Natco Pharma’s paclitaxel-based nano delivery drug Albupax to treat breast cancer has been declared not of standard quality fot human use the government.
Natco Pharma’s Albupax is considered a low-cost substitute for the branded drug Abraxane by Abraxis BioSciences, USA.
The Central Drug Laboratory, Kolkata – one of the authorized labs to ascertain quality of drug products marketed in India -in its test report has declared the drug “to be not of standard quality” due to the presence of endotoxin levels beyond acceptable limits, reports said.
Natco launched Albupax in Indian market in September 2008 at a price which nearly Rs 5000 less per vial than the retail selling price of Abraxis’ Abraxane which is marketed in India by the Bangalore-based Biocon Ltd.
Abraxis, in complaint letter to DCGI filed in early 2009 pointed out that Natco’s Albupax can lead to serious side-effects.
Following Abraxis complaint DCGI ordered a fresh round of laboratory anlysis for Albupax.
Examination of Albupax samples at the Kolkata-based Central Drug Laboratory (CDL) found that the breast cancer nanotech drug had high levels of endotoxins and chloroform.
DCGI immediately ordered recall of Albupax from the market, based on the CDL test report.
However, Natco Pharma, which recalled the drug following the DCGI directive, said test results on endotoxin levels are highly dependent on the test kit employed due to interference caused by the nano particulates and excipient proteins.
The kit by M/S Charles River is employed by the Govt. analyst CDL, Kolkata and the results obtained by this kit are known to vary by as much as 2-to-four fold according to manufacturer’s own manual, Natco explained in a press note.
The samples when analysed by a different kit (viz., the Lonza’s kit) yield different results all within the specified limits for endotoxins. These results are further confirmed by the National Accreditation Board for testing and calibration for Laboratories (NABL) accredited laboratory. Natco obtained product license for Albupax using the Lonza’s kit.
Natco Pharma recalled Albupax from the market as DCGI had asked Natco to withdraw the drug within two weeks.
However, Natco approached the health ministry alleging that the DCGI’s decision based on the CDL parameters as unfair.
The Union health ministry, then, issued a stay order on DCGI directive to pull back the drug from market.
The ministry has directed more tests on Albupax and if these tests proved the drug to be safe Natco can relaunch the product, reports said quoting health ministry officials.
It has been reported recently that Natco Pharma was planning to relaunch Albupax in India following the Union health minister staying DCGI’s order prohibiting the sale of the drug, reports said.
Abraxane, which contains paclitaxel protein-bound particles for injectable suspension (albumin bound), is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Abraxane is a formulation of paclitaxel with a mean particle size of approximately 130 nanometers, that uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug.
Abraxane can be administered to patients at higher doses, resulting in higher concentrations of the drug at the tumor site and higher efficacy compared to solvent-based paclitaxel.
Clinical trials have demonstrated that the tumor response rate was nearly double for patients who received Abraxane compared to those who received solvent-based paclitaxel.
US Food and Drug Administration approved Abraxane in 2005 and the European Medicines Agency (EMEA) approved Abraxane in 2008.
Abraxane is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, melanoma, pancreatic and ovarian.
Apart from Natco Pharma, Fresenius Kabi Oncology, (formerly Dabur Pharma) is another firm which launched a generic version of Abraxane. Dabur Pharma launched the drug in the brand name Nanoxel in India in January 2007.
Abraxis’ claim for a patent for Abraxane in India was rejected following pre-grant opposition filed by Natco.
Abraxis then appealed to the Delhi high court. The high court has directed Abraxis to approach the Intellectual Property Appelate Board to settle the dispute.