Lupin, one of India’s largest pharma companies, said it has signed an agreement with mid sized firm Natco to market the generic version of Fosrenol(r) tablets, that are used to treat chronic kidney ailments. Although India is a key market for the product, the drug is reported to have totalled $108 million in sales in the US in December 2008.
The agreement with Lupin will also help Natco fight a patent lawsuit that Fosrenol(r) innovator, Shire, a UK-based company, had filed recently, said a Natco spokesperson. Shire had filed the lawsuit in response to an abbreviated new drug application (ANDA) filing by Natco seeking US FDA approval to market and sell the generic versions of Shire’s 500 mg, 750 mg and 1g Fosrenol (r) tablets.
Shares of Lupin were down marginally at Rs 652.50 in intraday trade on the BSE, while Natco Pharma surged 6.3% to Rs 55 on the BSE. Fosrenol is a drug used for hyperphosphatemia, a chronic kidney disease that leads to abnormally elevated levels of phosphate in the blood.
Both Lupin and Natco say they are amongst one of the first to file for an ANDA which would lead to 180 days exclusivity that would allow only the two Indian firms to sell the generic versions.
"The alliance creates synergies that will enable portfolio expansion and contribute to consolidating our presence in the US markets," said Lupin group president and executive director Nilesh Gupta. "Lupin's proven IP management capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make for a great combination."
According to Natco Pharma COO Rajeev Nannapaneni: "Our alliance brings together a strong philosophy of working together to maximize opportunities in an increasingly competitive generic business. We are very happy to be associated with Lupin, given their intellectual property management competencies and market strengths in the US."