Opportunities at Noven

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Can your company’s drug benefit by using Noven’s transdermal technology? We have an efficient means of determining just that before you expend time and money advancing to development. Our drug delivery experts and experienced formulators will present a detailed feasibility report to enable an informed “go/no-go” decision.

The steps in our business development
process are:

Initial discussions on product concept and whether the drug is conducive to transdermal delivery.

Signing a confidentiality agreement to permit information sharing and setting delivery specifications.

Signing an agreement for transdermal feasibility studies, which typically require less than six months and entail reasonable costs.

Noven then develops several transdermal formulations and performs the following activities to determine whether the drug meets the desired objectives:

• Conduct in vitro flux studies
• Develop prototype GMP (Good Manufacturing Practice) pilot batches
• Conduct one month preliminary stability studies
• Conduct skin irritation and sensitization studies in animals
• Prepare feasibility report for partner and produce limited samples

After establishing feasibility, the partner may elect to have Noven manufacture ICH (International Committee on Harmonization) batches for stability and clinical trials.

If feasibility is demonstrated, the next step is to negotiate a development, licensing, and supply agreement that meets the objectives of both partners.

Under the initial feasibility agreement, the partner will receive sufficient prototype patches to conduct pilot human pharmacokinetic studies. Noven has extensive product experience to demonstrate in-vitro to in-vivo correlation of drug permeability results.

Noven has an 80,000 sq. ft. state-of-the-art commercial manufacturing facility that complies with all regulatory requirements of the U.S. Food and Drug Administration as well as the European and most other regulatory authorities. Our facility has also been certified by the Drug Enforcement Administration for the manufacture of products containing controlled substances, including Schedule II drugs. Our blending and coating capacity is expandable and is currently 600 million patches annually. Prescription patches manufactured by Noven are approved for marketing in over 30 countries in North and South America, Europe, Asia, and Australia.

For additional information, contact Noven Business Development.