Recent reports in Emerging Markets Economy, MENA Report and Alternativa News reveal that India-based Glenmark Pharmaceuticals Ltd may be facing quite a number of problems, including quality control issues of several of its products, the deaths of clinical trial animals administered its drugs, and strife between companies in cooperation with the firm, to name a few.
Serious quality control issues have recently arisen with a popular antibacterial medication widely marketed under the name of Omnicef, Cefdinir, or Kefnir. The drug, a semi-synthetic oral antibiotic issued by the India-based Glenmark Pharmaceuticals Ltd., was recently found to have demonstrated persistent problems regarding moisture and agglomeration, according to Alternativa News.
The defects appear to be due to citric acid anhydrous used as a flavor enhancer in the drug's suspension form, especially under aggravated conditions of moisture exposure during shelf-life. Though a similar problem had occurred in the past and then been reduced after drying of both Xanthan & Gaur gums was introduced to the product, hospitals and consumers continue to express complaints that clots were noted inside the sealed bottles. As a result, thousands of bottles of the drug have been rejected by pharmacies and hospitals, the report went on to say.
Additional reports reveal that Glenmark’s asthma treatment drug, Oglemilast (PDE-4 inhibitor, GRC 3886), also used for chronic obstructive pulmonary disease, is also at the center of debate.
As a result of the unexpected death of monkeys involved in clinical trials of the drug, further experiments have been halted until further notice. Clinical pathology and histopathology data from the tests revealed that the deaths were caused by an acute inflammatory response and septicemia after receiving doses of Glenmark's Oglemilast molecule.
Meanwhile, other problems have surfaced, such as the seizure by the Russian Ministry of Health of some 75,000 bottles of Glenmark’s Relcer, an antacid drug after the product reportedly failed several quality control tests. In addition, contamination had been found as well in batches of Glenmark’s Ketoplus product.
Furthermore, it appears that the firm is facing trouble with its partner, Forest Laboratories, with whom it is developing Oglemilast, reported Emerging Markets Economy. During the second quarter of fiscal 2005, Glenmark Pharmaceuticals entered into a collaboration agreement with Forest for the North American development and marketing of GRC 3886, a PDE4 inhibitor which will be developed for the treatment of asthma and COPD. However, according to Form 10-Q of Forest Laboratories Inc., filed on August 09, 2006, "The initiation of Phase II testing, originally scheduled for calendar 2006, has been delayed pending the provision of certain additional preclinical data to the FDA."
The process ran into obstacles and created significant tension between the parties, although both are trying to minimize this fact. Forest claimed that in addition to the unexpected deaths of trial monkeys, it became clear that associates at Glenmark had failed to properly communicate the developments of the trial's progress to Forest Laboratories. As a publicly traded company, Forest cannot afford to bare the risks of consequences wrought on it by the mismanagement of its partner, Glenmark.
The unfortunate developments of Forest-Glenmark come at the heals of other signs of trouble for the company, such as the seizure by the Russian Ministry of Health of some 75,000 bottles of Glenmark’s Relcer, an antacid drug after the product reportedly failed several quality control tests. In addition, contamination had been found as well in batches of Glenmark’s Ketoplus product.
Furthermore, Merrill Lynch recently lowered is rating of Glenmark from 'Buy' to 'Neutral' indicating a significant risk profile for the company. In addition, it pointed out that further delays or disappointments could impact the stock negatively.
In addition to all the above, reports reveal that the company seems to have run into trouble in the accounting procedures of a firm it was in the process of acquiring in the Czeck Republic, a fact that had led to an investigation on the part of local authorities. So in South America, financial practices of Brazil’s Farmacon firm, with close relations to Glenmark, are currently under scrutiny upon suspicions of money laundering.
With such mounting charges against the firm, it remains to be seen how Glenmark will handle the coming months, and how those directly affected by its operations.
