Your guide to the pharmaceutical world Volume 10 Issue 3 Process, control and automation Streamlining the process Cleaning and maintenance On the spot inspection Warehousing and distribution A more resilient system Process, control and automation Streamlining the process Cleaning and maintenance On the spot inspection Warehousing and distribution A more resilient system www.pbiforum.net 01.qxp_Layout 1 10/06/2022 14:55 Page 1The new event at the heart of European pharma dedicated to innovative packaging, drug delivery systems, CDMO/CMO and filling & assembling processes 14 & 15 September 2022 | Geneva, Switzerland Founding partners Register to attend using the code 5003 connectinpharma.com SINGLE BEST WAY TO DELIVER 02.qxp_Layout 1 10/06/2022 14:56 Page 112 16 20 24 Steve Fisher (s.fisher@blmgroup.co.uk) Michael Fisher (m.fisher@blmgroup.co.uk) Tess Egginton (t.egginton@blmgroup.co.uk) Angie Cooper (a.cooper@blmgroup.co.uk) Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Angela Sharman (a.sharman@blmgroup.co.uk) Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 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 M&A deals are picking up pace, from those worth hundreds of millions to the multi-billion strikes being made by pharma giants expanding their drug pipelines and embracing innovative technologies. Process, control and automation12 Keeping up with changes in manufacturing can be difficult, especially with the world changing so much thanks to COVID. Training and skills development16 With skills shortages and the great resignation squeezing recruitment pools and agencies alike, pharma businesses may want to look to creating their own ideal candidate rather than waiting for one to show up. Flow measurement and control20 There’s a myriad of flow meters available to pharma manufacturers depending on the product and requirement. As well as exploring these options, we break down the advantages and disadvantages and some of the challenges to overcome. Warehousing and distribution24 Lean, efficient, resilient. With the pandemic behind us and a fuel crisis currently being experienced, perhaps “resilience” will become a more important feature than efficiency for warehousing and distribution. Cleaning and maintenance 28 Tighter working conditions and more consumer attention on pharma companies than ever before have left little room for mistakes. Is it time to take a closer look at how we clean and maintain factory equipment? Events 32 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy:stock.adobe.com/Mike Mareen 03.qxp_Layout 1 10/06/2022 14:56 Page 14 Pharma Business International www.pbiforum.net Latest news Taiho Pharmaceutical to acquire Cullinan Pearl Taiho Pharmaceutical and Cullinan Oncology have announced an agreement through which Taiho will acquire Cullinan Pearl and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417, an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR. Under the agreement, Taiho will acquire Cullinan Oncology’s subsidiary, Cullinan Pearl, which has worldwide rights outside of Japan to CLN- 081/TAS6417, for an upfront payment to Cullinan Oncology of $275 million and up to an additional $130 million tied to EGFR exon20 non-small cell lung cancer (NSCLC) regulatory milestones. Cullinan Oncology will co-develop CLN-081/TAS6417 and will retain the option to co-commercialize CLN-081/TAS6417 in the United States together with Taiho Pharmaceutical through its U.S. subsidiary, Taiho Oncology. Taiho will commercialize CLN-081/TAS6417 in territories outside U.S. and China. Taiho and Cullinan Oncology will equally contribute to the future clinical development of CLN-081/TAS6417 in the U.S., with each receiving 50% of the profits from potential U.S. sales. Editas Medicine receives FDA Orphan Drug Designation for beta thalassemia treatment The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Editas Medicine’s EDIT-301, an investigational, gene editing medicine, for the treatment of beta thalassemia. The FDA previously granted Rare Pediatric Disease designation to EDIT-301 for the treatment of beta thalassemia and sickle cell disease. “Beta thalassemia is a devastating disease that leads to severe anemia, organ failure, and premature death. Receiving Orphan Drug Designation for EDIT-301 for beta thalassemia highlights the urgent need for new treatment options for patients,” said James C. Mullen, chairman, president, and Chief Executive Officer, Editas Medicine. “Preparations to initiate the Phase 1/2 clinical trial of EDIT-301, a potentially transformative medicine for people living with beta thalassemia, are underway, and we look forward to dosing the first patient in the clinical trial this year.” © stock.adobe.com/toeytoey © stock.adobe.com/steph photographies © stock.adobe.com/ zakalinka Sernova and Evotec enter into exclusive global strategic partnership for ‘functional cure’ for diabetes Sernova and Evotec have entered into an exclusive global strategic partnership to develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two companies will combine and leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited insulin-producing cell source to treat patients with insulin-dependent diabetes. The collaboration agreement is a partnership that combines Sernova’s Cell Pouch System technologies, which has demonstrated Phase 1/2 clinical proof- of-concept using human donor islets, with Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people suffering from diabetes using a cGMP controlled and scalable off-the-shelf product. 