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8-K - FORM 8-K - NOVELION THERAPEUTICS INC. | c12138e8vk.htm |
Exhibit 99.1

news release
QLT ANNOUNCES PHASE II CLINICAL TRIAL RESULTS FOR THE OLOPATADINE
PUNCTAL PLUG DELIVERY SYSTEM (O-PPDS)
PUNCTAL PLUG DELIVERY SYSTEM (O-PPDS)
For Immediate Release | February 9, 2011 |
VANCOUVER, CANADAQLT Inc. (NASDAQ: QLTI; TSX: QLT) (QLT or the Company) today announced
results from a Phase II proof-of-concept clinical trial for the olopatadine punctal plug delivery
system (O-PPDS).
Interim results from the randomized, placebo-controlled, double-masked Phase II proof-of-concept
trial have shown that O-PPDS is generally safe and well tolerated in subjects with allergic
conjunctivitis. An analysis has been performed on data from subjects in Group 1 of the study, in
which the PPDS (O-PPDS or placebo-PPDS) was placed in subjects lower puncta bilaterally for 4
days. Subjects were then exposed to ragweed allergen for 4 hours in an environmental exposure
chamber (EEC). Itching and other signs and symptoms of allergic conjunctivitis were assessed during
the 4-hour EEC session. Following a twelve-day washout period, the subjects were then assessed
during an EEC session after treatment with Patanol® (commercially available olopatadine eye drops)
or placebo eye drops.
The data demonstrate that there were no significant differences noted between the O-PPDS and
placebo-PPDS subjects with respect to reduction in the signs and symptoms of allergic
conjunctivitis with both cohorts showing similar improvements. Internal study controls, including
the olopatadine (Patanol®) and placebo eye drop cohort responses, also failed to confirm the
models efficacy relative to the trial design.
These equivocal results from the first trial examining the potential utility of sustained low dose
olopatadine delivery in the eye support the notion that the EEC model, as utilized in the conduct
of this trial, was not sufficiently sensitive to adequately demonstrate the potential benefit of
the O-PPDS in patients suffering from allergic conjunctivitis, said Dipak Panigrahi, MD, Senior
Vice President, Research and Development and Chief Medical Officer of QLT. Given these findings,
we have decided to stop the current study at this time.
We are disappointed that the O-PPDS study model could not generate definitive clinical results,
however we plan to continue to evaluate alternative study designs for the O-PPDS, said Bob
Butchofsky, President and Chief Executive Officer of QLT. We do not plan to begin further
clinical trials of the O-PPDS pending the outcome of our ongoing Latanoprost-PPDS trial in
glaucoma.
Detailed Results from the Phase II Proof-of-Concept Study
This is a randomized, placebo-controlled, double-masked, proof-of-concept study investigating the
short-term safety and efficacy of O-PPDS in subjects with seasonal allergic conjunctivitis to
ragweed in an EEC model. The study includes two sequential groups: Group 1 subjects are fitted with
PPDS (O-PPDS [130 µg olopatadine] or placebo-PPDS) in the lower puncta of each eye, and Group 2
subjects are fitted with PPDS in both the upper and lower puncta of each eye (O-PPDS [130 µg
olopatadine in lower puncta, 39 µg olopatadine in upper puncta] or placebo-PPDS). An interim
analysis has been
performed on the complete data for Group 1 and we will not continue the trial beyond those patients
already tested.
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Allergic response to ragweed exposure in an EEC (4-hour exposure) is determined for each subject at
baseline. The O-PPDS or placebo-PPDS is worn for 4 days and then subjects undergo another EEC
session during which symptoms (itchiness, redness, lid swelling, tearing and mucous discharge) are
assessed. After a 12-day washout, subjects receive 2 days of treatment with Patanol® (commercially
available olopatadine eye drops) or placebo eye drops before undergoing another EEC session to
assess allergic response.
