Ex-Ranbaxy Laboratories Executives Set Up Their Own Venture Bion Pharma In NJ
Published: Nov 12, 2014
November 12, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Five executives who left Ranbaxy Laboratories’ U.S. division in October have formed their own new company, dubbed Bion Pharma. The new venture will be a “one-stop shop” headquartered in Princeton, N.J. to assist pharmaceutical and biotech companies in securing regulatory permissions and distribution deals for Indian and European companies wishing to work in the U.S.
The team will include former Ranbaxy U.S. CEO Venkat Krishan, former Ranbaxy CFO Gaurav Mehrotra, Bill Winter, head of sales, Lavesh Samtani, the former legal director of Ranbaxy, and Phanindranath Punji, former head of supply chain management.
“The core team collectively possesses more than 10 decades of varied experience and has navigated through some very excruciating circumstances, including enforcement actions, import alerts and other similar hurdles,” Krishnan said in an interview with The Economic Times. “As a team, we have been instrumental in launching some very large value products in this background and we will bring all these experiences to effectively build the businesses of our partners, helping them learn about every aspect of this market.”
Ranbaxy had numerous difficulties, including having its manufacturing facilities banned from importing drugs to the U.S. It also paid enormous fines in the hundreds of millions of dollars for manufacturing malpractices. In April 2014 it was announced that Mumbai-based Sun Pharmaceutical Industries Limited was purchasing Ranbaxy Laboratories from Japan-based Daiichi Sankyo for $3.2 billion.
In January 2014, Ranbaxy’s API plant in Toansa, India was hit with a U.S. import alert, the second Ranbaxy facility to receive a warning. Four of the company’s five FDA-approved facilities were barred from selling to the U.S. “The quality of business at Ranbaxy is in no way inferior to business at Sun Pharmaceutical,” Sun Pharma Managing Director Dilip Shanghvi stated to Reuters in April. “Our focus will be to address the issue of achieving compliance. We are not looking at synergies of manufacturing; the focus is to achieve compliance.”
Last week the U.S. FDA revoked its tentative approval for Ranbaxy Laboratories to exclusively market generic versions of Roche ’s Valcyte and AstraZeneca ’s Nexium. In a statement, Ranbaxy said, “In FDA’s view, Ranbaxy hash forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets (Valcyte).”
On a more positive note, they did launch generic versions of Pfizer ’s Lipitor and Novartis ’ Diovan under a six-month exclusivity window.
“These concerns have made customers, retailers, distributors here wary and apprehensive about India-based companies in general and more specifically about new players wanting to enter the US market,” said Krishnan in a statement regarding his new venture. “Our longstanding relationship with customers can help bridge these gaps of apprehension.”