Trimeris, a small Research Triangle Park pharmaceutical firm that produced the first drug in a new class of HIV medications last year, has recently encountered some bumps in the road.
Arising from the labs of Duke University Medical Center in the late 1990s, Trimeris launched Fuzeon in March 2003, after accelerated FDA-approval. Fuzeon is a fusion inhibitor, which prevents HIV from fusing to cells within the immune system, and is used in combination therapy for HIV-positive patients who have developed resistance to more established treatments such as antiretrovirals and protease inhibitors.
Earlier this month, Trimeris and Roche, a partner firm, issued a joint press release pledging continued commitment to "discover, develop and commercialize the next generation of HIV fusion inhibitors." The next fusion inhibitor, Trimeris' T-1249, was to be Fuzeon's successor. More importantly, the release later states that Roche and Trimeris have decided to put the early stage clinical program of T-1249 on hold because of challenges in achieving the desired technical profile of the current formulation of the investigational compound T-1249.
"The T-1249 program was put on hold until we find a formulation that is longer acting, perhaps requiring weekly or monthly dosages," said Robin Fastenau, director of public relations for Trimeris. "It could be a delay of several years."
Dr. John Bartlett, professor of medicine at Duke, praised the potential of T-1249 as the next generation of fusion inhibitors, but was disappointed in Trimeris' announcement to delay its development, as much for the greater philosophical implications as the lost potential of its clinical efficacy.
"This is a very important precedent," Bartlett said. "The realities of resource availabilities are impacting on drug development, in the context of a drug that has been shown to have a unique characteristic."
As a patient advocate, Bartlett said he saw T-1249 as being "potentially important" for HIV/AIDS patients, and preliminary results, as presented last fall, were promising.
While Trimeris waits to conceive a more effective method of delivery, the firm has been forced to lay off 25 percent of its workforce--largely the programmatic staff related to the project, Fastenau said.
She added that Trimeris would turn to Fuzeon to improve the drug in terms of better delivery devices and improving formulations to reduce the number of subcutaneous injections and extend the dosage.
Trimeris, a publicly traded company, has netted $18.3 million since the launch of Fuzeon. The company will release its fourth quarter results Feb. 3. However, analysts downgraded Trimeris' stock rating Jan. 6 as a result of the previous day's press release, which some analysts perceived as "deceptive," causing the stock to fall 14.5 percent within the day. It has recovered from some of that drop since.
As Trimeris faces these setbacks, HIV/AIDS patients who need Fuzeon are also facing barriers to obtaining the drug.
In a Jan. 13 article, the Wall Street Journal reported that the high price of Fuzeon was restricting North Carolina's AIDS Drug Assistance Program, a federally and state-funded program, from providing appropriate care for patients unable to afford it. ADAP, unlike Medicaid, is not an entitlement program, and is the last resort for many patients not poor enough for Medicaid, which also only covers patients with fully developed AIDS.
Steve Sherman, director of NC's ADAP, said the program set a cap for 25 state residents to be eligible for Fuzeon treatment at any one time, creating a system of rationing medical care. ADAP serves approximately 3,500 HIV/AIDS patients total, he added. The eligibility requirements for the program are state residency, HIV-positive status, a family income at or below 125 percent of the poverty level--one of the tightest criteria of the nation--and no third party coverage.
"Despite what is a fairly hefty cost, we were willing to include Fuzeon in the formulary," he said. Although the going price for Fuzeon stands around $20,000, ADAP, whose 2004 budget is $25 million, does receive pricing considerations. Sherman, however, would not reveal the negotiated rate.
Although North Carolina was able to include Fuzeon on its formulary--the list of drugs ADAP can cover--the WSJ reported that Alabama's ADAP decided not to include Fuzeon and, in doing so, denied more affordable HIV/AIDS treatment to many more residents. Currently, Fuzeon is included in the formulary for 31 states, Fastenau said.
"ADAP nationally has been on a budget crisis," she said. "This was the case even before Fuzeon was launched." She added that North Carolina has had one of the largest waiting lists due to the nature of the virus afflicting the lower-income segment of the population, and that Fuzeon was in no way responsible for the budgetary problems.
Roche also maintains a charity program, providing Fuzeon free to certain low-income patients demonstrating need. Fastenau, however, could not comment on how many people the program served.
"Use of drugs like [Fuzeon] is clearly cost effective, and these programs need to be given adequate resources to provide the best treatment," Bartlett said. "If the [ADAPs] are underfunded, difficult decisions need to be made to allocated resources," resulting in the rationing of medical care.
Only three state residents are on the waiting list for Fuzeon, but the application process through which patients must go to meet eligibility criteria, requires a clinician assess the severity of the need before ADAP can recommend immediate treatment or placement on the waiting list.
Currently, 2002 estimates of North Carolinians afflicted with HIV/AIDS ranges from 17,000 to 24,000, Sherman said. The ambiguity in the infected population is due to high number of people who could be infected and not have sought out treatment due to factors such as income, location or stigma associated with sexually transmitted diseases, especially AIDS.
Despite the combination of state and national budgetary crunches and the prohibitive cost of Fuzeon, Sherman said he did not expect Fuzeon to be removed from the formulary in the near future.
"While I'm not convinced our budget will grow over the next several years--maybe not even at all--I don't think we will lose any of our budget," he said. "Given that, I'm not anticipating we will drop Fuzeon or any other AIDS medication."
Get The Chronicle straight to your inbox
Signup for our weekly newsletter. Cancel at any time.