Hyseq Pharmaceuticals Inc. is buying its way into the clinic, having acquired alfimeprase from Amgen Inc.
The thrombolytic alfimeprase, discovered by Thousand Oaks, Calif.-based Amgen, is a derivative of the fibrolase enzyme and is being developed to treat peripheral arterial occlusions (PAO). Hyseq will now control the compound’s development while Amgen will handle manufacturing. However, if and when the compound earns approval, Amgen has an option to lead the commercialization, although Hyseq, of Sunnyvale, Calif., also would participate.
Ted Love, Hyseq’s CEO and president, said the agreement serves a purpose for both companies.
“We had discussions with Amgen about a potential deal structure and one thing I had mentioned was getting into the clinic by in-licensing a product,” he told BioWorld Today from the JPMorgan H&Q Healthcare Conference in San Francisco. “[Amgen] was about to begin enrolling patients, but they felt they weren’t a cardiovascular company. This made a lot of sense for them, also.”
Thus, Amgen divested it to a company with cardiovascular experience and can now mull over its marketing option from now until FDA approval.
Although Love said Hyseq granted Amgen warrants to purchase stock at “a premium to our current price,” no other financial details were disclosed.
Hyseq’s stock (NASDAQ:HYSQ) fell 4 cents Wednesday, ending the day at $8.01. Amgen’s stock (NASDAQ:AMGN) fell 77 cents, closing at $55.77.
Alfimeprase is a derivative of a direct fibrinolytic product, Love said, explaining that a related compound is found in the venom of copperhead snakes. Once injected into prey by snakebite, that compound acts to prevent blood clotting and therefore help the snake’s eventual digestion of the unlucky animal.
The same anticoagulation concept applies in PAO, where preclinical studies have shown that alfimeprase has potential for dissolving clots. Love said a catheter clearance indication also “makes a lot of sense,” but it will be PAO first.
“PAO is the major indication that we are planning to pursue up front and is the largest one,” Love said. “Amgen has estimated that market is in excess of $200 million in the U.S. alone. It’s not Amgen money; Amgen likes billion-dollar products.” For Hyseq, however, a company that has not yet seen product revenue, a $200 million drug would draw few complaints.
It should take a couple of months for Amgen’s investigational new drug application to be transferred to Hyseq, Love said, and for Hyseq to verify that “the trial they have approved is the one we want to run.” After that, Hyseq should move its first compound into humans.
“This will be our first product that enters the clinic,” Love said. “We think that, long term, the proprietary genes that we have identified will be our focus, but this will get us in the clinic in 2002, maybe even through Phase I this year.”