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Momenta Pharmaceuticals Inc.

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Momenta’s sales of Glatopa 20mg continue to do well and have captured approximately 40% of the market in the U.S. We are pleased with the company’s efforts to bring biosimilars to the market. In addition, a potential approval of M923 will boost investor confidence. The company has collaborated with Mylan to develop, manufacture and commercialize six of its current biosimilar candidates. However,  the ANDA approval for Glatopa 40mg is contingent on the satisfactory resolution of the compliance observations stated in the warning letter issued by the FDA, resulting in a delay of approval. The warning letter will remain a major over hang on the shares till the issue is solved. Additionally, Glatopa faces competition from Teva’s thrice-weekly Copaxone. Moreover, the company's patents covering Enoxaparin Sodium Injection were declared invalid and unenforceable. Shares of the company have underperformed the industry so far in 2017.