Statement in response to The Times of London report on 20 May 2017 on Florinef

Having noted the report published in The Times of London on 20 May 2017 titled “Massive price rise for vital drug put pets’ lives at risk”, Aspen wishes to express its disappointment and concern that much of the information and clarification it provided to The Times’ Billy Kenber prior to the report being published has been excluded. In particular, the Times chose to omit the fact that the product in question, fludrocortisone, is not indicated for use in animals and that the original Aspen product, Florinef, continues to trade actively in the United Kingdom under European Union free trade arrangements. To provide a balanced account of the facts, Aspen wishes to communicate the following information which was shared with the Times, in response to questions:

1. Aspen replaced Florinef with a new product formulation with an improved product stability profile. Florinef is a cold chain product, requiring continuous refrigeration, creating challenges for transportation and storage both in the supply chain and by the patient. The new product is a different formulation which is heat stable and no longer requires such refrigeration. It also removes the risk of discard in case of storage temperature change. The price at which the product was launched in the United Kingdom was considered appropriate considering the cost of developing and launching the new formulation.

2. Pricing approval for the new formulation fludrocortisone was obtained via the NHS BSA prior to launch and the price is registered on the NHS DM&D site.

3. Florinef remains available in the United Kingdom through the free trade arrangements of the European Union and continues to be actively sold in the United Kingdom.

4. Neither Florinef nor the new formulation fludrocortisone are indicated for use as a veterinary product and Aspen can accordingly not take accountability for utilisation of these products by pet owners. We do note that the apparently substantial mark-up by others on the price of the product sold to pet owners contributes to the cost of using this product off-label by pet owners, but must point out that Aspen cannot be deemed to be responsible for this mark-up.

5. As Aspen has the rights to register and supply this improved fludrocortisone tablet formulation globally, there may be scope for cost and price reductions as the product is registered in more countries and the volumes of off-take for it increase.

Any further queries in this regard may be directed to Aspen via its website at http://www.aspenpharma.com/contact-form.