New finance head for Thorn Medical

by Amy Schofield 26. April 2016 11:00

Thorn Medical PLC has appointed Roderick Stead as Group Finance Director.

Stead joins the international healthcare group from PTS Consulting, where he served in a number of roles including Chief Financial Officer, Chief Risk Officer, and Non-Executive Director.

Jack Kaye, Thorn Medical's Chief Executive, said: "We're delighted to welcome Roderick Stead to the Board as Group Finance Director. His experience in fundraising and international acquisitions will be a great help to achieving our challenging global expansion plans."

Stead added: "Thorn Medical has ambitious plans for growing the company rapidly to become a major international force in the medical and healthcare arena and I look forward to working with the team to ensure its success."

Thorn Medical is an investor and acceleration partner which acts as an aggregator of innovative medical technology, pharmaceutical products and healthcare services businesses.

Image: Roderick Stead, Group Finance Director, Thorn Medical PLC (PRNewsFoto/Thorn Medical PLC)

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NICE U-turn on Sanofi's prostate cancer therapy

by Amy Schofield 26. April 2016 08:07

Sanofi has gained a positive recommendation for cabazitaxel from NICE after increasing the discount and taking steps to reduce waste.

NICE has issued final guidance recommending cabazitaxel (marketed as Jevtana by Sanofi) for some prostate cancer patients, in a change from the appraisal committee’s draft guidance.

The committee previously did not recommend cabazitaxel because of concerns about its cost-effectiveness compared with standard treatments such as abiraterone, enzalutamide or radium-223 dichloride.

Sanofi increased the discount in response to the draft guidance. The company also committed to reducing waste by confirming that it can supply cabazitaxel in intravenous bags instead of vials. These actions led to NICE's new positive recommendation and cabazitaxel is now judged a cost-effective treatment option.

Between 2013 and 2015, over 550 patients accessed cabazitaxel (as a second-line treatment after docetaxel chemotherapy) through the Cancer Drugs Fund (CDF). Cabazitaxel will now move into routine use and out of the CDF. The number of patients receiving the treatment is not anticipated to change as a result of the move.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "I am very pleased that this improved discount for cabazitaxel means we are now able to recommend it. This is an excellent example of how pharma companies can work with us to ensure that patients have access to all of their treatment options.”

One a treatment receives a positive recommendation from NICE, the NHS is legally obliged to begin funding it within three months of the final publication date.

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AstraZeneca secures US launch for Zurampic

by Amy Schofield 25. April 2016 18:10

AstraZeneca has entered into a licensing agreement with Ironwood Pharmaceuticals which includes US rights to Zurampic® and lesinurad/allopurinol fixed-dose combination in gout.

The agreement confers the exclusive US rights to Zurampic (lesinurad) to Ironwood. Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

Ironwood will additionally gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016.

Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on product sales. AstraZeneca will manufacture and supply Zurampic, provide some support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “Our new agreement with Ironwood will ensure the successful launch of Zurampic in the US, while allowing us to concentrate our resources on the innovative medicines in our main therapy areas.”

The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.



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J&J Ebola vaccine shows promise in first human study

by Amy Schofield 21. April 2016 09:18

The first human study into J&J's experimental Ebola vaccine has found 100% immune response eight months later.

Administration of the vaccine from Johnson & Johnson, called AdVac, boosted by a second immunisation shot from biotechnology company Bavarian Nordic A/S, generated a powerful immune response among volunteers in its first tests in humans.

This study, published in the Journal of the American Medical Association, found that 100% of people getting the one-two combination were still producing antibodies against the virus eight months later. 

The novel approach may provide durable protection against the Ebola virus which swept across parts of West Africa in 2014, killing over 11,000 people and infecting almost 29,000.

The study of the vaccine’s real-world effectiveness is a challenge because Ebola isn’t currently circulating in large numbers. The World Health Organization declared an end to the public health emergency last month.

The companies are instead working to confirm the vaccine's safety and further test the immune system’s response in preparation for the possibility of another outbreak or emergency. 

Johnson & Johnson's Chief Scientific Officer Paul Stoffels said: “If there is a large epidemic, we should be able to use it to study the efficacy. Hopefully we will never need it, but if it is a problem, we’ll be ready to step in.”

With this new approach, the first shot is used to prime the immune system and the second boosts the response, perhaps creating a longer benefit.

