Your guide to the pharmaceutical world Volume 8 Issue 4 Clinical testing Diagnosing the issues with clinical trials Coronavirus update The race for a vaccine Marketing Connecting with consumers PharmaBUSINESS INTERN ATION AL The total package From development to dispensing The total package From development to dispensing Clinical testing Diagnosing the issues with clinical trials Coronavirus update The race for a vaccine Marketing Connecting with consumers www .pbiforum.net 01.qxp_Layout 1 10/08/2020 15:08 Page 1 INTER N Food Food &&& Food Food & N ATI O N &&Drin Drin Drin &&Drin AL nk nk nkk app A r f h hi ts a ews Ingredient spotlight End offline packkaaging For businesses that are serious about reducing their carbon footprint www.blmgroup.co.uk VOLUME 4 ISSUE 1 W W W. R E N E W A B L E S A N D E N V I R O N M E N T. C O M E A S T M I D L A N D S L E A E A D I N G B U S I N E S S M A G A A Z I N E APRIL 2020 0 £3. .50 BUS SUP SINES T PPOR SS TING B THCART HEAL YY FACTOR RE OFF FICE ea Stopping the spr THCAR WW HEAL d thinkin Forwar TT AUTOMA Y AFACTOR ad WW EASTMIDL RE A hea SOL OFF ng factories LANDSBUSINE TION ficef althy of LUTIONS ESSLINK CO U FICE w UK www.blmgroup.co.uk EMPOWER Your Business Focus on T A Pharm rld o our guide to the pharmaceutical w Y B U S I N E S S I N T E R N A L ma olume 8 Issue 1 V T I O N declares g rrld Hea oooW coron F ganisa gg l b l g l h O virus na g gency ti medi Nucle Prev aaccin V The nuclea b f treatment ve The P l t k aage n e t eelopment t vv om de rF w w w di i k . p b i f o r u m . n yorkshire & lincolnsh hire’s leading business ma magazine april 2020 £3.5 50 TO T RES C THE SPOND CRISIS DING S YY FACTOR C TT HEAL OFF THCARE FICE safety Ensuring e TT HEAL e of factories The futur TION T AUTOMA YY AFACTOR fices healthy f Keeping of SOLUTIONS OFFICE employee THCARE V w VOLUME 35 ISSUE 4 .blmgroup.co.uk www Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 10/08/2020 15:09 Page 1Contents Volume 8 Issue 4 4 8 20 24 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. Ummunotherapy exposé8 Although immunotherapy is a standard treatment for some cancers, it is yielding some of the most exciting and promising developments in the oncology space and, as researchers search for a COVID-19 treatment, immunotherapies will likely have a key role to play in combatting the global pandemic. Clinical testing12 Despite their necessity, especially in the wake of COVID-19, clinical trials are still beset by many challenges. However, digital technology is helping to change things. Antibodies16 Expanding treatment options for a variety of conditions, drugs based on antibodies are a mainstay in medicine. Start-ups20 Recognised as key in innovation, large pharma companies are looking to start-ups to make up for falling R&D activity. Marketing24 Data shows that more pharmaceutical companies than ever are adopting digital marketing strategies. But what’s driving this change? Coronavirus update 28 Since the beginning of the year, Pharma Business International has endeavoured to bring readers the latest breakthroughs and developments in the ongoing effort to mitigate, manage and treat COVID-19. In this latest dedicated update, we explore some of the most promising therapeutic avenues as we move towards a vaccine. Events 32 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pharma-business- international Cover photo courtesy: Shutterstock / Natali_ Mis 03.qxp_Layout 1 10/08/2020 15:10 Page 1Novartis expands sickle cell disease programme to Uganda & Tanzania Novartis and its partners have expanded the Africa Sickle Cell Disease program to East Africa with the signature of two new memoranda of understanding with the Ministries of Health of Uganda and Tanzania. The programme – first launched in Ghana in November 2019 – aims to improve and extend the lives of people with sickle cell disease (SCD) in sub-Saharan Africa, with plans to reach a total of 10 countries by 2022. The partners intend to develop and implement a comprehensive approach that includes making diagnosis and treatment available, accessible and affordable for patients and their families; promoting scientific research, training and education; and pursuing robust monitoring and evaluation of the program. As a next step, Novartis plans to work with the respective Ministries of Health to further define the scope of each collaboration and explore opportunities for additional partnerships. In Ghana, the program is already making progress with more than 2,000 patients being treated with hydroxyurea in 11 treatment centres across the country. 4 Pharma Business International www.pbiforum.net Latest news Beckman Coulter’s SARS-CoV-2 IgG antibody test now available in markets accepting the CE Mark Beckman Coulter’s Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark. The company has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the US and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analysers worldwide and has ramped its manufacturing to deliver more than 30 million tests a month. Henry Ford Health System was one of the first health systems to receive the test and independently validate its performance. “The very high sensitivity and specificity of this assay provides a high positive predictive value, even when the overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analysers, it can be adapted to a variety of healthcare settings to best meet the needs of each community,” said Shamiram R. Feinglass, M.D., MPH, Chief Medical Officer Beckman Coulter. To find out more, visit www.beckmancoulter.com. Carmine Therapeutics & Takeda to develop novel on-viral gene therapies