Bausch Health will continue litigating over its Xifaxan drug, threatening to appeal all the way up to the US Court of Appeals for the Federal Circuit. The Quebec-based company, through its gastroenterology business Salix Pharmaceuticals, said it will file an appeal if the final order is consistent with an oral order in a Delaware district court last week centered around a case against Norwich Pharmaceuticals. The company has been here before, having previously entered into settlement agreements with Teva, Sun Pharmaceuticals and Novartis’ Sandoz unit concerning a generic rifaximin product. In the case vs. Norwich, also known as Alvogen, Bausch and its Salix unit are attempting to retain the patent on Xifavan, known generically as rifaximin, for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence, a neurological disorder that is caused by chronic, severe liver disease. According to the oral order, not yet finalized, the US District Court of Delaware is expected to find certain US patents protecting the drug’s 550mg tablets for reduction in risk of HE recurrence valid and infringed, Bausch said in a statement on July 28. Further, the court is expected to find the US patents protecting the composition and use of Xifaxan for treating IBS-D invalid. “While the Court has not yet entered any final judgement, absent Norwich’s removal of the HE indication and data from their Abbreviated New Drug Application (ANDA), it is expected that the Court will enjoin Norwich’s pending ANDA until expiration of the XIFAXAN HE Patents in 2029,” Bausch said in a statement. With that, Bausch intends to “vigorously oppose any attempt by Norwich to remove the HE safety data from its ANDA” in an effort to sidestep the patents. The company thrice mentions it will “vigorously” defend its IP and pursue any route possible to do so. Norwich can’t launch a generic equivalent of Xifaxan until a revised ANDA approval from the FDA and an expected injunction modified by the court, Bausch said. “We are disappointed with today’s development. We strongly disagree with any conclusion that our patents are not valid and intend to file an appeal to any such order,” Bausch CEO Thomas Appio said in a statement. Under previous agreements with Teva, Sun and Sandoz, a generic version of the drug can’t be sold until 2028 or upon earlier approval and launch of such a product. The IBS-D indication was approved in May 2015 after securing the HE nod in March 2010. It had also been approved for traveler’s diarrhea in 2004.

2022-07-14

·GlobeNewswire-Health Care

Alvotech Expands its Board of Directors as part of Transition from Private to Publicly Traded Company

