INDUSTRIAL IMPACT

BioDuro-Sundia Acquires 2nd US-based Commercial Drug Product Manufacturing Facility along with Commercial Supply Agreement

BioDuro-Sundia | November 09, 2021

BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has entered into a definitive agreement to acquire a fully-operational 45,000 ft2 commercial oral solid dose drug product manufacturing facility located at 9601 Jeronimo Road, Irvine, CA. As part of the acquisition, BioDuro-Sundia will employ most of the current staff and provide continuous operations to support production of multiple existing products through a commercial supply agreement. Subject to customary closing conditions, BioDuro-Sundia will assume operations on January 1, 2022.

The Jeronimo facility is located in Irvine, California on the same campus as BioDuro-Sundia’s first US-based commercial facility, announced in August 2021. The deal includes an additional 25,000 ft2 of future space with combined facilities representing ~100,000 ft2 holding a supply capacity > 4 billion doses annually. Commercial production capabilities include aqueous and organic solvent process for fluid bed and coating capabilities, amorphous solid dispersion, along with multiple high speed tableting and encapsulation machines.

The continuity of the operation, including a highly experienced team and established processes, allows a seamless transition for commercial manufacturing in a facility with outstanding production track record and audit history But, we are also adding new commercial-scale capabilities, such as spray dry dispersion and hot melt extrusion, which establish us as a top provider for amorphous solid dispersion manufacturing in North America.”

 Alex Rodriguez, GM of the Irvine Facility at BioDuro-Sundia

“The acquisition of these commercial drug production facilities is a significant milestone in our 25-year history pioneering bioavailability enhancement for oral solid dosage forms, and a credit to our team’s dedication to quality operations, client satisfaction, and growth,” said Kent Payne, who led the acquisition in his role as President, Development and Manufacturing US/EU at BioDuro-Sundia. “It is also representative of our commitment to clients across the company and the investments we continue to make to grow capacity, establish new technology, and help our partners achieve success. We look forward to supporting our commercial-stage clients with quality drug product manufacturing, as we do all of our clients who entrust us with critical programs from discovery to development to manufacturing.”

BioDuro-Sundia’s US-based clinical development facility is located only an hour drive south in San Diego, California. The development operation has a track record of 1,000+ clinical programs, specializing in solubility enhancement leveraging amorphous solid dispersions.

About BioDuro-Sundia
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and 10 global sites.

Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.

BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.


About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.

About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group's private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.


Spotlight

Modern biotechnology and pharmaceutical companies are using the latest techniques in molecular biology to synthesise agents that could target disease causing agents within the body. This includes the synthesis of proteins or biologics which mimic naturally occurring molecules within the body. This animation shows the different molecular biology techniques which are being employed to deliver contemporary solutions to the many challenges posed by numerous diseases.

Spotlight

Modern biotechnology and pharmaceutical companies are using the latest techniques in molecular biology to synthesise agents that could target disease causing agents within the body. This includes the synthesis of proteins or biologics which mimic naturally occurring molecules within the body. This animation shows the different molecular biology techniques which are being employed to deliver contemporary solutions to the many challenges posed by numerous diseases.

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INDUSTRIAL IMPACT

ImaginAb Executes New License and Supply Agreement for CD8 ImmunoPET Technology with TriSalus Life Sciences

ImaginAb | November 23, 2022

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CELL AND GENE THERAPY

Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® First FDA-Approved Smallpox Oral Antiviral for All Ages

TEMBEXA and Smallpox | September 27, 2022

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INDUSTRIAL IMPACT

Emergence Therapeutics Licenses Synaffix ADC Technology Platform in $360M Deal

Synaffix | September 07, 2022

Synaffix B.V. and Emergence Therapeutics AG announce that the Companies have entered into a licensing agreement of up to $360 million, providing Emergence access on a target-specific basis to Synaffix's proprietary antibody drug conjugate technologies comprising GlycoConnect™, HydraSpace™ and SYNtecan E™ linker-payload. Under the terms of the agreement, Synaffix will be eligible to receive up to $360 million in upfront and milestone payments plus royalties on commercial sales. The first program will commence at signature, with the option to expand the collaboration to additional targets. The agreement is the result of positive proof of concept data following a successful initial discovery research collaboration between the companies. Emergence will be responsible for the research, development, manufacturing and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies. Jack Elands, Chief Executive Officer of Emergence Therapeutics, commented: "This transaction demonstrates our commitment to the development of our pipeline of first-in-class and/or best-in-class ADCs. Beyond our lead program ETx-22, a next generation Nectin-4 ADC, we are actively advancing further programs to develop treatments for high unmet-need cancers. We are impressed with the Synaffix technology and are pleased to select it as a key component to accelerate our pipeline of ADCs." "This marks an important milestone for Synaffix as this is the 10th ADC developer who has licensed our innovative ADC technology to develop proprietary ADCs for their own pipeline. By consolidating all essential technologies within Synaffix, we have repeatedly enabled the development of best-in-class and first-in-class ADCs under a single technology license agreement. We are thrilled that Emergence has selected Synaffix as its long-term ADC technology partner and look forward to working closely with Emergence as they build out their portfolio of ADC candidates." Peter van de Sande, Chief Executive Officer of Synaffix About Synaffix B.V. Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform. In addition to GlycoConnect™ and HydraSpace™ technology, the toxSYN™ linker-payload platform rounds out a fully complementary technology platform that enables any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Granted patents covering Synaffix' technology provide end-to-end protection of the manufacturing technology as well as the resulting products through at least 2035. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen, Innovent Biologics, ProfoundBio, Kyowa Kirin, Genmab and Macrogenics. About Emergence Therapeutics AG Emergence Therapeutics is a European biopharmaceutical company developing novel antibody drug conjugates (ADC) to treat high-need cancers. Its lead program combines a highly specific antibody with optimized linker and payload technology to target Nectin-4 – an important target for a broad range of cancers which has been clinically validated as an ADC target by enfortumab vedotin, now approved for the treatment of urothelial cancers by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Emergence Therapeutics is also actively developing a pipeline of further first- or best-in-class ADCs driven by therapeutic need. Emergence is supported by a network of world-leading experts in immuno-oncology and a leading international investor syndicate. Emergence Therapeutics AG is based in Duisburg, Germany with a subsidiary in Marseille, France. For more information, please visit: www.emergencetx.com About The Synaffix ADC Platform Technology Synaffix' proprietary ADC technology platform consists of GlycoConnect™, HydraSpace™ and toxSYN™ technologies. Both GlycoConnect™ and HydraSpace™ are clinical-stage technologies that enable best-in-class ADCs with significantly enhanced efficacy and tolerability. GlycoConnect™ is a conjugation technology that exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. HydraSpace™ is a compact and highly polar spacer technology that is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN™ is a linker-payload platform that spans key, validated MOAs for ADC product development, including SYNtecan E™ and SYNeamicin G™, among other linker-payloads.

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