WALTHAM, MA – June 27, 2018– Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced an agreement with Navigo Proteins GmbH (“Navigo”) for the advancement of exclusive novel affinity ligands used in monoclonal antibody (mAb) and non-mAb downstream purification processes. Under the terms of this agreement, Repligen and Navigo will co-develop a portfolio of next generation ligands, utilizing Navigo’s proprietary Precision
Capturing® technology platform. As part of the collaboration, Repligen will receive intellectual property rights and exclusivity on all affinity ligands developed with Navigo and Navigo will receive a series of milestone and royalty payments.
This formal agreement expands on a two-year relationship between Repligen and Navigo that has produced a best-in-class Protein A ligand with strong caustic stability and ultra-high binding capacity. Scale-up and validation for manufacturing of this novel ligand is underway at Repligen for near-term commercial production.
Tony J. Hunt, Repligen CEO said, “We are very pleased to solidify our partnership with Navigo on a product portfolio that reinforces Repligen’s market leadership position in bioprocessing and as a market and technology leader in affinity ligands. Navigo’s powerful Precision Capturing® platform enables Repligen to home in on specific attributes that are most important to product performance – for example, binding capacity, flow rate, pH elution and base stability. This agreement is a natural extension of our initial collaboration with Navigo that resulted in a best-in-class Protein A affinity ligand with outstanding performance attributes. We look forward to making this ligand available to the marketplace, and to further employing Navigo’s state-of-the-art protein engineering technology to introduce additional highperformance ligands to our bioprocessing customers over the coming years.”
Dr. Henning Afflerbach, Navigo CEO added, “We are delighted to enter into this agreement and expand our relationship with Repligen, a global leader in bioprocessing and affinity ligands. Our work to date demonstrates the strength of our proprietary Precision Capturing® platform to create extremely stable and high-capacity ligands, compatible with state-of-the-art industrial downstream processing. Our large and versatile ligand libraries are based on concepts from the broadly applied Protein A biology, and as such are applicable not only to antibody purification, but also to a broader range of biopharmaceuticals including recombinant proteins, vaccines, viral vectors and others. We are convinced that our Precision Capturing® platform is remarkably well-paired with Repligen’s overall bioprocessing business and their understanding of market needs.”
About Repligen Corporation
Repligen Corporation (NASDAQ:RGEN) is a global bioprocessing company that develops and commercializes highly innovative products that deliver cost and process efficiencies to biological drug manufacturers worldwide. Our portfolio includes protein products (Protein A affinity ligands, cell culture growth factors), chromatography products (OPUS® pre-packed columns, chromatography resins, ELISA kits) and filtration products (including XCell™ ATF systems, TangenX™ Sius™ flat sheet TFF cassettes, and Spectrum KrosFlo™ hollow fiber TFF cartridges and systems). The Protein A ligands and growth factor products that we produce are essential components of Protein A affinity resins and cell culture media, respectively. Protein A affinity resins are the industry standard for downstream separation and purification of monoclonal antibody-based therapeutics. Our growth factors are used in upstream processes to accelerate cell growth and productivity in a bioreactor. Our innovative line of OPUS® chromatography columns, used in downstream processes for bench-scale through clinical-scale purification needs, are delivered pre-packed to our customers with their choice of resin. Our XCell™ ATF Systems, available in stainless steel and single-use configurations, are used upstream to continuously eliminate waste from a bioreactor, to concentrate cells and increase product yield. Single-use Sius™ TFF cassettes and hardware are used for biologic drug concentration in downstream filtration processes.
Spectrum KrosFlo™ TFF cartridges and systems are used in both upstream and downstream filtration processes. Repligen’s corporate headquarters are in Waltham, MA (USA), with additional administrative and manufacturing operations in Shrewsbury, MA, Rancho Dominguez, CA, Lund, Sweden and Ravensburg, Germany.
About Navigo Proteins GmbH
Navigo Proteins is specialized in creating novel affinity ligands for PRECISION CAPTURING® and PRECISION TARGETING™. These proteins serve either as highly specific binders for affinity purification of complex biologics or as ligands in active biotherapeutic or diagnostic molecules. Navigo’s unique protein engineering expertise is based on the company’s proprietary Affilin® platform of different small and stable, yet highly engineerable scaffold proteins. Navigo has built a robust, rapid and reliable highthroughput, robotics-assisted protein engineering platform to design, produce, analyze and select suitable affinity ligand proteins, optimized for their tasks in industrial downstream processing or as biopharmaceutical drugs. Navigo’s PRECISION CAPTURING® platform creates ligands which can bind literally any biologic and notably enable downstream processes to include a Protein-A-like capture step with competitive binding capacities, caustic stabilities, usage-cycles and flow rates. It is applicable for purifying any recombinant protein, monoclonal antibody, virus, VLP and others. Navigo works with renowned partners to convert its affinity ligands into ready-to-use, GMP-compliant affinity resins. The company’s PRECISION TARGETING™ platform creates ligands for biopharmaceutical or diagnostic use, e.g. radiopharmaceuticals, Affilin®-drug conjugates, or theranostics, in which the same Affilin® binder is employed in diagnosis, treatment and treatment monitoring.
The following constitutes a “Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, express or implied statements regarding market demand for Protein A ligands, customer acceptance of next-generation affinity ligands, manufacturing scale-up and validation activities for the commercialization of Protein A ligands, and the expected synergies from Repligen’s partnership with Navigo constitute forward-looking statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to successfully grow our bioprocessing business, including as a result of acquisition, commercialization or partnership opportunities; our ability to successfully integrate any acquisitions, our ability to develop and commercialize products and the market acceptance of our products; reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; our compliance with all Food and Drug Administration and EMEA regulations; our volatile stock price; and other risks detailed in Repligen’s most recent Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements.
These forward looking statements reflect management’s current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.
Sondra S. Newman
Senior Director Investor Relations