Your guide to the pharmaceutical world Volume 8 Issue 1 Focus on coronavirus World Health Organisation declares global emergency Nuclear medicine The nuclear option Vaccines Prevention before treatment Focus on coronavirus World Health Organisation declares global emergency Nuclear medicine The nuclear option Vaccines Prevention before treatment www.pbiforum.netINTERNATIONAL FoodDrink FoodDrink www.fdiforum.netOCTOBER 2019 £3.50 STERLING News The natural choice The natural choice For businesses that are serious about reducing their carbon footprint www.blmgroup.co.uk VOLUME 4 ISSUE 1 WWW.RENEWABLESANDENVIRONMENT.COM OCTOBER 2019 EAST MIDLANDS LEADING BUSINESS MAGAZINE www.blmgroup.co.uk WWW.EASTMIDLANDSBUSINESSLINK.CO.UK WWW.EASTMIDLANDSBUSINESSLINK.CO.UK £3.50 In the eye of the law Better. Smarter. Faster. Seeking help when growing EMPOWER Your Business Your guide to the pharmaceutical world Volume 7 Issue 4 Antibiotic Resistance Exposé Resistance is futile Manufacturing Automate, automate, automate Vaccines A shot in the arm Antibiotic Resistance Exposé Resistance is futile Manufacturing Automate, automate, automate Vaccines A shot in the arm www.pbiforum.net september 2019 £3.50 yorkshire & lincolnshire’s leading business magazine www.blmgroup.co.uk VOLUME 34 ISSUE 9 Boosting wellbeing TAKING STOCK TAKING STOCK Keeping up with the market Train old or train new? Often Imitated - Never Equalled www.blmgroup.co.uk@pbiforumwww.pbiforum.net company/pharma-business-international Contents Volume 8 Issue 1 4 12 25 38 Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Journalist: Dominic Cuthbert (d.cuthbert@blmgroup.co.uk) Tess Egginton (t.egginton@blmgroup.co.uk) Sales Director: Angie Cooper (a.cooper@blmgroup.co.uk) Sales Manager: Sam Trott (s.trott@blmgroup.co.uk) Sales: Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Accounts & Subscriptions: Angela Sharman (a.sharman@blmgroup.co.uk) Design & Production: Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Editorial: Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Part of BLMGroup: Armstrong House, Armstrong Street, Grimsby, North East lincolnshire DN31 2QE England All rights reserved. No part of this publication may be reproduced, transmitted, photocopied, recorded or otherwise without express permission of the copyright holder, for which application should be addressed first to the publisher. While every reasonable care is taken, neither the publisher nor its participating agents accept liability for loss or damage to prints, colour transparencies, negatives or other material of whatever nature submitted to this publication. The views expressed in this publication are not necessarily the views of those held by the publisher. COVER PHOTO: © SHUTTERSTOCK / SO l ARSEVEN News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A Round-up8 In the first M&A round-up of the new year, we spotlight two major deals that have completed, check in with AbbVie and Allergan, and explore the sector’s first billion-dollar-plus deal of 2020. Focus on coronavirus12 As the World Health Organisation declares the novel coronavirus a global emergency, Pharma Business International takes a closer look at the outbreak and what researchers are doing to combat the virus. Q&A - future of healthcare16 We spoke with François-Henri Boissel, CEO of French biotechnology company Novadiscovery, and Tanja Dowe, CEO of Debiopharm Innovation Fund, about advances in drug discovery, clinical trials and what the future holds for healthcare. Antibiotics exosé18 With the threat of antimicrobial resistance only growing, funding, incentives, overprescribing and diagnostic tests are all topics on the tongue of the antibiotics field. Blockchain22 Hailed as a technical advancement that can push the pharmaceutical industry further than ever, several companies and countries are already investing – but blockchain isn’t without its disadvantages. Exploring antibodies25 In exploring antibodies scientists have made significant progress in developing new treatments for diseases and delivery methods. Q&A - Interview with Russell Basser 28 Pharma Business International spoke with Russell Basser, Chief Scientist and Senior Vice President of Research and Development at Seqirus, a UK-based leader in influenza vaccine. Nuclear medicine30 Nuclear medicine is unique in that it can be used both as a diagnostic imaging tool and a therapeutically. We take a closer look at the possibilities offered by this approach and what the future holds. Drug discovery34 From dramatically reducing development times, dealing with big data, and cutting costs, artificial intelligence is upending the traditional model of drug discovery. Vaccines38 Anti-vaxxers, super viruses and industry predictions. It’s a hectic timetable for the vaccination industry, but as one of our main lines of defence against infectious diseases, we can’t afford to take it easy. Events36 We give a rundown of pharma events happening around the world.Researchers develop edible ‘security tag’ to beat