Mar 6, 2017
Agreement with Theratechnologies Inc. for the commercial rights to ibalizumab in the European Territory.
TaiMed Biologics Inc. is pleased to announce that it has reached an agreement with Theratechnologies Inc. for the commercial rights to ibalizumab in the European Union, Israel, Norway, Russia and Switzerland.
Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of multidrug resistant (MDR) HIV-1 infection. Theratechnologies first acquired the commercial rights to ibalizumab in the United States and Canada in March 2016. The existing agreement between both companies has been amended to include the additional territories and related new obligations.
Transaction terms
Under the terms of the agreement, Theratechnologies will assume regulatory responsibilities and associated costs.
Clinical trial activity required by the EMA, if any, and associated costs will be the responsibility of TaiMed.
Both parties have agreed to a transfer price of 52% for European sales up to US$50M. The transfer price will increase to 57% on sales above the US$50M threshold.
The agreement also provides for development, launch and sales milestones including:
Upfront payment of US$3M payable through the issuance of 906,077 Common Shares of Theratechnologies;
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An approval milestone representing 50% of the cost of the clinical trials required, if any, to obtain approval in Europe, payable through transfer price increase of 5% of net sales;
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A launch milestone payment of US$10M, payable as follows:
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US$5M, one year after launch; and
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US$5M, one year after reaching European sales of US$50M over four consecutive quarters;
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A milestone of US$10M upon European sales reaching US$150M over four consecutive quarters;
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A milestone of US$20M upon European sales reaching US$500M over four consecutive quarters;
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A milestone of US$50M upon European sales reaching US$1B over four consecutive quarters;
The agreement has a 12-year term following marketing approval on a country-by-country basis.
Theratechnologies intends to initiate discussions with the European Medicines Agency (EMA) as soon as possible to discuss the strategy in regards to the potential filing of an application.
While a definitive sales and marketing strategy has yet to be developed, Theratechnologies will analyze different options to ensure the optimal commercialization approach in Europe.
Source：TaiMed Biologics Inc.
http://www.taimedbiologics.com/news/info/56