Amunix Announces Exclusive Agreements with Naia to Develop GLP-1 and GLP-2 XTEN® Products
Mountain View, CA – January 5, 2015 – Amunix Operating Inc. (Amunix), a leader in the field of protein half-life extension, today announced a research and development partnership with Naia Limited (Naia), an international drug development company that employs an innovative global strategy to clinically advance drug candidates. Amunix and Naia signed two exclusive worldwide licenses to further develop two Amunix receptor agonist product candidates: GLP-1-XTEN, a glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes and GLP-2-XTEN, a glucagon-like peptide-2 receptor agonist for the treatment of short bowel syndrome.
Under the terms of each license agreement, Naia will be responsible for all preclinical and clinical activities of the product resulting from the collaboration. Upon achievement of certain development, regulatory, commercial and sales-based milestones, Amunix will be eligible to receive milestones totaling up to $70 million for each project, as well as tiered royalties on worldwide annual net sales for the licensed products upon commercialization.
“We are delighted to enter into this strategic partnership and we look forward to our collaboration with Naia, a new company founded and led by an experienced management team in the field of drug development,” said Volker Schellenberger, PhD, Amunix President and Chief Executive Officer. “Amunix continues to add collaborations with partners that can leverage our half-life extension technology to bring better therapeutic options for patients worldwide.”
The two companies will collaborate closely on creating, developing, manufacturing and marketing both products – GLP-1-XTEN (renamed NB1001) and GLP-2-XTEN (renamed NB1002). Specifically, Amunix will provide drug development support and technical assistance to Naia for the development of the XTEN-based molecules. All construct work for both projects will be performed by Amunix.
“Naia’s strategy consists of building a strong and diverse portfolio of drugs through in-licensing agreements with partners with compelling drugs, such as Amunix’s GLP-1 and GLP-2 XTEN receptor agonists,” said H. Daniel Perez, MD, Co-founder, Chairman and Chief Executive Officer of Naia Limited. “We look forward to the rapid clinical advancement and potential commercialization of these drug candidates and bringing to international markets the much needed treatments for type 2 diabetes and short bowel syndrome.”
XTEN is a proprietary recombinant polypeptide that extends the in vivo half-life of therapeutics payloads. XTEN consists of naturally occurring hydrophilic amino acids and is biodegradable. Pharmaceuticals such as proteins, peptides and synthetic compounds can be XTENylated via chemical conjugation or genetic fusion. The XTEN platform technology is unique in that it offers better options than other half-life extension technologies for developing new therapeutics with tailored and enhanced pharmaceutical properties.
Amunix Operating Inc., based in Mountain View, CA, is a privately held biotechnology company focused on the discovery and development of novel therapeutics with improved in vivo half-lives. Amunix’s half-life extension technology is based on XTEN – hydrophilic, unstructured, biodegradable polypeptides that impart a number of favorable properties upon the molecules to which they are attached. XTEN can be recombinantly fused or chemically conjugated to peptides, proteins, and other pharmaceuticals. In addition to the advantages of reduced dosing frequency, XTENylation also stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Two genetically fused XTENylated products, VRS-859 (Exenatide-XTEN) and VRS-317 (Human Growth Hormone-XTEN) have completed Phase 1 studies. Amunix partner Versartis recently completed a Phase 2a clinical trial with VRS-317 in children with growth hormone deficiency. Amunix is also working with other partners including Biogen Idec, Janssen, Baxter, Ambrx, Zealand, Noxxon and other undisclosed partners in a wide range of therapeutic areas. Amunix is actively seeking partnerships for application of its XTEN technology. For additional information about the company, please visit www.amunix.com.
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 global healthcare ecosystem currently straining to contain costs while improving access to therapies. The company has a global 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 international 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.
Amunix Media Contact:
Debra Catz Bannister
Naia Limited Contacts; Investors:
Mark Bagnall, CFO
Andreas Marathovouniotis, W2O Group