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BY OUR PHARMA CORRESPONDENT 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.
BY OUR PHARMA CORRESPONDENT |
