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Needle-free
injections finally become a reality
Is
controlled release to become obsolete?
The
market demand for non-invasive drug delivery has finally been met,
with the launch January 10th 2001 of Bioject’s ‘cool.click’
formulation of Saizen (rh somatropin). This needle-free delivery
system of Ares-Serono’s growth hormone is entering a market
with high demand and challenge products that are injected using
traditional needles. The Canadian launch follows a roll out in the
US in late 2000 and cool.click Saizen is expected to be launched
in further markets soon.
However, if needle-free systems prove to offer the promised advantages
of reduced pain and increased patient compliance, will anyone use
needle-delivered controlled release formulations?
Datamonitor’s new report, Drug Delivery: A Key Company and
Market Analysis, reveals: Cool.click Saizen marks the end of promises
and the start of actual results for needle free drug delivery.
Reduce pain, increased compliance: why would anyone want to inject
even a controlled release formulation?
Cool.click
Saizen marks the end of promises and the start of actual results
for needle free drug delivery Companies focused on injectable drug
delivery have been pursuing two different development strategies:
either improving bioactivity in the body or delivering a therapeutic
dose without traditional needles. Bioject’s cool.click system
uses spring powered compression to force a high pressure liquid
jet through the skin. This offers significant safety benefits compared
to penetrating the skin with a needle and reduces patients’
apprehension of pain, leading to increased patient compliance.
Bioject’s first approved product is a formulation of Ares-Serono’s
growth hormone, Saizen (rh somatropin), which received US approval
in June 2000 and Canadian approval on January 10 2001. Growth hormones
are a friendly market for launching needle-free delivery, as the
majority of indications are pediatric and need long term dosing.
Parents are often deeply reluctant to commit their children to the
trauma of regular injections and, with the need for long term daily
dosing, this is compounded. Therefore, a needle-free formulation
could prove more popular. However, although the theory has been
heavily marketed, commercial success may prove trickier. Safety
benefits are obvious, but the reduction in pain may be more hoped
for than real, and the system is physically bulky and priced at
a premium compared to more traditional injections.
Regardless of the long term outcome of needle-free delivery, for
the next few years a large number of products that have previously
been administered using a needle are due to move from development
onto the market. For example, PowderJect’s Lidocaine (lidocaine)
anaesthetic, a needle free injection, is in phase II trials. Such
launches will drive sales of this drug delivery market and will
ensure it remains a high profile arena.
Reduced pain, increased compliance: why would anyone want to
inject even a controlled release formulation?
Drugs
delivery companies specialising in injectable formulations not only
develop needle-free delivery but are also developing and marketing
products with extended and controlled bioactivity but delivered
using a traditional injection. By focusing on improving bioactivity
in the body, companies like Takeda have developed long acting or
controlled release formulations of marketed products as a means
to guard against patent loss or to differentiate a product from
otherwise similar competitors. For example TAP’s LupronDepot
(leuprolide acetate), indicated for prostate cancer, employed a
formulation which requires injection on a 16 week cycle as a way
of overcoming increasing competition from AstraZeneca’s Zoladex
(goserelin).
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