Naia Limited, New International Drug Development Company, Launches With Experienced Executive Team And Licensing Agreements For Rare And Metabolic Diseases Assets

--Naia enters into long-term strategic partnership with Pharco Pharmaceuticals--

GREENBRAE, Calif.--(BUSINESS WIRE)--Naia Limited (Naia), an international drug development company that employs an innovative global strategy to clinically advance drug candidates, today announced its formation. Concurrently, Naia announced in-licensing agreements with Amunix Operating Inc. for its GLP-1 and GLP-2 XTEN™ receptor agonist product candidates and a licensing agreement with Cedars-Sinai Medical Center in Los Angeles for a use patent for GLP-1. Naia is developing a diverse portfolio of therapeutics that address regional and global unmet medical needs in various markets with an initial focus on rare and metabolic diseases. These assets are the basis of Naia’s first two subsidiaries -- Naia Rare Disease Inc. and Naia Metabolic Inc.

“Naia is taking a unique, rational approach to drug development that is designed to meet the challenges of today’s complex, global healthcare ecosystem”

Naia also announced a long-term strategic partnership with Pharco Pharmaceuticals, one of the largest pharma companies in the Middle East, in which Naia will access Pharco’s sophisticated manufacturing capabilities and will share certain development and marketing activities with the company. Pharco, headquartered in Alexandria, Egypt, is also an initial investor in Naia.

“Naia is taking a unique, rational approach to drug development that is designed to meet the challenges of today’s complex, global healthcare ecosystem,” said H. Daniel Perez, M.D., co-founder, chairman and chief executive officer of Naia Limited. “We bring together diverse perspectives, from regulatory to payer, to develop strategies for drug development and licensing with an eye toward ultimate gains in efficiency. We will undertake progressive licensing efforts on a local and regional basis to expedite access to new therapeutics while extracting maximal value. We expect that this approach will translate into opportunities for more affordable therapeutics.”

Naia’s operating structure includes a Cayman Islands-based international management company and several holding companies where each focuses its development activities on specific compounds or therapeutic areas. This shared infrastructure and management team is expected to increase efficiency in drug development and decrease operating costs. The holding companies will have operations in multiple locations, depending on market needs, including in Hong Kong, Ireland, Singapore, the United Kingdom, and the United States. Naia will target drug development in emerging markets where the demand for branded drug opportunities is large, such as in the Middle East, Latin America and Asia Pacific. Naia also will take advantage of strategic opportunities in developed markets.

“Knowing the individual backgrounds of the management team, combined with the approach of the business model, it was immediately evident that the right components were in place,” said Sherine Helmy, Pharm. Bsc., DBA, chief executive officer of Pharco Pharmaceuticals and a member of Naia’s Corporate Board of Directors. “Pharco decided to invest in Naia because we are confident that its experienced management team and innovative business model for global drug development will be successful in exploiting untapped opportunities on a worldwide basis and lead to the development of new drugs that will address unmet medical needs on a regional and global level, especially in emerging markets, such as Egypt.”

Diverse Product Portfolio

Naia’s diverse portfolio of therapeutics is currently focused on drug candidates for rare and metabolic diseases. The company’s pipeline of drug candidates in rare diseases includes GLP-1 XTEN (NB1001) and GLP-2 XTEN (NB1002) receptor agonists, which were acquired via a licensing agreement with Amunix and will be evaluated in short bowel syndrome. The company’s pipeline in the area of metabolic diseases includes NC 101, which it obtained through an undisclosed acquisition, and NB1001. Naia plans to evaluate NC101 in a Phase 2 study in patients with Type 2 diabetes and abnormal liver function and to evaluate NB1001 in a Phase 1b study in patients with Type 2 diabetes.

Experienced Senior Leadership Team

In addition to Dr. Perez, Naia’s senior leadership team consists of Mark N. K. Bagnall, chief financial officer and chief operating officer, Thomas F. Unger, Ph.D., chief strategy officer, and David N. Chernoff, M.D., chief medical officer. Each has significant experience in drug development, product sourcing, and global operations and business transactions:

• Dr. Perez, co-founder, chairman and chief executive officer, was previously a venture partner at Bay City Capital. Earlier in his career, he was president and CEO of Berlex Biosciences, where he led R&D efforts in the United States, Berlin and Kobe, initiated multiple clinical trials, and oversaw the execution of numerous collaborations, licensing deals, spin-outs and acquisitions until he left the company upon its acquisition by Bayer.
• Mr. Bagnall, co-founder, chief financial officer, chief operating officer and director, has held senior management positions in public and private biotechnology companies for more than 20 years. Previously, he served as president, CEO and a member of the Board of Directors of GenturaDx, a development-stage molecular diagnostics company until its sale to Luminex Corporation.
• Dr. Unger, co-founder and chief strategy officer, previously was at Pfizer Inc. where he held a number of senior roles within the Development Operations, Worldwide Regulatory Strategy and Pfizer’s Global R&D organizations. He was the head of strategy for Pfizer’s Biotherapeutics and Bioinnovation Center where he was responsible for all strategic planning initiatives for the division. While at Pfizer, Dr. Unger co-founded MIT’s NEW Drug Development ParaDIGmS (NEWDIGS) program, for which he serves as a member of the Executive Committee and senior advisor.
• Dr. Chernoff, chief medical officer, previously served as senior advisor of medical affairs, vice president of medical affairs and acting chief medical officer for Adamas Pharmaceuticals, Inc. He has served as chief medical officer for Schiff Nutrition International Inc., Crescendo Bioscience, Inc., Aquinox Pharmaceuticals Inc., and Pulse Health LLC. Prior to these positions, he was medical director at Chiron Corporation/Chiron Diagnostics and vice president of corporate technology for Elan Pharmaceuticals.

Leveraging Global Advisory Network and Strategic Partners

Naia’s experienced management team is supported by a Corporate Board of Directors, a Business Advisory Board and a Scientific & Clinical Advisory Board. Current members include:

• Sherine Helmy, Pharm. Bsc., DBA., chief executive officer, Pharco Pharmaceuticals
• Omar Haffar, Ph.D., chief executive officer, Eos Biosciences, Inc.
• Robert F. Williamson, III, chief executive officer, PharmAkea
• Jorge Puente, M.D., managing partner, Pleasanton Pharma Ventures
• Mark Pimentel, M.D., professor of medicine and director, Gastrointestinal Motility Program at Cedars-Sinai Medical Center, Los Angeles

In addition to leveraging this global advisory network of business, clinical and regulatory experts, Naia also will work with reputable contract research organizations (CROs) and strategic partners, including Pharco Pharmaceuticals. Additionally, Naia has entered into strategic partnerships with PharmaDirections, Inc. and Amunix to provide drug development support. The company has also developed strategic relationships with consultants and additional service providers.

About Naia Limited

Naia Limited is employing a creative business model for global drug development that exploits untapped opportunities on a worldwide basis. This business model is designed to meet the needs of a complex healthcare ecosystem currently straining to contain costs while improving access to therapies. The company has an international base of operations to develop therapeutics better, faster and more inexpensively – in proximity to target markets. Naia’s operating structure includes a Cayman Island-based management company and several holding companies that focus on development activities of like assets. The company is developing a diverse portfolio of therapeutics that address regional and global unmet medical needs in various markets with an initial focus on rare and metabolic diseases. For more information, please visit www.naiapharma.com.