Friday, May 4, 2007

Spain's Biotech Revolution

Continued from Page 6

Growing New Companies
Though Spain has a number of home-grown pharmaceutical companies, as well as a few companies formed in past decades that focus on biotechnology, the most significant increase in companies formed has taken place in only the last five years.
One of the most prominent examples of this new growth is Genetrix, formed by Cristina Garmendia (who also heads the Spanish biotech trade association ASEBIO). Genetrix spun off from the CNB in 2001, when Garmendia realized that while Spain produces a significant amount of quality research, there were limited paths to commercialization. She came to an agreement with the Spanish Research Council to buy a number of patents. The company began acquiring patents and building a base of widely varied services and research. Today, Genetrix has given rise to seven other spinoff companies.

“When I first joined, a year ago, we had 50 or 60 employees,” says Claudia Jimenez, who is in charge of the company’s corporate development. “We’re already up to 100. And every month there are two or three new faces in the office.”

In new labs being constructed for the spinoff Cellerix, the most advanced company in the Genetrix family, researchers walk around covered from head to toe in white, with white caps covering all exposed hair. They’re preparing a new lab to work with adult stem cells. This is the only company in Spain with the authority to produce stem cells suitable for use in medicine.

Cellerix has two different lines of research. One, in clinical trials, uses stem cells from fat tissue commonly found in the abdominal region to treat complex perianal fistulas. There is currently no truly effective treatment for these fistulas, which occur when an opening forms between two passages in the body in the course of a variety of diseases, particularly Crohn’s disease. “The only treatment today is surgery, and in most cases the fistula reappears after surgery,” says Gabriel Marquez, vice president of research at Genetrix. “Plus, the surgeon almost always has to cut the sphincter muscles, so there’s practically a 100 percent guarantee that the patient will suffer from incontinence.”

In the treatment that Cellerix is studying, adult stem cells are isolated from the patient through liposuction, cultivated, and then implanted in the patient. In trials, this therapy has healed the ruptures. This is one of the most advanced studies using adult stem cells from easily obtained lipids (as opposed to bone marrow, for example) for therapeutic purposes.

A second line of Cellerix’s research, also in clinical trials, is devoted to the rare skin disease epidermolysis bullosa, in which patients lack a critical protein. Even slight contact can cause the patient to literally lose skin. The skin substitutes in use today are not transplants and must be periodically replaced. ­Cellerix is developing a transplant consisting of a mixture that includes cells from the patient’s epidermis and cells from healthy, compatible donors. The company has already achieved clinical proof of concept.

Working with adult stem cells is so new that the Spanish government has had to develop new regulations for this type of research. Even among European regulators, such research raises questions. “We are one of the few companies in Europe working with adult stem cells,” says Marquez, “so the EMEA, which is the European FDA, calls us to give our views on the research. The whole field is so new that even the regulators have to figure out how to regulate.”

Another Genetrix company, ­Imbiosis, has developed a novel method for detecting gluten. This is important to food processors in marketing to patients with celiac disease, which makes them sensitive to gluten. The company Sensia is creating a small, easy-to-handle biosensor to detect tiny amounts of a given compound in the environment.

With a handful of years of experience in starting biotechnology companies, Genetrix is also becoming a service company, starting to offer professional assistance to outside
startups in, for instance, patenting, business development, and human resources. And the company has created something of a buzz in the biotech world. “Now, people come to us from the academic world to tell us about their data,” says Marquez. “They want to know if we’re interested in licenses or patents, or helping them go ahead with preclinical testing. We’ve managed in recent years to create real credibility.”