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Sandoz Brazil launches Tadalafil, first generic version of Cialis® to treat erectile dysfunction

  • Licensing agreement with Eli Lilly enables Sandoz to commercialize and distribute Cialis® in the Brazilian market

Sao Paulo, December 18, 2014 – Sandoz, the generics pharmaceutical division of Novartis, announces today that it is launching Tadalafil, a generic version of Cialis®, indicated to treat patients with erectile dysfunction. With the launch, Sandoz will be the first pharmaceutical company to market a generic version of Cialis® in Brazil.

Tadalafil is the result of a trade agreement with Eli Lilly Brazil®, which allows Sandoz to commercialize and distribute the product in December, ahead of the patent expiration. As part of the agreement, Sandoz will be responsible for marketing and the packaging of the product under the Sandoz brand in Brazil.

With the launch, Sandoz will expand its portfolio of men’s healthcare products in Brazil, which includes Sildenafil (generic version of Viagra®), Doxazosin, indicated for benign prostatic hyperplasia, and Lectrum® (leuprorrelin), indicated for the treatment of prostate cancer.

"Sandoz is pleased to launch Cialis ahead of its patent expiration in March next year. This launch is an excellent example of our mission to provide access to high quality medicines," said André Brázay, Sandoz Brazil Country Head. "We will be the only company in Brazil to have both Sildenafil and Tadalafil molecules, key products to meet the needs of patients with erectile dysfunction.”

Tadalafil is indicated primarily for patients aged over 40 with erectile dysfunction, caused as a result of cardiovascular disease, diabetes, neurological disorders, and benign hyperplasia or prostatectomy surgery.

In Brazil, a study estimates that about 11.3 million men aged 18 and over have some degree of erectile¹ dysfunction and the country also holds one million new cases each year². Tadalafil will be launched in versions of 20 mg single-doses, two and four tablets of 5 mg and presentation with 28 tablets for everyday use. The action of the active ingredient Tadalafil starts on average from 30 minutes after intake of and may work for up to 36 hours, according to the presentation in use.

The active ingredient Tadalafil is indicated for the treatment of erectile dysfunction. Daily use in low doses of 5mg, proven safety and efficacy for the treatment of patients with symptoms of Lower Urinary Tract (LUTS) / Benign Prostatic Hyperplasia (BPH) in addition to DE chronic. In both concentrations, the drug can be taken with or without food and its plasma concentration is not affected by alcohol.

About Sandoz

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.

In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).

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References

1 Moreira Jr., ED; Abdo, CHN; Torres, EB; Lobo, CFL; Fittipaldi, JAS. Prevalence and correlates of erectile dysfunction: results of the Brazilian Study of Sexual Behaviour. Urology 2001; 58: 583-588.

2 Moreira Jr., ED; Lobo, CFL; Diament, A; Nicolosi, A; Glasser, DB. Incidence of erectile dysfunction in men 40 to 69 years old: results from a population-based cohort in Brazil. Urology 2003; 61: 431-436.

For further information, contact:

Sandoz Global Communications
Neil Moorhouse
Head Global Media and External Relations
T: +49 8024 476 2597
M: +49 172 442 8491
neil.moorhouse@sandoz.com

Sandoz Brazil Communications
Patricia Pêcego
Communications Head
T: + 55 11 5532 4556
M: + 55 11 99140 8049
patricia.pecego@sandoz.com