Sandoz Canada launches the first generic versions of two original drugs: PrSandoz® Posaconazole and PrSandoz® Silodosin

• ^PrSandoz^®Posaconazole is used to treat Aspergillus fungal infections and to prevent fungal infections caused by Aspergillus and Candida, particularly in oncology patients who have had stem cell transplant.
• ^PrSandoz® Silodosin is used to treat the signs and symptoms of benign prostatic hyperplasia.
• Sandoz is the first manufacturer to launch generics of ^PrPOSANOL and ^PrRapaflo, thereby helping to generate substantial savings for patients and public and private drug insurance plan providers.

Boucherville, January 26, 2021 – Sandoz Canada Inc. announced today the launch of ^PrSandoz^® Posaconazole and ^PrSandoz^® Silodosin, making Sandoz the first company to offer posaconazole and silodosin generics on the Canadian market. The launch of ^PrSandoz^® Silodosin follows a patent litigation whereby the Federal Court ruled that the Sandoz product does not infringe a patent for this drug. These new Sandoz products make these treatments more accessible to patients and their healthcare professionals and reduce pressure on the healthcare system.

^PrSandoz^® Posaconazole is a generic antifungal agent of ^PrPOSANOL*(posaconazole). Posaconazole is indicated for the prophylaxis of Aspergillus and Candida infections in patients who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT) recipients, and for the treatment of invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole, or in patients who are intolerant of these medicinal products. The drug is available as 100 mg delayed-release tablets.

^PrSandoz^® Silodosin is the generic equivalent of ^PrRapaflo** (silodosin). It is a selective antagonist for ALPHA1A adrenoreceptor subtype in the prostate and bladder used to treat the signs and symptoms of benign prostatic hyperplasia (BPH). It is sold in pharmacies in 4 mg and 8 mg capsules.

“We are proud to be paving the way for the generics of silodosin and posaconazole. Sandoz Canada is committed to its role as a leading player in the healthcare sector, and our teams are constantly working to expand our product portfolio and improve patient access to affordable, high-quality prescription drugs,” said Michel Robidoux, President and General Manager of Sandoz Canada. “In addition to working toward a continued supply of essential medicines despite the challenges of the COVID-19 pandemic, we make it our duty to continue introducing new drugs that will contribute to the strength of our healthcare system in the future and the health of Canadians.”

Disclaimer

This press release contains forward-looking statements, including, but not limited to, potential future revenues from the sale of ^PrSandoz^® Posaconazole and ^PrSandoz^® Silodosin. You should not place undue reliance on these statements. These forward-looking statements reflect management's current beliefs and expectations regarding future events and involve known and unknown risks and significant uncertainties. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no assurance that ^PrSandoz^® Posaconazole and ^PrSandoz^® Silodosin will be submitted or approved for other additional indications or labelling in other markets, or at any particular time, nor can it be guaranteed that ^PrSandoz^® Posaconazole and ^PrSandoz^® Silodosin will be approved by a regulatory body or will be commercially successful in the future. In particular, management’s expectations regarding ^PrSandoz^® Posaconazole and ^PrSandoz^® Silodosin could be affected by a number of factors, including: uncertainties inherent in research and development, including unexpected clinical study results and additional analysis of existing clinical data; unexpected regulatory actions, delays or government regulations in general; the company’s ability to obtain or maintain intellectual property protection; general economic and industry conditions; the global trend towards streamlining healthcare costs, including constant pressure regarding pricing; impacts of the COVID-19 pandemic; unexpected manufacturing problems, and other risks and factors mentioned in form 20-F filed by Novartis AG with the US Securities and Exchange Commission. Sandoz is providing the information in this media release as of today and does not undertake any obligation to update any forward-looking statements described herein as a result of new information, future events or otherwise, except as required by law.

About Sandoz Canada

Sandoz is a world leader in generics and biosimilars and a division of the Swiss multinational Novartis AG. A true leader in its field, Sandoz Canada markets and distributes a wide range of generics, biosimilars and specialty products.

www.sandoz.ca

Follow us on LinkedIn: www.linkedin.com/company/sandoz-canada/

* ^PrPOSANOL (posaconazole) is a trademark of Merck Canada Inc.

** ^PrRapaflo (silodosine) is a trademark of Allergan Inc.

###

For interview requests, please contact Paule Pelletier (see contact information below).

Information:

Paule Pelletier

Sandoz Canada Inc.                    

[email protected]