour T-cell responses. The three-party agreement is focused on development of companion diagnostics to assess PD-L1 protein expression levels in tumour tissue and its microenvironment. Financial terms of the deal were not disclosed.
Biogen enters into a five-year collaboration with BioMotiv to discover and develop new neuroscience focused treatments. BioMotiv is the accelerator of the Harrington Project for Discovery & Development, a project centered at Cleveland’s University Hospitals. Under the terms of the agreement, BioMotiv will receive $15 million over five years, and Biogen will get the exclusive rights for neuroscience programs arising from the partnership.
AstraZeneca makes preclinical data for more than 50 drugs public, as part of a crowd-sourcing challenge to find new and best cancer drug combinations. The company is releasing results from around 11,500 tested drug combinations measuring cell viability over 118 therapies and 85 cancer cell lines, and monotherapy drug response data for each drug and cell lines. In parallel, the Wellcome Trust Sanger Institute is also making genomic data available for the same cell lines, offering researchers a unique data set from which to seek out combinations with the most synergistic potential.
Boehringer Ingelheim has finalized the crowd-sourced chronic obstructive pulmonary disease (COPD) R&D team it has put together with BioMed X Innovation Center (Heidelberg, Germany). The initiative is an attempt by Boehringer to tap into expertise outside of its own R&D to better understand the epigenetics of COPD.
Approval of drugs, vaccines, diagnostics and devices
US FDA approves Taiho Oncology’s Lonsurf, a new combination therapy for the treatment of colorectal cancer. The drug combines an anticancer drug called trifluridine, able to interfere with DNA function, with tipiracil hydrochloride, which maintains blood concentration of the former and is already approved in Japan.
European Regulators have approved Keryx Biopharmaceutical’s Fexeric (a ferric citrate coordination complex) for the treatment of hyperphosphatemia in both non-dialysis and dialysis chronic kidney disease patients. The drug got US FDA approval in September last year under the brand name Auryxia, but only for patients on dialysis.
St Jude Medical (St Paul, MIN, USA) obtains CE mark for its new Infinity Deep Brain Stimulation (DBS) system. DBS systems include a surgically-implanted neurostimulator, which generates the electrical pulses and thin wires called leads that carry the pulses to the brain to determine the irregular nerve signals responsible for many of the symptoms of movement disorders in patients suffering from Parkinson's disease, tremor and dystonia, a disorder that causes involuntary muscle contractions.
Drugs at clinical stage
US FDA gives Pfizer and Merck KGaA’s avelumab, an anti-PD-L1 antibody, Orphan Drug designation for the treatment of Merkel cell carcinoma, a rare and aggressive type of skin cancer.
Pfizer’s XELJANG (tofacitinib citrate) was successful in two late-stage studies in ulcerative colitis in achieving its primary efficacy endpoints at week 8. Tofacitinib is a Janus kinase (JAK) inhibitor which blocks cytokine signaling.
Novo Nordisk’s long acting GLP-1 analogue, semaglutide, was more active than AstraZeneca’s Bydureaon (exenatide-extended–release for injectable suspension) in lowering HBA1c levels in type diabetic patients. The study assessed the safety and efficacy of 1.0 mg semaglutide compared to 2.0 mg exenatide once-weekly for 56 weeks in 813 patients with type 2 diabetes. The trial successfully achieved its primary endpoint of showing the superiority of semaglutide in lowering HbA1c levels. 66% of patients treated with semaglutide achieved the treatment target of HbA1c below 7% compared to 40% of patients treated with exenatide.
Merck & Co is preparing to file its investigational antitoxin bezlotoxumab in the US, Europe and Canada after late-stage data showed the potential of the drug in preventing the recurrence of Clostridium difficile infection. Bezlotoxumab, a selective, fully-human, monoclonal antibody designed to neutralise C. difficile toxin, could become the first treatment to prevent the bacteria infection from recurring.
Science and Technology
Scientists at Uppsala University are using a research robot to accelerate novel cancer discovery by finding optimal drug combination. Instead of just combining a couple of substances at a time, the system has the ability to handle dozens drugs simultaneously, and the researchers are aiming to raise this to hundreds. “The idea is to gradually refine combinations of substances so that they kill cancer cells without harming healthy cells.” says Dr Claes Andersson, one of the lead scientists in the project.
