NovaDel Pharma Inc. is looking to make lingual sprays the delivery mechanism of choice for a variety of drugs - both prescription and over-the-counter - which it says will provide faster impact with fewer side effects than the forms currently offered.
And last week's news that it has raised $14 million in a private financing is likely to make that process easier. The funding, which will leave NovaDel, of Fleming, N.J., with about $12.9 million in net proceeds, will be devoted to human pilot pharmacokinetic studies of lingual spray versions of its product candidates, which are four currently marketed drugs with combined annual sales of more than $4 billion, the company said.
NovaDel's vice president of business and new product development Barry Cohen said that the funding involved a wide range of investors. Paramount Capital Inc., of New York, acted as placement agent for the offering.
What's more, NovaDel expects to file its first new drug application in the second or third quarter of this year for a lingual spray version of nitroglycerin, which would be the company's first product.
NovaDel said its lingual spray formulations are designed to provide rapid therapeutic blood levels of compounds to allow for faster onset via absorption through the oral mucosa. By that route, drugs can be absorbed directly into the systemic circulation, thus avoiding the typical disintegration or dissolution that can happen in the stomach. With the elimination of the first-pass metabolism, accompanied by a reduction in hepatic metabolites, it is expected that the lingual spray formulations will cause less adverse side effects.
Cohen said the company is following a drug approval pathway called 505 (b)(2), which shortens the length of the time to possible approval. That FDA regulation allows companies like NovaDel that want to take an existing approved product and improve it to use studies from the original innovators of the drug that helped earn initial approval.
"What 505(b)(2) allows me to do is to submit my version of their product to the FDA, referencing their studies that they conducted for that base product," Cohen said.
The regulations allows NovaDel to use the studies, despite the fact that they may not have "right of reference" from the original company that did preclinical and clinical studies, Cohen said.
Money from the funding will be dedicated to pharmacokinetic studies - which are required under 505(b)(2) - of London-based GlaxoSmithKline's Zofran, an anti-emetic; New York-based Pfizer Inc.'s Xanax, an anti-anxiety drug; Glaxo's migraine drug Imitrex; and Paris-based Sanofi-Synthelabo SA's Ambien, a sleep-inducing drug.
NovaDel also is seeking partnerships with pharmaceutical and biotechnology firms to convert drugs into lingual sprays, thus offering what it calls a part of "life cycle management" for big-selling drugs like Imitrex.
"The strategy is this: Our preference would be for major pharma companies to view our technology as a life-cycle management tool to their franchise," Cohen told BioWorld Today.
Cohen said NovaDel also could work with smaller pharmaceutical companies that wanted to move into a particular area, for example, analgesics. In that case, NovaDel would license rights to the lingual spray form and collect royalties.
NovaDel's patents are for the formulations of drugs - not the delivery device. The patents first cover solvents that are oily or non-oily used to deliver drugs through the oral mucosa. Then, the company has patents that allow for the creation of categories like analgesics. It also has patents pending for particular drugs delivered through oral mucosa.
NovaDel has one current partnership, with Manhattan Pharmaceuticals Inc., of New York, for Diprivan, a drug used for sedation.
And Cohen noted that the company always has the option of keeping drugs for itself and retaining all profits.
NovaDel's stock (OTCBB:NVDL) fell 19 cents Friday to close at $1.80.