Baxa to shut down, suspend research and shut down a clinical trial
Baxalus Pharmaceuticals, the makers of the drug Baxter, said on Wednesday it plans to shut its two remaining clinical trials and suspend the development of two other drugs, an indication that the company will likely be forced to shut the remaining clinical trial.
The drug development phase of Baxter, an inhibitor of the enzyme tyrosine hydroxylase, will likely shut down by the end of the year, Baxali Srinivasan, vice president of clinical development at Baxter, told reporters.
The drug is currently under investigation for its potential role in causing a rare condition called tyrosinase deficiency.
The second phase of the Baxter trial is also likely to close by the year’s end, Srinivasa Rao, chief executive of Baxter’s India unit, said.
The two trials, which involve the production of a new class of compounds, are likely to be suspended as well, he added.
Baxter’s decision to shut one of its clinical trials, the development and approval of a drug for patients with a genetic variant of Bax’s tyrosase gene, could make it difficult for the company to proceed with the other trials, Rao said.
Baxalas decision to close the trial is in line with those of other companies that have faced similar difficulties with trials, he said.
A number of these companies are in the process of exiting the clinical trials process, and it is difficult for us to maintain a positive outlook.
Battles over the Baxter trials have also been a source of tension with regulators and patients.
Last year, a panel of scientists and clinicians said the trials are “not clinically useful” and called for a reopening.
Baxas chief executive, N. Venkataraman, defended the drug in an interview with The Wall Street Journal, saying the trials have proved their value in the treatment of rare and life-threatening disorders.
The trials have been used in the last 20 years in more than 20 countries, according to data from the U.S. Centers for Disease Control and Prevention.