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Duopharma unit gains exclusive distribution rights for HFMD vaccine

The agreement covers Malaysia, Singapore and Brunei, with regulatory approval required in each market.

Vaccine vials and syringes on a clinical work surface
Photo: The Edge Malaysia

Duopharma Biotech Bhd said on Oct 15 that its wholly owned subsidiary Duopharma (M) Sdn Bhd (DMSB) has obtained exclusive distribution rights for a hand, foot and mouth disease (HFMD) vaccine from Taiwan-based Enimmune Corp. The arrangement covers Malaysia, Brunei and Singapore but remains subject to regulatory approval.

In its bourse filing, the group said DMSB would handle applications for regulatory clearance for the EnVAX-A71 Vaccine. The supply agreement also gives the subsidiary exclusive advertising, marketing and sales rights, alongside the right to seek marketing approval. DMSB's obligations cease in any country that rejects approval.

The agreement runs until the fifth anniversary of the vaccine's launch in each market, provided DMSB meets minimum annual order requirements after registration is approved. Enimmune may terminate the deal if DMSB fails to meet 70% of the yearly minimum for two consecutive contract years.

Duopharma said Enimmune would bear the costs of Good Manufacturing Practice assessments and support marketing for the Malaysian launch. The group described the agreement as part of its strategy to broaden its biologics portfolio.

The EnVAX-A71 Vaccine targets Enterovirus A71 (EV71), a strain associated with severe neurological complications and deaths in children. No HFMD vaccine is currently approved for use in Malaysia.

Duopharma shares closed at RM1.10 on Oct 15, down one sen or 0.90%, giving the group a market value of RM1.06 billion.

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