Profile: Repligen Corp (RGEN.OQ)

RGEN.OQ on NASDAQ Stock Exchange Global Select Market

10.23USD
1 Aug 2013
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$0.06 (+0.59%)
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Repligen Corporation (Repligen), incorporated in May 1981, is a supplier of critical products used to manufacture biologic drugs. The Company manufactures Protein A for life science companies under long term supply agreements and also sell products directly to end users for use in their manufacturing processes. It also applies its biologic product development to RG1068, a synthetic hormone being developed as an imaging agent for the diagnosis of a variety of pancreatic diseases. On June 22, 2012, the Company had two central nervous system (CNS) rare disease programs in Phase 1 clinical trials. As of March 31, 2011, the Company sold a range of commercial bioprocessing products based on Protein A, as well as a line of pre-packed chromatography columns, which are used in the production of monoclonal antibodies and other biopharmaceutical products. On December 20, 2011, the Company completed the acquisition of the business of Novozymes Biopharma Sweden AB. As of December 31, 2011, the Company had three active development stage programs underway including its diagnostic imaging program and two early stage central nervous system rare disease programs.

Products for Biologics Manufacturing

The Company’s bioprocessing products are used in the production of biologic drugs which include a range of recombinant therapeutic proteins, monoclonal antibodies and vaccines. Through the Novozymes Acquisition, the Company manufactures a native Protein A product which is used in the production of several of the early monoclonal antibody drugs. The combined Company manufactures all five forms of commercial scale Protein A. This media is then packed by end-users into cylindrical columns. After fermentation of a monoclonal antibody, the broth containing the monoclonal of interest as well as numerous fermentation by-products and contaminants is passed over a column filled with Protein A chromatography media which selectively captures the monoclonal. Protein A has a specific affinity for the monoclonal antibody and as a result, the antibody stays bound to the Protein A media and the impurities wash through. After the impurities are washed away, a change in conditions releases the purified antibody. The result is a purified and concentrated monoclonal antibody from a single purification step. Further purification steps are usually necessary to increase purity to a level greater than 98%.

SecreFlo for Pancreatic Diagnosis

SecreFlo is a synthetic version of the human hormone secretin. Secretin is a gastrointestinal hormone produced in the small intestine that regulates the function of the pancreas as part of the process of digestion. It has completed a Phase 3 clinical trial evaluating the sensitivity and specificity of SecreFlo in combination with MRI to improve the detection of structural abnormalities of the pancreas relative to MRI alone. The Food and Drug Administration FDA has granted Fast Track designation to the development of SecreFlo.

RG3039 for Spinal Muscular Atrophy

The Company is pursuing development of RG3039 for treatment of patients with spinal muscular atrophy (SMA).

Intellectual Property on CTLA4-Ig Orencia (CTLA4-Ig) Royalties

CTLA4 is a key regulator of the activity of the immune system. CTLA4 turns off the immune system after it has cleared a bacterial or viral infection by blocking the activation of T-cells, the immune cells responsible for initiating an immune response. CTLA4-Ig’s mechanism of action is different from the therapies for autoimmune disease or organ transplant rejection, thus it may provide a treatment for patients who are refractory to existing therapies. The FDA approved Bristol’s application to market CTLA4-Ig, under the brand name Orencia, for treatment of rheumatoid arthritis.

Company Address

Repligen Corp

Building #1, Suite 100, 41 Seyon
WALTHAM   MA   02453
P: +1781.2500111
F: +1781.2500115

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