SteadyMed Ltd. has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO). No terms were set in the filing, but the offering is valued up to $55 million. The company will list on the Nasdaq Global Market under the symbol STDY.
The underwriters for the offering are Wells Fargo, JMP Securities and RBC Capital Markets.
SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets. The primary focus is to obtain approval for the sale of Trevyent for the treatment of pulmonary arterial hypertension (PAH). There are also two product candidates being developed for the treatment of post-surgical and acute pain in the home setting.
These product candidates are enabled by SteadyMed’s proprietary PatchPump, which is a discreet, water-resistant and disposable drug administration technology that is aseptically prefilled with liquid drug at the site of manufacture and preprogrammed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously.
Trevyent is looking to serve a market of approximately 30,000 patients in the United States that are currently diagnosed with PAH. Trevyent is designed to provide an effective alternative for PAH patients that overcomes the limitations associated with the administration of the current market-leading prostacyclin PAH therapy, Remodulin.
The annual cost of Remodulin is reported to be between approximately $125,000 and $175,000 per patient, and United Therapeutics generated Remodulin revenues of $491.2 million in 2013.
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SteadyMed plans to apply for orphan drug designation in mid-2015, and expects to submit a New Drug Application for Trevyent to the U.S. Food and Drug Administration (FDA) in the first quarter of 2016. Additionally, the company expects to submit a Marketing Authorization Application to the European Medicines Agency in the first half of 2016, in collaboration with one or more partners.
The proceeds from this offering are anticipated to be used for the commercialization process of Trevyent. Other proceeds will be used on enhancements for the PatchPump delivery system to broaden its applicability to future product candidates.
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