Novalar Pharmaceuticals, Inc™. is a privately-held specialty pharmaceutical company based in San Diego, California and founded by Dr. Eckard Weber of Domain Associates. Our premier product offering, OraVerse™, has been developed to rapidly reverse the lingering and debilitating lip and tongue numbness associated with local dental anesthesia. Our intent is to introduce and promote this novel solution as a standard of care in dentistry.

Market Opportunity

Extensive market research studies have confirmed extremely strong consumer and dental professional interest in OraVerse and its ability to reverse unwanted numbness.

In the U.S., there are approximately 130,000 dentists who administer 300 million cartridges of local dental anesthetic annually. As OraVerse becomes a standard of care, the potential market size for OraVerse could reach $1-2B in the United States alone. At 20% penetration, United States peak sales would be in the $200-400M range with further upside expected in additional market penetration as well as sales in the European Union and Asia.

OraVerse can be easily adopted by dentists since no additional chair time, training or equipment are required. Dentists also gain flexibility in scheduling patients who otherwise would avoid daytime appointments because the numbing effect may interfere with business activities. Many of the dentists interviewed consider OraVerse as a competitive advantage for their practice, due to increased patient satisfaction.

Development Progress

Clinical Studies
Data from two Phase 3 studies shows that OraVerse was well tolerated, safe, and met its primary and secondary endpoints. In both studies, OraVerse treated patients reported the return of sensation and function in less than half the time it normally took after receiving local dental anesthesia. OraVerse induced a 54.8 percent and a 62.3 percent decrease in time to normal for those with anesthesia administered in the mandible and maxilla respectively. These reductions were statistically different than control (p<0.0001) with no serious adverse events (SAE’s) reported.

Further confirmation of the return of sensation following administration of OraVerse came through new, validated assessment tools that evaluated the perception of deficits and functional deficiencies created by local anesthesia such as eating, drinking and speaking.

In the Phase 2 pediatric study for OraVerse, the time to normal sensation was reduced by 55.6 percent, a clinically and statistically significant (p<0.0001) acceleration of the return to normal sensation. As in the Phase 3 studies, OraVerse continued to be well tolerated with no SAE’s reported in the pediatric population studied.

In April 2007, Novalar announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of OraVerse.  If approved by the FDA, OraVerse will be the only local anesthetic reversal agent that accelerates the return to normal sensation and function following restorative and periodontal maintenance procedures.

Manufacturing
Novalar has contracted with the leading North American supplier of dental anesthesia cartridges to manufacture OraVerse.

Patents
Novalar developed a novel formulation of OraVerse, which is packaged in a pre-filled dental cartridge with a two year shelf life. Novalar’s product is protected by multiple issued and pending patent applications which broadly protect the liquid, stable formulation of OraVerse, its packaging in dental cartridges, as well as, the use of OraVerse and other vasodilators to reverse local dental anesthesia.