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Agreements

Date: 2013-11-19

Type of information: Distribution agreement

Compound: Avdesp™ (biosimilar for darbepoetin alfa Aranesp®)

Company: Avesthagen Pharma (India) Elpen Pharmaceuticals (Greece)

Therapeutic area: Cancer - Oncology - Renal diseases - Kidney diseases

Type agreement:

distribution

Action mechanism:

Disease: anaemia resulting from chronic kidney disorders and cancer chemotherapy

Details:

* On November 19, 2013, Avesthagen Pharma has announced an agreement with Elpen Pharmaceutical Co. Inc., a leader in life-sciences, for the distribution of Avdesp, a biosimilar product for darbepoetin alfa Aranesp®, in seven EU and six non-EU territories namely Greece, Cyprus, Bulgaria, Romania, Croatia, Slovenia, Slovakia, Serbia, Bosnia, Macedonia, Albania, Montenegro and Kosovo with a collective population base of over 70 million. Avdespwill be used for the treatment of anaemia resulting from chronic kidney disorders and cancer chemotherapy. Avesthagen Pharma is currently engaged with many other opportunities for a number of its ‘Biosimilars’ and ‘Biobetters’ with strong principals in several countries. The indian group is working with different outsourcing organizations to make sure the product come to the market at the earliest. It has identified SyngeneInternational Ltd. for fill and finish, and Kemwell Bioharma as a CMO and PRA International, a global CRO to conduct the carry out the Phase I Clinical Trial in The Netherlands followed by Phase III in India.

Financial terms:

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Is general: Yes