Industry News Mergers & Aquisitions

Orgenesis to acquire cell therapies specialist Koligo Therapeutics

Cell and gene therapy specialist Orgenesis Inc has agreed to acquire regenerative medicine company Koligo Therapeutics, Inc. Koligo is a leader in developing personalized cell therapies utilizing the patient’s own, ie autologous, cells and has successfully launched its first commercial product, KYSLECEL. The company also has plans to commence a Phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligo’s development-stage technology utilizes 3D bioprinting and vascularization with autologous cells to create biodegradable and shelf- stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants. Following closing of the transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the US and, subject to regulatory and logistical considerations, in international markets as well. Also after closing, and subject to FDA review and clearance of the company’s IND, Orgenesis expects to start patient recruitment for a Phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligo’s 3D-V bioprinting technology across its POCare platform.

IMCD to acquire Indian speciality chemicals distributor Signet

Speciality chemicals and food and pharma ingredients distributor IMCD NV is to acquire Signet Excipients Private Limited, a leading excipients distributor in India. IMCD says Signet is well aligned with its the IMCD business model and strategy and that it provides a significant platform for further growth in India and the Asia-Pacific region. Founded in 1986, Signet grew from a small distribution company to one of the leading distributors of excipients in India. The company focuses on the distribution of pharmaceutical, nutraceutical and bio- pharma excipients including diluents, fillers, sweeteners, disintegrants, binders, surfactants and others. Based in Mumbai, Signet is active in India, Bangladesh, the Middle East and Africa currently serving more than more than 900 customers with over 400 products from major excipients producers. Signet has about 100 employees and generated revenue of 13.2 billion Rupees (about €152 million) in the past twelve months up to and including June 2020, and realized a normalized EBITA of 3.4 billion Rupees (about €39 million).

The transaction will take place in two tranches, with IMCD now acquiring 70% of the share capital from the founders and the remaining 30% by 2024. The transaction is expected to have high single-digit cash EPS accretion in the first full year post acquisition. The founders of Signet will continue to lead the company post completion of the first tranche.

Gelest closes sale to Mitsubishi Chemical

Gelest has completed the sale of Gelest Intermediate Holdings, the parent company of Gelest, Inc. and Bimax, Inc. to Mitsubishi Chemical America, Inc, the US subsidiary of Mitsubishi Chemical Corporation. Gelest was founded in 1990 and has become a global leader in silicones, organosilanes, metal-organics, and speciality monomers technology, manufacturing, and supply for high-growth materials science applications such as medical devices, life sciences, microelectronics, and personal care.

14 DSM to sell Resins & Functional Materials business R

oyal DSM has agreed to sell its Resins & Functional Materials (RFM) and its associated businesses to

Covestro AG for €1.6 billion. DSM says the proposed transaction is

another step forward in its evolution as a company operating in the fields of nutrition, health, and sustainable living. The sale follows DSM’s recent acquisitions of the Erber Group, Glycom and CSK.

The transaction will include all of DSM’s Resins & Functional Materials businesses, including DSM Niaga, DSM Additive Manufacturing and the coatings activities of DSM Advanced Solar. These businesses represented

€1.012 billion of DSM’s 2019 total annual net sales and €133 million of the company’s 2019 total EBITDA.

The combination of RFM and Covestro is intended to create a business of enhanced scale and technological capability that will benefit DSM’s existing and potential customers as well as

its employees through a stronger platform for growth. Completion of the transaction, which is subject to customary conditions and approvals, is expected in H1, 2021. DSM Resins & Functional Materials, which includes a Sustainable Coatings division and a Functional Materials division, provides highly-specialized products such as resins for use in paints and other industrial applications, and optical fibre coatings. This includes DSM Niaga, a VOC-free adhesive and a proprietary production technology for fully-recyclable carpets, mattresses and furniture components. DSM Additive Manufacturing provides performance materials and application expertise in 3D-printing while DSM Advanced Solar coatings are high performing anti-reflective coatings used for solar glass activities. The division’s activities in next-generation backsheets for photovoltaic modules remains as DSM Advanced Solar as part of DSM.

DKSH to distribute Eastman Chemical’s personal care products throughout Asia Pacific

Eastman Chemical Company has entered into a distribution agreement with Switzerland- headquartered DKSH in which DKSH will work on growing Eastman’s Personal Care business in existing markets and on expanding into new ones as a distributor for Eastman across the whole of the Asia-Pacific region. “As a speciality materials company, we continue to expand our in-house R&D and formulation skills and capabilities,” commented Christian Derbez, Sales Director AP region at Eastman. “Complementary to this, we will now also be drawing

on the valuable formulation expertise of a company deeply rooted in communities across the Asia Pacific region that has its own labs. This will help local customers get access to our personal care and cosmetics innovations more swiftly and easily.”

Eastman has a long history of providing speciality ingredients to the personal care and cosmetics industry, the company’s products ranging from adhesion promoters to film formers to emollient esters, all designed to improve the performance of final formulated products.

