|The PatchPump device--Screenshot courtesy of SteadyMed|
Drug delivery specialist SteadyMed filed for a $55 million IPO to list on the Nasdaq, as it seeks to raise funds for its PatchPump drug delivery device to treat the orphan disease pulmonary arterial hypertension (PAH), or high blood pressure in the arteries of the lungs.
Founded in 2005, the company has no commercialized products and booked a net loss of $19 million in 2014. Its main innovation, the PatchPump, is designed to deliver a reformulated candidate of United Therapeutics' ($UTHR) market-leading Remodulin (treprostinil), dubbed Trevyent. SteadyMed says delivery challenges with United Therapeutics' version of treprostinil are the reason an estimated 3,000 out of 24,000 eligible patients are on the Remodulin.
Those challenges include complex dose calculations, multiple precise steps and restrictions on daily activities, according to SteadyMed's SEC filing. The company says its PatchPump is the solution because it is preprogrammed and convenient. SteadyMed plans to price Trevyent between $125,000 and $175,000 per patient per year.
Both Trevyent and Remodulin require continuous dosing because they are parenterally delivered, meaning they avoid the digestive system. Remodulin can be delivered subcutaneously or intravenously.
United Therapeutics also has an oral extended release tablet of treprostinil, Orenitram. It was approved by the FDA in late-2013, but only to improve exercise capacity in PAH patients. If the indication were to be expanded, that could spell trouble for SteadyMed.
SteadyMed intends to apply for orphan drug designation (given for medications that treat a disease or condition affected fewer than 200,000 individuals in the U.S.) in mid-2015 and file an NDA with the FDA in the first quarter of 2016.
Trevyent is undoubtedly a drug/device combination product. One pitfall is the possibility that FDA may opt to regulate the candidate as a device. Combination product companies prefer to be regulated under the pathway for drugs because it is often faster.
SteadyMed also says it intends to file an NDA for PatchPump-based drugs for "post-surgical and acute pain in the home setting" and "short-term management of moderately severe acute pain" in 2017.
- read the SEC filing