CAMBRIDGE, Mass., Feb. 23,
2023 /PRNewswire/ -- Blueprint Medicines Corporation
(NASDAQ: BPMC) today announced it will regain global
commercialization and development rights to GAVRETO® (pralsetinib),
excluding Greater China, following
a decision by Roche to discontinue the collaboration agreement
between the companies for GAVRETO for strategic reasons.
Under the terms of the agreement, the termination will be
effective 12 months from the notification date of February 22, 2023. During the transition period,
Blueprint Medicines and Roche are mutually committed to ensuring a
smooth transition process with no anticipated interruptions or
changes to patient access. In addition, the company will explore
options to advance and simplify the continued global
commercialization and development of GAVRETO.
"At Blueprint Medicines, we are dedicated to driving innovation
and changing outcomes for patients with lung cancer. GAVRETO is an
important treatment option for patients with RET fusion-positive
lung cancer and other RET-altered cancers, and we are committed to
ensuring that patients being treated with GAVRETO in the commercial
and clinical trial settings continue to have access," said
Kate Haviland, Chief Executive
Officer of Blueprint Medicines. "Over the next year, we will work
alongside Roche to transition the GAVRETO program. In parallel,
Blueprint will determine the optimal path forward to bring GAVRETO
to patients in a way that maximizes its impact and value. As we do
this, we will remain focused on our 2023 goals, with our highest
priorities being the anticipated U.S. launch of AYVAKIT®
(avapritinib) in indolent systemic mastocytosis and the ongoing
advancement of our pipeline of investigational medicines."
Since the initiation of the collaboration with Roche in
July 2020, Blueprint Medicines has
benefited from approximately $1
billion between upfront and milestone payments and from
cost-sharing the commercialization and development of GAVRETO. The
company anticipates no impact to its 2023 revenue guidance, which
includes $40 million to $50 million in collaboration revenues from
existing collaborations, or its anticipated operating expenses in
2023. In addition, the company continues to expect that its
existing cash, cash equivalents and investments, together with
anticipated future product revenues, will provide sufficient
capital to enable the company to achieve a self-sustainable
financial profile.
About GAVRETO (pralsetinib)
GAVRETO (pralsetinib) is a once-daily oral targeted therapy
approved by the U.S. Food and Drug Administration (FDA)
for the treatment of three indications: adult patients with
metastatic RET fusion-positive NSCLC as detected by an FDA approved
test, adult and pediatric patients 12 years of age and older with
advanced or metastatic RET-mutant medullary thyroid cancer (MTC)
who require systemic therapy, and adults and pediatric patients 12
years of age and older with advanced or metastatic RET
fusion-positive thyroid cancer who require systemic therapy and who
are radioactive iodine-refractory (if radioactive iodine is
appropriate). In addition, GAVRETO has conditional marketing
authorization from the European Commission as a monotherapy for the
treatment of adults with RET fusion-positive advanced NSCLC not
previously treated with a RET inhibitor. GAVRETO is also approved
by the National Medical Products Administration (NMPA)
of China for the treatment of adult patients with locally
advanced or metastatic RET fusion-positive NSCLC after
platinum-based chemotherapy, adult and pediatric patients 12 years
of age and older with advanced or metastatic RET-mutant MTC who
require systemic therapy, and adult and pediatric patients 12 years
of age and older with advanced or metastatic RET fusion-positive
thyroid cancer who require systemic therapy and are radioactive
iodine-refractory (if radioactive iodine treatment is
appropriate).
Blueprint Medicines has an exclusive collaboration and
license agreement with CStone Pharmaceuticals for the
development and commercialization of GAVRETO in Greater China,
which encompasses Mainland China, Hong
Kong, Macau and Taiwan.
GAVRETO is designed to selectively and potently target oncogenic
RET alterations, including secondary RET mutations predicted to
drive resistance to treatment. For more information,
visit GAVRETO.com.
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company
that invents life-changing therapies for people with cancer and
blood disorders. Applying an approach that is both precise and
agile, we create medicines that selectively target genetic drivers,
with the goal of staying one step ahead across stages of disease.
