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PROXY STATEMENT
8787
Item 8. Shareholder Proposal Regarding Animal Testing
The board recommends that you vote AGAINST this proposal.
Animal Testing
Whereas, statistics published by research oversight bodies in North America and Europe document that the vast
majority of painful and distressing animal experiments are conducted to satisfy outdated, government-mandated
testing requirements2 and that such testing is on the rise;3 and
Whereas, nearly 60% of animals used in regulatory testing suffer pain ranging from moderate to severe, all
the way to pain near, at, or above the pain tolerance threshold,4 generally without any pain relief; and
Whereas, non-animal test methods are generally less expensive,5 more rapid, and always more humane, than
animal-based tests; and
Whereas, unlike animal tests, non-animal methods have been scientifi cally validated and/or accepted as total
replacements for the following fi ve toxicity endpoints: skin corrosion (irreversible tissue damage), skin irritation
(milder and reversible damage), skin absorption (the rate of chemical penetration), phototoxicity (an infl ammatory
reaction caused by the interaction of a chemical with sunlight), and pyrogencity (a fever-like reaction that can oc-
cur when certain intravenous drugs interact with the immune system);
Now Therefore Be It Resolved, that the shareholders request that the Board:
(1) Commit specifi cally to using only non-animal methods for assessing skin corrosion, irritation, absorption,
phototoxicity, and pyrogenicity.
(2) Confi rm that it is in the Company’s best interest to commit to replacing animal-based tests with non-ani-
mal methods.
(3) Petition the relevant regulatory agencies requiring safety testing for the Company’s products to accept
as total replacements for animal-based methods, those approved non-animal methods described above,
along with any others currently used and accepted by the Organization for Economic Cooperation and De-
velopment (OECD) and other developed countries.
Statement of Support: This Resolution is designed to harmonize the interests of sound science with the elimina-
tion of animal-based test methods where non-animal methodologies exist. It seeks to encourage the relevant
regulatory agencies to join their peers in accepting validated in vitro and other non-animal test methods. It will not
compromise consumer safety or violate applicable statutes and regulations.
Further, this Resolution commits the Company to end animal testing for fi ve specifi c endpoints in favor of valid
non-animal methods. These include the 3T3 Neutral Red Uptake Phototoxicity Test, human skin equivalent tests for
corrosivity, and a human blood-based test for pyrogenicity, all of which have been successfully validated through
the European Centre for the Validation of Alternative Methods.6 Several non-animal methods have also been
adopted as Test Guidelines by the OECD7 (an alliance of 30 member countries including the US, EU, Japan, Canada
and Australia). Regulatory agencies in OECD member countries are not at liberty to reject data from non-animal
tests for skin corrosion, skin absorption and phototoxicity where such data have been generated in accordance with
an OECD Test Guideline.
Statement in Opposition to the Animal Testing Proposal
The public policy and compliance committee of the board has reviewed this proposal and recommends that you
vote against it. We are committed to the responsible treatment of all laboratory animals and work to eliminate or
reduce their use in our pharmaceutical research. Where animals must be used, we take every measure to assure
that the fewest number of animals are used and that discomfort and distress are either eliminated or minimized.
All animals at the company are cared for under the close supervision of experienced veterinarians and trained ani-
2 CCAC Animal Use Survey-2001: http://www.ccac.ca/english/FACTS/Facframeaus2001.htm
3 Statistics of Scientifi c Procedures on Living Animals—Great Britain—2002.http://www.offi cial-documents.co.uk/
document/cm58/5886/5886.htm
4 CCAC Animal Use Survey—2001
5 Derelanko MJ and Hollinger MA (Eds.). (2002). Handbook of Toxicology, Second Ed, 1414 pp. Washington, DC: CRC
Press.
6 ECVAM website: http://ecvam.jrc.it
7 OECD test guidelines: http://www.oecd.org/document/22/0,2340,en_2649_34377_1916054_1_1_1_1,00.htm