A leader in the supply of recombinant Protein A, a key ingredient used in the production of most monoclonal antibodies, Waltham, Massachusetts-based Repligen Corp. (RGEN) has a couple of events coming up related to its therapeutic pipeline.
The most advanced product candidate in the company's pipeline is SecreFlo (RG1068), which has completed a phase III study to improve MRI (magnetic resonance imaging) of the pancreas in patients with pancreatic diseases.
SecreFlo is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. Secretin signals the release of fluids into the ducts of the pancreas which results in an increased delineation of the pancreatic ducts and improved MRI imaging.
According to Repligen, in the phase III study, there was a statistically significant improvement in sensitivity of detection of abnormalities in patients who received an MRI of the pancreas with SecreFlo compared to MRI without SecreFlo. The company believes that the use of SecreFlo-MRI is a safe, non-invasive approach to the identification of pancreatic abnormalities.
In June of this year, the company concluded a pre-New Drug Application meeting with the FDA related to SecreFlo, and preparations are underway to submit the NDA in November. SecreFlo has been granted Fast Track and Orphan Designation, and Repligen intends to request priority review for its NDA.
The company has also received approval from the European Medicines Agency's Pediatric Committee on the design of the Pediatric Investigation Plan for SecreFlo. A marketing application seeking approval for SecreFlo in Europe is expected to be filed by the end of the year.
According to Repligen, about 300,000 MRI procedures are conducted in patients with pancreatitis in the U.S. and Europe each year that could directly benefit from the addition of SecreFlo.
Repligen is also evaluating the ability of SecreFlo to improve detection and characterization of pancreatic cancer in combination with contrast-enhanced MRI and computed tomography, and a pilot study for the same was initiated in July of this year. With roughly 250,000 people worldwide diagnosed with pancreatic cancer annually, early detection of the disease is believed to increase the identification of patients who are candidates for surgery and improve patient outcomes.
The other product candidates in the company's pipeline includes, RG3039 in phase I for spinal muscular atrophy and RG2833 in preclinical development for Friedreich's ataxia. Spinal muscular atrophy and Friedreich's ataxia are serious and debilitating neurodegenerative diseases characterized by a defect in a single gene which results in diminished production of a key protein.
Spinal muscular atrophy, or SMA, is caused by a defect in SMN1 ("survival motor neuron") gene , resulting in low levels of the protein SMN, leading to progressive damage to motor neurons and loss of muscle function. Friedreich's ataxia, or FA, is caused by inadequate production of the protein frataxin and leads to degeneration of the nerves controlling muscle movements in the arms and legs and the nerve tissue in the spinal cord.
It is estimated that there are approximately 20,000 patients in the U.S. and Europe with SMA and 15,000 patients with FA worldwide. Repligen sees a combined market opportunity for spinal muscular atrophy and friedreich's ataxia at more than $1 billion.
A quick look at the balance sheet...
Repligen generates product revenues from the sale of bioprocessing products to customers in the pharmaceutical and process chromatography industries. The bioprocessing products include, recombinant Protein A affinity chromatography resins, Opus Pre-Packed columns, Protein A ELISA Kits and recombinant Protein A ligands.
The company also recognizes revenue from sponsored research and development projects as well as royalty payments from Bristol-Myers Squibb Co. (BMY) on the U.S. sales of rheumatoid arthritis drug Orencia. Repligen began recognizing royalty revenue for Bristol-Myers' net sales in the United States of Orencia from fiscal year 2009 following the 2008 settlement of a patent infringement suit between the two companies.
In the second quarter of fiscal year 2012, ended September 30, 2011, Repligen's total revenue rose 18 percent to $8.63 million from $7.31 million in the comparable quarter a year before. Bioprocessing product revenue, which accounted for a major chunk of the revenue, rose 30 percent to $5.74 million, the highest level recorded to date.
Net income in the second quarter of fiscal year 2012 was $0.60 million or $0.02 per share compared to $0.62 million or $0.02 per share in the year-ago quarter.
Seeking to expand its product offering and customer base while doubling the manufacturing capacity, Repligen acquired Novozymes Biopharma Sweden AB last week in a cash transaction of about $22.7 million and future potential milestone payments of approximately $5.6 million. The products acquired in the Novozymes transaction are anticipated to generate $16 million to $17 million in revenue in 2011, and are sold primarily under long-term supply agreements with major life sciences companies including EMD Millipore, Sigma-Aldrich Corp and GE Healthcare.
The acquisition is said to have the potential to yield sustainable growth and profitability in fiscal year 2013, beginning April 1, 2012. The combined company is expected to generate total revenues of approximately $50 million in fiscal year 2013.
Founded in 1981, Repligen began trading on the NASDAQ from May 1986. In the past year, the stock has hit a 52-week low of $2.90 and 52-week high of $5.36. RGEN closed Friday's trading at $3.39.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.