Savient Pharmaceuticals launched Krystexxa (pegloticase), an orphan drug for chronic gout, on Monday, and deployed a mix of sales reps, education specialists and business managers to help expedite reimbursement from payers, executives said on a conference call.
Savient will target an initial 4,000 rheumatologists and 800 nephrologists, who have “a number of chronic gout patients that are refractory to conventional therapy,” as well as “infusion centers associated with medical centers or academic institutions, which multiple specialists might be using for infusion,” said Paul Hamelin, president at Savient, on the call.
Field forces include 60 “field-based territory sales managers, and six regional business unit directors to manage that team,” said Hamelin. “In addition, we have six managed care executives deployed, and we have [six] medical science liaisons in the field, and we have added  nurse educators to help with in-service at key institutions where infusion occurs,” he said. Also, 12 “area business solutions managers” have been deployed to help “ensure reimbursement at the infusion centers works efficiently,” said Paul.
John Johnson, most recently SVP and president of Lilly Oncology, and appointed as Savient's CEO in late January, emphasized the importance of speedy reimbursement on the call. “We added area business solutions managers because reimbursement is so important,” said Johnson. Prior authorization from insurance plans “can take 12 weeks…our business solutions managers will help compress that,” said Johnson on the call.
The Krystexxa launch will include “traditional marketing tactics, including the web to activate patients,” but there are no plans to roll out a large primary care sales force, said Johnson. “We may do some select tests here and there with contract [sales] organizations and the like, but we don't have any plans to burden ourselves with a large PCP sales force,” he said. H4B Chelsea has the AOR assignment on Krystexxa, and the agency is working on professional and consumer materials, according to Mike Peto, managing director, at H4B Chelsea.
FDA approved Krystexxa last September, and Savient made the drug available on a limited basis in December, through distribution channels intended to reach “any immediate medical need.” Krystexxa sales in December were $18,000, and the company anticipates “sales to ramp up gradually,” said Johnson. The total US patient population eligible for Krystexxa is approximately 330,000, although Savient will target the most sever chronic gout sufferers at first, a population of roughly 170,000 patients, said Johnson.
Krystexxa's mechanism of action differs from xanthine oxidase inhibitors like Takeda's Uloric, but comes with a black box warning about possible severe allergic reactions, experienced by a quarter of all patients. In a note to investors yesterday, Eun Yang at Jefferies & Company wrote that Krystexxa's “potential safety and reimbursement issues, coupled with much smaller numbers of refractory tophaceous gout patients, will result in limited use. Based on [a] Krystexxa price of $2,300 per injection, we estimate approximately 650 patients treated in 2011, and forecast revenues in 2011 and 2012 of approximately $18 million and $55 million,” respectively.
Savient announced a manufacturing snafu in early January, which led to batches of Krystexxa that failed to meet the company's manufacturing standards. The problem has been corrected, according to Johnson. Bad batches of the drug were produced at two third party CMO sites, one in Israel, and one at the Merck Biomanufacturing Network, in Indiana, according to a company statement.
Johnson said on the call that Savient will file Krystexxa with the EMA for European Union approval "by the end of the first quarter or shortly thereafter," and the company is also eying Asian markets, where "the prevalence of gout is among the highest in the world," said Johnson.