In just another two months, biopharmaceutical company Repligen Corp. (RGEN) will be facing an advisory panel review of SecreFlo, its investigational pancreatitis detector.
For readers who are new to Repligen, here's what to expect in the coming months...
The company is seeking regulatory approval to use SecreFlo for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging, or MRI, in patients with pancreatitis - an inflammation of the pancreas.
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.
The FDA's Gastrointestinal Drugs Advisory Committee is scheduled to review the New Drug Application for SecreFlo on May 31, 2012. The SecreFlo NDA has a priority review status and the FDA is scheduled to announce its decision on June 21, 2012. In the EU, the application seeking approval for SecreFlo was submitted earlier this month.
In the pivotal phase III study of SecreFlo, 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.
A standard procedure for pancreatitis is endoscopic retrograde cholangio-pancreatography, or ERCP. Given that the use of MRI, a safer and noninvasive alternative to diagnostic ERCP, is currently limited by the lack of an approved agent to clarify MRI images of the pancreatic ducts in order to achieve a definitive diagnosis, the approval of SecreFlo will help to fill the unmet need.
The company believes that the use of SecreFlo in combination with MRI is a safe, non-invasive approach to the identification of pancreatic abnormalities.
SecreFlo has an orphan drug status in the U.S. The market opportunity for SecreFlo in the U.S. is estimated to be approximately $100 million for the initial pancreatitis indication.
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 last July. 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 include, RG3039 in phase I testing for spinal muscular atrophy and RG2833, which entered phase I trial as recently as mid-March, as a potential treatment of 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.
There are approximately 20,000 patients in the U.S. and Europe with Spinal muscular atrophy and 15,000 patients with Friedreich's ataxia worldwide, and their combined market opportunity is estimated to be over $1 billion, according to Repligen.
Seeking to expand its product offering and accelerate its path to near-term profitability, Repligen acquired Novozymes Biopharma Sweden AB, a supplier of critical products for manufacturing biologic drugs, in October of 2011 for about $26.9 million in cash and future potential milestone payments of roughly $5.2 million. The acquisition was completed last December.
A quick look at Repligen's balance sheet...
The company generates revenue from sales of bioprocessing products based on Protein A and IFG-1 (Insulin-like growth factor 1) growth factors, as well as a line of pre-packed chromatography columns, which are used in the production of monoclonal antibodies and other biopharmaceutical products. Yet another stream of Repligen's revenue is royalty received from Bristol-Myers Squibb Co.(BMY) on net sales of rheumatoid arthritis biologic drug Orencia.
In the quarter ended December 31, 2011, the company slipped to a loss of $2.16 million or $0.07 per share, reversing a year-ago quarterly profit of $376 thousand or $0.01 per share, as operating expenses rose 28%. The quarterly revenue in 2011 was $7.17 million, up from $7.06 million in 2010.
The stock was profiled on our site last October when it was trading around $3.35. RGEN touched a new 52-week high of $5.75 yesterday (March 28) before closing the day's trading at $5.73. That implies a gain of 71% in five months if you had bought the stock last October.
As the FDA panel review date and decision date approaches, it will be interesting to watch how this stock plays out. Stay tuned...
by RTT Staff Writer
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