SANTA MONICA, CA / ACCESSWIRE / May 24, 2018 / When Leonard Mazur and Myron Holubiak put their heads together to collaborate on building a new pharmaceutical company, the two men had decades of success to help guide their decisions as to the most efficient way to target areas of unmet medical need. Both men were seasoned vets at the full gamut of pharma activity and it didn't take them long to know exactly where they were headed when they entered the public markets through a merger with Citius Pharmaceuticals in March 2016.

Holubiak came through the ranks at drug behemoth Roche Labs (RHHBY), ultimately serving as President of the company's U.S. operations. Mazur's curriculum vitae reads like a page right out of a chapter of Who's Who in Pharma M&A. In aggregate, the two have an incredible breadth of experience ranging from sophisticated biotech products like interferon alpha all the way up to branded generics (Mazur launched the tetracycline antibiotic dynacin) and everything in between.

This type of background lends to a broad scope of opportunities from which to choose a development strategy. In a phone conversation, the men explained that they knew that they wanted to develop new drugs that had a great benefit to man without all the risk of starting from scratch. Moreover, they knew exactly how to do it.

During his time at Roche, Holubiak saw it all, from early bench tests to marketing strategies. He launched drugs that became standards in healthcare, including Tamiflu, Bactrim and the blockbuster antibiotic Rocephin (ceftriaxone), to name just a few successes that play a meaningful role in Holubiak's decision-making process today.

Answering questions on how to most successfully develop and market a new drug is part of Holubiak's DNA. In fact, during a hiatus from Roche, he started his own consulting company called Emron that was dedicated to the economics of new technology underscored by his contention that the traditional ways of simply having a lot of marketing muscle wasn't the way of the future. As it turns out, Holubiak was spot on, as rationalizing the benefit/economics paradigm of a new product – as opposed to just a marketing blitz – is where value is created. This has proven especially true now, as the world has shifted more towards personalized therapies versus small molecules.

His experiences at Roche made his acutely aware of how critical risk management is in the design and development of a new drug. It also taught him to look for combinations to improve patient outcomes and capture market.

This is exemplified by the development of Bactrim, the combination of the synthetic antibiotics sulfamethoxazole (Gantanol) and trimethoprim (Septra) for treating an array of serious infections, including urinary tract infections, bronchitis, Pneumocystis pneumonia and MRSA. Powerful drugs independently, scientists discovered that putting the two antibiotics together created a double blockade for organisms that greatly decreased the likelihood of antibiotic resistance developing. This one of the reasons Bactrim is effective against MRSA, a nasty bug known worldwide for its resiliency against today's common antibiotics.

Holubiak knew he could compete with Pfizer's (PFE) Septra with Roche's sulfamethoxazole, but the combination made a lot more sense from every angle, including using the marketing power of Pfizer to build the Bactrim brand. This same strategy was used for the heartburn drug Zantac, which was launched under Holubiak's supervision and co-promoted with GlaxoSmithKline (GSK), going on to at one point be the most successful selling drug in history.

Mazur spent his first 10 years working for Cooper Laboratories, starting in sales and rising into positions of strategic planning, then acquisitions and eventually head of one of the Cooper divisions. Thanks in part to Mazur, Cooper built its brand as an expert in developing medical specialty silos – acquiring companies and building business units around their medical specialties.

It was Mazur that put together the first strategic plan and got the first unit operational, which was in the ophthalmology space. In a matter of roughly seven years, the unit went from acquiring a tiny prescription eye-drop company to about $800 million in revenue as one of the largest eye care companies in the world, called CooperVision. The business remains a leading brand of The Cooper Companies (NYSE:COO) today.

Mazur was involved in many of Cooper's approximately 150 acquisitions and integral to the creation of Cooper Dermatology, which had Aveeno as one of its flagship products.

During Mazur's tenure, Cooper also launched Cooper Dental, which started by acquiring an upstart toothbrush company doing less than $1.0 million in annual sales that it grew into Oral-B, the best selling toothbrush in the world that was bought by Gillette in 1984 for $118.5 million and as part of Procter & Gamble's (PG) $57 billion buyout of Gillette in 2005.

From Cooper, he took the job as Director of Marketing at the BASF company Knoll Pharmaceuticals where he launched the painkiller Vicodin, amongst other strong sellers. Following Knoll, Mazur moved on to ICN Pharmaceuticals, now called Valeant Pharmaceuticals (VRX)(VRX), which has never been a stranger to merger and acquisition activity. As VP of Sales and Marketing at ICN, Mazur launched ribavirin, a staple in treating hepatitis C and other maladies.

Next, Mazur become EVP at the microcap startup Medicis Pharmaceutical, where he successfully created and launched Dynacin, a drug with minocycline in it that became one of the best-known anti-infection generics of all time. In 2012, Valeant acquired by-then NYSE-listed Medicis for $2.6 billion.

Mazur certainly wasn't done there, as his entrepreneurial juices really started flowing, creating the dermatology company Genesis Pharmaceutical in 1995 and selling it to French specialty pharma Pierre Fabre in 2003 and then founding Triax Pharmaceuticals (sold to PreCision Dermatology in 2012, which was acquired by Valeant in 2014 for $475 million) and Akrimax Pharmaceuticals (~$100 million in sales before pieces started being acquired). He was also part of New American Therapeutics, a company that acquired the topical herpes labialis drug Denavir from Novartis (NVS) that was later sold for a profit to Renaissance Pharma.

