Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects

February 26, 2009

READING, England, February 26 /PRNewswire/ –

– Intranasal Apomorphine for the Treatment of Motor Fluctuations in
Advanced Parkinson’s Disease

– Intranasal Diazepam for the Treatment of Acute Repetitive Seizures in

– Phase II Trials on Both Projects to be Initiated During 2009

Archimedes Pharma Limited, the pan-European specialty pharmaceutical
company, today announces positive headline data from its recently completed
proof-of-concept trials for two of its intranasal (IN) development projects.
Both the IN Apomorphine and IN Diazepam Phase I studies showed high
bioavailability, positive pharmacokinetics and good tolerability and
confirmed that each candidate has the potential to replace existing
formulations in high value markets. The agents are being developed for the
treatment of motor fluctuations or “off episodes” in Parkinson’s disease and
Acute Repetitive Seizures (“ARS”) in refractory epilepsy patients

Richard de Souza, CEO of Archimedes, said: “Both these trials have
generated exciting results, highlighting the quality of our development
capabilities and providing further validation of our business model. We look
forward to driving our in-house development projects through to
commercialization to provide an ongoing stream of novel products to our
rapidly growing pan-European commercial organisation in therapeutic areas in
which we already have an established presence. The strength of this strategy
is exemplified by our lead development project, NasalFent(R), an intranasal
fentanyl spray that has recently shown a best-in class profile for
breakthrough cancer pain in our Phase III programme and the regulatory
filings for which will begin in the first half of 2009.”

Archimedes’ IN Apomorphine and IN Diazepam have been developed by
applying the world class drug delivery expertise of its subsidiary Archimedes
Development limited which also developed PecSys(TM), the proprietary
technology which underpins NasalFent.

Dr Alan Smith, VP Research & Development, at Archimedes, commented:
“These results illustrate the expertise at Archimedes in taking well
characterized therapeutic compounds such as apomorphine and diazepam and
creating innovative, tangible products with clear potential advantages over
currently marketed agents. We look forward to taking these exciting
therapeutics into further trials.”

Archimedes will now begin preparations to take both IN Apomorphine and IN
Diazepam into further clinical trials and management anticipates the
initiation of Phase II studies later in 2009. If development proceeds to
plan, both IN Apomorphine and IN Diazepam could be approved in 2012.

IN Apomorphine – trial design, results and development rationale

The pharmacokinetics (PK) and safety/tolerability of Archimedes’ IN
Apomorphine formulation (3.5 mg dose), compared with a commercial
subcutaneous (SC) injection (2 mg dose), were demonstrated in a Phase I proof
of principle study in 12 healthy volunteers. IN Apomorphine was well and
reproducibly absorbed via the nasal route with therapeutically relevant
plasma concentrations reached within 10 minutes of administration. The
product showed good nasal tolerability and systemic adverse effects were
comparable to those after SC injection and typical of adverse effects that
commonly occur in apomorphine naïve individuals. The significant and
reproducible plasma levels with IN Apomorphine are consistent with a
potential for rapid treatment of hypomobility in advanced Parkinson’s disease
(PD) and illustrate the product’s potential to replace apomorphine injections.

Apomorphine, a potent dopamine agonist, is currently the only drug
approved specifically for the treatment of acute motor
fluctuations/hypomobility (freezing or “off” episodes) in patients with
advanced Parkinson’s disease. Presently, apomorphine is administered by
intermittent SC injection usually via a pre-filled autoinjector pen, or by
continuous (waking day or round the clock) SC infusion. Drawbacks associated
with SC therapy for patients and carers include the need for multiple
injections, which can be painful and are often associated with the
development of troublesome nodules at the injection site, and the requirement
for a degree of manual dexterity that some PD patients find difficult. IN
Apomorphine, an innovative aqueous nasal spray formulation has been designed
to counter these issues by offering improvements in convenience and
acceptability to both patients and physicians combined with ease/speed of use
and rapid onset of action. Archimedes’ unique formulation is based on
enhanced solubility providing a stable, high strength solution, allowing a
wide range of doses to be administered in a small spray volume using
conventional, approved nasal spray devices.

