Specialised Therapeutics Asia (ST), an independent biopharmaceutical company, has expanded its specialised portfolio by entering into an exclusive distribution agreement with the Danish company Ascendis Pharma.

The collaboration introduces three new endocrinology therapies to ST’s offerings. The products covered by the agreement are Ascendis Pharma’s Skytrofa (lonapegsomatropin), a weekly injectable paediatric human growth hormone treatment; Yorvipath (palopegteriparatide), a hypoparathyroidism treatment; and TransCon CNP (navepegritide), an investigational achondroplasia therapy.

The distribution agreement encompasses ST’s key regions, including Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam. Two of the products covered in the agreement have already received international approval:

Skytrofa: A once-weekly human growth hormone (hGH) approved in the US for treating paediatric patients aged over one year and weighing more than 11.5kg, experiencing growth failure due to inadequate secretion of endogenous growth hormone (GH). It is also approved in the European Union for addressing growth failure in children and adolescents aged three to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]).

Yorvipath: A first-in-class parathyroid hormone (PTH) replacement therapy designed to treat chronic hypoparathyroidism, a rare and potentially serious condition characterised by the insufficient or absent production of PTH. Yorvipath is approved in the European Union for the treatment of adults with chronic hypoparathyroidism.

The third product, TransCon CNP, is currently in development by Ascendis Pharma for the treatment of achondroplasia (ACH), which is the most common genetic form of skeletal dysplasia resulting in disproportionate short stature. This development follows successful Phase 2 trial results.

Dr Veronica Preda, an Australian endocrinologist, highlighted that Yorvipath stands as the inaugural specialized therapeutic choice available for Australian patients grappling with hypoparathyroidism.

Dr Preda said: “Hypoparathyroidism can seriously impact quality of life and has potentially life-threatening consequences.

“To have an option that is able to treat the underlying cause of the disease, moving beyond standard oral calcium and active Vitamin D, is a great step forward.”

Specialised Therapeutics  CEO Carlo Montagner has announced the partnership, emphasising that this agreement marks a significant milestone for the company. It signifies ST’s venture into the realms of endocrinology and paediatric medicine, showcasing its commitment to diversification and growth.

Montagner added: “We are delighted to have been selected as Ascendis Pharma’s exclusive partner for commercialising their portfolio in Oceania and these South-East Asia countries and look forward to launching these critical endocrinology products in our regions as soon as possible.

“All three products are valuable inclusions to our broad therapeutic pipeline and our international business, as we continue to leverage our substantial experience commercialising specialist medicines across multiple regions.

“We look forward to working with endocrinologists across our territories to make these endocrine therapies available to all eligible patients who may benefit.”