Novartis withdraws application for Exelon/Prometax extended indications

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The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for  Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.

In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.

The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.

Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.


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Vivelle-dot, an estrogen patch.

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Welcome back to the Medical Technology Blog once again Mylan are under fire from the authorities (see related articles below) please read on…

Mylan is being sued by Noven Pharmaceuticals and Novartis over alleged infringement of the latter’s Vivelle-Dot (oestradiol transdermal system) patch product. Noven filed the lawsuits in the US District Court for the Southern District of New York and the US District Court for the District of Vermont after Mylan submitted an ANDA application in the US for approval to market a generic version of Vivelle-Dot, before the expiration of the product’s patent protection in 2014.

As Noven and Novartis filed the suit within 45 days of hearing about Mylan’s ANDA submissions, the FDA is not allowed to approve the generic product until June 2013 at the latest, or until a district court decides the patent is invalid or the product infringing. However, Mylan believes it is the first to file an ANDA containing Paragraph IV certification for all strengths, and hopes to qualify for 180 days of marketing exclusivity, if approval is granted.

Mylan’s patch, a twice-weekly oestradiol transdermal system, has been submitted for approval for 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day and 0.1mg/day strengths, for the treatment of the symptoms of menopause, the treatment of hypoestrogenism and the prevention of post-menopausal osteoporosis.

IMS Health says that Vivelle-Dot had sales in the US of around US$215 million for the 12 months ended 31st December 2010. Vivelle-Dot, which was launched in 2002, is marketed by Novogyne Pharmaceuticals, a joint venture specifically set up by Noven and Novartis to promote the product. With the prospect of generic competition taking a slice of its revenues, neither Noven nor Novartis are going to give up that easy and have served notice that they will “vigorously defend” their intellectual property rights from infringement.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s newsletter Drug Delivery Insight.

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