Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects
READING, England, February 26, 2009 /PRNewswire/ --
- Intranasal Apomorphine for the Treatment of Motor Fluctuations in Advanced Parkinson's Disease
- Intranasal Diazepam for the Treatment of Acute Repetitive Seizures in Epilepsy
- 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 respectively.
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 naÃ?Â¯ve 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 technologies.
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
CONTACT: Enquiries: 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)
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Posted: February 2009