BUDAPEST (Reuters) – Hungarian drugmaker Richter’s clinical data for its uterine fibroid treatment Esmya indicate no demonstrable link with liver damage, the firm said on Monday.
The European Medicines Agency (EMA) has opened a review into Esmya after four reports of serious liver damage in patients treated with the drug, three of which ended up requiring liver transplants.
Richter, which makes gynecological, cardiovascular and central nervous system drugs, earns most of its revenue from exports. The company, which has built a Western European expansion drive on female healthcare medicines, such as Esmya, has a market capitalization of $4.52 billion.
“Based on the clinical data at our disposal, we consider that there is no demonstrable link between liver damage and treatment with Esmya,” spokeswoman Zsuzsa Beke said, adding that Richter believed the product should not be suspended.
The uncertainty around the medicine, which Richter expects to bring in 85 million euros of revenue this year, hit the company’s share price, which touched 8-1/2-month lows of 6,371 forints ($24.07) in early trade and closed down 5.8%.
“Given the seriousness of the observed liver injury and its possible link to the medicine, a more in-depth review is warranted,” the EMA said in a statement on its website.
The body said its risk assessment committee would look at all available data and determine whether there were any implications for the use of Esmya, which accounted for about 6% of Richter’s total revenues in the first nine months.
Beke said Richter was fully cooperating with the EMA, adding that about 670,000 patients have been treated with Esmya, first authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids.
Beke said additional factors, such as the affected patients being treated concurrently with other medicines, or viral infections, could have contributed to the reported cases of liver damage.
Richter’s U.S. partner Allergan said it did not expect the probe to affect its New Drug Application (NDA) for the medicine. The U.S. Food and Drug Administration accepted the NDA filing from Allergan in October.
“There were no cases of liver transplantation in any of the controlled clinical trials for Esmya, including those for the European, Canadian and US registrations,” Allergan said in a statement.
The steep falls in Richter’s shares also dragged Budapest stocks lower on Monday, although analysts at Hungarian brokerage Erste Investment said the market reaction was probably overdone.
The brokerage affirmed its “buy” recommendation on the stock with a price target of 7,289 forints.
($1 = 264.68 forints)
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