Momenta Hit With a Setback After Warning Letter From the FDA
Published: Feb 20, 2017
Approval of the Glatopa 40 mg ANDA will be dependent on resolution of Pfizer facility compliance issues
Warning letter does not restrict the production or shipment of Glatopa 20 mg
CAMBRIDGE, Mass., Feb. 17, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter. The Pfizer facility is a key part of the supply chain for the Company’s Glatopa products. Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20 mg (glatiramer acetate injection) product that is currently marketed by Sandoz in the United States.
The Glatopa 40 mg ANDA remains under regulatory review. The Company believes the application review could be completed at any time. However, under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product, and Momenta expects that an approval in the first quarter of 2017 is unlikely. Momenta is working with its collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible.
Momenta plans to provide a further update on the status of the Glatopa 40 mg product candidate on its fourth quarter and year-end 2016 conference call and webcast. The call will be held on Tuesday, February 21, 2017 at 8:00 am ET. A live webcast of the conference call may be accessed on the “Investors” section of the company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call. To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 62528080. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through February 28, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 62528080.
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.
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Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including without limitation the timing of the completion of review of the Glatopa 40 mg ANDA, the timing of Glatopa 40 mg approval, and the timing of further updates on the status of Glatopa 40 mg are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "believe," "expect," “plan,” “unlikely,” or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
MOMENTA INVESTOR CONTACT: Sarah Carmody Momenta Pharmaceuticals 1-617-395-5189 IR@momentapharma.com MOMENTA MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications 1-781-235-3060 Momenta@macbiocom.com