Repligen Corporation (RGEN) recently announced that it received a complete response letter (CRL) from the U.S. Food & Drug Administration (:FDA) for RG1068 (synthetic human secretin). The company is looking to get the candidate approved for the detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis.
While issuing the CRL, the FDA asked the company to conduct an additional study to evaluate the safety and efficacy of RG1068. Although the CRL did not mention any safety concern regarding RG1068, the company will still monitor the safety factor in its future studies. Importantly, there were no issues regarding the manufacturing, pharmacology or toxicology sections of the NDA, as per the CRL.
In December last year, Repligen had filed the New Drug Application (:NDA) for RG1068 backed by the re-read of phase III clinical trial results. The FDA accepted the company’s NDA filing in February this year. The US regulatory body granted Fast Track designation to RG1068 in April 2008, on the basis of which it received priority review.
Repligen also submitted a Marketing Authorization Application (MAA) in March 2012, to the European Medicines Agency (:EMA). RG1068 is currently under review in the EU.
Repligen is also running a phase II program on the candidate for pancreatic cancer. Also, the company has two central nervous system rare disease programs – RG3039 and RG2833 – in phase I clinical trials.
The news, while disappointing, did not come as a major surprise. Earlier this year, Repligen had announced that it expects to receive a CRL from the FDA for RG1068. Repligen had made this announcement on receiving a notification from the FDA regarding the cancellation of an FDA advisory panel meeting for RG1068.
The requirement of an additional study will not only push up Repligen’s research and developments costs, it will also defer the approval timeline of the candidate significantly. The company had cash and investments of $37.9 million as of March 31, 2012.
We currently have a Neutral recommendation on Repligen. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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