Your guide to the pharmaceutical world Volume 7 Issue 1Cystic Fibrosis Exposé The price of life Training & Development Always recruiting Procurement Procuring a solutionPharmaBUSINESS INTERNATIONALThe total package From development to dispensingThe total package From development to dispensingCystic Fibrosis Exposé The price of life Training & Development Always recruiting Procurement Procuring a solutionwww.pbiforum.net01.qxp_Layout 1 11/02/2019 09:33 Page 17–9 May 2019 Palexpo, GenevaShaping the food industryfor optimal health through science and innovationSource innovativeDiscover productMeetDo business withproducts & ingredientsdevelopment solutionstechnical experts1,200+ global suppliersREGISTER NOW SAVE €150BE HERE. THE PLACE WHERE INNOVATION HAPPENS. vitafoods.eu.comEMPOWER YOUR BUSINESS 2019JANUARYINTERNFoodFoodFoo £3.50.fdiforum.netwwwNATIONDrinDrinDri 0 STERLINGALnknkn SNACK FOODS & COLOURINGS FLAVOURING & CONVEYINGFor businesses that areserious about reducing theircarbon footprintwww.blmgroup.co.ukVOLUME 4 ISSUE 1WWW.RENEWABLESANDENVIRONMENT.COM JANUARY 2019EAST MIDLANDS LEA £3.50EADING BUSINESS MAGA ZINE PREDICTIO ONS arorwooking f e oIn the eLAW llof the a wticsogisocation fhe ideal www.m TAPharmrld oour guide to the pharmaceutical wYBUSINESS INTERN ALmaolume 6 Issue 6VTION o apwar py r www .pbiforum.net yorkshire & lincolnsh hire’s leading business mag agazine y 2yfebruar 2019 £3.5 50 THE egAn engineering rSPOTLIGHTENGINEERIN ime to evolveTACKAGINAPRINTING gionNG Facing theAPPRETRAININGG AND e skills crisiENTICESHIPSING ANDVw VOLUME 34 ISSUE 2.blmgroup.co.ukwwOften Imitated - Never Equalled www.blmgroup.co.uk02.qxp_Layout 1 11/02/2019 09:34 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContents Volume 7 Issue 1News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A Round-up8 2019 has had a strong start for the pharma M&A market with major deals completing and the announcement of one of the industry’s biggest acquisitions to date. Cystic Fibrosis Exposé12 Cystic fibrosis is the most common life-threatening inherited disease; yet for many patients, the drug that would help extend their lives remains prohibitively expensive. Now a battle is waging in the UK to help usher in cheaper generics. PPE16 When it comes to personal protection, those working in the pharmaceutical industry expect the highest of standards. Standards that are not always being met, especially in large, Government organisations. Training and Development20 There’s big money in pharma, but that attracts competition, and every company is drawing from an ever-shrinking pool of talent. Cold Chain24 When it comes to maintaining the temperature integrity of pharmaceutical products, it’s best to look at the supply chain and, in particular, storage and distribution centres. Procurement28 There’s a lot of financial and regulatory hurdles to overcome in the procurement of drugs and medical treatments. Sometimes, however, there’s also pharmaceutical companies themselves to consider as the NHS discovered. Events32 We give a rundown of pharma events happening around the world.4122028Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Journalist: Dominic Cuthbert (d.cuthbert@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, N E Lincs DN31 2QE England All rights reserved. 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COVER PHOTO: © SHUTTERSTOCK / GOFFKEIN.PRO03.qxp_Layout 1 11/02/2019 09:35 Page 1Making drug development cheaper with genetically modified chickens Roslin Institute researchers at the University of Edinburgh claim that chickens genetically modified to produce human proteins in their eggs can offer a cost-effective method of producing drugs. High quantities of the proteins can be recovered from each egg using a simple purification system. Certain types of drugs work at least as well as the same proteins produced using existing methods. Published in BMC Biotechnology, the findings provide sound evidence for using chickens as a cheap method of producing high-quality drugs for use in research studies and, potentially one day, in patients. The study – which has initially focused on producing high-quality proteins for use in scientific research – observed no adverse effects on the chickens themselves, which lay eggs as normal. Researchers say they haven’t produced medicines for use in patients yet, but the study offers proof-of-principle that the system is feasible and could easily be adapted to produce other therapeutic proteins.4 Pharma Business