Positive results for Dymista in three clinical studies

Positive results for Dymista in three clinical studies

Meda announced today positive results of three studies of MP29-02 (tentatively
called Dymista), a novel intranasal formulation of azelastine hydrochloride and
fluticasone propionate. The first study demonstrated that continuous treatment
with MP29-02 for 1 year was well tolerated in patients with chronic allergic or
non-allergic rhinitis, only 2.7% of patients treated with MP29-02 and 2.9% of
patients treated with fluticasone propionate discontinued the study due to an
adverse event. MP29-02 also provided sustained efficacy over the one-year study
period. MP29-02-treated patients experienced consistently greater relief from
their nasal symptoms than fluticasone treated patients over the course of the
study. Statistically significant (P<.05) differences favoring MP29-02 over
fluticasone were observed at months 1 through 7 and at months 9 and 11. 

The second and third studies in patients with seasonal allergic rhinitis (SAR)
provided evidence that MP29-02 demonstrated significantly more effective relief
of nasal symptoms (P<.05 vs. azelastine, fluticasone, and placebo) and
significantly greater ocular benefits compared to placebo (P<.05) over a 2-week
study period. The new data was the subject of platform presentations on Sunday,
March 4, 2012 at the annual meeting of the American Academy of Allergy Asthma
and Immunology (AAAAI) in Orlando, Florida. MP29-02 is currently under review by
the U.S. Food and Drug Administration (FDA) for the treatment of SAR.

“These data show support for the safety and efficacy of this novel nasal spray
formulation, especially for patients who have persistent symptoms of seasonal
allergic rhinitis that may require longer-term treatment,” said William E.
Berger, MD, FAAAAI, FACAAI, Asthma & Allergy Associates of Southern California,
lead author of the first study.

In the United States, ocular symptoms linked to allergies, also known as
“allergic conjunctivitis” or “ocular allergy”, are known to affect more than 20
percent of the
population[i] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%
20Dymista%20in%20three%20clinical%20studies.docx#_edn1) and can have a negative
effect on visual function, daily activities, and quality of life.  It is common
for patients with allergic rhinitis to suffer from bothersome ocular symptoms in
addition to nasal symptoms, with a high prevalence and pattern that correlate
with season, region, and environmental triggers.  

“In addition to nasal congestion, runny nose and sneezing, ocular symptoms such
as watering and red, itchy eyes are particularly prevalent in seasonal allergic
rhinitis sufferers and can be extremely irritating and distressing”, said Paul
H. Ratner, M.D., M.B.A., Sylvana Research, San Antonio, TX, principal
investigator and lead author of the second and third studies. “The potential for
more complete relief of the constellation of symptoms would represent a
significant benefit to patients and a major advance in the treatment of seasonal
allergic rhinitis.”

Long-Term Safety Study
In study MP4000, presented by Dr. Berger, the long-term safety of MP29-02 was
evaluated in 612 patients with chronic allergic or non-allergic rhinitis over
the course of one year.  In this randomized, open-label, active-controlled,
parallel-group study, patients were treated with either MP29-02 one spray per
nostril twice daily (total daily doses of azelastine and fluticasone were 548
mcg and 200 mcg, respectively) or fluticasone propionate two sprays per nostril
once daily (total daily dose 200 mcg).  Safety and tolerability assessments were
conducted at regular intervals during the one-year study and efficacy was
assessed as a secondary endpoint by the 12-hour reflective total nasal symptom
score (rTNSS) scored once daily in the evening each day of the study. 

The results showed that MP29-02 was well tolerated. The most common
treatment-related adverse events were headache in 4.3 percent of patients taking
fluticasone and dysgeusia in 2.5 percent of patients taking MP29-02.  There were
no clinically relevant nasal examination findings, in particular no evidence of
nasal ulceration or perforations in either group.  Ocular examinations were also
unremarkable. No appreciable changes in laboratory values were observed during
the study and there were no significant changes from baseline in serum cortisol
levels in either treatment group.
In addition, based on the rTNSS, the efficacy of MP29-02 was sustained over the
one-year duration of the
study.[ii] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20D
ymista%20in%20three%20clinical%20studies.docx#_edn2)
[iii] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymist
a%20in%20three%20clinical%20studies.docx#_edn3) MP29-02-treated patients
experienced greater relief from their nasal symptoms than fluticasone propionate
treated patients, with statistical significance (P<0.05) achieved up to and
including week 28, and treatment difference maintained consistently for 52
weeks.

Ocular Symptoms Studies
In an analysis of two pivotal studies (MP4002 and MP4004), presented by Dr.
Ratner, MP29-02 was evaluated for the treatment of ocular symptoms associated
with SAR, a key secondary endpoint in the MP29-02 clinical development program. 

These key clinical efficacy and safety studies of MP29-02 were randomized,
double-blind, placebo- and active-controlled two week trials conducted in more
than 1600 patients with moderate-to-severe SAR. While the primary endpoint was
change from baseline in the 12-hour reflective total nasal symptom score
(rTNSS), the key secondary endpoint was the 12-hour reflective total ocular
symptom score (rTOSS), consisting of itchy eyes, watery eyes, and eye redness.
All patients were treated with one spray per nostril twice daily using the same
vehicle and delivery device.