The research was funded in part by the U.S. National Institutes of Health and grants from a European consortium that includes the London School of Hygiene & Tropical Medicine, the University of Oxford and the French National Institute of Health and Medical Research.



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GSK opens UK respiratory manufacturing facility

by Amy Schofield 21. April 2016 08:24

GSK has opened a £56 million manufacturing facility in Ware, creating 150 new UK jobs.

The company created the state of the art facility in response to growing export demand for GSK’s portfolio of respiratory medicines delivered by the Ellipta inhaler.

The new 4500m2 facility was opened by UK Life Sciences Minister George Freeman MP and GSK Chief Executive Officer Sir Andrew Witty. It is the latest expansion for Ellipta manufacturing at Ware, with investment totalling over £100 million over the past five years. More than 400 jobs have been created at the site since 2013, including over 30 apprentice and 50 graduate roles, forming the total workforce of 1200.

The new facility is expected to almost double production of Ellipta inhalers at Ware to at least 37 million per year by 2017. 95% of these will be exported.  

GSK's CEO Sir Andrew Witty said: "We have been leaders in respiratory since the 1960s when we first began making inhalers for the treatment of respiratory diseases in Ware and it continues to be a critically important site for us, both in terms of researching and developing innovative new inhaler technology, and as a world-leading manufacturing hub. The new facility will increase capacity to meet growing demand for our new portfolio of respiratory medicines worldwide.”

George Freeman MP said: “As well as driving growth and creating 150 new jobs, this expansion of GSK's medicines manufacturing facility in Ware is a strong endorsement of the UK's leadership in manufacturing and respiratory medicine."

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Solid Q1 2016 growth for Roche

by Amy Schofield 20. April 2016 09:07

Roche has reported solid sales growth in the first quarter of 2016, with Pharmaceutical Division sales up 4%, driven by oncology and immunology medicines. 

Group sales are also up 4% at constant exchange rates, 5% in Swiss francs, while Diagnostics Division sales grew 5%, led by immunodiagnostic product demand.

The growth in sales in the Pharmaceuticals Division were driven by Perjeta, MabThera and RoActemra. Pharmaceuticals sales in the US increased, led by Esbriet, Xolair and HER2-positive breast cancer medicines. The recently launched medicines Cotellic in skin cancer and Alecensa in lung cancer are reported to be doing well initially. In the US, sales of Tamiflu and Lucentis declined.

The main growth contributors in the International region were Avastin, MabThera and Herceptin at 4%. In Japan, sales rose 4% driven by Avastin, HER2 medicines and Alecensa.

The US FDA has also granted priority review for investigational cancer immunotherapy medicine atezolizumab in advanced bladder cancer and lung cancer and breakthrough therapy designation for ocrelizumab in multiple sclerosis.

Roche CEO Severin Schwan said: “We have started the year with solid growth in both our Pharmaceuticals and Diagnostics Divisions. Overall, we are on track to meet our full-year targets for 2016.”

Roche expects sales to grow at constant exchange rates in 2016. 


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Skin cancer combo raises survival rates

by Amy Schofield 20. April 2016 08:12

A combination regimen from Bristol-Myers Squibb for the treatment of skin cancer has demonstrated an improved overall survival rate when compared to a single drug.

The first overall survival results from CheckMate -069, a Phase II trial evaluating the investigational combination of nivolumab and ipilimumab vs. ipilimumab alone in patients with previously untreated advanced melanoma showed a two-year overall survival rate of 69% compared to 53% for ipilimumab alone in patients with BRAF wild-type advanced melanoma.

22% of patients who received the combination therapy achieved a complete response, compared to 0% of patients treated with ipilimumab alone.

These data were presented at The American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans as a late-breaking abstract.

Dr. James Larkin, Consultant Medical Oncologist, The Royal Marsden, said: “Both nivolumab and ipilimumab have changed survival expectations in advanced melanoma over the last few years and these latest data show us that combining these two immunotherapies is an effective two-pronged attack against the cancer.”

“The overall survival rates observed using the regimen of nivolumab plus ipilimumab are very promising and provide further hope for patients and their families affected by this disease.”

