Bivalirudin

Company’s second product to begin shipping to wholesale partners in January SCHAUMBURG, Ill.--(BUSINESS WIRE)-- Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Bivalirudin for Injection in the United States as a therapeutic equivalent generic for Angiomax® for Injection (bivalirudin) approved by the U.S. Food and Drug Administration. Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. This press release features multimedia. View the full release here: (Photo: Business Wire) Avenacy’s injectable product contains 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution. In line with Avenacy’s mission to champion patient safety and streamline patient care, Bivalirudin for Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Bivalirudin for Injection to wholesale partners this week. The Company is supported by a global network of development and FDA-approved cGMP-certified contract manufacturing partners. Bivalirudin for Injection had U.S. sales of approximately $25 million for the twelve months ending in June 2023.1 Please see link for Full Prescribing Information. Angiomax® is a registered trademark of Sandoz, Inc. 1Source: IQVIA About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit .

REDWOOD CITY, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced it will host a virtual key opinion leader (KOL) event focused on its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis™ platform and the broader RNA interference (RNAi) therapeutics manufacturing landscape on Friday, December 8, 2023, at 10:00 am ET. The event will feature John Maraganore, PhD, Founder and Former Chief Executive Officer of Alnylam Pharmaceuticals, and David Butler, PhD, Chief Technology Officer at Hongene Biotech Corporation. These distinguished experts will discuss the RNAi therapeutics manufacturing landscape and share their perspectives on the potential role of an enzymatic route of synthesis in commercial-scale production. During the event, Codexis management will also provide an overview of the ECO Synthesis™ platform and the associated commercial opportunity. A live Q&A session with all presenters will follow the formal presentations. To register for the event, please click here. A replay of the presentation will be archived in the Investor Relations section of the Company’s website, https://ir.codexis.com, following the event. About John Maraganore, PhD John Maraganore, PhD, served as the founding CEO and a Director of Alnylam from 2002 to 2021, where he built and led the company from early platform research on RNA interference through global approval and commercialization of the first five RNAi therapeutics, creating a whole new class of medicines. At Alnylam, Dr. Maraganore built a leading, global biopharmaceutical company with over 1500 employees in over 20 countries around the world. He led the company’s value creation strategy, building over $25B in market capitalization. Prior to Alnylam, he held scientific and business leadership roles at Millennium Pharmaceuticals, Inc.; at Biogen, Inc. where he invented and led the discovery and development of ANGIOMAX® (bivalirudin); at ZymoGenetics, Inc.; and at the Upjohn Company. Dr. Maraganore is currently the principal and owner of JMM Innovations, LLC. He serves as an advisor to a number of venture and public company investment firms, and as a member of the Board of Directors of multiple publicly traded companies, including Beam Therapeutics, Kymera Therapeutics, ProKidney Corp., and Takeda Pharmaceuticals. He is on the Board of a number of private companies and non-profit organizations, and also serves as a strategic advisor to other public and private biotechnology companies. Finally, Dr. Maraganore is on the Board of the Biotechnology Innovation Organization, or “BIO,” where he was Chair from 2017-2019 and is Chair Emeritus. Dr. Maraganore received his BA, MS, and PhD in biochemistry and molecular biology at the University of Chicago. About David Butler, PhD David Butler, PhD, is the Chief Technology Officer at Hongene Biotech Corporation, a fully integrated supplier of raw materials and contract development and manufacturing organization (CDMO) services to customers in the RNA therapeutics space, the scope of which includes mRNA, vaccines, oligonucleotides, gene editing, gene therapy and diagnostics. Prior to Hongene, Dr. Butler led organizations driving platform discovery and development of oligonucleotide therapeutics as Vice President (VP) and Head of Medicinal Chemistry at Wave Life Sciences, VP and Head of Therapeutics Development at Alltrna, and VP and Head of Chemistry at Korro Bio. He also spent time as a Principal Scientist at Alnylam Pharmaceuticals developing early lipid nanoparticle technologies for small interfering RNA delivery that were the progenitors of those used for messenger RNA related products today. About the ECO Synthesis™ Platform Ribonucleic acid (RNA) as a therapeutic modality has gained tremendous traction in recent years with the growing number of messenger RNA (mRNA) vaccines and small interfering RNA (siRNA) candidates advancing in clinical studies. However, large-scale production of RNA interference (RNAi) therapeutics using traditional chemical synthesis faces complex challenges in nucleic acids quality and quantity, as well as overall economics. With over 450 RNAi therapies currently in clinical development, including more than 40 assets in Phase 2 and Phase 3 clinical trials targeting disease indications impacting millions of patients, RNAi therapeutic demand is projected to outpace current production capabilities by the end of the decade. Codexis’ proprietary ECO Synthesis™ technology platform is being designed to address these scalability and cost limitations by potentially enabling the commercial-scale manufacture of RNAi therapeutics through an enzymatic route. The Company is on track to demonstrate gram-scale synthesis by the end of 2023, where it will demonstrate the preparative-scale manufacture of an oligonucleotide, composed of the modified nucleotide building blocks typically used in RNAi therapeutics, under process-like conditions. About Codexis Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis’ unique enzymes can drive improvements such as higher yields, reduced energy usage and waste generation, improved efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. For more information, visit https://www.codexis.com. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management, including but not limited to statements regarding whether Codexis will be able to, and the timing of it demonstrating gram-scale synthesis with its ECO Synthesis™ technology by the end of 2023; the potential of the ECO Synthesis™ platform, including its ability to be broadly utilized, and it providing an opportunity for Codexis to efficiently capture meaningful market share; and expectations regarding future demand for RNAi technologies. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis’ control and that could materially affect actual results. Factors that could materially affect actual results include, among others: Codexis’ dependence on its licensees and collaborators; if any of its collaborators terminate their development programs under their respective license agreements with Codexis; Codexis may need additional capital in the future in order to expand its business; if Codexis is unable to successfully develop new technology such as its ECO Synthesis™ platform; Codexis' dependence on a limited number of products and customers, and potential adverse effects to Codexis’ business if its customers’ products are not received well in the markets; if Codexis is unable to develop and commercialize new products for its target markets; if competitors and potential competitors who have greater resources and experience than Codexis develop products and technologies that make Codexis’ products and technologies obsolete; if Codexis is unable to accurately forecast financial and operational performance; and market and economic conditions may negatively impact Codexis' business, financial condition and share price. Additional information about 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 February 27, 2023 and in Codexis’ Quarterly Report on Form 10-Q filed with the SEC on November 3, 2023, including under the caption “Risk Factors,” and in Codexis’ other periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. For More Information Investor ContactCarrie McKim(336) 608-9706ir@codexis.com Media ContactLauren Musto(781) 572-1147media@codexis.com