Reports of increased global supplies of Fuzeon, coupled with longer-term data on the product, gave Trimeris Inc. a boost from investors eyeing higher earnings from early sales of the FDA-approved HIV drug.
Shares in the Durham, N.C.-based firm (NASDAQ:TRMS) gained 99 percent Tuesday, a $4.93 climb, to close at $54.54 as the news came out at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Paris.
While clinical data supported prior findings of Fuzeon's ability to improve immune responses, Trimeris and development partner F. Hoffmann-La Roche Ltd. turned heads with news of increased quantities of the drug. They said they would make Fuzeon (enfuvirtide) available to up to 18,000 patients by the end of this year, up from prior supply estimates that ranged from 12,000 patients to 15,000 patients.
The total supply figures include enough units for 12,000 patients in the U.S., where Trimeris will receive royaltiesof 50 percent. Given a lower figure on overseas sales, investment bankers buzzed on the increased supply news, which resulted from improved manufacturing yields and from a slower-than-expected launch in the European Union.
"They have to obtain reimbursement on a country-by-country basis, and given the high cost of the product, it will likely take a little bit of time to negotiate in each territory," Yaron Werber, an analyst with SG Cowen Securities Corp., told BioWorld Today. "Essentially what it means is that since there are fewer European patients on the drug currently, there is more supply available from the start."
He said Trimeris would receive royalties between 10 percent and 12 percent outside the U.S. The partners have scheduled their production to maintain a six-month supply per treated patient, and Werber added that previous capacity guidance of 32,000 patients by the end of next year and an average of 39,000 patients in 2005 remains unchanged.
"Supply output is greater than originally projected at this point in time," Robin Fastenau, the corporate communications manager at Trimeris, told BioWorld Today. "That means that more drug is available for patients in 2003."
Others in the investment community factored the increased manufacturing capacity into added revenue for Trimeris. Deutsche Bank analysts Dennis Harp and Andrew Fein bumped their worldwide Fuzeon revenue forecasts northward, increasing 2003 sales projections from $59 million to $75 million, 2004 sales from $342 million to $437 million and 2005 sales from $667 million to $727 million.
"We believe that Fuzeon has the potential to drive Trimeris into substantial profitably," they wrote in a research note. "We are projecting EPS of $1.32 in 2005, $3.27 in 2006 and $4.28 in 2007 based on peak Fuzeon sales of $900-plus million in 2007."
Another analyst, Sharon Seiler with Punk, Ziegel and Co., wrote, "We assume that improvement in yield translates into higher gross margin for Fuzeon."
All three New York-based firms make a market in Trimeris, which, along with Basel, Switzerland-based Roche, received FDA approval for Fuzeon under fast-track priority review guidelines this spring. The drug is indicated for combination treatment with other antiretroviral agents for HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Also approved in the European Union and Switzerland, Fuzeon is designed to work outside the cell to block the virus from entering, as opposed to traditional HIV products that are designed to work inside the cell. (See BioWorld Today, March 17, 2003.)
Its $20,000-per-patient cost could limit use of the drug, as could logistical issues related to a patient eligibility process that initially took about three weeks. Physician acceptance also could take time, a factor that could hinge on the wait for approval of other HIV drugs, Werber said.
But he added that the latest findings supported Fuzeon's clinical benefit. Data revealed that two-thirds of treatment-experienced patients who began combination therapy with Fuzeon achieved undetectable levels of HIV when they began therapy with less-advanced disease and had been exposed to fewer anti-HIV drugs.
"The data once again suggests two things," Werber said. "No. 1, once a patient is treated with Fuzeon, there is a longevity of response and the emergence of resistance is fairly low between 24 and 48 weeks. Two, it showed that patients who are treated earlier in their disease course have a more favorable response, suggesting that patients and physicians really should not wait until the patient becomes refractory to all options before starting Fuzeon."
The findings, culled from a subanalysis of combined Phase III studies called TORO 1 (T-20 [Fuzeon] vs. Optimized Regimen Only) and TORO 2, showed that 68 percent of less-advanced patients who began a Fuzeon-based regimen with a CD4 cell count of greater than 100 cells/mm3 and prior treatment with six to 10 anti-HIV drugs achieved undetectable levels of HIV (less than 400 copies/mL) at 24 weeks. That compared to 39 percent treated with an optimized combination of anti-HIV drugs without Fuzeon. In more advanced patients with CD4 cell counts less than 100 cells/mm3 and prior treatment with more than 10 anti-HIV drugs, 23 percent of those receiving Fuzeon-based regimens achieved less than 400 copies/mL of HIV at 24 weeks, compared to 5 percent without Fuzeon in their regimen (p<0.05).
Roche and Trimeris said they would release separate data at the conference showing that 91 percent of patients who achieved undetectable levels of HIV at 24 weeks maintained the response at 48 weeks (p<0.0001).
Werber said the data bolster findings already indicated in the drug's label, which should help patient reimbursement. He also pointed to physician acceptance of the product based on the results of a Cowen survey that found that more than a quarter of the 335,000 patients treated in the U.S. could be candidates for Fuzeon.
"We believe this is largely going to be a supply-driven market in the next few years," he said. "In our view, any increase in capacity will ultimately translate into an increase in sales."
Additional 48-week data showed that among patients whose virus was sensitive to one drug in the background regimen, 29 percent of Fuzeon patients achieved undetectable levels of HIV, compared to 7 percent in the control arm. Also, 38 percent of patients who had at least two active agents in their background regimen achieved undetectable HIV in the Fuzeon arm at 48 weeks compared to 18 percent in the control arm (p<0.05).
In the pipeline, Trimeris and Roche continue to collaborate on T-1249, a second-generation Fuzeon designed for increased potency. The product is scheduled to enter Phase II testing by the end of the year.