INDIA – Zydus Lifesciences has acquired rights to market MonoFerric (iron isomaltoside) injection, used to treat iron deficiency in adult patients, in India and Nepal from Denmark-based Pharmacosmos.

MonoFerric is indicated for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly, the company said in a regulatory filing.

Zydus Lifesciences did not disclose the financial details of the transaction.

Speaking on the development Dr Sharvil Patel, Managing Director, Zydus Lifesciences Ltd. said, “Iron Deficiency is a severe healthcare challenge and also impacts the quality of life more so in chronic kidney disease (CKD) patients.

“With this introduction, he said these patients will get access to this critical therapy which will be enhanced by the company’s “strong last-mile delivery”.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.

The condition affects 850 million people worldwide. However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.

With the in-licensing of the critical drug, Zydus will be importing the injection from Denmark to India.

The MonoFerric iron isomaltoside 1,000 solution for injection/infusion, is a rapid, single dose IV iron (up to 20 mg/kg body weight) developed to reduce the number of infusions required to achieve iron correction, the company said in a regulatory filing

MonoFerric is indicated for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

It is typically recommended for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

The company said MonoFerric is available in over 30 countries including the US and Europe and over 28 million doses have been administered since launch.

Zydus Lifesciences is a major pharma among key players in India for the treatment of nephrology segment and has added one more drug for CKD patients to its portfolio.

Earlier this year, the company received regulatory approvals from the drug controller general of India (DCGI), for its drug Oxemia, also used to treat patients with CKD-linked anemia.

More recently, the company is expected to begin with Phase-VI clinical trials for Desidustat – a drug used to treat chronic kidney disease (CKD)-induced anemia patients.

Other brands in the nephrology segment with a super-specialty portfolio with brands like Oxemia, Zyrop, Renocrit, Kbind, Grafalon, Tacromus and Mycomune.

In separate development, China has approved AstraZeneca’s Forxiga for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes.

According to AstraZeneca, Forxiga is now approved in 100 countries around the world including the US, where it is known as Farxiga, Europe, and Japan for the treatment of CKD in adults with and without type 2 diabetes.

The drug generated sales of US$1.1 billion in the second quarter, up 51% year-over-year.

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