Evonik and Phathom Pharmaceuticals partner to produce novel acid-blocker vonoprazan

• Evonik to produce commercial quantities of the drug substance vonoprazan for use in VOQUEZNA™ TRIPLE PAK™ and DUAL PAK™, and other products containing vonoprazan
• Supply security through production at sites in Europe and North America 
• Agreement strengthens Evonik’s track record as leading contract development and manufacturing organization (CDMO)

10 October 2022

Essen, Germany. Evonik has entered into a long-term supply agreement with Phathom Pharmaceuticals, a U.S. biopharmaceutical company focused on developing and commercializing new treatments for gastric acid-related diseases. Through the agreement Evonik will produce large-scale volumes of vonoprazan at its FDA-inspected manufacturing sites in Tippecanoe, Indiana, USA and Dossenheim, Germany.

“The manufacture of vonoprazan requires multi-step syntheses involving complex chemistries. We are delighted to be able to bring the right mix of technologies and assets to this collaboration,” said Thomas Riermeier, head of the Health Care business line at Evonik. “We provide customer-focused CDMO services in combination with excellent quality, enabling our trusted partner Phathom to fight gastrointestinal disorders worldwide.”

As one of the world’s leading CDMOs for active pharmaceutical ingredients (APIs) and intermediates, Evonik’s Health Care business is part of the life science division Nutrition & Care and represents a key growth business for Evonik. The agreement with Phathom builds on the company’s track record of delivering complex APIs to meet the clinical and commercial supply needs of biotech and large pharma customers around the world.   

“We are excited to partner with Evonik to help us bring novel, first-in-class treatment options to patients suffering with gastrointestinal disorders,” said Jay Buchanan, Vice President of Manufacturing and Supply Chain at Phathom Pharmaceuticals. “We value Evonik’s commitment to quality and expertise with API production and believe our partnership brings us closer to delivering on our mission to improve the lives of patients with gastrointestinal disorders.”

“We are proud to work with Phathom. Our fruitful collaboration through the process development, pilot campaign, and validation stages has laid the foundations for a productive partnership for supplying commercial quantities,” said Stefan Randl, head of the Drug Substance product line at Evonik’s Health Care business.   

To address the specific needs of large or complex projects, Evonik has established a broad portfolio of differentiating technologies which can be combined to support multi-step API and HPAPI synthesis. These technologies include catalytic and biocatalytic reactions, large-scale cryogenic chemistry, continuous processing, fermentation, PEGs and mPEGs, catalysts, and polymer APIs. Evonik’s expertise in heterogeneous catalysis, in particular, was fundamental to achieving high efficiency and purity of the API used in vonoprazan. In addition to superior technological expertise and an integrated portfolio of services, customers are also attracted by Evonik’s reliability and commitment to sustainability.

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Further Information

Vonoprazan

Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions. It was first approved in Japan in 2014 and is sold under the brand name Takecab® by Takeda. Phathom Pharmaceuticals has been granted an exclusive license to develop and sell vonoprazan in the U.S., Canada, and Europe.