<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 8-K
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 5, 1999
CV THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE
(State or other jurisdiction of incorporation)
<TABLE>
<S> <C> <C>
0-21643 43-1570294
(Commission File No.) (IRS Employer Identification No.)
</TABLE>
3172 PORTER DRIVE
PALO ALTO, CA 94304
(Address of principal executive offices and zip code)
Registrant's telephone number, including area code: (650) 812-0585
<PAGE>
ITEM 5. OTHER EVENTS.
On May 5, 1999, CV Therapeutics entered into a commercial
arrangement with Quintiles Transnational Corp. to commercialize CV
Therapeutics' ranolazine, which is further described in the press
release filed as an exhibit hereto.
ITEM 7. EXHIBITS.
<TABLE>
<S> <C>
99.1 Press Release, dated as of May 11, 1999 entitled "CV Therapeutics Announces
Agreement with Innovex to Commercial Ranolazine."
</TABLE>
<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.
CV THERAPEUTICS, INC.
Dated: May 17, 1999 By: /s/ Louis G. Lange, M.D., Ph.D.
Its: Chairman and CEO
<PAGE>
PRESS RELEASE
FOR IMMEDIATE RELEASE
Contact: Dan Spiegelman
Chief Financial Officer
650/812-9509
or
Christopher Chai
Director of Strategic Planning
and Investor Relations
650/812-9560
CV THERAPEUTICS ANNOUNCES AGREEMENT WITH INNOVEX TO
COMMERCIALIZE RANOLAZINE
PALO ALTO, CA (May 11, 1999) CV Therapeutics, Inc. (Nasdaq:
CVTX) today announced the signing of an innovative
commercialization agreement with Innovex, a leading commercial
solutions provider for the global pharmaceutical industry, for
the U.S. marketing and sales of CVT's ranolazine. Ranolazine is
currently in Phase III clinical trials for the potential
treatment of chronic stable angina, a disease that affects
approximately 7 million people in the United States.
The agreement calls for Innovex to conduct pre-launch
activities, hire and train a dedicated cardiology sales force to
launch and promote ranolazine, and provide post-launch marketing
and sales services. Innovex has agreed to provide services for
at least three years after launch and to provide services in
years four and five after launch if certain minimum sales levels
are met.
In the first year after launch, Innovex will provide a sales
force and fund marketing activities and will be paid on a
standard fee-for-service basis. Based on the minimum sales
force and marketing spend specified in the agreement, the first
year fee would be at least $19 million. In year two, the
agreement specifies that Innovex will provide a sales force of a
certain minimum size. Per the agreement, total compensation for
these first two years will not exceed, and in most cases is
expected to be roughly equal to, 33% of total revenues during
that period.
The size of the sales force and the marketing spend in year
three or any subsequent year will be tied to the performance of
the product. Total compensation to Innovex for years three
through five will not exceed, and is expected to be roughly
equal to, 25% to 30% of total revenues during that period, and
deferred compensation in years six and seven after launch will
not exceed 7% and 4% respectively.
-more-
<PAGE>
The agreement also calls for Innovex's parent company, Quintiles
Transnational Corp. (Nasdaq: QTRN), to make a $5 million
investment in common stock of CVT and, upon the FDA's acceptance
of the ranolazine New Drug Application filed by CVT, make
available up to a $10 million secured credit facility to CVT for
funding of pre-launch activities to be performed by Innovex
under a traditional fee-for-service agreement, or in some
limited cases to be performed by vendors approved by Innovex.
This credit facility is convertible into CVT stock at the
election of Quintiles under certain circumstances. Quintiles
will also make a milestone payment of $10 million payable at
product launch which can be offset by the outstanding loan.
The agreement represents an innovative commercialization model
designed to maximize commercial successes of both parties while
preserving resources for discovery and development efforts. The
agreement provides CVT access to Innovex's high-quality,
full-service marketing and sales operation and strategic
consulting services. As such, this agreement allows CVT to
maintain its focus and dedicate internal resources to the
development of its product portfolio. The minimum amount of
services Innovex is expected to provide over the full five-year
period after launch, if ranolazine is approved and meets the
minimum sales levels specified in the agreement, would otherwise
cost CVT about $110 million under a traditional fee-for-service
basis. CVT has final decision-making control on all strategic
issues regarding ranolazine throughout the term of the
agreement, and has the option after five years to convert the
Innovex sales force to a CVT sales force.
