Merck KGaA : Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables

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Karen Tiano +1 978 495 0093

July 12, 2016

Merck Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables

• Allows for more precise control of release kinetics
• Enables development of drugs requiring fewer injections for enhanced patient comfort and compliance

Darmstadt, Germany, July 12, 2016 - Merck, a leading science and technology company, has entered into an agreement with PCAS S.A. (Longjumeau, France) to expand Merck's excipients portfolio. Under the agreement, Merck will be the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers.

The portfolio will include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing customers to optimize and precisely control release kinetics of final drug products. The ability to better control and sustain the release of drugs allows for delivery via reduced numbers of injections with the same therapeutic efficacy, improving patient comfort and compliance.

"The pharmaceutical industry is increasingly interested in controlling the release of small molecules and selected peptides delivered via injection," said Andrew Bulpin, Head of Process Solutions at the life science business of Merck. "The addition of the Expansorb® polymers to our broad portfolio of excipients improves drug developers' ability to protect molecules with short in vivo half-lives and achieve the desired therapeutic effect while enhancing patient comfort and compliance."

Poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) polymers are biocompatible and biodegradable synthetic substances that have already been

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approved by the United States Food and Drug Administration and the European Medicines Agency with several drug products on the market and many more drug products in clinical development.

Expansorb® PLA and PLGA polymers are manufactured under cGMP conditions by PCAS and are expected to be sold under Merck's industry-leading Emprove® program once rigorous evaluations and certifications are complete. The pharmaceutical manufacturing industry relies on Emprove® products for documentation and regulatory information to facilitate risk assessment workflows and supplier qualification.

"PCAS is excited to bring our Expansorb® polymers to Merck and together offer the potential of significant value creation for pharmaceutical customers," said Didier Combis, Head of Custom Synthesis & Pharma Chemicals, PCAS. "This is an important collaboration, allowing us to broaden access to this powerful technology through Merck's global network and facilitate development of improved therapeutic solutions for patients."

Nanosphere and microsphere formulations based on PLGA polymers have been studied extensively for use in the delivery of peptides, therapeutic proteins, hormones and antibiotics. Future applications are expected to include the development of targeted drug-containing nanoparticles using site-specific ligands.

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About PCAS (Euronext Paris: PCA)

PCAS specializes in the development and production of complex molecules for Life Sciences and Innovative Technologies. With 7 percent of its turnover dedicated to R&D and a wide international presence, PCAS is the preferred industrial partner of market-leading major global groups. The company offers a growing range of proprietary products and solutions in leading-edge segments, and also includes two subsidiaries with very strong potential: Protéus in biotechnology and Enersens in high-performance insulation. With a particularly high standard of performance, PCAS achieved net sales of €179,1 million in 2015 and employs more than 900 people in six countries.

For more information about PCAS: www.pcas.com

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of €

12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. The company holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.