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Alex Kesin and Matthew Pech

Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology. www.approved.fm

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  1. 2D AGO

    Episode #1: Amylin Pharmaceuticals

    Listen on Spotify Listen on Apple Podcasts TABLE OF CONTENTS (00:00:00) - Introduction (00:04:40) - $50 of Dried Lizard Venom (00:29:17) - Fax of Death (00:43:04) - Sleeping Beauty Awakens (00:52:07) - Carl Icahn Sends a Letter (01:09:19) - Endgame (01:13:40) - Postmortem & Playbook CREDITS Co-hosted by Alex Kesin and Matthew Pech Written, edited, and produced by Alex Kesin Music: “Food” by nerowski * Special thanks to the team at NFX for the use of their recording studio. SOURCES Last updated: January 2026 I. PRIMARY DOCUMENTS FDA Regulatory Documents Symlin (pramlintide acetate) - NDA 21-332 * Approval Letter & Package (March 16, 2005) * Medical Review * Statistical Review * Clinical Pharmacology & Biopharmaceutics Review * Administrative Documents & Correspondence Byetta (exenatide) - NDA 21-773 * Approval Letter & Package (April 28, 2005) * Medical Review * Statistical Review * Clinical Pharmacology & Biopharmaceutics Review * Administrative Documents & Correspondence Bydureon (exenatide ER) - NDA 22-200 * Approval Letter (January 27, 2012) * Other Action Letters (Complete Response) * Summary Review * REMS * Administrative Correspondence SEC Filings & Financial Documents * Amylin 2005 Results Press Release (Ex-99.1, 8-K) * Amylin 2007 Results Press Release (Ex-99.1) * Amylin 2011 Form 10-K (Net Product Sales) * Carl Icahn SEC Filing (Schedule 13D) Proxy Fight & Legal Documents * Carl Icahn Letter to Amylin (April 15, 2009) * Amylin Response to Icahn (April 20, 2009) * Police Fund v. Bradbury (Amylin) Trial (May 4, 2009) * Lilly Litigation Ruling (May 25, 2011) II. ORAL HISTORY & INTERVIEWS * Howard Greene Oral History (UCSD Library, October 8, 2008) - Primary source for Hybritech founding, Ted Greene’s background, and early Amylin history III. NEWS & TRADE PRESS 2000 * “The Rumsfeld Resume” - CBS News (December 28, 2000) - Donald Rumsfeld’s board tenure at Amylin (1991-1996) * “Roller Coasting” - Forbes (July 24, 2000) - Joe Cook narrative, J&J partnership collapse 2005 * “Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005) - Allen Andersson investment story, “tablecloth deal” 2006 * “Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006) - “Lizzie” nickname, patient testimonials * “4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006) - Manufacturing shortage, 400,000+ patients * “Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006) - Policy perspective on Byetta’s potential impact * “Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe - ADA conference chaos, “one man cried” 2007 * Dr. John Eng Profile - Diabetes In Control (September 18, 2007) - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations 2008 * Xenome/Amylin Partnership - BioSpace (February 5, 2008) - Venom peptide library partnership 2009 * Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009) - End of Eastbourne activist campaign * Survey: Additional Diabetes Drugs Needed - Cardiovascular Business (December 21, 2009) - Market research on GLP-1 adoption 2012 * “FDA review accuses Amylin of withholding data” - FierceBiotech (June 26, 2012) - Bydureon approval controversy IV. ACADEMIC & SCIENTIFIC SOURCES * “Structural insights into multiplexed pharmacological actions of tirzepatide...” - Nature Communications (February 25, 2022) - Tirzepatide structure, exenatide C-terminus connection * “Structural and dynamic features of cagrilintide binding...” - Nature Communications (April 10, 2025) - Cagrilintide/pramlintide structural relationship * “If You Poison Us Do We Not Die?” - BYU Law Review (May 1, 2010) - Legal analysis of poison put provisions * “How GLP-1 Receptor Agonists Evolved from Diabetes to Weight Loss Treatments” - Historical overview of GLP-1 development V. HARVARD BUSINESS SCHOOL CASES * “Amylin Pharmaceuticals: Diabetes and Beyond” (December 9, 2008) - Authors: Richard G. Hamermesh, Rachel Gordon * “Amylin Pharmaceuticals: Diabetes and Beyond” (November 2, 2012 revision) - Authors: Richard G. Hamermesh, Carin-Isabel Knoop VI. CORPORATE DOCUMENTS & PRESENTATIONS Amylin investor presentations from corporate IR archives. Specific slides referenced in the script are noted below. Investor Presentations (Full Decks) * 2006 R&D Day Presentation (PDF) - Phybrids platform, GIP mimetic program (slides 43, 46, 58-59) * 2007 R&D Day Presentation (PDF) - Market sizing, obesity portfolio positioning (slides 14, 28, 29, 78) * 2007 J.P. Morgan Healthcare Conference (PDF) - Symlin Pen timeline (slide 25) * 2007 Lehman Brothers Healthcare Conference (PDF) - Investor overview and pipeline update Individual Slide Presentations (HTML Archives) * Early Corporate Presentation (WFVK) - Early-era company overview * 2003 Headquarters Presentation - January 2003 corporate update * ADA IR Presentation - American Diabetes Association investor materials VII. ADDITIONAL REFERENCES * Encyclopedia.com: Amylin Pharmaceuticals, Inc. * Miami Serpentarium Laboratories (Gila monster venom source) * Dan Bradbury (former Amylin CEO) - Vivani Board Profile - Now developing exenatide implant for weight loss * Full-year 2008 results - FierceBiotech VIII. PRIMARY SOURCE FIGURES IX. ANALYSIS FIGURES This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.approved.fm

    1h 46m

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Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology. www.approved.fm