Fortress Biotech Announces Filing of Provisional Patent Application for Caelum Biosciences’ CAEL-101
July 17 2017 - 8:00AM
Fortress Biotech, Inc. (NASDAQ:FBIO) (“Fortress”), a
biopharmaceutical company dedicated to acquiring, developing and
commercializing novel pharmaceutical and biotechnology products,
today announced that Columbia University (“Columbia”) has filed a
provisional patent application with the U.S. Patent and Trademark
Office (USPTO) pertaining to CAEL-101, which was licensed from
Columbia to Fortress subsidiary Caelum Biosciences (“Caelum”) in
January 2017.
The patent application, once converted into a
U.S. non-provisional, utility application, will provide composition
of matter protection for CAEL-101, effective upon a grant of a U.S.
patent. The legal protection offered by a granted U.S. patent
will exceed any data exclusivity periods associated with Orphan
Drug Designation and/or an original, branded biologic product
approved for marketing in the U.S. Caelum also plans to
pursue an international (PCT) application, from which national
stage patent applications can be submitted in both industrial
jurisdictions and developing countries around the world.
A provisional patent application offers a patent
applicant an option of filing without including a formal patent
claim. In Columbia’s case, however, numerous patent claims
have been included in the provisional application, as filed, which
are directed to an antibody, which is CAEL-101, pharmaceutical
compositions comprising same, methods of treatment, production and
detection, as well as vector constructs, polypeptides and
polynucleotides. The aim of a provisional patent application
is to establish an early effective filing date, in addition to
allowing the patent applicant or a licensee to ascribe the phrase
“patent pending” to any commercial products, methods, or services
contemplated by the subject matter claimed.
About Caelum BiosciencesCaelum
Biosciences, Inc. (“Caelum”), a Fortress Biotech (NASDAQ:FBIO)
Company, is a clinical-stage biotechnology company developing
treatments for rare and life-threatening diseases. Caelum’s lead
asset, CAEL-101 (11-14F), is a novel antibody in Phase 1b clinical
trials for the treatment of patients with amyloid light chain
(“AL”) amyloidosis. Interim Phase 1a/1b data presented at the
American Society of Hematology’s 58th Annual Meeting in December
2016 support CAEL-101’s potential to be a safe and well-tolerated
therapy that promotes amyloid resolution. CAEL-101 has received
Orphan Drug Designation from the U.S. Food and Drug Administration
as a therapeutic agent for patients with AL amyloidosis, and as a
radio-imaging agent in amyloidosis. For more information,
visit www.caelumbio.com. About Fortress
Biotech
Fortress Biotech, Inc. (“Fortress”) is a
biopharmaceutical company dedicated to acquiring, developing and
commercializing novel pharmaceutical and biotechnology products.
Fortress develops and commercializes products both within Fortress
and through certain subsidiary companies, also known as Fortress
Companies. In addition to its internal development programs,
Fortress leverages its biopharmaceutical business expertise and
drug development capabilities and provides funding and management
services to help the Fortress Companies achieve their goals.
Fortress and the Fortress Companies may seek licensing
arrangements, acquisitions, partnerships, joint ventures and/or
public and private financings to accelerate and provide additional
funding to support their research and development programs. For
more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis press release may
contain “forward-looking statements” within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, as amended. Such statements include, but are
not limited to, any statements relating to our growth strategy and
product development programs and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
dependence on third-party suppliers; risks relating to the results
of research and development activities; uncertainties relating to
preclinical and clinical testing; risks relating to the timing of
starting and completing clinical trials; our ability to obtain,
perform under and maintain financing and strategic agreements and
relationships; our ability to attract, integrate, and retain key
personnel; the early stage of products under development; our need
for substantial additional funds; the risk that the non-provisional
patent application for CAEL-101 is not granted, or is granted in a
limited manner; patent and intellectual property matters;
competition; as well as other risks described in our SEC filings.
We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
Contacts:
Fortress Biotech, Inc.
Jaclyn Jaffe
(781) 652‐4500
ir@fortressbiotech.com
Caelum Biosciences, Inc.
Michael Spector, President & Chief Executive Officer
(212) 574-2811
mspector@caelumbio.com
Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com
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