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Agreements

Date: 2014-03-17

Type of information: Milestone

Compound: ocriplasmin (microplasmin)

Company: Thrombogenics (Belgium) Alcon (USA -TX), a Novartis subsidiary (Switzerland)

Therapeutic area: Ophtalmological diseases

Type agreement:

commercialisation

Action mechanism:

Ocriplasmin is a truncated form of the human serine protease plasmin that retains its enzymatic properties. This small molecule has been designed specifically for use in the eye. It is believed to primarily target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina.

Disease: symptomatic vitreomacular adhesion

Details:

* On March 16, 2012, ThromboGenics has entered into an agreement with Alcon (a division of Novartis), the global leader in eye care, for the commercialization of ocriplasmin in all markets outside the U.S. As a result of this important strategic deal, ThromboGenics will concentrate on commercializing ocriplasmin in the U.S. where it plans to build its commercial and medical organization to support the product’s anticipated launch within the next 12 months. Under the agreement ThromboGenics will have a strategic and focused operational role in the commercialization of ocriplasmin in the five largest European markets, enabling it to build the foundation for an expanding ophthalmology franchise. In addition to the commercial introduction of ocriplasmin in markets outside the U.S., the agreement specifies that Alcon and ThromboGenics will work together, and share the costs, to further develop new clinical applications of the product that the companies will introduce in their respective territories. 
Alcon plans to introduce ocriplasmin in more than 40 countries worldwide. ThromboGenics retains all U.S. rights to ocriplasmin and will commercialize the product itself in the U.S.

Ocriplasmin is currently under review by the European Medicines Agency as the first pharmacological treatment for symptomatic Vitreomacular Adhesion (VMA) including macular hole. ThromboGenics has completed an extensive clinical development program, including two successful Phase III studies that have shown that ocriplasmin could play an important role in treating symptomatic VMA including macular hole.

Financial terms:

Under the terms of the agreement with Alcon, ThromboGenics will receive an up-front payment of €75 million. The Company is also entitled to a further €90 million in potential near-term milestone payments. Additional milestones bring the potential total of up-fronts and milestones to €375 million. In addition, ThromboGenics will receive royalties on net sales of ocriplasmin that are commensurate with a product that has successfully completed Phase III development and that has been filed for regulatory approval.

Latest news:

* On March 17, 2014, Thrombogenics has announced that US sales of Jetrea® were €20.2 million in 2013, with close to 7000 patients treated. The company also said that it received a total of €90 million in milestone payments from Alcon following the approval and first launch of Jetrea® in Europe.

Is general: Yes