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)
August 10, 1994 (August 1, 1994)
Synergen, Inc.
(Exact name of registrant as specified in its charter)
Delaware 0-14339 84-0868248
(State or other juris- (Commission (I.R.S. Employer
diction of incorporation) File No.) Identification No.)
1885 33rd Street, Boulder, Colorado 80301
Address of principal executive officers (Zip code)
Registrant's telephone number including area code:
(303) 938-6200
Item 5. Other Events.
On August 1, 1994, Synergen, Inc. ("Synergen" or "the
Company") announced that it had reduced its staff by 60
percent, or 375 employees. (See press release filed as
Exhibit 1 to this report.) The staff reduction followed
Synergen's announcement on July 18, 1994 that it had stopped
its follow-up Phase III clinical trial of ANTRILtm for
severe sepsis because an interim analysis of the data showed
a lack of efficacy of the product for that indication. The
staff reduction is part of the Company's efforts to conserve
cash and permit continued development of its priority
projects. The Company is also evaluating strategic alternatives
for its business and research and development programs.
Item 7. Financial Statements and Exhibits.
1. Press release dated August 1, 1994
2. Letter to Stockholders dated August 4, 1994
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 thereunto duly
authorized.
SYNERGEN, INC.
August 10, 1994 Kenneth J. Collins
Executive Vice
President, Finance and
Administration
NEWS RELEASE
SYNERGEN, INC.
1885 33rd Street
Contact: Susan Eustes
Boulder, Colorado 80301
(303) 938-6242
(303) 938-6200
FOR IMMEDIATE RELEASE
SYNERGEN REDUCES WORKFORCE BY 60 PERCENT
BOULDER, CO -- August 1, 1994 -- Synergen, Inc. (Nasdaq:SYGN)
announced that, effective today, 60 percent of its workforce is
terminated.
The reduction in staff comes two weeks after the Company
announced that it stopped its follow-up Phase III clinical
trial of ANTRILtm (anakinra) for severe sepsis because an
interim analysis of the data showed a lack of efficacy of
the product for that indication. The reduction in staff
and the elimination of some operations and development
activities are being taken to conserve cash and permit
continued development of Synergen's priority projects.
Synergen's LakeCentre manufacturing plant in Boulder is
being closed. The Company will also evaluate strategic
alternatives for its operations.
Synergen is terminating approximately 375 positions, 340 of
which are from Boulder. The remaining 35 positions being
terminated are located in Europe and Japan. Synergen is
closing its Japan office and will maintain a clinical group
in Europe to oversee the conduct of a Phase II clinical
trial of the Company's interleukin-1 receptor antagonist
(IL-1ra) for rheumatoid arthritis.
With a staff of about 250, the Company will retain its
capabilities in discovery research, clinical development
through the Phase II stage, and process development and
manufacturing. In addition to the Phase II clinical trial
of IL-1ra for rheumatoid arthritis, the Company is currently
conducting a Phase I clinical trial of tumor necrosis factor
binding protein (TNFbp) for inflammatory diseases and,
through a neuroscience joint venture with Syntex (U.S.A.)
Inc., a Phase II/III clinical trial of ciliary neurotrophic
factor (CNTF) for amyotrophic lateral sclerosis (ALS or Lou
Gehrig's disease). Synergen also will continue preclinical
development of glial derived neurotrophic factor (GDNF) for
Parkinson's disease.
Gregory B. Abbott, president and chief executive officer,
said, "We are following through on our commitment to
restructure Synergen's operations. We regret deeply the
necessity of these actions; however, it was imperative that
we reduce our staff and operations to allow the Company
adequate resources to continue to assess the clinical
prospects of our other lead products and move earlier stage
discovery research farther along in development."
Synergen ended its second quarter on June 30, 1994 with
approximately $135 million in cash. The Company expects
to substantially reduce its expenditures after recognition
of certain restructuring charges reflecting severance packages
and reductions in operations and asset valuations.
Synergen is a biopharmaceutical Company in Boulder, Colorado
engaged in the discovery, development and production of
protein-based pharmaceuticals. The Company's research is
targeted at products for inflammatory and neurological diseases.
August 4, 1994
Dear Stockholder:
The last two weeks at Synergen have been tough weeks, filled
with disappointment, but also a lot of hard work directed
toward the future. On July 18, we announced that we were
stopping our follow-up Phase III clinical trial of ANTRILtm
(anakinra or interleukin-1 receptor antagonist) for severe
sepsis. After conducting an interim analysis of the data, an
independent safety and efficacy monitoring committee reported
to Company management that the trial was not demonstrating
efficacy in severely ill sepsis patients.
We believed, based upon the data from the previous Phase III
clinical trial, that ANTRIL would work in severely ill sepsis
patients according to prospectively identified patient
groups, including patients with organ dysfunction and/or
shock. Unfortunately, the follow-up trial did not confirm
this. Based on this result, we will not pursue the sepsis
indication further with ANTRIL, and we are withdrawing our
regulatory applications of ANTRIL for severe sepsis in the
European Union and other countries.
We had previously stated that if the ANTRIL trial for severe
sepsis did not provide results that would allow us to seek
marketing approval for the drug, we would have to reduce our
scope of operations and staff and refocus on our other
projects. This restructuring is being implemented rapidly.
On Monday, August 1, we reduced our staff by 60 percent, from
630 employees to 250 employees. This reduction will allow us
to preserve cash without compromising our capabilities from
discovery research through Phase II clinical development.
Our reductions in staff were primarily in the areas of
Phase III clinical development, commercial manufacturing,
marketing and administration. We have closed our LakeCentre
manufacturing plant which was producing ANTRIL and will evaluate
alternative uses for this plant, including contract
manufacturing or sale. We are also closing our offices in
Europe and Japan, although we will retain a small staff in
Europe to oversee the Phase II clinical trial of interleukin-1
receptor antagonist for rheumatoid arthritis. We will have
more information on our restructuring charges in our second
quarter 10-Q Report which will be filed with the Securities
and Exchange Commission in midAugust.
We are continuing our discovery research programs and our
development of interleukin-1 receptor antagonist for
rheumatoid arthritis, tumor necrosis factor binding protein
(TNFbp) for inflammatory diseases, glial derived neurotrophic
factor (GDNF) for Parkinson's disease and, through our
neuroscience joint venture with Syntex (U.S.A.) Inc., ciliary
neurotrophic factor (CNTF) for amyotrophic lateral sclerosis
(ALS or Lou Gehrig's disease). We are also evaluating
strategic alternatives for the Company.
I have enclosed two recent press releases announcing the
termination of the ANTRIL trial for severe sepsis and the
staff reductions. We assure you that we are taking the
necessary steps to restructure the Company's operations while
focusing on the development of our biopharmaceutical products
to treat unmet medical needs.
Sincerely,
Gregory B. Abbott
President and CEO
