Your guide to the pharmaceutical world Volume 11 Issue 1 Laboratories Advancing technology Sorting and weighing The correct measurements Health, safety and hygiene The final barrier Laboratories Advancing technology Sorting and weighing The correct measurements Health, safety and hygiene The final barrier www.pbiforum.net 01.qxp_Layout 1 10/02/2023 14:21 Page 1 NTERN NATION AL als spotlight eadyR mea ackPaging Microbiolog testing gy and T FEBRUA 295£ RY2023 Fabl Foundat B ti pitipositive Feeling fashion F gardens Homesa d COLNSHIRETODAY.NETCOLNSHIRETODAY.NET WWW.LINCWWW.LINC BLM G www.blmgroup.co.uk FEBRUARY 2023 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE UK www.blmgroup.co.uk Closing the gap levelled up Has our en busine Making p? ngineering ANDSBUSINE oad ess abr g the most of ESSLINKCOU w EMPOWER Your Business Edf rld o our guide to the pharmaceutical wY Issue 60olume 1 V Looking bac succes E k2022kk ti ear Depos df a df s llll Outso tmea Accur rements Someone e businesss’ l ss net www .pbiforum.n y 2023 februar yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME 38 ISSUE 02 .blmgroup.co.ukwww g packaging V w eamliningStr e ravel once morrT engineering Levelling up our Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 10/02/2023 14:21 Page 112 20 24 28 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 After an underwhelming year for M&A in the pharma sector, a busier 2023 is predicted. Laboratories12 With recent advances in technology combining with a shrinking workforce, more and more labs are looking to ways to cut back on staffing through digitalisation. Microbiology and R&D16 There’s a lot of change going on in microbiology, and a lot of it is adapting to the changing circumstances going on around the world. Pumps and fluids20 The correct and efficient handling of fluids is integral to the sector’s continued success, but there are hurdles to get by if it’s going to reach its potential. Sorting and weighing24 With consumer trust in pharma at an all-time low it’s more important than ever to get everything right and avoid scandal. Perfect measurements come into that. Health, safety and hygiene 28 While all labs and manufacturing plants should seek to be incident free, accidents will always happen, and it’s up to the PPE provisions in place to mitigate risk. 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/BrunoWeltmann 03.qxp_Layout 1 10/02/2023 14:22 Page 14 Pharma Business International www.pbiforum.net Latest news Upperton Pharma Solutions breaks ground on new development and manufacturing facility Upperton Pharma Solutions, a UK contract development and manufacturing organisation (CDMO), has begun construction work for its new Development and GMP Manufacturing headquarters in Nottingham. The 50,000 square foot facility is expected to be fully operational by the end of 2023. The new site is situated at the recently opened Trent Gateway Business Park in Beeston (less than two miles from Upperton’s current headquarters) and will provide a significant expansion of the company’s capabilities in terms of capacity and scale of manufacture with the incorporation of ten new GMP manufacturing suites, Quality Control laboratories and dedicated Analytical and Formulation Development laboratories with pilot plant facilities. The Trent Gateway site will have the capability to handle a range of dosage forms including solids, liquids, semi-solids, nasal and inhaled products, allowing it to support early formulation development, provide clinical trial supplies from Phase 1 to Phase 3 and niche-scale commercial manufacture. The GMP facility design, equipment procurement and containment capabilities have been aligned with larger scale process trains, supporting batch scales of up to 250kg. Sandoz acquires antifungal agent Mycamine from Astellas Sandoz, a division of Novartis, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas. Sandoz CEO Richard Saynor said: “Acquiring this leading and respected global brand will significantly reinforce the Sandoz global hospital offering, as well as complement our existing global leadership position in generic antibiotics.” He added: “This will also be an important addition to our growing portfolio of anti-infective therapies aimed at combatting the spread of antimicrobial resistance, by providing the right drug to the right patient at the right time.” Mycamine is indicated for treatment of invasive candidiasis and espophageal candidiasis, which are currently both on the rise with a higher occurrence of associated hospital outbreaks, as well as prevention of candida and aspergillus infections in patients undergoing hematopoietic stem cell transplantation. The financial terms of the asset purchase agreement involve $62.5-75 million upfront, depending on the date of the closing of the transaction, and potential sales-based milestone payments. © stock.adobe.com/ Arnéll Koegelenberg/peopleimages.com Shift to consumer-first mindset is highest priority for digital pharma products going into 2023 A new report from Graphite