Advair and Symbicort Looming Patent Expiration

#1 Dee

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02 September 2008 - 10:05 AM

GSK and AstraZeneca Pursue Strikingly Different Strategies to Recapture Market Share from Looming Patent Expiries of Advair and Symbicort

NEW YORK – Aug. 27, 2008 - The pivotal role of fixed-dose combinations (FDCs) in asthma management and the increasing use of these combinations in chronic obstructive pulmonary disease (COPD), coupled with looming patent expiries for GlaxoSmithKline’s Advair (fluticasone/salmeterol) and AstraZeneca’s Symbicort (budesonide/formoterol), have spurred significant clinical trial activity. In an article published in the September issue of GCPj, Citeline authors, Drs. Sylvia Marecki and Laura Runkel examine the fixed-dose-combination (FDC) trials landscape for asthma and COPD and find that, alongside some new hopeful market entrants, GSK and AstraZeneca are pursuing different strategies for their looming patent expiries.

According to author Sylvia Marecki, “Both GlaxoSmithKline and AstraZeneca stand to lose significant market share to new entrants in the FDC market segment following patent expiries and they appear to have strikingly different strategies for recapturing share. GlaxoSmithKline is protecting near-term market share with next-generation FDCs and exploring novel targets that could result in new revenue streams in the longer term. AstraZeneca is not developing any novel clinical-stage FDCs independently or as part of a collaboration but instead is heavily invested in developing novel agents for long-term market growth.”

This article also examines clinical trials activity involving novel targets, and discusses the key role that alliances are playing in shaping the FDC trials landscape for asthma and COPD. Says Dr. Runkel, “Several of the emerging FDCs are being spearheaded through alliances among originators or marketing companies. A common feature of many of these collaborations is the contribution of one or more drug candidates to the programme from each company. Among the top eight collaborations in asthma, COPD and allergic rhinitis ranked by number of ongoing trials, six involve development of an FDC.”

Author Marecki notes, “FDC-driven growth of the respiratory market will probably be dominated by GlaxoSmithKline and new entrants such as Novartis, Boehringer-Ingelheim and Almirall; whereas AstraZeneca stands to regain market share in the longer term through development of novel therapies.”

#2 BLC

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02 September 2008 - 01:00 PM

Does the ending of the patent mean that we could be seeing generic forms of Advair. I hope, I hope, I hope! :(

#3 Guest_Eileen/MA_*

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02 September 2008 - 01:07 PM

It sure does, Brian! That's the same thing that happened with Spiriva/Symbicort. The much cheaper Symbicort was available overseas for a year or two but couldn't be sold here until the patent expired.

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