Rentschler Fill Solutions and Ultragenyx Start Fill & Finish Collaboration for the US Commercial Supply of Drug Product Mepsevii

- Collaboration provides Ultragenyx access to Rentschler Fill Solutions' new center of excellence for the aseptic filling of biopharmaceuticals.

- MepseviiTM, developed in collaboration with Rentschler Biopharma, is the first and only drug approved for the treatment of children and adults with mucopolysaccharidosis VII, a rare genetic disorder.

RANKWEIL, Austria--()--Rentschler Fill Solutions GmbH, a CMO and expert for aseptic fill and finish services, today announced a collaboration with Ultragenyx Pharmaceutical, Inc. for the drug product production of the injectable MepseviiTM (vestronidase alfa), a recombinant form of the human enzyme beta-glucuronidase, to treat patients with mucopolysaccharidosis (MPS) VII, a rare genetic disorder.

“For many years, Rentschler Biopharma has been a trusted partner of Ultragenyx in the development of MepseviiTM”

"Identifying a reliable and proactive drug product CMO partner for MepseviiTM was critical for Ultragenyx," said Dennis Huang, Chief Technical Operations Officer for Ultragenyx. "MepseviiTM is our first commercial product and treats an ultra-rare disease. Rentschler Fill Solutions understood our specific needs and shared our vision of serving patients with MPS VII who previously had an important unmet medical need. We look forward to working with Rentschler Fill Solutions and Rentschler Biopharma to smoothly transition the fill and finish activities." MepseviiTM was developed by US-based Ultragenyx in close collaboration with the biopharmaceutical CDMO Rentschler Biopharma SE in Laupheim, Germany, and was approved by the US FDA in November 2017. Ultragenyx has applied for European marketing approval of MepseviiTM and the application is currently under review. Fill and finish activities for the drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions GmbH, the new center of excellence, featuring comprehensive services for the aseptic filling and freeze drying of drug products.

Reinhold Elsaesser, one of the two Managing Directors of Rentschler Fill Solutions, said: "We are delighted to be working with Ultragenyx at our facility in Austria, the cutting-edge center of excellence for fill and finish solutions. The US is a key market for us and we are pleased that this collaboration provides the opportunity for us to demonstrate our facility's US FDA compliance. We will be closely collaborating with our partner Rentschler Biopharma throughout the project, from drug substance delivery to regulatory affairs and drug product supply. Our processes are aligned to ultimately deliver a high-quality product for our joint client Ultragenyx."

Rentschler Biopharma SE will continue to manufacture the drug substance. Ultragenyx benefits from the advantages of the strategic partnership between Rentschler Fill Solutions GmbH and Rentschler Biopharma SE.

"For many years, Rentschler Biopharma has been a trusted partner of Ultragenyx in the development of MepseviiTM," Dr. Frank Mathias, CEO of Rentschler Biopharma SE, commented. "We welcome their decision to continue and broaden our joint success story together with Rentschler Fill Solutions. This project reaffirms our strategic partnership with Rentschler Fill Solutions, announced a year ago, as we are able to meet our clients' needs not only as a solution provider for clinical trials but also for market supply in growing international markets."

Rentschler Fill Solutions offers its clients fill and finish services on both a clinical and commercial scale. Through the strategic partnership of Rentschler Fill Solutions, Rentschler Biopharma and Leukocare, clients also benefit from one-stop solutions from gene to vial and clinic to market.

"Today's news proves the high value that our services can provide our clients all along the biopharmaceutical value chain. Together with Rentschler Fill Solutions and Leukocare, renowned for best-in-class formulation development, we offer our clients end-to-end solutions, all from a single source," Dr. Frank Mathias concluded.

Rentschler Fill Solutions, together with Rentschler Biopharma and Leukocare, will present their end-to-end service offerings during the BIO International Convention, taking place June 4-7 in Boston, MA, USA, at booth 1155.

About Rentschler Fill Solutions GmbH

Rentschler Fill Solutions GmbH, located in Rankweil, Austria, is a contract manufacturing organization (CMO) for the aseptic filling of liquid and lyophilized biopharmaceutical products. With their complete focus on clients' projects, the company provides state-of-the-art facilities which comply with the latest regulatory, quality and safety standards. Rentschler Fill Solutions focuses on delivering small to medium-sized batches (up to 60,000 vials per batch) to meet clinical as well as market needs with its highly scalable solutions. Owned by the Rentschler family, Rentschler Fill Solutions is a company with a highly skilled team offering extensive experience and reliable services in aseptic filling. For further information, please visit www.rentschler-fill-solutions.com.

About Rentschler Biopharma SE

Rentschler Biopharma SE, located in Laupheim, Germany, is a leading contract development and manufacturing organization (CDMO), focused exclusively on clients' projects. Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. The company's clients include innovative biotech companies and major pharmaceutical companies around the world. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer optimal solutions across the entire value chain, the company has entered into a strategic alliance for formulation development with Leukocare AG and into a strategic partnership for fill & finish with Rentschler Fill Solutions GmbH. Rentschler Biopharma is an independent, family-owned company employing more than 850 people. For further information, please visit www.rentschler-biopharma.com.

Contacts

Rentschler Fill Solutions GmbH
Andrea Kitzelmann
Expert Marketing
Andrea.kitzelmann@rentschler-fill-solutions.com
or
Rentschler Biopharma SE
Dr. Alexander Starnecker
Manager Company Development
communications@rentschler-biopharma.com
or
Media Inquiries:
MC Services AG Dr. Cora Kaiser / Jessica Breu
+49-89-210228-0
rentschler@mc-services.eu

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