Carmine Therapeutics has signed a research collaboration agreement with Takeda to discover, develop and commercialise transformative non- viral gene therapies for two rare disease targets using Carmine’s REGENT technology, based on red blood cell extracellular vesicles. In addition, Takeda has committed a $5 million convertible loan in support of the development of Carmine’s novel REGENT platform. Under the terms of the agreement, Carmine will receive an upfront payment, research funding support, and is eligible for over $900 million in total milestone payments plus tiered royalties. Takeda has an option to license the programs following the completion of pre-clinical proof of concept studies and would be responsible for clinical development and commercialisation. © Shutterstock/Lightspring © Shutterstock / Natali_ Mis 04-07.qxp_Layout 1 10/08/2020 15:11 Page 1Pharma companies launch $1bn AMR Action Fund More than 20 major biopharmaceutical companies have launched the AMR Action Fund, a ground-breaking partnership that aims to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections (AMR). The companies have raised so far nearly $1 billion new funding to support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. Through the AMR Action Fund, pharma companies will join forces with philanthropies, development banks, and multilateral organisations to strengthen and accelerate antibiotic development. The Fund will focus on urgent public health needs. It will provide much needed financial resources, as well as important technical support to help biotech companies bring novel antibiotics to patients. The Fund is expected to be operational during the fourth quarter of 2020. Pharma Business International 5 www.pbiforum.net Latest news Kymera and Sanofi to advance novel protein degrader therapies Kymera Therapeutics has entered into a multi-program strategic collaboration with Sanofi to develop and commercialise first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. The companies will also partner on a second earlier stage program. Kymera will receive $150 million in cash up-front and may receive more than $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. Kymera retains the option to participate in US development and commercialisation for both programs. This includes the ability to participate equally in the costs, profits and losses after opt-in, and to co-promote partnered products in the US. Sanofi will make an upfront payment of $150 million in cash to Kymera for global rights to develop its small molecule IRAK4 protein degraders in inflammation and immunology indications, and a second earlier stage undisclosed program. Sarepta & Codiak to research, develop exosome-based therapeutics Precision medicine specialist, Sarepta Therapeutics, and Codiak BioSciences, a company at the forefront of advancing engineered exosomes as a new class of biologic medicines, are collaborating to design and develop engineered exosome therapeutics to deliver gene therapy, gene editing and RNA technologies for neuromuscular diseases. The engineered exosome approach offers the potential to effectively deliver genetic therapeutics without triggering the adaptive immune response. The two-year agreement includes up to five neuromuscular targets. Codiak is eligible to receive up to $72.5 million in upfront and near- term license payments plus research funding. Sarepta is granted an option to any of the candidates developed pursuant to the research alliance. The collaboration will leverage Codiak’s exosome engineering capabilities with Sarepta’s expertise in precision genetic medicine to develop next generation therapeutics for patients with neuromuscular diseases that have few or no treatment options. © Shutterstock / Arkadiusz Wos © Shutterstock / i viewfinder © Shutterstock / anyaivanova 04-07.qxp_Layout 1 10/08/2020 15:11 Page 26 Pharma Business International www.pbiforum.net Latest news mRNA technology collaboration for GSK & CureVac GlaxoSmithKline (GSK) and CureVac will together research, develop, manufacturer and commercialise up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The strategic collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform. By using mRNA technology in vaccines and medicines, specific proteins, or antigens, can be produced by the body’s own cells, enabling the human immune system to prevent or fight disease. The companies will combine their mRNA expertise on development opportunities across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology, while addressing significant unmet medical need and economic burden. CureVac’s existing COVID-19 mRNA and rabies vaccines research programmes are not included in the collaboration. Adagio launches with $50m financing to develop coronavirus antibody portfolio Adagio Therapeutics has launched with the closing of a $50 million Series A financing to advance its portfolio of coronavirus antibodies as both therapeutics and prophylactics against SARS-CoV-2 as well as future coronavirus outbreaks. Adagio’s antibody candidates have been uniquely engineered and optimised to provide broad protection against SARS-CoV-2, SARS-CoV-1, and additional circulating bat coronaviruses that virologists are actively monitoring. The company believes these broadly neutralising antibodies will offer best-in-class potency and coverage against SARS-CoV-2 and protection against future coronavirus outbreaks. A spin out of Adimab, Adagio expects this financing to enable the advancement of lead development candidates through IND-enabling studies and into early clinical development. The financing was led by Polaris