Santhera grants exclusive North America license for vamorolone to Catalyst Pharmaceuticals in deal valued at up to $231 million plus royalties.
Santhera Pharmaceuticals announces that it has signed an exclusive license and collaboration agreement for vamorolone in North America (NA) with Catalyst Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on novel medicines for patients living with rare diseases
Total consideration to Santhera is up to $ 231 million (including equity investment), plus royalty payments from product sales, with near-term cash proceeds for Santhera of $ 126 million.
Under the terms of the agreement, Santhera will grant Catalyst exclusive commercialization rights to vamorolone in North America, comprising the U.S., Canada and Mexico. At closing, Santhera will receive an upfront cash payment of $ 75 million. In addition, Catalyst will make an equity investment of $ 15 million through the purchase of 14,146,882 treasury shares at a price of CHF 0.9477 per share which corresponds to the ten-day volume-weighted average price ending two days prior to signing of the agreement, subject to a six-month post-closing lock-up and standstill. Use of proceeds from the equity investment will support Phase IV studies in DMD and joint development of additional indications.
Upon FDA approval of vamorolone in DMD, a decision expected on October 26, 2023 (PDUFA date), Santhera would receive an additional $ 36 million from Catalyst, of which Santhera would pay contractually agreed third-party regulatory milestone obligations ($ 26 million). Furthermore, Catalyst may pay Santhera sales-based milestones of up to $105 million as well as up to low-teen percentage royalties and will assume corresponding third-party royalty obligations of Santhera on vamorolone sales in all indications in North America.
In Europe, Santhera plans to commercialize vamorolone in key geographies (including Germany, France, UK, Italy, Spain, Benelux), and will seek partners for commercialization in all other countries. Market access, the build-up of a core organization and stakeholder engagement activities in these priority countries are ongoing. Already ahead of the European approval decisions expected at year-end, the early access programs submitted in the UK and France could allow treatment of first DMD patients with vamorolone. For certain countries, where Santhera chooses not to market vamorolone directly, including certain European countries and Japan, it has granted Catalyst a right of first negotiation in partnering discussions.
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