A history of taking on challenges

A biotech company with a history as long as ours is rich in ups and downs. Learnings and insights. Failures and successes. Throughout our existence, we have always stayed true to our core commitment to discover, develop, and deliver treatments to patients that may have an extraordinary impact on their lives.

We are a commercial-stage biotech company with US headquarters in Durham, North Carolina. Our European headquarters is in Dublin, Ireland, and our Discovery Center of Excellence is rooted in Birmingham, Alabama, with many other regional offices around the world. As world leaders in structure-guided drug design, we draw on the strengths and expertise of all our colleagues—from those of us in the field or behind the scenes in our labs, to others based in home offices and around the globe.

BioCryst through the years

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BioCryst was founded in Birmingham, Alabama, by William Spencer, III, a local businessman; Charles Bugg, MD, a crystallography professor of biochemistry and director of the Center of Macromolecular Crystallography at the University of Alabama at Birmingham; and John Montgomery, PhD, a medicinal chemist from the Southern Research Institute.

Dr. Yarlagadda S. Babu joined BioCryst as its first employee. Dr. Babu, who currently serves as Chief Discovery Officer, began working on a project that would become one of the core discovery targets around which BioCryst was founded.

In January, Dr. Bugg was named Chairman and Chief Executive Officer of BioCryst, serving in this role until his retirement in 2007. Two months later, BioCryst announced its IPO and began trading on NASDAQ on March 7.

BioCryst and Torii Pharmaceutical formed a partnership in Japan to develop BCX-34, a PNP inhibitor for the treatment of rheumatoid arthritis, T-cell cancers, and atopic dermatitis.

BioCryst and Johnson & Johnson entered into a worldwide collaboration focused on developing drugs for influenza. The collaboration was terminated 3 years later when Johnson & Johnson halted development of the lead molecule.

BioCryst received US Food and Drug Administration (FDA) approval to initiate human testing of BCX-1812 (peramivir injection) – the culmination of independent work by BioCryst on the molecule in the wake of the terminated Johnson & Johnson collaboration.

BioCryst expanded its footprint by establishing its first facility in North Carolina’s Triangle region, which was focused on supporting clinical development and regulatory efforts.

Jon Stonehouse was appointed Chief Executive Officer in January, joining BioCryst from Merck KGaA.

Bill Sheridan, MD, joined BioCryst as Chief Medical Officer from Amgen.

The FDA issued its first-ever emergency use authorization for peramivir during the H1N1 pandemic.

BioCryst moved its headquarters from Birmingham, Alabama, to Durham, North Carolina.

Shionogi & Co. received approval of peramivir in Japan, which launched as RAPIACTA®, marking the first regulatory approval of a BioCryst-discovered drug.

BioCryst refined its pipeline strategy to focus on its hereditary angioedema (HAE) and antiviral programs. BCX7353—later known as ORLADEYO® (berotralstat)—is discovered in September.

BioCryst received its first FDA approval for RAPIVAB® (peramivir injection). The drug would go on to receive approval for a pediatric indication 3 years later.

BioCryst announced positive results from its phase 2 APeX-1 trial for berotralstat in HAE. The data were then published in the New England Journal of Medicine. Later this year, the FDA granted fast-track designation for berotralstat.

BioCryst executed its license agreement with Torii to commercialize berotralstat in Japan. Since then, BioCryst has formed partnerships with multiple companies to commercialize the drug outside of the United States, including Neopharm Group, NewBridge Pharmaceuticals, Pint Pharma, and Swixx BioPharma.

ORLADEYO® (berotralstat) received FDA approval in December 2020. BioCryst launched the drug this same month, and it has since launched in multiple global markets.

BioCryst initiated pivotal trials for its oral factor D inhibitor, BCX9930, in complement-mediated diseases.

BioCryst refined its pipeline strategy to focus on complement-mediated diseases, announcing a next-generation oral factor D inhibitor, BCX10013.

Leading by example

Flexible, transparent, and human. Just a few words to describe our leadership team, whose members are dedicated to bringing out the best in our people. Get to know them-and how they enable us to move quickly to achieve the mission at hand.

