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MGI Pharma’s Aloxi (palonosetron) is under FDA review for an expanded label in post-operative nausea and vomiting, but two doctors said lower-priced, alternative anti-emetics are available and preferred.
While generic versions of the market-leading drug of the same class could represent a hurdle, along with other less expensive options, a spokesperson for the Minnesota company stressed that two of Aloxi’s characteristics would make it a compelling choice in this setting, saying that it is longer lasting and more consistent than Zofran (ondansetron). Both drugs are 5-HT3 receptor antagonists, and nearly 30 million doses of such products are used annually in the US for post-operative nausea and vomiting.
Dr Jim York, an anesthesiologist with Anesthesia Consultants Medical Group in Alabama, said he frequently doses patients with oral prophylactics first, before they are sedated, followed by intravenous Zofran or other products like it just before they resume consciousness. Noting that such combinations “seem to work pretty well,” he added that cost-effectiveness issues might make it difficult to justify using newer, pricier drugs.
“It’s a balance of the drug’s efficacy,” York said, “against the drug’s cost.”
However, he declined to comment specifically on Aloxi, as did Dr Mark Fahey, an anesthesiologist at Kaiser-Permanente Medical Center in California. But Fahey pointed out that the multiple options currently available in the post-operative setting make it “pretty hard to interest anesthesiologists in anything else.” He added that he prefers an older drug called droperidol, especially in rescuing patients after their nausea and vomiting begins, though it is difficult to use these days because of black box restrictions on its label and resultant patient monitoring costs.
Fahey noted that Zofran works fine in his practice, compared to the other approved 5HT3 antagonists like Anzemet (dolasetron), from the French firm Aventis, and Kytril (granisetron), from the Swiss company Roche. He said, “there’s not going to be a lot that’s going to be marketable” like Zofran. Further, he dismissed the need for longer-acting anti-emetics because far fewer patients spend hours or days feeling nauseous after anesthesia than they did in the past.
“It’s rare that I have patients coming back and telling me about having a recent horrible anesthetic experience in which nausea was the major problem for 24 to 48 hours after surgery,” Fahey said.
Analysts estimate that the US market for post-operative nausea and vomiting to total more than USD 700m, and have also speculated that use in this space could help Aloxi’s peak annual sales reach USD 750m. The drug was already approved by the FDA to prevent nausea and vomiting associated with chemotherapy, and it generated USD 251m in sales last year. That was level with the previous year, a plateau largely driven by the introduction of generic versions of UK-based GlaxoSmithKline’s Zofran, which also is approved for chemotherapy-induced nausea and vomiting.
But changes in Medicare reimbursement for generic Zofran will make it less profitable for doctors, analysts have said, which has led observers to believe that Aloxi sales will ascend again. According to MGI, Aloxi’s dose in the post-operative setting is about one-third the dose used in the chemotherapy setting, so it follows that the drug would likely cost between USD 30 and USD 40 per post-operative procedure.
Two Phase III trials underlying Aloxi’s supplemental new drug application met their primary efficacy endpoint of complete response, defined as no emesis or use of rescue medication, for the first 24 hours, as well as a secondary efficacy endpoint of complete response for the entire 72-hour period following surgery for the proposed dose of 0.075 mg. The incidence, pattern, and intensity of adverse events were similar among all treatment groups including placebo, and the most frequently observed side effects were headache and constipation.
MGI’s spokesperson said Aloxi would be most appropriate for patients following select surgeries, such as gynecological, abdominal and breast operations. The drug’s patent lasts into 2015.
The FDA is scheduled to complete its review by March 4, 2008.
MGI, a listed biopharmaceutical company focused in oncology and acute care, also markets Dacogen (decitabine) and the Gliadel Wafer (polifeprosan 20 with carmustine implant) in the US and collaborates with partners to reach international markets. It pays a royalty to a private Swiss firm, Helsinn, on Aloxi sales.
MGI expects to expand its sales force for Aloxi in post-operative nausea and vomiting by hiring more reps who would also be used to market another drug coming down the line, a sedative for outpatient procedures called Aquavan (fospropofol) scheduled for an FDA filing later this quarter. The common synergy is found in accounts on which the sales staff would call. The company’s spokesperson said more reps would likely be hired next year, adding that MGI would not seek to buy another company in order to grow its sales staff.
MGI’s market cap is about USD 1.95bn.
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