Medicis sues Glenmark on skin drug fluocinonide (Vanos) patents in US

Medicis settled a similar patent dispute with Perrigo in April 2009.

India’s generics drug maker Glenmark has been sued for alleged patent infringement fluocinonide cream (Vanos) by Medicis Pharmaceutical Corp in the District Court of New Jersey.

Vanos, which contains fluocinonide 0.1% as active ingredeint in a cream base is used to relieve inflammation and itching caused by certain skin conditions that respond to corticosteroids.  Vanos is also used in psoriasis and atopic dermatitis.

Delaware-based Medicis Pharmaceutical Corp alleged that Glenmark Generics Inc. has violated two of valid patents through filing an abbreviated new drug application (ANDA) seeking para IV approval for its generic version of  fluocinonide cream.

Glenmark Generics Inc., USA is the US arm of Mumbai-based Glenmark Generics Ltd.

Glenmark has infringed U.S. Patent Nos. 6,765,001 and 7,220,424 – both refer to compositions and methods for enhancing corticosteroid Delivery – and were issued on July 20, 2004 and May 22, 2007, Medicis alleged in the lawsuit.

Since the patents are still valid, Glenmark should be permanently restrained from commercial manufacturing and  sale of  fluocinonide cream in the United States, Medicis

argued.

In April, Medicis Pharmaceutical Corp settled a similar patent dispute with Perrigo Corp.  Medicis had filed the suit in the U.S. District Court for the Western District of Michigan in June 2008 following Perrigo’s ANDA filing seeking to market a generic version of Vanos.

Under the terms of the agreement, Perrigo can commence marketing its generic version of Vanos on December 13, 2013 and will, in return, pay royalties to Medicis based on sales.  Medicis also agreed to make an initial $3 million payment, to be followed by a payment of up to $5 million, at certain achievement milestones as the drug progresses through the hurdles of regulatory approval, commercialization, and development.  Medicis has also agreed to pay royalties to Perrigo based on sales of the drug terminating the lawsuit.

Vanos, a Class I corticosteroid launched in April 2005,was originally indicated for the treatment of plaque-type psoriasis. In 2006, the Food and Drug Administration  broadened the indication to primary therapy for all inflammatory and pruritic skin conditions in patients 12 years of age or older which are responsive to corticosteroids. Such conditions include eczema and poison ivy, which occur commonly.

The market for relieve plaque-type psoriasis is approximately $329 million annually.

Vanos is patent protected until 2021 and is available by prescription in a 30-gram and 60-gram size.

Medicis Pharmaceutical Corporation is the leading specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. Apart from Vanos (fluocinonide), Medicis products list include the brands Dysport (abobotulinumtoxinA), Restylane (hyaluronic acid), Perlane (hyaluronic acid), Dynacin (minocycline HCl), Loprox (ciclopirox), Plexion (sodium sulfacetamide 10% and sulfur 5%), Solodyn (minocycline HCl, USP) Extended Release Tablets, Triaz (benzoyl peroxide), Lidex (fluocinonide) cream 0.05%, Ziana (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, Buphenyl (sodium phenylbutyrate) tablets and powder, Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%, the Liposonix system and the over-the-counter brand Esotreica.

Headquartered at Mumbai, India, Glenmark Pharmaceuticals Ltd has several new molecules in the areas of inflammation (Asthma/COPD, etc.), and metabolic disorders (Diabetes, Obesity,etc.) in its discovery pipeline. Glenmark’s first Asthma/COPD molecule, Oglemilast (GRC 3886), was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in

two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211 has been outlicensed to Eli Lilly & company.

The Rs 2000 crore plus Glenmark Pharmaceuticals has suffered heavy setback during the year ended March 2009 on account of slower growth in top line, higher interest burden as well as employees cost and the absence of outlicensing revenue due to overall global recession. Glenmark’s  consolidated net profit for the first nine months decreased to Rs.3141.68 Mn [USD 69.58Mn] from Rs. 4122.96 Mn [USD 101.93 Mn] for the previous year, a decrease of 23.80%.