Four new members enhance independence and diversity of Board of Directors Alvotech (NASDAQ and First North Growth Market: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, today announced the expansion of its board of directors as part of its transition from a private to a publicly traded company. The four incoming board members, Lisa Graver, Arni Hardarson, Linda McGoldrick and Ann Merchant joined Robert Wessman, founder and Executive Chairman, Richard Davies, Tomas Ekman and Faysal Kalmoua. Ms. Merchant, Ms. McGoldrick, and Mr. Davies serve as independent directors of the board. “I am delighted to welcome our new members of our board at a crucial time in our evolution,” said Robert Wessman, Executive Chairman and founder of Alvotech. “The scientific expertise, operational experience, and capital markets acumen of the new board members will be important in supporting our mission to enhance the sustainability of the global healthcare system by expanding access to biologic medicines.” Robert Wessman founded Alvotech in 2013 and has served as Chairman of the Board of Directors since 2019. He is also Chairman of the board of directors of Alvogen and Lotus Pharmaceuticals and serves as a board member at Fuji Pharma Co. Ltd. Prior to founding Alvotech, Mr. Wessman as CEO led Actavis, a small domestic pharmaceutical company, into a global generics company. He then founded Alvogen, transforming it from a CMO into a global generics company and has served as Alvogen’s CEO and Chairman. Mr. Wessman is also a partner in the Aztiq Group (“Aztiq”). He has a BS degree in Business Administration from the University of Iceland. Richard Davies currently serves as Deputy Chairman of the Board of Directors for Alvotech and Chairman of the Remuneration Committee. He also currently serves as CEO of Auregen Bio Therapeutics, and previously served as CEO of Bonesupport, Senior VP and CCO of Hospira and in various leadership roles at Amgen. Mr. Davies holds a BS degree in applied chemistry from the University of Portsmouth and an MBA from the University of Warwick. Linda McGoldrick serves as Chairman of Alvotech’s Board of Directors’ Audit Committee. She has served in numerous management and non-executive director roles in the healthcare and life sciences industries, internationally. These include leadership positions at Marsh-MMC Companies, Veos, Kaiser Permanente International, Compass Pathways and Zillion. She founded and currently serves as Chairman and CEO of Financial Health Associates International and is the CEO of 2EnableHealth. In 2012, Ms. McGoldrick was named as one of the Top 100 Corporate Directors in Remuneration of Fortune 100 Companies by the Financial Times. She received an MSW in Healthcare from the University of Pennsylvania and an MBA from The Wharton School. Thomas Ekman has served as one of Alvotech’s directors since 2019. He is a partner at CVC Capital Partners and a member of CVC’s Nordics team. Previously Mr. Ekman was partner and MD at 3i Group. He holds Master of Science degrees from the University of Strathclyde and Chalmers University of Technology and an MBA from IMD in Switzerland. Lisa Graver has served in various leadership positions at Alvogen since June 2010, including as CEO of Alvogen U.S. since August 2015. Prior to joining Alvogen, Ms. Graver was VP of Intellectual Property and Senior Director of Intellectual Property at Actavis. She holds a BS degree in biology from Lakehead University and a Juris Doctor degree from Case Western University School of Law. Arni Hardarson is a partner in Aztiq and served as General Counsel and Deputy CEO of Alvogen and been part of Alvogen’s executive team since 2009. Prior to joining Aztiq and Alvogen, Mr. Hardarson was VP of Tax and Structure at Actavis, and served as head of tax and legal services at Deloitte. He holds a master’s degree in law from the University of Iceland. Faysal Kalmoua has served as one of Alvotech’s directors since 2020 and is a partner in Aztiq. Previously, Mr. Kalmoua held various management positions at Alvogen Iceland ehf. and Alvogen Inc, and for Synthon. He holds a Master of Chemistry degree from Radboud University Nijmegen and an executive MBA from Insead. Ann Merchant has served as VP for MorphoSys since 2018 and Head of Global Supply Chain since January 2019. Prior to joining MorphoSys, Ms. Merchant served as President of Schreiner Medpharm and held various roles at Amgen, including VP Head of International Supply Chain. She holds an MBA from Henley Business School and a BS degree in languages from Georgetown University. Alvotech’s shares were listed on the Nasdaq stock exchange in New York on June 16, 2022. Following the debut of Alvotech as a publicly traded company, the largest Icelandic company to make its debut on a U.S. stock exchange, Alvotech was also listed on the Nasdaq First North Growth Market in Iceland on June 23, 2022, thus becoming the first dual-listed Icelandic company on both a United States and Icelandic stock exchange. About Alvotech Alvotech specializes in making biosimilars, to improve lives by expanding access to affordable biologic medicines. Founded by Robert Wessman, Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective biologics, enabled by a vertically integrated approach from R&D to fill and finish manufacturing. To enable global reach, Alvotech has formed a network of strategic commercial partnerships in over 90 countries, including the United States, Canada, Europe, Asia, Latin America, Africa and the Middle East. Alvotech’s current portfolio of eight biosimilars and biosimilar candidates, includes AVT02, a biosimilar to Humira® which is approved and marketed in Europe (Hukyndra®) and Canada (Simlandi®) and seven biosimilar candidates targeting immunology, oncology, respiratory, bone disease and ophthalmology. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. CONTACTS Alvotech Investor Relationsalvotech.ir[at]alvotech.com Alvotech Corporate Communicationsalvotech.media[at]alvotech.com

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