teva pharmaceutical-sp adr (TEVA) Snapshot

Teva Pharmaceutical Industries Limited and Active Biotech announced the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus)that can lead to chronic kidney failure. Treatment with laquinimod provided an additive effect in improving renal function when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone. The data will be presented during the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, 12-15 June, 2013 as part of the late-breaking news session. The clinical trial, NCT01085097, was a multicenter, double-blind, placebo-controlled, exploratory study of 46 patients with active lupus nephritis that evaluated oral laquinimod (0.5 and 1mg/day) versus placebo in combination with standard of care treatment. The study showed that at 24 weeks, 62.5% of patients with active lupus nephritis who received 0.5mg/day of laquinimod achieved renal response, compared to 33.3% of patients who were administered placebo. Renal response is a composite end point that measures several parameters of renal improvement.

Teva Pharmaceutical Industries Limited announced that it has entered into a settlement agreement with Wyeth/Pfizer and Altana/Nycomed to resolve all claims relating to Teva's sales, commencing in December 2007, of its 20 mg and 40 mg generic Protonix(R) (pantoprazole sodium) tablets. As part of the settlement, which provides for the release of all claims against Teva and its subsidiaries, Teva agreed to pay $1.6 billion to Wyeth/Pfizer and Altana/Nycomed. Teva will pay $800 million in 2013 and the remainder in 2014. As a result of this settlement, Teva expects to incur a charge of approximately $930 million in the second quarter of 2013 in addition to the $670 million provision previously recorded in its 2012 financial statements. The Company believes it may have up to $560 million of net insurance coverage in connection with this settlement, subject to recovery from the insurance carriers.

Pfizer Inc. announced a $2.15 billion settlement reached with Teva Pharmaceuticals Industries, Limited and Sun Pharmaceutical Industries, Limited for patent-infringement damages resulting from their at-risk launches of generic Protonix in the United States. The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed sought to enforce the patent for its blockbuster acid reflux medicine. Pfizer and Takeda will divide the proceeds of the settlement with Pfizer receiving 64%. Under the terms of the settlement, Teva and Sun will pay a total of $2.15 billion to compensate Pfizer's subsidiary Wyeth and Takeda for the damages they suffered when Teva and Sun launched "at-risk" generic versions of Protonix prior to the January 2011 expiry of the patent for pantoprazole, the active ingredient in Protonix. These "at-risk" launches were determined by a jury in New Jersey federal court to violate United States Patent No. 4,758,579, which is owned by Takeda and was licensed exclusively to Wyeth in the United States. The parties reached the settlement shortly after the commencement of a trial to determine damages in the same New Jersey federal court. Teva will pay Pfizer and Takeda $1.6 billion and Sun will pay $550 million. Teva will pay $800 million in 2013 and the remaining $800 million by October 2014; Sun's entire payment will be made in 2013. As part of the settlement, both Teva and Sun have admitted that their sales of generic pantoprazole infringed the patent that was held valid by the court.