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NovaDel Receives Notice of Allowance for New U.S. Patent Covering its Oral Spray Drug Delivery Technology

Date : 11/05/2009 @ 9:03AM
Source : Business Wire
Stock : Novadel Pharma, (NVD)
Quote : 0.17  0.0 (0.00%) @ 2:05AM
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NovaDel Receives Notice of Allowance for New U.S. Patent Covering its Oral Spray Drug Delivery Technology

Novadel (AMEX:NVD)
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NovaDel Pharma Inc. (NYSE AMEX: NVD), today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. Patent Application No. 10/671,715, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaMist™ Oral Spray spray technology. Once issued, this patent will expire in 2018.

As previously announced, NovaDel’s Zolpimist ™ (zolpidem tartrate) 5 mg and 10 mg Oral Spray product is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist is NovaDel’s second product approved by the FDA that uses NovaDel’s proprietary NovaMist oral spray technology. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien®, the world’s leading sedative hypnotic for the treatment of insomnia.

NovaDel maintains an extensive worldwide portfolio of intellectual property rights for select compounds using its pioneering oral spray delivery system. Upon issuance of the application, the Company will have been granted nine patents in the U.S., three patents in Canada and 66 patents throughout Europe, including Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Monaco, Netherlands, Portugal, Spain, Sweden and Switzerland. Additionally, NovaDel has over 80 patents pending around the globe.

Important Safety Information

Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Due to its rapid onset of action, patients should take Zolpimist immediately before bedtime and be prepared to get a full night's sleep (7-8 hours). Patients should use extreme care in or avoid engaging in activities requiring full alertness such as driving or operating hazardous machinery the morning after taking any sleep medication. Do not take any sleep medicine with alcohol. Complex behaviors such as somnambulism (sleepwalking), including driving or eating while not fully awake, with amnesia for the event, as well as cases of severe allergic reactions have been reported in patients who have taken a sedative hypnotic. Patients reporting such events should contact their physician immediately, discontinue use and not be rechallenged. Prolonged usage of a sedative hypnotic should be avoided without first consulting a physician. Patients experiencing unusual changes in thinking or behavior, or if sleep problems persist, should see their physician as these may be indicative of another medical condition. Sedative hypnotics are non-narcotic, however they do have some risk of dependency. The most commonly observed side effects in controlled clinical trials were headache, somnolence and dizziness. For full prescribing information, including the FDA medication guide and patient instructions for use, please visit www.novadel.com.

Ambien is a registered trademark of sanofi-aventis.

ABOUT NOVADEL PHARMA

NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The Company’s proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.

NovaDel’s oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The Company’s most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. (NYSE AMEX: NVD), visit our website at www.novadel.com.

FORWARD-LOOKING STATEMENTS:

Except for historical information contained herein, this document may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development and the acceptance in the marketplace for oral spray products. The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company’s control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company’s most recent Annual Report on Form 10-K and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings.



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