By Randall Osborne
SangStat Medical Corp., which develops treatments for patients undergoing organ transplants, continued "advanced" talks aimed at the acquisition of Imtix, the transplant-focused business unit of French vaccine maker Pasteur Merieux Connaught (PMC).
"There are no obstructions whatsoever at this stage, and we're confident of the outcome," said Philippe Pouletty, chairman and CEO of Menlo Park, Calif.-based SangStat.
The proposed cash buyout of Imtix would involve an upfront payment by SangStat and installments over five years, plus royalties "over a number of years which would vary depending on sales volumes," Pouletty said.
Subject to various legal requirements, the deal could be nailed down in the second quarter of this year, with closing in the third quarter.
"Under French labor law, [PMC] must consult with the labor union to inform them of ongoing negotiations and give workers time to ask questions," Pouletty said. "This is not to say the labor union has any veto power, but it's important they are consulted in the matter."
Imtix, of Lyon, France, has about 80 employees. The company is expected to generate up to $28 million in sales this year, and its established European sales force is important to SangStat, Pouletty said.
"That's where Imtix is very strongly positioned," he said. "They have about 25 people in the marketing and sales channel."
Products are manufactured in Lyon and distributed by PMC affiliates in more than 60 countries outside North America.
SangStat's Thymoglobulin License From Imtix
In 1993, SangStat licensed from Imtix the North American rights to Thymoglobulin (rabbit antithymocyte polyclonal antibody) for acute transplant rejection and Celsior, an organ preservation solution.
"Certainly, it's a much bigger step we would be taking [with the acquisition], but the fact that the two companies have been working together was very useful."
The FDA issued a "complete review" letter for Thymoglobulin in January. SangStat and PMC said they would respond to the FDA's questions about the product license application, after which the companies could receive marketing clearance.
SangStat expects to file an application with the FDA for Celsior marketing clearance later this year.
In February, the FDA sent SangStat a "minor deficiency" letter related to the company's marketing application for cyclosporine as a treatment for chronic transplant rejection. The company responded to questions by the FDA and is awaiting further word.
Also in February, SangStat filed in Europe for cyclosporine marketing clearance.
"Right now, we're mostly talking about the U.S. side," Pouletty told BioWorld Today. "Within a three- to six-month time frame, we could have two products launch in the same [treatment] segment — Thymoglobulin for acute transplant rejection and cyclosporine for chronic."
SangStat's formulation of cyclosporine is called Sang-35. The company filed with the FDA for clearance of the drug as bioequivalent to Neoral, the formulation marketed by Basel, Switzerland-based Novartis AG, with worldwide sales of $1.3 billion last year.
Imtix's product portfolio includes Lymphoglobuline, a horse-derived polyspecific antibody which, like Thymoglobulin, is already distributed in Europe and other countries; Odulimomab (anti-LFA-1), currently in Phase III evaluation for preventing delayed graft reaction in transplant patients; and Celsior.
PMC, the world's largest vaccine company, is part of the Paris-based Rhone-Poulenc Group.
As of Dec. 31, 1997, SangStat had $92 million in cash, with a net loss for the year of $20.9 million. The company's stock (NASDAQ:SANG) closed Wednesday at $32.50, up $1.687. *