Evonik enters long-term agreement to produce large-scale volumes of vonoprazan for supply to US-based Phathom Pharmaceuticals; Evonik will produce the drug substance from FDA-inspected sites in Tippecanoe, Indiana and Dossenheim, Germany

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October 10, 2022 (press release) –

  • 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) 

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. 

Further information on 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. 

Company information

Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of €15 billion and an operating profit (adjusted EBITDA) of €2.38 billion in 2021. Evonik goes far beyond chemistry to create innovative, profitable and sustainable solutions for customers. About 33,000 employees work together for a common purpose: We want to improve life today and tomorrow.

About Nutrition & Care

The focus of the business of the Nutrition & Care division is on health and quality of life. It develops differentiated solutions for active pharmaceutical ingredients, medical devices, nutrition for humans and animals, personal care, cosmetics, and household cleaning. In these resilient end markets, the division generated sales of €3.56 billion in 2021 with about 5,300 employees. 

Disclaimer

In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release. 

About Phathom Pharmaceuticals, Inc.

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Vonoprazan-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin). Phathom has a New Drug Application under review by the FDA for vonoprazan in erosive esophagitis (EE) and is studying the use of vonoprazan for the treatment of non-erosive reflux disease (NERD). For more information about Phathom, visit the Company’s website at www.phathompharma.com and follow the Company on LinkedIn and Twitter.  

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