NovaDel Grants Exclusive License for Animal Drugs Using Proprietary Lingual Spray Technology

Date : 09/14/2004 @ 8:29AM
Source : PR Newswire
Stock : Novadel Pharma, (NVD)
Quote : 0.25  0.02 (8.70%) @ 4:00PM
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NovaDel Grants Exclusive License for Animal Drugs Using Proprietary Lingual Spray Technology

NovaDel Grants Exclusive License for Animal Drugs Using Proprietary Lingual Spray Technology Former Senior Animal Health Executives Will Commercialize NovaDel's Drug Delivery Technology for Pets, Other Animals

FLEMINGTON, N.J., Sept. 14 /PRNewswire-FirstCall/ -- NovaDel Pharma, Inc.

(AMEX:NVD) granted an exclusive worldwide license to its patented lingual spray drug delivery technology to Velcera Pharmaceuticals, Inc. of Langhorne, PA, for development of innovative veterinary medicines.

Velcera is a development-stage, privately-held animal health company headed by former senior executives at the animal units of Merial, Merck, and Schering-Plough.

NovaDel received an equity stake in the new venture along with an upfront cash technology fee. The agreement provides NovaDel with milestone payments for each product developed by Velcera and royalties on product sales. Products will be formulated in NovaDel labs at Velcera expense and Velcera will fund all development and regulatory activities. The resulting Velcera products will be manufactured by NovaDel.

"This is a way for NovaDel to expand its lingual spray technology into another market by capitalizing on Velcera's resources and expertise in this area," said Gary A Shangold, MD, NovaDel's chief executive officer. The animal health market is $14 billion globally and growing and our technology offers what appear to be very special advantages in drug administration and compliance. We are fortunate to have a partnership with a company of very seasoned executives whose focus is on improving animal health by way of NovaDel's patented delivery system."

NovaDel's technology is expected to overcome the well-known problem of poor compliance when it comes to administration of pills by pet owners. Cats and dogs are often uncooperative in taking a pill. Some pets appear to take the pill, only to then spit it out later when out of sight of the owner. Still others will intentionally avoid ingesting medication mixed with their food.

With NovaDel's technology, pet owners would more easily administer drugs by dispensing a fine mist of the product onto the gum and/or inner cheek areas. Rapid absorption through the oral mucosa takes the drug into the bloodstream.

In human health, this direct delivery into the bloodstream generally means lower doses are sufficient for the same therapeutic effect achieved with higher doses in a pill form of the same drug. The technology offers the additional advantage of largely avoiding first pass liver metabolism. NovaDel's first human drug was submitted for approval to the US FDA earlier this year.

"In our years of experience and technology assessment, we have yet to see a drug delivery platform as robust and versatile as NovaDel's lingual spray technology," commented Velcera's Chief Executive Officer Dennis Steadman, the former vice president of North American Operations for Merial Ltd.

"Particularly in the pet market, which is our initial focus," he continued, "there is a definite unsatisfied need to ease the physical and emotional discomfort of drug administration by pet owners and to help improve compliance for better therapeutic outcomes. We have an excellent team at Velcera and strong financial backing. Now, with our NovaDel partnership we have a strong proprietary position to offer better versions of high value off- patent animal pharmaceuticals as well as look at some newer molecules."

A trial conducted at an independent facility sponsored by Velcera showed that NovaDel's delivery technology was well accepted by cats and dogs and that it could represent a significant leap forward in simplifying pet-owner administration of medicines.

The animal health market is estimated to be valued at about $14 billion worldwide. The companion pet category is the fastest growing segment, currently valued at about $5 billion worldwide.

NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the development of novel drug delivery systems for prescription and over-the- counter drugs. The Company's proprietary lingual spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the required drug dosage and reducing side effects; (iii) improved patient convenience and compliance; and (iv) enhanced dosage reliability. The Company plans to develop such products independently and through collaborative arrangements with major pharmaceutical and biotech companies.

Except for historical information contained herein, this document contains 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 lingual spray products.. 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 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.

Velcera Pharmaceuticals, Inc. is a privately-held, development-stage animal health company dedicated to breaking-through the administration barriers in veterinary medicine to bring new convenience, improved compliance and therapeutic benefits to veterinarian medicines. Velcera combines patented drug delivery technology with in-depth animal health expertise and solid financial backing to develop and market new and unique animal health medicines. The new Velcera name is constructed from Vela (Latin root, to pass through) and Cere (Latin suffix, breaking through) reflecting the company's dedication to breaking-through to improve veterinary medicine. Velcera, headquartered in Langhorne, Pennsylvania USA, is lead by President and CEO, Dennis Steadman and staffed with expertise from major global animal health companies.

Contact: Barry C. Cohen VP Business & New Product Development NovaDel Pharma Inc.

908.782-3431 x 2160

Thomas Redington Redington, Inc.

203.222.7399 212.926.1733

DATASOURCE: NovaDel Pharma Inc.

CONTACT: Barry C. Cohen, VP Business & New Product Development of

NovaDel Pharma Inc., +1-908-782-3431 x 2160; or Thomas Redington of Redington,

Inc., +1-203-222-7399, or +1-212-926-1733,

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