Following missed endpoints discovered in preliminary analyses made public in April, Corvas International Inc. said late Friday that Pfizer Inc. would not develop Corvas' anti-inflammatory product any further, instead returning the rights and scuttling the companies' potential $31.4 million deal.
Pfizer, of New York, completed its analysis of the Phase IIb trial it conducted with UK-279,276 (formerly neutrophil inhibitory factor, or rNIF) and saw that the product had no effect on recovery in acute ischemic stroke patients, nor did it have any effect on any subgroups investigated. While not good news, the end of the agreement with Pfizer was anticipated, said Randall Woods, San-Diego-based Corvas' president and CEO.
"I don't believe this is a surprise," Woods told BioWorld Today. "Basically what we had told people back in April was that Pfizer had informed us that the preliminary results had shown us that they did not warrant taking [UK-279,276] into Phase III. They said they would let us know by the middle of the year what their plans were." (See BioWorld Today, April 25, 2002.)
The day the missed endpoints were made public in April, Corvas' stock (NASDAQ:CVAS) fell $2.83, or 47.3 percent, closing at $3.15. Its stock closed Monday at $2.45, up 4 cents.
Although the product is back in house for Corvas, the next step - whether that's to forge ahead alone, investigate other indications, or perhaps look to re-partner - is not yet known.
"We have not seen the data, so we are in the process of scheduling face-to-face meetings with Pfizer for the transfer of information back to Corvas," Woods said. "We will then decide if there is anything to go forward with in some capacity." However, he added that it "would be fair to say" that there would be no further pursuit of ischemic stroke.
Pfizer picked up an option to develop UK-279,276 in 1997. The deal called for as much as $31.4 million in milestone payments, of which Corvas received $4.4 million. The silver lining, Woods said, is that Pfizer was conducting the trials. (See BioWorld Today, Feb. 25, 1997.)
"There were not people here working on this project," he said. "Corvas was not spending any money on this project - all development costs were borne by Pfizer and all the work was being done in the UK facility. The good news for us is - although obviously you'd like to take [UK-279,276] forward - that we still have another drug in clinical development."
Corvas has the anticoagulant rNAPc2 in development. It expects to initiate a Phase IIb trial of the product in the second half of the year in patients with acute coronary syndromes.
"We had excellent results in a Phase IIb trial of rNAPc2 in deep-vein thrombosis in total knee replacements," Woods said. "We want to pursue now the unstable angina market because it is large and not well served."
Corvas will aim to conclude the Phase IIb itself, then look to attract a partner for Phase III work. The company also has preclinical work under way in cancer indications.
The company is not in a cash-crunch situation. It raised about $115 million through the public markets in November 2000 and still has an enviable cash position today. (See BioWorld Today, Nov. 9, 2000.)
"We're very glad we raised cash when we did," Woods said. "The most recent figures show we had $106 million in the bank at the end of the first quarter. And we've advised The Street that our burn would be in the lower $30 million range [annually]. We're in good shape."