Business Strategy

Product Development & Co-Development

Our highly talented team of scientists have successfully launched and marketed NDAs, 505(b)(2)s and complex generic products across a wide range of dosage forms and technology platforms. Our trained professionals have the know-how to go from selection of a lead candidate to commercially launching a product, which includes a complete product development life-cycle – a must-have in this highly competitive marketplace.

Our scientific staff is keenly aware of protecting our intellectual property by means of patent protection, and, in some cases, challenging existing patents to bring patients desperately needed new products to the marketplace. Our co-development model looks to partner with companies who have synergies with us, and that specifically have disruptive technologies and breakthrough innovations.

Benefits for our co-development partners are that they get our highly talented and experienced team who have great track records leveraging our partner’s technologies with a speed of execution that enables us improve the health care of millions of patients. That, after all, is Nivagen’s primary objective: to improve the healthcare of millions of patients and create a better world for all.

Acquisition and Licensing

The US generic market is large and growing. The market is complex and fragmented, requiring a variety of infrastructures to reach all major channels and segments. This is usually a difficult process for all except the few big pharmaceutical players. Nivagen has exceptional market access and is looking to in-license products from pharmaceutical companies whose products are either already FDA approved, or are in the developmental stage and in need of Nivagen’s expertise to launch into the US market.

Possible Frameworks for Acquisitions and In-licensing:

CROs

If you have formulations ready, Nivagen can provide market research on potential market size and the competitive environment. Nivagen can acquire your formulation, do the BE study, FDA submission and then commercialize the product. If you have ANDAs ready to go, Nivagen is always actively looking to acquire and launch new products.

CRAMs

If your formulation is ready for FDA filing, we can provide regulatory assistance and commercialize the product for you. We can efficiently manage the FDA approval process and shorten the time to launch new products. We are open to each and every possible arrangement.

Partnerships

Nivagen believes the success of our partnerships is dependent on the success of each of our partners – meaning our partners’ success is crucial to our success. To this end, Nivagen is actively looking for development and co-development partners. Beginning in the lab, to the logistics team, to the contract and finance experts.

The pharmaceutical industry is highly research and innovation intensive. Nivagen partners with specialized and industry-leading research labs around the world to co-develop branded and complex generic products on a shared risk and profit basis. Nivagen forms strategic alliances with leading pharmaceutical industry participants to co-develop products from any stage of development, by providing scientific, financial, and regulatory support to complete the filing of NDAs/ANDAs, and to subsequently commercialize the products in North America.

Working with Nivagen allows you to have access to our market research which is the key in helping you identify niche products with attractive markets and margins. We then invest in product development and the commercialization in the US market.