PledPharma to acquire Rare Thyroid Therapeutics

Rare Daily Staff

Swedish drug developer PledPharma said it has agreed to acquire privately held Rare Thyroid Therapeutics International for $6.75 million (60 MSEK) and 63.8 million shares of stock.

The deal will provide PledPharma with the ultra-orphan experimental therapy Emcitate, which is being developed to treat MCT8 deficiency, a rare congenital disorder of thyroid hormone trafficking with no therapy currently available. The combined company will have two orphan drugs entering pivotal stages, Emcitate and Aladote.

“The acquisition of RTT is an important step, building a new company with a strategic focus on the attractive orphan drug segment, with Aladote and Emcitate as the company’s key assets in late stage development,” said Nicklas Westerholm, CEO, PledPharma. “The RTT team, specialized in orphan drugs, will complement PledPharma’s late-stage development focused organization, building a new orphan drug company named Egetis Therapeutics, dedicated to development and commercialization of therapies for rare diseases.”

To finance the development of the two drugs, the company also announced it is embarking on rights offering to raise an additional $22.5 million (200 MSEK).

Emcitate successfully completed a phase 2b trial in patients with MCT8 deficiency. A pivotal Phase 2b/3 early intervention trial in very young patients is planned to start before the end of the year. Interim results are planned to be available in 2022 and are expected to pave the way for regulatory approvals and commercial launch. Regulators in the United States and Europe have granted Emcitate Orphan Drug designation.

Aladote is in development as a first-in-class drug candidate to reduce liver damage caused by paracetamol poisoning. Paracetamol is one of the most widely used drugs in the world for the relief of pain and fever, but also one of the most common drugs taken in overdoses, both intentional and accidental. A pivotal phase 2/3 study is currently being planned.

In addition to the cash and stock, Rare Thyroid Therapeutics stockholders are entitled to earnout payments based on the future net sales of Emcitate, as well as an earnout which is payable in connection with a potential sale of a U.S. Rare Pediatric Disease Priority Review voucher.

“Emcitate and RTT’s capabilities and expertise within orphan drugs fit well with the new strategy of PledPharma. The merger allows us to build a stronger combined company, dedicated to development of therapies for rare diseases. By joining forces, we will be able to run multiple programs that create critical mass, generate synergies and improve operational effectiveness’, said Peder Walberg, Founder and CEO, Rare Thyroid Therapeutics. “Ultimately, we believe this will also benefit patients with MCT8 deficiency, who today remain without therapeutic options, and for which Emcitate holds promise to become the first approved therapy.”

Photo: Nicklas Westerholm, CEO, PledPharma