Got Allergies? FDA to the Rescue

Spring flowers mean spring allergies and big bucks for an industry hoping to crack the allergy code.

Apr 12, 2014 at 10:00AM

Fresh-cut grass is Kryptonite to allergy sufferers, but a new pill from French drug company Stallergenes may get millions of weekend warriors back outdoors this summer.

The FDA's approval of Stallergenes' grass-allergy pill, Oralair, offers a new, more convenient choice for the 3 million or so Americans who visit doctors offices for weekly allergy shots.

The once-daily Oralair combats allergies to five common grasses: sweet vernal, orchard, perennial rye, timothy, and Kentucky bluegrass. The pill, which dissolves under the tongue, helps the body's immune system build up resistance to the pollen from those grasses.

The FDA is also considering two more allergy pills made by industry giant Merck (NYSE:MRK).  

Claritin

Source: http://www.claritin.com/products/index.aspx.

New treatments are in bloom
Merck has long been at the forefront of allergy treatment, and millions of people are already taking the company's widely successful over-the-counter allergy drug Claritin.

Merck hopes it can follow up Claritin's success with a flurry of promising new drugs, including Grastek -- its own grass-allergy tablet.

Merck submitted Grastek for FDA consideration last year, and the agency is expected to decide whether to approve the hay-fever treatment before summer.

Grastek breezed through the allergy panel responsible for making recommendations to the FDA in December, and approval would make the drug the first treatment specifically designed for allergies to timothy grass, which is native to Europe -- where Merck is already selling Grastek as Grazax -- and has become widespread in North America.

If approved, whether your doctor prescribes Oralair or Grastek first would likely depend on which grasses are most common in your area and your overall exposure to them. Regardless, an approval would give doctors a second tablet option that could be used in patients who don't respond well to the other product, or to shots.

The FDA is also considering Merck's ragweed pollen pill Ragwitek. Ragweed is among the most common late-summer allergies, and between 10% and 30% of Americans are allergic to pollen from its 17 different species. Although ragweed is more common in eastern states and the Midwest, it's found just about everywhere.

The FDA's allergy advisory panel in January recommended the agency approve Ragwitek, clearing the way for a decision soon.

That's all good news for those suffering outdoor allergies, but what about indoor allergens? Don't worry, Merck is developing a potential treatment for dust-mite allergies, too. 

In March, Merck announced that its dust-mite allergy pill improved 24-week nasal symptoms by nearly 50% at its highest dose during human trials. As a result, the company plans to start enrolling patients in a final phase 3 trial soon -- so stay tuned.

Fool-worthy final thoughts
The over-the-counter allergy market has become increasingly crowded over the past few years as Claritin battles against its own generic version and against the generic versions of Johnson & Johnson's (NYSE:JNJ) Zyrtec and Sanofi's (NYSE:SNY) Allegra. 

All three were former blockbusters before losing their patent exclusivity. Zyrtec racked up more than $1.5 billion in sales back in 2008, while Allegra notched a similar annual sales rate back in 2005. And Claritin generated more than $2 billion a year in its heyday.

Today, sales of each are measured in the hundreds of millions rather than the billions. While Johnson & Johnson doesn't break out sales for Zyrtec, Sanofi sold a bit more than $550 million worth of Allegra last year. That was down 12% from 2012. Claritin's sales came in a bit north of $450 million last year, but that represented less than 1% of Merck's global sales. 

Unlike Merck, Johnson & Johnson and Sanofi's allergy aspirations seem to have stalled -- neither shows any allergy products in their drug pipelines.

As a result, Merck seems fine with jettisoning its consumer products business, including Claritin, to a competitor, a move made less difficult by the potential launch of these new allergy pills. Although it's unclear how much the pills will cost and how many doctors will prescribe them, it seems a new day may be dawning for allergy sufferers.

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