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Download the press release in PDF format - Aptar

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PRESCRIPTION DIVISION<br />

PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE<br />

APTAR PHARMA’S ORO-MUCOSAL SPRAY DEVICE CHOSEN FOR SPASTICITY IN<br />

MULTIPLE SCLEROSIS MANAGEMENT<br />

Sativex ® Oromucosal Spray, which uses an <strong>Aptar</strong> Pharma spray pump, is <strong>the</strong> first<br />

approved cannabis-based prescription medic<strong>in</strong>e to be launched <strong>in</strong> Germany <strong>in</strong> <strong>the</strong><br />

field of spasticity <strong>in</strong> multiple sclerosis management.<br />

Louveciennes, France – December 15 th , 2011 – World leader <strong>in</strong><br />

nasal and pulmonary drug delivery devices, <strong>Aptar</strong> Pharma worked<br />

closely with GW Pharmaceuticals to develop <strong>the</strong> mouth spray<br />

device which allows Sativex ® (Delta-9-Tetrahydrocannab<strong>in</strong>ol (THC)<br />

and Cannabidiol (CBD), a cannab<strong>in</strong>oid medic<strong>in</strong>e, to be delivered to<br />

multiple sclerosis (MS) patients suffer<strong>in</strong>g from muscle spasticity.<br />

The adm<strong>in</strong>istration of Sativex ® by oromucosal spray (sprayed <strong>in</strong>to <strong>the</strong> mouth<br />

ei<strong>the</strong>r onto <strong>the</strong> <strong>in</strong>side of <strong>the</strong> cheek or under <strong>the</strong> tongue) provides patients with<br />

a flexible dos<strong>in</strong>g regime, particularly appropriate given <strong>the</strong> variable nature of<br />

both spasticity and multiple sclerosis from patient to patient.<br />

Sativex ® approved <strong>in</strong> Germany & Denmark and soon <strong>in</strong> more EU countries<br />

Sativex ® has recently been approved <strong>in</strong> Germany & Denmark for <strong>the</strong> relief of spasticity associated with<br />

MS. These new market launches follow successful completion <strong>in</strong> March 2011 of <strong>the</strong> European Mutual<br />

Recognition Procedure (MRP) with all six member states <strong>in</strong>volved recommend<strong>in</strong>g approval. Market<br />

launches <strong>in</strong> additional EU countries such as Sweden and Italy are expected <strong>in</strong> <strong>the</strong> months to come.<br />

Sativex ® has also been launched <strong>in</strong> <strong>the</strong> UK, Spa<strong>in</strong> and Canada.<br />

Sativex ® is marketed <strong>in</strong> Europe (exclud<strong>in</strong>g <strong>the</strong> UK) by Almirall S.A. The medic<strong>in</strong>e is marketed <strong>in</strong> <strong>the</strong> UK<br />

and Canada by Bayer Healthcare AG.<br />

A new step forward <strong>in</strong> systemic drug delivery via <strong>the</strong> oro-mucosal route<br />

Estimated at over 2 billion US dollars <strong>in</strong> 2009, <strong>the</strong> world market for nasally/buccally adm<strong>in</strong>istered<br />

systemic drugs has seen strong growth <strong>in</strong> <strong>the</strong> last few years. Systemic nasal sprays <strong>in</strong>clude such<br />

products as Miacalc<strong>in</strong> ® (Calciton<strong>in</strong>) for osteoporosis; Stimate ® and M<strong>in</strong>ir<strong>in</strong> ® (Desmo<strong>press</strong><strong>in</strong>e) for<br />

enuresis; Imitrex ® (Sumatriptan Succ<strong>in</strong>ate) and Zomig ® (Zolmitriptan) for migra<strong>in</strong>e attacks; non-opioid<br />

