Codexis, Almelo and RC2 Announ
REDWOOD CITY, Calif., October 18, 2021 (GLOBE NEWSWIRE) – Codexis, Inc. (CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, has announced a tripartite collaboration agreement with Almelo Private, Ltd. , an Indian producer of active pharmaceutical ingredients (API), and RC2 Pharma Connect, LLC, a leading US-based pharmaceutical manufacturing representative, to license and manufacture for internal use a proprietary Codexis enzyme used in the process for the manufacture of sitagliptin, an API in the treatment of diabetes. Under the agreement, Almelo will be responsible for the development, scale-up and implementation of a commercial manufacturing process for sitagliptin incorporating Codexis proprietary enzyme technology. Once complete, the enzyme manufacturing will be established at the Almelo API manufacturing site to further reduce costs. RC2’s role in the collaboration will be to leverage its relationships with global pharmaceutical partners to establish downstream supply channels for the future generic sitagliptin market.
“We are delighted that Almelo has taken the opportunity to take advantage of Codexis’ highly optimized enzyme to reduce costs and improve the efficiency and sustainability of their sitagliptin API manufacturing,” said John Nicols, President and CEO of Codexis. He added: “Almelo is a forward-looking, innovation-driven company, and we are very happy that it has made a commitment to install the ability to self-produce the enzyme, allowing it to reduce so much as possible the costs of its process. The addition of RC2’s expertise enables a low-cost integrated supply chain to uniquely position the partnership for success in the upcoming competitive generic sitagliptin market. “
Anand Tatambhotla, Executive Director of Almelo Operations, said: “Codexis is the leading enzyme developer in pharmaceutical manufacturing and we are delighted to have gained access to their proprietary biocatalyst for the production of this important API, including the ability for us to drive to the lowest possible cost position through the self-manufacture of the enzyme. Sitagliptin is an important strategic product for Almelo and with this collaboration, along with our proven capabilities in process innovation and efficiency optimization, we are positioned for long term success following the loss of exclusivity of the innovator.
Dwight Raff, President and CEO of RC2, added: “We are delighted to have negotiated this agreement between three companies with very different capabilities and areas of expertise, in what we believe to be much more than the sum collaboration of parts. We look forward to working closely with Codexis and Almelo to drive market penetration through our pharmaceutical relationships and to generate significant value for the partnership as well as for customers and patients. “
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver software® platform to discover and develop new high performance enzymes and new biotherapeutic products. Codexis enzymes have applications in the sustainable manufacture of pharmaceutical, food and industrial products; in creating the next generation of life science tools; and as gene therapy and biological therapy. The company’s unique performance enzymes lead to improvements such as: reduced energy consumption, waste generation and capital requirements; higher returns; more accurate diagnoses; and more effective therapies. Codexis enzymes hold the promise of synthetic biology to improve the health of people and the planet. For more information, visit www.codexis.com.
Almelo has a state-of-the-art manufacturing facility located near Hyderabad, India. Almelo works closely with traditional NCE companies and generic manufacturers to develop efficient processes for commercial APIs. Almelo has a very strong development team that emphasizes vertical integration down to basic raw materials. Please see our website for more information on our capabilities. For more information, visit https://almelochem.com.
RC2 Pharma Connect is a manufacturer representative specializing in helping businesses identify and develop reliable and cost-effective sources for projects that require custom manufacturing (both cGMP and non-cGMP) or for products that require technological development. important or are hard to find. RC2 works on a wide range of different materials, including major starting materials, intermediates, APIs, and finished dosage forms. This allows RC2 customers to extend their “reach” of supply. RC2 works with a network of partners with many different capabilities that operate manufacturing facilities located all over the world. For more information, visit www.rc2pharma.com.
To the extent that the statements contained in this press release are not descriptions of historical fact relating to Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made in accordance with the safe harbor provisions of Private Law. Securities Litigation Reform Act of 1995. You should not place undue reliance on these forward-looking statements as they involve known and unknown risks, uncertainties and other factors which are, in certain cases, beyond the control of Codexis and which could affect materially the actual results. Factors which could materially affect actual results include, but are not limited to: Codexis’ dependence on its licensees and collaborators; Codexis’ dependence on a limited number of products and customers; the regulatory approval processes of the United States Food and Drug Administration and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if our associates are unable to obtain regulatory approval for their product candidates, and the potential adverse effects on the business of Codexis if its collaborators’ products are not well received in the markets, or if their products, or the processes used by our collaborators to manufacture their products, are not approved, or if our employees are interrupting their development activities for any reason. Additional information on factors that could materially affect actual results can be found in Codexis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021, and in the Codexis Quarterly Report on Form 10. -Q filed with the SEC on August 6, 2021, including under “Risk Factors” and in other Codexis periodic reports filed with the SEC. Codexis expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law.
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Stephanie Marks / Carrie McKim