Posiga-Sitagliptin Combination 'Sidapvia'
Approved by MFDS Last Month
Planned for Overseas Supply via AZ
SK Chemicals will undertake the contract manufacturing (CMO) and supply of the diabetes combination drug 'Sidapvia' from the multinational pharmaceutical company AstraZeneca (AZ). According to the contract signed by the two companies, the supply of Sidapvia is expected to expand to other countries following South Korea.
On the 20th, SK Chemicals announced that it had signed a CMO supply contract for Sidapvia with AZ. However, the contract amount was not disclosed due to business confidentiality.
Under this supply contract, SK Chemicals will be responsible for the production and supply of Sidapvia. AZ will handle commercialization as the marketing authorization holder of the Forxiga combination drug. AZ plans to proceed with approval and sales overseas, starting with the launch in South Korea.
Sidapvia is a combination of Forxiga (active ingredient dapagliflozin) and sitagliptin. The two companies previously signed an agreement in 2020 for the joint development of a diabetes combination drug. Accordingly, AZ has cooperated by providing SK Chemicals with the active pharmaceutical ingredient (API) and supporting research and development (R&D) costs. Sidapvia was approved by the Ministry of Food and Drug Safety on the 30th of last month as a treatment for type 2 diabetes in adults aged 18 and over.
Forxiga is the original drug containing dapagliflozin and generates the highest sales in the sodium-glucose co-transporter (SGLT)-2 inhibitor class. SGLT-2 inhibitors work by inhibiting glucose reabsorption in the kidneys, thereby lowering blood sugar levels. Sitagliptin ranks first in sales among dipeptidyl peptidase (DPP)-4 inhibitors. DPP-4 inhibitors regulate blood sugar by inhibiting the breakdown of incretin hormones in the body.
Since Sidapvia is a combination of SGLT-2 and DPP-4 inhibitors, SK Chemicals explains that it is expected to provide a stronger blood sugar-lowering effect for type 2 diabetes patients through different mechanisms of action.
Ahn Jae-hyun, CEO of SK Chemicals, stated, "Being recognized for SK Chemicals' pharmaceutical technology and production capabilities has laid the foundation to supply medicines to more countries." He added, "Starting with this diabetes combination drug, we plan to continuously create various collaboration cases."
Meanwhile, the patent for Forxiga expired domestically in April. As a result, more than 150 Forxiga generics (including combination drugs) have been launched in the domestic market.
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