Citius Pharmaceuticals Nears Market Breakthrough With Two Leading Products

July 30, 2024 at 08:45 AM EDT

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By Meg Flippin, Benzinga

From fighting cancer to treating bloodstream infections, Citius Pharmaceuticals Inc. (NASDAQ: CTXR) is busy trying to solve some of the world’s ills. That’s picking up steam with two of its lead products close to commercialization.

Take Mino-Lok (MLT), Citius Pharmaceuticals' novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium to treat patients with catheter-related blood stream infections. Mino-Lok offers hospitals an alternative to removing and replacing a central venous catheter (CVC), and that could reduce the number of serious adverse events like air embolism and bleeding. It could also save hospitals money.

Bringing It To The Market

Citius Pharmaceuticals CEO and co-founder Leonard Mazur told Benzinga that his company has “extremely positive” topline data from a Phase 3 Trial of Mino-Lok. Now Citius is meeting with the U.S. Food and Drug Administration (FDA) to move ahead with Mino-Lok, he said. Once Mino-Lok is approved, the company says it will be the only FDA-backed product for infected catheters in the market, presenting a big opportunity for the company.

“The market potential is about $2 billion,” said Mazur. “Positive announcements will come out of the meeting but I can’t predict that moment.”

Then there is LYMPHIR, a recombinant fusion protein designed to treat T-cell lymphomas. The drug agent combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis.

In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of peripheral T-cell lymphoma (PTCL) and Cutaneous T-cell lymphoma (CTCL). In 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain other parts of Asia.

In March this year, the FDA accepted Citius’s Biologics License Application (BLA) for LYMPHIR with a decision expected on August 13, the FDA's assigned Prescription Drug User Fee Act (PDUFA) action date. If approved, Citius is preparing for LYMPHIR commercialization later this year.

“We’re very excited about this launching during the fourth quarter,” said Mazur. “We go from no revenue to revenues.” The executive pegged the market opportunity at $300 to $400 million, telling Benzinga LYMPHIR is an additive and won’t take market share from anyone.

Shoring Up Shareholder Value

Bringing two drug products to market isn't the only way Citius is enhancing shareholder value. The company is also spinning out its wholly-owned oncology unit to form Citius Oncology, a stand-alone publicly traded entity. It is doing it via a SPAC deal with TenX Keane (NASDAQ: TENK).

Citius Pharma is getting 67.5 million shares in Citius Oncology at $10 per share, valuing the stake at $675 million and will retain majority ownership of approximately 90%.

This transaction is expected to unlock significant value for Citius shareholders by separating the oncology business, potentially leading to increased access to capital markets and further development of new applications and additional intellectual property, reports Citius. It also underscores Citius’s strategy to purchase assets, develop them and bring them to market and then unlock shareholder value.

Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies, with LYMPHIR the first to go to market. The company said the deal is expected to provide Citius Oncology with improved access to the public equity markets and thereby facilitate the commercialization of LYMPHIR and position the company to explore additional value-creating opportunities more fully.

“The reason we are doing it is we get a Nasdaq listing by having the SPAC acquire the assets and at the same time it enables us to do something to prevent dilution for shareholders,” said Mazur. The CEO counts himself as one of them; he has invested $22.5 million of his own money in the business. “During the first year on the market we will be profitable. All that benefits Citius shareholders.”

Featured photo by Nataliya Smirnova on Unsplash.

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