FDA clears Olerup SSP’s Taq-polymerase-free HLA typing kit for sale in the U.S.

Sep 15 2009

Regulatory News:

Olerup SSP, a wholly owned subsidiary of LinkMed (STO:LMED), has had its Taq-polymerase-free HLA typing kit registered and cleared by the FDA. This means that Olerup SSP’s entire product range for HLA typing, with or without Taq polymerase, can now be marketed and sold to a greater number of healthcare centers in North America. The U.S. is the single largest market for HLA typing and represents over 40 percent of the global tissue typing market. Olerup SSP’s HLA typing kit with Taq polymerase has been approved by the FDA for sale in the United States since March 2009.

“Olerup SSP’s products are currently being re-launched in the U.S. market since Olerup International took over the distribution of products from Qiagen, so the FDA decision is very timely,” said Olle Olerup, founder and CEO of Olerup SSP.

FDA registration is furthermore an important step in working up a market in the U.S. and opens the door for sales in South America.

The typing kit is marketed and sold by Olerup SSP’s distributor Olerup International, a company that acquired the distribution rights from the previous distributor Qiagen this summer. Olerup International has two wholly owned subsidiaries, Olerup GmbH based in Vienna, and Olerup Inc based in West Chester, Pennsylvania, from where the company manages marketing and sales in the North American market. Olerup Inc. is also responsible for sales of the AbSorber’s product XM-ONE® in the U.S. Olerup International is owned by LinkMed, together with the Norwegian biotechnology company NorDiag and Olle Olerup’s company SSP Primers.

Olerup SSP is the world leader in the development of kits for genomic HLA typing, which is used prior to transplantations to match donors with recipients. Better matching reduces the risk of complications following transplantation. HLA typing is a standard procedure in bone marrow transplantation (hematopoietic stem cell transplantation) but is also used in organ transplantations (kidney, lung, heart, and others).

Olerup SSP had sales of SEK 43 million for the period January to June 2009 and reported an EBIT profit of SEK 25 million. The company was founded in 1992 by Professor Olle Olerup and has a total of 23 employees. Since July 2008, Olerup SSP is 100 percent owned by LinkMed.

LinkMed develops life-science companies in collaboration with innovators and other financiers. By contributing management expertise and capital, LinkMed has created a portfolio of thirteen companies, four in drug development and biotechnology and nine in diagnostics and medical technology. The largest shareholders are FastPartner, Mohammed Al Amoudi, and Koncentra. LinkMed is listed on the NASDAQ OMX Nordic Exchange in the Small Cap section (ticker: LMED).

www.linkmed.se