Stephanie Angelini, BioCryst® Chief People Officer

Chief People Officer

Yarlagadda S. Babu, PHD, BioCryst® Chief Discovery Officer

Chief Discovery Officer

Alane Barnes, BioCryst® Chief Legal Officer

Chief Legal Officer

John Bluth, BioCryst® Chief Communications Officer

Chief Communications Officer

Anthony Doyle, BioCryst® Chief Financial Officer

Chief Financial Officer

Clayton Fletcher, BioCryst® Chief Business Development Officer

Chief Business Development Officer

Charlie Gayer, BioCryst® Chief Commercial Officer

Chief Commercial Officer

Philip George, BioCryst® Chief Strategy Officer

Chief Strategy Officer

Chief Regulatory Officer

Jinky Rossell

Chief Data and Insights Officer

William P. Sherican, MB BS, BioCryst® Chief Development Officer

Chief Development Officer & Interim Chief Medical Officer

Jon P. Stonehouse, BioCryst® President & Chief Executive Officer

President, Chief Executive Officer

Helen Thackray, MD, BioCryst® Chief Research & Development Officer

Chief Research & Development Officer

Guiding our path forward

With strong governance and insight from many decades of industry experience, our distinguished Board of Directors provides us with the counsel and support to help advance our program and business objectives with urgency and purpose.

Nancy Hutson, PhD

Chair of the Board

Dr. Hutson was appointed to the Board in January 2012, and was elected Chair of the Board in March 2023. She brings over 30 years of experience as a seasoned professional and leader within the pharmaceutical industry. She retired from Pfizer, Inc., in 2006 after spending 25 years in several research and leadership positions, most recently serving as Senior Vice President of Global Research & Development (R&D) as well as director of Pfizer’s pharmaceutical R&D site, Groton/New London Laboratories. Dr. Hutson currently serves on the board of directors for Clearside Biomedical, Inc., Endo International plc., and PhaseBio Pharmaceuticals, Inc. She received a Bachelor of Arts degree from Illinois Wesleyan University and a Ph.D. in physiology from Vanderbilt University.

George B. Abercrombie

George B. Abercrombie was appointed to the Board in October 2011. Mr. Abercrombie has over 30 years of experience as a business leader in the pharmaceutical industry. He served from 2001 to 2009 as the President and Chief Executive Officer of Hoffmann-La Roche Inc., a pharmaceutical company, where he was responsible for leading operations in both the United States and Canada. During his tenure, Mr. Abercrombie also served as a member of the Roche Pharmaceutical Executive Committee, which was responsible for developing and implementing global strategy for the pharmaceuticals division. In 1993, Mr. Abercrombie joined Glaxo Wellcome Inc., as Vice President and General Manager of the Glaxo Pharmaceuticals Division, and was later promoted to Senior Vice President, US commercial operations. Prior to joining Glaxo, he spent over 10 years at Merck & Co., Inc., where he gained experience in sales and marketing, executive sales management, and business development.

Mr. Abercrombie began his career as a pharmacist after receiving a Bachelor’s degree in pharmacy from the University of North Carolina at Chapel Hill and later earned an MBA from Harvard University. Mr. Abercrombie served as Senior Vice President and Chief Commercial Officer at Innoviva, Inc. from June 2014 until September 2018.  He currently serves as an adjunct professor at Duke University’s Fuqua School of Business, a board member of the North Carolina GlaxoSmithKline Foundation, an inaugural member of the Duke University Psychiatry and Behavioral Sciences Advisory Board, a member of the North Carolina Board of Science, Technology, and Innovation, and the Chief Executive Officer of Abercrombie Advisors LLC. Mr. Abercrombie’s executive experience in the pharmaceutical industry and management positions with major pharmaceutical companies provide an excellent background for service on the board.