International www.pbiforum.netLatest newsBacteria-inspired robots could ‘revolutionise’ drug delivery In the future, tiny ingestible robots could deliver drugs directly to diseased tissue, according to research being undertaken at ETH Zurich and EPFL. Modelled after bacteria, these robots optimise their movements to get to hard-to-reach areas of the human body. The scientists say they stand to “revolutionise targeted drug delivery”. The team – led by Bradley Nelson, Professor at ETH Zurich, and Selman Sakar, Professor at EPFL – drew inspiration from bacteria to design smart, biocompatible microrobots that are highly flexible. The robots can swim through liquids and change shape as needed to move through narrow blood vessels and intricate systems without compromising on speed or manoeuvrability. They are made of hydrogel nanocomposites and are based on the Japanese Origami folding technique. In addition, they contain magnetic nanoparticles allowing them to be controlled via an electromagnetic field as the researchers report in the journal Science Advances.Record year of fundraising for UK biotech Last year, the UK biotech sector raised a record £2.2 billion from investors, according to figures from the UK BioIndustry Association (BIA) and Informa Pharma Intelligence. According to ‘Confident capital: backing UK biotech’, 2018 saw over £1.1 billion of venture capital invested into UK biotech companies, with more than £1 billion raised on public markets. Looking at Europe as a whole, the report found that UK companies accounted for 40% of all biotech venture capital raised and 45% of funding raised through IPOs. Venture capital deals were larger than the previous years with the report stating that there were more late-stage post-B rounds showing companies are choosing to stay private for longer. The figures show that global investors continue to see the quality of the science and businesses in the UK as a great investment opportunity. The UK is the leading life sciences cluster in Europe and continues to challenge clusters in California and Massachusetts.© Shutterstock / steved_np3© Shutterstock / Volodymyr Horbovyy© Shutterstock / busliq04-07.qxp_Layout 1 11/02/2019 09:38 Page 1Vampire bat venom could ‘hold key’ to new treatments A new class of blood pressure-regulating peptides discovered in the venom of the common vampire bat could hold the key to new treatments for a range of serious medical problems. But the international team led by The University of Queensland have hit a snag accessing the specimens needed to advance their work. UQ School of Biological Sciences researcher Associate Professor Bryan Fry said the peptides could help revolutionise treatments for a wide range of conditions but his team has been hampered by criminal activity at a Mexican field site. “We can’t access our original field site in Mexico anymore, because we’re told that region has been taken over by drug traffickers,” he said. “We’ll have to find new field sites that are safe to work in, but once we do that we’ll be on track to find new peptide variations and potential wonder drugs, helping improve and save lives.”Pharma Business International 5www.pbiforum.netLatest newsUK launches AMR action plan The UK has published a 20-year vision and outlined a 5-year national action plan to contain and control antimicrobial resistance (AMR) by 2040. It includes cutting the number of drug-resistant infections by 10% by 2025; reducing the use of antibiotics in humans by 15% and preventing at least 15,000 patients from contracting infections as a result of their healthcare each year by 2024. A major focus is to make sure current antibiotics stay effective by reducing the number of resistant infections and supporting clinicians to prescribe appropriately. New technology will also be used to gather real-time patient data, helping clinicians understand when to use and preserve antibiotics in their treatment. The government has committed to working with vets and farmers to further reduce antibiotic use in animals by 25% between 2016 and 2020, with objectives to be refreshed by 2021. The pharmaceutical industry will also be expected to take more responsibility for antibiotic resistance.Malaria vaccine passes test in humans A vaccine against pregnancy malaria has demonstrated promising results in the first tests in humans undertaken in Denmark. For many years, a team of researchers at the University of Copenhagen have been focussing on developing a vaccine that can protect against pregnancy malaria from which 220,000 people die every year. Now they have come a significant step closer to being able to introduce such a vaccine to market. A study published in Clinical Infectious Diseases shows the vaccine has been subjected to so-called phase one clinical trial, and the results are encouraging: the vaccine is safe to use, and it passes the test by inducing the right antibody response in the blood. The University of Copenhagen owns the patent on the vaccine technology, but the researchers have also cooperated with a series of companies on realising the malaria vaccine.