As Horizon Therapeutics' one-and-a-half-year-old thyroid eye disease med Tepezza starts to spread its wings, the drugmaker is standing up in-house manufacturing to help blunt any further supply disruptions.
Horizon is putting up $65 million in cash to acquire a drug product manufacturing plant from OPKO Health's EirGen Pharma, the company said in a release. The 44,000-square-foot facility in Waterford, Ireland, comes equipped with a filling line and lyophilizer—or freeze dryer—that the company is eyeing for production of its commercial rare disease meds Tepezza, Krystexxa and Uplizna, plus its pipeline of biologics. The plant also boasts analytical laboratory capabilities, Horizon said.
Tepezza launched last February with blockbuster ambitions, but it faced two early launch hurdles from the COVID-19 pandemic. Nationwide closures of ophthalmologist offices and an eleventh-hour supply disruption took their toll, but the drug could now be recovering some of its pre-pandemic momentum, analysts predicted this week.
The plant sale is expected to close in the third quarter and will see around 40 EirGen staffers move under the Horizon umbrella. Horizon also plans to increase its headcount there by 50 over the next two years.
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The rare disease specialist will work with Ireland's drug regulator and the U.S. FDA to clear the factory for sterile fill-finish operations. Horizon expects the first medicine approved for release in about two years.
The plant is housed in an IDA Ireland business park, with adjacent land up for grabs if Horizon chooses to expand in the future. Horizon's global headquarters has been based in Dublin since 2014.
As Tepezza and Horizon's chronic gout med Krystexxa gain traction, the company feels "it is the right time to add in-house manufacturing capabilities,” CEO Tim Walbert said in a statement. The dedicated plant will build on Horizon's network of contract manufacturers and should offer a bit of a safety net to prevent situations like the one with its production partner Catalent, which came to light in December.
That month, the U.S. ordered Catalent to prioritize work on COVID-19 vaccines, forcing it to cancel production slots planned for Tepezza. The CDMO restarted production in April after the FDA cleared Horizon to make more Tepezza vials per batch, but the damage to first-quarter revenues had already been dealt. The drug generated just $2.1 million for the period—a steep decline from the $343.7 million it snared in 2020's fourth quarter.
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Despite its bumpy launch, Tepezza is getting back on course to blockbuster land, Jefferies analysts wrote in a note to clients Monday, citing a call with a high-volume oculoplastic surgeon who is a key opinion leader in the field.
Most of the doctor's patients have been able to restart therapy since the supply disruption, the Jefferies team wrote. April also also marked Tepezza's strongest patient enrollment month since the drug launched last year, Horizon has said.
Some of the momentum can be chalked up to the drug's rising profile in the field, plus a highly effective ad campaign, according to the expert on the Jefferies call. The opinion leader pointed to an “increasing call volume from other physicians—particularly endocrinologists and community doctors—seeking advice on treating TED patients with Tepezza."
Overall, Tepezza pulled in more than $800 million during its first year on the market.