A Pittsburgh-based drug producer is seeking $50 million in its initial public stock offering. Thar Pharmaceuticals, a clinical-stage, specialty pharmaceutical firm with only one product, submitted its S-1 Securities and Exchange Commission IPO registration filing, describing itself as an “emerging growth company” that will trade as “THAR” on the Nasdaq Global Market.
Thar, which has accumulated nearly $20 million through June 30, produces an oral version of an existing intravenous drug used to treat the estimated 80,000 Americans diagnosed annually with complex regional pain syndrome. CRPS is a chronic pain condition usually affecting a limb after an injury or trauma, according to the National Institute for Neurological Disorders and Stroke.
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In its 163-page filing, Thar disclosed the standard boilerplate risks, pointing out: “We have incurred significant losses since our inception and anticipate that we will incur continued losses for the foreseeable future and thus may never achieve or maintain profitability. We have not generated any revenue from any commercial products and may never be profitable.”
But the 10-year-old company also enumerated its long-term strategy to develop and commercialize “a pipeline of novel, oral therapies designed to solve clinical limitations of existing intravenous-only therapies for serious and life threatening conditions.”
Thar plans to use the proceeds of the IPO to fund clinical trials for its sole drug, T121, an oral version of zoledronic acid already used in IV form to treat certain bone-related cancer pain. Thar holds worldwide rights for the development and commercialization of T121 with no royalty obligations to third parties, it said in its S-1.
The company hopes to fund two “double-blind, placebo-controlled, multisite Phase 3 clinical trials to evaluate the safety and efficacy of T121 for the treatment of pain associated with CRPS.”
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The company has conducted eight smaller nonclinical pharmacokinetic and toxicological studies with developmental formulations of T121. “In our Phase 1 clinical trial, we observed, among other things, no serious adverse events or unexpected safety issues related to T121 relative to IV zoledronic acid.”
Thar said its research indicated “a significant unmet need for more effective management of pain associated with CRPS, as none of the current therapies used off label consistently provide meaningful analgesic relief.”
The National Institutes of Health said several drugs have proven effective for treating CRPS, but no drug has been approved by the U.S. Food and Drug Administration specifically for the debilitating condition. Its cause is believed to be damage to the peripheral and central nervous systems, and its sufferers experience severe pain.
The FDA has designated CRPS as an orphan condition. FDA orphan drug designations usually receive a period of marketing exclusivity, seven years in the United States and 10 years in Europe.
Thar said if its Phase 3 clinical trials are successful and receive FDA approval, “we intend to commercialize T121 in the United States through an approximately 50-person sales force targeting an estimated 4,000 pain specialists who treat patients with CRPS.”
Photo: Flickr user Simon Cunningham
