Allergan, Inc. and Inspire Pharmaceuticals, Inc. announced that they have entered into a co-promotion agreement in the United States for Elestat (epinastine HCL ophthalmic solution 0.05per cent) within the ophthalmic specialty area. The US Food & Drug Administration approved Elestat in October 2003 for the prevention of itching associated with allergic conjunctivitis.
Under the terms of the agreement, Inspire will provide Allergan with an up-front payment and Allergan will pay a royalty to Inspire on Elestat net sales. In addition, this agreement calls for Allergan to significantly reduce its existing royalty payment to Inspire for Restasis (cyclosporine ophthalmic emulsion 0.05per cent) that is covered by a previous agreement between Allergan and Inspire.
Inspire will have the primary responsibility for selling, promotional and marketing activities related to Elestat, and will incur associated costs. Allergan and Inspire will work collaboratively on overall product strategy and management.
Allergan will record Elestat sales and retain all other product costs and licensing rights. Allergan will also maintain responsibility for all international marketing and selling activities and expects to launch Elestat in Europe under the brand name Relestat in early 2004.
David Pyott, Allergan's chairman, president and CEO said: "With four new Allergan Eye Care products approved in the last 12 months, this partnership with Inspire for Elestat will allow Allergan to focus its sales and marketing organization on its key business drivers: Lumigan, (bimatoprost ophthalmic solution 0.03per cent) Restasis, Zymar (gatifloxacin ophthalmic solution 0.3per cent), and Acular LS (ketorolac tromethamine ophthalmic solution 0.5per cent) while maximizing the value of this recently approved technology with a high quality company such as Inspire."
Christy L Shaffer, PhD, CEO of Inspire, said, "Inspire has made significant progress in building its ophthalmology sales and marketing organization and will have a first-rate force in place to launch Elestat in the first quarter of 2004. This will be the first product launch for Inspire -- a major milestone for our growing company as we prepare for the potential approval of diquafosol."
Elestat, a topical antihistamine with mast cell stabilizing and anti-inflammatory activity, is licensed from Boehringer-Ingelheim and was developed by Allergan for the relief of ocular itching associated with ocular allergies. Its multi-action effects inhibit binding to both H1 and H2 receptors, while preventing recruitment and activation of pro-inflammatory mediators that can trigger and exacerbate the allergic response. Elestat has a rapid onset of action, and in pivotal clinical trials was well tolerated by patients and demonstrated a favorable safety profile. The most frequently reported ocular side effects occurring in approximately 1-10per cent of patients included burning sensation in the eye, folliculosis, hyperemia and pruritus. The annual US market for ocular allergy approximates $325 million, with a strong growth rate of 23per cent.