Roche's ($RHHBY) announcement that it will acquire InterMune and its orally delivered drug pirfenidone has pushed the rare lung condition idiopathic pulmonary fibrosis (IPF) into the spotlight. Boehringer Ingelheim also has an oral drug for IPF on the horizon, but a little-known candidate for the condition has the potential to steal the big boys' thunder due to its differentiated delivery mechanism.
Genoa Pharmaceuticals' inhaled version of pirfenidone boasts an orphan drug designation from the FDA to combat the competing compounds' breakthrough designations. The company received little fanfare when it obtained the designation in early August, but the excitement surrounding InterMune's pirfenidone (which was central to Roche's $8 billion offer) suggests that the privately held company is in a promising market.
The company says delivery directly to the lung will enable the candidate (dubbed GP-101) to achieve similar efficacy to that of InterMune's pirfenidone-based product--already available in Europe, Asia, Canada and Argentina--with a dose 160 times smaller. This advantage should result in fewer side effects, improved patient compliance, and make possible a larger inhaled dose of pirfenidone--resulting in improved efficacy. In addition, an inhaled product should enable combination regimes, such as with Boehringer Ingelheim's oral IPF candidate, nintedanib, Genoa says.
Xconomy says the Roche-InterMune deal comes at an "opportune time" for Genoa, for the San Diego company is in the process of raising funds for a Series A financing round to advance the candidate into human clinical trials.
"Investor interest has increased (since the Roche-InterMune deal), but the biggest interest increase has been on the partnering front," wrote Genoa CEO Mark W. Surber, in an email to FierceMedicalDevices. Many big- and mid-cap pharma companies are looking to get into this technology "sooner rather than later," he wrote.
The orphan drug designation allows for 7 years of exclusivity follow marketing approval, but that day is still far away and not guaranteed. Still, Genoa's unique formulation and delivery mechanism make it a player to keep an eye on in the suddenly prominent market for treatments for IPF.
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Editor's Note: This article has been updated with comments from the CEO.