PHILADELPHIA, July 15, 2019 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX, "Aevi") today announced it has
entered into an exclusive license agreement with OSI
Pharmaceuticals, LLC, an indirect wholly-owned subsidiary of
Astellas Pharma Inc. ("Astellas") for the worldwide development and
commercialization of Astellas' second generation mTORC1/2
inhibitor, ASP7486 (OSI-027). Aevi's initial focus of study with
ASP7486 will be for congenital Lymphatic Malformations, which
includes a number of rare and orphan diseases. The mTORC1/2 pathway
is believed to be involved in greater than 80% of patients with
congenital Lymphatic Malformations.
Under the terms of the license agreement, Aevi will pay Astellas
an up-front license fee of $500,000
and Astellas will be eligible to receive milestones payments based
upon the achievement of specified development and regulatory
milestones. Upon commercialization, Astellas will be entitled to a
tiered, single-digit royalty on worldwide annual net sales. Aevi
will be responsible for all clinical development, manufacturing,
and commercialization activities and costs.
Lymphatic Malformations are rare congenital and potentially
life-threatening diseases of the lymphatic system. Some of
the diseases involved are Generalized Lymphatic Anomaly (GLA),
Kaposiform lymphangiomatosis (KLA), and Gorham-Stoudt disease
(GSD). Most lymphatic malformations are evident at birth or within
the first two years of age. The exact prevalence of lymphatic
malformations in the general population is unknown, but is thought
to be approximately 1 in every 4000 live births. There may be
as many as 30,000 to 60,000 Americans living with congenital
lymphatic malformations. In some cases, the disease may be
familial and have a recognizable genetic cause. In most cases
it appears to be sporadic, although genetic mutations are often
present.
There are currently no approved drug therapies for these
conditions. ASP7486 represents a new targeted therapy that may
address the underlying cause in the majority of these patients.
"We are delighted to enter into this agreement with a world
class company like Astellas," said Mike
Cola, Chief Executive Officer Aevi. "We believe that the
mTOR pathway is a promising novel target with clinical proof of
concept that may benefit many children and adults with these
potentially devastating diseases. Entry into this license agreement
highlights the broad potential of our unique R&D capabilities
and further supports Aevi's strategy to rapidly bring novel and
life altering therapies to children and adults suffering from rare
and life-threatening orphan diseases.
About Aevi Genomic Medicine, Inc.
Aevi Genomic
Medicine, Inc. is dedicated to unlocking the potential of genomic
medicine to translate genetic discoveries into novel therapies.
Driven by a commitment to patients with pediatric onset
life-altering diseases, the company's research and development
efforts leverage an internal genomics platform and an ongoing
collaboration with the Center for Applied Genomics (CAG) at The
Children's Hospital of Philadelphia (CHOP).
Forward-looking Statements
This release contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, Section 21E of the Securities Exchange Act
of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995, which include all statements other
than statements of historical fact, including (without limitation)
those regarding the Company's financial position, its development
and business strategy, its product candidates and the plans and
objectives of management for future operations. The Company intends
that such forward-looking statements be subject to the safe harbors
created by such laws. Forward-looking statements are sometimes
identified by their use of the terms and phrases such as
"estimate," "project," "intend," "forecast," "anticipate," "plan,"
"planning, "expect," "believe," "will," "will likely," "should,"
"could," "would," "may" or the negative of such terms and other
comparable terminology. All such forward-looking statements are
based on current expectations and are subject to risks and
uncertainties. Should any of these risks or uncertainties
materialize, or should any of the Company's assumptions prove
incorrect, actual results may differ materially from those included
within these forward-looking statements. Accordingly, no undue
reliance should be placed on these forward-looking statements,
which speak only as of the date made. The Company expressly
disclaims any obligation or undertaking to disseminate any updates
or revisions to any forward-looking statements contained herein to
reflect any change in the Company's expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based. As a result of these factors,
the events described in the forward-looking statements contained in
this release may not occur.
CONTACT:
Aevi Genomic Medicine,
Inc.
Mike Cola
Mike.cola@aevigenomics.com
Westwicke Partners
Chris
Brinzey
+1-339-970-2843
Chris.brinzey@westwicke.com
MEDIA INQUIRIES:
FTI Consulting
Irma
Gomez-Dib
+1-212-850-5761
+1-415-706-9155
irma.gomez-dib@fticonsulting.com
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SOURCE Aevi Genomic Medicine, Inc.