Mumbai: German Remedies, a Zydus Group company, will be launching Miltefosine, the world's first oral therapy to treat kala azar in India. The drug opens up a new line treatment for patients suffering from kala azar as the drugs currently used to treat the disease are administered by injection or infusion with patients often having to be hospitalised.
The group entered into an exclusive agreement with Zentaris AG, a biopharmaceutical company and a part of Aeterna Laboratories Inc, to launch the novel drug in India.
One of the most problematic tropical infections, kala azar, or visceral leishmaniasis, is caused by leishmania and transmitted by the bite of the sandfly. More commonly known as black fever, kala azar is endemic in 62 countries with over 90 per cent of the cases being reported in India, Bangladesh, Nepal, Sudan and North Brazil.
India, which aims to eradicate kala azar by 2010, accounts for 50 per cent of these cases. The infection is most prevalent in Bihar, Jharkhand, Uttaranchal, Uttar Pradesh and West Bengal. As per World Health Organisation estimates more than 315,000 are infected annually in India alone.
So far, treating kala azar in India has been difficult with nearly 40-60 per cent of the patients from Bihar being resistant to antimonial compound, the first-line of treatment, which causes high toxicity and mortality among patients.
The second line of treatment, Pentamidine, also has serious side effects and can cause irreversible damage such as diabetes. Amphotericin, a third option, has to be infused every day for 15-20 days. The drug is also known to cause severe shivering, fever and sometimes anaphylaxis and kidney damage.
A high efficacy rate and the convenience factor in administering the drug is to make Miltefosine the most preferred line of treatment. Besides, the recent concessions in the customs duty by the Indian government will make the drug more affordable. A part of the Rs 1,100-crore Zydus group, German Remedies markets several leading brands in the areas of female healthcare, gastrointestinals, respiratory care, oncology and diagnostics.
Zentaris AG, the innovator of Miltefosine, is a biopharmaceutical company focused on the development of novel therapeutic treatments, mainly in oncology and endocrinology. The group's product pipeline includes 12 products ranging from the pre-clinical stage up to commercialisation.