Glenmark Brings to the Notice of the Authorities Irregularities of the Clinical Investigator at its Jamnagar Site in Gujarat

MUMBAI -

- A Police Complaint has Been Lodged by Hospital Authorities Citing Fraudulent Activity by the Clinical Investigator Dr. A Bhattacharya Working at the GG Hospital and the MP Shah Medical College

- Glenmark Not Only Acts as the Whistle-Blower but Also Discontinues its Clinical Study at the Mentioned Site

After receiving approval from the Drug Controller General of India(DCGI) for a multi-centre Phase IIb clinical study for its lead COPD/asthma molecule, Oglemilast, Glenmark Pharmaceuticals Limited contracted Omnicare Clinical Research(Omnicare), a leading international CRO to conduct this Phase II asthma study on its behalf. Appropriate preclinical and clinical evaluations were completed prior to initiating this phase IIb asthma study. Being a multi-centre clinical study, one of the sites chosen was Guru Gobind Hospital, Jamnagar, Gujarat. Dr. A Bhattacharya, who was at that time working with the hospital was the clinical investigator for this mentioned site.

After Dr. Bhattacharya provided all necessary approvals and completed documentation, the site was initiated at the end of 2008. During monitoring activities immediately after initiation of the site, Omnicare suspected fraudulent activity. Without delay, Glenmark along with Omnicare carried out the appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the Chairman of the Ethics Committee at the concerned Hospital. Omnicare along with Glenmark acted swiftly and closed the site in line with normal regulatory requirements, to ensure the appropriate care/safety of the patients was protected. It is important to confirm that no patients have been put at risk, and no further patients have been or will be recruited in the clinical study at Jamnagar. Glenmark also immediately formally notified the DCGI of the situation at Dr Bhattacharya’s site in early April 09 and in June provided the DCGI with an update of its actions and findings at the site.

Dr Bhattacharya has been accused of fraudulent behaviour by the Hospital Superintendent in Jamnagar, and as a result Dr Bhattacharya has now been suspended from the Baroda Medical College (where he was transferred from Jamnagar) while the police complete their investigations regarding the full extent of potential fraud by Dr. Bhattacharya in all clinical trials he had been involved in with other CROs and pharmaceutical companies.

Glenmark and Omnicare remain wholly committed to ensuring the highest quality and care in all their clinical trials in keeping with international regulatory and safety standards, and remain fully committed to taking strict action for early identification and prevention of such fraudulent activities in future. Glenmark has already decided that it will not consider any data received from this site pertaining to the study. The Phase IIb study continues to progress as per plan at other sites across the country. Being a leading company in the area of drug discovery and development, Glenmark Pharmaceuticals Ltd conducts all its clinical trials to the highest internationally recognised regulatory standards as defined by the International Conference on Harmonisation of Good Clinical Practice (ICH-GCP) and to local Indian regulations as recognised in Schedule Y of the Drugs and Cosmetics Act. In addition, Glenmark conducts all clinical trials in accordance with the internationally recognised ethical principals laid down in the Declaration of Helsinki, and the local Indian ICMR Ethical Guidelines.

Source: Glenmark Pharmaceuticals Ltd.

Jason D’Souza, Medha Satam, Glenmark, Mumbai, India, Tel: +91-22-40189919 / 40189993, Email : connect at glenmark-generics.com