Cipla, Amgen settle case involving generic cinacalcet hydrochloride tablets

Drug major Cipla said it has reached settlement with Amgen Inc on pending litigation involving generic cinacalcet hydrochloride tablets.

Drug major Cipla on Monday said it has reached a settlement with Amgen Inc on pending litigation involving generic cinacalcet hydrochloride tablets, used in treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease.
"The civil action filed by Cipla Ltd and Cipla USA Inc, wholly owned step-down subsidiary of Cipla Ltd (hereinafter together referred to as Cipla), in the US District Court for the District of Delaware in January 2019 has been resolved as between Cipla and Amgen Inc," Cipla said in a regulatory filing.

A formal stipulation of dismissal has been filed with the court and is awaiting signature by the presiding Judge, the filing added.

It further said "the resolution entitles Cipla and its affiliates to continue importing, marketing, and selling its generic cinacalcet hydrochloride tablets in the United States".

Cipla's cinacalcet hydrochloride tablets, in the strengths of 30mg, 60mg and 90mg, are generic versions of Sensipar, a branded drug marketed by Amgen Inc.

Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma, and for treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Shares of Cipla were trading 1.43 per cent lower at Rs 679.75 apiece on the BSE.

Gilead enters licensing pact with 5 drug firms in India, Pak for remdesivir

According to the agreement the companies Cipla, Hetero Labs, Jubilant Life Sciences, Mylan, and Pakistan based Ferozsons Labs, to manufacture and sell remdesivir in 127 countries.

US-based Gilead Sciences said that it has signed non-exclusive licensing agreements with five generic drug makers in India and Pakistan to expand the supply of antiviral drug remdesivir. The re-purposed Ebola drug is being considered as a potential therapy for coronavirus (Covid-19).

According to the agreement the companies Cipla, Hetero Labs, Jubilant Life Sciences, Mylan, and Pakistan based Ferozsons Labs, to manufacture and sell remdesivir in 127 countries. The stocks of Cipla and Jubilant were trading high on the BSE in morning trade - Jubilant was up about 5 per cent, Cipla 2.5 per cent.

Most of these 127 countries are low-income and lower-middle-income nations along with some upper-middle and high-income countries that face significant obstacles to healthcare access. Under terms of the licensing agreement, these companies will have the right to receive a technology transfer of the Gilead manufacturing process and can scale up production. This would, however, be subject to approvals by regulatory authorities in the respective countries.

India can also start using the drug on patients on compassionate grounds. The government was checking with pharma companies on how soon the drug can be manufactured here for trials.

Gilead had earlier indicated that it was working to build a global consortium to expand the production of remdesivir and make it available across countries. The drug, which is an injectable, got emergency approval from the US drug regulator recently. The trials show that patients administered with remdesivir recover faster than others. However, remdesivir remains an investigational drug and has not been approved by the USFDA.

Hetero chairman B Partha Saradhi Reddy said that this agreement illustrates the significance of global collaboration and the need to come together to fight the health crises impacting humanity. "Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for necessary studies and approvals to bring this product to treat COVID-19 patients in India," he added. It will make remdesivir in its Hyderabad facility which has USFDA and EU approvals. Hetero has developed a fully vertically integrated supply chain for this product.