ACT UP Press Release ____ Contact: John Riley 917-653-7267
March 13, 2003________.,,,,,,,,,,,,,_._ Mark Milano 212-475-4889

ACT UP CREATES  "FUZEON GRAVEYARD" AT ROCHE HEADQUARTERS

Activists say that $25,000 price of new AIDS drug
will lead to thousands of deaths in the U.S.

A dozen members of ACT UP/NY erected a graveyard at gates of Roche's U.S. headquarters in Nutley, NJ this morning.  Tombstones bearing the epitaph, "DIED OF AIDS,  KILLED BY ROCHE'S GREED," were erected in front of the drug maker, along with a banner that read "ROCHE GRAVEYARD" and "FUZEON'S PRICE KILLS."

Roche, the pharmaceutical giant, recently announced a European price of  $20,424 for a year's supply of its anti-HIV drug Fuzeon. This will translate into an AWP (Average Wholesale Price) in the U.S. of close to $25,000.  "Roche has priced Fuzeon at almost three times the price of the most expensive AIDS drug," said ACT UP/NY member Mark Milano. "This excessive price will force ADAP programs to cut other cut other life-saving drugs, restrict entry to their programs, or increase already long waiting lists.  This will hasten the death of thousands of people with HIV in the U.S."

The AIDS Drug Assistance Programs (ADAPs), programs that pay for treatment for people with HIV who are uninsured or underinsured, are expected to experience a $140  million dollar shortfall for this year unless new monies are appropriated. Currently, ADAP programs in 14 states are limiting enrollment or the drugs available on their formularies.  ADAP directors are holding a series of meetings with pharmaceutical companies next week to negotiate discounts on all AIDS-related drugs, including Fuzeon, but it is doubtful these discounts will be enough to address the problem.  The White House is also proposing sweeping changes to Medicaid which may cut prescription coverage for people unable to work.

"Roche claims that Fuzeon is more expensive to produce than other anti-HIV drugs, but that doesn't justify this excessive price," said Eustacia Smith. "Roche claims it spent $600 million developing the drug, but they refuse to open their books to verify that.  Our research  suggests they spent closer to half that amount, and also that significant portions of the research costs were paid for by the NIH including the drug's discovery and the initial phase I clinical trial." {see accompanying fact sheet)

"Drug companies have lied about their drug costs for years" said Laurie Wen. "The same HIV drugs that cost up to $15,000 a year in the U.S. can be made for less than $300 a year by generic manufacturers overseas.   We demand that Roche drastically drop the price of Fuzeon and open its books to justify its price. Overpricing guarantees lives will be needlessly lost."

 

ACT UP Press Release
February 25, 2003

Roche Pharmaceuticals Tells People with AIDS:
YOUR MONEY OR YOUR LIFE

Roche, the pharmaceutical giant, announced a European price of $20,424 for a year's supply of its anti-HIV drug Fuzeon. "Roche has priced Fuzeon at over two times the price of the most expensive AIDS drug," said ACT UP/NY member Mark Milano. "While Fuzeon may be more expensive to produce than other anti-HIV drugs, its manufacturing costs in no way justify this excessive price. Roche claims it spent $600 million developing the drug, but it offered no independent verification of this figure and publicly available information suggests it spent closer to half that amount."

The price of the new drug, which may be needed by tens of thousands of people with AIDS, is far too high for the public programs that pay for treatment for most people with AIDS. The AIDS Drug Assistance Programs (ADAPs), programs that pay for treatment for people with HIV who are uninsured or underinsured, are expected to experience a $140 million dollar shortfall for this year unless new monies are appropriated. Currently, ADAP programs in 14 states are limiting enrollment or the drugs available on their formularies. If these programs are to add Fuzeon, they will have to cut other drugs they offer, restrict entry to their programs, or increase already long waiting lists. The White House is also proposing sweeping changes to Medicaid which may cut prescription coverage for people unable to work.

"In 1987, Glaxo Wellcome (then Bouroughs Wellcome) announced a price of $10,000 for AZT (Retrovir) and tried to justify its price by referring to the 'expense and difficulty of making AZT,' but that price was clearly based on lies," said Eustacia Smith also of ACT UP. "Today Cipla, the Indian generic drug manufacturer produces AZT for less than $100 for a year's supply. We demand to see Roche's books. We won't be fooled by Roche's unsubstantiated claim," Smith added.

