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Our Business Strategy
Our goal is to acquire, develop, and commercialize innovative late-stage biopharmaceutical and medical device products that offer the potential for superior efficacy and safety as compared to competitive products and that address significant unmet medical needs. To achieve this goal, the four key elements of our strategy include:
Completing clinical development and obtaining regulatory approval for SinuNase and BiovaxID:
- We intend to complete our Phase 3 clinical trials for SinuNase and, through our majority-owned subsidiary, Biovest International Inc, BiovaxID and to aggressively pursue regulatory approvals for both products in the US and EU.
Identifying and acquiring additional late-stage clinical products, especially ones that are based on already approved drugs for new indications and/or new formulations pursuant to issued patents:
- We intend to pursue the acquisition of additional late-stage products that could increase the value of our development pipeline and complement our existing products and product candidates. This may consist of product or technology acquisition, in-licensing, or company acquisitions. Although our primary emphasis in acquiring new products will be in the respiratory and oncology therapeutic areas, we will consider products in other therapeutic areas that meet our stringent criteria. By focusing on the development and commercialization of already approved products in new formulations or for new indications pursuant to issued patents, Accentia believes that it can expand its product offerings with less risk, less expense, and less time than required for new chemical entities (NCE).
Leveraging our broad range of internal capabilities to support our ongoing development and commercialization efforts:
- We believe that our broad range of in-house capabilities provides a platform on which to commercialize new biopharmaceuticals and medical device products. In particular, we have demonstrated competencies in product selection, licensing, contracting for manufacturing, regulatory approvals in the US and EU, pricing, reimbursement, contracting with Medicaid, Medicare part D, and managed care organizations.
Pursuing strategic relationships on a selective basis for product development or distribution:
- We may from time to time consider entering into strategic relationships with third-parties in order to facilitate the development of new products and to market and distribute our approved and pipeline products. Such strategic relationships could be in the form of product sale, licensing, distribution arrangements, spin-offs, co-promotions, or joint ventures. At the present time, we intend to promote SinuNase to ENTs and Allergists in the US using our own respiratory sales force and to seek co-promotion partners to address the larger patient population under the care of primary care physicians. During 2006, we revised our commercialization agreement with Biovest on Biovaxid by converting it to a passive royalty on net sales worldwide, thus enhancing Biovest’s ability to attract financing and strategic partners.
We evaluate on a continuing basis, and as appropriate, adjust, our business strategy as discussed above in light of market conditions and other relevant factors such as available financing, opportunities for strategic relationships, and changes impacting our current and future products and product candidates.
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