Your guide to the pharmaceutical world Volume 8 Issue 2 PPE Defence against infection Clinical trials Race for treatment Digital innovations The digital response to COVID-19 PPE Defence against infection Clinical trials Race for treatment Digital innovations The digital response to COVID-19 www.pbiforum.netwww.fdiforum.netAPRIL 2020 £3.50 STERLING Ingredients spotlight A refreshing approach A refreshing approach INTERNATIONAL FoodDrink FoodDrink For businesses that are serious about reducing their carbon footprint www.blmgroup.co.uk VOLUME 4 ISSUE 1 WWW.RENEWABLESANDENVIRONMENT.COM APRIL 2020 EAST MIDLANDS LEADING BUSINESS MAGAZINE www.blmgroup.co.uk £3.50 Stopping the spread Forward thinking factories A healthy office EMPOWER Your Business 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.net april 2020 £3.50 yorkshire & lincolnshire’s leading business magazine www.blmgroup.co.uk VOLUME 35 ISSUE 4 The future of factories Ensuring employee safety Keeping offices healthy Often Imitated - Never Equalled www.blmgroup.co.uk@pbiforum www.pbiforum.net company/pharma-business-international Contents Volume 8 Issue 2 4 12 16 32 Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Assistant Editor: Dominic Cuthbert (d.cuthbert@blmgroup.co.uk) Journalist: 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. News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A Round-up8 Although there’s been an understandable slowdown in the pharma M&A market, there’s been major progress in AbbVie’s pending takeover of Allergan and a few multi- billion-dollar deals to explore.. HIV and Aids exposé12 Pharma Business International considers some of the recent advances in HIV treatment, its simplification, and the fight to find a vaccine. Clinical trials16 We explore the clinical trials currently taking place to test vaccine candidates for COVID-19. Security20 Pharma Business International explores how coronavirus is disrupting medicine supply, and the safety and security measures being utilised in delivery. Manufacturing24 Keeping up with changes in manufacturing can be difficult, which is why so many outsource such concerns to others. Digital innovations28 The COVID-19 pandemic has forced the historically hesitant healthcare industry to become more digital. PPE 32 It only takes one case of contamination to spell disaster for a manufacturer, especially if the effects are devastating Your guide to the pharmaceutical world Volume 8 Issue 2 PPE Defence against infection Clinical trials Race for treatment Digital innovations The digital response to COVID-19 PPE Defence against infection Clinical trials Race for treatment Digital innovations The digital response to COVID-19 www.pbiforum.net Cover photo courtesy: Shutterstock / science photoCureVac developing mRNA-based coronavirus vaccine CureVac is developing an mRNA-based coronavirus vaccine, the Germany biopharma has confirmed. With development efforts underway, the company says it is in contact with the Coalition for Epidemic Preparedness Innovations (CEPI) and other global organisations and authorities. Based on its inherent mode of action, CureVac sees mRNA as one of the most potent molecules to provide fast and efficient solutions in outbreak scenarios – such as COVID-19. The company is leveraging its potent vaccine platform to focus on developing a potent, efficacious and safe and fast to produce vaccine against COVID-19. It is working on expanding its manufacturing capacities to be able to provide up to billions of doses for outbreak situations like Covid-19. “The combination of mRNA science, disease understanding, formulation and production expertise make CureVac a unique player to fight against any infectious disease, no matter whether they are seasonal or pandemic,” said Chief Technology Officer, Mariola Fotin-Mleczek. 4 Pharma Business International www.pbiforum.net Latest news Watch this space The unprecedented response from the pharmaceutical sector in the wake of the coronavirus outbreak has led to dozens of developments of potential vaccines and therapies. In this round- up, we shine a light on the some of the most promising. Covid-19 vaccine ‘a year away’, says Globaldata It will probably take at least a year for a COVID-19 vaccine to be approved and made available to patients, says GlobalData. Allie Nawrat, the company’s Senior Medical Reporter, said that “experts are clear that it will take at least a year for a vaccine to be developed against Covid-19; this situation is not helped by the likelihood that the virus has already mutated into two strains. “One of the leaders in vaccine development for this current outbreak is the Norwegian Coalition for Epidemic Preparedness Innovations (CEPI). “Since the outbreak first started spreading globally in January, CEPI has funded multiple vaccine candidates from biotech firms, pharma companies and university labs; importantly, the innovations CEPI supports are those that not only intend to produce a vaccine against this novel virus, but involve pioneering technologies that can speed up the development of vaccines in future outbreaks.” AlloVir & Baylor College expand collaboration for COVID-19 T-cell therapies AlloVir has expanded its R&D collaboration with Baylor College of Medicine to develop allogeneic, off-the-shelf virus specific T-cell therapies to combat SARS-CoV- 2, the virus that causes COVID-19. With AlloVir’s proprietary technology, in addition to targeting SARS-CoV-2, the investigational virus specific T-cell therapy may also address other coronavirus (CoV) strains including SARS-CoV, MERS-CoV, and also the endemic CoVs that commonly afflict immunocompromised patients. AlloVir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR106, which is designed to address other devastating and life-threatening community-acquired respiratory viruses. “Given the worldwide coronavirus pandemic and risks to immunocompromised patients now and in the future, we believe it is our responsibility to leverage our scientific