"We are too far along in the conversation about drug company price gouging for Roche to now claim this is a reasonable price. ACT UP/NY condemns Roche's stratospheric pricing of Fuzeon and we vow to fight their outrageous price-gouging. We demand that Roche drastically drop the price of Fuzeon and open its books to justify its new price." Smith emphasized. "Roche will enjoy a monopoly for 20 years, it can afford a price that is close to the production price. Overpricing guarantees lives will be needlessly lost."


Taxpayer Dollars Paid for Fuzeon's Discovery and Development
Roche and Trimeris Gouge Tax Payers Three Times Over

Roche and Trimeris, both pharmaceutical companies, are partners in the marketing of an experimental AIDS drug T-20, also called Fuzeon, which is likely to be approved in the United States in mid March 2003.  The drug is approved in Europe and priced at $20,424 making it the most expensive AIDS drug by more than a factor of two. The drug is expected to cause a crisis in publicly funded health care systems such as the AIDS Drug Assistance program (ADAP), which provides AIDS drugs to 25% of those taking anti-retroviral drugs and to Medicaid which provides drugs for 50% of those with AIDS. Drug companies typically price drugs  5-20%higher in the US because European countries have national health care systems that negotiate discounts, unlike the US.

This price is  outrageous because the drug was discovered and developed with significant investment of government and other public monies. In the following document entitled Fuzeon Drug Development Time Line, the initial patent on the drug and important studies are listed which include a summary of the findings and information about the source of the funds to conduct the studies. The money for the research and development of the AIDS treatment came from diverse sources. Initially funds came from the National Institutes of Health (NIH) which is funded by the tax dollars, then from the founders of Trimeris and various foundations and foreign public institutions including those based in Australia, Canada and France. The drug's brand name is Fuzeon, it's generic name Enfuvirtide

June 7, 1993 Bolognesi et al. filed US Patent # 5,464,933 on the invention of T-20 (then called DP-178) delineating its structure and function. The funding for the discovery came from the National Institutes of Health, Grant Number AI-30411-02. The patent assignee was Duke University.  Under federal law, the government has certain rights on the patent including march-on rights delineated in the Bayh-Dole Act because it funded the research.

That same year more laboratory and animal testing of T-20 began at the newly formed Trimeris.  Trimeris's main contribution to the development of the drug was the large scale production technique for preparation of the peptide. The initial Phase 1 trial which provided proof-of-concept was funded by both Trimeris and NIH Grants (P30 A127767) and (NCRR MO1 RR00032). Later studies detailing the cause of an injection site reaction that most users experience were conducted by NIH as were studies of how resistance to Fuzeon arises and the drugs possible use with other current AIDS drugs that are in clinical or pre-clinical trials.

Eight of the studies listed in the time line were conducted by the NIH or with NIH grants. Five were conducted with funds contributed by the non-profit Howard Hughes Medical Institute and several using grants from other foundations. Three studies received support from public institutions in other countries. Some studies received a combination of public, foundation and private funds. Because non-profit foundations receive exemption from taxes they too constitute a type of public funding.

Tax payers are billed three times when they pay for the research to develop the drug, then pay again when they buy it for themselves and a third time when their tax dollars buy it for publicly funded health programs like Medicaid and ADAP.

Technically under US Code TITLE 35 > PART II > CHAPTER 18 > Sec. 202. The fact that the US Government gave funds that contributed to the invention means that the government has a license to produce the drug. This  means the government has the right to produce the drug, and probably could do so at a cheaper price which would make considerable savings since it purchases 3/4 of the total domestic supply.

"With respect to any invention in which the contractor elects rights, the Federal agency shall have a nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world"

While it is clear Trimeris contributed much to the development of the fuzeon, the drug would likely not have been discovered without government funding.

Recovery of cost. We believe Roche and Trimeris intend to recoup the cost of the development of the drug over the course of the first two years of its 20 year patent. This quick recovery of investment  is typical practice of drug companies and is why the drug companies are 3-4 times more profitable than other sectors. All of this profit is at the expense of the government, taxpayer and people who have a life threatening disease.

