Chronic Disease Fund Integrity Agreement

“Today`s colonies are a warning to all pharmaceutical companies, foundations and others who are trying to undermine the nonprofit donation process for their own financial gain at the expense of American taxpayers. Both the Chronic Disease Fund and the Patient Access Network have taken advantage of their charitable status to protect the illegal activities of pharmaceutical companies trying to maximize profits,” said Joseph R. Bonavolonta, special agent in the FBI`s Boston division. “The FBI and our partners will continue to hold organizations to account and protect and preserve the Medicare system and the taxpayers who fund it against kickback programs like this one.” In particular, the government stated that Good Days worked with Novartis, Dendreon, Astellas, Onyx and Questcor from 2010 to 2014 to create funds to pay Medicare patients who take their medications or pay for travel, but not to patients taking other medications and, in some cases, to provide data on the number of patients receiving money from the Fund. Similarly, the government claimed that PANF had worked with Bayer, Astellas, Dendreon and Amgen from 2011 to 2014 to create certain funds that primarily, if not exclusively, financed drug co-payments by the only company that financed each fund. PANF SHPT Fund for Amgen. Sensipar, an Amgen product, is licensed for the treatment of secondary hyperparathyroidism (“SHPT”). The FDA has also authorized other drugs for the treatment of SHPT. In September 2011, Amgen approached PANF to create a SHPT fund. PANF and Amgen then collaborated to determine the hedge parameters of the fund, so that it only covers Sensipar. In November 2011, PANF launched a SHPT fund, for which Only Amgen provided the funding. Until June 2014, patients with Sensipar received all of the money from PANF`s SHPT fund. Similarly, Novartis would have learned with Afinitor (a treatment for advanced renal carcinoma (RCC) and progressive neuroendocrine pancreatic tumours (PNET)) that Novartis would be the sole donor for the 2010 fundraising year for a Copay RCC fund created by a non-profit foundation (National Organization for Rare Disorders – NORD).

Novartis reportedly informed NORD that it would only be willing to make a donation to the Fund if the foundation`s eligibility was limited, to ensure that more of the copay assistance would go to patients taking Afinitor. As a result, the government stated that in reviewing the fund`s definition, the Fund has helped patients who take Afinitor disproportionately relative to its overall rate of use of CCR drugs. Then, in 2012, Novartis reportedly asked another foundation (CDF) to open a copay fund to pay copays for patients with PNET – which Novartis knew would only be used to pay supplements for patients with Afinitor. PNET Co-Pay Fund of CDF for Novartis. In May 2011, Afinitor, a Novartis product, was approved for the treatment of progressive neurodocreas neurodepinekris tumors of the pancreas (“PNET”).