Your guide to the pharmaceutical world Volume 7 Issue 5 Parkinson’s Exposé Putting Parkinson’s in its place Ethics Injecting creativity in compliance training Digital Therapeutics A digital world Parkinson’s Exposé Putting Parkinson’s in its place Ethics Injecting creativity in compliance training Digital Therapeutics A digital world www.pbiforum.netEnvironmental Spotlight BrauBeviale INTERNATIONAL 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 7 Issue 5 4 12 18 30 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. COVE r P h OTO: © S h UTTE r STOC k / ALE x E y BOLDI n News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A Round-up8 In the penultimate M&A round-up of the year, Pharma Business International shines a light on the billion- dollar mergers and acquisitions that have taken place over the past few months. Parkinson’s Exposé12 Issues around funding, understanding and diagnosis need to be overcome if there’s ever to be a cure for Parkinson’s. Fortunately, there’s plenty of encouraging researching taking place. Ethics16 Louise Vamvoukaki, Director, Sustainability Education and Engagement at AstraZeneca, explores the importance of creativity in compliance training for the pharmaceutical industry. Digital Therapeutics18 As people become more digitally connected, the pharma industry sees opportunities to tackle big diseases through information. Securing Approval22 Pharmaceutical companies are expected to comply with the various criteria introduced by organisations such as the US Food and Drug Administration and the European Commission. One way in which they can do this is by making use of high-quality inspection and detection systems. Innovative Approaches26 Fully entering the digital world, pharmaceutical companies are putting into practice innovative, digital approaches to research, trials and product development. Funding30 There are several means through which to raise the capital vital for pharma firms and research organisations, from charities and foundations to government bodies and investment funds. Events34 We give a rundown of pharma events happening around the world.NHS saves £700m by adopting generics & best value biologics Thanks to the use of generic and best value biologic treatments, the NHS has saved more than £700 million from the annual medicines bill. This cost saving will be reinvested into new treatments as part of the NHS Long Term Plan. The widespread adoption of generic and biologic treatments to treat conditions including arthritis and cancer is largely the result of an NHS-wide campaign. New figures show that the uptake of best value medicines lowered costs to taxpayers by £294 million last year alone. The NHS says that it is now “on track” to meet its target of a further £400 million annual savings by 2021. A single drug treatment for arthritis and other diseases, saved £110 million alone thanks to a ‘smart procurement’, after the drug – adalimumab – came off patent at the end of 2018. Previously adalimumab was the individual medicine on which hospitals spend the most, at a cost of more than £400 million a year. 4 Pharma Business International www.pbiforum.net Latest news Medicine produced from sunlight via ‘artificial leaf’ An ‘artificial leaf’ technology has produced medicine using sunlight for the first time and, according to its developers, is ready for commercial upscaling. Chemists from Eindhoven University of Technology in the Netherlands have developed a ‘mini rector’ that, like leaves in nature, absorbs sunlight and drives chemical reactions. As an ultimate demonstration, they succeeded in having the reactor produce two types of medicine, the antimalarial artemisinin and the antiparasitic drug ascaridole. Writing in the magazine Angewandte Chemie, they describe how this reactor can be easily scaled up, can be used for a wide range of chemical reactions and maintains stable production under changing weather conditions. According to the chemists, the technology has the potential to provide sustainable drug production for the pharmaceutical industry. They add that its “seems ready for commercial upscaling”. The latest version of the technology is a refinement of an earlier artificial leaf mini- reactor developed by the team in 2016. J.K. Rowling donates £15m to fund MS research Harry Potter author J.K. Rowling has donated £15.3 million to the Anne Rowling Regenerative Neurology Clinic at the University of Edinburgh to fund research into multiple sclerosis (MS) and similar conditions. The Clinic was set up following a previous donation from Ms Rowling in 2010 and is named in memory of her mother who died of MS, aged 45. It has established itself as an integrated care and research facility focusing on MS and neurological conditions with the aim of bringing more clinical studies and trials to patients. The donation will also support research projects focussing on invisible disabilities experienced by people living with MS – such as cognitive impairment and pain. University experts hope the donation will have an enduring global legacy that will have a lasting impact on people with MS and their families. © Marbury / Shutterstock.com © Eindhoven University of Technology J.K. RowlingAI system expediates drug discovery from years to days A new AI system has been developed by a Hong Kong start-up that dramatically accelerates the drug discovery process from years to days. In the industry’s first successful experimental validation of such AI technology for drug discovery in cells and animals, Insilico Medicine successfully created a series of entirely new molecules capable of combating disorders like fibrosis. The traditional drug discovery starts with the testing of thousands of small molecules in order to get to just a few lead-like molecules and only about one in ten of these molecules pass clinical trials in human patients. Insilico was able to ideate and generate a novel molecule from start to finish in 21 days. In a similar technique used by DeepMind to outcompete human GO players, GENTRL – powered by generative chemistry that utilises modern AI techniques – can rapidly generate novel molecular structures with specified properties. Pharma Business International 5www.pbiforum.net Latest news Atomwise & Atropos launch company to discover cancer drug targets A new company is being launched to discover and advance a pipeline of compounds for promising drug discovery targets for the treatment of cancer. The joint venture company is being launched by Atomwise, who specialises in AI powered drug discovery, and senescence platform discovery company, Atropos Therapeutics. They will use their platform technologies and complementary capabilities to perform screens to identify and develop novel compounds for undisclosed targets that modulate cellular senescence and evaluate their potential for development as safe and effective drugs for the treatment of cancer. The joint venture company will have access to Atropos’ and Atomwise’s cutting-edge technology and expertise in aging, cancer biology, computational and medicinal chemistry, and artificial intelligence for drug discovery. Gates Foundation support safer use of medicine during pregnancy A grant from the Bill & Melinda Gates Foundation will support the Medicines and Healthcare products Regulatory Agency (MHRA) research for the safer use of medicine during pregnancy. The grant – worth $360,000 over two years – will support the organisation’s research to help predict the need for adjusting a medicine’s dose during different trimesters of pregnancy. Worldwide, data in this area remain limited, and new insights could potentially impact the health of pregnant women around the world. In this research, MHRA specialists will use prediction models to develop recommended medicine dosages for pregnant women in the UK. This includes evaluating existing models— known as physiologically based pharmacokinetic models and simulations to develop a full picture for all stages of pregnancy. The Agency will also provide training for healthcare professionals on how to use the models, and there will be a dedicated web portal. © Shutterstock / Syda Productions © Shutterstock / any_keen © Shutterstock / Elnur6 Pharma Business International www.pbiforum.net Latest news Gilead & Elton John AIDS Foundation launch HIV initiative Gilead Sciences and the Elton John AIDS Foundation have launched the ground-breaking RADIAN initiative which seeks to meaningfully address new HIV infections and deaths from AIDS-related illnesses in Eastern Europe and Central Asia (EECA). It builds on the existing collaboration between the Foundation and Gilead in the EECA Key Populations (EECAKP) fund, leveraging both organisations’ greater understanding of the region’s needs to drive forward bold and meaningful action to address specific challenges. The initiative is comprised of two key elements – the RADIAN “Model Cities” program and the RADIAN “Unmet Need” fund. By adapting a dual-track program, RADIAN can direct resources to communities in need that are immediately ready to scale interventions through targeted funding, while simultaneously building capacity in others. The first RADIAN Model City will be Almaty, Kazakhstan. RADIAN will support Almaty in achieving improved HIV outcomes by addressing stigma, strengthening healthcare infrastructure and care models and increasing access to innovation. GSK CEO nominated to join Microsoft board Emma Walmsley, CEO of GlaxoSmithKline (GSK) has been nominated to join to the Microsoft board of directors. Ms Walmsley was appointed CEO of GSK in April 2017 and has been a member of the company’s corporate executive team since 2011. “Emma is an accomplished business leader who led major advances in research and development at GSK and will bring her significant insights and global experience to Microsoft,” said John W. Thompson, Microsoft independent board chair. “We believe she will be a valuable addition to the board.” Ms Walmsley will be presented for election at the company’s annual shareholders meeting, which will be held December 4 2019. New Google policy prohibits advertising of cell & gene therapies Google has introduced a new healthcare and medicines policy prohibiting the advertising of unproven or experimental medical techniques