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news.Pfizer and OPKO Health have entered into a partnership to develop and commercialize OPKO’s long-acting hGH-CTP, a growth-hormone deficiency treatment that would require a single weekly injection instead of the current standard of daily injections.
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The drug is used for growth deficiency in adults and children as well as for growth failure in babies born small who fail to catch up growth by two years of age.
Currently, hGH-CTP is in a global Phase III trial in adults and a global Phase II trial in children, while it also has orphan drug designation in the US and Europe for both adults and children with GHD.
As part of the deal, OPKO will receive an upfront payment of $295m and is eligible to receive up to an additional $275m if hGH-CTP meets certain regulatory approvals.
Pfizer will be responsible for commercializing hGH-CTP, which it said would be complementary to its existing Genotropin growth-hormone franchise.
OPKO CEO Phillip Frost said: "We believe this collaboration will help advance our commitments to patients with Adult and Pediatric Growth Hormone Deficiency as we believe Pfizer’s strengths, expertise and presence in the human growth hormone space makes them the ideal partner for our hGH-CTP program.
"Our collaboration enables full alignment between Pfizer and OPKO to optimize development and potentially bring an innovative treatment to patients. We believe that the global growth hormone market is currently valued at more than $3bn, and believe that hGH-CTP has the potential to be the best in class long-acting growth hormone product.
"Our long acting human growth hormone is our most advanced product candidate utilizing our CTP technology to extend the half-life of a broad range of therapeutic peptides and proteins. By reducing the number of injections, our technology can improve patient compliance."
Following the launch of hGH-CTP for pediatric GHD, which is subject to regulatory approval, the royalties will transition to gross profit sharing for both hGH-CTP and Pfizer’s Genotropin.
The deal will see OPKO lead clinical activities and fund initial development activities, while Pfizer will fund the commercialization and lead the manufacturing activities across the globe.
Additionally, Pfizer will fund the commercialization activities for all indications and lead the manufacturing activities covered by the global development plan.
The transaction is subject to customary Hart-Scott-Rodino approval and is scheduled to be completed during the first-quarter of 2015.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.