expertise and allocate resources for an allogeneic, off-the-shelf, coronavirus-specific T-cell program,” said Ann Leen, Ph.D., AlloVir Co-Founder, Chief Scientific Officer, and Professor of Pediatrics at Baylor College of Medicine. © Shutterstock/nobeastsofierce © Shutterstock / joel bubble ben © Shutterstock / Yurchanka SiarheiReference material developed to meet, expediate coronavirus detection efforts A new reference material has been developed with the aim of facilitating and expediating global efforts to detect the novel coronavirus. Developed by Texas biotech, Asuragen, the Armored RNA Quant SARS- CoV-2 Control is intended for use in developing assays in response to the COVID-19 pandemic. Asuragen’s proprietary Armored RNA Quant technology has been included in FDA-approved assays for over 20 years and, it says, is the gold standard for reliable, traceable standards for use with molecular assays developed for virus quantitation. The Armored RNA Quant SARS-CoV-2 Control targets the SARS-CoV-2 viral nucleocapsid (N) region and, along with the company’s new RNAse P construct, aligns with the CDC and WHO-recommended Diagnostic Panel to provide a safe, stable, and reliable way to test for the novel coronavirus. Armored technology encapsulates the in vitro transcribed RNA in a protective protein coat to resist nuclease degradation, enabling its use as RNA extraction, process quality, and positive diagnostic reference controls. Pharma Business International 5 www.pbiforum.net Latest news Hoth & Voltron form JV to develop self-assembling vaccine for COVID-19 New York biopharma, Hoth Therapeutics, is forming a joint venture with Voltron Therapeutics to develop a self-assembling vaccine for the potential prevention of COVID-19. The joint venture – dubbed HaloVax – will commence preclinical studies for the development of vaccine prospects to prevent COVID-19 based upon VaxCelerate, a self- assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). Supported by MGH, the two companies will work jointly on exploring and developing this SAV technology as a means to aid patients at risk of being infected with COVID-19. The VaxCelerate vaccine platform was developed as a means of rapidly generating and pre-clinically testing a new vaccine against specific pathogen targets. The technology which received Department of Defense (DoD) funding has demonstrated proof of concept in Lassa Fever, an emerging infectious disease. HaloVax intends to use these same SAV principles to assist in the development of a potential vaccine against the Covid-19 pandemic. Mologic secures £1m to develop rapid diagnostic test for COVID-19 The UK government has awarded Mologic £1 million to develop a rapid diagnostic test for the novel coronavirus. The funding comes from research charity, the Wellcome Trust, and the Department of International Development (DFID) as part of the government’s £46 million international COVID-19 prevention and research funding packaging. Mologic will use the funding alongside its global partners to develop a point-of-need diagnostic test for the virus, in addition to supporting it to initiate research for novel vaccine candidates. It will build on its experience developing a rapid test kit for Ebola to create a new hand-held diagnostics device to detect COVID-19. This will allow health officials to test for the virus at home or in the community, providing results in 10 minutes, without the need for electricity or a laboratory. Alongside their work on diagnostics, UK aid is also supporting Mologic in the development of a COVID-19 vaccine candidate for © Shutterstock / danielmarin © Shutterstock / Andrii Vodolazhskyi © Shutterstock / Gorodenkoff6 Pharma Business International www.pbiforum.net Latest news Funding could help Oz researchers cut timeline for effective COVID-19 vaccine The University of Queensland could help cut the timeline for an effective COVID-19 vaccine by six months thanks to a $17 million funding injection. The Queensland Government will allocate $10 million and the Australian Government has pledged $3 million to the project led by UQ’s School of Chemistry and Molecular Biosciences. UQ is the only Australian organisation tasked by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine against the novel coronavirus, and the funding is an important extension of CEPI’s ongoing financial support. Vice-Chancellor and President Professor Peter Høj said the funding would provide additional critical support to UQ and partners such as the Doherty Institute and CSIRO in the analysis of vaccine efficacy and their drive to commence clinical trials on the vaccine as early as July in Queensland. Queensland Premier Annastacia Palaszczuk said finding a safe and effective vaccine to prevent infection from COVID-19 was an urgent public health priority. Regenron & Sanofi to test mAB in patients with severe COVID-19 Regeneron and Sanofi have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalised with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody (mAB) that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19. This is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody. This US-based trial will begin at medical centres in New York and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo. The multi-centre, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enrol up to 400 patients. AbCellera & Lilly to develop antibody therapies for COVID-19 Eli Lilly has entered into an agreement with Canadian biotech AbCellera to co-develop antibody products for treating and preventing COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. Within a week of receiving a blood sample from one of the first US patients who recovered from COVID-19, AbCellera screened over five million immune cells looking for ones that produced functional antibodies that helped the patient neutralise the virus and recover from the disease. From this, AbCellera has identified over 500 unique fully human antibody sequences, the