Medical Devices and Diagnosis News
Wuxi NextCODE will provide genetic testing services for the Children’s Hospital of Fudan University in Shanghai.
Cost and Pricing
UK National Institute for Health and Care Excellence (NICE) recommends Daiichi Sankyo’s antithrombotic Liximia to prevent blood clots in adult patients with heart rhythm disorders as well as for the treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults. NICE concluded that, at a daily price of £2.10 per patient, the effectiveness ratio was in line with other oral anticoagulants pricing.
US Democratic presidential candidate Hillary Clinton proposed earlier this week a $250 monthly cap on out-of-pocket prescription drugs costs and several other measures such as reducing the 12-year exclusivity given to new biologics under the Biologics Price Competition and Innovation Act to seven years to stop what she called “price gouging” by the pharmaceutical industry. Clinton’s comments came after the New York Times reported how, Turing Pharmaceuticals, a startup company raised the price of the 62-year-old Daraprim, for the treatment of toxoplasmosis, from $13.50 a tablet to $750, an increase of more than 5000%. Biopharmaceutical companies have long faced similar criticism for steadily raising prices of their prescription drugs in the US, often by jumps of 10% or even more.
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood expressed opposition to Hillary Clinton's plan for reducing the costs of drugs and allow the importation of prescription drugs. "The proposal released today by the Clinton campaign would do irreparable harm to the nation's health innovation system," Greenwood said. He also noted that the provisions Clinton announced "have been proposed many times in the past and have always been rebuffed on a bipartisan basis because of the widely recognized fact that they are simply bad ideas for patients."
Amid the drug pricing brouhaha in the U.S. all over the week, Andrew Hill a researcher at the University of Liverpool told Reuters that he conducted a study showing Americans are paying up to three times higher prices for cancer drugs than their counterparts in Europe. For instance, Roche's lung cancer drug Tarceva carries a U.S. price of $79,000, compared with $26,000 to $29,000 in a selection of Western European nations, Hill found. Novartis’ leukemia drug Gleevec runs $106,000 in the U.S. compared with $29,000 to $35,000 in Europe. Tykerb the breast cancer drug Novartis has a U.S. list price of $74,000, compared with $35,000 in Europe. That puts U.S. prices at up to three and a half times those in Europe.
Novartis launches Novartis Access, an initiative for low-income countries whereby a portfolio of 15 of its medicines will be offered to healthcare providers for just $1 per drug per month. The treatments – both patented and generic – are geared towards treating chronic diseases such as diabetes, cardiovascular diseases, respiratory illnesses, as well as breast cancer, will be offered to governments, NGO’s and other public healthcare providers. The Novartis Access programme will be rolled out first in Kenya, Ethiopia and Vietnam, with plans to expand to 30 countries in the coming years.
In a U.S. Senate testimony, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the U.S. FDA, said that biosimilar interchangeability must rest upon “bulletproof” science. The exchanges were most intense between Woodcock and Sen. Elizabeth Warren (D-MA), who was particularly concerned about the delay in FDA's release of a number of guidance documents, particularly on interchangeability and labeling. "We have to get the science right. We can't have problems with the first biosimilars out of the block," Woodcock told Warren. Woodcock added that the remaining guidance documents that have yet to be issued are mostly tied to policy, rather than scientific issues. She also said FDA can't provide any specific dates for when the guidelines will be issued or when the draft guidelines will be finalized because of the complicated authorization process.
- 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
- Innovation Days on October 5-6 in Paris (France)
- FierceBiotech Executive Summitt on October 12 in London (UK)
- BIO Japan on October 13-16 in Yokohama (Japan)
- BIO Latin America on October 14-16 in Rio de Janeiro (Brazil)
- BIO Investor Forum on October 20-21 in San Francisco (USA)
- BIO Europe 2015 on November 2-4 in Munich (Germany)
- Biofit 2015 on December 1-2 in Strasbourg (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, firstname.lastname@example.org
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