TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA
(Thomson Reuters ONE) -
WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an
oncology-focused biopharmaceutical company, today announced that the Marketing
Authorisation Application (MAA) for niraparib has been submitted to and accepted
for review by the European Medicines Agency (EMA) for the maintenance treatment
of patients with platinum-sensitive, recurrent ovarian cancer who are in
response to platinum-based chemotherapy. With this acceptance, the review of the
niraparib marketing authorisation application in the Centralised Procedure will
now begin.
"TESARO is committed to improving the lives of patients with cancer by
responsible development and commercialization, and the validation of the
niraparib MAA represents a significant milestone for the Company," said Mary
Lynne Hedley, Ph.D., President and COO of TESARO. "We believe niraparib could
become an important new treatment option for patients. We look forward to
working with the EMA during the review process and expect to complete our
rolling NDA submission to the FDA for niraparib imminently."
The niraparib MAA is supported by data from the ENGOT-OV16/NOVA trial, which is
a double-blind, placebo-controlled, international Phase 3 study of niraparib
that enrolled 553 patients with recurrent ovarian cancer who were in a response
to their most recent platinum-based chemotherapy. The full results of the NOVA
trial were presented in detail at the European Society for Medical Oncology
(ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published at the
same time in The New England Journal of Medicine.
"The validation of our MAA for niraparib today marks an important step towards
globalizing our mission of providing transformative therapies to people bravely
facing cancer," said Orlando Oliveira, Senior Vice President and General Manager
of TESARO International. "With the MAA for oral rolapitant already under review
by the EMA, we are well positioned for two potential product launches in Europe
in 2017."
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being
evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib
franchise by assessing activity across multiple tumor types and by evaluating
several potential combinations of niraparib with other therapeutics. The ongoing
development program for niraparib includes a Phase 3 trial in patients with
platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a Phase 3 trial
in patients with first-line ovarian cancer (the PRIMA trial); a registrational
Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and
a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer
(the BRAVO trial). Several combination studies are also underway, including
trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen
Biotech has licensed rights to develop and commercialize niraparib specifically
for patients with prostate cancer worldwide, except in Japan.
Niraparib is an investigational agent and, as such, has not been approved by the
U.S. Food and Drug Administration, EMA, or any other regulatory agencies.
About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the
United States, and more than 65,000 women are diagnosed annually in Europe.
Ovarian cancer is the fifth most frequent cause of cancer death among women.
Despite high response rates to platinum-based chemotherapy in the second-line
advanced treatment setting, approximately 85% of patients will experience
recurrence within two years. If approved, niraparib may address the difficult
"watchful waiting" periods experienced by patients with recurrent ovarian cancer
in between cycles of platinum-based chemotherapy.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more information,
visit www.tesarobio.com.
To the extent that statements contained in this press release are not
descriptions of historical facts regarding TESARO, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," and similar expressions (as well as other words or
expressions referencing future events, conditions, or circumstances) are
intended to identify forward-looking statements. Examples of forward-looking
statements contained in this press release include, among others, statements
regarding our expectation to launch two products in Europe in 2017. Forward-
looking statements in this release involve substantial risks and uncertainties
that could cause our research and pre-clinical development programs, clinical
development programs, future results, performance, or achievements to differ
significantly from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, risks related to our
intellectual property, the uncertainties inherent in the execution and
completion of clinical trials, uncertainties surrounding the timing of
availability of data from our clinical trials, risks regarding ongoing
discussions with and actions by regulatory authorities, patient accrual rates
for clinical trials, risks from competitors, and other matters that could affect
the timing of availability of data from or initiation of our clinical trials,
uncertainties regarding regulatory approvals, uncertainties regarding certain
expenditures, risks related to manufacturing and supply, and other matters that
could affect the availability or commercial potential of our drug candidates.
TESARO undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the Company in general,
see TESARO''s Annual Report on Form 10-K for the year ended December 31, 2015 and
its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis(at)tesarobio.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TESARO, Inc. via GlobeNewswire
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 27.10.2016 - 16:05 Uhr
Sprache: Deutsch
News-ID 1466554
Anzahl Zeichen: 1992
contact information:
Contact person:
Town:
Massachusetts
Phone:
Kategorie:
Business News
Typ of Press Release:
type of sending:
Date of sending:
Anmerkungen:
Diese Pressemitteilung wurde bisher 165 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA
"
steht unter der journalistisch-redaktionellen Verantwortung von
TESARO, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
