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Generic for Lilly's Evista in US 'within a month'

Teva to launch copy of osteoporosis drug
Eli Lilly HQ

Lilly is finally facing direct competition to its big-selling osteoporosis drug Evista in the US after approval by the FDA of Teva's generic version.

Teva received a green light from the agency for a 60mg tablet version of Evista (raloxifene), which accounted for of $824m of Lilly's revenues in the US last year – around 4 per cent of the company's total revenue. The Israeli drugmaker said it plans to launch its version within 30 days.

Teva has first-to-file exclusivity so will have the generic raloxifene market in the US to itself for 180 days. Evista had already lost patent protection in Europe and many other world markets, although the company is still fighting to retain protection from generics in some countries such as Australia.

Lilly also loses data package exclusivity for its antidepressant Cymbalta (duloxetine) in Europe in the second half of this year, although it does not expect generic competition to start there until 2015. The US patent on Cymbalta expired last year.

The company is also awaiting a ruling on a method-of-use patent covering lung cancer therapy Alimta (pemetrexed) in the US in the coming months.

All told, these three drugs accounted for nearly 40 per cent of Lilly's $23bn turnover last year, so it is unsurprising that it is predicting a hefty revenue fall to somewhere between $19bn and $20bn this year.

Could Duavee fill the void?

The genericisation of Evista also provides an opportunity for Pfizer and partner Ligand Pharmaceuticals, whose Duavee (conjugated oestrogens and bazedoxifene) - formerly known as Aprela - was approved by the FDA last October for the treatment of moderate-to-severe menopause symptoms and osteoporosis prevention.

Duavee is an extension of Pfizer's $1bn-a-year Premarin franchise and is the only therapy on the market that combines oestrogens with a selective oestrogen receptor modulator instead of progestin, which should reduce the risk of uterine cancer.

It could be attractive as a safer alternative for women who would like to combine menopausal symptom treatment with osteoporosis prevention, although analysts have widely differing views on its potential, ranging from a relatively modest $200m a year to $1bn or more.

Article by
Phil Taylor

5th March 2014

From: PME

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