Celtic Therapeutics and Resolvyx Pharmaceuticals Announce an Alliance in Ophthalmology
By Celtic Pharmaceutical Holdings L.p., PRNEMonday, October 25, 2010
Celtic Therapeutics to Progress RX-10045 for Dry Eye Syndrome Through Phase III Clinical Development
NEW YORK and CAMBRIDGE, Massachusetts, October 26, 2010 - Celtic Therapeutics Holdings L.P. (Celtic Therapeutics), a successor firm
to Celtic Pharma, and Resolvyx Pharmaceuticals, Inc. (Resolvyx) announced
today that they have entered into an option agreement relating to Resolvyx's
RX-10045, a late-stage program for the treatment of dry eye syndrome and
other ophthalmic conditions. In connection with the RX-10045 option
agreement, Celtic Therapeutics purchased a note convertible into Resolvyx
equity.
Under the terms of the option agreement, Celtic Therapeutics has an
exclusive option to acquire and license rights to Resolvyx's RX-10045, in all
eye indications. RX-10045 is scheduled to enter a Phase III randomized,
placebo-controlled, multi-center study in 2011. As part of the agreement,
Celtic Therapeutics may also license rights to and develop another Resolvyx
compound in a topical formulation for ophthalmic indications. Resolvins are a
recently discovered family of naturally-occurring, small molecule lipid
mediators that can be targeted to treat a wide range of diseases. Resolvins
are shown to be highly potent and efficacious across a broad range of
pre-clinical models of asthma, atherosclerosis, rheumatoid arthritis,
inflammatory bowel disease, dry eye and retinal disease, among others.
Dry eye, one of the most common problems treated by ophthalmologists, and
a $1.7 billion global market today, is a chronic, multifactorial disease of
the tear ducts and ocular surfaces that results in symptoms of discomfort,
visual disturbance, and tear film instability with potential damage to the
ocular surfaces. RX-10045, a resolvin administered as a topical eye drop,
produced dose-dependent, significant improvement on the primary endpoints for
both the signs and symptoms of dry eye, and was generally shown to be safe
and well tolerated in a large placebo-controlled Phase II study.
"Celtic Therapeutics is excited to invest in Resolvyx's groundbreaking
technology, which has already demonstrated impressive efficacy and safety in
patients with dry eye syndrome," commented Peter B. Corr, Co-Founder and
Managing General Partner of Celtic Therapeutics. "The market for dry eye
products has grown substantially over the past several years, despite the
fact that most patients are not satisfied with current therapeutic options.
With the potential for improved efficacy, a much faster onset of action, an
improved tolerability profile, and a strong patent estate, we believe
RX-10045, if approved, would represent an important step forward in the
treatment of this widely prevalent condition."
"We are delighted to be allied with Celtic Therapeutics in maximizing the
therapeutic potential of Resolvins to treat dry eye syndrome and other eye
disease," said Jamie Nichols, Chief Operating Officer at Resolvyx. "Celtic
Therapeutics brings both the capital and the world class development
expertise to advance RX-10045 through Phase III development in dry eye and to
maximize the potential of Resolvins to treat eye disease more broadly. This
will allow Resolvyx to dedicate our resources to pursue the exceptional
therapeutic potential of resolvins for non-ophthalmic diseases."
"Our investment in Resolvyx and RX-10045 demonstrates Celtic
Therapeutics' focus on novel classes of biologic or small molecule
therapeutics that hold the promise of significant medical advances compared
to currently available treatment options," commented Stephen Evans-Freke,
Co-Founder and Managing General Partner of Celtic Therapeutics. "This is the
fourth such transaction we have announced to date; we have previously
announced our investment in Kolltan Pharmaceuticals, which is developing
second-generation monoclonal antibody drugs targeting tyrosine kinase
receptors for the treatment of many cancer types, and alliances with Spirogen
for the development of small molecule cytotoxic anti-cancer drugs designed to
circumvent drug-resistance mechanisms, and with Bellus Health for the final
Phase III development of Kiacta for the treatment of AA Amyloidosis."
About Dry Eye Syndrome
Dry eye occurs when the eye does not produce tears properly, or when the
tears are not of the correct consistency and evaporate rapidly. An estimated
9 million Americans suffer from moderate to severe dry eye and an additional
20 to 30 million Americans have milder cases of dry eye, with worldwide
prevalence of the disease closely paralleling that of the US. It is
accompanied by increased osmolarity of the tear film and inflammation of the
ocular surface. Dry eye can make it more difficult to perform some visual
activities for an extended period of time, and it can decrease tolerance for
individuals exposed to dry environments.
About Celtic Therapeutics
Founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr, Celtic
Therapeutics is a successor firm to Celtic Pharma Management L.P., pursuing
the same investment model on a larger scale. As a global private equity firm,
it identifies, acquires and develops therapeutic products and related
diagnostics in mid- and late-stage clinical development, in order to build
one of the most valued portfolios of late-stage drug development programs in
the global biopharmaceutical industry. Based in the US Virgin Islands, Celtic
Therapeutics maintains acquisition, origination and drug development
operations in New York City and Lausanne, Switzerland. The Celtic
Therapeutics team comprises extensive experience in all aspects of
management, acquisition and sale expertise as well as world class clinical
and commercial development experience in the pharmaceutical sector. For
further information, please visit www.celtictherapeutics.com.
About Resolvyx Pharmaceuticals
Resolvyx Pharmaceuticals is a privately-held biopharmaceutical company
dedicated to the discovery, development and commercialization of resolvins, a
novel class of therapies to treat inflammatory diseases and their
complications. Resolvyx's drug R&D programs are focused on characterizing and
developing resolvin-based compounds. Resolvyx currently has two programs in
clinical development. RX-10045 is a topical eye drop that has completed a
Phase II trial in chronic dry eye. RX-10001 is formulated for oral delivery
and has completed Phase I. With its experienced management team, world-class
scientists and leading investors, Resolvyx is well-positioned to capitalize
on its extensive portfolio of over 80 patents and applications. The company's
headquarters are in Cambridge, Massachusetts. For additional information,
please visit www.resolvyx.com.
About Resolvins
Resolvins are a recently discovered family of naturally-occurring, small
molecule lipid mediators that can be targeted to treat a wide range of
diseases. In particular, resolvins act to protect healthy tissue during an
inflammatory response to infection, injury or other environmental challenge,
and then act to resolve inflammation and promote healing after the insult has
passed. Resolvins are shown to be highly potent and efficacious in
pre-clinical models of asthma, atherosclerosis, rheumatoid arthritis,
inflammatory bowel disease, dry eye and retinal disease, among others.
Resolvins are potential drug candidates to treat a broad range of acute and
chronic diseases caused by a failure to resolve the inflammatory response and
restore immune homeostasis.
ENQUIRIES U.K. Media Relations Susan Quigley, tel: +44(0)207-269-7169; Susan.Quigley@fd.com U.S. Media Relations Robert Stanislaro, tel: +1(212)850-5657; Robert.stanislaro@fd.com Irma Gomez-Dib, tel: +1(212)850-5761; Irma.Gomez-Dib@fd.com
ENQUIRIES: U.K. Media Relations, Susan Quigley, tel: +44(0)207-269-7169; Susan.Quigley at fd.com; U.S. Media Relations, Robert Stanislaro, tel: +1(212)850-5657; Robert.stanislaro at fd.com; Irma Gomez-Dib, tel: +1(212)850-5761; Irma.Gomez-Dib at fd.com
Tags: Celtic Pharmaceutical Holdings L.p., Massachusetts, New York And Cambridge, October 26, United States of America