UNITED STATES
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
October 1, 1998
ICOS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 0-19171 91-1463450
(State or other jurisdiction of (Comission File No.) (I.R.S. Employer
incorporation or organization) Identification No.)
22021 20th Avenue Southeast, Bothell WA 98021
(Address of principal executive offices) (Zip code)
(425) 485-1900
(Registrant's telephone number, including area code)
<PAGE>
ITEM 5: Other Events
The registrant issued the following press release on October 1, 1998:
Eli Lilly and Company (NYSE:LLY) and ICOS Corporation (NASDAQ:ICOS) announced
today that they have entered into an agreement to form a 50/50 owned joint
venture to jointly develop and globally commercialize phosphodiesterase
type 5 inhibitors (PDE5) as oral therapeutic agents for the treatment of
both male and female sexual dysfunction.
The lead compound in the joint venture, IC351, is currently being evaluated in
Phase 2 clinical trials as an oral treatment for erectile dysfunction. A
recently completed European Phase 2 clinical trial designed to assess safety and
efficacy in male erectile dysfunction (erectile response), showed significant
improvement relative to placebo-treated patients. Phase 1 studies have
demonstrated that IC351 is safe and well tolerated.
Erectile dysfunction, in some form, affects as many as 30 million men globally.
Many older therapies are either inconvenient to administer or may lead to
troublesome side effects. In addition, female sexual dysfunction represents a
large unmet medical need where there are very few treatments.
Under the terms of the agreement, ICOS and Lilly will establish a 50/50 owned
joint venture. ICOS will receive a $75 million up-front payment and success
milestone payments based on the progression of IC351 through development. ICOS
and Lilly will both capitalize the joint venture through a cash infusion by
Lilly over a three-year period and the contribution by ICOS of intellectual
property associated with IC351 and its research platform. Subsequently, both
parties will equally provide for the future capital requirements of the company.
The joint venture will market products resulting from this collaborative effort
in North America and Europe. For countries outside North America and Europe,
products will be licensed exclusively to Lilly for commercialization with a
royalty paid to the joint venture.
"The combined strength of both organizations allows us to enhance our
commercialization efforts and accelerate the pace of this program," commented
ICOS Chairman and Chief Executive Officer, George Rathmann. "Our joint venture
with Lilly represents ICOS' largest collaborative effort to date. We believe
Lilly possesses a strong collection of capabilities that will help drive the
collaboration's success."
"The creation of this joint venture will give us an opportunity to work with an
ICOS research and management team that is well respected and very talented,"
said August M. Watanabe, M.D., Lilly executive vice president, science and
technology. "Our partnership with ICOS represents an aggressive step for Lilly
as we continue to evaluate leading and innovative technologies that can
supplement our own research and development programs."
In addition, Lilly announced that the combined impact of the up-front payment to
ICOS, plus certain other payments made to the joint venture, will be reflected
as a one-time after-tax charge of approximately seven cents per share to
earnings in the third quarter.
ICOS is discovering and developing new pharmaceuticals by seeking points of
intervention in disease processes that may lead to more specific and efficacious
drugs. The Company's research and drug development programs involve both acute
and chronic conditions.
Lilly is a global, research-based pharmaceutical corporation headquartered in
Indianapolis, Indiana that is dedicated to creating and delivering innovative
pharmaceutical-based health care solutions that enable people to live longer,
healthy and more active lives.
Additional information about Eli Lilly and Company and ICOS Corporation is
available on the World Wide Web at http://www.lilly.com or http://www.icos.com.
-------------------- --------------------
ITEM 7: Financial Statements, Pro Forma Financial Information and Exhibits
(c) See Exhibit Index
<PAGE>
INDEX TO EXHIBITS
Page
20.1 Press Release issues October 1, 1998 #
- --------------------------
# Filed with this document
<PAGE>
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 thereunto duly authorized.