The following is a partial list of studies funded by public money :

**First Patent Filed Filed June 7, 1993: Pre-clinical proof of activity.

This invention was made with Government support under Grant No. AI-30411-02 awarded by the National Institutes of Health. The Government has certain rights in the invention.  The inventors are Bolognesi; Dani P. (Durham, NC); Matthews; Thomas J. (Durham, NC); Wild; Carl T. (Durham, NC)  The patent was assigned to Duke University (Durham, NC)

 **Filed: March 23, 1998 Basic methodology for making large scale batches of T-20. Patented by Trimeris. United States Patent 6,281,331; Kang ,   et al. August 28, 2001 were inventors the Assignee is Trimeris, Inc. (Durham, NC)

**Filed: May 1, 1998  More methods for T-20 synthesis
Patented under number 6,015,881 by Kang ,   et al. The assignee is Trimeris, Inc..

Published November 1998 Paper published showing proof of concept that T-20 can safely be administered to humans and lower viral load at high dose levels. Research supported by Trimeris and NIH Grants (P30 A127767) and (NCRR MO1 RR00032)

2000 Jun 16 Paper published demonstrating possible source of injection site side effects caused by T-20.  Study done at NIH.  Injection site reactions occur in most patients receiving the drug.

2000 Sept. Paper published showing how different receptors interact with T-20 and with where these receptors interact with the virus. This research was supported by Howard Hughes Medical Institute and NIH grants R37A133319  ,R37AI24745 and P30-A1-27767.    This research is important in helping define the mechanism of the drug's action.

2001 Apr 1. Preclinical experiments show that T-20 combined with another entry inhibitor, both currently in  Phase I/II trials, can have a synergistic effect allowing the combination to act at much lower doses than individually. Research supported by NIH grants AI-43084 and AI-43847

2001 Sep Preclinical experiments show mechanisms action of T-20 and T-649 (a version of T-1249). Research was supported by HHMI and NIH grants R37AI33319 , R01AI24745 , P30-A1-27767.

May 2002 Test tube studies provide more evidence that T-20 is useful in combination with standard approved AIDS drugs and that it is synergistic in its action in with other not-yet-approved entry inhibitors. Funded by NIH grant number CA12464, and from Schering-Plough Research Institute. (C.L.T. was a Research Fellow supported by the Fonds de Recherche en Sante du Quebeq).

2002 June. Mechanism of creation of T-20 resistant virus is studied yielding information that may affect the treatment strategies used when using the drug. The study was done on virus isolated from individuals who became resistant from the phase I trial. Research funded by  NationalInstitute of Health grants CA73470, R41 AI46112, and AI35467; and  (P30-AI-27767). Trimeris provided T-20. Howard Hughes Medical Institute, also provided support for the studies.

2002 July Phase III trial results reported at International AIDS Conference for T-20 show that 32.7% of those treatment resistant patients receiving T-20 had undetectable levels of virus vs. 15% of those not taking the drug.  The study was funded by Trimeris and Roche.

2002 July Study by Community Research Initiative on long-term treatment satisfaction with subcutaneous T-20,. Study funded by Roche

2002 July Study by the Pediatric AIDS Clinical Trial Group shows that a 24-week regimen of twice daily s.c. dosing of T-20 in HIV-1-infected children is safe and tolerable and that it is associated with suppression of HIV-1 replication during 24 weeks of administration.

2002 July Study conducted by investigators at Howard Hughes Medical Institute shows how resistance to T-20 and similar drugs arises.

2002 July Another study funded by Howard Hughes Medical Institute shows how resistance to T-20 arises

2002 July Another study by Roche tests pharmaco-kinetics (drug safety and blood levels) in patients using higher dose of T-20.

2002 September- October Study by Roche shows patients daily lives are not negatively impacted by use restrictions in behavior required to use T-20

2002 Dec 10 Preclinical studies show more about the mechanism of action of T-20 and how resistance might develop and which individuals might benefit most from the drug. Studies Funded by NIH Grant #AI40880, a Burroughs Wellcome Fund Translational Research Award, and an Elizabeth Glaser Scientist Award (to R.W.D.). S.P. was supported by a fellowship from the Deutsche Forschungsgemeinschaft.  (drugs supplied by Trimeris)

2003 Jan French Scientists show that co-receptors are very important in how effective T-20 is at inhibiting fusion of the virus with the cell. Research supported in part by the French National Agency for AIDS Research (Agence Nationale de Recherche sur le SIDA [ANRS]). B.L. is the recipient of a Sidaction fellowship.