Nivolumab is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors. It has an innovative mode of action that works by harnessing the ability of the immune system to fight cancer. Ipilimumab has a similar mode of action but acts on a different receptor, called CTLA-4. Combining the two medicines means blocking both receptors at the same time, which then potentially allows the immune system to recognise and destroy tumour cells.

Melanoma is the most dangerous form of skin cancer. In 2013 around 14,500 people were diagnosed in the UK and approximately 2,100 people died from the disease.


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Immune protein could reverse progression of Alzheimer's

by Amy Schofield 19. April 2016 09:08

An immune system protein could offer a potential new target for Alzheimer’s disease treatments, according to research published today.

Findings from the research, carried out by scientists at the University of Glasgow and the Hong Kong University of Science and Technology, suggest that an immune system protein could help to reverse some of the physical and cognitive changes seen in Alzheimer’s disease.

The research, published in Proceedings of the National Academy of Sciences (PNAS), showed that the protein IL-33 reduced the amount of amyloid in the brains of mice that showed symptoms similar to Alzheimer’s. Improvements in memory were also recorded in the mice.

IL-33 is a protein that acts as a chemical signal for immune cells and the scientists found that it appears to work by activating immune cells to find and destroy amyloid plaques, the clumps of sticky protein that cause damage in the brains of people with Alzheimer’s disease.

Some genetic studies have suggested a link between this protein and the development of Alzheimer’s.  Inflammation is also known to play a key role in the development of dementia.

Dr James Pickett, Head of Research at Alzheimer’s Society, said: “The researchers have shown that the protein can lead to short-term improvements in memory and reductions in the amount of amyloid in the brains of mice with symptoms similar to Alzheimer’s disease. They suggest that the protein can switch the function of the immune cells in the brain.

Instead of causing harmful inflammation, the immune cells seek out and destroy the toxic amyloid plaques caused by Alzheimer’s disease. It’s still early days for this line of research and we will need to see if similar mechanisms occur in people as in mice."

Dr Pickett went on to say that clinical trials that target inflammation "may be a promising approach" in the race to find new treatments that can slow or halt Alzheimer's disease progression.


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Opdivo gets EU approval

by Amy Schofield 19. April 2016 07:54

Bristol Myers Squibb has received EU approval for the use of its cancer immunotherapy Opdivo (nivolumab) to treat patients with the most common forms of advanced lung and advanced kidney cancer. 

The move by the European Commission to grant approval for the use of the potentially life–extending cancer treatment significantly broadens the current label for nivolumab to include the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy. This is in addition to adult patients with advanced renal cell carcinoma (RCC) who have received prior therapy.

Nivolumab was designated a Promising Innovative Medicine in both indications by the UK Medicines and Healthcare Products Regulatory Agency, however access for NHS patients is currently uncertain. The therapy offers potential for longer survival than current standard therapy.

Commenting on the implications for advanced lung cancer patients, Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester, said, “Until today, chemotherapy has been the main option, offering limited benefits and significant side effects. The launch of nivolumab will irrevocably change the treatment of this condition and represents one of the biggest advances in almost two decades. We hope access will be as prompt as possible across the UK.”


Antibiotic resistance poses 'greater threat than cancer'

by Amy Schofield 15. April 2016 09:05

Antimicrobial resistance to antibiotics will present more of a threat to mankind than cancer by 2050 unless world leaders come together to formulate international action to tackle the problem, Chancellor George Osborne has said.

Unless radical action is taken, 10 million people a year could die around the world by 2050 because of resistance to antibiotics, Osborne told an expert panel at an International Monetary Fund meeting in Washington. This figure is higher than that of the number of people who die of cancer every year.  

“Unless we take global action, antimicrobial resistance will become an even greater threat to mankind than cancer currently is," said Osborne. He predicted that the cumulative cost to the global economy could be as high as £70 billion ($100 billion) as a result of the cut to global GDP.  

“The cost of doing nothing, both in terms of lives lost and money wasted, is too great, and the world needs to come together to agree a common approach," he added.

Antimicrobial resistance has been declared a threat to global public health by the World Health organisation, which warned that the world could be facing a ‘post-antibiotic era’ in which common infections and minor injuries can kill. Osborne called for radical steps to be taken to shift incentives for pharmaceutical companies to develop new antibiotics. 

A 2014 review commissioned by the government estimated that antimicrobial resistance would become the world’s biggest killer by 2050 unless a new generation of effective antibiotics is developed.




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