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ACCENTIA BIOPHARMACEUTICALS
www.accentia.netAccentia Biopharmaceuticals is a vertically-integrated biopharmaceutical company formed by the Hopkins Capital Group and its affiliates.
Accentia Biopharmaceutical's business model represents a disruptive innovation in and of itself. We engineered Accentia Biopharmaceuticals to have the favorable investment risk profile of a specialty pharmacehutical company but with the return potential of a biotech. As such, it is a novel biopharmaceutical company.
Essentially, we have created a solid foundation of value built around our currently marketed specialty pharmaceuticals, enhanced that valuation by establishing a robust pipeline of near- and intermediate- term, patent-protected, specialty products with low-risk regulatory and commercialization strategies, and deployed a sophisticated suite of core competencies to guide our product selection, product development, regulatory pathways, pricing, and marketing. To this, we have added two late-stage blockbuster therapeutics which have substantial clinical evidence of safety and efficacy.
This Company is at the nexus of specialty pharmaceuticals and customized biologics, and represents a new pharmaceutical entity that combines the best aspects of the specialty pharmaceutical and biotech business models while minimizing their negative attributes.
The Accentia Strategy: Specialty Pharmaceuticals Combined with Biotech
Accentia consists of three wholly-owned subsidiaries, and a majority, controlling interest in a fourth company. Together, these assets provide for a comprehensive ability to commercialize biopharmaceuticals, in particular commercialization of "targeted" therapeutics in patent-protected drug delivery technologies related to respiratory, oncology and critical care.
Accentia’s vertical integration allows careful risk management while reaping the rewards of innovation. The company offers the investment security of a specialty pharmaceutical model with the investment upside of a biotech model.
- Accentia has deep expertise and years of combined experience in providing pre-market, commercialization and biologic manufacturing capabilities.
- The company has a wide range of approved products and near-term products to sustain aggressive biotech development and licensing.
- Accentia continuously seeks licenses to late-stage pharmaceutical and biologic “blockbusters” addressing unmet needs and with extensive clinical experience supporting safety and efficacy.
The company’s strategy is based on identification of late-stage, targeted therapies that have proven efficacy in early trials and meet an unmet need in patient treatment and disease, and focuses on:
- Acquisition of fully operational companies with proven expertise and existing revenue in the needed areas of commercialization, manufacturing and market research;
- Integration of those companies into a single biopharmaceutical company;
- Extension of the pipeline through acquisitions avoiding the high risk of bench science research.
- Use the existing revenue streams from those companies to fund current and mid-term development products
- Fund long-term strategies with revenue from near term pipeline products, license revenue from European commercialization rights to pipeline products, and investment funding.
Accentia has two major therapeutic products under development:
Biologics: BIOVAXID™ Exclusive licensee to autologous (personalized) vaccine (immunotherapeutic) for non-Hodgkins lymphoma developed at National Cancer Institute. BIOVAXID uses each patient’s tumor to make a customized vaccine for them, with little to no toxicity. The vaccine is an extremely targeted technolog, exploiting the fact that vaccinated patient’s immune system seek and destroy only tumor cells. Long term follow up of Phase II patients suggests at least a 50% cure rate for this vaccine. BIOVAXID is currently in a Phase III registration study started by NCI.
Specialty Pharmaceuticals Accentia is the exclusive licensee to the Mayo Clinic patented technology on treatment of chronic rhinosinusitis using the lead anti-fungicidal, amphotericin B. This debilitating condition affects over 37 million patients in the USA, and has no approved pharmaceutical.
Accentia’s Services and Current Operations
From its diverse subsidiaries, Accentia combines all stages of pharmaceutical development into a single core which provides a current revenue stream and manages the company’s advanced targeted therapeutics development from clinical trials to post-approval marketing.
- Pharmaceuticals sales and marketing
- Product acquisition and business development
- Product launch
- Distribution
- Biologics and manufacturing
- Clinical trials
- Product positioning
- Outcomes assessment and research
- Reimbursement analysis
- Managed care (MC) formulary development and MC contracting
- Medical communications
Biologics Development and BIOVAXID
Accentia’s biologics division specializes in contract manufacturing of biologics, from protein therapeutics to monoclonal antibodies, cytokines, and cell amplification technologies, including autologous stem cells. The company’s patented production technology, a hollow-fiber bioreactor, makes it cost-effective to develop customized biologics. The division currently manages the National Cell Culture Center for the National Institutes of Health.
The company has licensed from the National Cancer Institute a revolutionary new targeted therapeutic, BIOVAXID. This kind of customized vaccine is the ultimate targeted therapeutic, delivering the promise of a non-toxic “cure” and featuring an ability to seek out tumor cells wherever they are lurking in the body and providing an ongoing surveillance and attack system for early tumor recurrence. Accentia’s hollow fiber bioreactor enables production of these customized therapeutics.
Development Services
Accentia’s development group provides in-house analysis and for-contract healthcare market research on product candidates including pharmacoeconomic analysis and valuation, product positioning, market assessment and development services. In an era in which payors are increasingly challenging the pricing of expensive therapeutics, the company has in-house access to expert development of sophisticated economic modeling and clinical services.
Sales/Marketing
Accentias’ specialty pharmaceutical product sales and marketing force has years of proven ability to deploy pharmaceuticals successfully.
The company currently markets eleven pharmaceutical products, and maintains a strong revenue stream from contract manufacturing and clinical development services provided by its subsidiaries.
Accentia’s Product Pipeline
The Company an extensive product pipeline with several pharmaceuticals on the market and under development:
- Autologous vaccine for follicular non-Hodgkin’s lymphoma
- Phase III
- Amphotericin B for chronic rhinosinusitis
- Phase II/III
- MD Turbo – Unique delivery device for corticosteroids and bronchodilators
- 9 pipeline products for pain management
- Submissions Nov 04 through June 05
- 1 pipeline product for emesis
- Submission Jan/Feb 05
The Future
Accentia Biopharmaceuticals brings together specialty pharmaceuticals and customized biologics into a single company, and has an extraordinarily sophisticated suite of core competencies, experienced management, and a growing portfolio of highly-valued biopharmaceuticals.
BIODELIVERY SCIENCES INTERNATIONAL, INC.
www.bdsi.comPatented technology that can orally-deliver drugs that normally require parenteral administration such as insulin. Thus, by using this oral delivery system, BDSI can make an off-patent, generic injectable (eg. Amphotericin B, Vancomycin, calcitonin, etc) an orally delivered, patent-protected branded pharmaceutical. Importantly, the BDSI technology eliminates almost all the risk associated with new drug development. Moreover, many new biotech products are large molecules that normally require parenteral administration. The BDSI delivery system would expand the marketplace for these drugs by eliminating the need for painful injections. Additional applications include gene therapy and vaccine therapy.
BIOVEST INTERNATIONAL, INC.
www.biovest.comBiovest International develops personalized immunotherapies for life threatening cancers of the blood system. Biovest is the holder of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the commercialization of BiovaxID, a personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma. This therapy, referred to as BiovaxID, is currently in a phase 3 pivotal trial at 24 major medical institutions in the US.
Biovest has a long history of manufacturing biological drugs from small research scale quantities to large volumes for Phase 1 and Phase 2 clinical material. In addition, Biovest International develops, manufactures, and markets patented cell culture systems and equipment, including the innovative AutovaxID instruments, to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide.