Ardena Holding NV

Oct 14, 2024 – Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, announced today that it has entered into a definitive agreement to sell its oral solids development and small-scale manufacturing facility in Somerset, NJ to Ardena, a Contract Development and Manufacturing Organization (CDMO) with locations in Belgium, Spain, the Netherlands and Sweden. Financial details of the agreement, which is expected to close in early 2025, have not been disclosed. The Somerset facility also houses Catalent’s corporate headquarters, which in the near term will remain at the Somerset site during a transition period before shifting to a new location. The new location of the corporate headquarters will be announced at a later date. In recent years, Catalent has invested in oral solid capabilities at other facilities in the United States and Europe, expanding its commercial spray drying capabilities, oral high potent API handling capabilities, and manufacturing capacity across its network. Most notably, in October 2022, Catalent acquired its 333,000-square-foot Greenville, NC facility for $475 million. This state-of-the-art facility features fit-for-scale capacity with potent handling capabilities and specializes in turnkey solutions for oral solid dosage forms, including formulation development, analytical services, commercial manufacturing and packaging.

Race Oncology executes agreement with leading global contract development and manufacturing organisation, Ardena as additional partner for GMP manufacturing of flagship RC220 bistanrene formulation Ardena has a long track record of providing sterile injectable products for all stages of clinical development Partnership strengthens the existing manufacturing programs by serving as a primary source for EU compliant supplies required for EU clinical studies, while also providing a backup source for US and Australian clinical programs. SYDNEY, July 12, 2023 /PRNewswire/ -- Race Oncology Limited ("Race") is pleased to announce that it has signed an agreement with leading global contract development and manufacturing organisation (CDMO), Ardena Holding NV (Ardena) to provide additional Good Manufacturing Practice (cGMP)-standard manufacturing capability for Race's flagship intravenous (IV) formulation of bisantrene, RC220. Ardena is a fully integrated CDMO which assists biopharma companies with services spanning the drug development life cycle. The company has a long track record of providing sterile injectable products for all stages of clinical development. The partnership strengthens Race's existing manufacturing programs by serving as a primary source for EU compliant supplies of RC220 required for EU clinical studies. It also provides a backup source for US and Australian clinical programs. CEO and Managing Director, Damian Clarke-Bruce commented: "We are pleased to welcome Ardena as a manufacturing partner, adding to our existing contracted manufacturing capability. Ardena's position in Europe ensures ease of access to RC220 product for our European clinical trials and adds a second source of FDA-compliant pharmaceutical grade product." The initial development budget contracted is approximately USD $1m. Ardena is expected to provide Race's first EU and international compliant GMP supplies with goal of completion being by the end of 2023. Technology transfer to formally commence the program will occur in the coming months. The agreement with Ardena is for an initial period of 5 years and shall then be automatically extended for successive one year periods unless terminated earlier in accordance with the terms of the agreement. Company Codes: Australia:RAC

CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services. The merger will see Ardena onboard ChemConnection’s facility in Oss, the Netherlands, which has process and analytical development capabilities, and manufacturing and stability study technology for active pharmaceutical ingredients (APIs) and nanomedicine. Ardena did not disclose which drug ingredients are made at the site, nor how much it paid for the company. The acquisition will increase Ardena’s headcount from 140 to 200 employees. Ardena CEO Harry Christiaens told us its acquisition strategy focuses on API development, rather than commercial API manufacturing. “Our strategy is to be a development company providing integrated services throughout the clinical supply chain: API, drug product, pack and label, patient kits and bioanalysis.” ​ Until this acquisition, the firm was primarily focused on pharmaceutical development manufacturing of drug products, said Christiaens. “With the acquisition of ChemConnection, we strengthen our offering with complementary drug substances services. ​ “Moreover, the team in Oss is globally reputed for its nanomedicine expertise enabling the targeted delivery of complex small molecules and biomolecules.” ​ Belgium-headquartered Ardena – the result of a merger between Pharmavize, Crystallics and Analytical Biochemical Laboratory (ABL) – launched ​ in September last year. The contract development and manufacturing organisation (CDMO) offers solid-state chemistry, analytical and formulation development, and early-phase clinical supply manufacturing services.