Date: 2016-01-05
Type of information: Termination of an agreement
Compound: Afrezza® (rapid-acting inhaled human insulin)
Company: Sanofi (France) Mannkind Corporation (USA - CA)
Therapeutic area: Metabolic diseases
Type agreement: collaboration licensing manufacturing production
Action mechanism: Afrezza® is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of Afrezza® Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza® Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.
Disease: type 1 and type 2 diabetes
Details: * On January 5, 2016, MannKind Corporation announced the termination of its license and collaboration agreement with Sanofi for the development and commercialization of Afrezza® (insulin human) Inhalation Powder. The parties will promptly commence transition discussions in order to effect a smooth and orderly transition in the development and commercialization of Afrezza® from Sanofi to MannKind over the next 90 - 180 days. In any event, termination of the license agreement in its entirety will be effective no later than six months from the effective date of Sanofi's notice of termination, or July 4, 2016. * On August 11, 2014, Sanofi and MannKind Corporation announced that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. On June 27, 2014, the FDA approved Afrezza® (insulin human) Inhalation Powder to improve glycemic control in adults with diabetes mellitus. The companies plan to launch Afrezza in the United States in the first quarter of 2015. Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezz®a at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary. Sanofi’s diabetes solutions portfolio includes medications as well as drug delivery systems and blood glucose monitoring devices. As a leader in diabetes management, the addition of Afrezza to Sanofi’s leading portfolio of pharmaceuticals represents the latest opportunity for the company to bring another insulin option to people with diabetes around the globe. The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation. Greenhill & Co. served as exclusive financial advisor to MannKind with respect to this transaction.
MannKind is reviewing its strategic options for Afrezza as a result of the termination of the collaboration with Sanofi.
Financial terms: Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of $175 million.
Latest news: * On September 29, 2014, MannKind Corporation announced that it had received a $150 million upfront payment in connection with an exclusive worldwide collaboration and licensing agreement with Sanofi for development and commercialization of Afrezza® (insulin human) Inhalation Powder. * On September 24, 2014, MannKind Corporation announced the closing of a worldwide exclusive collaboration and licensing agreement with Sanofi for development and commercialization of Afrezza® (insulin human) Inhalation Powder. The closing follows completion of the US Federal Trade Commission's review of the transaction under the Hart-Scott-Rodino Act and the completion of documentation related to the $175 million loan facility being provided to MannKind by an affiliate of Sanofi in connection with the collaboration and license agreement. Under the terms of the collaboration and license agreement, MannKind will receive a $150 million upfront payment within ten days of the closing.
