Enzymes get cheaper and better

After 10 years of work, Novozymes announced it can make enzymes that brings down the production costs of  cellulosic ethanol to below $2 per gallon. The enzymes, called Cellic CTech2, have shown to work in corn cobs and stalks, wheat straw and woodchips.

All commercially available fuel ethanol is made by turning the starches in corn kernels into sugar. The goal has long been to switch from corn, which is also a food source, to biomass waste such as corn stalks and woodchips. But the cost of the enzymes that break down the cellulose in biomass to sugar has always been too high for cellulosic ethanol to compete with gasoline and corn ethanol at the pump.

Novozymes is a Danish enzyme producer with a large production plant at its U.S. headquarters in Franklinton, north of Research Triangle Park. Part of the research to bring down the cost for Cellic CTech2 was done in Franklinton, but marketing director Poul Anderson told Transport & Logistic News that the enzymes will be produced at Novozymes’ proposed Nebraska facility.

Horizant raises safety concerns

An experimental restless leg treatment that GlaxoSmithKline, a British drugmaker that has its U.S. headquarters in RTP, developed with a California partner fell short of regulatory approval because of safety concerns.

The Food and Drug Administration raised questions about pancreatic tumor cells in rats that were found in preclinical tests of the drug, which goes by the name Horizant and is a longer-lasting version of an epilepsy drug that is already on the market. The epilepsy drug was approved despite having raised similar safety questions, because the seriousness of the condition it treated justified the risk.

A Jeffries analyst estimated that Horizant could have generated up to $500 million in annual sales.

Hamner establishes ties to Norway

The Hamner Institutes for Health Sciences, an RTP research institute, set up a second partnership to help biotech companies overseas speed up their drug development.

A few months ago, the Hamner established ties to China, now a link to Oslo, Norway, and one of the leading European clusters to develop cancer treatments followed.

As part of the emerging international network, the Hamner will provide the Norwegians access to three comprehensive cancer centers located in North Carolina, the Shanghai Center for Disease Control, and Tianjin Institute for Hematology. Training and education will include post-doctoral training in innovative drug safety technologies, business training for entering the U.S. market, and regulatory training for compliance with FDA standards. Oslo will contribute its research and Phase I resources and potential access to its own growing European network of collaborators.

Liquidia’s nanotechnology attracts more investors

Liquidia Technologies completed a third round of fundraising that added $20 million to the about $30 million in venture capital the Durham company had previously received from investors. The new cash will help get Liquidia’s first vaccine into clinical trials faster.

Founded in 2004, the company is developing nanotech delivery systems that use a material developed at the University of North Carolina at Chapel Hill. The material is a clear, nonstick liquid at room temperature and hardens when exposed to ultraviolet light. Liquidia uses the material to make molds for particles so tiny, they’re small enough to slip into a human cell.

The goal is for the nanotech particles to deliver medicine more safely and effectively than pills, injections and inhalers.

Roche sets up a technology pipeline to RTP

Dani Bolognesi

B3Bio, a biotech startup in Research Triangle Park, signed a deal with pharma giant Roche that could turn the company into a brain trust of cutting-edge technologies.

The deal allows b3bio, a two-year-old company with 10 employees, to be Roche’s eyes and ears for drug development and delivery technologies that are in the works at universities. Technologies that suit both partners could then be nurtured at the Hamner Institutes for Health Sciences, where b3bio has its labs, before they are turned over to Roche for further development, said Dani Bolognesi, co-founder and chief executive of b3bio.

Bolognesi declined to talk about financial details of the deal. But as an incubator of new technologies, b3bio stands to gain from successful projects, particularly if Roche decides to buy the rights to a technology, he said. Other large drugmakers could follow Roche and become partners. Also, b3bio might add a technology it incubates to its own drug development efforts.

Read more here.

Inspire’s dry eye drug fails a third test

Prolacria’s record is now 2-in-3. The dry eye drug that Inspire Pharmaceuticals, a Durham pharmaceutical company, has been trying to get to market just failed its third late-stage clinical trial.

Inspire, which specializes in ophthalmic medicines, has spent more than $20 million on late-stage testing to get regulatory approval for Prolacria. About 2,500 patients have participated in the five tests. Following the second failed trial in 2005, Inspire negotiated for years with the Food and Drug Administration before an agreement was reached on two clinical endpoints – the measurements that would determine whether the drug would pass or fail the latest test.

When the test results from the fifth trial came in, Prolacria had failed to meet both key measurements.