Since 2011, we have leveraged our research platform, including
expertise in molecular targeting and world-class drug design
capabilities, to rapidly and reproducibly translate science into a
broad pipeline of precision therapies. Today, we are delivering our
approved medicines to patients in the United
States and Europe, and we are globally advancing multiple
programs for systemic mastocytosis, lung cancer, breast cancer and
other genomically defined cancers, and cancer immunotherapy. For
more information, visit www.BlueprintMedicines.com and
follow us on Twitter (@BlueprintMeds) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding: expectations concerning the transition process
with Roche and Genentech and continued patient access to
GAVRETO, and the anticipated impact of the termination of the
collaboration on Blueprint Medicines' 2023 financial guidance;
Blueprint Medicines' plans to explore options for the path
forward for GAVRETO; the anticipated U.S. launch of AYVAKIT®
for indolent systemic mastocytosis; expectations regarding
Blueprint Medicines' pipeline; and Blueprint Medicines' strategy,
goals and anticipated financial performance, milestones, business
plans and focus. The words "aim," "may," "will," "could," "would,"
"should," "expect," "plan," "anticipate," "intend," "believe,"
"estimate," "predict," "project," "potential," "continue," "target"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements in this
press release are based on management's current expectations and
beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, the actual timing of the transition of responsibilities
and activities related to GAVRETO from Roche and Genentech, and the
parties' ability to successfully execute the transition in an
orderly fashion and without interruptions or changes to patient
access to GAVRETO; risks and uncertainties related to the impact of
the COVID-19 pandemic to Blueprint Medicines' business, operations,
strategy, goals and anticipated milestones, including Blueprint
Medicines' ongoing and planned research and discovery activities,
ability to conduct ongoing and planned clinical trials, clinical
supply of current or future drug candidates, commercial supply of
current or future approved products, and launching, marketing and
selling current or future approved products; Blueprint Medicines'
ability to continue to establish and expand its commercial
infrastructure, and successfully launch, market and sell current or
future approved products; Blueprint Medicines' ability to
successfully expand the approved indications for AYVAKIT/AYVAKYT or
obtain marketing approval for AYVAKIT/AYVAKYT in additional
geographies in the future; the delay of any current or planned
clinical trials or the development of Blueprint Medicines' current
or future drug candidates; Blueprint Medicines' advancement of
multiple early-stage efforts; Blueprint Medicines' ability to
successfully demonstrate the safety and efficacy of its drug
candidates and gain approval of its drug candidates on a timely
basis, if at all; the timing and results of preclinical and
clinical studies for Blueprint Medicines' drug candidates, which
may not support further development of such drug candidates or may
impact the anticipated timing of data, publications or regulatory
submissions; actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials; the risk that
the partial clinical hold on the VELA trial may or may not be
resolved in a timely manner or that additional adverse events
observed could impact the extent of the partial clinical hold or
Blueprint Medicines' resolution of the partial clinical hold;
Blueprint Medicines' ability to obtain, maintain and enforce patent
and other intellectual property protection for AYVAKIT/AYVAKYT or
any drug candidates it is developing; Blueprint Medicines' ability
to develop and commercialize companion diagnostic tests for
AYVAKIT/AYVAKYT or any of its current and future drug candidates;
Blueprint Medicines' ability to successfully expand its operations
and scientific platform and the costs thereof; and the ability to
establish, and the success of, Blueprint Medicines' current and
future collaborations, partnerships, financing or licensing
arrangements. These and other risks and uncertainties are described
in greater detail in the section entitled "Risk Factors" in
Blueprint Medicines' filings with the Securities and Exchange
Commission (SEC), including Blueprint Medicines' most recent Annual
Report on Form 10-K, as supplemented by its most recent Quarterly
Report on Form 10-Q and any other filings that Blueprint
Medicines has made or may make with the SEC in the future. Any
forward-looking statements contained in this press release
represent Blueprint Medicines' views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Except as required by law, Blueprint Medicines
explicitly disclaims any obligation to update any forward-looking
statements.
Trademarks
Blueprint Medicines, AYVAKIT, GAVRETO and associated logos are
trademarks of Blueprint Medicines Corporation.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/blueprint-medicines-to-regain-global-rights-to-gavreto-pralsetinib-from-roche-301754042.html
SOURCE Blueprint Medicines Corporation