Chiasma Provides Year-End Corporate Update and Preliminary Outlook for 2017
January 09 2017 - 8:00AM
Chiasma, Inc. (NASDAQ:CHMA), a biopharmaceutical company focused on
improving the lives of patients with rare and serious chronic
diseases, today provided a corporate review of 2016 and preliminary
outlook for 2017.
“2016 was a challenging year for Chiasma due to our receipt of a
Complete Response Letter for Mycapssa from the FDA at the time of
our PDUFA date in April 2016. Despite this setback, we remain
committed to developing new treatment options for patients with
acromegaly,” commented Mark J. Fitzpatrick, president and chief
executive officer of Chiasma. “The enrollment in the Phase 3
MPOWERED™ study of Mycapssa to support the filing of a Marketing
Authorization Application with the European Medicines
Agency met our 2016 enrollment goals. Further, Chiasma is
well-funded and has an experienced and motivated team focused on
the continued pursuit of regulatory approval of octreotide capsules
for the treatment of patients with acromegaly in the United
States.”
Key Development and Regulatory Updates
- Chiasma continues to evaluate potential pathways
forward with the U.S. Food and Drug Administration (FDA) to
potentially secure regulatory approval in the U.S. for Mycapssa for
the treatment of adult patients with acromegaly
- On April 15, 2016 the FDA, in its Complete Response Letter
(CRL) to our New Drug Application (NDA) for Mycapssa, strongly
recommended that the company conduct a randomized, double-blind and
controlled trial that enrolls patients from the United States and
is of sufficiently long duration to ensure that control of disease
activity is stable at the time point selected for the primary
efficacy assessment
- Following an End of Review meeting, the FDA indicated that some
of its concerns could potentially be addressed through a
placebo-controlled study design
- Chiasma acknowledges this feedback and continues to evaluate
pathways forward to potentially secure approval in the United
States for Mycapssa
- Chiasma continues to enroll its MPOWERED™ Phase 3 trial
of Mycapssa while managing certain elements of the study to
preserve resources for a potential pathway forward in the
U.S.
- The MPOWERED trial enrolled patients consistent with our 2016
enrollment goals
- In light of its ongoing evaluation of potential U.S.
development pathways for Mycapssa in acromegaly, Chiasma is
modifying certain elements of the MPOWERED™ study in an effort to
preserve resources necessary to potentially produce data packages
that could be suitable for submission in both the United States and
the European Union
- Certain adjustments to the MPOWERED study may delay the
expected timing of a Marketing Authorization Application (MAA)
filing with the European Medicines Agency (EMA), previously
estimated to occur in 2019
Chiasma intends to provide further clinical and regulatory
strategy updates if and when it is able to reach an understanding
with FDA on the development path forward for Mycapssa. The
company remains committed to the advancement of Mycapssa for
acromegaly to potentially improve patient care.
Cash Position Update
- Chiasma ended 2017 with approximately $93M in cash, cash
equivalents and marketable securities
- The company’s year-end cash is in line with our expectations
and Chiasma expects that, under its current operating plan, this
cash is sufficient to fund operations beyond 2018
Key Personnel Changes
- Leadership Appointments
- Dr. William Ludlam, an endocrinologist, was recently promoted
to Sr. Vice President of Clinical and Medical Affairs from Vice
President, Medical Affairs. Dr. Ludlam joined Chiasma in 2015 from
Novartis Pharmaceuticals, where he was Senior Medical Director,
Pituitary Disorders, US Oncology CDMA, Rare Diseases. Prior
to joining Novartis, Dr. Ludlam spent 15 years in a number of
academic and clinical roles including as medical director at the
Seattle Pituitary Center within the Neuroscience Institute at the
Swedish Medical Center
- In December 2016, the company amended its services agreement
with Gary Patou, M.D. to cover his continuing support to the
company on a part-time basis through the end of 2020 as Head of
Clinical to Chiasma
- In October 2016, Mark J. Fitzpatrick was appointed President,
Chief Executive Officer and Director; Mr. Fitzpatrick previously
served as the company’s Chief Financial Officer
About Chiasma
Chiasma is focused on improving the lives of patients who face
challenges associated with their existing treatments for rare and
serious chronic diseases. Employing its Transient
Permeability Enhancer (TPE®) technology platform, Chiasma seeks to
develop oral medications that are currently available only as
injections. The company is conducting an international Phase
3 clinical trial of octreotide capsules (conditionally trade-named
“Mycapssa®”) for the maintenance treatment of adult acromegaly
patients to support a potential submission of a Marketing
Authorization Application to the European Medicines Agency.
Chiasma received a Complete Response Letter (CRL) from the U.S.
Food and Drug Administration (FDA) on April 15, 2016 regarding its
New Drug Application (NDA) for Mycapssa in the United States.
Chiasma is headquartered in the United States with a wholly owned
subsidiary in Israel. Mycapssa and TPE are registered
trademarks of Chiasma.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the company’s
commitment to develop new treatment options to patients with
acromegaly, the company’s efforts to explore pathways to
potentially enable regulatory approval in the US, the company’s
ongoing MPOWERED Phase 3 clinical trial and the timing of planned
regulatory filings related thereto, the company’s ability to
preserve resources necessary to enable it to potentially produce
data packages that could be suitable for submission in both the
United States and the European Union, approximate cash balance as
of the end of 2016, and the company’s expectation that its existing
cash, cash equivalents and marketable securities will be sufficient
to fund its operations beyond 2018. Any forward-looking
statements in this press release are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties
include, but are not limited to, risks associated with the
regulatory review and approval process generally; risks associated
with Chiasma’s Phase 3 clinical trial to support regulatory
approval of Mycapssa in the E.U.; risks associated with Chiasma
potentially conducting an additional randomized, double-blind and
controlled Phase 3 clinical trial of Mycapssa in accordance with
the FDA’s recommendation in the CRL to support regulatory approval
of Mycapssa in the United States, including risks related to the
enrollment, timing and associated expenses of any potential trial;
risks associated with Chiasma pursuing a development pathway other
than the path strongly recommended by the FDA; risks associated
with obtaining, maintaining and protecting intellectual property;
risks associated with Chiasma’s ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; the risk that octreotide capsules,
if approved, will not be successfully commercialized; the risk of
competition from currently approved therapies and from other
companies developing products for similar uses; risks associated
with Chiasma’s ability to manage operating expenses and/or obtain
additional funding to support its business activities; risks
associated with Chiasma’s dependence on third parties; and risks
associated with defending any litigation, including the risk that
we incur more costs than we expect and uncertainty involving the
outcome. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
in Chiasma’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016 filed with the Securities and Exchange
Commission (SEC) on November 9, 2016, and in subsequent filings
with the Securities and Exchange Commission. All information
in this press release is as of the date of the release, and Chiasma
undertakes no duty to update this information unless required by
law.
Contact
Cammy Duong
MacDougall Biomedical Communications
(781) 591-3443
cduong@macbiocom.com
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