Drug Delivery
SHARP FOCUS: Novel drug delivery technologies provide effective
life cycle management strategies for products nearing patent expiry
Deals def_i ne drug delivery space in 2008
The diverse and expanding drug delivery sector provided a hotbed of activity for companies wishing to
exchange business during 2008, with a number of important deals proving there is much to be gained
f_i nancially by players willing to invest in new and innovative technologies, writes Caroline Richards
D
evelopments in drug delivery have Pharmaceuticals is developing an oral insulin six-month sustained-release formulation
given rise to a range of innovative capsule for type I diabetes, ORMD 0801, of Decapeptyl (triptorelin), a luteinising
formulations of new and existing which has just entered Phase IIa trials. hormone releasing hormone agonist, being
products, from those that can be swallowed, More unusual routes of administration, a prime example. The product has just been
inhaled and injected, to medicines which are such as into the eyes, have been exploited f_i led in Europe for the treatment of locally
delivered intranasally, to the back of the eyes for ocular conditions like age-related macular advanced or metastatic hormone-dependent
or via a patch on the skin. Changing the way degeneration (AMD). Intravitreally-injected prostate cancer.
an existing medication is administered can compounds, such as Novartis Ophthalmics’ However, it is not all plain sailing in drug
have a profound effect on the convenience Lucentis (ranibizumab), have been developed delivery, as the f_l op of Pf_i zer’s inhaled insulin,
or effectiveness of the product, such as to replace intravenous products like QLT’s Exubera, in 2007 showed. More recently, the
greater bioavailability, enhanced absorption, Visudyne (verteporf_i n). f_i rst iontophoretic powered transdermal
faster onset of action and an improved Intranasally delivered drugs offer the fentanyl patch, Janssen-Cilag’s Ionsys, has run
dosing schedule, in turn leading to improved potential advantages not only of better
into problems associated with self-activation.
patient compliance and treatment success patient compliance, but also improved
rates. eff_i cacy by treating a condition at its source.
deals and more deals
Novel oral formulations coming onto the With this in mind, the UK CRO Retroscreen
Over the past 12 months, a series of
market include dissolve-in-the-mouth tablets, Virology is gearing up for its f_i rst clinical
collaborations, alliances and joint ventures
such as Orexo’s sublingual fentanyl tablet study of a novel, culture-based avian
have been f_i nalised to accelerate the
Abstral. The rapidly dissolving nature of the inf_l uenza (H5N1) intranasal vaccine, which
development of new drug delivery
product provides a signif_i cant advantage to is intended to halt the virus at the point of
formulations. Some of the more important
patients with breakthrough cancer pain as entry – the nose.
include oral f_i lm, needle-free injections and
it enters the bloodstream more quickly and Less frequent dosing has been inhaled vapours.
has a more predictable onset of action than accomplished largely by the advent of The Swiss company Applied Pharma
other products. extended-release formulations. Swiss-based Research, along with its joint venture
Oral formulations of drugs which would Biopartners, for example, is developing a partner Labtec, licensed APR’s thin-f_i lm oral
otherwise be injected have the potential to once-weekly sustained-release recombinant formulation (RapidFilm) of the anti-emetic
improve on current treatment regimens; for human growth hormone. The company has ondansetron to BioAlliance Pharma in an
example diabetics might welcome pain-free just announced three-year safety and eff_i cacy exclusive €6 million deal in August. The
alternatives to insulin injections. Phase II/III data for the product, showing it product dissolves rapidly on the tongue
Generex Biotechnology’s oral insulin has comparable eff_i cacy to existing, daily without the use of water, and it is hoped
spray, Generex Oral-lyn, was licensed to growth hormone products. Even longer- that this will improve patient compliance.
Dong Sung Pharmaceutical for the South acting formulations have also helped address The US company MonoSol Rx is also
Korean market in August 2008. Oramed the issue of patient compliance, with Ipsen’s developing thin-f_i lm formulations of existing
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