Bavarian Nordic seals $539 million vaccine deal

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Bavarian Nordic, a Danish biotech, has continued its partnership with the US government by agreeing a $539 million deal to deliver smallpox vaccines.

The partnership between Bavarian Nordic will see it provide the Biomedical Advanced Research and Development Authority (BARDA) with a freeze-dried formulation of the vaccine.

The company revealed that the US government is planning on stockpiling 132 million doses of the new formulation for the event of an outbreak. It is the third deal struck between the biotech and the US, with the total of previous deals raising $233 million.

The US will provide $100 million up-front, and the company has announced that it plans on investing $75 million over the coming years to construct a fill/finish manufacturing plant in Denmark. This will see the biotech be able to complete all stages of manufacturing process, as well as allowing the company the potential to provide this service to other companies.

The new formulation of the vaccine means that it can be stored safely for more than five years, as well as allowing significant reduction in the cost of shipping and storage compared with previous liquid-frozen formulations.

“We are proud to be part of a long-standing and successful partnership with BARDA and this latest contract starts a new chapter, as we supply an improved formulation of our vaccine as part of the U.S. government commitment to protect the nation from a smallpox outbreak”, said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline.”

It was also revealed that Bavarian Nordic expects to see further such deals in the future, as the US looks to continue stockpiling the vaccine.

The deal is a considerable boost to the company after it suffered a major setback when its cancer vaccine recently hit the wall. The six-year-long Phase 3 study into CV-301 was shuttered after final interim analysis revealed that the vaccine was not successful.

The hit to its pipeline slashed its share price by close to half, a figure that has recovered slightly since but still remains down 34% on its price prior to the release of the news.


Genome sequencing for antibiotic prescribing wins top tech prize

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A company that combines genome sequencing and AI to tackle antibiotic resistance has won a top medtech prize. 

Boston, Massachusetts-based Day Zero Diagnostics beat almost 600 other technology startups as part of the 2017 MedTech Innovator Global Competition, nabbing a $350,000 grand prize.

The technology allows doctors to move away from using broad-spectrum antibiotic treatment plans to treat infections.

Instead,  AI to analyse individual genomic data and combining it with insights from big data sources, means more targeted antibiotic regimens can be used leading to better treatment response, recovery and lower treatment cost.

The growth of antibiotic resistant ‘superbugs’ is a major concern worldwide, and poorly targeted prescribing of the drugs is one of the key factors.

The new technology helps bypass this, and also dramatically cuts the time to develop an effective treatment plan from days to hours.

On its way to claiming the grand prize, Day Zero was part of the MedTech Innovator Accelerator – a multi-stage programme where the company was given increasing amounts of industry exposure and fostering.

“It was a tremendous benefit to be part of the MedTech Innovator Accelerator, but to win the whole competition is invaluable,” said Jong Lee, CEO and co-founder of Day Zero Diagnostics. “We’re proud to be considered a startup that is doing transformational work in healthcare, and the resources and funding awarded through MedTech Innovator will help support us as we make our goals a reality.”

Renee Ryan, vice president of Venture Investments at Johnson & Johnson, said: “As a founding sponsor of MedTech Innovator, we’ve seen remarkable companies come through the programme, and we expect Day Zero Diagnostics’ technology to provide value to patients, providers and the healthcare system as a whole.”

Runners-up for the competition include Allotrope Medical – a company that offers a more precise method of ureter detection, reducing procedure time and injury risk; Abreos Biosciences – a biologics precision-dosing company; and Selio Medical – a lung cancer diagnostics company.


Amgen announces new T-cell collaboration

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Amgen and CytomX Therapeutics are set to co-develop a Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR).

The EGFR is a highly-validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumour microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific therapeutics induced tumour regressions and increased the therapeutic window for EGFR.

Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development. Amgen will lead later development and commercialisation with global late-stage development costs shared between the two companies.

Amgen will make an upfront payment of $40 million and purchase $20 million of CytomX common stock. CytomX will be eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program. Amgen will lead global commercial activities with CytomX able to opt into a profit share in the US and receive tiered, double-digit royalties on net product sales outside of the US.