Group 1 included 109 subjects: 54 in the O-PPDS arm and 55 in the placebo-PPDS arm. The mean age
was 41 years, and the majority of subjects were male (52%) and white (61%). In the O-PPDS arm, 54
subjects (100%) completed efficacy assessments to determine allergic response after O-PPDS
treatment, and 54 subjects (100%) completed efficacy assessments to determine allergic response
after Patanol® treatment. In the placebo-PPDS arm, 55 subjects (100%) completed efficacy
assessments to determine allergic response after placebo-PPDS treatment, and 54 subjects (98%)
completed efficacy assessments to determine allergic response after placebo eye drop treatment.
The primary variables are mean change from baseline in the area under the curve (AUC) of the
itching score during the EEC session, and mean change from baseline in the best (i.e., lowest)
itching score in the EEC. The difference between O-PPDS and placebo-PPDS in Group 1 was not
significant for either of these variables, nor were there significant differences in redness, lid
swelling, tearing or mucous discharge.
The O-PPDS was generally safe and well-tolerated in subjects with allergic conjunctivitis. The
incidence of adverse events considered associated with treatment was 33.3% during O-PPDS exposure
and 38.3% during placebo-PPDS exposure. There were no deaths or serious adverse events. The most
common adverse events noted during O-PPDS exposure were eye irritation (10.0%), eye pruritus
(itching) (6.7%), ocular discomfort (6.7%), and headache (6.7%). The most common adverse events
during placebo-PPDS exposure were ocular discomfort (18.3%), eye pain (10.0%), eye irritation
(8.3%), eye pruritus (8.3%), and ocular hyperemia (redness) (8.3%).
About the Olopatadine Punctal Plug Delivery System (O-PPDS)
The O-PPDS is a novel, sustained and controlled release drug delivery system that utilizes the puncta to house a drug-eluting device. The O-PPDS is currently being investigated as a treatment for allergic conjunctivitis. The punctal plug delivery system is a minimally invasive drug delivery system that is being developed with a goal of enabling delivery of a variety of drugs to the eye over time through sustained release to the tear film.
The O-PPDS is a novel, sustained and controlled release drug delivery system that utilizes the puncta to house a drug-eluting device. The O-PPDS is currently being investigated as a treatment for allergic conjunctivitis. The punctal plug delivery system is a minimally invasive drug delivery system that is being developed with a goal of enabling delivery of a variety of drugs to the eye over time through sustained release to the tear film.
About Olopatadine
Olopatadine blocks the release of histamine from mast cells. Olopatadine is an active pharmaceutical ingredient that has been approved by the Food and Drug Administration for the treatment of the signs and symptoms of allergic conjunctivitis and is marketed under the trade names Pataday and Patanol® in the U.S. (Alcon). U.S. sales of olopatadine were more than $380 million in 2009.
Olopatadine blocks the release of histamine from mast cells. Olopatadine is an active pharmaceutical ingredient that has been approved by the Food and Drug Administration for the treatment of the signs and symptoms of allergic conjunctivitis and is marketed under the trade names Pataday and Patanol® in the U.S. (Alcon). U.S. sales of olopatadine were more than $380 million in 2009.
About Allergic Conjunctivitis
Over 50 million people in the U.S. suffer from allergic diseases, and it is estimated that 40%-60% of the allergic population suffer from ocular symptoms. In allergic conjunctivitis, patients suffer from localized itchiness, redness, tearing, and swelling of the eyelid upon exposure of the eye to airborne allergens, such as pollen, mold, dust mites, or animal dander. In severe cases, chronic scratching of the eyes due to allergic symptoms may be associated with corneal or conjunctival scarring, growth of blood vessels in the cornea, and changes in visual acuity.
Over 50 million people in the U.S. suffer from allergic diseases, and it is estimated that 40%-60% of the allergic population suffer from ocular symptoms. In allergic conjunctivitis, patients suffer from localized itchiness, redness, tearing, and swelling of the eyelid upon exposure of the eye to airborne allergens, such as pollen, mold, dust mites, or animal dander. In severe cases, chronic scratching of the eyes due to allergic symptoms may be associated with corneal or conjunctival scarring, growth of blood vessels in the cornea, and changes in visual acuity.
