The U.S. Patent and Trademark Office (USPTO) recently issued a new U.S. patent to AMAG Pharmaceuticals, Inc. (AMAG) for Feraheme (U.S. Patent No. 8,501,158) expiring in 2020. The patent is Orange Book listed.
The patent will cover Feraheme (500 mg – 600 mg dose) for the treatment of patients suffering from iron deficiency anemia (IDA).
AMAG currently has three other Orange Book listed patents for Feraheme valid through 2020. All these patents are without patent term extension. However, AMAG has already applied for a patent term extension for an Orange Book listed patent for Feraheme, which can extend the patent protection through Jun 2023.
Feraheme is currently approved as an injectable drug for intravenous use as iron replacement therapy for the treatment of IDA in adults suffering from chronic kidney disease (CKD). In the second quarter of 2013, U.S. net sales of Feraheme amounted to $17.5 million, up 29% year over year. AMAG mentioned in its second quarter press release that this was Feraheme’s highest quarterly sales since its launch.
AMAG is also working on expanding Feraheme’s label. In Dec 2012, the company submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for Feraheme. AMAG is looking to get Feraheme’s label expanded for the treatment of CKD adults suffering from IDA with a history of unsuccessful oral iron therapy.
The U.S. regulatory body is expected to render a final decision on the proposed label expansion by Oct 21, 2013. Successful label expansion would boost the sales potential of the drug in the U.S.
AMAG has an agreement with Takeda Pharmaceuticals (TKPYY) for Feraheme, in the EU and Canada. We note that Rienso (EU trade name of Feraheme) was launched in the EU and Canada during the fourth quarter of 2012.
During the second quarter of 2013, Takeda also filed a regulatory application with the European Medicines Agency to expand Rienso’s current CKD indication to include treatment of IDA in all adults who have a history of unsatisfactory oral iron therapy or who cannot tolerate or do not respond to such therapy.
AMAG currently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Actelion Ltd. (ALIOF) and Biogen Idec Inc. (BIIB) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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