MEDA: New Positive Study Results Presented for Dymista

Update: Dymista (azelastine/fluticasone) Nasal Spray Now FDA Approved - May 1, 2012

GÖTEBORG, Sweden--(BUSINESS WIRE)--Jun 15, 2011 - Regulatory News: Meda (STO:MEDAA) 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.

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.

References

1. Bachert C, Hampel F, Sacks H, Maus J, Munzel U, Price D, Bousquet J. MP29-02 and time to response in the treatment of seasonal allergic rhinitis compared to marketed antihistamine and corticosteroid nasal sprays. Presenterad vid European Academy of Allergy and Clinical Immunology-kongressen, Istanbul, Turkiet, 11-15 juni 2011.

2. Meltzer E, Carr W, Sacks H, Price D, Bachert C, Bousquet J. MP29-02 in the symptomatic treatment of seasonal allergic rhinitis – a comparative Spring study. Presenterad vid European Academy of Allergy and Clinical Immunology-kongressen, Istanbul, Turkiet, 11-15 juni 2011.

3. Carr W, Bernstein J, Sacks H, Price D, Bachert C, Bousquet J. MP29-02 in the symptomatic treatment of seasonal allergic rhinitis – a comparative Fall study. Presenterad vid European Academy of Allergy and Clinical Immunology-kongressen, Istanbul, Turkiet, 11-15 juni 2011.

4. Carr W, Bernstein J, Sacks H, Bachert C, Price D, Maus J, Munzel U, Bousquet J. MP29-02 in the symptomatic treatment of ocular symptoms of seasonal allergic rhinoconjunctivitis. Presenterad vid European Academy of Allergy and Clinical Immunology-kongressen, Istanbul, Turkiet, 11-15 juni 2011.

5. Bachert C, Carr W, Sacks H, Munzel U, Maus J, Price D, Bousquet J. Time to response and onset of action of MP29—02 in the symptomatic treatment of seasonal allergic rhinitis. Presenterad vid European Academy of Allergy and Clinical Immunology-kongressen, Istanbul, Turkiet, 11-15 juni 2011.

6. EAACI Position paper 2006 - hämtat från [http://www.efanet.org/allergy/documents/EUSummitReportonAllergicDiseases.pdf] [den 11.03.28]

7. Bachert C, Van Cauwenberge P, Olbrecht, Van Schoor J. Prevalence, classification and perception of allergic and nonallergic rhinitis in Belgium. Allergy 2006;61(6):693-8.

8. Bousquet J, Khaltaev N, Cruz AA, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen).Allergy. 2008 Apr;63 Suppl 86:8-160.

9. Bousquet J, Bachert C, Canonica GW, Extended Global Allergy and Asthma European Network, World Allergy Organization and Allergic Rhinitis and its Impact on Asthma Study Group. Unmet needs in severe chronic upper airway disease (SCUAD). J Allergy Clin Immunol. 2009 Sep;124(3):428-33. Epub 2009 Aug 5.

10. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;62 Suppl 85:17-25.

11. Valovirta E, Myrseth SE, Palkonen S. The voice of the patients: allergic rhinitis is not a trivial disease. Curr Opin Allergy Clin Immunol. 2008 Feb;8(1):1-9.

12. Loh CY, Chao SS, Chan YH, et al. A clinical survey on compliance in the treatment of rhinitis using nasal steroids. Allergy. 2004 Nov;59(11):1168-72.

13. Demoly P, Allaert FA, Lecasble M; PRAGMA. ERASM, a pharmacoepidemiologic survey on management of intermittent allergic rhinitis in every day general medical practice in France. Allergy. 2002 Jun;57(6):546-54.

14. Hellgren J, Cervin A, Nordling S, Bergman A, Cardell LO. Allergic rhinitis and the common cold--high cost to society. Allergy. 2010 Jun 1;65(6):776-83.

15. Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76.

16. Marple BF, Fornadley JA, Patel AA, et al. Keys to successful management of patients with allergic rhinitis: focus on patient confidence, compliance and satisfaction. Otolaryngol Head Neck Surg 2007;136(6 Suppl):S107-24.

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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Posted: June 2011

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