Momenta Pharmaceuticals Announces FDA Warning Letter to Contracted Glatopa® (glatiramer acetate injection) Fill/Finish Manuf...
February 17 2017 - 6:00PM
Approval of the Glatopa 40 mg ANDA will be
dependent on resolution of Pfizer facility compliance issues
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 An archived version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.
About Momenta
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.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does
not form a part of this press release.
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.
Forward-Looking Statements
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
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