counterfeits Researches from Purdue University have developed a silk film designed to go on the surface of drug capsules. To imitate the drug, a counterfeiter would have to uncrack a complicated puzzle of patterns not fully visible to the naked eye. “Every single tag is unique, offering a much higher level of security,” said Young Kim, an associate professor in Purdue’s Weldon School of Biomedical Engineering. The tag acts as a digital fingerprint for each drug capsule or tablet, using an authentication technique called ‘physical unclonable functions’ (or PUF) that was originally developed for information and hardware security. Shining various LED light sources on the tag excites the fluorescent silk microparticles, causing them to generate a different random pattern each time. Digital bits can then be extracted from an image of those patterns to produce a security key. The researchers are currently converting this process to a smartphone app for both pharmacies and consumers. 4 Pharma Business International www.pbiforum.net Latest news Dozens of non-oncology drugs found to kill cancer A study has found that almost fifty non-oncology drugs can kill cancer cells, offering a pathway to repurpose existing drugs to treat cancer. Researchers from the Broad Institute of MIT and Harvard and Dana-Farber Cancer Institute analysed thousands of pre-existing drug compounds. Of those, almost fifty demonstrated anti- cancer activity. The study, published in Nature Cancer, is the largest to date to employ the Broad’s Drug Repurposing Hub. The study also marks the first time researchers screened the entire collection of mostly non-cancer drugs for their anti-cancer capabilities. The researchers hope to study the repurposing library compounds in more cancer cell lines and to grow the hub to include even more compounds that have been tested in humans. The team will also continue to analyse the data from this study, which have been shared openly with the scientific community, to better understand what’s driving the compounds’ selective activity. Researchers take step closer to universal flu vaccine A novel nanoparticle combining two major influenza proteins has been shown to be effective in providing broad, long-lasting protection against flu virus in mice. The double-layered nanoparticle vaccine contains the influenza virus proteins matrix protein 2 ectodomain (M2e) and neuraminidase (NA). Mice were immunized with the nanoparticle vaccine before being exposed to influenza virus, and they were protected against six different strains of the virus. The findings from researchers at the Institute for Biomedical Sciences at Georgia State University and published in Advanced Healthcare Materials suggest this unique combination has potential as a universal flu vaccine or component of such vaccines. In the study, mice were exposed to one of six influenza virus strains after receiving the nanoparticle vaccine by intramuscular injection. The vaccine proved to have long-lasting immune protection, which was unchanged against viral challenges up to four months after immunizations. Next, the researchers plan to load this double-layered nanoparticle vaccine onto microneedle patches for skin vaccination. © Purdue University photo/Jung Woo Leem © Shutterstock / PopTika © Shutterstock / Sherry Yates YoungUK accounts for over 12% of global cell & gene therapy clinical trials The UK now accounts for over 12% of global cell and gene therapy clinical trials, according to a report and database from the Cell and Gene Therapy Catapult (CGT Catapult). The UK therapies medicinal products (ATMPs) clinical trials database shows that the nation’s 127 ongoing trials account for 12% of the total global cell and gene therapy clinical studies. The database shows that 77% of UK cell and gene therapy trials are now sponsored by commercial organisations compared to only 25% in 2013. This reflects the continuous investment that companies are making in cell and gene therapies, and the transformative effects that these therapies are proving to have on patients’ lives. The main indication for cell and gene therapies clinical trials remains oncology (39%) followed by ophthalmology (13%) and haematology (12%). “These extraordinary figures show the UK’s life sciences sector is leading the world in getting cutting-edge treatments to NHS patients as quickly as possible,” said Health Minister Baroness Blackwood. Pharma Business International 5 www.pbiforum.net Latest news Landmark MND trial to test potential new treatments Patients with motor neurone disease (MND) across the UK are being sought for an innovative clinical trial to test potential new treatments. MND-SMART aims to find treatments that can slow, stop or reverse disease progression. Led by the Euan MacDonald Centre, it will include as many people with the condition as possible, regardless of how the disease or current treatments affect them. Typically, clinical trials focus on a single drug compared with a placebo, but MND-SMART will allow more than one treatment