-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WxVOrNpQpBWcI0nN4b+K3UoNYBS5hoHgu7Mpp2kzdQhKFjfmnrs+R2UOtkb4o0oB LN2DTZ6I6umMQdum4Fr/UA== 0000912057-02-023538.txt : 20020611 0000912057-02-023538.hdr.sgml : 20020611 20020610125114 ACCESSION NUMBER: 0000912057-02-023538 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020610 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020610 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ESSENTIAL THERAPEUTICS INC CENTRAL INDEX KEY: 0001010915 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943186021 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28006 FILM NUMBER: 02674663 BUSINESS ADDRESS: STREET 1: 850 MAUDE AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 BUSINESS PHONE: 4154281550 MAIL ADDRESS: STREET 1: 850 MAUDE AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 FORMER COMPANY: FORMER CONFORMED NAME: MICROCIDE PHARMACEUTICALS INC DATE OF NAME CHANGE: 19960319 8-K 1 a2082045z8-k.txt 8-K 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 JUNE 10, 2002 ------------------- Date of Report (Date of earliest event reported) ------------------- ESSENTIAL THERAPEUTICS, INC. --------------------- (Exact Name of Registrant as Specified in Charter) DELAWARE 0-28006 94-3186021 - ------------------------------- ------------------ ---------------------------- (State or Other Jurisdiction of (Commission (IRS Employer Incorporation) File Number) Identification No.) 1365 MAIN STREET, WALTHAM, MA 02451 --------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) (781) 647-5554 ---------------------------------------------------- (Registrant's telephone number, including area code) --------------- ITEM 5. OTHER EVENTS. On June 10, 2002, the Registrant issued a press release reporting its intention to advance clinical development programs and to restructure resources to focus on development goals. The press release has been filed as an exhibit to this Current Report on Form 8-K, attached hereto as Exhibit 99.1. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (c) Exhibits. EXHIBIT NUMBER DESCRIPTION 99.1 Press release, dated June 10, 2002. SIGNATURES 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. Date: June 10, 2002 ESSENTIAL THERAPEUTICS, INC. By: /s/ Paul J. Mellett ------------------------------------------ Paul J. Mellett, Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer) EX-99.1 3 a2082045zex-99_1.txt EXHIBIT 99.1 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. -----END PRIVACY-ENHANCED MESSAGE-----