Shire launches new ADHD drug Mydayis as it weighs a neuroscience exit

Despite earlier this month announcing it’s considering a sale of ADHD offerings, Shire has launched its latest Adderall formulation in the U.S. The company on Monday started selling Mydayis at a price of $271 per month before rebates and discounts, hoping to achieve $500 million in annual sales.

Shire had been marketing its new medication on a limited basis, but now the rollout has begun in earnest. It includes a copay offer for commercially insured patients, according to a release. In an interview, Shire’s head of global communications for ophthalmics and neuroscience, Clotilde Houzé, said the launch provides the ADHD community a new treatment option.

"We know that not all patients respond to medications in the same way," Houzé said. "We really want to support physicians and patients who might want different treatment options."

Mydayis won approval back in June based on 16 clinical trials incorporating more than 1,600 participants. The once-daily medication helped patients’ scores on a validated attention test, with effects starting within 2 to 4 hours and lasting up to 16 hours, according to the drugmaker. Mydayis is approved for ADHD patients 13 and older.

"We’ve been working since the FDA approval to properly train our salesforce and make sure that they have all of the information needed to talk to the physicians," Houzé said, without disclosing how many representatives are supporting the launch.

She added that the 16-hour effect for Mydayis may be a benefit physicians seek out for treating their patients.

Sales expectations are mixed on the new drug, with the company’s own thoughts coming in ahead of Wall Street’s. At the time of approval, consensus analyst projections were for $288 million in sales by 2020, significantly short of Shire’s aspirations of $500 million for that year.

Shire priced its drug "competitively and in consideration of the innovation and value it delivers," according to a company statement. Payer negotiations are ongoing, Houzé said, adding that the company looks "forward to sharing more news on that in the future."

To reach its $500 million sales ambition for 2020, Shire has said it’ll lean on its leadership position and experience in ADHD. Since the FDA approval for Mydayis, however, the Irish drugmaker has disclosed it may be looking to get out of neuroscience altogether.

In its second-quarter earnings announcement, the drugmaker disclosed it’s "assessing strategic options" for the group, potentially including an independent public listing. During the quarter, Vyvanse sales stayed flat versus the prior year at $518 million, while Adderall XR slipped 30% to $71 million.

Mydayis’ FDA approval followed a green light at the agency for Neos Therapeutics’ Cotempla,  an extended-release ADHD drug that melts in the mouth. More than 10 million adults have ADHD in the U.S., according to Shire.

The company will continue its disease awareness campaign, but because Mydayis is a class 2 stimulant, Shire needs to await FDA guidance for DTC advertising, Houzé said.