Catalyst (CPRX) to Gain DMD Drug Licensing Rights From Santhera
Catalyst Pharmaceuticals CPRX announced entering into a definitive licensing agreement with Santhera Pharmaceuticals Holding, which will grant Catalyst exclusive rights to manufacture and supply Santhera’s vamorolone in North America. Vamorolone is Santhera’s investigational dissociative steroid, which is currently under the FDA review for the treatment of Duchenne Muscular Dystrophy (“DMD”).
The North American region comprises the United States, Canada and Mexico territories. Furthermore, if Santhera chooses not to market vamorolone directly in certain countries, including Europe and Japan, it has granted Catalyst the right of first negotiation in partnering discussions.
The licensing agreement adds a promising drug candidate to Catalysts’ diversifying rare neuroscience product portfolio.
Shares of the company jumped 3.44% on Tuesday, following the encouraging news. Year to date, shares of CPRX have plunged 32.2% compared with the industry’s fall of 0.5%.
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Santhera’s new drug application for vamorolone was based on positive results from the company’s pivotal phase IIb VISION-DMD study. The study reportedly met its primary endpoint, demonstrating statistical significance over treatment with placebo. A decision from the FDA is expected on Oct 26, 2023. Subject to approval, Catalyst anticipates the commercial launch of vamorolone in early 2024.
Per the terms of the agreement, CPRX is liable to make an upfront payment of $75 million to Santhera, along with a concurrent strategic equity investment of $15 million into Santhera. Santhera plans to use the equity investment proceeds for phase IV studies in DMD and further development of additional indications. Additionally, Santhera is entitled to receive future payments from Catalyst, upon achieving certain regulatory and sales-based commercial milestones, along with tiered royalty payments.
Moreover, the companies have agreed to jointly oversee the development of vamorolone for additional indications beyond DMD. The transaction is expected to close in the third quarter of 2023, subject to regulatory and shareholders’ approvals.
DMD is a rare congenital disease, predominantly affecting males. Symptoms of DMD include inflammation, which is present at birth or shortly thereafter. Inflammation often leads to fibrosis of muscle, causing progressive muscle degeneration and weakness. The current standard-of-care treatment for DMD is corticosteroids.
The FDA had previously granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for vamorolone. The drug also enjoys Orphan Drug designation in the EU and similar status in the U.K. However, vamorolone is currently not approved for use in any market.
Catalyst Pharmaceuticals, Inc. Price and Consensus
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Zacks Rank and Stocks to Consider
Catalyst currently has a Zacks Rank #5 (Strong Sell).
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