Amgen will also receive exclusive worldwide rights to develop and commercialise up to three additional, undisclosed targets. Should Amgen  pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products. CytomX will also receive the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific programme; Amgen is eligible to receive milestones and royalty payments on any resulting products from this programme.


AbbVie adds biologic production capability to Singapore facility

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AbbVie has expanded the operational capability of its facility located at the Tuas Biomedical Park in Singapore with the addition of a biologics manufacturing facility.

The move means the plant will now add the production of biological drugs to its repertoire in addition to small molecule active pharmaceutical ingredients (APIs).

The plant is the 13th site within the company’s global manufacturing network which spans across the US, Europe and Puerto Rico, and is the only one of its kind within the network with the capability to produce both biologics and APIs. AbbVie employs around 400 workers in Singapore, around 250 of which serve at the manufacturing plant.

Singapore’s Minister for Trade and Industry, S Iswaran, was present at the opening ceremony, where he said the facility expansion came at an “opportune moment” to meet the increasing demands of ageing populations and technological advancement.

“While these shifts will disrupt existing business models, they also present significant new opportunities,” he said.

According to Iswaran, the country’s government is committed to investing S$4 billion in health and biomedical sciences in addition to a further S$3.2 billion in advanced manufacturing and engineering as part of the Research Innovation and Enterprise (RIE) 2020 plan, a programme jointly developed by Workforce Singapore and the Singapore Economic Development Board.

“A strategic goal of RIE 2020 is to strengthen linkages between public research performers and private enterprises to create greater value from our investments in R&D,” Iswaran noted.

Over 350 people have benefitted from the programme since its inception in 2014.


Leukaemia patients to get access to AbbVie’s Venclyxto via Cancer Drugs Fund

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AbbVie has struck a deal with NICE to make its leukaemia drug Venclyxto available through the Cancer Drugs Fund.

The new treatment Venclyxto (venetoclax) is to be available to NHS patients in England with chronic lymphocytic leukaemia (CLL), the common form of adult leukaemia via the CDF while it accrues more cost-effectiveness data.

Venclyxto will be available to adults with difficult-to-treat types of chronic lymphocytic leukaemia – those patients without 17p deletion or TP53 mutation who have failed both chemo-immunotherapy and a B-cell receptor (BCR) inhibitor.

Venclyxto has also been recommended for the treatment of adult CLL patients in the presence of 17p deletion or TP53 mutation who are either unsuitable for or have failed a BCR inhibitor.

The decision represents a U-turn from NICE, which had rejected Venclyxto in first draft guidance published in February.

But since then AbbVie has been in talks with NICE and in final guidance, the cost-effectiveness watchdog granted interim funding from the CDF.

This will allow NICE to gather further evidence to address uncertainties in the dossier of trial evidence submitted by AbbVie, while giving CLL patients a further treatment option when other drugs have failed.

One concern cited by NICE was how generalisable the results of trials were to clinical practice in England, as neither the M12-175 nor M14-032 trials included any UK centres.

NICE also questioned evidence showing that despite having several therapies, CLL appeared not to have a detrimental effect on health-related quality of life of patients in the Venclyxto trials.

The committee concluded that patients in the trials were not as sick as those for whom the drug would be an option in England, meaning the treatment benefits in the population were uncertain.

Although data showed overall survival was much higher with Venclyxto, NICE’s independent appraisal committee said the relative survival benefit compared with best supportive care was likely to be biased in favour of Venclexto.

Venclexto is likely to cost between £50,000-£60,000 per Quality Adjusted Life Year gained, above the £30,000 threshold usually used by NICE – but it has extra leeway as end of life criteria apply.

Dr Peter Hillmen, professor of Experimental Haematology and honorary consultant haematologist at Leeds Teaching Hospitals NHS Trust, said: “Today’s recommendation is great news for patients with CLL who have failed existing treatments, and provides clinicians with an important new treatment option.”

“The studies that NICE has assessed to reach this positive decision represent a milestone in the management of relapsed/refractory CLL.”

“The early clinical data is compelling, showing survival benefits for this challenging group of patients, including some who achieved complete remission. I would anticipate that collection of further data through the CDF will confirm these extremely promising early findings.”

Alice Butler, medical director at AbbVie, said: “Working together with the NHS to collect more long-term data provides an important opportunity to understand the impact of venetoclax on the survival of patients with this difficult-to-treat type of CLL.”

