Your guide to the pharmaceutical world Volume 10 Issue 1 Laboratories Digital transformation: the lab of the future Sorting and weighing Key for quality and safety Pumps and fluids The single-use revolution PharmaBUSINESS INTERN ATION AL The total package From development to dispensing The total package From development to dispensing Laboratories Digital transformation: the lab of the future Sorting and weighing Key for quality and safety Pumps and fluids The single-use revolution www .pbiforum.net 01.qxp_Layout 1 14/02/2022 08:44 Page 1 I NTER N Food Food &&& Food Food & N ATI O N &&Drin Drin Drin &&Drin AL nk nk nkk I Con nstan on nt d export I on Import and oading baLayy doors spotlight syyss and ackPPa kaaging doors ARY 2022 v Lo T e v FEBRUA £2.95 c Lin v L l ee hi h t hearts Healing inspi ti Valentin you’ll lov Fashion on ’ workout Winter i t W W W . L I N C 30+ y W W W . L I N CC O L N S H I R E T O oo ears y C O L N S H I R E T OO D A Y . N E T oung O D A Y . N E T BLM G FEBRUARY 2022 E A S T M I D L A N D S L E A £3.50 E A D I N G B U S I N E S S M A G A A Z I N E UP LEVELLIN NG UK www.blmgroup.co.uk U PRINT AND ENG TRAINING AND GINEERING The power of print ACKAGING A WW P Investing in the WW EASTMIDL APPRENTIC Indus SPO e e futur ANDSBUSINE CESHIPS stry level up ESSLINK CO U OTLIGHT w EMPOWER Your Business y er stor v Co TA 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 9 Issue 6 V T I O N Globa w varia A ne e C l M k eeducing th e R adetr t h d t aage The digital resear e M l h rc te k The l eelopment t v om de rF w w w di i k . p b i f o r u m . n e t y 2022 februar yorkshire & lincolnsh £3.50 shire’s leading business ma magazine LEVEL ON THE VOLUME 37 ISSUE 2 .blmgroup.co.uk www L TRAINING A ENGINEERING s all abIt’ ACKAA P PRINT ow Let your business gr APPRENTICESHIPS TRAINING AND Levelling up SPOTLIGHT ENGINEERING bout the print KAGING T AND V w Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 14/02/2022 08:44 Page 1Contents Volume 10 Issue 1 4 8 12 28 Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Journalists: Tess Egginton (t.egginton@blmgroup.co.uk) Eleonora Gallina (e.gallina@blmgroup.co.uk) Sales Director: Angie Cooper (a.cooper@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 In our last issue we predicted a flurry of acquisitions in the early stages of 2022, and even though it’s only been two months now we have several to report on. Pumps and fluids12 Is single-use equipment really the key to a better, more efficient and safer pharmaceutical manufacturing industry? Is it time to swap stainless steel pumps for single-use polypropylene ones to ensure better results? It might be. Microbiology and R&D16 The key objective for the pharmaceutical industry is making sure products are safe for human consumption and sterility is the main condition companies need to prioritise. Sterility testing in pharmaceutical is a market that has been flourishing and that is meant to grow even further because of its importance. Health, safety and hygiene20 Health and safety regulations are never easy to follow for any manufacturing company, but because of the nature of the products, it is more complicated for the pharmaceutical industry. Balancing good manufacturing standards and safety requirements can be challenging, but making sure everyone is safe at all times always has to be a priority. Laboratories24 With digitalisation, intelligent systems and heightened automation becoming the new norm for labs, facilities need to be transformed to beat competitors. Sorting and weighing 28 Sorting and weighing are crucial in developing and manufacturing safe and effective pharmaceuticals. 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/Gorodenkoff 03.qxp_Layout 1 14/02/2022 08:45 Page 14 Pharma Business International www.pbiforum.net Latest news Virology Research Services chooses Discovery Park as it relocates London team A leading virus-focused consultancy and experimental service provider working to accelerate vaccine and virus research efforts has relocated its laboratory and consultancy services to Discovery Park in Kent. Virology Research Services (VRS), founded in 2017 by Michela Mazzon and Chiara Mencarelli, provides high-level testing and analysis services to industry and academia. The business began with the founders providing testing services to small biotech and to the academic community and has grown from there to a team of seven. VRS now provides a range of services to support the work of scientists in pharma, industry, and academia, supporting vaccine development and antiviral drug discovery. VRS selected Discovery Park as its new home