 


Basel, Switzerland (AP) -- Swiss pharmaceuticals giant Roche on Monday set at $56 a day the European price tag for a new AIDS drug that could prolong the lives of patients with drug-resistant strains of HIV. Roche said it would make supplies of Fuzeon available in the European Union under a special program, ahead of formal approval by EU regulators who are soon expected to license the drug.

The yearly cost of Fuzeon treatment will be 18,980 euros ($20,409), Roche said. The most expensive AIDS drugs now available cost about $7,500 a year, although some combination treatments--a cocktail of different drugs--approach $15,000 a year. `This price reflects the structural complexity of Fuzeon and its highly sophisticated manufacturing process,'' said William M. Burns, head of the Roche pharmaceuticals division. ``Fuzeon is the most clinically advanced agent of the fusion inhibitors, a completely new class of drugs.''

Fusion inhibitors are designed to block HIV--the virus that causes AIDS--from entering healthy blood cells. Existing HIV drugs work inside the infected cell. Roche said Fuzeon represents ``the first significant breakthrough in HIV therapy since 1996.'' Roche said the while the average European Union price of the drug following EU approval would likely remain about 52 euros, it might vary from country to country because of taxes and trade margins. Roche, which developed Fuzeon with Trimeris, of Durham, North Carolina, said it would not release its U.S. price until the drug is formally launched on the American market. .Last August, Fuzeon won a priority, six-month review from the Food and Drug Administration.


T-20 : A New Drug Class Comes of Age

by Kristen Kresge, senior correspondent for the American Foundation for AIDS Research

see article with links: http://www.amfar.org/cgi-bin/iowa/td/newsan/record.html?record=70

August 2002

Introduction

Some of the most promising news from the 14th International AIDS Conference, held last month in Barcelona, Spain, included the results for the first of a new class of AIDS drugs called fusion inhibitors. This novel class holds hope for the growing population of treatment-experienced patients who have developed single- or multiple-drug resistance to the current market of antiretrovirals.

Currently available HIV drugs focus on preventing virus replication by targeting either the protease or reverse transcriptase enzymes. But fusion inhibitors hit the virus at an earlier stage. They are designed to prevent HIV from ever fusing with a host cell and inserting its genetic material.

The furthest along of any experimental drugs in this new class is T-20, a drug co-developed by Roche and Trimeris. (T-20 is also known as enfuvirtide or by the brand name Fuzeon.) Phase III data indicate that T-20 has considerable efficacy even for patients who have run through most standard drugs. But with questions growing about its usage and pricing, some doctors are reluctant to hail it as a "miracle drug" for resistant HIV.

The T-20 results come from two Phase III trials, known as TORO 1 and TORO 2. These included nearly 1,000 heavily treatment-experienced patients. Trial volunteers had been exposed to 11 or 12 previous antiretrovirals and started the study with HIV viral loads greater than 5,000 copies per milliliter. They were prescribed an individually optimized combination therapy of three to five standard anti-HIV drugs with or without T-20.

After 24 weeks in the TORO 1 trial, 20% of the volunteers taking T-20 had viral loads of less than 50 copies per milliliter. Only 7% in the control arm had equivalent reductions in viral loads.

The T-20 results in the TORO 2 study were a little weaker: at 24 weeks, 12% of patients receiving T-20 along with combination therapy had viral loads below 50 copies per milliliter, and 5% of those not receiving T-20 reached the same level.

"The results were very encouraging," said Dr. Jay Lalezari, lead investigator in the TORO 1 study and Director of Quest Clinical Research in San Francisco. "We've had enormous success at treating the later, more aggressive stages of HIV."

This 24-week data will be the basis for an application to the United States Food and Drug Administration and the European Union later this year. Roche and Trimeris have fast track approval status from the FDA, based on T-20's potential to help people who are unable to suppress their drug-resistant HIV with the current antiretroviral combinations, an area of treatment referred to as salvage therapy.

"Clinicians have a new card to play," said Dr. Keith Henry, director of HIV Clinical Research at Hennepin County Medical Center in Minneapolis, who sees T-20 as having a definite role in salvage treatment. But Henry cautioned that the TORO 1 and 2 study populations with highly drug-resistant HIV are not the ideal targets for adding a new class of drugs onto standard therapy, because this represents a "sub-optimal strategy for approaching HIV."

