GSK on Tuesday said it will pay up to $745 million, plus royalties, as part of a license deal with US biotechnology company Empirico Inc.
The London-based pharmaceutical company said the worldwide exclusive license agreement with San Diego, California-based Empirico is for EMP-012, a highly selective first- and potentially best-in-class siRNA, a type of oligonucleotide.
EMP-012 addresses a novel therapeutic target and is currently in a phase I trial for the treatment of chronic obstructive pulmonary disease, with the potential for expansion into other inflammatory respiratory diseases.
GSK will pay an $85 million upfront payment and up to $660 million in success-based development, regulatory and commercial milestones, as well as tiered royalties on net sales worldwide.
In addition to its potential as a monotherapy, EMP-012 provides GSK ‘further optionality’ for combinations across its COPD portfolio and pipeline, the company said.
The agreement grants GSK full worldwide development and commercial rights to EMP-012.
Empirico will continue to lead the clinical development of EMP-012 through the completion of the ongoing phase I clinical trial, following which GSK will assume responsibility for worldwide development, regulatory filings, and commercialisation.
In addition, GSK said GSK576422, its B7-H3-targeted antibody-drug conjugate has received orphan drug designation from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, a form of small-cell lung cancer.
The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage small-cell lung cancer who were treated with GSK576422 in the phase I Artemis-001 clinical trial.
It is fourth regulatory designation for GSK576422, which is being developed in a range of solid tumour types, including in lung, prostate and colorectal cancers.
Previously, it was granted Priority Medicines designation by the EMA for relapsed or refractory extensive stage small-cell lung cancer and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma granted by the US Food & Drug Administration.
Shares in GSK rose 0.4% to 1,647.00 pence each in London on Tuesday morning.
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