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By Timothy Tankosic, M.D.
Convergent therapeutics are drug-device combinations that may be defined functionally as the site-specific delivery of a therapeutic modality (or the site-specific availability of compounds in convergent diagnostic tests). Convergent product development is gaining momentum because it may provide answers to complex medical problems with large market potentials. Table 1 lists 15 companies and briefly describes their activities in convergent product development. Much of the information below was obtained at Convergence 2005: The Drug/Device Summit, a conference held recently in Pittsburgh, PA. Organizers included Windhover Information, Inc. (Norwalk, CT), Pittsburgh Life Sciences Greenhouse (Pittsburgh, PA), and others. For a review of convergent product development issues and companies not addressed below, see "Drug-Device Convergence: Development Challenges and Market Opportunities" in the June issue of Drug & Market Development.
Table 1
Convergent Product Development: Select company activities
| Company | Convergent product development |
| Alexza Molecular Delivery Corp. (Palo Alto, CA) | Cigarette lighter-sized, Staccato™ drug delivery device vaporizes compounds into inhalable condensation aerosols by rapid heating; See article in June 2005 Drug & Market Development. |
| ARC Pharmaceuticals, Inc. (Vancouver, BC) | Initial focus on the prevention of surgical adhesions the treatment; R&D also in the treatment of rheumatoid arthritis, osteoarthritis, and psoriasis; See text. |
| Celleration, Inc. (Eden Prairie, MN) | Low frequency therapeutic ultrasound (US) platform; MIST Technology™ utilizes US waves to produce an energized mist of sterile saline in a non-contact fashion; Initial focus on chronic diabetic foot ulcers. |
| Five Prime Therapeutics, Inc. (S. San Francisco, CA) | Improved efficiency, speed and quality of discovery of protein and antibody therapeutics; Validated hits in oncology and immune disorders, screening in type 2 diabetes, and early discovery in regenerative medicine. |
| FlowMedica (Fremont, CA) | Targeted renal therapy; Direct delivery of therapeutic agents to the kidneys via the renal arteries; Focus on radiocontrast nephropathy (resulting from radiocontrast agents used during coronary interventional and diagnostic procedures) and cardiorenal syndrome (fluid overload associated with CHF); Benephit System allows catheterization of both renal arteries. |
| Interface Biologics, Inc. (Toronto, Canada) | Surface enhancement of biomaterials to exhibit increased blood and tissue compatibility; Applications in controlled drug delivery and tissue regeneration; Advancing from biomaterials to bioproducts company; Spin-off from the University of Toronto, the Innovations Foundation. |
| MAP Pharmaceuticals, Inc. (Mountain View, CA) | Tempo™ inhaler: pressurized metered dose inhaler (pMDI); Tempo™ platform for development of high-value inhaled drugs uses proprietary formulations and drug delivery expertise; CNS (migraine) and lung (asthma) disorders. |
| Medtronic, Inc. (Minneapolis, MN) | A leader in several areas of convergent products, including neurological, spinal, and ENT surgery products |
| Neural Intervention Technologies, Inc. (Ann Arbor, MI) | Embolic materials, ALGEL™-I and -II, for cerebral arteriovenous malformations and aneurysms; Other targets include uterine fibroid embolization, treatment of endoleaks associated with abdominal aortic aneurysms, and liver tumors. |
| Pegasus Biologics (Irvine, CA) | OrthADAPT™ Bioimplant, for repair and reinforcement of soft tissue in orthopedic and sports medicine applications, and DurADAPT™ to repair dura mater after craniotomy, awaiting FDA approval; Graft for anterior cruciate ligament reconstruction; Technologies for stabilization "crosslinking," and terminal sterilization of biological tissues without adversely affecting the tissue. |
| Pittsburgh Life Sciences Greenhouse (Pittsburgh, PA) | Pittsburgh Greenhouse funded $100 million: $30 million from tobacco industry settlement, $70 million from private sources; Focus on convergent and tissue engineering product development; 16-company incubator. |
| pSivida, Ltd. (Western Australia) | BioSilicon™ biomaterial is a nanostructured form of elemental silicon; Applications include controlled release drug delivery, devices, and diagnostics; Therapeutic areas: targeted cancer therapy (e.g., brachytherapy and localized chemotherapy), orthopedics, and tissue engineering. |
| SurModics, Inc. (Eden Prairie, MN) | Surface modification and drug delivery (polymer matrix technology) for device and biomedical applications; Bravo™ drug delivery polymer matrix is used in the Cypher™ drug-eluting stent from Cordis (Johnson & Johnson company) and in the InnoRx ophthalmic helical coil. |
| TransForm Pharmaceuticals, Inc. (Lexington, MA) | Optimizes product performance through high-throughput form and formulation experimentation technologies and informatics; Formulation/excipients of small molecule drugs can affect stability, solubility, rate of onset, and bioavailability; For biologics and vaccines, activity, yield, and efficacy may be affected; Company acquired by Johnson & Johnson in April 2005. |
| Transport Pharmaceuticals, Inc. (Framingham, MA) | Iontophoretic transdermal drug delivery; Lead product delivers acyclovir for herpes labialis (cold sores) directly to affected skin at concentrations up to 40 times higher than topical formulations; Phase II trials included>300 subjects. |
Source: D&MD
Regardless of the therapeutic market pursued, all companies developing convergent products share a common strategy--the pursuit of products for indications with large market potential that support high-value products. ARC Pharmaceuticals is a University of British Columbia spin-off focused on prevention of surgical adhesions. ARCAD™ liquid instillate is an anti-inflammatory, which is loaded into a polymer barrier as a liquid. Although worldwide sales for this market are only around $300-$500 million per year, the potential for rapid growth is clear because surgical adhesions cause serious medical problems (morbidity and mortality) and may require costly surgical lysing. The current therapy (i.e., inert polymers) is not very effective; therefore, unmet medical need is great. This market condition is somewhat analogous to that of the cardiovascular stent market before drug-eluting stents; that is, serious morbidity and mortality problems caused by stent closure during the first 3 months after placement. Effective prevention of surgical adhesions could lead to the development of a large market for these products, just as the development of drug-eluting stents solved the restenosis problem and created a large market for a new class of products. ARC will seek a large company partner for commercialization of ARCAD. See Table 2.
Table 2
Surgical Adhesions Market
| Market | Market Parameters |
| U.S. and E.U. | 34 million operations per year |
| Annual sales: $300 million | |
| Growth: 20% per year | |
| Projection (2009):>$1 billion | |
| China | 20 million operations per year |
| Estimate: adhesions form in 90% of abdominal procedures | |
| Consequence: adhesions are a leading cause of infertility, organ dysfunction, and failed surgical procedures |
Source: ARC Pharmaceuticals, Inc.; Presented at Convergence 2005: The Drug/Device Summit.
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