© Shutterstock / Manjurul Haque© Shutterstock/Fahroni© Shutterstock / belizar04-07.qxp_Layout 1 11/02/2019 09:38 Page 26 Pharma Business International www.pbiforum.netLatest newsSandoz launch EpiPen generic in US Sandoz is the latest pharmaceutical company to launch a generic version of Mylan’s EpiPen in the US after announcing the introduction of Symjepi. Symjepi will be rolled out through a phased launch, first in the institutional setting followed by introduction into the retail market. The company is also launching the medicine as an “affordable, single-dose, pre-filled syringe alternative to epinephrine auto-injectors”. Symjepi 0.3 mg Injection is indicated for the emergency treatment of allergic reactions. It is intended for immediate administration in patients who weigh approximately 66 pounds or more, and who are determined to be at an increased risk for anaphylaxis – including individuals with a history of anaphylactic reactions. Last year, Teva Pharmaceuticals became the first company to launch a generic version of EpiPen in the US. Drug pricing remains pharma’s biggest concern for 2019 Drug pricing pressures and reimbursement concerns will remain the biggest concerns to the pharmaceutical industry, says GlobalData. The company’s latest annual outlook report – ‘The State of the Biopharmaceutical Industry - 2019’ – reveals that 51% of global industry respondents believe that drug pricing and reimbursement constraints will have the greatest negative impact on the pharmaceutical industry in 2019. According to Bonnie Bain, Global Head of Pharma at GlobalData, this response is not surprising, especially given that increased pressure from the Trump administration led to price freezes in 2018. “Despite this pressure, about three dozen drug manufacturers rang in the New Year by raising prices on hundreds of drugs in the United States,” she said. “The average price increase was about 6.3% and includes branded as well as generic drugs. Both democrats and republicans have reacted strongly to these latest increases and it could be an opportunity for bipartisanship to bring the cost of prescription drugs down.”Death now more likely from opioids than car crashes in US As if further proof were needed of the scale of the US opioid crisis, the National Safety Council (NSC) has revealed that for the first time in US history a person is more likely to die from an accidental opioid overdose that from a car crash. The odds of dying accidentally from an opioid overdose have risen to one in 96, eclipsing the odds of dying in a motor vehicle crash (one in 103). “We’ve made significant strides in overall longevity in the United States, but we are dying from things typically called accidents at rates we haven’t seen in half a century,” said Ken Kolosh, Manager of Statistics at NSC. “We cannot be complacent about 466 lives lost every day. This new analysis reinforces that we must consistently prioritize safety at work, at home and on the road to prevent these dire outcomes.”© Shutterstock / GoodMood Photo© Shutterstock / Amy Kerkemeyer© Shutterstock/Sherry Yates Young04-07.qxp_Layout 1 11/02/2019 09:38 Page 3Eye on approvals EUROPE Clovis picks up approval for Rubraca The European Commission has approved Clovis Oncology’s Rubraca (rucaparib) for second indication as monotherapy for the maintenance treatment of women with relapsed ovarian cancer. This expands rucaparib’s indication beyond its initial marketing authorisation in Europe granted in May 2018. With this expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Expanded approval for Amgen’s Blincyto European regulators have approved and expanded approval for Amgen’s Blincyto monotherapy to include adult patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursors acute lymphoblastic leukaemia (ALL). The approval was based on data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL – the largest prospective