November 1, 2010 (Vol. 30, No. 19)

Momentum Building as More Companies Are Founded and Products Steadily Advance

A functional therapeutic that reduces both blood cholesterol and ingested cholesterol was introduced by AB-Biotics  at last month’s “BioSpain” conference in Pamplona. Called AB-Life, this probiotic therapy reduced these two types of cholesterol by 14%, according to Miquel Àngel Bonachera, executive director.

This therapy is composed of three strains of Lactobacillus plantarum that, in the stomach, attach to the intestinal mucosa and colonize the small intestine. There, they incorporate the dietary cholesterol into the bacterial membrane and metabolize it. Levels of enterohepatic cholesterol are minimized by reducing the circulation of bile salts.

AB-Biotics, which went public this year, is one of many Spanish biotechs that have spun out of universities in the past five or six years and are joining a handful of more established pharmaceutical firms in the bid to build a strong biotech industry in Southern Europe. ASEBio—the Spanish Association of Bioenterprises—reports that 58 new companies were created in 2009.

The Spanish biotech industry has more than doubled during the past five years, and a hefty number of products—therapeutics, devices, and diagnostics—have advanced into clinical trials or clinical validation. A smaller number have been commercialized.

AB-Biotics’ first commercialized genotyping product, Neurofarmagen, is a DNA chip that uses saliva to assess the response to medications used to treat psychiatric diseases. The technology is being extended to other conditions, including certain types of cancers.  

Neuron BPh, established in Granada in 2006, focuses on neuroprotectants. “The current drugs are ineffective for Alzheimer and some other neurological diseases, and diagnosis is made long after the causative events. There are no symptoms for years,” Javier Burgos, Ph.D., biopharma unit director, pointed out.

The company has identified approximately 1,000 approved drugs that have the potential to be repurposed as neuroprotectants. Neuron BPh has two therapies in Phase II trials, three in Phase I, and proof of concept in another.

Vivia Biotech  has developed a rapid, automated, personalized medicine test for therapies targeting hematologic cancers such as leukemia, lymphoma, and multiple myeloma.

Joan Ballesteros, Ph.D., chairman and CSO, says the as-yet unnamed assay uses the ExviTech platform and is expected to go to market in about one year. “Applications include drug development, diagnostics, and reducing costs of clinical trials,” Dr. Ballesteros said. The device uses a flow cytometer and can reportedly screen 12 drugs, for up to 20,475 combinations of drugs and doses in a single blood sample, completing in 24 hours what otherwise could take one year.

Algenex  is developing insects as biofactories, eliminating the fermentation step from the production of recombinant proteins and thereby reducing the health risks associated with the use of mammalian systems. According to José Ángel M. Escribano, Ph.D., co-founder and scientific advisor, protein is being produced using a baculovirus expression system to introduce a foreign gene into insect larvae. Algonex has produced at least 80 different proteins in this expression system.

The system is “very economical,” Dr. Escribano reported. “It takes three months to establish a production plant.” As he explained, 500 out of 1,000 individuals, are females. Within three weeks there are about 125,000 females and after about six weeks, 31 million females, “so we can increase productivity in a short time.”

This technology produces 1,600 times more product than when mammalian cells are used, he emphasized. The Algenex pilot plant can produce 450,000 ELISA plates, or 1.2 million immunoblotting tests, or up to 1.5 million vaccine doses per week. In addition to being considered a “clean” technology, he said that although recombinant technologies are available only to wealthy nations, “this is available for all economies.”

During a panel discussion of international technology commercialization, Arturo Azcorra, Ph.D., managing director of the Centre for the Development of Industrial Technology (CDTI), Ministry of Science and Innovation, noted that Spain has designated biotech “a strategic sector” and devoted 14.8% of its budget toward research.

Dr. Azcorra said that most countries have regulations similar to the U.S.’ Bayh-Dole Act of 1980. Therefore, he described challenges in Europe as “fragmentation of EU regulations and overregulation of the market itself. Any legal agreement is more complex because lawyers in each country are involved. Europe has to become more cohesive.”

Legal and regulatory cohesion is particularly important because “tech transfer is a global activity,” noted José María Fernández Sousa-Faro, Ph.D., president of ASEBio and of the Zeltia Group. Therefore, “we need worldwide licensing rights.” 

Zeltia is a well-established pharmaceutical company, holding license agreements with organizations throughout the world. According to Dr. Fernández Sousa-Faro, there is no single formula for tech-transfer success, and little uniformity among transferring organizations—even among similar organizations within the same country. Creative negotiation is pivotal to success, he suggested. For example, although some entities may find a 2% royalty upon project completion untenable, they instead may arrange to bring students to their organizations for training.

To facilitate tech transfer, Jenny Hunt Cervera, executive vp of discovery and analytical sciences and corporate development for Research Triangle Park, suggested that companies and universities partner to bundle patents into logical portfolios to make them more attractive to prospective licensees. Panelists also advised emphasizing translational research as well as cross-disciplinary research such as the Drug and Device Development Center being established in Spain.

In terms of financing, one of the challenges is that university licenses are often in the early stages, without proof of concept data. “That’s a big problem. There are long development periods between beginning investments and profits,” Dr. Azcorra said.

“The CDTI is trying to help Spanish companies with research,” by creating venture capital funds. Two venture capital funds have been created, according to Dr. Azcorra. Neotech, a financing mandate created by the CDTI and the European Investment Forum about four years ago, provides a “fund of fund” and a co-investment vehicle.

More recently, the Ministry of Science and Innovation established a €150 million fund for technological investment. Because the fund will also work with private investors, between €400 million and €600 million will be available for Spanish venture capital, Dr. Azcorra predicted. “It’s not partitioned by sector,” he added, although, “we expect biotech to receive a significant amount of the funding.”

“It’s important to let companies know what’s going on at public centers, and vice versa, regarding grants for collaborations between companies and public centers, incentives, and partnership opportunities,” Dr. Fernández Sousa-Faro added.

Vivia Biotech is developing companion diagnostics for therapies targeting hamatologic cancers.

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