FOV1101 Licensing opportunity - Sanofi

oral or parenteral administration. Specifically, blood CsA levels are >600-fold higher in organ
transplant patients than for dry eye patients given eye drops of Restasis ® 0.05% emulsion
(which is 2.5 times more concentrated in CsA than FOV1101), and prednisolone plasma
levels have been predicted to be >400-fold higher for patients taking a 30-mg oral dose than
for those to be treated with FOV1101.
Sanofi-Fovea has conducted a series of local tolerance/toxicity studies of the topical
formulation in rabbits, either with the combination of CsA and PA, or with CsA alone. From
these nonclinical studies and in particular a 6-week safety rabbit study performed with topical
ocular administration of CsA and/or PA compared to vehicle, no overt local or systemic
toxicity effects are to be expected in patients treated with FOV1101 eyedrops QID for up to
6 weeks due to the low dose levels of the drug substances given locally and the subsequent
low systemic exposures
5. VALUE PROPOSITION
FOV1101, through its dual mode of action, represents a new potentially safe therapeutic
option for AC patients who cannot be relieved from their persistent inflammation with current
available treatment. In addition, the use of low doses of both CsA and PA would ensure a
better local tolerability while achieving sufficient efficacy to control symptoms in AC, and
hence achieve a better compliance than co-administration of separate products.
6. REFERENCES
American Academy of Ophthalmology (AAO). Cornea/External disease panel. Preferred Practice Pattern
Guidelines. Conjunctivitis. Limited Revision 2011. San Francisco, CA. American Academy of Ophthalmology.
Bacon AS, Ahluwalia P, Irani AM, Schwartz LB, Holgate ST, Church MK et al. Tear and conjunctival changes
during the allergen-induced early- and late-phase responses. J Allergy Clin Immunol.2000;106(5):948-954.
Baudouin C. Conditions bordering on allergy. J Fr Opthalmol.2007;30(3):306-313.
Bielory L. Ocular allergy treatment. Immunol Allergy Clin North Am. 2008;28(1):189-224, vii.
Choi SH, Bielory L. Late-phase reaction in ocular allergy. Curr Opin Allergy Clin Immunol. 2008;8(5):438-444.
Kari O, Saari KM. Updates in the treatment of ocular allergies. J Asthma Allergy. 2010;24;3:149-158.
Pitt AD, Smith AF, Lindsell L, Voon LW, Rose PW, Bron AJ. Economic and quality-of-life impact of seasonal
allergic conjunctivitis in Oxfordshire. Ophthalmic Epidemiol. 2004;11(1):17-33.
Shii D, Oda T, Shinomiya K, Katsuta O, Nakamura M. Cyclosporine A Eye Drops Inhibit the Early-Phase
Reaction in a Type-I Allergic Conjunctivitis Model in Mice. J Ocul Pharmacol Ther. 2009;25(4):321-328.
Shii D, Nakagawa S, Yoshimi M, Katsuta O, Oda T, Nakamura M. Inhibitory effects of cyclosporine a eye drops
on symptoms in late phase and delayed-type reactions in allergic conjunctivitis models. Biol Pharm Bull.
2010;33(8):1314-1318.
Sperr WR, Agis H, Semper H, Valenta R, Susani M, Sperr M, et al. Inhibition of allergen-induced histamine
release from human basophils by cyclosporine A and FK-506. Int Arch Allergy Immunol. 1997;114(1):68-73.
Whitcup SM, Chan CC, Luyo DA, Bo P, Li Q. Topical cyclosporine inhibits mast cell-mediated conjunctivitis.
Invest Ophthalmol Vis Sci. 1996;37(13):2686-2693.
6. CONTACTS
Guy Claude Anne Marie SIGOT
Vice President Out-Licensing &Special Projects Senior Manager Out-licensing and Special Projects
Strategy & Business Development Strategy & Business Development
Corporate Licenses Corporate Licenses
Guy.claude@sanofi.com Annemarie.sigot@sanofi.com
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