Navitas Pharma is a late-stage (Phase III) U.S. pharmaceutical company focused on cardiovascular and metabolic disorders. Its lead asset is introducing a new class of pulmonary hypertension agent to the US that will have at least 7-year orphan drug exclusivity, and may be protected further by intellectual property. The drug has been launched for hypertension in Europe, and has a favorable safety profile robustly supported by an extensive data package that includes:
- Over 10,000 patients exposed in clinical trials (mainly for hypertension).
- About 2,000,000 patient-years of post-launch pharmacovigilance data.
An End of Phase II meeting (based on data from US Phase II general hypertension studies) was held with the FDA on 16 June 2006. Navitas was encouraged by the dialogue at the meeting, whose official minutes are available under confidentiality. On the basis of recent industry events, as well as favorable experience under Investigational IND in the US, strategic focus has been shifted to pulmonary hypertension.
Navitas has isomer-based pipeline assets that have promise in primary care applications such as hypertension and diabetes, based on favorable clinical data in parent (racemic) compound trials. Proprietary data are available under confidentiality.
Navitas is currently in discussions with potential development partners. The company is operating on funds provided by private investors.
The company has an office in Palo Alto, California (where the CEO is located), and is headquartered in Laramie, Wyoming.