HIV does develop resistance to T-20. With only 24-week data available (follow-up will continue out to 48 weeks), Henry finds it hard to imagine years and years of use with T-20. "Durability would definitely be an issue if it's the only drug that's pulling the weight," he said.

In the clinic, Lalezari observed the most promising T-20 results in volunteers who had never taken the protease inhibitor Kaletra. They could then receive a regimen in which Kaletra and T-20 worked together to suppress HIV. Kaletra, manufactured by Abbott Laboratories, is a combination of the protease inhibitor lopinavir plus a small amount of ritonavir to achieve very high lopinavir levels in the body. These levels can overcome a certain amount of prior resistance to protease inhibitors on HIV's part. As with T-20, HIV can develop resistance to Kaletra if it is administered without active supporting drugs.

Lalezari's advice to practicing clinicians is to delay prescribing Kaletra until it can be used along with T-20 in salvage therapy. When administering the two together in this fashion, he saw major improvements in multi-drug resistant patients who were beginning to lose weight and get sick. "Our percentage of success was extraordinary," said Lalezari, referring to the number of patients whose viral levels fell below 50 copies per milliliter with T-20 and Kaletra. The use of T-20 alone in patients who had already failed on Kaletra was not as successful.

Henry believes that T-20's ideal role could be as a component of "induction/maintenance" therapy. This strategy would utilize T-20 as part of an optimized regimen of HIV drugs to get viral levels to an undetectable level (below 50 copies/mL). If this were achieved, after six to twelve months of receiving T-20, the drug could be withdrawn. The patient would receive the standard combination therapy alone, and T-20 could be reserved for occasions when HIV rebounded. This approach helps reserve available classes of HIV drugs for later use by preventing patients from burning through antiretrovirals, one by one as HIV develops resistance to each active drug in a succession of suboptimal regimens.

"We don't know about induction /maintenance regimens," commented Lalezari, but "it's an attractive idea."

T-20's Price

T-20's final role in salvage therapy may well depend on its price. Since the trial data were released in Barcelona, T-20's eventual market price has become a major concern. Roche has made no comment on pricing and will not do so until the drug is approved and available, said Heather Van Ness, the director of Product Public Relations at Roche Pharmaceuticals. Still, she acknowledged, "It will be more expensive than existing therapies."

This is due to T-20's structural complexity. Unlike most drug candidates, which are small molecules, T-20 is a synthetic peptide, or protein sequence made up of 36 connected amino acids. The synthesis of T-20 requires 106 steps. T-20's manufacture requires specially built equipment, and Roche is refurbishing a plant in Boulder, Colorado solely to produce T-20. Ness could not provide an estimate on the manufacturing costs of T-20.

"It's hard to imagine that there would be widespread use at the price being quoted," said Henry, referring to an early July Wall Street Journal article that reported estimates of the annual cost per patient being anywhere from $12,000 to $15,000 and above.

"All of the numbers that are floating around are analyst speculations," responded Roche's Ness. "We are investing $500 million dollars to develop fusion inhibitors."

The analysts' price forecasts could not come at a worse time for the AIDS Drug Assistance Programs (ADAPs). With most states' ADAPs in dire financial straits, the programs' ability to cover their low-income, uninsured clients' use of expensive new drugs is doubtful. In New York State, ADAP is taking a financial hit from an increase in enrollment, as well as from longer enrollment periods. That state's ADAP deficit is expected to reach $15 million this year, and New York is better off than many other states.

Use of T-20 will increase the overall cost of antiretroviral therapy, forcing ADAPs to begin prioritizing, or even cutting, their services. This might mean placing more restrictions on enrollment, or the state ADAPs might end up simply excluding T-20 from coverage because of its price tag. They would then direct patients to Roche's assistance program for indigent patients, but there is no guarantee that everyone in need would receive the drug.

Roche and Trimeris will begin enrollment in an expanded access program for T-20 on Sept. 1, although drug supply will not be available until the beginning of October. The modest program will provide T-20 to a maximum of 1,200 people worldwide - including only 600 in the United States. The program will be open only to those with a CD4 count of less than 100, a viral load of greater than 10,000 copies per milliliter, and the inability to construct a successful treatment regimen without T-20. The treating doctor will initiate the enrollment process and positions will be filled on a first-come, first-serve basis.

