Biopharmaceutical News Week7 2015
February 10, 2015
Roche buys German translational medicine company Signature
Roche announced that it acquires German translational oncology and genomics firm Signature Diagnostics (Potsdam, Germany) for an undisclosed amount. Roche has been on the forefront of Personalized Medicine which requires access to high quality biomarkers and biobanks. Signature develops large blood plasma and tissue biobanks in cancers, including lung and colorectal cancers. Roche will leverage Signature capabilities to accelerate the development of next generation sequencing (NGS) assays.
February 12, 2015
GSK acquires Swiss vaccine company GlycoVaxyn for $190 million
GlycoVaxyn, is a privately held Swiss biopharmaceutical company (based in Schlieren, near Zurich, Switzerland), which has developed a new generation of conjugate prophylactic vaccines against major bacterial infections. GSK, which had a minority stake in GlycoVaxyn since 2012, acquired the remaining stake in the company, which is now valued at $212 million, for $190 million in cash. The company was founded in 2004 as a spin-out company from the Swiss Federal Institute of Technology (ETH) to commercialize the recombinant DNA glycoprotein technology.
Valeant now offers $400 million to acquire Provenge
Valeant, a Canadian company, has offered $400 million in cash to acquire Provenge the Seattle based biotech. Both companies are waiting for a court approval on Feb. 20, and expect to close the deal later this month. The $400 million price is about 30% higher than the initial bid, made two weeks ago, when Valeant offered $296 million.
February 6, 2015
Myriad Genetics and Quest Diagnostics settle on breast cancer DNA test patent dispute
Under the agreement Myriad and Quest and their co-parties have agreed to dismiss their outstanding litigation over BRCA1 and BRCA2 gene patents for breast cancer testing.
February 9/10, 2015
Novo Nordisk announces its information technology spin off and an agreement with the Karolinska Institute in diabetes
Novo Nordisk, the Danish drugmaker, announces, on two consecutive days, the decision to spin off its information technology unit, NNIT, via an initial public offering (IPO) and the signature of a collaboration agreement to fully support a total of 12 post-doctoral fellows with a 3 year grant to conduct research in the diabetes field at the Karolisnka Institute in Stockholm.
February 11, 2015
Genzyme signs a major deal worth $845 million with Voyager to discover new CNS treatments
Genzyme, a Sanofi company, announces a deal, worth up to $845 million, for novel gene therapies developed by Voyager Therapeutics – a privately held company- based in Cambridge (MA, USA). Under the agreement both companies will join forces to discover and develop new treatments for various CNS diseases, such as Parkinson’s disease, amyotrophic lateral sclerosis, Friedreich’s ataxia and Huntington’s disease. The alliance will be focusing on novel gene therapies using their experience and the technologies on adeno-associated viruses (AAV). Genzyme will pay Voyager $100 million upfront: $ 65 million in cash, $ 30 million in equity investment and additional “in kind contributions”.
Merck hands over to Simcere the control of its Chinese Joint Venture
As a part of shift in strategy, Merck announces that its joint venture with Simcere (China), launched in 2011 “will be managed by Simcere Pharmaceutical Group”.
February 10, 2015
Gilead invests £19.6 million into new Headquarters and expansion at UK facilities
Gilead will create new commercial headquarters in Holborn and expand operations in Uxbridge and UK R&D headquarters in Cambridge. The $19.6 million investment will allow Gilead to double its UK workforces to 600 by the end of 2015.
Venture Capital prefer investments in rare-disease treatments
Recent statistics have shown a significant increase in regulatory approvals for new drugs in 2014 in the US as well as in Europe. Nevertheless a first analysis of this outcome indicates that almost two thirds of these approvals are for cancer drugs and specialty uses such as rare diseases. A report released by BIO, the biotechnology trade organization, indicates that Venture Capital funding for R&D drugs has recently shifted to specialty and rare-disease medicines. According to the report “VCs will pull back from areas that are seen as having unfavorable or unpredictable regulatory and reimbursement hurdles”. The report also said that developers of biologics now get 50% of VC funding and less money is going to novel drug R&D for diseases with large prevalence such as cardiovascular, respiratory, gastrointestinal or diabetic conditions.
February 10 and 12, 2014
Kythera licenses setipiprant for novel hair loss therapy
Kythera Biopharmaceuticals (Westlake Village, CA, USA) announces two separate license agreements with Actelion Pharmaceuticals (Allschwill, Switzerland) and the University of Pennsylvania for a novel treatment of hair loss. The deals give Kythera worldwide licensing rights to the experimental drug setipiprant, an oral antagonist of the prostaglandin PGD2 receptor, to treat men with androgenic alopecia. Actelion will receive up to $27 million in milestone fees plus sales royalties. The University of Pennsylvania granted Kythera rights to patents related to the use of PGD2 receptor antagonists for the treatment of alopecia.