Partners and Mithril Capital and includes investments by Fidelity Management & Research Company LLC, OrbiMed, M28 Capital, GV, and others. Sandoz investment to help strengthen future of antibiotics manufacturing Sandoz, the Novartis generics and biosimilars division, is planning to invest in a joint investment alongside the Austrian federal government to strengthen the long-term future of integrated antibiotics manufacturing in Europe. Sandoz intends to invest more than €150 million over the next five years to strengthen the long-term competitiveness of its integrated antibiotic manufacturing operations at Kundl, developing and introducing innovative manufacturing technology for both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). Under the joint plan, which is subject to formal approvals by both parties, the Austrian federal government would contribute or coordinate public funding totalling approximately €50 million towards the total investment, as part of its efforts to increase European-based production of essential medicines. Sandoz and the Austrian government anticipate a formal closing of the agreement before the end of the year. © Shutterstock/nobeastsofierce © Shutterstock / ustas7777777 © Shutterstock/Gorodenkoff 04-07.qxp_Layout 1 10/08/2020 15:11 Page 3Eye on approvals Conditional approval for Gilead’s remdesivir in Europe The European Commission has granted conditional marketing authorisation for Gilead’s Veklury (remdesivir) as a treatment for SARS- CoV-2 infection, the virus that causes COVID-19. The authorisation was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020. Under this authorisation, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen. European approval for Janssen’s preventative Ebola vaccine Johnson & Johnson has secured European approval for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health Organization (WHO) on vaccine pre- qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need. European approval for Novartis’ Cosentyx in paediatric psoriasis Novartis has gained European approval for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years. The approval is based on two Phase III international studies in children and adolescents aged 6 to <18 years. The studies showed that both low-dose (75–150 mg) and high-dose (75– 300 mg) of Cosentyx were highly efficacious in rapidly improving skin symptoms and quality of life, with a favourable safety profile up to 52 weeks. UK approves world first coronavirus treatment The UK government has immediately authorised the NHS to use the world’s first coronavirus treatment proven to reduce the risk of death. Dexamethasone, an anti-inflammatory drug, has been immediately approved to treat all UK hospitalised COVID-19 patients requiring oxygen, including those on ventilators. The drug has been proven to reduce the risk of death significantly in COVID-19 patients on ventilation by as much as 35% and patients on oxygen by 20%, reducing the total 28-day mortality rate by 17%. Tecentriq combination approved for advanced melanoma The FDA has approved Roche’s Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo plus Cotellic and Zelboraf. FDA approves Roche’s Phesgo for HER2- positive breast cancer The FDA has approved Phesgo, the fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single subcutaneous injection. US approves ViiV’s dispersible dolutegravir for children with HIV ViiV Healthcare has gained US approval for the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV. Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg. Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg. This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children. Brilinta approved in US to reduce the risk of first heart attack or stroke AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease. The approval was based on positive results from the Phase III THEMIS trial. www.pbiforum.net Pharma Business International 7 04-07.qxp_Layout 1 10/08/2020 15:11 Page 4IMMUNOTHERAPY EXPOSÉ́ 8 Pharma Business International www.pbiforum.net Immunotherapy makes an arsenal of our own immune system to fight cancer. It does this by helping the immune system recognise and, therefore, attack cancer cells. Depending on the specific needs of a patient, immunotherapy can be used on its own or in combination with other treatments. Last year, researchers from UC San Francisco confirmed that they had identified a key biological pathway in human cancer patients which, they said, appears to prime the immune system for successful response to immunotherapy drugs known as checkpoint inhibitors. The findings could better enable Innovating with immunotherapies Although immunotherapy is a standard treatment for some cancers, it is yielding some of the most exciting and promising developments in the oncology space and, as researchers search for a COVID-19 treatment, immunotherapies will likely have a key role to play in combatting the global pandemic. clinicians to predict which patients will naturally benefit from these promising new treatments and, potentially, to modify the immune response in other patients to allow more people to benefit from these therapies. The researchers claim that another potential application of these findings would be to use the presence of specific cells as a biomarker to identify patients who are naturally most likely to respond to immunotherapy. This could help outcomes for patients and provide 10 Á 08-11.qxp_Layout 1 10/08/2020 15:25 Page 1Pharma Business International 9 www.pbiforum.net IMMUNOTHERAPY EXPOSÉ́ © Shutterstock /Sergey Nivens 08-11.qxp_Layout 1 10/08/2020 15:25 Page 2Next >