FDA considers combo allergy pill
has been accepted for review by the US Food and Drug Administration
(FDA).
The new drug application (NDA) was made by Schering-Plough and Merck & Co under a joint venture partnership, and concerns a new treatment combining the active ingredients in the firms' best-selling allergy treatments, Claritin (loratadine) and Singulair (montekulast). The new combo will be for the treatment of allergic rhinitis symptoms and available via prescription, should it gain approval from US regulators. Back in 2002 the two companies reported that Phase III trials of their fixed-combination tablet did not demonstrate a "statistically significant improvement in the treatment of seasonal allergic rhinitis compared to each product administered separately," but opted to continue Phase III clinical development nonetheless. As to what developments occurred over the five year gap to make the combination product viable again after the 2002 stumbling block, a Schering-Plough spokesperson would only allude to "additional data" that was filed with the NDA, which presumably revealed some clinical benefit to be gained from the combo pill. Claritin and Singulair are both good earners for their respective companies, and a combination product that brings the best of both together in one pill could be a profitable addition to the firms' portfolios. Schering's Claritin is an anti-histamine marketed on the back of its non-sedative properties, and Merck's Singulair is a once daily leukotriene receptor agonist for the treatment of asthma and allergies. A Claritin/Singular combined formulation is hoped to have the potential to treat allergies by blocking two key mediators of inflammation in the respiratory tract, histamine and leukotrienes. Over-the-counter (OTC) Claritin has performed healthily over the first half of this year, bringing in $264m, with prescription Claritin sales bringing in another $214m. Merck's Singulair, however, eclipses these figures substantially, having brought in over a billion dollars over the second quarter alone. Following the second quarter results, Merck upped its guidance for the full year 2007, and has forecast Singulair sales to hit $4-$4.3bn. US-PharmaTechnologist.com understands that the figures enjoyed by Merck as a result of Singulair's success are being seen as a reasonable marker for potential sales of the new combination tablet should it gain approval. The product is the result of a collaboration between the two companies dating back to 2000, when Schering-Plough and Merck & Co formed a joint venture to develop and market the combination allergy treatment. At the same time, the companies instigated a separate collaboration working on products for cholesterol management. This partnership led to first-in-class drug Zetia (ezetimibe), combination product Vytorin (ezetimibe, simvastin) and a few months ago the announcement that the two firms would be embarking on a project to develop a new product combining ezetimibe with atorvastatin, the active ingredient in Pfizer's Lipitor. Should the FDA approve the new allergy treatment, a process that usually takes the best part of a year, the two companies appear to be hoping for a multi-million (if not multi-billion) dollar revenue stream to be generated from the new product - a figure definitely not to be sneezed at.