SIDEBAR: Administering T-20

The dosing requirements of T-20 also deserve consideration. The drug is injected twice daily under the skin. This method of administration is necessary to get the large, unstable molecule into the body. T-20, once inside the body, has minimal side effects partly because the drug directly enters the blood, acts and breaks down without ever entering cells.

But getting it into the body is the real problem. Before injection, T-20 must be taken out of refrigeration and combined with a sterile water solution in a syringe. The mixture must then sit at room temperature for 30 minutes to ensure proper mixing. This time-consuming procedure makes taking T-20 while working or traveling rather difficult.

"It's kind of inconvenient," said Matt Sharp, a treatment activist and writer who is taking T-20 in addition to standard anti-HIV therapy.

The problems don't stop with preparing T-20 for injection. Roche and Trimeris report that "most patients" receiving T-20 in both TORO studies experienced injection site reactions - nodules that appeared on the skin where the drug was injected. These nodules can remain for several weeks. In the TORO trials, only three percent of patients discontinued use due to these reactions.

Those taking T-20 have to inject the drug in a different place on the body every time they self-administer it. Since injections must be taken twice daily, "that doubles the issue," said Sharp. "Even if it were once a day it would be better."

Dr. Keith Henry urges clinicians who are considering T-20 for patients to "carefully look at patient populations," including their motivation to stick with the dosing regimen. "Injections are not the most user-friendly things to think about," says Henry.

Adherence to the complicated dosing regimen is likely to be less of an issue for those desperately needing T-20 for salvage therapy. "It would be really nice if there was another method of delivery," said Sharp, "but I'm glad it's there."
.

article with links: http://www.amfar.org/cgi-bin/iowa/td/newsan/record.html?record=70

This article originally appeared in the AmFAR Treatment Insider . www.amfar.org/globalink


Roche AIDS Drug's Steep Price May Put It Out of Patients' Reach

By VANESSA FUHRMANS
Staff Reporter of THE WALL STREET JOURNAL

A new AIDS drug that promises to help patients who have failed to respond to other medications is likely to carry a price tag more than double the most expensive treatments on the market, setting up a wrenching debate over who will get it and who will pay for it.

Roche Holding AG said it will price the drug, called Fuzeon, in Europe at ¤18,980 ($20,424) for a year's supply. Though Fuzeon isn't expected to receive marketing approval in the U.S. and Europe for several weeks, the Swiss drug maker took the unusual step of disclosing the European price now to provide advance notice to health-care officials in Europe and AIDS-treatment programs and advocacy groups in the U.S. Roche says Fuzeon requires an extraordinarily difficult manufacturing process that makes its cost unusually high.

The already-steep cost of AIDS treatment has stirred controversy because of the limits it puts on access to these drugs in Africa and other developing regions. Now, the spiraling price of new medicine threatens to further restrict access to new AIDS treatments even in relatively wealthy countries.

In the U.S., directors of state drug-assistance programs, which pay for roughly 25% of the country's AIDS medicines, are already rationing care. Some programs are now considering not providing Fuzeon at all or removing coverage of other vital drugs to make room in their budgets.

"Many of us are very hopeful about what this drug can do," said Michael Montgomery, chief of the Office of AIDS at the California Department of Health Services. He estimates some 30% of the program's 25,000 patients show signs of resistance to at least one or two existing AIDS drugs and might benefit from Fuzeon. "We just don't know if we'll have the money to pay for it," he says.

Doctors and patient groups consider Fuzeon the biggest advance in AIDS treatment since the advent of so-called protease inhibitors in the mid-1990s because of its ability to beat down the hardiest forms of the virus. Unlike existing AIDS drugs, which block replication of the virus after it infects a cell, Fuzeon stops it from entering a cell in the first place.

COSTLY TREATMENT

Most-expensive AIDS drugs, according to 2002 U.S. average wholesale prices, based on an annual regimen:

BRAND NAME DRUG MAKER ANNUAL PRICE
Fuzeon Roche $20,424.00*
Norvir Abbott Labs $9,387.22
Viracept Pfizer $9,206.03
Fortovase Roche $8,771.61
Agenerase GlaxoSmithKline $8,591.22
Kaletra Abbott Labs $8,559.18
Crixivan Merck $6,367.43
.... *Price in Europe, converted from euros at current rate.

