Merck & Co says it expects to file its allergy immunotherapy pills in 2013 which have been developed with Danish drugmaker ALK-Abello.
The announcement came after the drugs major presented results from a Phase III study of its investigational allergy immunotherapy tablet (AIT) for ragweed pollen. The study results showed that it significantly reduced the total combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo.
Specifically, the trial involved 565 patients between 18 and 50 with ragweed-induced allergic rhinoconjunctivitis, with or without asthma. They were randomised to receive a once-daily tablet of Ambrosia artemisiifolia (ragweed) allergen extract or placebo for a year.
Rupert Vessey, head of respiratory & immunology at Merck Research Laboratories, said the firm is pleased patients who took its AIT experienced a significant reduction in the nasal and eye symptoms caused by ragweed allergies. "These positive results are an important step in the development of this investigational therapy,” he added.
Merck plans to file New Drug Applications for its ragweed and grass AITs with the US Food and Drug Administration in 2013. The company already is a major player in the allergy market, notably through Nasonex/Asmanex (mometasone), which brought in $325 million in the fourth quarter, a rise of 7%.
FDA issues CRL on Zetia/Lipitor combo
More disappointing news for Merck came with the news that the US Food and Drug Administration has issued a complete response letter regarding its NDA for a combination of Zetia (ezetimibe) and Pfizer's now off-patent Lipitor (atorvastatin).
The agency advised Merck that additional data are needed and the company says it will discuss next steps with the FDA in the near future. Part of those discussions could include "new data that are expected to be available later this year, which may address the FDA's comments".
The matter is also complicated by a lawsuit filed by Pfizer last year which alleges that Merck's NDA for the combo infringed on patents covering atorvastatin.