thanks to access to high quality laboratories which meet its need for high-containment infrastructures for use with multiple viral systems. It requires state-of-the-art facilities to enable it to carry out research for start-ups to multi-national companies. VRS has taken a CAT2 laboratory and is planning to open a specialist CAT3 facility to allow it to work with higher-risk biological agents and hazards. For further information on VRS visit www.virologyresearchservices.com or visit www.Discovery-Park.co.uk Syros receives FDA orphan drug designation for tamibarotene for the treatment of MDS The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Syros Pharmaceuticals’ tamibarotene for the treatment of myelodysplastic syndrome (MDS). Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with azacitidine in the SELECT- MDS-1 Phase 3 trial for RARA-positive patients with newly diagnosed higher-risk MDS (HR-MDS). “The FDA’s orphan drug designation is an important milestone in the development of tamibarotene as a treatment for MDS,” said David A. Roth, M.D., Syros’ Chief Medical Officer. “We believe tamibarotene’s novel mechanism of action, promising clinical activity data, oral delivery, and favorable tolerability profile supports a potential new option for the approximately 30% of HR-MDS patients who are RARA-positive. We are focused on developing the first potential therapy for a targeted population in HR-MDS as we continue to advance our ongoing SELECT-MDS-1 pivotal trial.” © stock.adobe.com/Rustam Kholov Research collaboration launched to focus on repurposing existing antiviral therapies to treat COVID-19 A new £1.6m collaborative project has been launched to rapidly identify new treatments for COVID-19. The project, led by Queen’s University Belfast and funded by the Medical Research Council, will bring together experts from Queen’s, the University of Liverpool and the University of Oxford. The team will use a data-driven approach to identify novel drug combinations that are effective in tackling SARS-CoV-2, the causative agent of COVID-19. Despite the development of vaccines and drugs at an unprecedented pace to prevent and treat infection, there remains a huge gap in the development of antiviral therapies. Antiviral drugs are used specifically to treat viral infections by killing or preventing the growth of viruses. The research project will initially screen 138 drugs with known antiviral activity against SARS-CoV-2 to assess and identify combinations that enhance their antiviral potential. The most effective combinations will be presented to national organisations including the UK Antiviral Task Force and UK-CTAP, evidencing the need to bring the treatments forward to clinical trials phase. Michela Mazzon (left) and Chiara Mencarelli (right) © stock.adobe.com/denisismagilov 04-07.qxp_Layout 1 14/02/2022 08:47 Page 1Pharma Business International 5 www.pbiforum.net Latest news Australia approves its first oral COVID-19 treatments The Therapeutic Goods Administration (TGA) has granted provisional approval to two oral COVID-19 treatments: Pfizer’s Paxlovid (nirmatrelvir + ritonavir) and Merck Sharp & Dohme’s Lagevrio (molnupiravir). Both of these products, which are the first oral treatments to be approved for COVID-19 in Australia, have been granted provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death. Neither product is intended to be used as a substitute for vaccination against COVID-19. Either medicine should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms. Lagevrio is available as capsules, while Paxlovid comprise separate tablets of nirmatrelvir and ritonavir. In both cases, the medicines are taken twice a day for 5 days. PharmaLex extends reach to Japan, East Asia and Southeast Asia with Ascent Development Services merger PharmaLex Group, a provider of specialized services for the pharma, biotech and medtech industries worldwide, has announced a merger agreement with Ascent Development Services, a Japan- based leader in enabling the integration of Asia into global pharmaceutical product development. Founded in 2017, Ascent’s team of experts work with emerging biopharma companies to understand and overcome differences in medical practice, culture and language in order to achieve the optimal strategic and operational integration of Asia into global drug development. Headquartered in Tokyo, Ascent employs staff across Asia, including China, Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam and provides a balance of country-specific knowledge mixed with strategic advice from a global perspective. © stock.adobe.com/pogonici © stock.adobe.com/JRJfin © stock.adobe.com/sdecoret Endeavor BioMedicines closes $101m Series B financing to advance clinical- stage precision medicine pipeline Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, has announced the completion of a $101 million Series B financing, led by Ally Bridge Group and Avidity Partners. New investors participating in the round include Perceptive Advisors, Piper Heartland Healthcare Capital, Revelation Partners, funds managed by Tekla Capital Management LLC, and funds and accounts advised by T. Rowe Price Associates, Inc. Existing investors Omega Funds and Longitude Capital also participated. Proceeds will support the advancement of Endeavor’s pipeline programs, including ENV-101 (taladegib), a small molecule inhibitor of the PTCH1 receptor in the Hedgehog signaling pathway for the treatment of cancer and idiopathic pulmonary fibrosis (IPF), as well as ENV-201, a potentially best-in-class small molecule inhibitor of ULK1/2 for the treatment of KRAS-driven cancers. 04-07.qxp_Layout 1 14/02/2022 08:47 Page 26 Pharma Business International www.pbiforum.net Latest news LogiPharma leads the way as Tower takes cold chain containers on the road In its first appearance at the LogiPharma conference, Tower Cold Chain is speaking about the challenges in temperature-controlled logistics and exhibiting its robust, reliable and reusable containers. With the biggest names in pharmaceutical manufacturing and cold chain logistics attending the Nice-based conference, Tower will share insight on helping companies to transport temperature-critical products. Global Head of Supply Chain, Kevin Doran, will be speaking as part of a panel discussion at 2:30pm on Tuesday 5 April on using technology to improve sustainability in global logistics. Tower’s container range uses phase-change materials to keep contents at a stable temperature, and integrated datalogger technology to monitor performance during transit. Backed by a growing global network of hubs, Tower can meet all pharmaceutical temperature configurations and standards, in a variety of consignment sizes from multi-pallet to pallet to sub-pallet. Visitors to the Tower stand (booth #21) at LogiPharma will be guided through the specific features and benefits of the Tower range. For more information on Tower, visit www.towercoldchain.com Parkinson’s UK and Domainex to develop neuroinflammation therapies to slow progression of Parkinson’s Parkinson’s UK, the charitable funder of Parkinson’s research in Europe, and Domainex have announced a collaboration focused on developing small molecule therapies targeting neuroinflammation that could slow the progression of Parkinson’s. Domainex, an integrated medicines research services partner, will provide fully integrated drug discovery services including assay biology, medicinal and computational chemistry. The collaboration is anticipated to be undertaken over a two-and-a-half-year period, with Parkinson’s UK investing up to £3 million in the project via its drug development arm – the Parkinson’s Virtual Biotech. The innovative programme is plugging the funding gap to fast-track the projects with the greatest scientific potential to transform the lives of people with Parkinson’s. Inflammation is vital for defending the body from infections, injuries and toxins. However, in Parkinson’s there is excessive chronic inflammation within the brain. It is now believed that this may play a role in the damage to brain cells which occurs in the condition. Sarepta Therapeutics and GenEdit to develop gene editing therapeutics for neuromuscular diseases Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, and GenEdit, a developer of genetic medicines that leverage its NanoGalaxyTM polymer nanoparticle platform for tissue-selective delivery, have announced a research collaboration and option agreement under which the companies are employing GenEdit’s NanoGalaxy platform and Sarepta’s gene editing technology to develop gene editing therapeutics for the treatment of neuromuscular diseases. As part of the agreement, Sarepta obtains exclusive option rights to license polymer nanoparticles developed by GenEdit in the collaboration for up to four neuromuscular indications selected by Sarepta. Initial in vivo results from the research collaboration between GenEdit and Sarepta have demonstrated the potential of GenEdit’s polymer nanoparticles to deliver therapeutic cargo to specific muscle tissue after systemic administration to allow for targeted, non-viral systemic delivery of genetic medicines. The research collaboration and option agreement commenced in December 2020. © stock.adobe.com/vchalup © stock.adobe.com/Gorodenkoff 04-07.qxp_Layout 1 14/02/2022 08:47 Page 3Eye on approvals Pfizer’s LORVIQUA® The European Commission (EC) has granted marketing authorization for Pfizer’s LORVIQUA® (lorlatinib, available in the U.S. under the brand name LORBRENA®) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. The approval for the first-line use of LORVIQUA was based on the results of the pivotal Phase 3 CROWN trial, in which LORVIQUA reduced the risk of disease progression or death by 72% compared to XALKORI® (crizotinib). Bristol-Myers Squibb’s Abecma Abecma is the first CAR T cell therapy approved for the treatment of R/R multiple myeloma in Japan. With this approval, Bristol Myers Squibb is now the only company in Japan with two approved CAR T cell therapies—the CD19-directed Breyanzi, which received approval in March 2021, and the BCMA-directed Abecma. The approval is based on efficacy and safety data sourced from the global Phase 2 Study BB2121-MM- 001 conducted in Japan, the U.S., the EU, and Canada, and the Phase 1 Study CRB-401 in the U.S. AbbVie’s SKYRIZI® The U.S. Food and Drug Administration (FDA) has approved AbbVie’s SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis. The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints. Pfizer’s Paxlovid Paxlovid (PF-07321332 and ritonavir) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease. This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines. Janssen EMEA’s RYBREVANT® The Janssen Pharmaceutical Companies of Johnson & Johnson announced Conditional Marketing Authorisation (CMA) of RYBREVANT® (amivantamab) for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy. Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC. The CMA is based on results from the Phase 1 CHRYSALIS study, a multicentre, open-label, clinical study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy, which demonstrated efficacy and a generally well-tolerated safety profile. Merck Sharp & Dohme’s Lagevrio (molnupiravir) The Therapeutic Goods Administration (TGA) has granted provisional approval to Merck Sharp & Dohme’s Lagevrio (molnupiravir). This product, which is one of the first oral treatments to be approved for COVID-19 in Australia, has been granted provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death. The product is not intended to be used as a substitute for vaccination against COVID-19. www.pbiforum.net Pharma Business International 7 With fresh opportunities for more approvals as COVID-19 is slowly brought under control, many are now asking if expediated trials could not stay in place. While this may be unlikely to happen in the short term, there are still approvals to be reported on, and we’ve brought you some of the most exciting from the first few months of the year. 04-07.qxp_Layout 1 14/02/2022 08:47 Page 4M&A ROUND-UP 8 Pharma Business International www.pbiforum.net It’s only the start of 2022 and, as predicted, we’ve already had a flurry of merger activity within the industry. As lockdown lifts and with many companies sitting on large war chests, we predicted last issue that there would be a boom this year, and we’ve gotten off to a strong start – depending on how you look at it. In the US, President Biden has expressed some concerns when it comes to mergers, with some people claiming that the return of antitrust regulation is on the cards. This is a distinct possibility after trust in pharmaceutical firms took a significant hit in the recent years, in part due to the unscrupulous actions of a few figures and companies – Martin Shkreli to name one in particular. With public sentiment tarnished by his, and others’, actions, it paves a perfect opportunity for a politician wishing to be seen as proactive to sweep in and cause problems, and that may well happen in the future. We shall report on it if it does. For now, however, there have been several high-profile mergers that have caught the eye. Samsung BioLogics – Biogen’s Stake in Samsung Bioepis In a deal worth a whopping $2.3 billion, South Korean Samsung BioLogics are marked to acquire Biogen’s stake in the join venture between them and Samsung Bioepis. This is more to reclaim control of their joint venture, which Biogen initially invested 15% of the total value into. Mergers: Month in review In our last issue we predicted a flurry of acquisitions in the early stages of 2022, and even though it’s only been two months now we have several to report on. 10 Á Mergers: Month in review 08-11.qxp_Layout 1 14/02/2022 08:47 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © st ock. adobe .com/ unlimit3d 08-11.qxp_Layout 1 14/02/2022 08:47 Page 2Next >