I'd be very interested in the assessment of the Sanofi deal... what went wrong? How the deal could have been structured for better outcome for MNKD?
What went wrong? I'm just going to use some common sense and logic here to answer your question.
Sanofi and its Subsidaries are Corrupt = What Went Wrong• Currently has a multi-state Taxotere lawsuit on their hands. The first bellwether trial is set for September 2018, and last month a judge ordered a settlement conference for July 29, 2018. There have been over 1,200 Taxotere lawsuits filed.
• In January 2017 payed $61.5M for conducting a anti-competitive scheme involving pediatric vaccines in order to maintain their monopoly.
• In April 2017 payed 19.8M for overcharging the Department of Veterans Affairs
• In 2009 payed $95.5M for a false claims scheme where they deliberately misreported Azmacort, Nasacort and Nasacort AQ drug prices to Medicaid in order to reduce its rebate obligations.
• In 2012 payed $109M for colluding in a kickback scheme and reporting false claims involving the drug Hyalgan.
• In 2013 payed $22.38M for false claims involving drug reps teaching physicians how to alter Seprafilm to create a slurry version. Sanofi acquired Genzyme in 2011.
• The Sanofi FDA Warning Letters:
—In 2006 Sanofi received an FDA Warning Letter for having terrible CGMP: FDA investigators documented significant deviations from current good manufacturing practices (CGMP) in the manufacture of licensed biological products and Fluzone® monovalent concentrate batches.
—In 2007 Sanofi received an FDA Warning Letter for conducting in unethical conduct and falsifying data from clinical trials: FDA data validation inspections of several clinical investigators participating in study 3014 revealed multiple and significant violations of FDA regulations codified at 21 CFR 312 that affected the integrity of data submitted to NDA 21,144.
—In 2010 Sanofi received an FDA Warning Letter for again having terrible CGMP: During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of licensed biological products and bulk drug substances. These products include IMOVAX® RABIES, Imogam® Rabies, IPOL®, Act HIB®, and Typhim Vi®.
—In 2011 Sanofi received an FDA Warning Letter for having adulterated products because of their failure to maintain CGMP: During our September 6-10, 13-16, 2010 inspection of your pharmaceutical manufacturing facility, Sanofi Aventis Deutschland GmbH, Industriepark Hochst, Building H550, Frankfurt am Main, Germany, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
—Again in 2011 Sanofi received another FDA Warning Letter for failing to report post marketing Adverse Events: The Food and Drug Administration (FDA or “Agency”) inspected Sanofi-Aventis (Sanofi) pharmaceutical facility located at the address above from April 16, 2010 through May 13, 2010. The inspection focused on Sanofi’s compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements. FDA’s inspection found that your firm failed to comply with the postmarketing reporting requirements under 21 U.S.C. § 355(k) [Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)] and its corresponding regulations in Title 21 of the Code of Federal Regulations (21 C.F.R.) Section 314.80 and 314.81. Such failure to comply with Section 505(k) of the Act and its corresponding regulations is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)]. Therefore, FDA concludes that Sanofi has engaged in prohibited acts in violation of Section 301(e) of the Act.
Sanofi’s deviations from FDA’s reporting requirements observed during the inspection include, but are not limited to, the following: inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events as required by 21 CFR 314.80(b), failure to submit serious and unexpected adverse drug experience (ADE) reports within 15 calendar days to FDA under 21 CFR 314.80, and failure to include all postmarketing studies in the Annual Report to FDA under 21 CFR 314. 81.
—In 2012 Sanofi received an FDA Warning Letter for once again failing to have CGMP: During the inspections, FDA investigators documented deviations from current good manufacturing practice (CGMP) requirements in the manufacture of your licensed biological drug products and intermediates.