Patients in Wales are likely to get access to drug in the coming months following NICE’s ruling, while the Scottish Medicines Consortium already recommended funding in August in a separate decision.


ABPI bid to overturn NICE’s budget impact rules fails

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The UK pharmaceutical trade body has failed in an attempt to force a judicial review of the new evaluation process introduced by the National Institute for Health and Care Excellence (NICE) earlier this year.

The Association of the British Pharmaceutical Industry (ABPI) has been fighting a legal action to try to overturn NICE’s introduction of a £20m cost ceiling for new drugs that have already been assessed as cost-effective, a measure that could allow it to delay introduction for up to three years.

The High Court rejected the ABPI’s application to have the changes to the evaluation process struck down, which the trade body claimed were “inappropriate and unworkable”, would limit patient access to new treatments and lay outside the cost-effectiveness organisation’s remit. It said around one in five new medicines would be affected by the policy.

In a statement, it said: “The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps.”​

NHS England said in a statement that the High Court “has rejected ABPI’s flawed legal manoeuvres which the judge said would ‘produce an absurd result”.

“Rather than attempting to further frustrate NICE and the NHS’ work to ensure patients and taxpayers get maximum value out of the £15bn being spent on drugs, it now makes sense to work together towards that shared goal,” it continued.

In addition to the £20m budget cap, NICE also introduced a fast-track approval mechanism for treatments that offer ‘exceptional value for money’, and new rules on how it evaluates treatments for very rare conditions, raising the upper threshold limit to £300,000 from £100,000 for treatments considered to offer substantial clinical benefit.

Last year, the NHS spent £16.8bn on medicines, according to the British Medical Journal, up 8% on the prior year and almost £4bn more than was spent in 2011.


Lonza to buy US clinical manufacturing site

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The site is being acquired from Shire and adds early-phase clinical manufacture on the West Coast.

Lonza is acquiring a clinical-stage mammalian manufacturing site in the US from Shire. Financial details of the deal were not disclosed.

The 58,000-ft2 (approx 5,388m2) site, located in Hayward, California, has been operating as a multi-product cGMP facility since 1990 and has a successful regulatory track record.

Assets include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities. Currently the site employs more than 100 personnel, all of whom will have the opportunity to continue in their role with Lonza.

In response to Lonza’s Pharma&Biotech customers’ increasing demand for clinical-stage manufacturing capacity, the acquisition of the site will provide additional cGMP capacity and will supplement our existing assets in Slough (UK). Lonza customer batches will be initiated in 2018.

“As a committed partner to the pharmaceutical and biotechnology industry, Lonza recognizes the need for established and dependable global manufacturing facilities,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development, for Lonza. “The acquisition of this site allows our customers greater access to clinical capacity from a US site. The additional capacity will support the needs of our customers to secure manufacture for their products’ complete lifecycle across Lonza’s global manufacturing network.”

“We are confident in Lonza’s ability to continue the important work happening in Hayward and are pleased that they recognised the talent of the team already in place,” said Matt Walker, Shire’s Head of Technical Operations. “Moving forward, Lonza will serve as a partner to Shire, managing the manufacture and supply of reagents used in a number of Shire products.”

Lonza’s recently completed the acquisition of Capsugel increasing its ability to supply the pharmaceutical, biotech and specialty ingredients markets.


Global campaign to reduce cholera deaths by 90%

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A new campaign, launched by the WHO, has begun today to reduce deaths from cholera by 90% through to 2030.

The action will be instigated by the Global Task Force on Cholera Control (GTFCC), which is a network of 50 UN and international agencies, academic institutions, and NGOs that work to help countries struggling the most with the disease.

The push comes at a time when war-torn Yemen is facing the worst recorded outbreak of cholera that the world has ever seen – with 771,945 reported cases and 2,132 deaths. Globally, there are 2.9 million cases and approximately 95,000 deaths every year from the infection.

Cholera predominantly affects areas that have poor access to clean water supplies and poor sanitation facilities, it is most common in the poorest areas of the globe (see map above). The infection is relatively simple to treat, with rehydration salts offering a quick solution, and there has also been vaccine developed that offers protection from the bacteria for three years at a time.

