October 01, 2014 3:04 AM ET

Pharmaceuticals

Company Overview of Sandoz Inc.

Company Overview

Sandoz Inc. develops, manufactures, markets, and distributes generic pharmaceutical products. It offers therapeutic drug categories, such as anti-infectives for systemic use, central nervous system disorder treatments, cardiovascular medicines and systems, gastrointestinal agent, oncology therapies, respiratory therapies and systems, alimentary tracts and metabolisms, antineoplastic and immunomodulating agents, and blood and blood forming organs; and doxercalciferol injection vials for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. The company sells its generic pharmaceutical products to small and large retailers, wholesalers, hospitals, p...

506 Carnegie Center

Suite 400

Princeton, NJ 08540

United States

Founded in 1946

Phone:

609-627-8500

Fax:

609-627-8659

Key Executives for Sandoz Inc.

President and Head of North America
Chief Financial Officer
President of Oriel Therapeutics
Vice President of Legal
Vice President and Head of Biopharmaceuticals - North America
Compensation as of Fiscal Year 2014.

Sandoz Inc. Key Developments

U.S. District Court for the District of New Jersey Rules in United Therapeutics' Favor in Case against Sandoz, Inc

United Therapeutics Corporation announced that the U.S. District Court for the District of New Jersey has ruled in its favor in the company's case against Sandoz Inc. regarding United Therapeutics' Remodulin(R) product. In his opinion, Judge Peter Sheridan ruled that U.S. Patent No. 6,765,117 is both valid and enforceable against Sandoz Inc., and enjoined Sandoz from marketing its generic product until the expiration of that patent in October 2017. Judge Sheridan also ruled that U.S. Patent No. 7,999,007 expiring in 2029 is valid, but would not be infringed by Sandoz' generic product. Sandoz filed an Abbreviated New Drug Application in December 2011 seeking to market a generic version of Remodulin, and challenged patents covering Remodulin as part of that application. United Therapeutics filed the lawsuit that is the subject of this ruling shortly thereafter. United Therapeutics is analyzing the Court's opinion and assessing its next steps with respect to the '007 patent, which may include an appeal of the ruling to the U.S. Court of Appeals for the Federal Circuit.

Anacor Pharmaceuticals, Inc. and Sandoz Inc. Enter into an Agreement for the Commercialization of KERYDIN in the United States

Anacor Pharmaceuticals, Inc. announced that it has entered into an exclusive agreement with Sandoz Inc. pursuant to which Sandoz will distribute and commercialize Anacor's drug KERYDIN (tavaborole) topical solution, 5% in the United States. PharmaDerm will be responsible for the sales and marketing of KERYDIN. The agreement with Sandoz entitles Anacor to upfront payments totaling $40 million and an additional milestone payment of $25 million expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits (defined as net sales less cost of goods sold) accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50 million of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45 million. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacor's contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.

U.S. District Court for the District of New Jersey Grants Shire's Summary Judgment Motion in a Patent Infringement Lawsuit

Shire plc. said that the U.S. District Court for the District of New Jersey granted the company's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse or lisdexamfetamine dimesylate were both infringed and valid. The company said that the ruling prevents the five pharmaceutical manufacturers (the ANDA- Defendants) who have filed Abbreviated New Drug Applications or ANDAs from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, The ANDA Defendants must overturn the Court's rulings for each of the eighteen patent claims. The ANDA-Defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Vyvanse is indicated for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and above. Vyvanse capsules are currently available in six once-daily dosage strengths of 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.

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