Introduction to the Generic Animal Drug Alliance

1. Introduction to the Generic Animal Drug Alliance Presented to Dr. Bernadette Dunham, DVM, PhD Center for Veterinary Medicine January 14, 2009

2. Generic Animal Drug Alliance • An independent professional trade organization that represents the interests of generic animal health companies before Federal regulatory agencies and Congress • Member companies are focused on the development, approval and marketing of high quality generic drugs for livestock and pets

3. Our Mission • To create CVM-approved pharmaceutical options in order to make the cost of care for all animals affordable for veterinary practitioners, ranchers, farmers and pet owners • Recent focus has been working with CVM to enact user fees for generic animal drugs to help speed review of generic drugs and increase the number of generics available to the animal health community

4. AgriLabs, Ltd AmPharmCo., Inc. Banfield The Pet Hospital* Bimeda North America, Inc. CEVA Animal Health, Inc. First Priority, Inc. Gaddy & Associates* Ivy Animal Health, Inc. Lloyd, Inc. MedPharmex, Inc. Norbrook, Inc. PRN Pharmacal/Trophy Animal Health* Putney, Inc. Teva Animal Health Top Choice, LLC GADA Member Companies * Associate member companies

5. GADA Website • www.gadaonline.org • Online resource for CVM, Congress, veterinary practitioners, media, animal/pet owners and member companies • Content/areas of interest • Information on generic animal drugs • News • Summary of issues • User fees • Congressional appropriations • Pharmacy compounding • Generic innovation

6. Generic Animal Drugs: Background • $4.6 billion spent in 2007 on animal health pharmaceuticals • Market dominated by branded drugs even after loss of patent protection • For example, 16 of the top 20 selling companion animal drugs from 2005 to 2007 had expired patents, but generic options available for only 3 • Veterinarians are very familiar with, and routinely use generic drugs* • Veterinarians are open to new generics, especially alternatives to pricey, chronic treatments* * Source: Focus Group Study, February 2007

7. Generic Animal Drugs: Background • NADAs approved in 2008 (published) • 141-281 – Aviax II Type A Medicated Article - Phibro • 141-276 – Zilmax, Rumensin & Tylan – Intervet • 141-278 – Zilmax & Rumensin – Intervet • 141-280 – Zilmax, Rumensin, Tylan & MGA – Intervet • 141-282 – Zilmax, Rumensin & MGA - Intervet • 141-265 – Nuflor Gold – Schering-Plough • 141-286 – Panacur Plus Soft Chews – Intervet • 141-288 – Excenel RTU EZ Sterile Suspension – Pfizer • ANADAs approved in 2008 (published) • 200-438 – Petrem – Minrad, Inc. • 200-332 – Butorphic Injection – Lloyd, Inc. • 200-433 – Phenylbutazone Tablets – First Priority - 200-259 – Vetazine Cream – Modern Veterinary Therapeutics

8. Generic Animal Drugs: Value • Generic drugs save the end-user up to 70 to 80% • One example of savings attributed to generic drugs: • Ivomec Pour-On (pioneer) cost was > $500 per 5-liter container before generics were approved • Presently, generic ivermectin pour-on cost to the end-user is < $100 per 5-liter container • 28-33% of revenues for most veterinary practices come from dispensing prescription pharmaceuticals • Veterinary pricing being undercut by Internet pharmacies; generics offer veterinarians low priced alternatives and help keep prescriptions in the clinic

9. Generic Animal Drugs: Value • Cost sometimes influences care decisions* • High costs to treat serious or chronic problems can reduce compliance* * Source: Focus Group Study, February 2007

10. “If generics were available it would change the way I practice and allow me to base decisions on medicine rather than on price.”—Scott Shuler, DVM, Portland, OR

11. Generic Animal Drugs: Challenges • Overall time to approval • Review cycle time too long even with AGDUFA • Current review cycle is ~700 days • AGDUFA 2009 performance goal 700 days; 2010 = 680; 2013 = 270 • Current allocation of Congressional appropriations combined with user fees will not be enough to enable CVM to reduce the review cycle to statutory 180 day timeframes • Current ADUFA review cycle 180 days for NADAs

12. Generic Animal Drugs: Challenges • Overall time to approval • One cycle review is critical to Industry success • Even with shorter review cycles, typical reviews are > 1 cycle • Success of industry is dependent on products reaching market • Only achievable through consistent and predictable reviews • Potential Solutions to Review Cycle Duration • Telephone amendments • CVM efficiencies • CVM priority – allocation of resources • Quarterly meetings will yield higher quality submissions A stronger generic industry will help ensure the viability of AGDUFA II

13. Generic Animal Drugs: Challenges • Ability to innovate • CVM Policy Guides post-GADPTRA allow for: • (b)(1) supplements to ANADAs for differences in dosage form, strength, route of administration, active ingredient or to add a claim or species • Hybrid applications that reference safety and effectiveness of approved drugs with changes as above that require additional study(ies) (such as human 505(b)(2) applications) • Policy should continue to allow for (b)(1) supplements and hybrid applications for such changes to ANADAs that require certain additional safety and/or effectiveness data, as determined and reviewed by the NADA review teams and subject to ADUFA user fees • Regulatory framework should be based on sound science and not require repetition of studies when safety and effectiveness is established

14. Generic Animal Drugs: Challenges • Full label claim interpretation • Current interpretation that a generic must provide bioequivalence data for each species on a pioneer product label prior to approval • Onerous requirement, especially if dealing with swine or feline species • We believe generics should be allowed to provide BE data on one species, gain approval, and follow later with additional data to gain additional species claims if desired

15. Generic Animal Drugs: Challenges • Illegal pharmacy compounding • Compounded drugs are not pre-approved by FDA and are only permitted by FDA under limited circumstances when needed by a veterinarian for a particular animal patient • Illegal pharmacy compounding leads to further price deterioration for CVM approved pioneer and generic drugs • GADA is seeking greater surveillance by CVM on illegal pharmacy compounding activities

16. Moving Forward: Working with CVM • Continue open communication • Quarterly meetings • ADUFA workshops • Telephone and email communications • Public/prescriber perception of generics • Increase visibility of issues specific to generic animal health • Meet with FDA Commissioner • Continued dialog with CVM Management • Additional recommendations?

17. Thank you for your time.