A revolution in HIV treatment: Fusion Inhibitors that Target HIV in a
Completely New Way
Basel, 12 July 1999 - Roche and Trimeris Inc., of Durham, North Carolina, have
concluded an agreement for the full-scale clinical testing and development of
Trimeriss two novel anti-HIV fusion inhibitors, T-20 and T-1249. Roche will market
the compounds worldwide.
Unlike traditional AIDS drugs that work in the cell after the virus has taken over its
machinery and is replicating, T-20 attacks HIV outside the cell before it begins infection
of new cells. Preliminary data on T-20 from phase I/II clinical studies show that the
Trimeris lead compound produces a potent anti-HIV effect, even in people who have
had extensive previous exposure to existing HIV medications. This group is at greater risk
of treatment failure because of drug-induced HIV resistance.
In the United States and Canada, Roche and Trimeris will share equally development
expenses and profits for the two fusion inhibitors. Outside of these two countries, Roche
will fund all development costs and pay Trimeris undisclosed royalties on net sales of
these products. Roche will make an initial cash payment to Trimeris of USD 10 million and
up to an additional USD 78 million in cash and funding upon achievement of developmental,
regulatory and commercial milestones.
"When you consider that as many as 40% of people infected with HIV are currently
on their third or fourth set of HIV combination treatments because of treatment failures
or cross-resistance between drugs, the huge demand for a completely new approach to
fighting HIV is clear," said Dr Franz B. Humer, Chief Executive Officer of F.
Hoffmann La Roche Ltd and head of the pharmaceuticals division. "By combining
our powerful existing anti-HIV treatments and cutting-edge diagnostic technology with the
potential of these new compounds, we are moving HIV treatment into the 21st
century. We believe that the integration of these approaches will provide the best
long-term healthcare solutions for people living with HIV."
"Trimeris has been successful in overcoming the hurdle of producing small
quantities of a long and complex peptide, paving the way for the therapeutic use of such
molecules. We now will leverage our strong track record of developing and optimizing the
use of treatments before, during, and after their regulatory approval to bring these
compounds to the patient," said Humer.
"The collaboration with Roche provides all of the essential elements for rapid
development of fusion inhibitors, a new class of antiviral agents," said Dani P.
Bolognesi, Ph.D., Chief Executive Officer, Trimeris and former director of Duke
Universitys Center for AIDS Research. "Trimeris is very pleased to be teaming
with Roche, a world-class pharmaceutical partner. Roche is a recognized leader in the AIDS
arena with unique strengths in HIV diagnostics, drug development and global marketing.
Moreover, the cultures of the two companies mesh well and we share a common vision about
the importance of developing new weapons to combat HIV. We are excited about the prospect
of working closely with Roche. I do not believe we could have a better partner."
T-20 Principal Investigator Michael Saag, M.D, Director of the AIDS Outpatient Clinic
at the University of Alabama at Birmingham said, "The antiviral activity of fusion
inhibitors' appears to be as promising as protease inhibitors did at a similar stage of
their development. The major difference is that T-20 is effective even against viruses
that are resistant to protease inhibitors and reverse transcriptase inhibitors. In our
clinic, we have used T-20 in patients for whom a change in therapy normally would have
resulted in little or no benefit. When T-20 was added, we began to see quite impressive
T-20 has demonstrated the significant ability to inhibit fusion in controlled clinical
trials to date (Kilby JM et al Nature Medicine 4 (1998):1302- 1307);
newer-generation T-1249 is in a Phase I dosing escalation trial to examine its safety and
antiviral activity. T-20 and T 1249 can both be administered by subcutaneous injection.
Roche and Trimeris plan to initiate a full-scale clinical development program and
clinical trials in coming months for both T-20 and T-1249, including the initiation of a
pivotal clinical trial for
Trimeris is a development-stage biopharmaceutical company engaged in the discovery and
development of novel therapeutic agents that block viral infection by inhibiting viral
fusion with host cells. The company's lead product candidate, T-20, which inhibits fusion
of the human immunodeficiency virus (HIV) with host cells, is currently in Phase II
clinical trials and has received fast track designation from the FDA. The company's second
product, T-1249, which also inhibits HIV fusion, has received fast track designation from
the FDA and is in a phase I clinical trail.
Headquartered in Basel, Switzerland, Roche is one of the worlds leading
healthcare groups in the fields of pharmaceuticals, diagnostics, vitamins and fragrances
and flavours. Roches products and services address all stages of individual health
maintenance and disease management, including prevention, diagnosis and treatment, thus
enhancing peoples well being and quality of life.
The Roche Heritage in HIV
Roche currently offers one of the most extensive HIV portfolios in the world. The Roche
heritage in HIV includes:
- Development and marketing of the nRTI HIVID (zalcitabine)
- Support for the two landmark studies - ACTG 175 and DELTA - that established combination
therapy as the standard of care in HIV
- Groundbreaking research that led to the first identification of the HIV protease enzyme
- Development and marketing of the worlds first HIV protease inhibitor, INVIRASE
(saquinavir mesylate), part of a class of drugs that has helped hundreds of thousands to
survive with HIV
- Development and marketing of FORTOVASE, an optimized formulation of saquinavir
- Marketing outside of the United States of VIRACEPT (nelfinavir mesylate), the
worlds leading anti-HIV protease inhibitor
- Development and marketing of CYMEVENE/CYTOVENE (ganciclovir) for the prevention of CMV
retinitis, and Cymeval (valganciclovir), a newer version of ganciclovir that is in the
late stages of development
- Development and marketing of the AMPLICOR HIV-1 MONITOR, the first test to accurately
and precisely measure quantities of HIV-1 RNA
- Development and marketing of the AMPLICOR HIV-1 MONITOR ultrasensitive PCR technology
that gives doctors and patients a real-time, direct and reliable window into the success
- A partnership to bring HIV genotyping into clinical practice through its support for the
GREAT trial (with Virology Networks and PE Biosystems), an effort that will help doctors
provide targeted treatment for each patient based his or her individual needs and
treatment experiences, and
- A collaborative research project with Progenics Pharmaceuticals to identify small
molecules targeting chemokine receptors on the host cell such as CCR5. Due to the fact
that such inhibitors will target the cell whereas the T-20 type inhibitor targets the
virus, the two approaches are viewed as being complimentary.