About Novalar
 Dr. Eckard Weber | Novalar began with a simple conversation between Dr. Howard Katz and his dental patient, Dr. Eckard Weber of Domain Associates. What started as a challenge to reverse local dental anesthesia soon became a mission for Dr. Weber when he founded Novalar Pharmaceuticals in 2000. The company was established in the high-tech hub of San Diego to bring the power of biotech and medical creativity to bear to solve this long-standing dental issue. What followed is a methodical road to success. |
Historical Timeline of Major Events
Novalar's Initial Product OraVerse™ (phentolamine mesylate) Injection
Product Pipeline
Intellectual Property
Vision, Mission and Values
As a new kind of dental partner, Novalar has shaped a distinctive vision for serving professionals and patients. This vision drives our mission and values, and we'd like to share them all with you.
VisionAs architects of inventive dentistry, we partner with professionals to enrich the patient experience through targeted and novel oral pharmaceutical solutions.
A team in action - inspired by passion, guided by integrity, driven by purpose - redefining possibility.
MissionNovalar is a specialty pharmaceutical company that partners directly with dental professionals to enrich the patient experience. The company is uniquely positioned to develop targeted oral pharmaceutical products and translate the full value of these novel solutions to clinical practice.
ValuesWe are a team in action...
Inspired by passion - leading the charge with aspiration, tenacity and fun.
Guided by integrity - committing to ethical, credible and
honest relationships with customers, partners, and each other.
Driven by purpose - delivering on the promise of our people,
our technologies, and our industry.
Historical Timeline of Major Events
Pharmaceutical innovation takes time and significant resources. Since our founding in 2000, Novalar has been extremely fortunate to attract excellent financial supporters to allow us to continue advancing our programs. Below is a snapshot of some of our major achievements:
| May 2008 | Novalar receives FDA Approval for OraVerse |
| July 2007 | Novalar announces exclusive license to develop and commercialize NV-201 for root canal therapy |
| April 2007 | Novalar submits New Drug Application for OraVerse |
| October 2006 | Novalar announces positive Phase 3 Results for novel dental anesthesia reversal agent |
| March 2006 | Novalar Initiates Pivotal Phase 3 Clinical Trials for novel dental anesthesia reversal agent |
| 2002 | Novalar obtains initial funding. Phase 1b/2a Dose Range Finding Studies initiated on its First Product, OraVerse |
| 2000 | Novalar Pharmaceuticals, Inc. a Delaware corporation founded |
Novalar's Initial Product OraVerse (phentolamine mesylate) Injection
Our first product, OraVerse, a local anesthesia reversal agent which rapidly reverses the lingering effects of soft tissue numbness, was approved by the FDA in May 2008. This product provides dentists with the solution to one of the most commonly asked questions in dentistry, "Can you take this lingering numbness away?" Dentists will finally be able to offer their patients something to answer this question and allow them to return to their normal activities in approximately half the time. And bringing innovations like this to the dental community makes us proud.
The potential market opportunity for OraVerse is considerable, with approximately 275 million cartridges of local dental anesthetic administered annually in the United States. There are currently no known competitors to OraVerse. Market research demonstrates strong interest from both dentists and consumers and Novalar anticipates significant opportunities in the U.S and international markets.
Novalar has contracted with Novocol Pharmaceuticals of Canada, Inc. the leading North American supplier of dental anesthetic cartridges to manufacture OraVerse.
back to topProduct Pipeline
And we're not done yet. In an effort to expand our dental pipeline, in June 2007, Novalar licensed the patent rights for a novel endodontic therapy (designated NV-201) from the Forsyth Institute, based in Boston, MA. NV-201 utilizes a polymer fiber to locally deliver an antibiotic directly into the root canal for the purpose of reducing the bacteria most often associated with inter-appointment pain. The antibiotic used in NV-201 is clindamycin, an antibiotic commonly used systemically in endodontics. Novalar believes there is a significant market opportunity for a novel therapeutic used in treating root canals. It is estimated there are 17 million root canal procedures performed annually in the United States. Preliminary market research conducted by Forsyth indicates there is demand from endodontists and general dentists for the product concept.
Novalar is continually and aggressively searching for new dental technologies to license to bolster our product pipeline.
back to topIntellectual Property
The investment required to develop our products is considerable therefore Novalar has invested a significant amount of resources in protecting our "know-how" through strong intellectual property portfolios. Strong patent protection is the key to successful pharmaceutical innovation.
Novalar developed a novel formulation of phentolamine mesylate (the active ingredient in OraVerse), which is packaged in a pre-filled dental cartridge with a three year shelf life. OraVerse is protected by two series of patent families with 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. Novalar's OraVerse patent strategy is to prosecute its two main series forcefully and globally.
There are two issued U.S. patents that cover NV-201 and additional claims are pending worldwide, and are expected to provide protection for method of use, dose of antibiotic used, and fiber formulation/composition. As with OraVerse, Novalar's NV-201 patent strategy is to prosecute its patent portfolio forcefully and globally.
Novalar will focus on identifying, pursuing and acquiring any additional intellectual property necessary for the successful commercialization of OraVerse as well as the commercialization of NV-201 and any additional product opportunities. The company regularly reviews its IP portfolio and makes adjustments to ensure all products have the appropriate regional coverage necessary for global commercialization. In addition, Novalar works with outside IP attorneys to review any patents for in-licensing and to determine if any additional IP may be required.
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