Steve Aselage

Steve Aselage was appointed to the Board in January 2019. Mr. Aselage most recently served as Chief Executive Officer of Travere Therapeutics, a biopharmaceutical company specializing in identifying, developing, and delivering life-changing therapies to people living with rare diseases, which he joined in 2012. He has more than 40 years of experience in the biopharmaceutical industry, including substantial rare disease, commercial, and business development experience. From 2005 to 2012, Mr. Aselage served as Executive Vice President and Chief Business Officer of BioMarin. Prior to BioMarin, Mr. Aselage held positions of increasing responsibility at a number of companies, including Bristol Laboratories, Genentech, and Sangstat. He continues to serve as chairman of Acer Therapeutics and on the advisory council of the University of Notre Dame Department of Science.

Steven Galson, MD, MPH

Dr. Galson was appointed to the Board in September 2021. Most recently, Dr. Galson served as the Senior Vice President, Research and Development at Amgen. Prior to joining Amgen in 2010, where he also led regulatory affairs, Dr. Galson spent more than 20 years in public service roles across the US Department of Health and Human Services, Department of Energy, Environmental Protection Agency, and Centers for Disease Control and Prevention. From 2001 to 2007, he progressed from Deputy Director to Acting Director to Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration. From 2007 to 2009 he served as acting Surgeon General of the United States. Dr. Galson received a B.S. in biochemistry from the State University of New York at Stony Brook, an M.D. from the Mt. Sinai School of Medicine, and a master’s degree in public health from the Harvard School of Public Health.

Theresa Heggie

Theresa Heggie was appointed to the Board in December 2018, bringing more than 30 years of experience as a business leader in the pharmaceutical, biotechnology, and rare disease industries. Ms. Heggie most recently served as Chief Operating Officer of ProQR, a company developing RNA therapies for genetic eye diseases. Prior to joining ProQR in 2021, she was Chief Executive Officer of Freeline, and before that was Senior Vice President, Head of Europe, Middle East, and Africa, and Canada for Alnylam Pharmaceuticals, and Global Chief Strategy and Marketing Officer for Bupa. Ms. Heggie also served as Senior Vice President of global commercial operations for Shire Human Genetic Therapies (HGT).

Ms. Heggie joined Shire in 2005 as part of the acquisition of TKT where she was responsible for HGT’s business in Europe, Middle East, and Africa, and, following the acquisition of Jerini in 2008, was appointed Chief Executive Officer of Jerini AG based in Berlin. Prior to joining Shire, Ms. Heggie spent more than 20 years in the pharmaceutical industry with Janssen Pharmaceuticals, Ohmeda Pharmaceutical Products Division (part of BOC), and Baxter in marketing, sales, and clinical research roles. Ms. Heggie received her B.S. from Cornell University.

Alan G. Levin

Alan G. Levin was appointed to the Board in February 2020. In addition to his 20-year career at Pfizer, where he served as Chief Financial Officer, Mr. Levin served as Chief Financial Officer of Endo Pharmaceuticals, Inc. over a five-year period where the company experienced a nearly 400 percent increase in its market capitalization. He currently serves on the board of directors of Diffusion Pharmaceuticals, Inc., a development-stage company focused on therapeutics to enhance the effectiveness of treatments for stroke and cancer, and on the advisory board of Auven Therapeutics, a global private equity fund that acquires and pursues accelerated development of breakthrough therapeutic drugs, prior to licensing them to commercial partners.

From 2013 through 2019, Mr. Levin served on the board of directors of Aceto Corporation, a multinational company involved in the sale and distribution of generic drugs, pharmaceutical intermediates, and performance chemicals. He also serves on the board of directors of the Critical Path Institute, a nonprofit collaboration between the US Food and Drug Administration and the pharmaceutical industry, focused on streamlining and accelerating the development and regulatory pathways for innovative medicines. Mr. Levin is an audit committee financial expert, as defined by the Securities and Exchange Commission, and is a certified public accountant. He holds a Bachelor’s degree from Princeton University and a Master’s degree from New York University’s Stern School of Business.

Amy McKee, M.D.

