EXHIBIT 99.1
Contacts: Lisa Burns (Investors)
Mark Skaletsky Justin Jackson (Media)
Chairman and CEO Burns McClellan
(718) 647-5554 Ext. 206 (212) 213-0006
Paul Mellett
Chief Financial Officer
(781) 647-5554 Ext. 213
ESSENTIAL THERAPEUTICS TO ADVANCE CLINICAL DEVELOPMENT PROGRAMS
-COMPANY TO FOCUS RESOURCES ON DEVELOPMENT GOALS-
WALTHAM, MASS., JUNE 10, 2002 -- Essential Therapeutics, Inc. (Nasdaq: ETRX)
announced today its plans to initiate three new Phase II clinical trials in the
areas of hematology/oncology and infectious diseases. These three studies are
expected to define the optimal dose and schedule of the Company's lead compound
ETRX-101, as well as ascertain the potential clinical benefits of the compound
for cancer patients with anemia, neutropenia, thrombocytopenia, infection,
mucositis and chemotherapy-induced alopecia. The Company also intends to focus
resources on advancing the development of several promising antibiotic and
antifungal compounds that have emerged from its research pipeline. As a result,
the Company also announced that it is eliminating several early discovery
programs that currently employ approximately 80 people to shift discovery
funding to these lead compounds and clinical development candidates.
"We're at a pivotal and important stage in the Company's development," commented
Mark Skaletsky, Essential Therapeutics Chairman and CEO, "with multiple products
showing promise in early clinical studies and late-stage pre-clinical testing.
After carefully reviewing our internal programs, we believe that the promise of
our current pipeline warrants significant resource allocations to our clinical
and pre-clinical programs. We have sufficient cash to support multiple clinical
programs for at least two years in a broad range of important clinical
indications representing large market opportunities. Strategically, these
opportunities require us to shift away from early stage platform discovery
efforts and to focus on pre-clinical and clinical development. While I am
excited about the prospects of our emerging product portfolio, I am nevertheless
saddened by the circumstances that require us to eliminate certain positions in
the Company." Skaletsky continued, "Upon taking leadership of Essential
Therapeutics, I committed to focusing the Company and its resources on the
greatest opportunities to create commercial value. Over the last year, we have
developed a platform of product candidates and pre-clinical candidates that
represent important potential product assets. Now, we are prepared to move those
assets forward."
CLINICAL DEVELOPMENT PROGRAMS
The Company announced specific plans in each of its development programs.
- - HEMATOLOGY/ONCOLOGY
Essential Therapeutics' lead compound, ETRX-101, is a small molecule therapeutic
in clinical studies for restoring blood cell counts due to myelosuppression.
Three Phase II trials are expected to be launched in the near future. These
Phase II trials will be randomized, placebo controlled studies designed to
further elucidate the effects of ETRX-101 on red blood cell, white blood cell,
and platelet lineages in patients receiving chemotherapy. In these studies, the
Company will explore the dose response relationship of ETRX-101 alone and in
combination with erythropoietin (EPO) and granulocyte colony stimulating factor
(G-CSF) and other marketed longer-acting forms of these agents. These studies
are designed to build on the information gained in the first Phase I study
performed in patients with metastatic breast cancer. The first Phase II study
will compare the effects of ETRX-101 to placebo in patients receiving moderate
intensity first line chemotherapy with the goal being to define further its
activity as a single agent. The second study will be performed in patients who
are undergoing second line or "salvage" chemotherapy and will assess the effects
of G-CSF (Neulasta(R), Neupogen(R)) plus ETRX-101. The third study will be
performed in patients receiving cancer chemotherapy who have developed anemia.
These patients will receive EPO(R) (Epogen(R), Aranesp(R), Procrit(R)) plus
placebo or EPO (Epogen(R), Aranesp(R), Procrit(R)) plus ETRX-101. These three
studies are expected to define the optimal dose and schedule of ETRX-101 in
relevant clinical settings and ascertain the potential clinical benefits of
ETRX-101 for patients with anemia, neutropenia, thrombocytopenia, infection,
mucositis and chemotherapy-induced alopecia.
- - INFECTIOUS DISEASE PROGRAMS
As previously announced, Essential Therapeutics has been working with Johnson
and Johnson Pharmaceutical Research and Development LLC, to complete
pre-clinical research on a prodrug of our lead parenteral cephalosporin
(RWJ54,428), prior to re-entering Phase I trials. This compound has
broad-spectrum activity against clinically important, antibiotic-resistant
Gram-positive bacteria and the prodrug is expected to provide a formulation
that will eliminate the injection-site irritation observed in previous Phase
I trials.
In addition, Essential Therapeutics expects its partner Daiichi Pharmaceuticals
to undertake pre-clinical toxicology studies prior to IND submission for an
efflux pump inhibitor. Preliminary results have shown that this compound
potentiates the activity of certain antibiotics (fluoroquinolones and
beta-lactams) against the gram-negative bacterium, PSEUDOMONAS AERUGINOSA. One
of these fluoroquinolones, Levoflaxcin, discovered by Daiichi Pharmaceuticals,
is one of the world's largest selling antibiotics.
Additionally, Essential Therapeutics is developing internally a class of novel
broad-spectrum azoles for treating serious fungal infections derived from a lead
compound discovered at NAEJA Pharmaceuticals. The lead compounds currently under
consideration for pre-clinical development are potent novel agents with
significant activity against fungal pathogens that are not susceptible to
currently marketed azoles, which represent one of the world's largest selling
antifungal classes. The Company's goal is to complete IND-enabling studies
within 12 months and launch a Phase I study in the second quarter of 2003.
- - ADDITIONAL PRE-CLINICAL PROGRAMS
The Company also has a series of additional pre-clinical programs exploring
and/or developing potential product candidates in several areas including fungal
efflux pump inhibitors in combination with certain azoles, wound healing, and
infection control.
ABOUT ESSENTIAL THERAPEUTICS
Essential Therapeutics is committed to the discovery and development of
breakthrough biopharmaceutical products for the treatment of life-threatening
diseases. With an emerging pipeline of lead programs and product candidates in
the anti-infective and hematology/oncology therapy areas, Essential
Therapeutics is dedicated to commercializing novel small molecule products
addressing important unmet therapeutic needs. Additional information on
Essential Therapeutics can be obtained at http://www.essentialtherapeutics.com.
Statements contained herein that are not historical fact may be forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, that are subject to a
variety of risks and uncertainties. There are a number of important factors that
could cause actual results to differ materially from those projected or
suggested in any forward-looking statements made by the Company. These factors
include, but are not limited to, the Company's ability to: (i) maintain
appropriate cash reserves and fund operations; (ii) successfully take discovered
compounds through pre-clinical development, clinical trials and
commercialization; (iii) obtain required governmental approvals; (iv) move its
platform of product candidates and pre-clinical candidates forward; (v)
successfully complete Phase II studies for ETRX-101; (vi) provide prodrug
formulations that eliminate injection-site irritation; and (vii)complete
IND-enabling studies on schedule, or at all. For a discussion of other risks and
uncertainties affecting Essential Therapeutics' business, see the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2002. Actual
results and timing of certain events could differ materially from those
indicated in the forward-looking statements as a result of these or other
factors.