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FTC: a 3TC like drug for HIV
  Today (July 30) Triangle Pharmaceuticals announced by two press releases, both are below, 2 important things: (1) they released data from the phase III study comparing FTC, which is taken once daily & is similar to 3TC, to d4T; d4T was taken twice daily in this study. Both study arms also received ddI and efavirenz. (2) Abbott and Triangle ended their agreement to co-market Triangle's drugs for HBV & HIV. Since 3TC is now approved to be taken once daily, the potential appeal of FTC may have some limits. Focusing on their own drugs may be more effective and productive for Abbott than relying on FTC in HIV and the other potential drug candidates in Triangle's pipeline.
If individuals have resistance to 3TC, FTC is cross-resistant and will not be useful. So, FTC will be used only for treatment-naive patients or perhaps if a patient is on a 3TC regimen and undetectable and wishes to switch to FTC.
Triangle also released a preliminary presentation of data from this study (FTC-301). They released 24 week results:
FTC + ddI + efavirenz vs d4T + ddI + efavirnz
24 week results
--285 patients in each treatment group
--<50 copies/ml: 70% in d4T group, 81% FTC group
--<400 copies/ml: 87% FTC group, 80% d4T group
--stopping due to adverse events: 10.5% d4T group, 5.6% FTC group
Presumably, the full study results will be presented at ICAAC. There was no mention of whether these analyses were ITT or on-treatment.
Triangle Pharmaceuticals, Inc. Announces Data Safety Monitoring Board's Recommendation to Unblind Coviracil Pivotal Trial Early
Coviracil(R) Demonstrates Superiority to Zerit(R) in FTC-301; All Patients Offered Rollover to Coviracil Regimen
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) today announced positive findings from FTC-301, an ongoing pivotal Phase III trial of Coviracil (emtricitabine), its nucleoside reverse transcriptase inhibitor for the treatment of HIV disease. With these results, the Company confirmed plans to submit an NDA in the third quarter of this year.
FTC-301 is an ongoing 48-week, double-blind, placebo-controlled Phase III trial comparing once-a-day Coviracil to Zerit (stavudine) given twice daily, each combined within a background regimen of Sustiva(R) (efavirenz) and Videx(R) EC (didanosine). A total of 571 patients were enrolled in the United States, Europe, Mexico and South America. An independent Data Safety Monitoring Board (DSMB), established to provide oversight of the study, reviewed a planned interim analysis. In view of a compelling difference in favor of the Coviracil arm, the DSMB recommended that the study be unblinded and all patients be offered the regimen containing Coviracil. The interim results evaluated by the study's DSMB showed that the Coviracil arm was statistically superior to the stavudine arm for primary and secondary endpoints for safety and efficacy. Eighty-seven percent of the patients in the once-a-day Coviracil arm had persistent virologic response through six months compared to 80% for the twice daily Zerit arm. Patients in the Coviracil arm also had significant improvements in immunologic function.
The full results of the trial will be presented at upcoming scientific meetings.
Commenting on the results, Chris Rallis, Triangle's President and Chief Operating Officer, said, "We are very pleased with the results of this trial, which exceeded our expectations. We believe that Coviracil will become another option for clinicians designing once daily regimens for patients with HIV disease."
Given these favorable interim results, Triangle confirmed its plans to submit an NDA for Coviracil with the FDA in the third quarter of this year. Regulatory submission packages for Europe and other countries are also scheduled to be completed this year.
Triangle Pharmaceuticals, Inc. Announces Reacquisition of Product Rights From Abbott Laboratories Mutual Decision to Benefit R&D Efforts of Both Companies
Triangle Pharmaceuticals, Inc.today announced that it has reacquired from Abbott Laboratories full product rights, including rights to all profits, for four drug candidates in clinical development, including Coviracil(R) (emtricitabine) for HIV.
"We have moved aggressively to reacquire full rights to our products not only because of our enthusiasm for the compounds but also because we believe this is a win-win outcome for Triangle and Abbott," said Chris Rallis, President and Chief Operating Officer of Triangle. "For Triangle, we believe that the reacquisition of the rights to Coviracil, amdoxovir and clevudine, all currently in clinical development, allows us to maximize the potential return on investment for the portfolio."
"The agreement with Triangle to end our alliance will enable Abbott to focus exclusively on our core areas of expertise and scientific success in HIV and hepatitis C research, which will include the delivery of a third-generation, breakthrough protease inhibitor and the discovery and development of effective therapies for hepatitis C, a disease with a high co-morbidity with HIV," said John Leonard, Vice President of Global Pharmaceutical Development of Abbott Laboratories.
Triangle and Abbott entered into a series of collaborative agreements in 1999 related to the development and commercialization of Triangle's products, including a profit-sharing arrangement whereby each company would receive roughly half of the profits from the sales of these products. Significant terms related to the reacquisition of rights include the following:
  • Triangle reacquired all worldwide rights, which include the rights to all profits from the sale of its drug candidates, including Coviracil for the treatment of HIV and hepatitis B, amdoxovir for the treatment of HIV, and clevudine for the treatment of hepatitis B.

  • Triangle will no longer be required to provide Abbott a right of first discussion on all future compounds which Triangle develops.

  • Triangle will have access to two unsecured lines of credit totaling $42.5 million, subject to certain terms and conditions. Upon approval of Coviracil for the treatment of HIV in the United States, Abbott will make available to Triangle an unsecured line of credit of $30 million. Upon approval of Coviracil for the treatment of HIV in Europe, Abbott will make available to Triangle an unsecured line of credit of $12.5 million. The available lines of credit may be reduced by certain types of non-dilutive financing Triangle may receive from other parties.

  • Under a new manufacturing and supply agreement, Abbott will manufacturwinitial launch quantities of Coviracil, expected to be sufficient for approximately the first year's sales, and will supply additional material through July 31, 2005, at Triangle's request. Abbott will also provide resources as needed to transfer the manufacturing process for Coviracil to a third-party manufacturer.

  • In exchange for the above rights, Triangle will forego rights to all remaining milestone payments and the right to co-promote Abbott's HIV product, Kaletra(R), in the United States.

  • Abbott will also receive a 1% royalty on the first $200 million of cumulative sales of Coviracil for the treatment of HIV.

    Abbott's representative on Triangle's Board of Directors will resign and Abbott's right to purchase additional Triangle shares will terminate.
"Triangle's reacquisition of these product rights allows us to optimally move our antiviral development programs forward," said Rallis. "Our four drug candidates in active clinical development - Coviracil for HIV, Coviracil for hepatitis B, amdoxovir and clevudine - represent the cornerstone of a bright future for Triangle. All four programs continue to show encouraging clinical progress."
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