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AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine

Tuesday, January 22, 2008 General News
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LOS ANGELES, Jan. 21 AIDS Healthcare Foundation(AHF) today urged Tibotec Pharmaceuticals Ltd., a division of Johnson &Johnson, to reconsider and reduce its steep price for its newest AIDS drug,etravirine (TMC 125), a non-nucleoside reverse transcriptase inhibitor,(NNRTI), which received Food and Drug Administration (FDA) approval on Fridayafter a fast track or 'priority review' and approval process granted tocompanies for medications and therapies intended to treat life-threateningillnesses such as AIDS. Immediately following FDA approval of the drug, whichTibotec will sell under the brand name Intelence, Reuters reported that thedrug's wholesale cost will be $5.45 per tablet. At the approved dose of twotablets twice per day, a 30-day supply would be $654-or close to $8,000 perpatient, per year (PPY) wholesale cost.
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"We commend Tibotec for the development of this promising new HIV/AIDSdrug, but strongly urge them to immediately reconsider and price this life-saving AIDS medicine more fairly," said Michael Weinstein, AIDS HealthcareFoundation President. "As with many AIDS drugs before it, the cost ofIntelence will simply be out of the price range for most AIDS patients andthreatens to further stress Medicaid and AIDS Drug Assistance Programsnationwide. Just last week, Governor Arnold Schwarzenegger announced plans tocut $7 million dollars from California's ADAP, a program that helps low-incomeCalifornians living with HIV/AIDS access such lifesaving drugs. AIDS drugs arepriced at the maximum the market will bear, regardless of production costs. Itappears Tibotec is once again following suit with the steep price of itsnewest AIDS drug."
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Tibotec drew earlier criticism from AIDS advocates back in June 2006 afterit received FDA approval for its Protease Inhibitor, Prezista (darunavir, orTMC 114) and began marketing that HIV/AIDS drug at a price well above otherdrugs in its class -- close to $10,000 per patient per year. According toTibotec's own website at the time, Prezista had been found to be, " ...highly-active in vitro against HIV with Protease Inhibitor resistancemutations...," and was found to be particularly effective as part of a secondor third line 'salvage' therapy used in combination with Roche and Trimeris'drug, Fuzeon ($20,000 per patient per year) and Abbott's Norvir ($7,800).Taken together -- as these medications are usually prescribed as part of alifesaving AIDS drug cocktail or regimen -- the cost for these drugs for oneHIV/AIDS patient runs between $35,000 and $40,000 per patient per year.

In clinical trials, Tibotec's latest drug, Intelence, has been found to beeffective for many HIV-infected patients who are NNRTI-resistant and whoseinfections are not responding to currently available medications. It is widelyexpected to be prescribed and used in conjunction with other AIDS drugs aspart of salvage regimens for patients whose previous drug combinations havefailed them.

"As many states and the federal government also face significant budgetconstraints and are drastically cutting budgets and services, we questionTibotec's judgment and timing in pricing this latest AIDS drug so high," addedAHF's Weinstein. "When Governor Schwarzenegger proposed eliminating $7 millionin drugs for co-morbidities and opportunistic infections from the ADAPformulary last week, AIDS Healthcare Foundation said that instead of cuttingany drugs from the ADAP formulary, the Governor and state lawmakers shouldinstead reduce reimbursements to drug companies and try to purchase drugs forADAP and other crucial state programs at federal pricing levels such as thosethat the Department of Veterans Affairs has successfully negotiated with theindustry. We vow to work in Sacramento and in Washington to ensure that ADAPand other similar government programs do not continue to become glorifiedcorporate welfare programs that boost the coffers and bottom lines of dr
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