Danish allergy group ALK is trying to break into the US market, which is the most important global medicines market.

Tablet sales are slowly but steadily increasing, but the company still hasn't cracked the code to significantly increase its US sales.

The deal, which has just been publicized, secures ALK exclusive rights to market Otiprio, primarily to American ear, nose and throat doctors.

Otiprio is an antibiotic gel for severe middle ear infections, which affect 3.4 million patients a total of 4 million times a year in the US.

According to the group head of sales and marketing at ALK, Søren Niegel, the deal is the latest part of ALK's USA strategy, where the number of prescribing doctors is being significantly expanded.

"We are happy to collaborate with Otonomy over this deal, which offers ALK an FDA-approved product which is on the market, has a strong effect profile and has a patient-friendly dosage structure," Niegel says to MedWatch.

There are around 4,500 allergy specialists in the US, and the number of ear, nose and throat doctors is almost three times that.

As increasing numbers of these doctors are starting to treat allergies, it is crucially important for ALK to get their foot in the door with this group of doctors.

"For ALK, ear, nose and throat doctors are the next big group of doctors in the US that we would like to focus on after allergy doctors. They already make up a large portion of our revenue, and have been the fastest growing new segment of our US business," says Niegel.

On the market next month

ALK's three-year growth plan was initiated by CEO Carsten Hellmann in December 2017, and one of the most central focus areas was a large US effort, where a US sales and marketing department was to be built through a DKK 1 billion (USD 150 million) investment.

According to the company itself, ALK is ahead of schedule, and despite the corona pandemic, which has limited access to doctors and has delayed several of ALK's studies, is well on the way to realizing its goal of 10 percent annual growth and income levels at the same level as the rest of the market.

The sales rights to the new treatment will contribute to realizing these ambitions.

"I expect ALK to have Otiprio on the market as early as July or August this year," says Niegel, reporting that the US market for ear, nose and throat treatments is currently dominated by Novartis' product Ciprodex, and that generic products like Cortisporin also have significant shares in the market.

The deal with Otonomy, which was part of Novo Holding's venture portfolio until mid-2015, is long-term, and reimburses Otonomy for some of the support costs.

ALK is focusing on marketing to ear, nose and throat doctors, and will get a percentage of the gross sales of Otiprio, Niegel explains, without giving any specific figures.

Middle ear infections are more common during the summer, which fits in well with ALK's tablet portfolio, where most treatments are started in fall or winter, he says.

"As well as building a growth platform for our tablet products on the US market, we are focusing on developing new partnerships that will strengthen our product portfolio and commercial footprint in the USA," Niegel explains.

Failed in 2017

As well as Otonomy, ALK has recently entered into partnership agreements with a number of other companies, including biotech firm X-Chem from Massachusetts. The two companies will develop future allergy treatments together.

"The Otonomy deal is a good example of our efforts to increase our presence on the important US market by following up on opportunities through external partners as well as through our own research and development pipeline," says Niegel.

Otonomy was founded in 2008 and specializes in the development of new therapeutic treatments within neurotology - neurological disorders that affect the ears and other structures in the head and face.

The company is listed on the New York stock exchange, and has a number of other treatments in development, including Otividex for dizziness, which failed dramatically in a late stage study back in 2017.

This caused investors to eradicate 80 percent of the company's market value in one blow. However, shortly afterwards, a new phase III study of the drug showed such promising tendencies that it sent Otonomy's share prices rocketing by 83 percent up to USD 5.2.

Today, shares of the biotech company are being traded at a more modest USD 2.9.

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