Noden Pharma Companies
Noden is comprised of a series of companies. Noden Pharma DAC is incorporated in Ireland and headquartered in Dublin, Ireland. Noden Pharma DAC is responsible for development and commercialization activities worldwide and the manufacture of the worldwide supply of bulk and tableted product as well as the ex-US supply of fill and finished product. Noden DAC has a subsidiary in Switzerland.
Noden Pharma USA Inc, which is domiciled in Delaware, is responsible for commercialization activities in the United States as well as the manufacture of filled and finished product for the United States market. Noden Canada has similar responsibilities in Canada.
Noden Pharma and Novartis Agreements
The asset purchase agreement between Noden Pharma DAC and Novartis Pharma AG to acquire worldwide rights to make, market and sell the branded prescription medicines sold under the brand names Tekturna® (aliskiren) and Tekturna HCT® (aliskiren and hydrochlorothiazide) in the United States and Rasilez® and Rasilez HCT® in the rest of the world became effective on July 1, 2016. The asset purchase agreement also included certain related assets, inventory and certain liabilities.
Under the terms of the asset purchase agreement, Noden Pharma DAC agreed to pay $110.0 million as of the closing of the transaction. In addition, Noden Pharma DAC committed to make milestone payments of $89 million due on the first anniversary of the closing date or June 30, 2017 and up to an additional $95.0 million in payments contingent upon the attainment of sales targets and the date of launch of a generic drug containing aliskiren, the active ingredient in Tekturna and Rasilez and one of the two active ingredients in Tekturna HCT and Rasilez HCT.
The terms of the asset purchase agreement and related agreements provide for a transition in the commercialization of these products from various Novartis companies to various Noden Pharma companies. In the United States, from the closing of the transaction on July 1, 2016 through September 30, 2016, Novartis continued to distribute the products. Noden Pharma DAC received a transfer of the profits during the third quarter defined as gross sales less typical discounts, rebates, etc. and a small handling fee. As of October 1, 2016, the United States marketing authorization was transferred from Novartis companies to Noden Pharma USA Inc.. In the first quarter of 2017, Noden Pharma USA deployed a fully, dedicated sales force to support the commercialization of these products. This salesforce will be supported by an experienced commercial organization. Outside the United States, Novartis companies will continue to distribute the products through the first half of 2017 and Noden Pharma DAC will receive the profit transfer from Novartis as described above. During this period, Novartis and Noden Pharma DAC will work to transfer the marketing authorizations from Novartis companies to Noden Pharma DAC. The primary focus of the commercialization efforts of Noden Pharma DAC will be EU, Switzerland and Canada. Noden Pharma DAC will likely seek distributors for certain territories, such as Japan.
Novartis Pharma AG and Noden Pharma DAC also entered into a manufacturing and supply agreement which became effective contemporaneously with the closing of the asset purchase agreement. In general, Novartis entities have agreed to supply the worldwide API requirements of the various Noden Pharma entities while Noden Pharma DAC seeks a third-party manufacturer for API but in no event longer than November 2020. Novartis entities have agreed to supply tableted product and finished product while Noden Pharma DAC seeks a third-party manufacturer to provide such services but in no event longer than June 2019 except with respect to the United States where Noden Pharma US has contracted with a third-party manufacturer to provide finished product as of the fourth quarter of 2016.