"This agreement allows CVT to retain product control while
avoiding most of the significant burden of acquiring a dedicated
sales force," said Louis G. Lange, M.D., Ph.D., Chairman and
Chief Executive Officer of CV Therapeutics. "By paying for
these services under a fee agreement based on a percentage of
revenues, CVT retains product control while mitigating both the
risks of acquiring a dedicated sales force and of financing it.
And with access to the unique market research derived for the
non-patient-identified pharmacy and medical transactions data of
Quintiles' ENVOY subsidiary, we believe Innovex is in a unique
position to market ranolazine effectively."
David Stack, President and General Manager of Innovex Inc.,
said: "We're extremely pleased about the opportunity to launch
ranolazine, potentially the first new class of anti-anginals in
over 20 years. This innovative service agreement is a response
to our customers' current needs and requests and demonstrates
again Innovex's commitment to providing overall
commercialization solutions to the pharmaceutical industry. The
fee structure gives us potential for much greater return on our
investment if sales meet the minimum sales levels specified in
the agreement. We have the opportunity to exceed twice our
normal margins. The agreement also allows for Innovex to change
the size of the sales force if sales are lower or higher than
the minimum sales levels specified in the agreement."
As the leader in providing contract sales and marketing
solutions to the healthcare industry, Innovex has built over 30
sales teams ranging in size from five to 500. With more than
7,500 employees worldwide and sales forces in 19 countries,
Innovex has worked with virtually all of the major
pharmaceutical companies in almost every
-more-
<PAGE>
therapeutic area. Innovex, through Quintiles' propriety
QUINTERNETTM technology platform, also has developed one of the
first Web-based sales force automation systems offering
territory planning, alignment, sample accountability and call
reporting capabilities.
CV Therapeutics, Inc., headquartered in Palo Alto, California,
is a biopharmaceutical company focused on the application of
molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the
treatment of cardiovascular diseases. CV Therapeutics is a
development stage company. Ranolazine has not been approved for
marketing by the Food and Drug Administration or other foreign
agencies. Ranolazine is presently being investigated in Phase
III clinical trials subject to a United States IND and
applicable foreign authority submissions. CV Therapeutics has
not yet submitted an NDA to the FDA or equivalent application to
any other foreign regulatory authorities for ranolazine and
ranolazine has not yet been determined to be safe or effective
in humans for its intended use. In addition to historical
information, this press release contains forward-looking
statements that involve risks and uncertainties, including, but
not limited to, uncertainties related to CV Therapeutics' early
stage of development and clinical trials and dependence on
collaborative and licensing arrangements, which may cause actual
results to differ materially. These factors are more fully
discussed in CV Therapeutics' Annual Report on Form 10K for the
year ended December 31, 1998. For more information, please
visit CV Therapeutics' web-site at www.cvt.com.
Innovex, a service group of Quintiles Transnational Corp., is
the worldwide leader in providing pharmaceutical and
biotechnology companies integrated solutions to enhance the
commercial success of their products. Quintiles is the market
leader in providing a full range of integrated product
development and commercialization solutions to the
pharmaceutical, biotechnology and medical device industries.
Quintiles also is a leader in the electronic data interchange
and healthcare informatics industry and provides healthcare
policy consulting to governments and other organizations
worldwide.
Headquartered near Research Triangle Park, North Carolina,
Quintiles is a Fortune 1000 company and a member of the
Nasdaq-100 Index. With more than 16,000 employees worldwide and
offices in 31 countries, Quintiles operates through specialized
work groups dedicated to meeting customers' individual needs.
For more information, please visit the Quintiles Transnational
web site at www.quintiles.com.
Information in this press release contains "forward-looking
statements." These statements involve risks and uncertainties
that could cause actual results to differ materially, including
without limitation, actual operating performance, the ability to
maintain large client contracts or to enter into new contracts.
Additional factors that could cause actual results to differ
materially, including the affect of recent acquisitions, are
discussed in Quintiles Transnational Corp.'s recent filings with
the Securities and Exchange Commission, including but not
limited to its S-3 and S-4 Registration Statements, its Annual
Report on Form 10-K, its Form 8-Ks, and its other periodic
reports, including Form 10-Qs.
-end-