Dani Bolognesi

The deal allows b3bio, a two-year-old company with 10 employees, to be Roche’s eyes and ears for new drug development and delivery technologies that are in the works at universities. Technologies that suit both partners could then be nurtured at the Hamner Institutes for Health Sciences, where b3bio has its labs, before they are turned over to Roche for further development, said Dani Bolognesi, co-founder and chief executive of b3bio.

Bolognesi declined to talk about financial details of the deal. But as the incubator of new technologies, b3bio stands to gain from successful projects, particularly if Roche decides to buy the rights to a technology, he said. Other large drugmakers could follow Roche  and become partners. Also, b3bio might add a technology it incubates to its own drug development efforts.

“The diversification is a real opportunity for us,” Bolognesi said. “I’m happy [Roche] picked us.”

Bolognesi has worked with Roche before. In fact, the deal is the latest collaboration in a relationship that goes back a decade.

In 1999, Roche teamed up with Trimeris, then a Durham biotech company developing a novel HIV/AIDS drug. Bolognesi, a pioneer AIDS researcher at Duke University, headed Trimeris. Fuzeon came to market in 2003 and Roche still makes and sells the drug. But  the drugmaker ended its research collaborations with Trimeris in 2007, a few months after investors ousted Bolognesi in a radical restructuring.

In 2008, Roche again collaborated with Bolognesi. This time to get a shot at a technology b3bio was working on. The technology was developed at Duke and the University of Texas and Bolognesi and Robert Bonczek, Trimeris’ former chief financial officer, set up b3bio to see whether it could be used to develop a new class of therapies for cancer, inflammation and infection.

The second deal with Roche, which b3bio announced Thursday, also builds on Bolognesi’s network of university contacts and his and Bonczek’s experience to take a novel medicine from bench to bedside. But it goes way beyond the previous collaborations. Essentially, Roche is looking to b3bio to take over part of its research and development efforts.

“It’s broad, not an extension of what we [already] do,” Bolognesi said.

In that, Roche is not alone. Large drugmakers, including GlaxoSmithKline, which has its U.S. headquarters in RTP, are relying more and more on discoveries they license from other companies. With the b3bio deal, Roche has now established a direct pipeline to an outside incubator.

A lot of large drugmakers are scaling back their own discovery efforts, Bolognesi said. “The ability to source them is a way a lot of companies are thinking right now.”

Tranzyme signs partnership with Bristol-Myers Squibb

It’s a deal that both companies needed and that will add 10 to 12 jobs in the Research Triangle Park area.

Tranzyme Pharma, a Durham drug develop company that employs 25, had been looking to raise at least $30 million to get its first drug to market. (More on that here.) The deal with Bristol-Myers Squibb will net Tranzyme $16 million in the next two years. But if the partners are successful in finding new medicines, developing them and bringing them to market, the deal could be worth hundreds of millions of dollars.

To expand discovery and early development work under the partnership, Tranzyme plans to add 10 to 12 employees.

Like other large drugmakes, New York-based BMS is facing serious generic competition. In the next five years, the company stands to lose about 37 percent of its sales as two of its biggest sellers go off patent and compete with cheaper generic copy cats. The deal with Tranzyme offers BMS hope to find replacements for its product lineup.

In other business news:

• Credit Suisse will start hiring 300 at its RTP operations, where the Swiss banking giants already employs about 1,000.
• Quintiles Transnational raises $525 million on the bond market to pay its large stakeholders a fat dividend.
• Swiss ag biotech company Syngenta, which develops all of its new biotech crop seeds in RTP, added 100,000 square feet to the about 200,000 square feet it already had in RTP and agreed to buy 50 acres for future expansions.

RTI receives $101 million contract to reduce malaria

Anopheles mosquito having a meal.

RTI International, a research institute in RTP, received a $101 million contract from the U.S. Agency for International Development to fight malaria in Africa.

Under the contract, RTI workers will spray the inside walls of homes to kill anopheles mosquitos, which carry the parasite that causes malaria and transmit it to humans.

Foom 2006 to 2008, about 6 million homes in 11 African countries were sprayed. Under the new contract, the effort will be extended to a dozen.

The five-year program aims to cut the malaria-related childhood mortality in 15 African countries in half. Malaria kills more than 1.2 million people every year and causes worldwide economic losses of $12 billion.

In other research news:

• RTI researchers calculated the cost of mandatory CO2 emission reductions. (More about that here.)
• The 15 percent of adult Americans with a disability account for 27 percent of U.S. adult health-care spending. (More about that here.)
• Dr. Ronald Kahn of the Joslin Diabetes Center visits RTP to talk about digging for the roots of diabetes, and UNC researchers stumble over a genetic marker for diabetes in African-Americans. (More about that here.)

