Moneycontrol Bureau
Alkem Laboratories shares fell more than 7 percent intraday Monday after the Germany's health regulator accused company of fudging data on clinical trials of an antibiotic and brain disorder drug.
The medicines are now being reviewed by the European Medicines Agency (EMA) on the recommendation of the German regulator Federal Institute of Drug and Medical Devices, which inspected Alkem's Taloja plant in western India last March.
Alkem was found to have engaged in "intentional misrepresentation" of data and duplicated results of electrocardiogram (ECG) readings of patients in trials, the German regulator said in a notice sent to the EMA on March 24, 2016.
The drugs include the antibiotic cefuroxime and rulizole, used to treat the neurological disorder amyotrophic lateral sclerosis, sold both by Alkem and Slovenia's Krka, the EMA said. Alkem was conducting trials on the drugs for Krka.
The German regulator made Alkem aware of its findings on September 8, 2015, according to the notice. It said last month that UK regulator MHRA had inspected the Taloja plant and made eight observations.
The German regulator said Alkem's quality management system "neither avoided nor detected" the data manipulation. The regulator has urged the EMA, the medicines regulator for the European Union, to take necessary action and consider if impacted drugs need to be suspended or recalled.
After this notice, Alkem informed exchanges that the referral under Article 31 of the Directive refers to bioequivalence studies conducted for the period between March 2013 and March 2015 and in particular to bioequivalence trials of two products, of which one is commercialised and another is yet to be commercialised.The company said it will be submitting a suitable clarifications to the European Medicines Agency within the stipulated timelines to enable the Committee for Medicinal Products for Human Use (CHMP) take a balanced risk-benefit view with respect to these two products.It confirmed that the Federal Institute of Drug and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint inspection in March 2015 at Alkem’s bioequivalence facility at Taloja.Alkem said after the inspection of March 2015 by German regulator, BfArM, it had responded to the regulator with a robust remedial plan and has also been implementing several measures which include changes in staffing, upgrading equipment and improving quality assurance systems to ensure proper controls during bioequivalence studies and thorough review of the acquired data, it added.
Currently sales from Europe contributes less than 1 percent to Alkem’s total consolidated sales for 9MFY16.Alkem Labs shares gained 27 percent since listing on December 23, 2015.
At 10:06 hours IST, the scrip of Alkem Laboratories was quoting at Rs 1,274.25, down Rs 61.25, or 4.59 percent on Bombay Stock Exchange.(With inputs from Reuters)
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