ACCENTIA BIOPHARMACEUTICALS

www.accentia.net

Accentia 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.

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BIOVEST INTERNATIONAL, INC.

www.biovest.com

Biovest 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.

BIODELIVERY SCIENCES INTERNATIONAL, INC.

www.bdsinternational.com

Patented 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.

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RETINAPHARMA TECHNOLOGIES, INC.

www.retinapharma.com

This biopharmaceutical company exclusively focuses on therapies and anti-apoptotic therapies for macular degeneration and retinal degenerations. The Company also employs a worldwide, exclusive license to patented technology developed at the Johns Hopkins School of Medicine that provides for unprecedented targeted delivery of drugs in the human body. The leading application of this technology is to the treatment of macular degeneration, the primary cause of irreversible blindness in older adults. The HCG supported the founding and early-stage development of this company since 1998.

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PEN2NET

Pen2Net, Inc is a privately-held company commercializing the patented CompuPen™: a wireless, networkable digital writing instrument. The CompuPen™ is a ballpoint writing pen that effortlessly creates a digital copy of any document created with the pen.

CompuPen™ Bluetooth Wireless Networked Pen Shaped as a regular pen, and capable of writing on regular paper, Pen2Net's CompuPen™ device offers data acquisition, storage, and transmission. With digitized, easy-to-use handwriting acquisition, the technology offers freedom from bulky, stylus-based PDAs and tablet PCs. The CompuPen™ features a regular ballpoint ink cartridge, AA battery, and storage capacity of forty pages of cursive text. The CompuPen™ provides128-bit encryption of the digital copy of the written document with a unique identifier for each pen attached to each file accompanied by date/time stamping as well. The device offers wireless data transfer and readily interfaces with devices supporting the Bluetooth™ wireless protocol.

Unlike competing digital pen technologies, CompuPen™ does not require specially marked paper, special attachments, or special writing pads to capture a digital copy of the document.

Applications include note taking in business and education, documentation of intellectual property, e-commerce, inventory control and healthcare.

Healthcare: MediPen™ Marketing the CompuPen™ as MediPen™, Pen2Net offers for the first time an effortless electronic medical record (EMR). Providers use the MediPen™ to chart as they would with a regular ballpoint pen. The digital copy created by the CompuPen™ enables the comprehensive monitoring of clinical notes. It allows for the capture from primary source documents information about disease incidence, outcomes data, drug side-effects and interactions, prescribing habits, emerging public health problems (eg new communicable diseases), diagnostics including imaging studies, nursing and allied medical services, and medical inventory consumption.

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