-- New collaboration and license agreement with
CSL to develop Fc multimer programs, including M230, with a $50M
upfront license fee --
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today provided a corporate update and reviewed key
anticipated highlights for 2017.
“This week we announced a significant research
collaboration and license agreement with CSL for M230 and potential
future Fc multimer programs. We also announced an agreement with
Shire for the early return of full rights to the M923 program,”
said Craig A. Wheeler, President and Chief Executive Officer of
Momenta Pharmaceuticals. “We start 2017 with a strong balance
sheet, a validation of our approach to Fc biology, a fully-owned
biosimilar HUMIRA candidate that remains on track for regulatory
submission in mid-2017, and the potential for the approval and
launch by Sandoz of Glatopa® 40 mg product in the first quarter of
2017.”
Recent and Year-End 2016 Updates and 2017
Anticipated Milestones
BIOSIMILARS
M923: a fully-owned proposed
biosimilar of HUMIRA® (adalimumab)
- On January 3, 2017 the Company announced it will receive a
one-time asset return payment of $51.2 million from Shire for the
early termination of the collaboration agreement to develop and
commercialize M923. The collaboration termination was first
announced in September 2016. Momenta will use the one-time payment
to fund the estimated costs that would have been incurred by Shire
through September 2017.
- In November 2016, the Company announced positive Phase 3
top-line results of M923 in patients with moderate-to-severe
chronic plaque psoriasis.
- Momenta is targeting mid-2017 for the first submission for
marketing approval of M923.
M834: a proposed biosimilar of
ORENCIA® (abatacept) being developed in collaboration with
Mylan
- Momenta and Mylan initiated a Phase 1 trial in November 2016
and patient accrual is currently ongoing. The companies plan to
report top-line data from the Phase 1 trial in the second half of
2017.
- In November, Momenta received a milestone payment of $25.0
million from Mylan to be applied toward the funding of Mylan’s 50%
share of collaboration expenses.
- On December 22, 2016, the U.S. Patent and Trademark Office’s
Patent Trial and Appeal Board issued their decision upholding the
validity of U.S. Patent No. 8,476,239, related to Bristol Myers
Squibb’s ORENCIA (abatacept) product following the Company’s 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 December, Momenta received a $35.0 million milestone payment
from Mylan to be applied toward the funding of Mylan’s 50% share of
collaboration expenses.
COMPLEX GENERICS
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.
- Momenta expects that in the fourth quarter of 2016 its share of
profit on Sandoz’s sales of Glatopa 20 mg will be reduced by
approximately $3.5 million to reimburse Sandoz for the Company’s
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 January
28, 2017.
- A district court trial challenging four of Teva’s five Orange
Book-listed patents for COPAXONE 40 mg (glatiramer acetate
injection) concluded on October 6, 2016. The Company expects a
decision to be issued in the first quarter of 2017.
NOVEL DRUG CANDIDATES
M230 (SIF3): a Selective
Immunomodulator of Fc receptors
- On January 5, 2017, the Company announced that it has entered
into a worldwide license agreement and an exclusive research
collaboration with CSL to develop and commercialize Fc multimer
proteins, including Momenta’s M230, a selective immunomodulator of
Fc receptors, expected to enter the clinic in 2017. The
effectiveness of agreement is subject to clearance under the
Hart-Scott-Rodino Act.
- When the agreement becomes effective, Momenta will receive a
$50 million upfront license fee from CSL and is eligible to receive
up to $550 million in future milestone and royalty payments for
M230. In addition to advancing M230, the agreement initiates a
research collaboration to develop additional Fc multimer proteins
that may originate from Momenta’s or CSL’s research.
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.
Financial Guidance
Momenta provides non-GAAP operating expense
guidance, which it believes can enhance an overall understanding of
its financial performance when considered together with GAAP
figures. Refer to the section of this press release below entitled
"Non-GAAP Financial Information and Other Disclosures" for further
discussion of this subject.
- Today, Momenta reiterated its non-GAAP operating expense
guidance of approximately $40 - $45 million for the fourth quarter
of 2016. Non-GAAP operating expense is total operating
expenses (which is net of Mylan's share of collaboration expenses),
excluding stock-based compensation expense and net of collaborative
reimbursement revenues from Sandoz and Baxalta, now part of
Shire.
- The Company expects to report approximately $350.0 million of
cash, cash equivalents and marketable securities at December 31,
2016. This cash balance does not include the expected one-time
payment of $51.2 million from Shire nor the expected $50.0 million
upfront payment from CSL.
- The Company is currently assessing the U.S. GAAP accounting
treatment for the Shire and CSL agreements and plans to discuss the
accounting for these transactions, as well as provide 2017
financial guidance on its fourth quarter and full year earnings
conference call and webcast to be held on February 21, 2017.
Non-GAAP Financial Information and Other
Disclosures
Momenta uses a non-GAAP financial measure, non-GAAP
operating expense, to provide operating expense guidance. Momenta
believes this non-GAAP financial measure is useful to investors
because it provides greater transparency regarding Momenta's
operating performance and excludes non-cash stock compensation
expense and is net of collaborative reimbursement revenues from
Sandoz and Baxalta. This non-GAAP financial measure should not be
considered an alternative to GAAP total operating expense and
should not be considered a measure of Momenta's liquidity. Non-GAAP
financial measures should not be considered as substitutes for
measures calculated in accordance with GAAP and should only be used
to supplement an understanding of Momenta's operating results as
reported under GAAP. Momenta has not provided a GAAP reconciliation
for its forward-looking non-GAAP fourth quarter 2016 operating
expense because Momenta cannot reliably predict without
unreasonable efforts the timing or amount of the factors that
substantially contribute to the projection of stock compensation
expense, which is excluded from the forward-looking non-GAAP
financial measure. The Company has provided the anticipated
reconciling information that is available without unreasonable
effort in the section of this press release above entitled
"Financial Guidance."
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, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including but not limited to statements about the
Company's ability to meet its development goals; expectations
regarding long-term growth and sustainability; program costs,
operating expenses, profits and cash and cash equivalents for the
fourth quarter of 2016 and at December 31, 2016; the effectiveness,
future payments and number of products to be developed under the
CSL agreement; program development and collaboration plans; timing
of regulatory submissions, regulatory approvals and product
launches; timing of clinical trials and the availability and
announcement of clinical data; timing of patent litigation and
other patent-related proceedings and decisions and available
options related to such litigation and proceedings; and the ability
to generate value from our product candidates. Forward-looking
statements may be identified by words such as "believe,"
"continue," "expect," "guidance," "opportunity," "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 factors, including those
referred to under the section "Risk Factors" in the Company's
Quarterly Report on Form 10-Q for the quarter ended September 30,
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 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. The preliminary, unaudited financial
information provided above is based on the Company’s current
estimate of its non-GAAP operating expense for the fourth quarter
of 2016, and its cash, cash equivalents and marketable securities
at December 31, 2016, and remains subject to change based on the
Company’s closing procedures, including execution of its internal
controls over financial reporting, and the subsequent occurrence or
identification of events prior to the formal issuance of the
Company’s annual audited financial statements. The Company 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.
INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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