Hungarian pharmaceutical company Gedeon Richter said on Friday that the European Medicines Agency (EMA) has recommended temporarily restricting prescriptions of its uterine fibroid drug Esmya until a review of potentially related liver damage, launched in December, has been completed.
The EMAʼs Pharmacovigilance Risk Assessment Committee (PRAC) has recommended regular live monitoring of women taking Esmya, reported Hungarian news agency MTI. It has also recommended that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another.
Treatments started before the PRAC decision are allowed to be completed, Richter noted.
Richter confirmed early in December that the EMA had started a review of Esmya after reports of serious liver damage in four patients treated with the drug.
Richter said today that the PRAC recommendations are temporary measures and that a final decision depends on the conclusion of the review of Esmya, which started in December 2017 and is expected to be completed before the end of May 2018.
In January, the company indicated that it might postpone guidance when it publishes fourth-quarter earnings in February if uncertainty continues surrounding Esmya. Richter was scheduled to publish its Q4 and full-year report on Thursday, February 8, but is now set to do so on the morning of Monday, February 12.
"Richter is determined to work with the PRAC and provide the necessary information to allow them to complete a fair assessment in a timely manner," the drugmaker said. "Richter continues to believe that all the available data for Esmya support a favorable benefit-risk profile and is committed to providing this unique treatment option to women suffering from uterine fibroids."
Richterʼs share price fell sharply after the announcement. It was quoted at HUF 6,090, down 4.92%, at 2 p.m. on Friday afternoon. The share price continued to slip, closing at HUF 5,985, down 6.56% for the day.
Analysts polled by online financial and stock market news portal portfolio.hu were said to be "unusually divided" over the likely results to be published by Richter for the fourth quarter of 2017, with respect not only to revenues, but principally also to after-tax profit.
On average, analysts expect Richterʼs total revenues, gross margin and operating profit may have risen in the last quarter of 2017, but see after-tax profit being slashed by as much as half, portfolio.hu reported.
While differences are substantial in terms of analyst expectations for the companyʼs Q4 revenues, predictions vary even more sharply between the lowest (HUF 9.4 billion) and highest (HUF 19.4 bln) forecast figure for after-tax profit. The median prediction, however, is closest to the lower figure, at HUF 9.9 bln, which - if borne out - would represent a 55.4% drop on Q4 2016.
MTI noted that Richter earlier projected sales of Esmya would reach EUR 85 million in 2017.