Trimeris Receives $7.5M Bill From Roche for Additional Costs of Supplying Antiretroviral Drug Fuzeon

Durham, N.C.-based biotechnology company Trimeris on Tuesday said it has received a $7.5 million bill from Swiss drug maker Roche -- the biotech firm's partner in developing and marketing the antiretroviral drug Fuzeon -- for additional costs related to drug supply, the Durham Herald-Sun reports (Durham Herald-Sun, 4/20). Roche and Trimeris jointly developed Fuzeon, which is in a class of drugs called fusion inhibitors and is designed for HIV/AIDS patients who have failed to respond to other medications. The drug has encountered resistance from doctors and patients because of its high cost and injection delivery method. The drug costs about $20,000 per patient per year. Roche says that the high cost of Fuzeon is attributable to its complex manufacturing process, which takes about six months and requires 44 different raw materials and more than 100 manufacturing steps (Kaiser Daily HIV/AIDS Report, 4/16). Trimeris said that the bill includes additional costs for supplying the drug during the past year and costs stemming from a charge in depreciation method on capital connected to the drug's development, according to the Herald-Sun. Officials said that the drug supply charges come from higher costs "early in Fuzeon's production," the Herald-Sun reports. Trimeris CEO Dani Bolognesi said, "We are currently in discussions with Roche regarding this claim," adding, "This is not a dispute. This is normal business" (Durham Herald-Sun, 4/20). Trimeris said in a release, "The ultimate resolution of this claim cannot presently be determined, nor can the ultimate liability be estimated at this time." Trimeris and Roche split profits from Fuzeon sales using a "complicated formula" that includes development and marketing expenses, Reuters reports.

Q1 Sales Up
Trimeris on Tuesday announced it lost $9.9 million, or 46 cents per share, in the first quarter of 2004, compared with a loss of $15.9 million, or 75 cents a share, in the same period of 2003, Reuters reports. Although analysts have been disappointed with initial sales of Fuzeon, global first quarter sales of the drug increased 36% over 2003 fourth quarter sales to $24 million, according to Reuters (Reuters, 4/20). Net sales of Fuzeon in the United States and Canada increased 20% from $13.3 million in the fourth quarter of 2003 to $16 million in the first quarter of 2004, according to a Trimeris release. Net sales outside of the United States and Canada were $8 million during the first quarter of 2004, compared with $4.3 million during the fourth quarter of 2003 (Trimeris release, 4/20). Trimeris and Roche earlier this month announced that the drug will be available at the end of the month in retail and specialty pharmacies. In order to make the drug available to patients, physicians previously had to fax a prescription to the drug's only mail-order distributor. However, Roche is expanding its manufacturing process, which will allow patients to take their prescriptions directly to pharmacies. In addition, to increase demand for the drug, Trimeris said it is working on a new formula for Fuzeon that would reduce injections from twice daily to once per week or even less frequently (Kaiser Daily HIV/AIDS Report, 4/16).