ThromboGenics Enters into Commercialization Agreement for Ocriplasmin with Alcon Outside the United States

LEUVEN, Belgium, March 16, 2012 /PRNewswire/ --

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

A webcast/conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, today at 10:00 AM Central European Time - details are at the end of this release.

 

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^[1] 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."

Webcast details

ThromboGenics' senior management team will make a live webcast presentation to investors, analysts and the media at 10:00 AM Central European Time. The webcast can be accessed at http://www.thrombogenics.com, and questions can be submitted live during the webcast. A replay of the webcast will be available after the event.

Conference call details  

A conference call will be held in conjunction with the webcast.

The dial-in numbers and Participant Passcode for the call are set out below:

UK - London:        +44(0)20 3450 9987

USA - New York      +1646 254 3362

Belgium - Brussels: +32(0)2 789 2126

Participant Passcode:       4548071

We request that participants dial in 5-10 minutes prior to the start time of 10.00am CET.

^[1]ThromboGenics Phase III MIVI-TRUST Phase III Clinical Data

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The MAA for ocriplasmin has been accepted for review in Europe and the BLA will be re-submitted in the U.S. by April 2012. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.

ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International. These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer in partnership with Roche.

ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.

Important information about forward-looking statements

This press release is for information purposes only and is not intended to constitute, and should not be construed as, an offer to sell or a solicitation of any offer to buy shares in the share capital of ThromboGenics.

Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.

For further information please contact:

ThromboGenics NV
Dr. Patrik De Haes, CEO
Tel: +32-16-75-13-10
[email protected]

Chris Buyse, CFO
Tel: +32-16-75-13-10
[email protected]

Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
Tel: +44(0)207-638-9571
[email protected]

SOURCE ThromboGenics NV