Validus chooses Ranbaxy as partner to sell calcium deficiency drug generic calictriol in US

Ranbaxy Pharmaceuticals Inc has been selected by Validus Pharmaceuticals LLC as its marketing partner for  distributing an authorized generic version of calcitriol in both softgel capsules and an oral liquid formulation in US.

Calcitriol is currently marketed by Roche in the brand name Rocaltrol in US. Rocalcitrol softgel capsules and oral liquid are having a market size of $70 million, as per IMS – MAT, June 2009.

Calcitriol is a synthetic vitamin D analog. Calitriol regulates of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, parabens (methyl and propyl) and sorbitol.

Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure not yet on dialysis, and in the management of hypocalcaemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis.

Calicitriol is also indicated in the management of hypocalcaemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypo-parathyroidism.

“Ranbaxy was very pleased to be selected by Validus as their distribution partner for an authorized generic version of Rocaltrol. This product represents an excellent commercial opportunity for Ranbaxy which will increase our visibility and presence in the U.S. healthcare system,” said Jim Meehan, vice president of Sales and Distribution for RPI in a report.

Ranbaxy expects to be the only generic company offering all forms and strengths of generic Rocaltrol. Ranbaxy will launch the product immediately to all classes of trade in the US market.

Recently, Ranbaxy recalled one batch of its acne drug Sotret (isotretinoin) from the US market, following US FDA recommendation. Sotret Isotretinoin is used for treating skin infections including acne.

Ranbaxy Pharmaceuticals Inc is a wholly-owned subsidiary of RanbaxY India.

Ranbaxy, in which Japan’s Daiichi Sankyo owns about 64 percent, posted losses because of wrong-way bets on foreign- currency hedges as the Indian rupee weakened against the dollar for the fifth straight quarter.

Ranbaxy’s sales in the US, the world’s largest drug market, also dropped 14 percent.

Ranbaxy Laboratories Ltd reported net loss of 7.78 billion rupees ($156 million) in its fiscal first quarter ended March 2009, compared with a profit of 1.03 billion rupees in the year-ago quarter.

Ranbaxy Laboratories Ltd also said it anticipated a loss of $150 million on sales of $1.4 billion in the year ending December 2009.

Ranbaxy’s sales in North America, which accounts for about 27 percent of Ranbaxy’s revenue, fell 7 percent to 4.04 billion rupees in the fourth quarter of financial year 2008-2009. Sales in the U.S. declined to 3.4 billion rupees. Ranbaxy also said sales dropped 14 percent in Europe, and gained 9 percent in India.

Ranbaxy reported 9.19 billion rupees as losses on foreign-currency options before tax. The company also wrote down the value of convertible bonds due 2011 as the Indian currency weakened 3.9 percent against the dollar in the three- month period, its fifth straight quarterly decline.

Validus Pharmaceuticals LLC is focused on acquiring, developing and marketing effective, underutilized branded products in specialty therapeutic areas.