RADNOR, Pa. - Marinus (NASDAQ:MRNS) Pharmaceuticals, Inc. (NASDAQ:MRNS), a company specializing in seizure disorder therapeutics, announced today its intention to vigorously defend its patent portfolio following an Inter Partes Review (IPR) challenge. The challenge, initiated by Ovid Therapeutics (NASDAQ:OVID), Inc. on March 26, 2024, disputes Marinus's U.S. Patent 11,110,100, which covers the use of the drug ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE).
Marinus has invested significantly in the development of ganaxolone, with over $100 million allocated over two decades toward research programs for SE treatment. The company's CEO, Dr. Scott Braunstein, emphasized the strength of their patent portfolio and the robust clinical data supporting ganaxolone's pharmacology and effective dosing. He expressed confidence in the face of the IPR challenge, labeling it as a distraction from their mission to provide new treatment options for patients with unmet needs.
The disputed patent is part of a series of patents that Marinus has been granted, including two method-of-use patents for intravenous (IV) ganaxolone in SE treatment. These patents are foundational to the clinical dosing regimen for SE patients, a regimen informed by Phase 2 trial findings that showed rapid cessation of SE with a sustained resolution when a minimum plasma concentration of ganaxolone was maintained.
Marinus's first provisional patent application for ganaxolone in SE was filed in February 2015, predating Ovid's provisional patent application in August 2016.
Marinus has also initiated a Patent Trial and Appeal Board (PTAB) post-grant review (PGR) to challenge an SE patent held by Ovid, with Marinus arguing that the Ovid patent should not have been granted. In response, Ovid abandoned the majority of its claims, and the PTAB has since instituted the PGR, indicating that Marinus is likely to succeed in invalidating the remaining claims. A final decision on this matter is expected by mid-2024.
The company continues to focus on bringing ganaxolone, which was first introduced as an FDA-approved medication in the U.S. in 2022, to patients in need.
This report is based on a press release statement from Marinus Pharmaceuticals.
InvestingPro Insights
In light of Marinus Pharmaceuticals' ongoing patent dispute and its dedication to advancing ganaxolone, a look at the company's financial health and market performance offers additional context for investors. According to InvestingPro data, Marinus has a market capitalization of $480.31 million, reflecting its position in the biopharmaceutical market. Despite a challenging financial landscape, with a negative gross profit margin of -226.96% for the last twelve months as of Q4 2023, the company's revenue growth stands at 21.63% during the same period, indicating a potential for recovery and growth.
InvestingPro Tips suggest that Marinus is rapidly depleting its cash reserves and that analysts have revised their earnings estimates downwards for the upcoming period. This could be a concern for investors looking at the company's short-term prospects. However, it's noteworthy that Marinus's liquid assets surpass its short-term obligations, providing some financial cushioning. Additionally, the company is trading at a high Price/Book multiple of 28.65, which might be of interest to investors looking for growth-oriented stocks.
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As Marinus Pharmaceuticals navigates both its legal challenges and market dynamics, these InvestingPro Insights provide a snapshot of the company's financial bearings, which could be instrumental for investors making informed decisions.
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