Digital – Overcoming Contradictions – reveals that moving to a consumer-first mindset when it comes to digital products is the highest priority for pharma leaders over the next two years. To deliver customer-first products, pharma companies must understand the customers for whom they are delivering – but only a quarter say they are always conducting user research – leaving them ‘designing in the dark’. As a result, nearly one in five pharma leaders admit their digital product launches often do not deliver the expected results. Meanwhile, nearly a quarter admit they do not know how successful their digital products launches are because they do not measure them. Graphite Digital’s CEO Rob Verheul said: “Data collection and analysis is essential for the success of a digital product – from understanding the customer or end-user to identifying areas for improvement or measuring success. Getting it right when it comes to data is critical for generating that all- important customer-first mindset and delivering effective digital products that meet the needs of users.” Graphite Digital collaborates with healthcare and pharmaceutical organisations to create innovative digital patient and HCP experiences through research, strategy and customer-centric design. Download the Overcoming Contradictions white paper at https://www.graphitedigital.com/downloads/overcoming-contradictions 04-07.qxp_Layout 1 10/02/2023 14:23 Page 1Pharma Business International 5 www.pbiforum.net Latest news NextPoint Therapeutics raises $80m in Series B financing to advance novel immuno-oncology programs NextPoint Therapeutics, a biotechnology company developing a new world of precision immuno-oncology, has raised $80 million in Series B financing co-led by Leaps by Bayer, the impact investment arm of Bayer AG, and Sanofi Ventures, the strategic venture capital arm for Sanofi. The financing will be used to advance NextPoint’s two lead precision immuno-oncology programs into the clinic, both targeting the newly discovered HHLA2 pathway to activate anti-tumor immune responses. Additional new investors in the round include Invus, Catalio Capital Management, Sixty Degree Capital and PagodaTree Partners. Existing investors that took part in the financing include MPM Capital Management, Dana-Farber Cancer Institute’s Binney Street Capital and NextPoint founder Gordon Freeman, PhD. As part of the financing, Rakhshita Dhar, senior director of Venture Investments Health at Leaps by Bayer, and Paulina Hill, partner at Sanofi Ventures, will join the NextPoint Board of Directors. © stock.adobe.com/Kenishirotie © stock.adobe.com/weyo Moderna granted FDA Breakthrough Therapy Designation for RSV vaccine Moderna’s mRNA-1345, an investigational mRNA vaccine candidate for respiratory syncytial virus (RSV), has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older. The designation was based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial. “The FDA’s Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need,” said Stéphane Bancel, Chief Executive Officer of Moderna. “With this designation, we look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly. Moderna’s mRNA platform has now demonstrated two positive Phase 3 infectious disease trial results and we continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases. We are grateful to the FDA for this designation.” © stock.adobe.com/ stockdevil Qurient and TB Alliance enter exclusive license agreement for new anti-tuberculosis agent Qurient, a clinical-stage biotechnology company based in South Korea, and TB Alliance have entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for the treatment of tuberculosis (TB) and other non-tuberculosis mycobacterium infections. Under the terms of the license agreement TB Alliance obtains the exclusive worldwide license (except for South Korea, Russia and the Commonwealth of Independent States (CIS) countries) to develop and commercialize telacebec for the treatment of tuberculosis and some non-tuberculosis mycobacteria (NTM) infections. Kiyean Nam, Ph.D., CEO of Qurient, said: “As telacebec’s unique mechanism of action of blocking energy metabolism of the Mycobacterium can address all types of TB, including drug-resistant TB, we expect telacebec to potentially become an essential component of drug combination regimens for the treatment of TB. “We believe telacebec will greatly contribute to the global efforts to combating the TB pandemic, which remains a serious public health challenge worldwide. Our partnership with the TB Alliance will accelerate the widespread availability of telacebec and bring it to those in need.” 04-07.qxp_Layout 1 10/02/2023 14:23 Page 26 Pharma Business International www.pbiforum.net Latest news Orphagen receives Rare Pediatric Disease Designation from FDA for pediatric adrenocortical carcinoma treatment The US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for Orphagen Pharmaceuticals’ OR-449 for the treatment of pediatric adrenocortical carcinoma (ACC). OR-449 is a selective, first-in-class, potent