largest panel of anti-SARS-CoV-2 antibodies ever reported. The next step is to screen these antibodies to find the ones most effective in neutralising SARS-CoV-2. © University of Queensland © Shutterstock / Savanevich Viktar © Shutterstock/Design_Cells Premier Annastacia Palaszczuk Green light for new Cushing’s disease treatment Isturisa (osilodrostat) oral tablets have been approved in the US for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Made by Novartis, Isturisa is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta- hydroxylase and preventing cortisol synthesis. FDA approves Ofev for progressive interstitial lung diseases Boehringer Ingelheim’s Ofev (nintedanib) oral capsules, the first treatment for patients with chronic fibrosis interstitial lung diseases with a progressive phenotype, has been approved in the US. Ofev received Priority Review designation, meaning the agency plans to take action on the application within six months because the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. It also received Breakthrough Therapy Designation. First generic of Daraprim approved in US The first generic version of Daraprim, the anti-infective treatment whose price was raised 5,000% by Turing Pharmaceuticals, has been approved by the FDA. Martin Shkreli, the disgraced former hedge fund manager and former CEO of Turing Pharmaceuticals, oversaw the company’s acquisition of Daraprim (pyrimethamine) in 2015. Under his leadership, the price was raised from $13.50 per treatment to $750 million. But now, New York company Cerovene’s application for the first generic version of the Daraprim tablets for the treatment of toxoplasmosis when used with a sulfonamide (a group of medicines used to treat bacterial infections) has been approved in the US. First IV preventative treatment for migraine approved in US Developed by Danish pharma company, Lundbeck, Vyepti (eptinezumab-jjmr) has been rubber-stamped by the FDA for the preventative treatment of migraine in adults. The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). The recommended dose is 100 mg every 3 months. Vyepti will be available in April. FDA approves flu vaccine for adults 65 years and older The first adjuvanted quadrivalent influenza vaccine has been approved to help protect adults 65 years and older against seasonal influenza. FDA approval was granted to Seqirus, the flu prevention and pandemic response specialist, who earlier this month secured US approval for Audenz. Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A in the event of a pandemic. Novel non-opioid approved to treat pain in US Anjeso, a novel non-opioid, has been approved in the US for the management of moderate-to-severe pain, alone or in combination with other nonsteroidal anti-inflammatory drug (NSAID) analgesics. With the FDA having approved Baudax Bio’s New Drug Application (NDA), Anjeso (meloxicam injection) has become the only approved 24-hour intravenous COX-2 preferential NSAID that offers once-daily dosing. The approval is supported by two Phase III efficacy studies and one double-blind, placebo-controlled Phase III safety study. Anjeso is expected to be available to patients in late April or early May. FDA okays trial to test Actermra in severe COVID-19 pneumonia A clinical trial to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia has been approved by the US FDA.The randomised, double-blind, placebo-controlled Phase III trial is run by Roche member Genentech in collaboration with the Biomedical Advanced Research and Development Authority. The trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19. FDA Emergency Authorisation for Roche’s cobas SARS-CoV-2 test Roche’s cobas SARS-CoV-2 test to detect the novel coronavirus that causes COVID-19 has received Emergency Use Authorisation from the FDA. It is intended for the qualitative detection of SARS- CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the US and around the world. www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net S ince the coronavirus crisis was declared a pandemic by the World Health Organization (WHO) and countries implement unprecedented lockdown measures, the pharmaceutical mergers and acquisitions market has seen an understandable slowdown – certainly compared to first quarter activity in previous years. Nevertheless, since our last issue, there have been some major developments in the sector’s currently biggest pending takeover, and a few multi-billion-dollar acquisitions announced besides. Firstly, our attention turns to AbbVie’s $63 billion acquisition of Ireland’s Allergan. The deal was first announced back in June 2019 and, since then, has sought to secure shareholder backing on both sides and clear the requisite regulatory hurdles. In November, it secured the approval of Allergan’s shareholders, satisfying the former requirements and it is rapidly closing in on securing the latter. Back in January of this year, the European Commission (EC) ruled that its final approval of the takeover was contingent upon Allergan’s divestiture of brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to a suitable purchaser on competition grounds. At the same time, Allergan also agreed to divest zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestlé. Allergan soon found a suitable buyer, and in early March, the EC approved the divestiture of the inhibitor to AstraZeneca. The acquisition remains subject to additional closing conditions but with EC’s final approval in place, the transaction is cleared in Europe to close. Things are progressing well over in the US, with the companies having recently entered into a consent agreement with A trio of takeovers Although there’s been an understandable slowdown in the pharma M&A market, there’s been major progress in AbbVie’s pending takeover of Allergan and a few multi-billion-dollar deals to explore. 10 Á 08-11.qxp_Layout 1 08/04/2020 10:47 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © Shutterstock /Trismegist sanNext >