trial for minimal residual disease-positive ALL ever conducted. Label extension for Vertex’s CF treatment Vertex Pharmaceutical has secured European approval for its label extension of Orkambi for treating children aged 2 to 5 with the most common form of cystic fibrosis. The label update is based on data from a Phase 3 open-label safety study in 60 patients that showed treatment with lumacaftor/ivacaftor was generally well tolerated for 24 weeks, with a safety profile in these paediatric patients generally consistent with that in patients aged 6 years and older. Europe approves first cell-based quadrivalent influenza vaccine UK flu specialist Seqirus has secured marketing approval in Europe for its new cell-based flu vaccine, Flucelvax Tetra. This will be the first cell-based quadrivalent influenza vaccine available in Europe and is licensed for use in people nine years and above. UNITED STATES Gazyva/Imbruvica combo green-lit for CLL/SLL The combination of Gazyva and Imbruvica for treating patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) has been approved in the US. This latest approval from the FDA expands the use of Imbruvica for adult CLL/SLL patients. Jointly developed by Abbvie company Pharmacyclics and Janssen Biotech, Imbruvica is a once-daily first-in-class Bruton’s tyrosince kinase (BTK) inhibitor that is administered orally. First US oncology approval for Samsung Bioepis Korea’s Samsung Bioepis has had its first oncology medicine green-lit in the US after the FDA approved Ontruzant, a biosimilar referencing Herceptin across all eligible indications. Merck will now market and distribute Ontruzant (trastuzumab-dttb) across these indications – namely adjunctive treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma. US accepts Roche’s sBLA for Tecentriq Roche’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with chemotherapy as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC) has been accepted in the US. The FDA is expected to make a decision on approval by 2 September 2019. First generic version of Sabril approved for epileptic patients The first generic version of Sabril (vigabatrin) 500 mg tablets has been approved in the US for treating seizures in patients with epilepsy. Specifically, the treatment – made by Teva – has been green-lit as an adjunctive therapy in patients 10 years and older who have responded to several alternative treatments. www.pbiforum.netPharma Business International 704-07.qxp_Layout 1 11/02/2019 09:38 Page 4M&A ROUND-UP8 Pharma Business International www.pbiforum.netSign of things to come 2019 has had a strong start for the pharma M&A market with major deals completing and the announcement of one of the industry’s biggest acquisitions to date. 08-11.qxp_Layout 1 11/02/2019 09:41 Page 1Pharma Business International 9 www.pbiforum.netM&A ROUND-UP© Shutterstock /Maksym PovozniukIt should come as no surprise that our first M&A round-up of the year should begin with the completion of deals first struck in 2018. In fact, last year’s biggest deals completed in January, chief among them is Japan’s Takeda finalising its game-changing £46 billion acquisition of Shire after clearing all the necessary regulatory hurdles and securing a strong shareholder backing. The deal has been a mainstay in this column for much of 2018 so it’s hardly worth repeating the ins and outs again. Suffice it to say that bringing Shire into the fold positions Takeda amongst the top ten pharmaceutical companies in the world, allowing it to hold its own against Roche, Merck Pfizer, Johnson and Johnson and the rest. But the Takeda/Shire deal wasn’t the only major acquisition which concluded in January. Only a few weeks later, GSK completed its £4 billion acquisition of Massachusetts-based biopharma Tesaro in a move that significantly fortifies its burgeoning oncology pipeline. The deal was announced back in December 2018, giving the M&A market one last huzzah before the new year. It’s an advantageous move for GSK, having gained access to Zejula (niraparib), an oral PARP inhibitor currently approved for use in ovarian cancer. At the time of completion, Doctor Hal Barron, Chief Scientific Officer and President of Research and Development at GSK, said: “The acquisition of Tesaro… significantly strengthens our oncology pipeline and brings new scientific capabilities and expertise that will increase the pace and scale at which we can help patients living with cancer.” 10 Á08-11.qxp_Layout 1 11/02/2019 09:41 Page 2Next >