Researchers team up to probe drug side effects

David Threadgill

Dr. Paul Watkins

Dr. Paul Watkins, a liver toxicity expert at the University of North Carolina at Chapel Hill and a founding member of the Hamner-UNC Institute for Drug Safety Sciences in RTP, is teaming up with David Threadgill, head of the genetics department at N.C. State University, to study why some patients have serious liver reactions to otherwise safe drugs.

The two researchers were awarded a $1 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases to conduct their work.

For the two-year project, Watkins and Threadgill will use a specially bred mouse that represents the genetic diversity in the human population. The researchers expect to uncover genetic risk factors that could lead to tests to identify patients at risk and improve the safety of future medicines.

That’s what Rick Williams, chief business officer at the Hamner Institutes of Health Sciences, thinks. (Photo at right.)

China, which has a great scientific heritage, is establishing about 100 research parks, about half of them the size of Research Triangle Park. Large pharmaceutical companies, including GlaxoSmithKline, have begun to take notice, setting up shop and shifting research and development jobs to China.

The Hamner has also staked its claim in one of them. In May, the Research Triangle Park-based research center established a partnership with China Medical City, the largest medical research park in China.

North Carolina’s Gov. Beverly Perdue not only announced the deal, but last month she went on an economic development mission to China, which is already one of the state’s largest trading partners.

Following a one-year crash course in learning about China, which included three trips there and visits from eight Chinese delegations, Williams acknowledges that challenges remain. He compares China to a combination of the Gold Rush and the Wild West – an assessment shared by William Zarit of the U.S. Commercial Service, the trade promotion unit of the International Trade Administration. At a business forum in Raleigh four months ago, Zarit said that ”China is not for sissies.”

But focusing on business development, translational research and labor force training, Williams said, “will lead to long-term economic development opportunities for North Carolina with China.

“These opportunities will begin with the Research Triangle Park,” he said, and then expand to research parks in the Triad, Kannapolis and western North Carolina.

Listen to a podcast of Williams’ thoughts about China at: www.thehamner.org/docs/Rick_Williams_-_China_podcast.mp3

The research lab is the first result of a partnership between the University of North Carolina at Chapel Hill and the Hamner Institutes of Health Sciences, which was estbalished last September with about $10 million in funding.

On the tour, scientists from the Hamner and UNC explained how they are trying to better understand rare but potentially fatal side effects new medicines may have. The goal is to detect the risks specific drugs pose to certain people before the drugs come to market.

The research lab plans to initially look into liver toxicity and then expand into cardiovascular and kidney side effects.

The FDA currently receives about 250,000 reports of serious and unexpected side effects drugs have on people every year, Woodcock said. Regulators have begun to require diagnostic tests that screen out patients particularly at risk for some of the side effects. Also, the FDA is setting up a drug safety surveillance system that taps elecrtonic health records.

But generally, the FDA is limited to listing all possible side effects of a drug in the packaging information even though some patients might be more at risk and should worry more than others.

Headed by Dr. Paul Watkins, a UNC professor of medicine, the Hamner Institute for Drug Safety Sciences will draw from  three decades of experience Hamner scientists have accumulated about chemicals’ health effects, a new approach in animal testing, access to genetic information and patients at risk for side effects and a virtual liver, a computer-based simulation of drug-induced liver injuries.

The brand new research lab at the Hamner, which features sophisticated equipment and row upon row of lab benches, has already begun to work with the Shanghai Center for Disease Control to conduct a study in patients who have experienced liver toxicity as a result of taking tuberculosis treatments.

For the first time, Woodcock said, “the science to reduce the worldwide drug safety problem is at hand.”

The partnership with China Medical City, a RTP-size research park the Jiangsu provincial government is establishing about three hours north of Shanghai, also aims to bring Chinese investment and jobs to North Carolina.

The partners will create an institute for international drug development on the Hamner’s campus to focus on preclinical drug development and compliance with U.S. regulatory standards. New technologies that are validated on the Hamner campus will then be transferred to China Medical City.

Newsummit Biopharma, a China Medical City partner, will establish its North American business center at the Hamner. The contract research company has business relationships with other science and technology parks in China. It’s offices will be in the Hamner’s bioscience accellerator, which opened last year and is home to two startup companies: BioMedomics, a diagnostics company started by a Chinese-American scientist, and b3bio, a Duke University spinoff.