Industrial Impact

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

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

Spotlight

Related News

Medical

BenevolentAI Signs Strategic Collaboration with Merck

Business Wire | September 26, 2023

BenevolentAI a leader in the development of advanced AI that accelerates biopharma discovery, announces that it has signed a strategic collaboration with Merck, a leading science and technology company headquartered in Darmstadt, Germany. The collaboration will enable Merck to leverage BenevolentAI’s powerful end-to-end AI platform capabilities and gain access to an expert team of interdisciplinary drug discovery scientists with the aim of identifying and developing innovative compounds, through Hit Identification (Hit ID) to pre-clinical stage. BenevolentAI will leverage its suite of AI chemistry design tools, in combination with its fully equipped wet lab facility in Cambridge (UK), to deliver small molecule drug development candidates into the Merck pipeline, ready for onward pre-clinical and clinical development. Under the terms of the agreement, BenevolentAI will be eligible for payments of up to $594 million, consisting of a low double-digit million dollar upfront payment on signing and then potentially discovery, development and commercial milestones. Tiered royalties will also be payable on net sales of any commercialised products. Joanna Shields, Chief Executive Officer of BenevolentAI, said: “Our strategic collaboration with Merck exemplifies BenevolentAI’s unique capability to leverage AI to accelerate drug discovery. Our proprietary technology and extensively validated approach of combining AI, molecular biology, medicinal chemistry, and in vivo pharmacology supports the discovery of innovative drug candidates in fewer cycles. We look forward to working with the Merck team and are excited at the opportunities in our partnership.” Public disclosure of inside information in accordance with article 17(1) of the Regulation (EU) No 596/2014 on market abuse (Market Abuse Regulation) About BenevolentAI BenevolentAI is a leading developer of advanced artificial intelligence technologies that unlock the value of multimodal data, surface novel insights, and accelerate biomedical discovery. Through the combined capabilities of its AI platform, its scientific expertise, and wet-lab facilities, the Company is developing an in-house drug pipeline of high-value assets. The Company is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.

Read More

Industry Outlook

Amicus Therapeutics and Blackstone Enter into $430 Million Strategic Financing Collaboration

GlobeNewswire | October 03, 2023

Amicus Therapeutics a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases, today announced that it has entered into a definitive agreement for a $430 million financing collaboration with funds managed by Blackstone. As part of the collaboration, Blackstone Life Sciences and Blackstone Credit have agreed to provide Amicus with a $400 million senior secured term loan facilitating a refinancing of existing debt and a $30 million strategic investment in Amicus’s common stock. The financing collaboration allows Amicus to grow revenues and move toward profitability while delivering on its mission for patients and its vision of being one of the leading biotechnology companies focused on rare diseases. Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, stated: “This new financing with Blackstone strengthens our balance sheet and financial profile by reducing the interest rate versus our current debt, pushing out the amortization schedule and extending the amortization period. This strategic investment demonstrates Blackstone's commitment to Amicus’ future and belief in the strong growth potential of Galafold and Pombiliti™ + Opfolda™ as we continue on our mission to develop medicines for people living with rare diseases.” Key features of this transaction include $400M senior secured term loan facility; interest rate at adjusted Term SOFR plus 6.25%, subject to a 2.50% floor on Term SOFR $30M investment in Amicus common stock Requires interest-only payments until late 2026 and matures in October 2029 The full amount of the loan and equity purchase will be available and fully drawn at the initial funding The proceeds will be used to refinance Amicus’s existing debt and fund ongoing operations Commenting on the arrangement, Craig Shepherd, Senior Managing Director with Blackstone Life Sciences and Brad Colman, Senior Managing Director with Blackstone Credit said: "Blackstone aims to provide customized financing solutions for the world’s leading biotech and pharma companies across therapeutic areas to support mission critical scientific innovation. We are excited to collaborate with Amicus and provide capital to advance their mission of bringing important new medicines to people living with rare diseases around the world." Simon Harford, Amicus Chief Financial Officer, added: “Securing this financing with Blackstone as we launch Pombiliti™ + Opfolda™ around the world, allows us to better align our borrowing with anticipated cash flows while at the same time enhancing our ability to maximize access to our therapies for people living with rare diseases.” Subject to completion of customary conditions, the loan is expected to be funded and the equity investment is expected to close on October 5, 2023. About Amicus Therapeutics Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. About Blackstone Life Sciences Blackstone Life Sciences is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines and medical technologies that improve patients’ lives and currently has more than $8 billion in assets under management.

Read More

Medical

Repligen Announces Agreement to Acquire Fluid Management Innovator Metenova

GlobeNewswire | September 28, 2023

Repligen Corporation a life sciences company focused on bioprocessing technology leadership, announced that it has entered into a definitive agreement to acquire privately-held Metenova AB (Metenova) of Mölndal, Sweden. Metenova is projected to generate revenues of $24 million to $25 million for fiscal year 2023, led by the success of its magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations (CDMOs). The company recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing stainless steel (repeat-use) product line. Metenova is expected to contribute approximately $5 million in revenue to Repligen in the fourth quarter of 2023, and to contribute $25 million to $27 million in revenue in 2024, with 20%-25% revenue growth in 2025 forward. The acquisition is anticipated to be accretive to Repligen’s adjusted gross and operating margins in 2024, and to be accretive to adjusted earnings per share in 2025. Over the past decade, Metenova has established market leadership through design innovation in magnetic mixing, with a state-of-the-art suite of both stainless steel and single-use impellers (mixer heads) and drive trains – key components of mixing vessels. The company offers a broad range of products, including high power solutions for efficient media and buffer preparation, and low shear solutions for gentle mixing of sensitive proteins. Metenova’s high performance aseptic mixing technologies are designed to minimize product damage and improve product yield and product consistency, contributing to improved ROI for customers. The company’s solutions are applicable to a wide range of small molecule and large molecule therapeutics and vaccines, including monoclonal antibodies, recombinant proteins, and cell and gene therapies. Tony J. Hunt, President and Chief Executive Officer at Repligen said, “The addition of Metenova further strengthens our Fluid Management portfolio, with a product line that expands on the market success of our systems and fluid management assemblies and complements our recently acquired single-use bag business from FlexBiosys. We are excited to welcome the Metenova team to Repligen and we look forward to further developing and integrating their differentiated magnetic mixing technologies into our portfolio.” Johan Westman, Chief Executive Officer at Metenova said, “We have made tremendous progress over the last ten years, building a market leading mixing portfolio. We are now at a stage in our development where we can benefit from more rapid expansion into the single-use market where many of our customers are scaling today. Repligen is the ideal partner for us to take this next step of growth and we look forward to working with our colleagues at Repligen to drive additional global demand for our single-use mixing products, while continuing to advance innovative single-use solutions for the industry.” About Metenova AB Metenova is a leading innovator and manufacturer of magnetic mixers for pharmaceutical and biotechnology use. We provide aseptic cutting-edge mixing technology for critical applications. Sales are mainly performed by distributors in over 30 countries with approximately one-third of sales in North America, one-third of sales in Europe and one-third of sales in Asia/ROW. Metenova recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing repeat-use (stainless steel) product line. Metenova is headquartered in Mölndal in the Gothenburg area and has approximately 50 employees. About Repligen Corporation Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. We are “inspiring advances in bioprocessing” for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our focus areas are Filtration and Fluid Management, Chromatography, Process Analytics and Proteins. Our corporate headquarters are in Waltham, Massachusetts, and the majority of our manufacturing sites are in the U.S., with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden.

Read More