Fresh money for Santhera and Idorsia

Under the terms of the license and collaboration 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 USD 75 million. In addition, Catalyst will make an equity investment of USD 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. Use of proceeds from the equity investment will support Phase 4 studies in DMD and joint development of additional indications.

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.

The new drug application (NDA) for vamorolone in DMD is under review in the U.S. by FDA, which has set October 26, 2023 as the Prescription Drug User Fee Act (PDUFA) date for its regulatory decision on approval. In Europe, the review of the marketing authorization application (MAA) for vamorolone by the European Medicines Agency (EMA) is ongoing. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in Q3-2023, followed by an approval decision by the European Commission (EC) in late 2023. In the UK, a corresponding MAA is under review by the Medicines and Healthcare products Regulatory Agency (MHRA). Subject to approvals, vamorolone could be launched in both the first EU countries and the U.S. in late 2023 and early in the first quarter 2024, respectively.

Founder finances Idorsia 

Idorsia Ltd has secured bridge financing in the amount of CHF 75 million to extend the company’s cash runway until the end of July and in the meantime allow the completion of the recently announced prospective strategic transaction for its Asia Pacific (ex-China) operations. Two weeks ago Idorsia announced that it has entered into exclusive negotiations with an undisclosed party regarding its operating businesses in the Asia Pacific (ex-China) region, including selected license rights to products from Idorsia’s portfolio in those territories, for a total consideration of up to CHF 400 million. The transaction is subject to completion of satisfactory due diligence and legal documentation. The credit facility has been provided by Jean-Paul Clozel, CEO, Member of the Board of Directors and Idorsia’s largest shareholder.