Rapid growing device market in China
According to Access China Management Consulting, the Chinese medical device market is expected to pass the $55 billion in 2015, coming second to the US. In 2014, the Chinese authorities have laid out new regulations to fast-track approval of innovative medical devices. A Reuters report indicates that is represents a highly lucrative market for companies involved in medical imaging, patient monitoring and life support products.
Approval of drugs, vaccines, diagnostics and devices
February 12, 2015
US FDA is soliciting input on use of biomarkers in drug development
The FDA is asking for input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers. "FDA intends to facilitate identification of the most promising biomarkers and the areas important to drug development and to promote efforts that will aid in the qualification and regulatory adoption of the drug development framework”.
Drugs at clinical stage
February 13, 2015
Novartis’ new heart failure drug, LCZ696, receives FDA priority review
In August 2014, Novartis had stopped clinical studies of LCZ696, a new heart drug, due to compelling efficacy. The FDA will review New Drug Application (NDA) for LCZ696- a mixed angiotensin receptor-neprilysin inhibitor (ARNI)– for the treatment of heart failure, under its Priority Review program. The process will shorten the total review time from twelve months to eight. Approval could happen in August 2015.
Groundbreaking studies show that devices can treat stroke
Studies presented at the International Stroke Conference in Nashville, (TN, USA) showed evidence that revascularization devices that physically remove blood clots from the brain are a valuable and potentially lifesaving addition to pharmaceutical therapy in stroke patients. Two studies published in the New England Journal of Medicine showed the benefits to be so obvious that they were stopped early. The Escape study of 316 participants in Australia and New Zealand found that 71% of stroke patients in the treatment arm returned to functional independence and had a lower risk of death, compared to 40% of patients who received intravenous t-PA (tissue Plasminogen Activator) as a standard of care medication. Covidien helped to fund the trials, which used the company's Solitaire FR Revascularization device. The device uses a guide wire to position a microcatheter on either side of the clot. Then the mesh Solitaire FR is deployed and the microcatheter is withdrawn. Lastly, the Solitaire FR and microcatheter are withdrawn as a unit, along with the blood clot, which is trapped in the mesh.
Image de Solitaire FR Revascularization device – courtesy of Covidien
Danish scientists discover potential blood circulating biomarker for early detection of dementia
A research team at Denmark's Rigshopitalet, Herlev Hospital and the University of Copenhagen have uncovered a blood circulating biomarker that could predict risk for dementia. The study performed with 76,000 people is published in a February 2015 issue of the Annals of Neurology and shows that low levels of apolipoprotein E, in the blood, may increase a patient's risk of developing dementia. Apolipoprotein E helps prevent amyloid β buildup in the brain, and low levels of the biomarker in the blood could indicate similar low levels in the brain.
Ebola and other viral diseases
Stada Pharma to enter the Ebola field with novel diagnostics
Stada Pharma (Bad Vilbel, Germany) will begin marketing a rapid diagnostic test for Ebola. The test has been validated in several hundreds of patients in Guinea.
February 12, 2015
US troops pull out from West Africa Ebola zone
US President Obama announced plans to withdraw US troops assigned to combat the Ebola outbreak in West Africa. The decision came after the confirmation by WHO that new infections have dropped from 1,000 new cases a week, in October 2014, to about 150 in the last weeks.
February 11, 2015
India announces an outbreak of H1N1 flu virus
India’s Health Ministry announces that 407 patients have died from H1N1 flu virus since the beginning of 2015 and half of them in the ten first days of February. More than 5,000 infected patients have been diagnosed. In August of 2010, WHO had declared the end of the pandemia which has started in Mexico and killed thousands of people.
February 12, 2015
Novavax starts early stage Ebola vaccine trial
Novavax (Gaithersburg, Md. USA) starts patient enrollment in a clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate. The study, being conducted in Australia, involves 230 healthy subjects.
February 13, 2014
Janssen launches three new platforms to increase disease prevention and interception
To better cope with its “raison d’être”, the biopharmaceutical industry will need to tackle the entire spectrum of healthcare needs from the prevention of disease, to its diagnosis and treatment. Along this way, Janssen R&D has unveiled the launch three new research platforms focused on “redefining healthcare” and looking at disease prevention and interception: A Janssen Prevention Center, a Disease Interception Accelerator and a Janssen Human Microbiome Institute. William Hait, global head of Janssen R&D said “by advancing science in these areas our new research platforms will strive to deliver the next generation of transformational medical innovation”.
Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)
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