to be tested against a shared placebo group. The trial is designed to be adaptive so that the researchers can modify their approach according to emerging results. New drugs can be added once the trial has started, while medicines that prove ineffective can be dropped. Initially researchers will test drugs that are already licensed for use in other conditions to check whether they offer any benefit for people with MND. Novartis and NHS to tackle cardiovascular disease Novartis will work alongside NHS England to tackle the burden of cardiovascular disease (CVD) in the UK. The aim is to create a pioneering collaboration that brings together three projects that aim to tackle the healthcare challenge of CVD, whilst also providing increased opportunities for UK life science sector The first proposal, upon regulatory approval and the National Institute for Health and Care Excellence (NICE) assessment, would be to provide inclisiran (currently in Phase III development) to secondary prevention atherosclerotic CVD patients through a population-level The second proposal is to explore a large-scale clinical trial to evaluate the use of inclisiran to patients at very high risk of having their first cardiac event (primary prevention). The final proposal includes the creation of an industry and academic consortium to look at manufacturing synergies that could improve the efficiency and scale at which the UK can manufacture oligonucleotide medicines – such as inclisiran. © Shutterstock / Jarun Ontakrai © Shutterstock / nobeastsofierce © Shutterstock / Giovanni Cancemi6 Pharma Business International www.pbiforum.net Latest news UK biotech investment increases 400% Despite global economic uncertainty, the UK biotech sector raised £1.3 billion in 2019, industry figures show. According to the UK BioIndustry Association (BIA) and Informa Pharma Intelligence, 2019’s figure is the third highest year recorded by the trade association and, since 2012, investment has increased by over 400%. Of the £1.3 billion, more than £679 million was raised in venture capital; £64 million in Initial Public Offerings (IPOs), and £596 million in all other public financings. The figures show that the biotech sector has enjoyed five consecutive years of raising over £1 billion-plus investment. The UK has therefore remained the leading cluster in Europe for amounts raise through venture capital. Steve Bates, Chief Executive of the BIA, praised the findings but added “while we welcome overseas investment, diversifying the domestic life sciences investor base is critical to capturing the full benefits of this key sector of the UK economy.” HIV transmissions fall as UK scales-up testing & combination prevention A Public Health England report revealed a 71.4% fall in HIV transmissions among gay, bisexual and other men who have sex with men from 2012 to 2018. Since 2014, the number of gay, bisexual and men who have sex with men living undiagnosed with HIV has halved from an estimated 7,000 to 3,600 in 2018. The results demonstrate that the scale-up of combination prevention – such as condoms, HIV testing and the availability of Pre-exposure Prophylaxis (PrEP) for those who are negative – is working. HIV testing, especially, has greatly increased over the last decade, leading to a reduction in the number of those remaining unaware of their HIV status. However, in 2018 there was an estimated 7,500 people living with HIV and were unaware of it. Though the report is encouraging, these efforts need to be scaled up to reach the UK’s goal of zero HIV transmissions by 2030. Spread of breast cancer slowed with anti-stress drugs Anti-stress drugs have been found to slow the spread of breast cancer in research that could help pave the way for new treatment options. A study undertaken by researchers from the Monash Institute of Pharmaceutical Sciences (MIPS) alongside teams from Peter MacCallum Cancer Centre found that beta-blockers stop cancer cells spreading through the body of women with breast cancer. Published in Clinical Cancer Research, the study is the first to demonstrate that beta-blockers independently reduce biomarkers of metastasis in breast cancer. In the randomised controlled trial, women were either given a placebo or propranolol – a beta-blocker used to treat cardiac disease and anxiety disorders. The trial ran from the time of diagnosis until after the breast cancer surgery. They found that just one week of beta-blockers therapy inhibited cancer invasion. The researchers believe the findings support the need for larger clinical trials that can prove that beta-blockers improve survival after a cancer diagnosis. © Shutterstock/kurhan © Shutterstock / Marc Bruxelle © Shutterstock/Shidlovski EUROPE Approval for Mayzent in secondary progressive MS Mayzent has been approved in Europe for treating patients with secondary progressive multiple sclerosis (SPMS) with active disease. The approval makes Mayzent the first and only indicated oral treatment proven in SPMS patients with active disease based on a randomised clinical trial of a broad range of SPMS patients. It is based on data from the EXPAND study, a randomised, double-blind, placebo-controlled trial, comparing the efficacy and safety of Mayzent versus placebo in a broad range of SPMS patients. Conditional approval for Roche’s Polivy with BR in lymphoma The combination of Roche’s Polivy with bendamustine plus MabThera for patients with previously treated aggressive lymphoma has been conditionally approved in Europe. Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. In this case, approval is based on the results from the phase Ib/II GO29365 study. Approval for Sunosi Sunosi (solriamfetol) has become the only licensed therapy in Europe for treating excessive daytime sleepiness in adults living with obstructive sleep apnea. Approval was granted to Ireland’s Jazz Therapeutics and was based on data from four randomised placebo-controlled studies. Data from the studies in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) programme demonstrated the superiority of solriamfetol relative to placebo. Nod for Roche’s Kadcyla as adjuvant treatment European approval has been granted to Roche for Kadcyla for the adjuvant treatment of adult patients with HER2-positive early breast cancer with residual invasive disease afar neoadjuvant treatment. The approval is based on results from the phase III KATHERINE study, which showed that Kadcyla (trastuzumab emtansine) significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. UNITED STATES First treatment approved for thyroid eye disease Horizon Pharma has become the first company with an approved treatment for thyroid eye disease after the FDA rubberstamped Tepezza (teprotumumab-trbw). It was approved based on the results of two studies consisting of a total of 170 patients with active thyroid eye disease who were randomised to either receive Tepezza or a placebo. The FDA granted the application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Additionally, Tepezza received Orphan Drug designation. FDA approves first precision therapy for GIST Blueprint Medicines has gained the green light in the US for Ayvakit for treating adults with unresectable or metastatic gastrointestinal stromal tumour (GIST) harbouring a platelet- derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Ayvakit (avapritinib) is now the first precision therapy approved to treat a genomically defined population of patients with GIST, a rare, genomically driven sarcoma of the gastrointestinal tract. The approval was based on efficacy results from the Phase 1 NAVIGATOR clinical trial, as well as combined safety results from multiple clinical trials for avapritinib. First generics of blood thinner Eliquis approved The FDA has approved the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The first two approvals of the blood thinner were granted to Micro Labs and Mylan. Apixaban is also indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery. Ervebo becomes first vaccine approved in US for preventing Ebola Merck’s Ervebo has become the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in adults. The approval is supported by a study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older. Ervebo is administered as a single-dose injection, and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus. www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net In early January, Ernst & Young (EY) released its annual report on dealmaking which revealed, perhaps unsurprisingly, that the life sciences sector set an all-time record for mergers and acquisitions last year. In 2019, EY recorded $357 billion worth of deals among life sciences companies – which encompasses pharma, biotech and medtech – overtaking the previous high benchmark set in 2014. Driven by pharma buyers, the success of this record year looks set to continue but, the consultancy said it was unlikely to top 2019. As the first round-up of the new year, we’re beginning with the big deals that have recently concluded. Before the end of 2019, Merck announced its intention to acquire ArQule, a Massachusetts-based biopharma focussed on kinase inhibitor discovery and development. It only took a month to clear the requisite regulatory hurdles and secure shareholder backing for the $2.7 billion deal to complete. By mid- January, the New Jersey firm had acquired all the outstanding shares of common stock of ArQule via a subsidiary. The deal strengthens Merck’s pipeline by providing access to several clinical stage oral kinase inhibitors which have novel and important properties. Chief among these is ArQule’s lead investigational candidate – ARQ 531 – a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies. The lifecycles of acquisitions In the first M&A round-up of the new year, we spotlight two major deals that have completed, check in with AbbVie and Allergan, and explore the sector’s first billion-dollar-plus deal of 2020. 10 ÁPharma Business International 9 www.pbiforum.net M&A ROUND-UP © Shutterstock /Atmosphere1 Next >