Sandoz launches higher dosage strengths of authorized generic version of Lotrel®
Princeton, New Jersey; January 3, 2010 - Sandoz today announced the introduction of two higher dosage strengths of amlodipine besylate/benazepril capsules, an authorized generic equivalent of Lotrel®, which is currently marketed by Novartis Pharmaceuticals Corporation. Sandoz will now market amlodipine besylate/benazepril in 5-40 mg and 10-40 mg strength capsules in the US, in addition to the existing strengths of 2.5-10 mg, 5-10 mg, 5-20 mg and 10-20 mg originally launched in June 2007.
Amlodipine besylate/benazepril combines in a single capsule the angiotension converting enzyme inhibitor benazepril hydrochloride and the calcium channel blocker amlodipine besylate. It is indicated for the treatment of hypertension. Research suggests that in 2006 approximately 74.5 million Americans suffered from this condition.1
"This line extension of generic Lotrel represents an exciting start to the new year for Sandoz and an important additional treatment option for patients with severe cases of hypertension," said Don DeGolyer, President of Sandoz Inc. "The launch of these higher dosage strengths of generic Lotrel also represents another example of our success in partnering with our Novartis Pharmaceuticals colleagues on authorized generics."
According to IMS Health, US sales for 5-40 mg and 10-40 mg strength capsules of Lotrel were approximately USD 313 million for the 12 months ending October 2010.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," "introduction," "launch," "will," or similar expressions, or by express or implied discussions regarding potential future revenues from amlodipine besylate/benazepril. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that amlodipine besylate/benazepril will achieve any particular levels of revenue in the future.
In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including potential FDA approval of additional versions of amlodipine besylate/benazepril; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; 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. 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, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of about 1000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria) and Oriel Therapeutics (US). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion.
* * * For further information Sandoz US Communications: Ted Deutsch 609 627-5287 Sandoz Global Communications: Marija Mandic +49 8024 476 2597 Lotrel® is a registered trademark of Novartis Pharmaceuticals Corporation.
1 The American Heart Association, High Blood Pressure Statistics. Available from: http://www.americanheart.org/presenter.jhtml?identifier=4621.