SOURCE: Sandoz Canada

Sandoz Canada

June 21, 2016 09:34 ET

Sandoz Canada Launches First Non-Prescription Naloxone Approved by Health Canada for Treating Opioid Overdoses

BOUCHERVILLE, QC--(Marketwired - June 21, 2016) - Sandoz Canada announces the launch of S.O.S. Naloxone™ Hydrochloride Injection on the Canadian market. It is the first non-prescription medicine to have been approved by Health Canada for the emergency treatment of opioid-related overdose. Prior to the launch of this new product, naloxone had been sold by prescription only for more than 20 years. This prescription product remains available.

"Sandoz Canada is the first pharmaceutical company in the country to have completed the filing process for non-prescription naloxone. Marketing authorization was granted by Health Canada on March 22, 2016 for S.O.S. Naloxone™ Hydrochloride Injection," said Michel Robidoux, President and General Manager of Sandoz Canada. "We are proud to be manufacturing this product at our Boucherville plant. We are also pleased to be making this life-saving drug more easily accessible in Canada, especially at a time when opioid-related overdoses are rising sharply."

S.O.S. Naloxone™ Hydrochloride Injection can be administered with care by a bystander, family members, friends or by a healthcare professional to a person who is experiencing or is suspected to be experiencing an opioid overdose (such as fentanyl or oxycodone) to reverse the effects before emergency medical assistance arrives.

This product is available at the pharmacist's counter in ampoules, each containing 0.4 mg/mL naloxone hydrochloride. A patient information leaflet with step-by-step illustrated instructions for the injection process will be provided with the product.

Sandoz Canada has already signed a major agreement with one province for the sale of ampoules that will be used in naloxone injection kits to be distributed for free in that province.

"The launch of this life-saving product demonstrates that patients remain central to our decisions as we endeavour to deliver innovative solutions to improve people's lives. This launch is also in line with our commitment to facilitate people's access to healthcare by providing a wide range of high-quality medicines," noted Mr. Robidoux.

Opioid drugs work by acting on specific receptors in the brain and nervous system. When they are attached to these receptors, they reduce the amount of pain experienced. Although many people may use opioids without consequences, serious and potentially fatal risks are associated with opioid overdose.

S.O.S. Naloxone™ Hydrochloride Injection blocks opioid receptors and reverses the effects of overdose of these substances, including trouble breathing, extreme drowsiness, pale and clammy skin, slow or no heartbeat and unable to be woken up. However, the product does not reduce the effects of overdose caused by other drugs, such as barbiturates, benzodiazepines, psychostimulants, anesthetics, sedatives or alcohol (this list is not exhaustive).

For more information about S.O.S. Naloxone™ Hydrochloride Injection, consult healthcare professionals, visit Health Canada's or the manufacturer's websites (www.sandoz.ca) or call 1-800-343-8839.

TM: Trademark owned or used under license by Sandoz Canada Inc.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "new", or similar expressions, or by express or implied discussions regarding potential new indications or labeling for S.O.S. Naloxone™ Hydrochloride Injection or regarding potential future revenues from S.O.S. Naloxone™ Hydrochloride Injection. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with S.O.S. Naloxone™ Hydrochloride Injection to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that S.O.S. Naloxone™ Hydrochloride Injection will achieve any particular levels of revenue in the future. In particular, management's expectations regarding S.O.S. Naloxone™ Hydrochloride Injection could be affected by, among other things, new clinical data or additional analysis of existing data, unexpected regulatory actions or delays or government regulation generally; uncertainties regarding actual or potential legal proceedings, including, among others, intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling S.O.S. Naloxone™ Hydrochloride Injection, and the uncertain outcome of any such litigation; the particular prescribing preferences of physicians and patients; competition in general; government, industry and general public pricing pressures; unexpected manufacturing difficulties or delays; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sandoz is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of over 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

Contact Information