Nilotinib (Tasigna) to treat blood cancer by Novartis AG, has been granted a patent in India, reports said.
Novartis’ leading blood cancer therapy Gleevec (imatinib) has been denied a patent protection in India.
Novartis is currently in a legal battle with Indian patent office questioning the validity of section 3 (d) of Indian Patent Act on rejecting patent protection on Gleevec.
Last year Novartis was also denied patent for a different form (alfa crystal) of Gleevec and a hypertension drug, which combined valsartan and amilodipine. Both applications were rejected citing Section 3(D) of the Patent Act.
Niotinib is considered superior to imatinib in fighting a form of blood cancer called chronic myeloid leukemia.
In studies Novartis unveiled in December last year, nilotinib (Tasigna) showed superior efficacy over Glivec (imatinib)
in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, according to a Novartis release.
Both the drugs – nilotinib (Tasigna) and Glivec (imatinib) are oral pills developed by the Swiss drug major Novartis.
Tasigna is a selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML.
Following initial reports of resistance in the Glivec registration trials, Novartis scientists created Tasigna, just a year after the launch of Glivec.
The first clinical trials began just 21 months after discovery. The drug received its first regulatory approval in the second-line indication in 2007.
In a head-to-head comparison of nilotinib (Tasigna) and Glivec (imatinib) as initial treatment for this life-threatening blood cancer, Tasigna results showed statistically significant improvement over Glivec in every measure of efficacy, including major molecular response (MMR), complete cytogenetic response (CCyR) and prevention of progression to accelerated or blastic phase, Novartis announced while presenting the data at the 51st annual meeting of the American Society of Hematology (ASH), held in December, in New Orleans, USA.
The clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is a Phase III randomized, open-label, multicenter trial comparing the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase.
It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients. Designed to detect a difference in MMR between Tasigna and Glivec after 12 months of treatment, it is also the first registration study in which molecular traces of a key biomarker specific to Ph+ CML have been used as a primary endpoint for regulatory review.
ENESTnd is being conducted at 220 global sites with 846 patients enrolled. Patients were randomized to receive Tasigna 400 mg twice daily, Tasigna 300 mg twice daily or Glivec 400 mg once daily.
At 12 months, fewer patients progressed to accelerated or blastic phase on Tasigna 300 mg twice daily than on Glivec 400 mg once daily.
Tasigna was also well tolerated in patients.
“The outstanding rates of response observed with Tasigna, combined with the very low rate of disease progression, strongly indicate that patients who begin their treatment with Tasigna may have long-term improvement of progression-free survival,” said Giuseppe Saglio, University of Turin, San Luigi Hospital, Orbassano-Torino, Italy, a member of the study management committee.
Novartis now plans to file worldwide applications for approval of Tasigna as a treatment for adult patients with newly diagnosed Ph+ CML.
Tasigna is currently approved in more than 80 countries including the European Union, United States and other countries for the treatment of adult patients with Ph+ CML in chronic phase or accelerated phase who are resistant or intolerant to prior treatment including Glivec.
Headquartered in Basel, Switzerland, Novartis Group offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the group.