Date: 2014-01-09
Type of information: Production agreement
Compound: commercial-grade antisense oligonucleotide (ASO) compounds
Company: Isarna Therapeutics (Germany) Sanofi (France)
Therapeutic area: Cancer - Oncology
Type agreement: manufacturing
production
Action mechanism:
Disease:
Details: * On January 9, 2014, Isarna Therapeutics has announced that it has signed a strategic manufacturing agreement with Sanofi under which Sanofi will manufacture clinical- and commercial-grade antisense oligonucleotide (ASO) compounds for Isarna, enabling Isarna to advance its promising next generation ASOs rapidly into clinical trials.
As per the agreement, Sanofi’s Industrial Affairs division will act as Isarna Therapeutics’ contract manufacturing organization. Sanofi will scale-up and validate the production of ASOs and supply future commercial batches. Isarna will benefit from Sanofi’s Commercial and External Partnership (CEPiA)’s organization, the commercial branch of Sanofi’s Industrial Affairs activities, which brings strong GMP manufacturing expertise within the field of ASOs. The manufacturing site of Frankfurt, Germany, which will manufacture Isarna Therapeutics’ next generation ASOs, is FDA, EMEA and PMDA approved and has all the capabilities to support the registration of the compounds.
Isarna Therapeutics is developing TGF-? inhibitors that stimulate the human immune system to effectively fight cancer. Its pipeline includes oligonucleotides (trabedersen) and combination modalities to transcend clinical response and improve patient outcomes.
Financial terms: Financial details of the agreement have not been disclosed
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Is general: Yes