Wockhardt's USA based subsidiary Wockhardt USA LLC has executed a settlement and license agreement with Orion Corporation regarding Wockhardt's submission of ANDAs for the generic versions of Orion's Comtan and Stalevo products.
Comtan is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. Stalevo is a combination of carbidopa, levodopa and entacapone for the treatment of Parkinson's disease. Both products contain entacapone, a COMT enzyme-inhibiting agent. As per IMS December 2008, the annual sales of Comtan and Stalevo products in the US were $87 million and $113 million respectively.
Commenting on the settlement, Wockhardt chairman Habil Khorakiwala commented, "We are pleased with the agreement and are excited to have capitalised on these first-to-file opportunities, which are an indication of the strength of our R&D and intellectual property initiatives. With over sixty products in the US market and a growing ANDA pipeline of technologically challenging products, we will look to continue our success in the United States market."
Orion filed the first lawsuit in the US in 2007 and thereafter two additional lawsuits were filed in 2008. The settlement agreement relates to all three suits. Under the terms of the settlement agreement, Wockhardt will be able to launch generic versions of Comtan and Stalevo on September 30, 2012, or possibly even earlier, subject to certain conditions.
Wockhardt, as the first generic challenger to the Comtan patents, is eligible for 180 days of marketing exclusivity upon launch. Wockhardt also is the first-to-file on four strengths of Stalevo and is hence eligible to have 180 days of marketing exclusivity on these strengths upon launch. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the US Department of Justice and the Federal Trade Commission.
Meanwhile, the Audit Committee and Board of Directors of Wockhardt appointed BDO Haribhakti as Statutory Auditors of the company from the financial year commencing from January 1, 2009. It is proposed that BDO Haribhakti be retained for a term of 5 years.
"This new appointment is keeping in line with Wockhardt's policy, as well as, SEBI's guidelines which highlights the need of having a rotational policy for Statutory Auditors for transparency. BDO is the fifth largest accountancy network worldwide" said Khorakiwala.
BDO International is present in 110 countries with more than 1000 offices, 2520 partners, 44,000 professional staff and world wide fee income of US$ 5.2 billion. Shailesh Haribhakti is the executive chairman and managing partner of the firm.