Sources: Fair Pricing Coalition; Roche

In each of two large-scale clinical trials, results of which were published last year, one group of patients was given a traditional mixture of AIDS drugs and a second group received a similar mixture plus Fuzeon. Fuzeon patients saw their virus levels fall below detectable levels at twice the rate of other patients.

In the first trial, 37% of those on the drug experienced such a drop, compared with 14% in the group without Fuzeon. Nearly all of the 1,000 patients had shown resistance to other drugs before entering the study.

In both groups, patients were tested first to see which drugs they responded to best and put on tailored combination therapies, then randomly selected to receive Fuzeon.

Most AIDS-treatment organizations have been bracing for a high price tag for Fuzeon. Still, most expectations have been for a price of between $12,000 and $15,000. AIDS medicines in the U.S. typically cost 5% to 25% more than they do in most European countries, where drug-price regulations have kept prices lower. U.S. public assistance programs normally receive discounts, but previous examples of AIDS-drug pricing suggest these programs will pay at least the going rate in Europe.

Roche said the price, scheduled to be announced Monday, applies to special drug-access programs in Europe. The company said it expects to disclose a similar price for commercial sales in European markets after it receives regulatory approval from the European Union.

The U.S. Food and Drug Administration is expected to rule on the drug next month. Roche said it won't yet disclose how much it will charge for Fuzeon in the U.S. but that the European pricing provides a signal. "This really narrows it down and removes a lot of the speculation," said David Reddy, head of Roche's HIV products and disease strategy.

In each U.S. state, an AIDS Drug Assistance Program, mainly funded by the federal government, pays for medications for lower-income or uninsured patients. Funding for the programs this year was raised by $80 million, to $719 million. Even without the added cost of Fuzeon, program directors say that leaves them more than $100 million short of making ends meet.

Fourteen states have capped enrollment in the programs, started waiting lists for patients or cut back on provided drugs. Six other states say they will probably have to take similar measures. In Texas, which runs one of the country's biggest AIDS assistance programs, officials say they plan to lower the income level needed to qualify for enrollment, a move that could knock 2,500 people out of the program later this year.

The state programs pay for about a quarter of all AIDS drugs, and the federal government's Medicaid plan pays for about a third. The balance is covered privately.

Current AIDS treatment typically consists of a "cocktail" of three or more drugs costing $10,000 to $16,000 a year. In clinical trials for Fuzeon, the new drug was added to the traditional mix, which suggests that the total price could be in the range of $30,000 to $36,000 a year. Doctors and AIDS groups are exploring whether Fuzeon could be used to supplant some of the other drugs, which would help to lower the total cost.

Mr. Montgomery, the California health official, says state governments have in the past helped fund the programs but are themselves now financially strapped. He says his AIDS program won't decide whether to put Fuzeon on its list of covered drugs, or take other rationing measures, until July, when it gets a better sense of what the state funding will be.

What makes Fuzeon so expensive is in part its manufacturing process. Most drugs are small molecules that are relatively cheap to produce. Fuzeon, on the other hand, is a synthetic peptide, or chain of amino acids, that many drug companies had thought would be impossible to produce commercially.

Roche, which teamed up with Fuzeon's discoverer, Trimeris Inc., Durham, N.C., in 1999 to develop the drug, has gone to unusual lengths to demonstrate the expense involved in overcoming the challenge, providing patient activists and treatment groups cost breakdowns that companies typically keep confidential.

The company says it has invested more than $600 million in the drug. Earlier this month, Roche flew in more than a dozen patient advocates to a Boulder, Colo., plant that the company had refurbished to make Fuzeon. Roche demonstrated how it takes 106 steps -- more than 10 times the usual number of chemical procedures -- to produce the lengthy peptide. About 100 pounds of raw materials are needed to produce a little more than two pounds of Fuzeon.

"It's been important to help people understand why it has to be priced different than other HIV medicines," Roche's Mr. Reddy said.

Roche says it will be able to make enough of the drug for only 15,000 patients this year as it continues to ramp up production. Doctors and patient groups estimate as many as 50,000 patients in North America and Europe are resistant to some other AIDS therapies and could benefit from Fuzeon. Experts don't expect the drug to be marketed in developing countries, where resistance to existing AIDS drugs hasn't yet become a problem.

MORE TO COME _______________

 

 



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