Drug Delivery
drugs using its proprietary PharmFilm
pulmonary products
time. And as trandermally delivered drugs
technology. In June it licensed exclusive US
Inhalable products that deliver bronchodilators
avoid systemic metabolism, they have the
marketing rights to its thin-f_i lm formulation
and corticosteroids for asthma or COPD
potential to show higher and more uniform
of ondansetron to Strativa Pharmaceuticals,
have been around for many years, but new
bioavailability and fewer adverse events.
a subsidiary of Par Pharmaceutical. MonoSol
technologies are still being developed.
Thus the transdermal drug delivery market
will receive developmental milestones and
One company specialising in drug delivery
has also witnessed a rapid expansion, with
sales-based revenues from Strativa.
technologies for respiratory conditions is
continued demand for products, such as
Another deal clinched in 2008 on the oral
nicotine patches, hormone therapies, pain
Italy’s Chiesi Farmaceutici, which is developing
drug delivery front was that between the UK
relief and other treatments.
Atimos (formoterol), an inhaled, long-acting
f_i rm Archimedes Pharma and Italy’s Molteni
The main challenge to transdermal drug
bronchodilator therapy using its HFA Modulite
Farmaceutici, the former granting the latter
delivery is, of course, the permeability of the
aerosol technology, for the treatment of
company German rights for Oramorph, the
skin, but new technologies can overcome this
asthma and COPD. The Modulite technology,
only oral liquid immediate-release morphine
barrier by employing pharmacologically inert
which uses an HFA propellant, has a fast
sulphate product available in Germany in
adjuvants. Companies are developing novel
onset but is long-acting. The aerosol particles
patient-friendly unit dose vials. The product
formulations based on active transdermal
administered by the inhaler are made extra
acts to quickly initiate morphine analgesia in
drug delivery, such as iontophoresis,
small, enabling the disease to be more
patients with cancer pain.
electrophoresis and thermal activation.
uniformly treated, according to the company.
Encore Therapeutics’ post-surgical pain
injectables
In July Chiesi’s novel technology attracted the
product, ETI-211, has been formulated using
New methods of injecting drugs are being
attention of Nycomed Canada, which licensed
the company’s proprietary phospholipid
developed to enhance patient compliance;
Atimos to advance its position in the Canadian
gel technology. The product works by
this is achieved through device technologies,
respiratory market.
delivering a sustained-release formulation
such as needle-free injection techniques
Another respiratory disease deal was that
of ropivacaine subdermally at the surgical
and implants, by developing sustained/
signed between SkyePharma and Kyorin site. It has the potential to reduce or stop
controlled-release formulations of drugs and
Pharmaceutical back in April, giving the post-surgical pain for up to 72 hours,
by PEGylation. The injectables space is being
Japanese f_i rm exclusive development and Encore says. As it acts locally, potential side-
driven by increasing patient awareness, a
distribution rights to the asthma treatment effects associated with systemic opiate or
stronger emphasis on healthcare providers’
Flutiform. Flutiform is a f_i xed-dose combination non-steroidal anti-inf_l ammatory drugs are
safety and a range of new drug delivery
of formoterol and f_l uticasone in a metered-
avoided.
technologies.
dose inhaler. SkyePharma was eligible to
The Israeli pain management company
One company working on needle-free
receive up-front and development milestones
PainReform entered into its f_i rst major
technologies is Oxford (UK)-based Glide
of “several millions of pounds” plus royalties as
licence agreement in July with Encore,
Pharma. Its Glide SDI (solid-dose injector)
part of the deal, thus helping it to ref_i nance its
which gave PainReform exclusive North
system administers solidif_i ed doses of
debt obligations.
American rights to ETI-211. The deal also
biologicals, small molecules and vaccines
Recently, companies have also started to
gave PainReform the option to expand the
non-invasively via a spring-loaded, handheld
exploit the lungs’ ability to transfer molecules
agreement to other countries, including
actuator. Glide says that vaccines delivered
into the bloodstream for other conditions
Japan and the EU.
using its SDI device have enhanced properties
including pain management, cystic f_i brosis and
Also collaborating on the transdermal
compared with those delivered by needles.
diabetes.
delivery front in 2008 was the Japanese
In June, Glide secured two separate
Alexza Pharmaceuticals, for example, has
company Hisamitsu Pharmaceutical, which
signed a co-marketing agreement with
biologics agreements with unnamed partners developed a condensation aerosol technology,
Kyowa Hakko in June for its fentanyl citrate
– one a vaccine company and the other a Staccato, which works by rapidly vapourising
transdermal tape for cancer pain. Under
listed US biotech f_i rm, to evaluate its needle- a drug to form a small particle aerosol
the agreement, Hisamitsu was to retain the
free technology. Glide signed an earlier deal in optimal for rapid-acting systemic delivery.
marketing authorisation for the product,
February with another pharma player for the At the start of 2008, the company signed a
HFT-290, with the partners carrying
delivery of a branded peptide; in total it has North American licence and development
out distribution and marketing activities
branched its technology out to f_i ve separate partnership with Endo Pharmaceuticals
independently.
companies. for AZ-003, a Staccato version of fentanyl,
New drug delivery technologies have
Another company developing needle- which has completed Phase I clinical trials
armed companies with opportunities to
free technology is Anesiva, whose single- and is in development for the treatment of
extend the lives of products nearing patent
use device Zingo (lidocaine hydrochloride breakthrough pain in both cancer and non-
expiry, thus sustaining and increasing their
monohydrate) uses a blast of helium to cancer patients. The product is designed for
revenues, as well as attracting attention from
deliver lidocaine powder into the skin to treat deep lung delivery of excipient-free fentanyl
potential collaborators. And if the f_l urry of
pain associated with peripheral intravenous
in a temper-resistant reusable controller using
drug delivery-focused business deals that
insertions or blood draws. Anesiva says this
disposable multiple-dose cartridges. were made in 2008 is anything to go by,
easy-to-administer method gives rapid onset
Alexza recently announced that its Staccato then 2009 looks set to provide an equally
of pain relief (one to three minutes after
version of loxapine (AZ-004) exerted positive lucrative environment for business exchange.
administration). The company expanded
effects in schizophrenic patients with acute
on an existing marketing and distribution
agitation, in a Phase III trial.
agreement with Sigma-Tau in May, giving
Sigma-Tau the right to distribute the product transdermal delivery
Caroline Richards is a
in all major European markets, except the UK If drugs that traditionally were administered
reporter for Scrip.
and Scandinavia. The deal included additional by injection could instead be delivered
up-front payments to Anesiva and transfer transdermally, and thus painlessly, patients
price, as well as a milestone payment. Zingo would in turn be more likely to take the
was launched in the US in late June. right amount of their medicines at the right
www.scripnews.com/supplements Scrip 100
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