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Hyderabad-based pharmaceutical major Dr Reddy’s Laboratories Limited (DRL) and Galena Biopharma on Wednesday announced a strategic partnership to develop and commercialise NeuVax in India. NeuVax is a vaccine aimed at preventing the recurrence of breast cancer in patients under remission.
Galena is an Oregan-based biopharmaceutical company commercialising and developing targeted oncology treatments that address unmet medical needs to advance cancer care.
Under the terms of the agreement Galena will license commercial rights of NeuVax to DRL for breast and gastric cancers. DRL will lead the development of NeuVax in gastric cancer, and help expand the scope of therapy by addressing a new patient population. Galena will receive development and sales milestones, as well as double-digit royalties on net sales. The licensing and development terms are conditioned to an agreement on ancillary activities.
“NeuVax promises to meet significant unmet need in breast cancer and gastric cancer patients especially due to late diagnosis for majority of the patients in India and therefore may have high probability of relapse of the disease,” Alok Sonig, DRL's senior vice president and head of India business (generics), stated in a press release.
“NeuVax potentially will reduce the risk of relapse significantly as demonstrated in successful phase 2 trials” he added.
“This partnership with Dr. Reddy’s is consistent with our strategy to expand the clinical utility of NeuVax in unmet medical needs while simultaneously increasing the commercial footprint of this innovative cancer immunotherapy,” said Mark J. Ahn, president and chief executive officer of Galena.
According to Ahn, the gastric cancer trial will add a significant indication to Galena's pipeline for NeuVax, while doubling its potential patient population if approved.
The press release stated that NeuVax (nelipepimut-S) is an immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival, the US Food and Drug Administration granted NeuVax a special protocol assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. Currently, the vaccine is undergoing Phase 3 trial.
According to the National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually. Of these women, about 25% are HER2 positive. NeuVax targets approximately 50-60% of these women.
