Momenta Pharmaceuticals,Inc. (NASDAQ:MNTA) Files An 8-K Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition.
On January6, 2017, Momenta Pharmaceuticals,Inc. (the Company)
announced certain preliminary financial results for the fourth
quarter ended December31, 2016. The full text of the press
release issued in connection with the announcement is attached as
Exhibit99.1 to this Current Report on Form8-K.
The information in this Item 2.02 of this Current Report on
Form8-K (including Exhibit99.1) shall not be deemed filed for
purposes of Section18 of the Securities Exchange Act of 1934, as
amended (the Exchange Act) or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 8.01 Other Information.
On January6, 2017, the Company provided a year-end 2016 corporate
update, which included the following items:
M834: a proposed biosimilar of ORENCIA
(abatacept) being developed in collaboration with Mylan
On December22, 2016, the U.S. Patent and Trademark Offices Patent
Trial and Appeal Board issued its decision upholding the validity
of U.S. Patent No.8,476,239, related to Bristol Myers Squibbs
ORENCIA (abatacept) product following the Companys Inter Partes
Review challenging this patent. The Company is considering its
options for appeal to the U.S. Court of Appeals for the Federal
Circuit.
M710: an early-stage biosimilar candidate being
developed in collaboration with Mylan
In December2016, Momenta received a $35.0 million milestone
payment from Mylan to be applied toward the funding of Mylans 50%
share of collaboration expenses.
Glatopa: First FDA-approved, substitutable
generic daily COPAXONE 20 mg for multiple sclerosis
Glatopa 20 mg remains the sole generic 20 mg product on the
market with approximately 40% penetration of the once-daily 20
mg/mL U.S. glatiramer acetate market.
The Company expects that in the fourth quarter of 2016 its share
of profit on Sandozs sales of Glatopa 20 mg will be reduced by
approximately $3.5 million to reimburse Sandoz for the Companys
share of Glatopa-related legal expenses.
The Abbreviated New Drug Application (ANDA) submitted by Sandoz
for a three-times-a-week generic COPAXONE 40 mg (glatiramer
acetate injection) is under U.S. Food and Drug Administration
(FDA) review. A tentative approval, if any, for Glatopa 40 mg
could be granted at any time and a final approval could be
granted following the expiration of COPAXONE 40 mg regulatory
exclusivity on January28, 2017.
M281: Fully human monoclonal antibody (mAb)
targeting the neonatal Fc receptor (FcRn), currently in an
ongoing Phase 1 study
The Company has successfully completed five cohorts in the Phase
1 single ascending dose (SAD) study in healthy volunteers. In the
SAD portion of the study a single dose of 30 mg/kg achieved up to
80% reduction of circulating IgG antibodies. M281 was
well-tolerated and no serious adverse events were observed.
The Company plans to report the full data from the single and
multiple ascending dose portions of the study in the second half
of 2017.
Item 9.01. Financial Statements and
Exhibits.
(d) Exhibits.
|
Exhibit No. |
|
Description |
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99.1 |
Press Release dated January6, 2017 |
Forward-Looking Statements
Statements in this Current Report on Form8-K regarding
managements future expectations, beliefs, intentions, goals,
strategies, plans or prospects, are forward-looking statements
within the meaning of the Private Securities Litigation Reform
Act of 1995, including but not limited to statements about
timing of patent litigation and other patent-related
proceedings and decisions and available options related to such
litigation and proceedings; expectations regarding the
reduction of the Companys share of profit on Sandozs sales of
Glatopa 20 mg in the fourth quarter of 2016; expected timing of
regulatory approval of the ANDA submitted by Sandoz for a
three-times-a-week generic COPAXONE 40 mg, and whether such
ANDA will be approved at all; and expected timing of clinical
trials and the availability and announcement of clinical data.
Forward- looking statements may be identified by words such as
believe, continue, expect, consider, could, plan, possible,
potential, will and other similar words or expressions, or the
negative of these words or similar words or expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other important factors, including those
referred to under the section Risk Factors in the Companys
Quarterly Report on Form10-Q for the quarter ended September30,
2016, filed with the Securities and Exchange Commission, as
well as other documents that may be filed by the Company from
time to time with the Securities and Exchange Commission. As a
result of such risks, uncertainties and important factors, the
Companys actual results may differ materially from any future
results, performance or achievements discussed in or implied by
the forward-looking statements contained herein. The Company is
providing the information in this Current Report on Form8-K as
of todays date and assumes no obligations to update the
information included in this Current Report or revise any
forward-looking statements, whether as a result of new
information, future events or otherwise.
About Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA)
Momenta Pharmaceuticals, Inc. is a biotechnology company. The Company is focused on developing generic versions of drugs, biosimilars and therapeutics for oncology and autoimmune disease. It focuses on three product areas: Complex Generics, Biosimilars and Novel Therapeutics. It has developed generic version of Lovenox (enoxaparin sodium injection). Its GLATOPA is a generic version of once-daily COPAXONE 20 milligrams/milliliter (mg/mL) indicated for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. It is developing M923, which is a biosimilar of HUMIRA and M834 as a biosimilar of ORENCIA. Its oncology product candidate Necuparanib, is an oncology product candidate, which have a range of effects on tumor cells and the environment, in which tumor cells grow. It focuses on M281, which is an Anti-FcRn program. Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) Recent Trading Information
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) closed its last trading session up +0.90 at 16.40 with 958,626 shares trading hands.