Archimedes estimates that there around 1.3 million Parkinson’s disease
patients in the US and Europe, of which around 250,000 suffer from acute
“off” episodes.

IN Diazepam – trial design, results and development rationale

A Phase I study in 12 healthy adult volunteers was conducted to assess
the bioavailability, PK and safety/tolerability of a single 5 mg dose of
Archimedes’ IN Diazepam compared to commercially available intravenous (IV)
and rectal formulations (2 mg and 5 mg doses respectively). Diazepam was
extensively and rapidly absorbed from the IN product and demonstrated an
enhanced bioavailability compared to the commercial rectal formulation, with
maximum plasma concentrations achieved in approximately 15 minutes. The
product was well tolerated and no clinically significant safety issues were
reported. Rapid and reproducible delivery via the nasal route illustrates the
potential of IN Diazepam to replace IV and rectal products.

Diazepam, a long established benzodiazepine, is available in IV and
rectal forms for the treatment of epileptic seizures including Acute
Repetitive Seizures “ARS” (also described as Bouts of Increased Seizure
Activity, ‘BISA’ or ‘breakthrough seizures’) in patients with refractory
epilepsy. These two routes of administration are associated with significant
logistical and compliance issues, especially as treatments are usually
administered while a patient is having a seizure. Archimedes IN Diazepam is a
simple low-volume solution, which can be delivered in simple, off-the-shelf
nasal spray devices offering similar efficacy but potentially greater
convenience and acceptability compared to IV and rectal diazepam. IN diazepam
has been developed as a ready-to-use disposable nasal spray that can be
carried by the patient for immediate use when required.

Archimedes estimates that ARS/BISA affects over 1 million patients in
Europe and the US.

About Archimedes Pharma

Archimedes Pharma is a fast-growing specialty pharmaceutical company
marketing an expanding portfolio of products to specialist prescribers in
Europe whilst building a platform for its future growth through the
development of a high-value pipeline from its world-class drug delivery

Archimedes has an established commercial presence in major European
markets and is growing through in-licensing and acquisition of late stage and
approved products. It is also building a robust pipeline of in-house products
in pain, Parkinson’s disease and critical care by applying its drug delivery
technologies to proven molecules which have yet to achieve their market
potential due to their current mode of delivery. This approach greatly
reduces the development risk while promising significant clinical – and thus
commercial – benefits. Archimedes’ lead product NasalFent(R), uses the
Company’s PecSys(TM) technology to produce fast, effective and convenient
treatment for breakthrough cancer pain. Results from Phase III trails show
NasalFent to have class-leading characteristics. This product, which has
blockbuster potential, is targeted for launch in 2010 and Archimedes will
market it through its own sales teams in Western Europe. Archimedes’ other
pipeline products include intranasal Apomorphine for advanced Parkinson’s
disease and intranasal Diazepam for acute repetitive seizures.

Archimedes technologies – ChiSys(R), PecSys and TARGIT(R) – are also used
in a number of partnered products in late-stage clinical development.
Additionally, Archimedes’ innovative drug delivery technology has proven
potential for vaccine delivery with pre-clinical and clinical studies of
nasally administered vaccines demonstrating enhanced immune response.

Archimedes marketed products include Gliadel, a biodegradable wafer
impregnated with an anti-cancer drug, carmustine, for high-grade glioma;
Zomorph and Oramorph both morphine products for pain; and Pabrinex, a high
potency vitamin formulation used to treat the symptoms of malnutrition
especially in patients with acute alcohol problems.

Archimedes Pharma is UK based, with offices in Reading and development
facilities in Nottingham. Further European commercial operations are
established in Ireland, France and Germany. The Company was founded in
December 2004 and is backed by Warburg Pincus, a leading private equity
investor with extensive experience in the healthcare sector. In 2008,
Archimedes had sales of GBP20.4 million.


Archimedes Pharma: Michael Clark, +44-118-931-5050

Citigate Dewe Rogerson: Chris Gardner/ Heather Keohane, +44-207-638-9571
(media enquiries)

Trout International LLC: Mike Booth, +44-20-7936-9326 (investor enquiries)

For more information on Archimedes, visit: http://www.archimedespharma.com

SOURCE Archimedes Pharma Limited

Source: newswire

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