Autumn 2020

Industry News

Cobra Biologics selected to manufacture plasmids for Phase I clinical trial of Scancell’s COVID-19 vaccine in 2021


obra Biologics (Cobra), part of the Cognate BioServices family, an international CDMO

manufacturer of biological materials and pharmaceuticals, and Scancell Holdings plc (Scancell), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announced that they have entered into a collaboration for Cobra to manufacture Scancell’s COVID-19 vaccine. The agreement covers Good Manufacturing Practice (GMP) production of plasmid DNA needed to generate the DNA vaccine, against SARS-CoV-2, for use in a Phase 1 clinical trial in 2021 (COVIDITY). The project is funded by an Innovate UK grant awarded to the consortium between Scancell,

the University of Nottingham and Trent University, as previously announced in August 2020. Scancell’s DNA vaccine will target the SARS-CoV-2 nucleocapsid (N) protein plus the key receptor binding domain of the spike (S) protein to generate both T cell responses and virus neutralising antibodies against the SARS-CoV-2 virus. This new vaccine has the potential to provide long lasting immunity against COVID-19 by generating protection not only against this strain, but also against new strains of coronavirus that may arise in the future.

The GMP production of

plasmid DNA represents a crucial development in the production of a COVID-19 vaccine for use in the Phase 1 clinical trial, COVIDITY.

Increasing production of plasmids to large scale and according to GMP requires management of the scale- up process to ensure plasmids are of therapeutic-grade quality. Cobra’s long-established plasmid production platform along with in-house expertise will ensure the highest quality plasmids are produced for COVIDITY. The initial stages of GMP manufacture are scheduled to start imminently.

Dr Cliff Holloway, Chief Executive

Officer, Scancell, commented: “Our collaboration with Cobra is critical to us moving forward with our novel SARS-CoV-2 vaccine into the planned Phase 1 clinical trial, COVIDITY. Cobra has the expertise needed to produce clinical grade plasmid at scale and we look forward to working

Catalent acquires North American biologics facility from AB BioTechnologies

Catalent has acquired a biologics manufacturing facility in Bloomington, Indiana, USA to create a North American centre of excellence for early-phase clinical biologics formulation development and drug product fill/finish services. The $14 million investment includes the acquisition, build-out, and qualification of the facility to begin supporting customer programmes starting in January 2021. The 23,000-square-foot facility, purchased from AB BioTechnologies,

Inc and its affiliate, includes a new Vanrx SA25 aseptic flexible filling line capable of filling liquid and lyophilized vials, syringes or cartridges under barrier isolator technology while also providing rapid changeover for faster manufacture of clinical batches. The facility also has formulation development capabilities, quality control laboratories, and controlled-temperature storage for biologic and sterile products. The site will be fully integrated with Catalent Biologics’ main Bloomington facility

People on the Move

Almac Sciences has appointed Dan Bayston as Vice President of Small Molecule API. Bayston has been a key member of the company’s global Chemical Development and Scale-up team for the past 17 years and in recent years has become increasingly involved in customer management, business performance assessment and business strategy. Prior to joining Almac in 2003, he completed a BSc at the University of Sheffield, a PhD at the University of Louvain-la-Neuve and he held a Post- doctoral research position at the University of Oxford. In addition, he has almost a decade of experience in various process development roles with a UK based chemical services company.

Gelest has promoted Dr Jonathan Goff to the role of Chief Technology Officer(CTO). Dr Goff joined the company in 2009 and currently manages the Polymer Development, Technical Services, Silanes & Metal-Organic, Research Engineering and Quality Control groups. He received his PhD in Macromolecular Science & Engineering from VirginiaTech, is cited as inventor on 12 patents, and has published more than 40 technical articles.

Autumn 2020 15

located nearby, where the company recently announced a $50 million investment to install an additional high-speed vial filling line.

“The addition of this new small-scale filling capability underlines Catalent’s commitment to our customers with early stage programmes looking to accelerate molecules into the clinic,” commented Mike Riley, Catalent’s Region President, Biologics, North America. “The filling line will also be fully leveraged as part of our OneBio offering, an integrated solution for

drug substance and drug product development, manufacturing and clinical supply, enabling faster development timelines to Phase 1 clinical trials and beyond.” This new line brings the drug product fill/finish manufacturing capacity across both Bloomington facilities to three high-speed vial lines, two high-speed syringe lines, one high-speed flexible filling line, and one small-scale flexible filling line, all of which is expected to be available by the end of 2021.

with them to advance our vaccine and demonstrate its potential effectiveness and protection against COVID-19.”

Peter Coleman, Chief Executive

Officer, Cobra Biologics, added: “We are excited by this further collaboration with Scancell, with whom we share a long-standing relationship, to provide plasmid DNA for a promising new vaccine and its Phase 1 clinical trial. Our in-house expertise in quality assurance and production will ensure the delivery of GMP quality plasmid and we have great faith that Scancell’s DNA vaccine will show promise against SARS-CoV-2.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30