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Par loses ondansetron case to GSK



13th August, 2005:The US District Court for the District of New Jersey ruled that two of GlaxoSmithKline's patents for ondansetron are valid, enforceable and infringed by Par's wholly-owned subsidiary, Kali Laboratories, Par Pharmaceutical Companies reported.

Kali’s ondansetron is the generic form of GlaxoSmithKline's Zofran ODT orally disintegrating tablets used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual US sales of Zofran ODT are approximately $225 million.
The two patents expire on 16th August 2005 and 24th December 2006, following the expiration of paediatric exclusivity.
Kali intends to appeal the decision, Par said.

Kali filed an ANDA with a Paragraph IV certificate with the FDA for the drug in September 2002, and this was accepted by the agency in October 2002. In October 2002, Kali’s ANDA was accepted for filing by the FDA. GlaxoSmithKline did not file suit against Kali on U.S. Patent Nos. 5955488 and 6063802, which expire in May 2016.

Kali was also the first to file on these composition patents and may be entitled up to 180 days of marketing exclusivity for the product. The 628 method of use patent expires August 16, 2005 and the 789 method of use patent expires December 24, 2006, following expiration of pediatric exclusivity, Par said. Par expects ondansetron hydrochloride (HCl) orally disintegrating tablets (ODT) to be launched no later than December 2006.
Under the terms of Kali’s agreement with Pliva, Inc., Pliva has exclusive rights to market, sell and distribute ondansetron HCl ODT in the US. The product will be manufactured by Kali and the companies will split profits from the sales of the product.

In June 2005, the FDA granted tentative approval for the company’s ANDA for ondansetron HCl ODT in 4 mg and 8 mg strengths. A tentative approval reflects the FDA’s preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent/exclusivity issues have expired.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets, the first of which is Megace ES. Par currently manufactures, markets or licenses more than 90 prescription drugs.

GlaxoSmithKline (GSK) is a leading research-based pharmaceutical company. Headquartered in the UK and with operations based in the US, the new company is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.

GSK also has leadership in four major therapeutic areas - anti-infectives, central nervous system (CNS), respiratory and gastro-intestinal/metabolic. In addition, it is a leader in the important area of vaccines and has a growing portfolio of oncology products.

The company also has a Consumer Healthcare portfolio comprising over-the-counter (OTC) medicines, oral care products and nutritional healthcare drinks, all of which are among the market leaders.
Based on 2004 Annual Results, GSK had sales of £20.3 billion ($37.2 billion) and profit before tax of £6.1 billion ($11.1 billion). Total pharmaceutical turnover was just over £17 billion ($31 billion) and consumer healthcare turnover was £3.2 billion ($5.8 billion).

GSK has over 100,000 employees worldwide. Of these, over 40,000 are in sales and marketing, the largest sales force in the industry. Around 35,000 employees work at 82 manufacturing sites in 37 countries and over 15,000 are in R&D. GSK’s R&D is based at 24 sites in 11 countries with a budget of about £2.8bn/$5bn.


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