| 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; See
www.medtronic.com.. |
| 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.
This brief review of select convergent product
development company activities was written by Timothy Tankosic, M.D.
He may be contacted via e-mail at
tt888@aol.com. |
