Trade Resources Industry Views The US Food and Drug Administration Has Granted Orphan Drug Status

The US Food and Drug Administration Has Granted Orphan Drug Status

OncoMed Pharmaceuticals and Celgene have entered into an agreement to jointly develop and commercialize about six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4).

Under the development, OncoMed will manage and conduct initial clinical studies, while Celgene will have an option to license worldwide rights to up to six novel anti-CSC therapeutic candidates.

In addition, OncoMed retains global co-development and US co-commercialization rights for five out of the six anti-CSC product candidates with equal US profit sharing as well as royalties to be received in other territories.

The deal will also see Celgene have research, development and commercialization rights to small molecule compounds in an undisclosed cancer stem cell pathway.

Celgene also gets an exclusive option on OncoMed's demcizumab, during or after the completion of certain future planned Phase II clinical trials to be carried out by OncoMed.

As of now, demcizumab is in three Phase Ib clinical trials in combination with standard-of-care therapeutics, including a trial in patients with first-line advanced pancreatic cancer.

Subsequent to option exercise, both the partners will co-develop demcizumab, sharing global development costs on a 1/3 OncoMed and 2/3 Celgene basis and also co-commercialize the product in the US with 50/50 profit sharing.

Outside the US, Celgene will be responsible for the development and commercialization, while OncoMed is eligible to receive milestones and tiered double-digit royalties on sales.

In addition to demcizumab, the deal also includes up to five preclinical- or discovery-stage biologics programs such as OncoMed's anti-DLL4/VEGF bispecific antibody and up to four additional biologics programs targeting either the RSPO-LGR CSC pathway or an additional undisclosed CSC pathway.

On these programs, Celgene will have exclusive options during or after completion of certain Phase I clinical trials to be carried out by OncoMed.

As part of the deal, OncoMed will receive an upfront payment of $155m, and Celgene will also purchase about $22.25m in a private placement of newly issued shares of OncoMed's common stock at a price of $15.13 per share.

The deal also includes option exercise payments and payments for achievement of development, regulatory and commercial milestones, paid on a per-program basis.

Source: http://drugdiscovery.pharmaceutical-business-review.com/news/oncomed-celgene-to-develop-new-multiple-anti-csc-therapeutics-for-cancer-patients-041213-4140753
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OncoMed, Celgene to Develop New Multiple Anti-CSC Therapeutics for Cancer Patients