KUALA LUMPUR (Oct 15): Duopharma Biotech Bhd (KL:DPHARMA) said on Thursday its wholly owned unit has secured exclusive rights to distribute Taiwan-based Enimmune Corp's hand, foot and mouth disease (HFMD) vaccine in Malaysia, Singapore and Brunei, subject to regulatory approval in the three countries.  

According to the group’s bourse filing on Thursday, the supply agreement was signed between Enimmune and Duopharma Biotech's wholly owned unit Duopharma (M) Sdn Bhd (DMSB).

Under the deal, DMSB is responsible for getting regulatory approval for the EnVAX-A71 Vaccine in the three countries.

The deal also grants DMSB exclusive rights to advertise, market, sell and obtain marketing approval for the vaccine.

If a country refuses to approve the vaccine, DMSB's obligations in that country are terminated.  

In a separate statement on Thursday, Duopharma Biotech chief executive officer Wan Amir-Jeffery Wan Abdul Majid said: “This partnership is a further step in strengthening our vaccine portfolio and building a sustainable presence in preventive healthcare.”

The group said Enimmune will cover costs related to Good Manufacturing Practice assessments and provide marketing support for the Malaysian launch.

The agreement will remain in force in each territory until the fifth anniversary of the launch date in the respective jurisdictions, contingent on DMSB fulfilling minimum annual order quantities once registration is approved.

If DMSB fails to fulfil 70% of the annual minimum order quantity for two consecutive contract years, Enimmune has the right to terminate the agreement.

Duopharma said the deal aligns with its strategy to expand its biologics portfolio.  

“Our focus is on bringing niche vaccines to Malaysia that address unmet needs and complement the healthcare options available today,” Wan added.

HFMD is a contagious disease that commonly infects children under the age of 5. Early symptoms include fever, sore throat and reduced appetite. 

It also causes painful mouth sores and rashes on the hands, soles of feet and buttocks.

Due to its contagious nature and severity, HFMD is a significant public health concern as outbreaks are common in Malaysia. 

HFMD is usually caused by enteroviruses Coxsackievirus A16 and Enterovirus A71 (EV71).

There is no cure for HFMD and there is currently no vaccine approved for use in Malaysia.

The EnVAX-A71 Vaccine is a monovalent inoculation that targets  EV71, which is the strain that causes severe neurological complications and fatalities in children.

Duopharma shares ended one sen lower or 0.90% at RM1.10 on Thursday, valuing the group at RM1.06 billion.