ALK readies Odactra launch after Merck exit
- ALK-Abello A/S gave an update on its sublingual allergy portfolio on Tuesday, touting the ability to launch the dust mite treatment in the U.S. and Canada now that it has gotten rights back from its former partner.
- The move will allow the company to push its North American launch date up for Odactra (called Acarizax in Canada and Europe) from mid-2018 to the fourth quarter of 2017.
- ALK intends to expand its Phase 3 trial in allergic asthma to include U.S. patients after discussions with the Food and Drug Administration.
The Danish drugmaker was left in a bit of a bind after its big pharma partner Merck & Co. abruptly pulled out of its partnership for a portfolio of under-the-tongue allergy treatments in July 2016. The portfolio includes a house dust mite tablet, as well as immunotherapies for ragweed and grass allergies. Merck signed on to the partnership in 2007, but gave rights back to the drugs amidst a late-stage clinical program and registration process.
Merck filed the Biologics License Application in 2016 for Odactra and the FDA granted approval for the treatment in March 2017. Yet, Merck still owned the rights to the drug, and the FDA did not transfer the approval to ALK until now.
"The transfer of the licenses from our former partner was the final regulatory formality on our pre-launch checklist. Now it has been completed, we will move forward the investments related to the launches in the USA and Canada," ALK CEO Carsten Hellmann said.
The company had to revise its full-year 2017 guidance down to a range of DKK 225-250 million ($355-395 million) from a previous estimate of DKK 300 million. The revision is based on sales and marketing costs being pulled forward for the launch of Odactra in North America.
Odactra is a once-daily tablet used under the tongue that helps increase the immune system reaction to house dust mites over time, reducing eye and nasal symptoms. But it takes approximately eight to 14 weeks before patients start experiencing relief.
Grastek and Ragwitek, the respective grass and ragweed tablets, were both approved in 2014, but failed to gain much traction. While neither company broke out sales of the drugs, analysts previously estimated they only pulled in low single-digit millions.
Though Merck was once big in the respiratory space, the big drugmaker has moved away from the therapeutic area in favor of its immuno-oncology portfolio. The company still has Phase 2 programs in cough and asthma, however.
- ALK-Abello Statement
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