A few years ago, Mazur was involved with buying and selling the generic skin-condition drug tretinoin (branded Retin-A) twice. Mazur's team at Triax sold it to PreCision, who sold it to Valeant who sold it back to Mazur's group at Matawan Pharmaceuticals, LLC for $65 million. 18 months later, Matawan sold it to Perrigo (PRGO) for $415 million.

Now Mazur is looking to make his latest success start with Leonard Meron Biosciences, the company merged into Citius about two years ago. Mazur and Holubiak created Leonard Meron for the purpose of licensing an experimental therapy called Mino-Lok from the venerable medical experts at M.D. Anderson Cancer Center.

Mino-Lok is a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution.

Mazur obviously had experience with minocycline (Dynacin). Holubiak knew people from M.D. Anderson from his work with Rocephin and certainly had plenty of experience with antibiotics. When challenging themselves to create new medications for the world, they determined the best approach would be not to go too far into high-tech biotech because of all the risks and expenses or too far to the other side of the spectrum with generics because of low margins and competition.

They settled in the middle, keeping the reward high by addressing areas of unmet need, while mitigating risk by using known active pharmaceutical ingredients (APIs) and putting them together to do something that has never been done before. Enter Mino-Lok, which is now being evaluated in a Phase 3 clinical trial for catheter-related bloodstream infections/central line-associated bloodstream infections.

Citius is checking all the boxes to move Mino-Lok through the FDA process quite quickly. The therapy has earned a Qualified Infectious Disease Product (QIDP) from the FDA, is being developed under an FDA "Fast Track" designation and through what is known as a 505(b)(2) pathway. Experimental therapies utilizing the 505(b)(2) are allowed to forego large portions of early-stage research because the APIs being used are already approved for other indications, therefore its safety profile is clearly defined.

Getting a green light from the FDA to use a 505(b)(2) designation can potentially shave years and millions of dollars off R&D, while somewhat de-risking the drug's development because of known attributes. It can come with a cost, though, as investors are often quick to judge the drug as un-sexy or just some different salt of an old drug being repackaged, even if nothing is further from the case.

Mazur and Holubiak see passed any stigma and straight into an opportunity by taking APIs that have been in man before and developing them as potentially category leaders in new indications where patients face a dearth of therapeutic options. Mino-Lok is a great example. Currently, if a doctor is trying to salvage a central venous catheter (CVC) for a patient with bacteremia, the options are non-existent. The standard is to pull out the CVC and insert a new one. When considering the discomfort to the patient and all the possible things that can go wrong during and subsequent to the procedure, it’s obviously far from ideal.

To put a little light on how dire the situation is, consider that about 500,000 out of 7 million CVCs that are used each year become infected, leading to serious, life threatening infections called catheter-related blood stream infections (CRBSIs).

Mino-Lok treats the infection with the catheter in place. A 90-patient, Phase 2b trial demonstrated 100% efficacy in salvaging the indwelling CVC without a single serious adverse event reported, versus 18% of patients undergoing CVC replacement experiencing some type of serious adverse event. Based upon the one-year timeline for the 700-patient, Phase 3 study listed on clinicaltrials.gov, the trial should be wrapping up somewhere around the first quarter of next year, given the first patient was enrolled in February. That certainly puts a potential milestone catalyst for the company on the mid-term horizon.

The company will also get to take an interim look at data halfway through the study.

With Mino-Lok cemented as the cornerstone of the company, management next added Hydro-Lido, a proprietary topical formulation combining hydrocortisone and lidocaine for the treatment of hemorrhoids. CTXR management recently disclosed that they are making an adjustment to the formulation, combing lidocaine with a higher potency corticosteroid, rather than hydrocortisone. The two products are not used together in any FDA-approved treatment currently, but both are approved independently for various dermatological disorders.

There is not a single prescription medication approved by the FDA for the treatment of hemorrhoids. This may come as a shock to the 10 million Americans that report symptoms of hemorrhoidal disease annually.

To that point, Hydro-Lido is a solid complement to Mino-Lok in meeting all the qualities of an ideal drug development candidate at Citius: large market, unmet need and rapid path to commercialization via existing APIs.

In a 210-patient, Phase 2a trial, 88.9% of patients on Hydro-Lido achieved greater relief with respect to itching at day 2 as compared to any patients receiving hydrocortisone or lidocaine alone. An 85.7% improvement at day 2 with respect to pain and discomfort for the Hydro-Lido group was reported also.

When you start talking about accomplishments of executive leadership, it's an anomaly to look through the microcap space (at $2.45 per share, Citius has a market capitalization of $26.1 million, according to QuoteMedia data) and see resumes like that of Mazur and Holubiak. Their names are attached to drugs like Zantac, Tamiflu, Bactrim, Rocephin, Dynacin, Vicodin, tretinoin, ribavirin and Denavir and companies like Roche, Medicis, Pfizer, Valeant, Perrigo and Novartis. The Citius founders have a long track record of building companies, launching drugs and growing value for either their employers or their shareholders, depending on where they were at that time. The history is not debatable and the question now looms: is Citius that next success that each will add to their legacy?

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