The oral vaccine itself is cost effective, working out at only $6 per person – a development that the WHO referred to the availability of two vaccines as a “game-changer in the battle to control cholera, bridging the gap between emergency response and longer-term control”.

Cholera itself is an acute diarrhoeal infection, caused by the bacterium Vibrio cholera. It spreads through the contamination of water or food with the bacteria, in areas with poor sanitation, it can spread rapidly.

As can be seen in the map above, the infection is isolated to a select group of countries, with 47 countries affected by cholera and in 20 of these the disease is endemic; the Roadmap put forward by the WHO aims to rid up to 20 of the infection.

“WHO is proud to be part of this new joint initiative to stop deaths from cholera. The disease takes its greatest toll on the poor and the vulnerable – this is quite unacceptable. This roadmap is the best way we have to bring this to an end,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO.

It is noted that Northern Europe and the US have managed to eliminate cholera 150 years ago. It is estimated that to provide all individuals with clean water, sanitation and hygiene the cost would amount to $40 per person.


FDA grants breakthrough status to new Hodgkin’s lymphoma therapy

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin’s lymphoma.

Jointly developed by Seattle Genetics and Takeda, adcetris an antibody-drug conjugate (ADC) directed to CD30. It is designed to employ a linker system that releases monomethyl auristatin E (MMAE) upon internalisation into CD30-positive tumour cells.

Seattle Genetics president and chief executive officer Clay Siegall said: “The decision by the FDA to grant this designation recognises the need for new options that can change the care of people with newly diagnosed advanced Hodgkin’s lymphoma.

“The designation supports our goal to make adcetris available to patients in this setting as soon as possible.”

The designation was granted based on data from the Phase III Echelon-1 study, which is a randomised, open-label clinical trial that investigated adcetris plus AVD versus ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine).

The multi-centre trial enrolled 1,334 patients and was conducted in North America, Europe, South America, Australia, Asia and Africa.

Siegall added: “The Phase III Echelon-1 study that supports the Breakthrough Therapy Designation for adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients.

“We look forward to presenting the data from our Phase III Echelon-1 trial at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017.”

Adcetris is being evaluated in more than 70 clinical trials, including four Phase III studies: the Echelon-1 trial, the ongoing Echelon-2 trial in frontline mature T-cell lymphomas, the completed Alcanza trial in cutaneous T-cell lymphoma and the recently initiated Checkmate 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

The drug has received marketing authorisation in 67 countries for relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL).

Adcetris is currently not approved as a frontline therapy for Hodgkin’s lymphoma.


AstraZeneca extends distribution contract with Yusen Logistics

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AstraZeneca has awarded a contract extension to healthcare logistics provider Yusen Logistics for the global distribution of its products.

As a Strategic Global Freight Partner to AstraZeneca, Yusen handles products throughout the manufacturing process, from active ingredient and bulk materials to prescription drugs.

The contract extension covers existing road business, air and sea volumes handled by Yusen Logistics.

The Yusen solution is based around its European ‘Pharma Superhighway’ road network, with movements managed by its ‘Control Tower’. This allows centralised planning of pan-European transport movements to maximise vehicle utilisation and reduce costs.

The Control Tower also manages air movements via strategic gateways at Schiphol, Frankfurt and Chicago, as well as ocean movements to and from Europe, supported by Yusen’s warehouses in Antwerp and the UK, which deliver strategic storage and customs clearance capabilities.

The Pharma Superhighway currently carries around 250,000 pallets for AstraZeneca, all of which are real time tracked with full temperature monitoring, from its manufacturing plants and third party manufacturers to over 100 destinations in Europe and 50 countries worldwide.

The companies have been working in close partnership since 2007, when Yusen Logistics was appointed to work with AstraZeneca on the creation of a lean supply chain.

Andy Fitt, Deputy MD Yusen Logistics (UK), said: “This renewal underlines the continued evolution of our collaboration with AstraZeneca. As a long-standing partner we are continuing to proactively deliver service and quality enhancements on a local, regional and global basis.”

Julian Wann, Global Category Lead: Freight & Logistics, AstraZeneca, said: “We are delighted to continue and further develop our strategic partnership with Yusen Logistics, working together to support AZ’s business objectives.”