such as cell and gene therapy. The new policy will prohibit advertisements selling treatments that, according to Google, “have no established biomedical or scientific basis”. It also includes treatments that are rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use. In a statement, Google said: “We know that important medical discoveries often start as unproven ideas — and we believe that monitored, regulated clinical trials are the most reliable way to test and prove important medical advances. At the same time, we have seen a rise in bad actors attempting to take advantage of individuals by offering untested, deceptive treatments. Often times, these treatments can lead to dangerous health outcomes and we feel they have no place on our platforms.” © Denis Makarenko / Shutterstock.com © PK Studio / Shutterstock.com © GSK Emma Walmsley ASIA Japanese approval for Trintellix in MDD Takeda and Lundbeck have secured approval in Japan for Trintellix (vortioxetine) for the treatment of Major Depressive Disorder (MDD). A New Drug Application for Trintellix was submitted to Japanese regulators in September 2018. Following approval, Takeda and Lundbeck will co-commercialise Trintellix in Japan. Chinese approval for Tagrisso in NSCLC indication AstraZeneca has received marketing authorisation from Chinese regulators for Tagrisso (osimertinib) as a first-line treatment for adults with EGFR-mutated locally-advanced or metastatic non-small cell lung cancer (NSCLC). The approval followed the Priority Review Pathway and is based on results from the Phase III FLAURA trial. Gilead picks up Chinese approval for HIV treatment Gilead Sciences has secured Chinese approval for Biktarvy, its once-daily single tablet regiment for treating HIV-1. The approval is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. Biktarvy received marketing approval from the US FDA and the European Commission in 2018. Japan first to approve personalised medicine Rozlytrek Japan has become the first country to approve Roche’s personalised medicine Rozlytrek after the Ministry of Health and Labour and Welfare (MHLW) gave the treatment the green light for patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours. Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). UNITED STATES Third US approval for Lilly’s Taltz injection Eli Lilly has secured US approval for Taltz (ixekizumab) injection for treating adults with active ankylosing spondylitis. This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It was then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis. Kyowa Kirin’s adjunctive PD treatment approved in US US approval has been granted to Kyowa Kirin’s Nourianz (istradefylline) for use as an adjunctive treatment for Parkinson’s disease (PD). Nourianz is a novel non-dopaminergic once-a-day oral treatment option to be used in conjunction with levodopa/carbidopa for PD. The approval is based on findings from randomized, multi-centre, double blind, placebo- controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications. US approves first new treatment for myelofibrosis in almost a decade Celgene has picked up US approval for Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis. With this FDA approval, Inrebic has become the first new treatment in almost a decade for patients with myelofibrosis. First treatment for patients with type of lung disease approved in US Ofev (nintedanib) capsules has become the first treatment approved in the US to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. Ofev received Priority Review designation which, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. It also received Orphan Drug designation. www.pbiforum.net Pharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net SHAKERS Movers and 8-11.qxp_Layout 1 07/10/2019 12:02 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © Shutterstock /iQoncept It was inevitable that this issue’s round-up would feature an update from Celgene’s still-gestating $74 billion merger with Bristol-Myers Squibb (BMS). The latest as of writing follows on from last issue, where Celgene announced its intention to divest Otezla (apremilast) – the only oral, non-biologic treatment for psoriasis and psoriatic arthritis – to expediate the merger deal in light of concerns expressed by the Federal Trade Commission (FTC). Now California-based biopharma, Amgen, has acquired the worldwide rights to the treatment in a deal worth up to $13.4 billion. As well as bringing the proposed deadline for the merger deal forward – to the end of 2019 or the beginning of 2020 – the deal makes a “strong strategic fit” for Amgen with its expertise in psoriasis and inflammation. “The acquisition of Otezla offers a unique opportunity for Amgen to provide patients an innovative oral therapy for psoriasis and psoriatic arthritis that fits squarely within our portfolio and complements our Enbrel and Amgevita brands,” said Robert A. Bradway, 10 Á In the penultimate M&A round-up of the year, Pharma Business International shines a light on the billion-dollar mergers and acquisitions that have taken place over the past few months. Next >