Boucherville, Quebec, January 31, 2017– Sandoz Canada announced today that it has launched Sandoz® Amphetamine XR (mixed amphetamine salts), a generic equivalent to Adderall XR*, a prescription medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Sandoz® Amphetamine XR, an extended release, mixed salts amphetamine product, is being sold under prescription in capsules for oral administration. Each capsule contains the same amount of each of the following salts: Amphetamine aspartate monohydrate; Amphetamine sulfate; Dextroamphetamine saccharate; and Dextroamphetamine sulfate.
“ADHD affects approximately 5% to 10% of all school-age children and the symptoms including inattention, hyperactivity and impulsivity can, if left untreated, seriously affect children as well as their families and friends,” said Martin Arès, VP Sales and Marketing, Generics and Specialty Products of Sandoz Canada. “With an increasing number of children being diagnosed with ADHD, Sandoz® Amphetamine XR will help to make a high-quality treatment more accessible to Canadians.”
While the neurobiological disorder is considered to be mainly a disorder affecting children, results from follow-up studies of subjects with ADHD suggest that up to 80% of children diagnosed with ADHD will continue to exhibit symptoms in adolescence and up to 60% in adulthood. What’s more, by extrapolating US data, untreated ADHD is estimated to cost the Canadian economy $6 to $11 billion annually in the loss of workplace productivity. The total cost of the illness, if extrapolated, is estimated at over $7 billion, which exceeds the cost of major depressive disorders.**
*® Trademark owned by its respective owner.
**CADDAC Socieconomic White Paper June 2013
The foregoing release contains forward-looking statements that can be identified by words such as “more accessible,” or similar terms, or regarding potential future revenues from Sandoz® Amphetamine XR. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Sandoz® Amphetamine XR will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Sandoz® Amphetamine XR will receive regulatory approval or be commercially successful in the future. In particular, management’s expectations regarding Sandoz® Amphetamine XR could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis 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.
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 approximately 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.