Opko Health, Inc. Rockets After Striking Deal Worth $570 Million With Pfizer

Opko Health, Inc. Rockets After Striking Deal Worth $570 Million With Pfizer
December 15, 2014
By Mark Terry, BioSpace.com Breaking News Staff

Miami-based Opko Health, Inc. and New York-based Pfizer Inc. announced today that they had inked a global agreement to develop and commercialize OPKO’s long-acting hGH-CTP. The compound, hGH-CTP, is presently in a global Phase 3 trial in adults and a Phase 2 trial in children.

OPKO, under the deal, will receive an upfront payment of $295 million. It may also receive an additional $275 million for various regulatory milestones. Pfizer will hold exclusive licensing rights to commercialize hGH-CTP globally.

The long-acting hGH-CTP is used for the treatment of growth hormone deficiency (GHD) in adults and children. It is also utilized for the treatment of growth failure in children who are born small for gestational age (SGA) who do not catch up to growth by 2 years of age.

As part of the agreement, OPKO will lead clinical activities and handle funding for development programs for key indications, including Adult and Pediatric GHD and Pediatric SGA. Pfizer will handle all development costs for additional indications, as well as for any and all post-marketing studies. Pfizer will also fund commercialization and spearhead manufacturing.

“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,” said OPKO’s chief executive, Phillip Frost, in a statement. “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 $3 billion, and believe that hGH-CTP has the potential to be the best in class long-acting growth hormone product.”

Upon news of the deal, OPKO stocks jumped 13.8 percent in pre-market trading. OPKO traded at $9.31. Pfizer shares traded at $31.08 pre-market, up 0.42 percent.

“This agreement strengthens Pfizer’s commitment to rare diseases, and we are pleased to work with OPKO to help provide a potential next-generation therapy for patients with Adult and Pediatric Growth Hormone Deficiency,” said Pfizer Global Innovative Pharma Group President Geno Germano in a statement. “Long-acting growth hormone is the first innovation in the GHD space in 20 years. hGH-CTP would be complementary to our existing Genotropin franchise, and could potentially provide an option that could improve patients’ adherence to treatment with once weekly dosing.”

Pfizer announced Nov. 17 a global development deal with Darmstadt, Germany-based Merck KGaA to develop an investigational anti-PD-L1 antibody as a possible treatment for several different cancer types. Part of that deal has the two companies co-promoting Pfizer’s XALKORI in the U.S. and other markets. XALKORI is used to treat anaplastic lymphoma kinase-positive non-small cell lung cancer that has metastasized.

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