Date: 2012-12-04
Type of information: Commercialisation agreement
Compound: Iluvien® (190 micrograms fluocinolone acetonide intravitreal implant in applicator)
Company: Alimera Sciences (USA) Quintiles Commercial Europe Ltd (UK)
Therapeutic area: Ophtalmological diseases
Type agreement: promotion - commercialisation - services
Action mechanism:
- corticosteroid. Iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic diabetic macular edema . The implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. Iluvien® is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.
Disease: vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies
Details:
- Alimera Sciences, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has signed a Master Services Agreement with Quintiles Commercial Europe. for the commercial launch of Iluvien® in certain European countries. Iluvien® is Alimera\'s product for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies. Services provided by Quintiles under the Master Services Agreement may include marketing, brand management, sales promotion and detailing, market access, regulatory, medical science liaison and communications and advisory services in certain European countries. Under this agreement, Alimera and Quintiles will enter into individual project orders that will specify the services to be provided.
The German Project Order, the first under the Master Services Agreement, was signed November 28, 2012. Under this project order, Quintiles Commercial Germany GmbH will provide services related to recruitment, employment, deployment and administration of the Iluvien® commercialization team in Germany through December 31, 2015. Alimera and Quintiles expect to sign additional project orders for similar services in the United Kingdom and France. Quintiles began interviewing and hiring personnel in Germany, the United Kingdom and France in September in anticipation of the execution of project orders in all three countries.
To date, Austria, the United Kingdom, Portugal, France and Germany have granted national licenses for Iluvien®.
Financial terms:
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Is general: Yes
