WHITEHOUSE STATION, N.J.—Roughly a month ago, Merck & Co.—known as MSD outside the United States and Canada—said it was “pleased with the positive discussion of Ragwitek at the Allergenic Products Advisory Committee [APAC] meeting of the U.S. Food and Drug Administration [FDA].”
Any why not? While the FDA isn’t bound by the guidance of APAC, the federal agency tends to go with the recommendations of its various committees. And this comes on the heels of Merck’s grass allergen tablet Grastek being unanimously endorsed by the APAC in December 2013. Merck partnered with Danish drugmaker ALK-Abello to develop its investigational sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite-induced allergic rhinitis in North America, and Grastek and Ragwitek are the first fruits of this collaboration.
“We appreciate the thoughtful discussion at today's advisory committee meeting,” said Dr. Sean Curtis, vice president of respiratory and immunology at Merck Research Laboratories, shortly after the APAC decision. “We believe Ragwitek has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer from ragweed-induced allergic rhinitis.”
But while Merck may be pleased with the APAC decision about a month ago and the prospect of FDA approval in the first half of this year most likely, will it be pleased with the take that London-based GlobalData has on the prospects of this therapeutic agent?
As the global research and consulting firm puts Merck’s position, “the healthcare giant still faces a number of significant challenges even if approval is granted.”
The APAC’s support for Ragwitek’s Biologics License Application (BLA) is a positive step forward for the ragweed allergen therapy, GlobalData notes of Merck’s second offering to arise from its partnership with ALK-Abello.
“If either of these tablets’ BLA is successful, it will become the first sublingual immunotherapy to be approved for use in [allergic rhinitis] in the U.S., as patients with a severe form of the increasingly prevalent condition are currently treated with subcutaneous immunotherapy (SCIT),” noted Dr. Claire Gibson, GlobalData’s healthcare analyst covering cardiovascular and metabolic disorders. “While highly inconvenient, SCIT-delivered allergen extracts are cheap and considered very safe, despite a lack of safety and efficacy testing in clinical trials. Meanwhile, allergy immunotherapy tablet (AIT) formulations are currently being evaluated in clinical trials, and even though this therapy is undoubtedly more convenient, allowing patients to self-administer the medication at home, its efficacy is often doubted.”
While the potential approval of Merck’s AITs will represent a pioneering step forward in registered, FDA-approved allergic rhinitis treatments in the United States, GlobalData does not expect them to revolutionize the allergic rhinitis immunotherapy market.
“Allergen extracts in the U.S. are currently prepared by physicians ‘in house’ according to individual patients’ needs,” Gibson said. “Without a financial incentive, physicians may be reluctant to prescribe the standardized allergen tablets over SCIT. Furthermore, both Ragwitek and Grastek are aimed at treating a single allergy, while Stallergenes’ AIT Oralair, which was also recommended by the APAC last year, contains grass allergens for Kentucky blue, orchard, perennial rye and sweet vernal. Additionally, Oralair is only taken for approximately six months a year, whereas Merck’s Grastek must be taken all year round.”
On the other hand, as a Reuters article about the APAC’s decision noted, many analysts see eventual Ragwitek sales of about $300 million annually, which could bode well for Merck, AK-Abello and Stallergenes, even if AITs don’t end up representing blockbuster potential. And perhaps they could, as Morningstar analyst Damien Conover expressed his belief that sales for Ragwitek alone could reach as much as $1 billion if enough allergy sufferers decide they prefer Ragwitek, which is a pill, to getting the injections that such allergy sufferers currently must turn to.