Meda (sto:MEDAA) 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) 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) [iii] (file:///C) 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)

"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 Lonner, 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) 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.

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

This press release is not an offer to sell or a solicitation to buy shares in 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 relate only to historical or current facts, and may sometimes include words such 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 results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, Meda's ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Meda AB's interim or annual reports, prospectuses or press releases. Listeners and readers are cautioned that no forward-looking statement is a guarantee of future performance and that actual result could differ materially from those contained in the forward-looking statements. Meda does not intend, nor undertakes, to update any such forward looking statements.

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[i] (file:///C) 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 (C) 2007 Medscape http://www.medscape.com/viewarticle/560750

[ii] (file:///C) 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) 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) 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) AAFA Allergy Fact & Figures. Available at http://www.aafa.org/display.cfm?id=9&sub=30 #_ftnref1. Accessed on January 20, 2012.

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SOURCE: MEDA

A New Drug Application for a novel formulation of azelastine hydrochloride and fluticasone
propionate, tentatively named “Dymista”, has been submitted to the U.S. Food and Drug

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.

Meda (STO:MEDAA) announced  positive results from a Phase III clinical trial of Dymista (also known as MP29-02), a novel formulation of azelastine hydrochloride and fluticasone propionate, in patients with seasonal allergic rhinitis (SAR). Patients treated with Dymista experienced a 40 percent greater improvement in nasal symptoms, including congestion, relative to fluticasone. The mono substances (in the nasal antihistamine and corticosteroid markets respectively) both have leading positions in the U.S. The fast onset compared to placebo, as well as more rapid relief and greater response rate compared to either fluticasone and azelastine alone, or placebo, was also demonstrated in this study. The study results are published online in Journal of Allergy Clinical Immunology and were  presented at the 2011 annual meeting of the American Academy of Asthma, Allergy and Immunology (AAAAI) in San Francisco, CA.

"Seasonal allergic rhinitis is a condition causing great discomfort and inconvenience for many people," said Warner W. Carr, MD, FAAAAI, FACAAI, Allergy & Asthma Associates of Southern California, principal investigator and lead author of this study. "These results suggest that Dymista provides greater relief of the most frequent nasal symptoms than these treatments alone, and is well tolerated."

Clinical Trial

Dymista was studied in a Phase III randomized, double-blind, placebo-controlled trial of two weeks duration conducted in nearly 800 patients with seasonal allergic rhinitis (SAR). The primary efficacy variable was the change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and running nose. Symptoms were scored twice daily on a 4-point scale. In this study, Dymista was compared to placebo (same vehicle as Dymista minus azelastine and fluticasone), azelastine hydrochloride monotherapy (in the Dymista vehicle) and fluticasone propionate (in the Dymista vehicle).

In this study, Dymista nasal spray significantly improved the TNSS compared to placebo and either fluticasone or azelastine alone during a 14-day treatment period. Dymista demonstrated a 40 percent improvement in TNSS relative to fluticasone. Both fluticasone or azelastine alone were more effective than placebo (P<.001). Dymista was effective for treating all individual symptoms of the TNSS (P<.001 vs. placebo), including nasal congestion vs. fluticasone. The therapy was generally well-tolerated. Headache (3.1%) and dysgeusia (2.1%) were the most commonly reported adverse events with Dymista.

In another analysis of this study, a key secondary efficacy variable was onset of action, defined as sustained statistically significant superiority versus placebo in instantaneous TNSS during a 4-hour observation period. Onset of action was achieved within 30 minutes following the first dose with Dymista vs. placebo. In a post-hoc analysis of time-to-treat response (50% change in TNSS), response was reached days earlier which was statistically significant and more responders were observed with Dymista (53.5% vs. ‰¤43.7%) than with either fluticasone or placebo.

"Optimal treatment of this common condition should reduce symptoms as effectively and quickly as possible", continued Dr. Carr. "These data clearly show that Dymista applied right at the site – in the nasal passage – is more effective than fluticasone proprionate, a current standard of care, and provides fast-acting relief of nasal symptoms associated with seasonal allergic rhinitis."

"Based on these positive data, we intend to submit a marketing application to the FDA during the first half of 2011," said Anders Lönner, CEO Meda AB. "Dymista could become the first product which has better efficacy than currently available standard allergic rhinitis nasal therapy. We hope to deliver this new option for the treatment of SAR to benefit the patients who routinely suffer from this condition."

[i] (https://connect.ne.cision.com/#_ednref1) Bernstein JA, Munzel U, et al. Onset of Action of MP29-02 in the Treatment of Seasonal Allergic Rhinitis. J Allergy Clin Immunol 2011; 127; 2; Abstracts 199

[ii] (https://connect.ne.cision.com/#_ednref2) Carr W, Shah SR, et al. MP29-02 in the Treatment of Nasal Symptoms of Seasonal Allergic Rhinitis. J Allergy Clin Immunol 2011; 127; 2; Abstracts 199

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.

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