May 26, 2015 I Dong-A ST, a leader in the Korean pharmaceutical market, has announced the successful completion of a Phase I clinical study in Europe with its darbepoetin alfa biosimilar (DA-3880), which is being developed for the treatment of anemia due to chronic renal failure and chemotherapy.
The randomized and 2-way cross-over study conducted in Europe compared the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles between DA-3880 and EU-sourced Aranesp® after single, intravenous (IV) or subcutaneous (SC) administration in healthy volunteers (Figure 1).
After single IV dose, the ratio of baseline-corrected geometric mean for area under the concentration-time (AUC0-t) between DA-3880 and EU-sourced Aranesp® was 95.3 to 101.1% [90% Confidence Interval (CI)], and after single SC dose, the ratio of baseline-corrected geometric mean for AUC0-t was 94.6 to 107.5% [90% CI]. These results were both well contained within the standard bioequivalence interval of 80 to 125% and demonstrated that DA-3880 after IV or SC administration is highly equivalent to EU-sourced Aranesp®.
DA-3880 also showed comparable PD parameters (AUEC0-t, Emax, Tmax) for reticulocytes (% and absolute counts), hemoglobin and hematocrit to EU-sourced Aranesp® after IV and SC administrations. In addition, DA-3880 was proven to be safe and well tolerated with overall incidences and types of TEAEs (Treatment-emergent Adverse Event) similar to those of EU-sourced Aranesp®.
In conclusion, comparative phase I data demonstrated that DA-3880 is bioequivalent to EU-sourced Aranesp® in terms of PK profiles. In addition, the PD parameters and safety profiles were similar between DA-3880 and EU-sourced Aranesp®.
DA-3880’s physicochemical and biological similarity to EU-sourced Aranesp®, including complicated glycan structure, was already confirmed in earlier preclinical studies. Based on the results, Dong-A signed a licensing agreement for DA-3880 with a Japanese pharmaceutical company last year, which granted the rights of DA-3880 in Japan.
According to Allied Market Research, the global erythropoietin (EPO) drugs market will be growing with CAGR of 9.7% during 2014 to 2020, and darbepoetin alfa will be the fastest growing market among them. It is expected that rising incidences of cancer and chronic renal failure will also drive the demand for EPO drugs in the future.
Considering its high similarity to Aranesp®, it is believed that DA-3880 will be a viable option to patients who are looking for good-quality treatment with reasonable price.
Dong-A is now seeking licensing/collaboration partners primarily focusing on the territories of US/EU and welcome such inquiries.(www.donga.co.kr)
SOURCE: Dong-A ST
Post Views: 84
May 26, 2015 I Dong-A ST, a leader in the Korean pharmaceutical market, has announced the successful completion of a Phase I clinical study in Europe with its darbepoetin alfa biosimilar (DA-3880), which is being developed for the treatment of anemia due to chronic renal failure and chemotherapy.
The randomized and 2-way cross-over study conducted in Europe compared the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles between DA-3880 and EU-sourced Aranesp® after single, intravenous (IV) or subcutaneous (SC) administration in healthy volunteers (Figure 1).
After single IV dose, the ratio of baseline-corrected geometric mean for area under the concentration-time (AUC0-t) between DA-3880 and EU-sourced Aranesp® was 95.3 to 101.1% [90% Confidence Interval (CI)], and after single SC dose, the ratio of baseline-corrected geometric mean for AUC0-t was 94.6 to 107.5% [90% CI]. These results were both well contained within the standard bioequivalence interval of 80 to 125% and demonstrated that DA-3880 after IV or SC administration is highly equivalent to EU-sourced Aranesp®.
DA-3880 also showed comparable PD parameters (AUEC0-t, Emax, Tmax) for reticulocytes (% and absolute counts), hemoglobin and hematocrit to EU-sourced Aranesp® after IV and SC administrations. In addition, DA-3880 was proven to be safe and well tolerated with overall incidences and types of TEAEs (Treatment-emergent Adverse Event) similar to those of EU-sourced Aranesp®.
In conclusion, comparative phase I data demonstrated that DA-3880 is bioequivalent to EU-sourced Aranesp® in terms of PK profiles. In addition, the PD parameters and safety profiles were similar between DA-3880 and EU-sourced Aranesp®.
DA-3880’s physicochemical and biological similarity to EU-sourced Aranesp®, including complicated glycan structure, was already confirmed in earlier preclinical studies. Based on the results, Dong-A signed a licensing agreement for DA-3880 with a Japanese pharmaceutical company last year, which granted the rights of DA-3880 in Japan.
According to Allied Market Research, the global erythropoietin (EPO) drugs market will be growing with CAGR of 9.7% during 2014 to 2020, and darbepoetin alfa will be the fastest growing market among them. It is expected that rising incidences of cancer and chronic renal failure will also drive the demand for EPO drugs in the future.
Considering its high similarity to Aranesp®, it is believed that DA-3880 will be a viable option to patients who are looking for good-quality treatment with reasonable price.
Dong-A is now seeking licensing/collaboration partners primarily focusing on the territories of US/EU and welcome such inquiries.(www.donga.co.kr)
SOURCE: Dong-A ST
Post Views: 84
