STOCK MARKET BSE NSE

Alkem Labs' Shares Fall on Row Over Fudging Trial Data

Shares fell as much as 8% after the company confirmed it was in talks with German authorities who had accused it of fudging data.

Published: 18th April 2016 11:32 AM  |   Last Updated: 18th April 2016 11:32 AM   |  A+A-

INDIA-BUDGET-reuters

People look at a screen displaying the Sensex on the facade of BSE building in Mumbai | Reuters

MUMBAI: Shares in Alkem Laboratories Ltd fell as much as 8 percent on Monday after the company confirmed it was in talks with German authorities who had accused it of fudging data in some clinical trials.

Reuters reported on Friday that German authorities had accused the company of manipulating heart readings of patients in some trials for the antibiotic cefuroxime and the brain disorder drug rulizole, following an inspection of Alkem's plant in Taloja in western India in March 2015.

The European Medicines Agency (EMA) is investigating the medicines after Germany reported its findings to the EMA and urged it to take action in a report that was posted on the EMA website.

Alkem said in a statement on Saturday that the company had responded to the German authorities with a "robust remediation plan" and would also submit "suitable clarification" to the EMA.

Similar findings by European regulators concerning manipulation of electrocardiogram data at two other Indian firms, GVK Biosciences and Quest Lifesciences, led to the recall of nearly 700 medicines last year.

Alkem said the inspection concerned studies conducted by the company between March 2013 and March 2015 on two products, one of which is selling, while the other is yet to reach the market. It did not name the products. (http://bit.ly/1Te0bTs)

It also said it had changed staff, upgraded equipment and improved its quality assurance systems at the Taloja plant since Germany's inspection.

Alkem, among the fastest-growing drugmakers in India, said sales from Europe made up less than 1 percent of its total revenue in the nine months to December 2015.

Still, the company's shares were down 5 percent at 0459 GMT on Monday, after falling as much as 8 percent earlier in the day - their lowest since Feb. 29. The company debuted on the Indian stock exchanges in December.

Stay up to date on all the latest Business news with The New Indian Express App. Download now

Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp