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Serendex Pharmaceuticals and CMC Biologics Enter Exclusive Agreement on Factor VIIa

30th January 2015

Serendex Pharmaceuticals A/S (XOSL: SENDEX) and CMC Biologics, Inc. have today signed an exclusive agreement on Factor VIIa. Through the agreement, Serendex Pharmaceuticals has secured access to a unique form of Factor VIIa and the agreement provides Serendex Pharmaceuticals with exclusive rights for the development and commercialization of Factor VIIa for pulmonary administration. The therapeutic focus will be on acute bleeding in the lungs (Diffuse Alveolar Hemorrhage) and if successful Serendex Pharmaceuticals might be able to offer breakthrough therapy in this indication.

CMC Biologics, which provides bioprocessing solutions to pharmaceutical and biotechnology companies, will develop, manufacture and supply Factor VIIa bulk drug substance for acute pulmonary administration for pre‑clinical and clinical studies as well as for commercialization on behalf of Serendex Pharmaceuticals.

"The agreement with CMC Biologics is key to the next phase of our development of Factor VIIa, as they have a demonstrated track record as one of the most successful, independent biologics contract manufacturers in the world." said Kim Arvid Nielsen, CEO, Serendex Pharmaceuticals. "We see a high unmet need within acute bleeding in the lungs as well as a high level of documentation on patient cases covering the use of Factor VIIa for this indication, so we look forward to explore and realize the full potential of Factor VIIa in collaboration with CMC Biologics."

"This strategic collaboration with Serendex is a natural fit for us and validates our technical excellence in complex protein development and manufacture," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "Through this agreement, Serendex and CMC Biologics will work together to address this critical patient group and bring this novel therapeutic to market quickly."
The contract is a great leap forward for Serendex Pharmaceuticals, which could lead to a market approval for FVIIa within five years.

About Serendex Pharmaceuticals A/S
Serendex Pharmaceuticals is listed at Oslo Axess and develop drugs to treat respiratory conditions such as PAP (Pulmonary Alveolar Proteinosis), BE (Bronchiectasis), CF (Cystic Fibrosis related lung infections) and DAH (Diffuse Alveolar Hemorrhage). The conditions have either an acute or a chronical medical need and we have therefore obtained Orphan Drug Designation (ODD) for many of our indications in both Europe and USA.
Common for all our drugs is that they are inhaled or induced to the lungs of the patient. This improves the risk/efficacy ratio of the drug and treatment.
The development strategy is a reposition strategy, e.g. finding new indications and administration routes for existing drugs. Repositioning reduces the risk and the time to market and thus, the costs of development.

You can read more about Serendex Pharmaceuticals A/S here: www.serendex.com

About CMC Biologics
CMC Biologics is leading the industry among CMO's in reliability, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale‐up and cGMP manufacture of protein-­ based therapeutics for pre­‐clinical, clinical trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-­‐batch and perfusion production processes.

More detailed information can be found at www.cmcbiologics.com.

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