MUMBAI, July 23 --

- 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@glenmark-generics.com