New positive study results presented for Dymista

New positive study results presented for Dymista

 

Meda presents new positive results from a Phase-III clinical trial of
Dymista (also known as MP29-02) at the annual meeting of the European
Academy of Allergy and Clinical Immunology (EAACI) in Istanbul, Turkey
(11-15th June 2011)1-5.

By 2015, half of all Europeans will suffer from an allergy according to
the European Federation of Allergy and Airway Diseases6. Allergic
rhinitis (AR) has become a challenge to treat, mainly due to an increase
in the prevalence of severe allergic rhinitis over the last decade.
Currently, 500 million people around the world suffer from AR with
approximately three quarters suffering from moderate-to-severe forms of
the disease7,8,9,10. Up to 77.8% are non-compliant with their intranasal
corticosteroid therapy11,12, while 3 out of 4 patients use various
combination therapies to control their symptoms13. The cost associated
with AR is significant14.

According to the ARIA (Allergic Rhinitis and its Impact on Asthma)
guidelines, there is a need for high-quality, direct comparison rhinitis
effectiveness studies15 that will allow healthcare professionals and
patients to assess the added value of new products over currently used
ones in their efforts to manage AR more effectively.

Earlier this year, Meda presented parts of the Dymista clinical
development program at the AAAAI meeting in San Francisco showing that
Dymista was more effective in reducing nasal rhinitis symptoms than the
leading nasal corticosteroid fluticasone. Meda will now present data
from 3 randomized, placebo-controlled, parallel-group studies at EAACI
2011, conducted with over 2,200 patients. The results show that Dymista
is a breakthrough product for the treatment of AR, as it is more
effective than intranasal fluticasone propionate or azelastine nasal
sprays in reducing nasal rhinitis symptoms, while presenting no safety
concerns1-5.

Importantly, Dymista provides clinically relevant symptom improvement
significantly earlier and in more patients than compared to current
standard therapies. It is also highly effective in controlling ocular
symptoms associated with allergic rhinoconjunctivitis.1-5

In study MP4001, a post-hoc responder analysis revealed that almost half
of all patients treated with Dymista (49.1%) achieved a
clinically-significant 50% improvement in rTNSS (Total Nasal Symptom
Score). Time to reach this clinically relevant response also favored
Dymista, at 5-6 days earlier than fluticasone propionate or azelastine
monotherapy.

The benefits of Dymista were summarized by Professor Claus Bachert
(Professor of Medicine at the University of Ghent in Belgium) who
concluded that “the novel Dymista nasal spray shows better efficacy than
standard therapy for AR and provides clinically relevant TNSS reduction
significantly earlier and in a larger number of patients”.

The fact that Dymista provides relevant TNSS reduction earlier than
standard therapy for AR was highlighted in the spring study (MP4002)
presented by Professor Jean Bousquet (Professor of Pulmonary Medicine at
the University of Montpellier in France and Founder and Chairman of
ARIA). The significant superiority of Dymista over conventional rhinitis
therapies became apparent from the first day of evaluation. The rapid
response to Dymista is important, as patients want fast-acting and
long-lasting symptom relief16.

Results from study MP4004, conducted during the autumn allergy season,
were presented by Professor David Price (Professor of Primary Care
Respiratory Medicine at the University of Aberdeen in Scotland) and Dr
Warner Carr (MD, FAAAAI, FACAAI, Allergy & Asthma Associates of Southern
California and principal investigator). In this study, onset of action
and efficacy against ocular symptoms (rTOSS) was assessed. Onset of
action was achieved within 30 minutes following Dymista administration.
Dymista also significantly reduced ocular (rTOSS) symptoms to a greater
extent than fluticasone propionate. This is an important attribute of
Dymista, as patients with AR frequently have the associated condition of
allergic conjunctivitis and as a result suffer from bothersome ocular
symptoms in addition to nasal symptoms.

“Dymista is an important product since it has the potential to help
millions of AR suffers find better relief from their symptoms. A new
drug application for Dymista was submitted to the FDA in April 2011. The
application was recently accepted by the FDA as sufficiently complete to
permit a substantive review. We expect to submit the file to European
regulatory authorities later this year”, said Anders Lönner, CEO of Meda
AB.

For further inquiries, please contact:

Anders Larnholt, Vice President Corporate Development & IR ph: 46
709-458 878