and orally bioavailable small molecule antagonist to steroidogenic factor-1 (SF-1 or NR5A1), an orphan nuclear receptor and transcription factor that is essential for the growth and development of the adrenal gland. Orphagen is developing OR-449 for both the adult and pediatric forms of ACC as well as other cancers known to express a high level of SF-1. “We are gratified that OR-449 has received an RPDD from the FDA. We currently plan to file an Investigational New Drug (IND) application with the FDA later this year to support initiation of a Phase 1 clinical trial,” said Orphagen CEO, Scott Thacher, Ph.D. “We speak to clinicians regularly who remind us of the urgent need for an improved therapy for patients with ACC, and this drives our commitment to the clinical development of OR-449, our first internal program to reach this stage.” ADVANZ PHARMA enters into exclusive agreement with Alvotech to commercialise a proposed biosimilar to Xolair ADVANZ PHARMA has entered into an exclusive agreement with Alvotech for the exclusive license and supply rights for a proposed biosimilar to Xolair (omalizumab). Alvotech will be responsible for the development and commercial supply and ADVANZ will be responsible for registration and commercialisation in the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand. Omalizumab is used to treat severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is an established treatment option to decrease the number of asthma attacks (sudden episodes of wheezing, shortness of breath, and trouble breathing) in adults and children six years of age and older with allergic asthma whose symptoms are not controlled with high dose inhaled steroids. According to IQVIA, the current addressable market for omalizumab is more than US$1bn in the markets in scope of the agreement. © stock.adobe.com/motortion © stock.adobe.com/ ibreakstock Avidity Biosciences granted FDA Fast Track designation for facioscapulohumeral muscular dystrophy treatment Avidity Biosciences, a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), has been granted Fast Track designation by the US Food and Drug Administration (FDA) for AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked by life-long, progressive loss of muscle function that causes significant pain, fatigue, and disability. AOC 1020 is being studied in the Phase 1/2 FORTITUDE clinical trial in adults with FSHD and is the company’s second muscle-targeting small interfering RNA (siRNA) AOC in clinical development. Avidity plans to share data from a preliminary assessment of AOC 1020 in approximately half of study participants from the FORTITUDE trial in the first half of 2024. Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Currently, there are no FDA-approved treatments for people living with FSHD. © stock.adobe.com/ JHVEPhoto 04-07.qxp_Layout 1 10/02/2023 14:23 Page 3 FDA approves Luye Pharma’s Rykindo for schizophrenia and bipolar 1 disorder The US Food and Drug Administration (FDA) has approved Luye Pharma’s Rykindo (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Rykindo was developed by Luye Pharma on its microsphere technology platform. The drug is administered via intramuscular injection once every two weeks and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology. “Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and the society. Rykindo is our first new drug developed in-house and approved for marketing in the US, demonstrating our long-standing commitment to serving patients around the world with innovative therapies,” said Yang Rongbing, president of Luye Pharma Group. STADA and Xbrane obtain British approval for Ximluci biosimilar referencing Lucentis The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for STADA and Xbrane’s Ximluci (ranibizumab), a biosimilar referencing Lucentis. Xbrane’s contribution to the partnership includes a patented protein-expression system and Europe-based production set-up, while STADA brings considerable heritage supplying biosimilars and other specialty medicines in the UK. Ximluci is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders, which are a leading cause of blindness globally. Ximluci has been approved in the UK for treating wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults. Alvotech and Bioventure’s AVT02 approved in Saudi Arabia The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02, a biosimilar for Humira (adalimumab), which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases. The biosimilar will be marketed as Simlandi in Saudi Arabia. “The approval of Simlandi by the SFDA marks an important milestone for local patients and physicians,” said Ashraf Radwan, division CEO of GlobalOne Healthcare Holding. “We are proud to partner with Alvotech, who share our mission to lower the cost burden on healthcare systems and improve patient quality of life. We look forward to bringing this essential treatment to patients in Saudi Arabia as well as other key markets in the Middle East and North Africa.” Dupixent approved by European Commission for eosinophilic esophagitis The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Sanofi and Regeneron say Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the US. George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, added: “Dupixent is also the only biologic shown in pivotal trials to help patients achieve histological remission, reduce difficulty swallowing and improve health-related quality of life – all of which are crucial to reducing the burden of this debilitating disease. Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.” MHRA approves RINVOQ as first oral advanced therapy to treat adults with moderately to severely active Crohn’s disease The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved AbbVie’s RINVOQ (upadacitinib), a janus kinase (JAK) inhibitor, for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent. “There have been limited new treatment options approved for Crohn’s disease in recent years and many people struggle to stay in remission, demonstrating a clear unmet need,” said professor James Lindsay, consultant gastroenterologist at the Royal London Hospital Barts Health NHS Trust. “We’ve seen in clinical trials that upadacitinib has the potential to help people gain control of their disease and, with this MHRA approval, we now have an approved advanced treatment option in a new class of therapy that can be taken as a once daily pill.” Jesduvroq approved by US FDA for anaemia of chronic kidney disease in adults on dialysis The US Food and Drug Administration (FDA) has approved GSK’s Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI), for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is said to be the first innovative medicine for anaemia treatment in over 30 years and the only HIF-PHI approved in the US, providing a new oral, convenient option for patients in the US with anaemia of CKD on dialysis. Tony Wood, president and chief scientific officer, GSK, said: “Over the last several decades, there has been little innovation in anaemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.” www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 10/02/2023 14:24 Page 4M&A ROUND-UP 8 Pharma Business International www.pbiforum.net © stock.adobe.com/juliasudnitskaya Looking ahead after a subdued year Looking ahead after a subdued year 08-11.qxp_Layout 1 10/02/2023 14:25 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP was a slow year for dealmaking in the pharma industry. Global life sciences mergers and acquisitions (M&A) investment totalled US$105 billion in the first 11 months of 2022, with deal value well down on 2021, according to a report from EY. Cautiousness was high, with the uncertainties of ongoing macroeconomic volatility and geopolitical tensions, but the year ended with signs of hope as Amgen made its $28.3 billion swoop for Horizon Therapeutics — one of the biggest deals of 2022 — indicating that the industry may be set to return to big ticket deals in 2023. With biopharma alone holding more than $1.4 trillion in dealmaking firepower at the beginning of December 2022, with reduced deal premiums being an enticement to use that capital, as highlighted by EY, the sector also has strategic reasons to pursue acquisitions this year. Many pharma giants are facing a growth gap over the next five years as myriad market-leading biopharmaceuticals lose patent exclusivity and meet competition from cheaper generic and biosimilar products, while with innovation flooding the industry, the number of potential acquisition targets to enrich pipelines with is flourishing. The resources, incentives and opportunities are there for major M&A moves in 2023. Subin Baral, EY global deals leader, life sciences, says: “Though biopharma and MedTech companies have been acting cautiously on their M&A activity for most of 2022, the right deals are still getting done. M&A financing has become more challenging with rising interest rates and inflation, and the impact of US legislation like the Inflation Reduction Act; the FTC’s [Federal Trade Commission] tougher stance on antitrust is also an obstacle. But companies have the Firepower to use, and if they can find deals that offer the right strategic fit, they will not hesitate. In the longer perspective, we may look back on 2022 as the calm before the storm; in the next 12 months companies may unleash their Firepower not just to bring new innovation into their portfolios, but to access the tech and data tools that can transform and improve their entire operating models. As companies seek to secure growth and future-proof their business models amid a rising tide of innovation, M&A will need to take a central strategic role.” The start of 2023 has not yet seen a major uplift in activity, though some significant deals have been announced. AstraZeneca - CinCor Pharma AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as 10 Á After an underwhelming year for M&A in the pharma sector, a busier 2023 is predicted. 08-11.qxp_Layout 1 10/02/2023 14:25 Page 2Next >