Inceptua Group Expands Early Access Program to Latin America

Inceptua Group Expands Early Access Program to Latin America

Luxembourg, May 15, 2024. Inceptua Group (Inceptua) – a global pharmaceutical service company – announces an expansion of an Early Access Program for cefiderocol for eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico, and Panama. In partnership with Shionogi & Co. Ltd. and the approval from and in accordance with local regulatory authorities, Shionogi will supply U.S.-labeled cefiderocol through the Inceptua Early Access Program on a case-by-case basis to patients outside of a clinical trial.

“Inceptua is pleased to announce the expansion of this Early Access Program to Latin America to allow physicians the opportunity to access this medicine for use with appropriate patients with certain serious gram-negative bacterial infections,” says Stuart Bell, Executive Vice President, Inceptua Early Access.

Inceptua and Shionogi have been working together to make cefiderocol available to patients through an Early Access program since 2020, starting initially in Europe, with subsequent expansions into Canada and the Asia Pacific region. The program has provided access to cefiderocol for nearly 1,000 patients to date.

Early Access Programs (also known as expanded access, managed access, compassionate use, named patient supply) are a compliant route through which medicines that are either still under development or not approved in their country of intended use can be made available for patients who either have limited or no alternative treatment option or have exhausted all other treatment options available in their country of residence.

In the U.S., cefiderocol is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Cefiderocol is also indicated in the U.S. in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

 

About Cefiderocol

Cefiderocol for injection is a siderophore cephalosporin antibiotic for the treatment of serious gram-negative infections manufactured by Shionogi & Co. Ltd

It has a novel mechanism for penetrating the outer cell membrane of gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.

While not yet being approved for commercial use in Latin America, cefiderocol has received approval from the U.S. Food and Drug Administration (FDA) in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023.

Please click here* for Full U.S. Prescribing Information for cefiderocol.

 

About Inceptua

Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas such as Clinical Trial Supply and Early Access.

Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, and distributes unlicensed and other medicines worldwide, Inceptua Early Access partners with pharma and biotech companies to provide truly global early access programs, which allow patients around the world access to potentially life-saving medicines. With offices in 8 countries, and a global warehousing and distribution network, Inceptua Early Access is the preferred partner for many companies in their efforts to bring promising medicines to patients as quickly as possible.

Inceptua Clinical Trial Supply provides clinical trial supply, services, and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services.

Inceptua has over 25 years of experience serving life science companies of all sizes, and has global operations with offices across Europe, North America and Asia.

Additional information is available at: www.inceptua.com.

For questions about the Early Access Program

Please contact Inceptua at access@inceptua.com or call +1-646-307-9770.

 

Inceptua Media Contact: 

Morten Grøn 

VP, Corporate Communication and Marketing 

Telephone:   +45 2556 4781 

E-Mail: morten.gron@inceptua.com 

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CEO and Board Member

Stefan Fraenkel

Stefan Fraenkel is the CEO of the Inceptua Group and is also on the Inceptua Board. He has extensive experience in the pharmaceutical industry. Before joining Inceptua, he held senior management positions at Sobi (Swedish Orphan Biovitrum), Sweden’s largest publicly listed specialty pharmaceutical company, leading Marketing & Sales and serving as Head of Corporate Development and Strategy.

Previously, Stefan worked at Pfizer and Wyeth in international commercial leadership roles across Europe and the USA, gaining deep insights into global pharmaceutical markets and strategies. Stefan has also spent part of his career in management consulting. Stefan holds a PhD in International Economics, an MBA, and a BSc in Engineering.

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Member of the Board

Chris Hasslinger

Chris Hasslinger is a Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2023 and is responsible for sourcing and evaluating new investment opportunities and general portfolio company management. Mr. Hasslinger has nearly three decades of experience in healthcare and technology strategy and deal-making within the industry as well as in investment banking and private equity. He has extensive M&A experience, having closed over $20 billion in transaction value, and has established and structured a number of large commercial partnerships.

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Executive Vice Chairman

Alan Raffensperger

Alan Raffensperger has a robust leadership background in the pharmaceutical industry, having served as CEO of Inceptua and COO of Sobi (Swedish Orphan Biovitrum), along with significant international executive roles at Amgen, Roche, and Pharmacia.

He has also been CEO for venture capital-owned medical device companies, showcasing his versatility in healthcare leadership. Alan’s early career as an advanced life support paramedic provided a strong foundation in emergency healthcare.

He holds an MBA and a BA in Emergency Health Care Management.

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Member of the Board

Blake Goodner

Blake Goodner is a founder member of the investment firm Bridger Capital. He previously worked as a healthcare analyst at Tiger Management and a healthcare investment banker at Morgan Stanley. He currently serves as an advisor and board member for a range of healthcare companies. Mr. Goodner has been a member of the Trinity College Board of Visitors and the Duke Annual Fund Executive Committee. He is a current advisory board member with The Duke Margolis-Center for Health Policy.

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Member of the Board

Adam Feinstein

Adam Feinstein is the Managing Partner of Vesey Street Capital Partners. Mr. Feinstein has 30 years of investment experience exclusively in the healthcare services sector. Prior to founding Vesey Street Capital Partners in 2014, he was a Managing Director on Wall Street and a healthcare industry executive. He held the position of Senior Vice President of Corporate Development, Strategic Investments, and Office of the Chief Executive Officer at LabCorp. Before his tenure at LabCorp, he spent 14 years as the Managing Director in Equity Research at Lehman Brothers/Barclays Capital. Mr. Feinstein is the Chairman of VSCP’s investment committee. He is also actively involved in working with portfolio company executives and sourcing new investment opportunities. At the same time, he oversees all of the firm’s investment activities and employees.

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Member of the Board

Larry Marsh

Larry is a General Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2016, and currently sits on the Board of QualityMetric, Safecor Health, and HRGi. He is responsible for portfolio company management and for evaluating new investment opportunities. Prior to VSCP, Larry was EVP, New Market Development & Chief Strategy Officer at Fortune 10 AmerisourceBergen. Prior to that, Larry was the #1 ranked Healthcare Technology & Distribution analyst on Wall Street for over a decade, at Barclays, Lehman Brothers, Salomon Smith Barney, and Wheat First Butcher & Singer. Larry worked with Adam, Bryan, Dan, and Joe at Barclays and Lehman. Larry received a B.S. in Economics & Management as well as an M.B.A. from the University of Richmond, and an M.P.H. from Columbia University.

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Member of the Board

Heyward Donigan

Heyward Donigan is a seasoned healthcare CEO, Board Member, and Private Equity Advisor with broad industry experience and a track record of profitable growth. From 2019 to 2023, Ms. Donigan served as Rite Aid’s president and chief executive officer, making her one of the few women CEOs of a Fortune 500 company. While at Rite Aid, Ms. Donigan led the company to through a major brand, merchandise and technology transformation, debt reduction/refinancing, while also leading the company through a pandemic. Ms.Donigan is currently a strategic advisor to Vesey Street Capital Partners, Arima Health, and a board member of OnMed.

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Executive Chairman

Doug Cook

Doug Cook is the Executive Chairman at Inceptua. Mr. Cook began his career driving the early success of Livingston Healthcare, leading to the purchase by UPS to become what is today UPS’s Global Healthcare business. After Livingston Healthcare, Mr. Cook moved to AmerisourceBergen (now called Cencora/COR) in 1998 and had an impressive career overseeing most of Cencora’s high growth, manufacturer-facing business. Mr. Cook ultimately served as the Executive Vice President, President Commercialization and Animal Health for COR.

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