Sprix ® for post operative pa<strong>in</strong>, and opioid-like Instanyl ® and PecFent ® /Lanzada ® (Fentanyl) for cancer<br />

breakthrough pa<strong>in</strong>. With Sativex ® GW Pharmaceuticals has developed a first-<strong>in</strong>-class treatment for <strong>the</strong><br />

relief of spasticity <strong>in</strong> multiple sclerosis.<br />

Systemic drug delivery via <strong>the</strong> oro-mucusal route has a number of advantages due to fast onset of<br />

action and reduced <strong>the</strong>rapeutic dose as a result of high bioavailability for well formulated selected<br />

compounds. After be<strong>in</strong>g sprayed <strong>in</strong>to <strong>the</strong> buccal cavity and absorbed by <strong>the</strong> mucosa, <strong>the</strong> medication<br />

enters <strong>the</strong> vascular system directly, allow<strong>in</strong>g <strong>the</strong> active <strong>in</strong>gredients to take effect rapidly while m<strong>in</strong>imiz<strong>in</strong>g<br />

<strong>in</strong>tolerable unwanted side effects.<br />

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PRESCRIPTION DIVISION<br />

PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE - PRESS RELEASE<br />

The VP7 spray pump – mak<strong>in</strong>g drug delivery easier and safer while improv<strong>in</strong>g patient comfort<br />

<strong>Aptar</strong> Pharma’s high-performance VP7 spray pump is widely used <strong>in</strong> drug delivery for both systemic<br />

and local treatment via <strong>the</strong> nasal and <strong>the</strong> buccal routes. For Sativex ® , GW Pharmaceuticals selected<br />

<strong>the</strong> VP7 spray pump fitted with a specific buccal actuator of ergonomic design that is comfortable to<br />

use by <strong>the</strong> patient. The VP7 platform is recognized globally for its comfort of use by patients as well as<br />

for its robustness coupled with outstand<strong>in</strong>g dose accuracy and spray performance.<br />

“GW Pharmaceuticals is a key client for <strong>Aptar</strong> Pharma, and we are proud that our collaboration<br />

has now led to <strong>the</strong> launch of <strong>the</strong>ir important new medic<strong>in</strong>e for patients suffer<strong>in</strong>g from multiple<br />

sclerosis.” said Pierre Carlotti, Vice President Market<strong>in</strong>g and Communication for <strong>Aptar</strong> Pharma<br />

Prescription Division.<br />

Sativex ® is a registered trademark of GW Pharmaceuticals.<br />

For more <strong>in</strong><strong>format</strong>ion about Sativex ® , visit http://www.gwpharm.com/Sativex.aspx<br />

Sativex ® is <strong>in</strong>dicated as treatment for symptom improvement <strong>in</strong> patients with moderate to severe<br />

spasticity due to multiple sclerosis (MS) who have not responded adequately to o<strong>the</strong>r anti-spasticity<br />

medication and who demonstrate cl<strong>in</strong>ically significant improvement <strong>in</strong> spasticity related symptoms<br />

dur<strong>in</strong>g an <strong>in</strong>itial trial of <strong>the</strong>rapy.<br />

About <strong>Aptar</strong> Pharma<br />

<strong>Aptar</strong> Pharma is part of <strong>the</strong> <strong>Aptar</strong>group family of companies, along with <strong>Aptar</strong> Beauty + Home and <strong>Aptar</strong> Food + Beverage. We create<br />

<strong>in</strong>novative drug delivery systems that meet <strong>the</strong> evolv<strong>in</strong>g needs of biotechnology, healthcare and pharmaceutical companies around <strong>the</strong><br />

world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise.<br />

<strong>Aptar</strong>group (NYSE: ATR) is headquartered <strong>in</strong> <strong>the</strong> US and has manufactur<strong>in</strong>g sites <strong>in</strong> North America, Europe, Asia and South America.<br />

For more <strong>in</strong><strong>format</strong>ion, visit http://www.aptar.com/pharma<br />

Press Contacts<br />

Elisa Eschylle, Events and Press relations manager<br />

Tel.: +33 (0)1 39 17 20 41 - Email : elisa.eschylle@aptar.com<br />

Marion Baschet Vernet , Press attaché<br />

Tel.: +44 (0)797 609 41 00 - Email : mbvernet@gmail.com<br />

Deliver<strong>in</strong>g solutions, shap<strong>in</strong>g <strong>the</strong> future.<br />

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