ICOS Corporation
Date: October 1, 1998 By:/S/ HOWARD S. MENDELSOHN
--------------- ------------------------
Howard S. Mendelsohn
Chief Accounting Officer
<PAGE>
ICOS CORPORATION
22021 20th Avenue SE
Bothell, WA 98021
PRESS RELEASE
- -------------
Contact: James P. Kappel Lacy J. Fitzpatrick
Eli Lilly and Company ICOS Corporation
(317) 276-5795 (425) 485-1900
For Release Thursday October 1, 1998 at 7:00 AMEDT:
- ---------------------------------------------------
LILLY AND ICOS ESTABLISH A JOINT VENTURE TO DEVELOP AND MARKET
PDE5 COMPOUNDS TO TREAT SEXUAL DYSFUNCTION
BOTHELL, WA -- October 1, 1998 -- Eli Lilly and Company (NYSE:LLY) and ICOS
Corporation (NASDAQ:ICOS) announced today that they have entered into an
agreement to form a 50/50 owned joint venture to jointly develop and globally
commercialize phosphodiesterase type 5 inhibitors (PDE5) as oral therapeutic
agents for the treatment of both male and female sexual dysfunction.
The lead compound in the joint venture, IC351, is currently being evaluated in
Phase 2 clinical trials as an oral treatment for erectile dysfunction. A
recently completed European Phase 2 clinical trial designed to assess safety and
efficacy in male erectile dysfunction (erectile response), showed significant
improvement relative to placebo-treated patients. Phase 1 studies have
demonstrated that IC351 is safe and well tolerated.
Erectile dysfunction, in some form, affects as many as 30 million men globally.
Many older therapies are either inconvenient to administer or may lead to
troublesome side effects. In addition, female sexual dysfunction represents a
large unmet medical need where there are very few treatments.
Under the terms of the agreement, ICOS and Lilly will establish a 50/50 owned
joint venture. ICOS will receive a $75 million up-front payment and success
milestone payments based on the progression of IC351 through development. ICOS
and Lilly will both capitalize the joint venture through a cash infusion by
Lilly over a three-year period and the contribution by ICOS of intellectual
property associated with IC351 and its research platform. Subsequently, both
parties will equally provide for the future capital requirements of the company.
The joint venture will market products resulting from this collaborative effort
in North America and Europe. For countries outside North America and Europe,
products will be licensed exclusively to Lilly for commercialization with a
royalty paid to the joint venture.
<PAGE>
"The combined strength of both organizations allows us to enhance our
commercialization efforts and accelerate the pace of this program," commented
ICOS Chairman and Chief Executive Officer, George Rathmann. "Our joint venture
with Lilly represents ICOS' largest collaborative effort to date. We believe
Lilly possesses a strong collection of capabilities that will help drive the
collaboration's success."
"The creation of this joint venture will give us an opportunity to work with an
ICOS research and management team that is well respected and very talented,"
said August M. Watanabe, M.D., Lilly executive vice president, science and
technology. "Our partnership with ICOS represents an aggressive step for Lilly
as we continue to evaluate leading and innovative technologies that can
supplement our own research and development programs."
In addition, Lilly announced that the combined impact of the up-front payment to
ICOS, plus certain other payments made to the joint venture, will be reflected
as a one-time after-tax charge of approximately seven cents per share to
earnings in the third quarter.
ICOS is discovering and developing new pharmaceuticals by seeking points of
intervention in disease processes that may lead to more specific and efficacious
drugs. The Company's research and drug development programs involve both acute
and chronic conditions.
Lilly is a global, research-based pharmaceutical corporation headquartered in
Indianapolis, Indiana that is dedicated to creating and delivering innovative
pharmaceutical-based health care solutions that enable people to live longer,
healthy and more active lives.
Additional information about Eli Lilly and Company and ICOS Corporation is
available on the World Wide Web at http://www.lilly.com or http://www.icos.com.
-------------------- --------------------
