Korean biotech firm Alteogen said April 26 has signed a letter of intent to license its long-acting drug for growth hormone deficiency with Brazil’s Cristalia for its development and sale in Latin America.
Under the non-binding agreement, Alteogen will decided whether to grant an exclusive license of its hGH-NexP, a week-lasting human growth hormone treatment, to the leading Brazilian pharma firm to co-develop and commercialize it by October this year.
“Once the two reach a license agreement in October, Cristalia will seek Brazilian health regulatory agency’s approval to begin clinical studies of hGH-NexP first with plans to clear regulatory hurdles in other Latin American countries,” Kim Ki-suk, an Alteogen official said.
HGH-NexP, which is targeted for the treatment of adult and pediatric growth hormone deficiency, is a once-weekly alternative to current drugs that need daily dosage.
Alteogen is vying with other long-acting growth hormone developers including domestic peer Genexine which released positive interim phase 2 clinical data in April. Global pharma firms such as Novo Nordisk and Versatis are a step ahead as their drugs are in late-stage trials. The market size for growth hormone is currently US$4 billion globally.
The KOSDAQ-listed firm applied its platform technology called NexPTM which enables longer activities of biologically active proteins and peptides in body, offering reduced injection frequencies and lower side effects.
In Korea, the hormone treatment is awaiting approval to enter phase 2 clinical trials. Alteogen expects it will receive the green light before June this year, Kim said.
“Entering the Latin American markets is the first priority at this time and then we will look for partner companies in the US and Europe,” he said.
Small drug makers typically break into the Latin American markets first as they have fewer regulatory hurdles and take shorter time to enter, compared with the US and Europe.
By Park Han-na (firstname.lastname@example.org