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About QLT
QLT Inc. is a biotechnology company dedicated to the development and commercialization of innovative therapies for the eye. We are focused on our commercial product Visudyne® for the treatment of wet-AMD, developing drugs to be delivered in our proprietary punctal plug delivery system, as well as developing our synthetic retinoid program for the treatment of certain inherited retinal diseases. For more information, visit our website at www.qltinc.com.
QLT Inc. is a biotechnology company dedicated to the development and commercialization of innovative therapies for the eye. We are focused on our commercial product Visudyne® for the treatment of wet-AMD, developing drugs to be delivered in our proprietary punctal plug delivery system, as well as developing our synthetic retinoid program for the treatment of certain inherited retinal diseases. For more information, visit our website at www.qltinc.com.
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QLT Inc. Media Contact:
Vancouver, Canada
Karen Peterson
Telephone: 604-707-7000 or 1-800-663-5486
kpeterson@qltinc.com
Vancouver, Canada
Karen Peterson
Telephone: 604-707-7000 or 1-800-663-5486
kpeterson@qltinc.com
The Trout Group Investor Relations Contact:
New York, USA
Christine Yang
Telephone: 646-378-2929
cyang@troutgroup.com
Or
Boston, Massachusetts, USA
Tricia Swanson
Telephone: 646-378-2953
tswanson@troutgroup.com
New York, USA
Christine Yang
Telephone: 646-378-2929
cyang@troutgroup.com
Or
Boston, Massachusetts, USA
Tricia Swanson
Telephone: 646-378-2953
tswanson@troutgroup.com
Visudyne® is a registered trademark of Novartis AG.
Patanol® is a registered trademark of Alcon Research, Ltd.
Pataday is a trademark of Alcon, Inc.
Patanol® is a registered trademark of Alcon Research, Ltd.
Pataday is a trademark of Alcon, Inc.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol QLTI and on The Toronto
Stock Exchange under the trading symbol QLT.
Certain statements in this press release constitute forward looking statements of QLT within the
meaning of the Private Securities Litigation Reform Act of 1995 and constitute forward looking
information within the meaning of applicable Canadian securities laws. Forward looking statements
include, but are not limited to: our clinical trial and other development plans related to our
punctal plug drug delivery system program, including the L-PPDS and O-PPDS, including progression
of studies and timing to receive data; our expectations relating to the potential benefits of the
L-PPDS and O-PPDS; and statements which contain language such as: assuming, may, prospects,
future, projects, believes, expects and outlook. Forward-looking statements are
predictions only which involve known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from those expressed in such statements. Many such
risks, uncertainties and other factors are taken into account as part of our assumptions underlying
these forward-looking statements and include, among others, the following: the Companys future
operating results are uncertain and likely to fluctuate; uncertainties relating to the timing and
results of the clinical development and commercialization of our products and technologies
(including, Visudyne, our punctal plug technology and our synthetic retinoid program); outcomes for
our clinical trials of our programs (including our punctal plug technology and our synthetic
retinoid program) may not be favorable or may be less favorable than interim results and/or
previous trials; there may be varying
interpretations of data produced by clinical trials; uncertainties relating to the associated costs
of our programs; the timing, expense and uncertainty associated with the regulatory approval
process for products; uncertainties regarding the impact of competitive products and pricing; risks
and uncertainties associated with the safety and effectiveness of our technology and products,
including our synthetic retinoid product; risks and uncertainties related to the scope, validity,
and enforceability of our intellectual property rights and the impact of patents and other
intellectual property of third parties; and general economic conditions and other factors described
in detail in QLTs Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings
with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities.
Forward looking statements are based on the current expectations of QLT and QLT does not assume any
obligation to update such information to reflect later events or developments except as required by
law.
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