After a year of uncertainty in 2010, an East Brunswick biotech is spending 2011 ramping up its sales efforts with an eye toward a blockbuster 2012.
Savient Pharmaceuticals Inc. is hard at work selling Krystexxa, a treatment for refractory chronic gout, a rare condition the company estimates affects about 120,000 people in the United States. The drug is a high-dollar biologic that targets a previously unmet medical need.
The main issue, according to Kenneth M. Bahrt, chief medical officer, is getting the word out.
“The chief challenge is just letting clinicians out there know that these patients exist,” said Bahrt, who joined the company in July. “There really hasn’t been an effective treatment out there for these patients.
Savient had a number of question marks in 2010. In May, the company’s board of directors announced that it would seek to sell the company following Krystexxa’s anticipated approval by the federal Food and Drug Administration. That approval came in September, but the next month, the board announced it was unable to find a buyer. In December, the board said it would seek to fill the company’s then-vacant post of CEO.
That search ended in late January with the hire of former Imclone Systems CEO John H. Johnson, who most recently was head of the oncology unit at Eli Lilly & Co.
Debbie Hart, president of the trade group BioNJ, said Johnson’s hire sent a positive message.
“The fact that John Johnson would sign on to Savient is certainly a vote of confidence for the company,” she said.
Savient launched Krystexxa in February. Since then, the company has been on a hiring spree, adding key executives and building out its sales force to 60 staffers.
Still, David Krempa, an equities analyst at Morningstar, said Savient has some catching up to do.
“The drug has really gotten off to a bad launch,” he said. “It got approved toward the end of last year. At that time, the old management just assumed they would turn around and sell the whole company as soon as they got FDA approval. So they weren’t really prepared to launch the drug.”
Savient’s efforts got a major boost in August, when its successful Phase III study was published in the Journal of the American Medical Association, a venerable periodical that accepts only 9 percent of the submissions it receives.
That’s particularly important for Krystexxa, as it’s aimed at a previously unmet need.
Gout, which is caused by the buildup of uric acid in the bloodstream, affects about 8.3 million Americans, Bahrt said. In those patients, uric acid crystallizes into what are known as tophi, which build up around joints and organs.
“The tophi can reach huge proportions,” Bahrt said. “It interferes with walking, with the hands. It really interferes with entire aspects of daily living.”
Bahrt said the conventional treatment blocks the formation of uric acid, but for a small percentage of gout patients, the treatment doesn’t work. Those patients are said to have chronic refractory gout. Krystexxa is designed not only to lower uric acid, but also to pull out the uric crystals, to help get rid of tophi.
Christine Mikail, who joined Savient in February as senior vice president of corporate development, said the company is using its sales force and other methods — such as a speakers bureau for physicians — to publicize the drug.
“We did say that we were going to have a slow and steady build in the market,” she said. “We expect to see an inflection post sometime in early 2012, when our permanent J-code is granted.”
A J-code is a reimbursement code used by physicians to request reimbursement from Medicare. Until the government grants a permanent J-code to the drug — a process that can take a year — doctors have to use a miscellaneous code, which can lengthen the amount of time it takes for the doctor to get reimbursed, Mikail said.
Krempa said he thinks the company is in good shape now, and he said its hiring spree makes it clear Savient is focused on Krystexxa’s success. With European regulators expected to render a decision on the drug next year, he said analysts are eager to see Savient’s plan for marketing abroad.
“They haven’t announced how they’re going to market the drug there,” Krempa said. “Ideally, we’d like them to find a partner.”
Krempa said a partner would have better knowledge of the European marketplace, and save the company from having to raise more debt.
While it’s unclear just what the long-term future of the company holds, Mikail said in the immediate future, all of Savient’s efforts are aimed in the same direction.
“We want to continue to focus right on Krystexxa,” she said. “Right now, the best interest (of the company) is Krystexxa.”
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