04-07.qxp_Layout 1 10/06/2022 14:58 Page 1Pharma Business International 5 www.pbiforum.net Latest news Pandemic Science Hub launched to fight lung disease A new multi-million pound research programme to develop treatments for lung infections such as COVID-19 and future pandemics has been announced at the University of Edinburgh with support from a significant donation by Baillie Gifford. The Baillie Gifford Pandemic Science Hub will use translational genomics – following clues from the human genome to identify, and rapidly test new treatments – with experimental medicine methods to quickly evaluate and develop drugs for lung inflammation and injury caused by infection. It will combine Edinburgh’s world-class ability to determine a person’s genetic predisposition to lung injury with advanced interventional robotics for drug delivery, cutting-edge sensing and sampling technologies, and innovative clinical trial design. Baillie Gifford is supporting the launch with a philanthropic gift of £14.7 million. The University aims to secure a total of £100 million investment to accelerate discoveries to drive clinical translation in COVID-19 and other human lung diseases, as well as aiding preparedness for future pandemics. £2.68m Innovate UK award to see NRG Therapeutics develop new medicines for Parkinson’s and motor neuron disease NRG Therapeutics Ltd, a neuroscience company targeting mitochondrial dysfunction, has received a highly competitive Biomedical Catalyst (BMC) award to fund pre-clinical development of its novel small molecule disease-modifying medicines for the treatment of Parkinson’s disease, motor neuron disease (MND) and other debilitating chronic neurodegenerative disorders. The £2.68 million early-stage BMC award part-funded by the government-backed agency Innovate UK will support a 24-month project. NRG is applying groundbreaking science in the field of mitochondrial biology to develop first-in-class treatments for Parkinson’s, MND (also known as ALS) and, potentially, other neurodegenerative disorders. Its approach is based on inhibiting the mitochondrial permeability transition pore (mPTP) in brain cells which has been shown to be neuroprotective in several preclinical models of Parkinson’s and MND. © stock.adobe.com/ Pixel-Shot © stock.adobe.com/ASDF © stock.adobe.com/JeromeCronenberger Innoviva to acquire Entasis Therapeutics Innoviva, a diversified holding company with a portfolio of royalties and a growing portfolio of innovative healthcare assets, and Entasis Therapeutics Holdings, an advanced late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products, have entered into a definitive merger agreement under which Innoviva is to acquire all of the outstanding shares of Entasis not already owned by Innoviva at a price of $2.20 per share in cash. Innoviva currently owns approximately 60% of the outstanding shares of Entasis common stock. The acquisition consideration values Entasis’ equity at $113 million on a fully diluted basis. The transaction has been unanimously approved by the Innoviva and Entasis Boards of Directors. “This acquisition will build upon our overall strategy to acquire differentiated, high-potential assets in attractive, yet often overlooked, disease areas where our capital and capabilities can make a difference,” said Pavel Raifeld, Chief Executive Officer of Innoviva. 04-07.qxp_Layout 1 10/06/2022 14:58 Page 202.qxp_Layout 1 11/10/2022 12:01 Page 1 FDA approves first treatment for eosinophilic esophagitis The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). The action marks the first FDA approval of a treatment for EoE. “As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” said Jessica Lee, M.D., director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research. EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus. In adults and adolescent patients with EoE, common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus. Dupixent is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc. MHRA approves faricimab for progressive eye diseases through international work-sharing initiative Faricimab, a new medicine for people with the progressive eye diseases wet age-related macular degeneration (wet AMD) and visual impairment due to diabetic macular oedema (DMO), has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). It is the first treatment approved by the UK regulator that has been made possible through the Access Consortium ‘New Active Substance Work Sharing Initiative’ – a collaboration of regulatory authorities including the United Kingdom, Australia, Canada, Singapore, and Switzerland. Faricimab (Vabysmo), an eye injection made by Roche Products Limited, is a bispecific antibody designed to block two different pathways implicated in causing vision loss in patients with wet AMD and DMO. The treatment has been shown to be effective in improving vision or reducing vision loss in these patient groups but has the added benefit in that it can be given less frequently in selected patients than other medicines currently available. FDA approves Lilly’s Mounjaro injection for type 2 diabetes The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) injection, Eli Lilly and Company’s new once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones. “Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro’s efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice. The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials,” said Juan Pablo Frías, M.D., medical director, National Research Institute and investigator in the SURPASS program. Novartis receives EC approval for Jakavi to be the first post-steroid treatment for acute and chronic graft-versus-host disease The European Commission (EC) has approved Novartis’ Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. “Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. The approval of Jakavi follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate compared to best available therapy. VYDURA granted first ever marketing authorization by EC for acute treatment of migraine and prophylaxis of episodic migraine The European Commission (EC) has granted marketing authorization for Pfizer and Biohaven’s VYDURA (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. VYDURA, an orally disintegrating tablet, is the first medicine approved for both acute and prophylactic treatment of migraine in the European Union. “There is a significant unmet need for people in the European Union living with the pain and disability caused by frequent migraines,” said Nick Lagunowich, global president, Pfizer Internal Medicine. “The comprehensive clinical program has established VYDURA’s efficacy and safety as both an acute and preventive treatment of migraine. Studies in acute migraine demonstrated a rapid and long-lasting relief of migraine headache and other symptoms with a single dose, while the prevention study found a significant reduction in migraine attacks with every other day dosing.” www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 10/06/2022 14:58 Page 4M&A ROUND-UP 8 Pharma Business International Pfizer - Biohaven Pharmaceutical Pfizer has claimed the biggest pharmaceutical M&A deal of the year so far (at time of writing), swooping for Biohaven Pharmaceutical for $11.6 billion. In May, the companies entered into a definitive agreement under which Pfizer will acquire the maker of NURTEC® ODT, a dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults. Under the terms of the agreement, Pfizer will snap up all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non- CGRP development stage pipeline compounds, per Biohaven common share. The boards of directors of both Biohaven and Pfizer have unanimously approved the transaction which will also see Pfizer make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock. The proposed transaction includes the acquisition of Biohaven’s calcitonin gene-related peptide (CGRP) programs such as rimegepant, zavegepant, and a portfolio of five pre-clinical CGRP assets. “Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women,” said Nick Lagunowich, global president, Pfizer Internal Medicine. “NURTEC® ODT, which is already the #1 prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients Pharma giants strike M&A deals are picking up pace, from those worth hundreds of millions to the multi-billion strikes being made by pharma giants expanding their drug pipelines and embracing innovative technologies. © stock.adobe.com/Wirestock 08-11.qxp_Layout 1 10/06/2022 14:59 Page 1Pharma Business International 9 M&A ROUND-UP suffering from migraine worldwide. We believe Pfizer is uniquely positioned to help the portfolio reach its full potential given our leading scale and capabilities.” Pfizer expects to finance the transaction with existing cash on hand. GSK - Affinivax A further recent major deal has seen GSK enter into a definitive agreement to acquire Affinivax, a clinical-stage biopharmaceutical company, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones. Affinivax is pioneering the development of a novel class of vaccines, © stock.adobe.com/ JHVEPhoto 10 Á 08-11.qxp_Layout 1 10/06/2022 14:59 Page 2Next >