SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) July 12, 1999
Commission File Number 0-23155
TRIMERIS, INC.
(Exact name of registrant)
Delaware 56-1808663
(State of organization) (I.R.S. Employer Identification Number)
4727 University Drive, Suite 100, Durham, North Carolina 27707
(Address of principal executive offices and zip code)
(919) 419-6050
(Registrant's telephone Number)
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ITEM 5. OTHER EVENTS
Trimeris, Inc. incorporates herein by reference the information contained
in the press release filed as Exhibit 99 to this Current Report.
ITEM 7. EXHIBITS
EXHIBIT NO.
99 Press Release by Trimeris, Inc., dated July 12, 1999
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
TRIMERIS, INC.
By:
-----------------------------------------
Matthew A. Megaro
President and Chief Financial Officer
Dated: July 13, 1999
EXHIBIT NO. 99
CONTACT:
Trimeris, Inc. Burns McClellan, Inc.
Matthew A. Megaro Jonathan M. Nugent (investors)
President and Chief Financial Officer Justin Jackson (media)
(919) 419-6050 (212) 213-0006
Hoffmann-La Roche
Kellie McLaughlin
Director of Public Affairs
973-562-2231
Pager 1(800) 946-4645, 6438692
TRIMERIS AND ROCHE SIGN AGREEMENT TO DEVELOP TRIMERIS'S COMPOUNDS
A REVOLUTION IN HIV TREATMENT: FUSION INHIBITORS THAT TARGET HIV IN A
COMPLETELY NEW WAY
DURHAM, NC and NUTLEY, NJ, JULY 12, 1999 - Trimeris, Inc. (NASDAQ:TRMS) and
Roche have concluded an agreement for the full-scale clinical testing and
development of Trimeris's two novel anti-HIV fusion inhibitors, T-20 and T-1249.
Roche will market the compounds worldwide.
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 $10 million and up to an additional $78 million in
cash and funding upon achievement of developmental, regulatory and commercial
milestones.
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.
"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, Roche's Chief
Executive Officer. "By combining our powerful existing anti-HIV treatments and
cutting-edge diagnostic technology with the potential of these new
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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 Dr. 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
University's 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 results."
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 T-20.
THE ROCHE HERITAGE IN HIV
Roche currently offers one of the most extensive HIV portfolios in the world.
The Roche heritage in HIV includes:
o Development and marketing of the nRTI HIVID (zalcitabine)
o Support for the two landmark studies - ACTG 175 and DELTA - that
established combination therapy as the standard of care in HIV
o Groundbreaking research that led to the first identification of the HIV
protease enzyme
o Development and marketing of the world's first HIV protease inhibitor,
INVIRASE (saquinavir mesylate), part of a class of drugs that has helped
hundreds of thousands to survive with HIV
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o Development and marketing of FORTOVASE, an optimized formulation of
saquinavir
o Marketing outside of the United States of VIRACEPT (nelfinavir mesylate),
the world's leading anti-HIV protease inhibitor
o 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
o Development and marketing of the AMPLICOR HIV-1 MONITOR, the first test to
accurately and precisely measure quantities of HIV-1 RNA
o 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 of treatments
o 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
o 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.
Headquartered in Basel, Switzerland, Roche is one of the world's leading
healthcare groups in the fields of pharmaceuticals, diagnostics, vitamins and
fragrances and flavours. Roche's products and services address all stages of
individual health maintenance and disease management, including prevention,
diagnosis and treatment, thus enhancing people's well being and quality of life.
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 trial.
NOTE: Except for any historical information presented herein, matters presented
in this release are forward-looking statements that involve risks and
uncertainties. The results of the company's previous clinical trials are not
necessarily indicative of future clinical trials, and future results could
differ materially from the results presented herein. Factors that could cause or
contribute to such differences include, but are not limited to, those discussed
in the "Risk Factors" section included in the Company's Form 10-Q for the three
months ended March 31, 1999 filed with the Securities and Exchange Commission on
May 17, 1999 and the company's Registration Statement on Form S-3 as declared
effective by the Securities and Exchange Commission on May 26, 1999.