Dr. McKee was appointed to the Board in September 2021. Dr. McKee currently serves as Chief Medical Officer and Global Head, Oncology Center of Excellence for Parexel, a leading global clinical research organization. Prior to joining Parexel in 2019, Dr. McKee spent more than a decade at the US Food and Drug Administration (FDA) in leadership roles of increasing responsibility. She served as a primary reviewer of new drug applications (NDAs) and biologics license applications (BLAs) across multiple divisions and served as both the acting Deputy Director and supervisory Associate Director of the Office of Hematology and Oncology Products where she managed four separate divisions performing NDA and BLA reviews. From January 2018 through February 2019, Dr. McKee was the deputy Center Director for the FDA’s Oncology Center of Excellence, which helps expedite development of innovative medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Dr. McKee received a B.A. in Russian and East European studies from Middlebury College and received her M.D. from Tulane University School of Medicine. She was a clinical fellow at the National Cancer Institute/Johns Hopkins University in the pediatric hematology/oncology fellowship program.

Vincent Milano

Vincent Milano was appointed to the Board in July 2021. Mr. Milano has over 25 years of rare disease leadership experience. He most recently served as Chief Executive Officer of Idera Pharmaceuticals, Inc., and previously served as Chairman, President, and Chief Executive Officer of ViroPharma, which successfully developed and launched Cinryze for the treatment of HAE in the United States and Europe, prior to its acquisition by Shire in 2014. Before joining ViroPharma in 1996, he served as a Senior Manager at KPMG LLP, an independent registered public accounting firm. Mr. Milano currently serves on the board of directors of Aclaris Therapeutics and is the chairman of the board of Aceragen, Inc. (previously Idera Pharmaceuticals) and Life Science Cares Philadelphia. He received his B.S. in accounting from Rider College.

Machelle Sanders

Machelle Sanders was appointed to the Board of directors in February 2022. She currently serves as North Carolina Secretary of Commerce. Ms. Sanders has over 30 years of pharmaceutical and biotechnology experience with increasing levels of quality assurance and manufacturing operations responsibilities with Biogen, Purdue Pharmaceuticals, and AkzoNobel. Most recently, she was the Product Operation Lead for Biogen’s $8 billion multiple sclerosis franchise and was Vice President of manufacturing and General Manager for Biogen’s 1200-employee Research Triangle Park facility, the company’s largest global manufacturing operation. Prior to being appointed as North Carolina’s Secretary of Commerce in February 2021, Ms. Sanders served as Secretary of the North Carolina Department of Administration from January 2017 until February 2021. Ms. Sanders currently serves on the board of directors of Fortrea. She received a B.S. in biochemistry from North Carolina State University and a Master’s in health administration from Pfeiffer University.

Jon P. Stonehouse

Jon P. Stonehouse joined BioCryst in January 2007 as Chief Executive Officer and Director. He was also named President in July 2007. Prior to joining the Company, he served as Senior Vice President of Corporate Development for Merck KGaA where his responsibilities included corporate mergers and acquisitions, global licensing and business development, as well as corporate strategy and alliance management. Mr. Stonehouse was responsible for leading the effort to develop a strategy for Merck that significantly changed the company. This culminated with the acquisition of Serono, S.A., the largest biotechnology company in Europe at the time of the agreement. Prior to joining Merck KGaA, Mr. Stonehouse held a variety of roles at Astra Merck/AstraZeneca. Mr. Stonehouse began his career in the pharmaceutical industry as a sales representative and held increasing sales leadership positions at Merck & Co., Inc. In 2011, Mr. Stonehouse joined the advisory board of Genscript, a private bioservices company. In December 2014, he joined the Board of Directors of Bellicum Pharmaceuticals, Inc., a publicly traded clinical-stage biopharmaceutical company focused on novel cellular immunotherapies.

Mr. Stonehouse earned his B.S. in Microbiology at the University of Minnesota. As Chief Executive Officer and President of BioCryst, Mr. Stonehouse brings to the board an intimate knowledge of our business, and his executive experience in a variety of capacities at major pharmaceutical companies provides industry-specific operational experience that is beneficial to the board.

State regulations/
disclosures

California

California Compliance Program Declaration Download here >>

 

Colorado

Colorado WAC Disclosure for ORLADEYO (berotralstat) Download here >>

 

Connecticut

Connecticut WAC Disclosure for ORLADEYO (berotralstat) Download here >>

 

Vermont

Vermont AWP Disclosure for ORLADEYO (berotralstat)

Download Short Form here >>

Download Long Form here >>