In addition to more effective relief of nasal symptoms, results demonstrated
MP29-02 significantly (P<.05) improved the total ocular symptom score (TOSS)
compared to placebo.  In a post-hoc analysis, significantly (P<.05) more
patients treated with MP29-02 experienced a clinically important 50 percent
improvement in ocular symptoms than patients treated with fluticasone or
azelastine in study MP 4004, and, in a second post-hoc analysis, MP29-02
appeared to be particularly effective in patients with more severe symptoms.
MP29-02 was well tolerated in these two-week studies and the incidence of
adverse events in the MP29-02 group generally was similar to the azelastine and
fluticasone treatment
groups.[iv] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20
Dymista%20in%20three%20clinical%20studies.docx#_edn4) 

“We are very pleased about the continuous flow of strong results from our Phase
III pivotal studies supporting the unique clinical profile of Dymista,” said
Anders Lönner, CEO of Meda AB.  “These data provide additional important
evidence that Dymista can offer significant benefits to patients and may play a
critical role in the future treatment of patients with SAR."

About Seasonal Allergic Rhinitis
Approximately 40 million people in the U.S. suffer from seasonal and perennial
allergic
rhinitis.[v] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%2
0Dymista%20in%20three%20clinical%20studies.docx#_edn5) Seasonal allergic
rhinitis occurs during a specific season, commonly in the fall and spring, and
is caused by outdoor allergy triggers such as tree, grass or ragweed pollen.
Perennial allergic rhinitis occurs throughout the year and is typically caused
by indoor allergens such as dust mites, mold and animal dander. Symptoms of
allergic rhinitis, or hay fever, frequently include nasal congestion, runny
nose, sneezing, nose and itching.

The U.S. Food and Drug Administration informed Meda that the PDUFA (Prescription
Drug User Fee Act) date for MP29-02 will be early May 2012.

For further inquiries, please contact:
Anders Larnholt, Vice President Corporate Development & IR        ph: +46
709-458 878

 
MEDA AB (publ) is a leading international specialty pharma company. Meda’s
products are sold in 120 countries worldwide and the company is represented by
its own organizations in 50 countries. The Meda share is listed under Large Cap
on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit
www.meda.se.
 

Forward-looking Statements
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Meda. This press release also contains certain forward-looking statements with
respect to certain future events and Meda’s potential financial performance.
These forward-looking statements can be identified by the fact that they do not
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as “may”, “will”, “seek”, “anticipate”, “expect”, “estimate”, “intend”, “plan”,
“forecast”, “believe” or other words of similar meaning. These forward looking
statements reflect the current expectations on future events of the management
at the time such statements are made, but are made subject to a number of risks
and uncertainties. In the event such risks or uncertainties materialize, Meda’s
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are not limited to, risks associated with the inherent uncertainty of
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commercialization, the impact of competitive products, patents, legal
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forward-looking statement is a guarantee of future performance and that actual
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statements. Meda does not intend, nor undertakes, to update any such forward
looking statements.
  

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[i] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymista%
20in%20three%20clinical%20studies.docx#_ednref1) Leonard Bielory, MD; C. H.
Katelaris, MD; Susan Lightman, FRCP, FRCOphth, PhD; Robert M. Naclerio, MD
Treating the Ocular Component of Allergic Rhinoconjunctivitis and Related Eye
Disorders, Medscape Today Posted: 08/15/2007; Medscape General
Medicine. 2007;9(3):35 © 2007  Medscape
http://www.medscape.com/viewarticle/560750

[ii] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymista
%20in%20three%20clinical%20studies.docx#_ednref2) Berger W, et. al. Long Term
Safety Study of MP29-02 (novel intranasal formulation of azelastine
hydrochloride and fluticasone propionate) in Subjects with Chronic Allergic or
Non-allergic Rhinitis.  Presented at the 2012 Meeting of the AAAAI Mar 4, 2012.

[iii] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymist
a%20in%20three%20clinical%20studies.docx#_ednref3) Berger W, et. al. Long Term
Safety Study of MP29-02 (novel intranasal formulation of azelastine
hydrochloride and fluticasone propionate) in Subjects with Chronic Allergic or
Non-allergic Rhinitis.  Presented at the 2012 Meeting of the AAAAI Mar 4, 2012.

[iv] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymista
%20in%20three%20clinical%20studies.docx#_ednref4) Ratner P, et. al. MP29-02
(Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate)
in the Treatment of Ocular Symptoms of Seasonal Allergic Rhinitis (SAR). 
Presented at the 2012 Meeting of the AAAAI Mar 4, 2012.

[v] (file:///C:/Users/chrgoi/Desktop/Utskick/Positive%20results%20for%20Dymista%
20in%20three%20clinical%20studies.docx#_ednref5) AAFA Allergy Fact & Figures. 
Available at http://www.aafa.org/display.cfm?id=9&sub=30#_ftnref1.  Accessed on
January 20, 2012.