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The dream of every biopharmaceutical CEO is to have a drug approved for sale to patients. schedule As of August 13, Citius Pharmaceuticals is continuing down that path with Lymphir, an immunotherapy for a rare blood cancer.
Leonard Mazur, CEO and Co-Founder, Citius Pharmaceuticals
Used with permission from Citius
Gaining approval for Linfeel to treat patients with persistent or recurrent cutaneous T-cell lymphoma would be a “breakthrough” for Citius, CEO Leonard Mazur said.
There is no cure for CTCL, but Few treatment options There are several treatments already available, including chemotherapy and radiation therapy, but Mazur said there is wide variability in treatment pathways and patient responses as the disease progresses through the two stages.
The drug is one of several late-stage, first-in-class candidates in Citius’ pipeline, which also includes a new antibiotic, Minoloc, to treat catheter infections, a topical prescription for hemorrhoids, Halorid, and therapies made from its stem cell platform.
The company’s president, who describes himself as an “all-in entrepreneur,” has personally invested $22.5 million in the company, while co-founder and executive vice chairman Myron Holbiak has put in $4 million, according to Mazur.
Mazur has made a habit of putting his own wealth at risk, dating back to early in his career when, in a previous role, he mortgaged his home to persuade another investor to close a deal.
“I remember meeting with a potential investor and doing a full presentation,” Mazur says, “and he asked, ‘How much are you going to invest?’ And I said, ‘I’ve got all my years of experience to draw on. I have a great business plan. All of this is valuable.’ And he said, ‘That’s not what I’m asking. How much are you going to invest? Because if you’re going to tell me to invest and take the risk, then I’m going to ask you the same thing.'”
Mazur has done so “many times” since then and has led several other pharmaceutical companies. Genesis Pharmaceuticals, Triax Pharmaceuticals We will be taking a look at Akrimax Pharmaceuticals from start-up stage to sale.
Asset Strategy
Citius’ strategy is focused on late-stage drug assets that may have a shorter path to commercialization, such as Lymphir, an improved version of denileukin diftitox, a protein fusion of interleukin-2 and diphtheria toxin that targets malignant and immunosuppressive T cells.
The drug, which has received orphan drug designation from the FDA, was previously approved under the name Ontac, but Eisai voluntarily withdrew it from the market due to manufacturing issues in 2014. In 2021, Citius purchased the licensing rights to an improved formulation of Ontac. $40 million The company has received development milestones of up to $70 million from Dr. Reddy’s Laboratories as part of the agreement for future indication expansion.
However, it wasn’t all smooth sailing for Lynfia. Complete Answer The company said the FDA imposed new regulations on it last year requiring it to step up product testing and agree to additional controls.
“That response letter arose because we had passed manufacturing testing but hadn’t completed that validation step,” Mazur said. “And we were going to continue to run it several months past the PDUFA deadline, so we got a full response letter. We had done all that work, Resubmitted everything And we are here praying.”
Commercialization Plan
Hoping for approval, the company is strengthening its commercialization strategy. 3,000 new cases Mazur said Lymphir is sold in the U.S. every year, and the market for Lymphir is worth $300 million to $400 million.
To raise start-up capital, Citius plans to spin off Lynphea and its oncology business into a separate company, Citius Oncology, which will then list on the Nasdaq under its own ticker as part of an acquisition deal with special acquisition company TenX Keene Acquisitions. Mazur said the deal is expected to close before the PDUFA deadline in August. The deal will give Citius control of “close to 90% of the company,” Valuation: $675 millionHe said.
If all goes well and the FDA approves the drug, Mazur said, Lymphir could be available as soon as November. Citius has already hired sales and marketing staff, and preparations have been going on for nearly a year.
Lynfia also has potential as a combination therapy, and the drug is being tested in two studies. University of Pittsburgh There, Keytruda is being used in combination with other drugs. University of Minnesota Trials with CAR-T therapy are underway.
Going forward, Citius will focus on similar asset types to acquire potential drug candidates, without being limited to any particular disease.
“We like small, specialized stores that don’t require a large sales force and can promote themselves with economies of scale,” Mazur said.
Mazur said that targeting rare diseases, which generally have low patient numbers, “works.”
“The pricing is very different than if it were a non-rare disease, so that’s one reason, but it’s not the only reason. For us, it’s also about wanting to contribute to improving people’s lives,” he said.
