ThromboGenics, Alcon collaborate to commercialize ocriplasmin outside the US

Mar 16 2012

ThromboGenics to concentrate on realizing ocriplasmin's significant commercial potential in the U.S.

• ThromboGenics to receive €75 million upfront and a further €90 million in potential near-term payments. Additional milestones bring the total of up-fronts and potential milestones to €375 million
• 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
• 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, a debilitating eye disease

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, announces today that it has entered into an agreement with Alcon (a division of Novartis), the global leader in eyecare, 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 launchwithin the next 12 months.

Under the terms of the agreement with Alcon, ThromboGenics will receive an upfront 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 upfronts 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.

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.

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. Symptomatic VMA is an increasingly recognized sight-threatening disease of the vitreoretinal interface. VMA may lead to symptoms such as distorted vision, decreased visual acuity and central visual field defects.  VMA can cause traction resulting in anatomical damage including formation of a macular hole, which may lead to severe visual consequences and central blindness.

Members of the international retina community have already shown great interest in ocriplasmin, as it could for the first time provide them with a pharmacological option to treat patients with symptomatic VMA including macular hole. The availability of ocriplasmin may also enable retina specialists to treat patients earlier than they do with surgery. This could address a significant unmet need as earlier intervention has been shown to limit the progress of the disease and its related complications.

ThromboGenics is confident that ocriplasmin has significant commercial potential, given estimates that more than 300,000 patients in Europe alone could potentially benefit from this novel treatment.

Dr Patrik De Haes, CEO of ThromboGenics, commented, "Today's collaborative deal with Alcon, the global leader in eye care, to commercialize ocriplasmin outside of the United Statesis a major milestone for ThromboGenics. We are pleased that Alcon has recognized the potential of ocriplasmin to change the way symptomatic VMA including macular hole is treated. Alcon is the ideal partner for an innovative retinal therapy given its global sales, marketing and medical capabilities in the ophthalmic market and its commitment to making ocriplasmin a success. We are now concentrating on bringing ocriplasmin to the U.S. market ourselves and are building the commercial and medical organization needed to support the product's anticipated launch. I have no doubt that today's deal will generate significant value for ThromboGenics' shareholders, and I am looking forward to working with Alcon to ensure that ocriplasminc an reach the thousands of patients globally who could benefit from this innovative  pharmacological treatment."

Kevin Buehler, Division Head ofAlcon said, "There are thousands of symptomatic vitreomacular adhesion patients who currently do not have an available treatment option. The clinical results for ocriplasmin show improved visual function and that earlier intervention may limit the progression of the disease," said Kevin Buehler, Division Head for Alcon. "Ocriplasmin is a strategic fit for Alcon and is expected to further enhance our portfolio of innovative treatments for the eye."

SOURCE ThromboGenics NV