Targacept scores $1.24 billion deal

Targacept, a Winston-Salem drug development company, has agreed to sell the rights for an antidepressant it is working on to British drugmaker AstraZeneca. The deal is worth up to $1.24 billion and adds to an existing partnership the two companies have had since 2005 to develop treatments for cognitive disorders.

Antidepressants generate about $20 billion in sales worldwide, but more than half of all patients don’t respond to the most commonly prescribed medicines.

This is the second large deal Targacept has signed with a British pharmaceutical giant. Two years ago, GlaxoSmithKline, which has its U.S. headquarters in Research Triangle Park, agreed to pay up to $1.5 billion for the right to experimental painkillers Targacept was developing. One of the painkillers failed a clinical trial and in March, Targacept mothballed it.

Under the GSK and the AstraZeneca deals, payments are dependent on how effective the drugs are.

Quintiles to add debt to pay dividend

Quintiles Transnational will take on more debt to pay the three private investment firms that are its largest owners a fat dividend. According to Standard & Poor’s credit research, the Durham-based company, which helps drugmakers test and sell new medicines, plans to sell $400 million in bonds next week, adding to an existing debt load of $1.2 billion.

The majority of the bond sale will benefit TPG Partners of Fort Worth, Texas, Bain Capital of Boston and London-based 3i Group.

TPG helped finance a $1.7 billion management-led buyout that turned Quintiles into a privately held company six years ago. Bain Capital and 3i became large investors in Quintiles in 2007.

AIDS researchers dare to speak of a cure

Dr. Myron Cohen, an infectious disease specialist at the University of North Carolina, dared to speak of a cure for HIV, the virus that causes AIDS.

A laboratory experiment gives him hope.

More on Cohen’s talk, which he gave on World AIDS Day in Research Triangle Park, here.

Quintiles scores kid and caboodle

Quintiles Transnational, a Durham company that helps drugmakers test and sell new medicines, has scored extensive contracts with British drugmaker AstraZeneca and Japanese drugmaker Eisai.

The AstraZeneca contract gives Quintiles responsibility for the majority of the drugmaker’s clinical pharmacology, which includes the composition of the new drugs and their side effects. The Eisai contract covers six experimental cancer drugs that the drugmaker wants to test on 11 tumors.

Drugmakers have long outsourced development of new drugs, but contracts with companies such as Quintiles used to be for just one drug or one clinical trials.

Quintiles is taking on whole programs to try to reduce the time it takes to bring new medicines to market.

Stiefel consolidates in RTP

Stiefel Laboratories, which was bought by British drugmaker GlaxoSmithKline for about $3 billion in cash, is closing its corporate headquarters in Coral Gables, Fla., and an operation in Duluth, Ga., to consolidate its business in Research Triangle Park.

Stiefel, which specializes in skin products, moved its research and development to RTP three years ago.

The consolidation following the deal with GSK will move a few Stiefel jobs from Florida and Georgia to RTP. But many of the 260 Stiefel employees in Florida and Georgia will be laid off.

Symposium identifies research gaps

RTI International organized its fourth symposium to identify areas that require more research. The RTI Fellows Symposium, which was held Monday and Tuesday at the University of North Carolina’s Friday Center in Chapel Hill, identified several areas lacking of scrutiny, including personal medicine, global warming and the role of biofuels.

Reports on some of the presentations:

• Genes as weather vanes for disease
• Global warming worries drive biofuels research

  Related to greenhouse gases, Amory Lovins, co-founder of the Rocky Mountain Institute in Snowmass, Colo., talked about his vision of lowering carbon dioxide emissions at Duke University Wednesday.

Patients grow wary of Tysabri

Concerns are on the rise about Tysabri’s side effects. The multiple sclerosis therapy, which Biogen Idec makes at its plant near Research Triangle Park, has been linked to more than a dozen cases of a potentially deadly brain infection called progressive multifocal leukoencephalopathy, or PML.

A few months ago, Biogen stopped reporting new PML cases, but during his third-quarter earnings call with analysts, Biogen’s chief executive acknowledged that the risk of developing PML seems to increase the longer a patient takes the drug.

The risk of coming down with PML has had an effect on patients and doctors. The number of new patients starting on the drug every week decreased slightly in the third quarter compared to the second quarter.

Biogen temporarily withdrew Tysabri from the market in 2005 and reintroduced the drug a year later with closer patient monitoring in place and with approval from the Food and Drug Administration.

BDSI goes on publicity blitz

BioDelivery Sciences International has been on a publicity blitz to appeal to institutional investors as Onsolis, a pain patch that is the Raleigh drug development company’s first product, hits the market.

Mark Sirgo, BDSI’s chief executive, rang the bell at the NASDAQ stock market’s opening and sat for interviews with TheStreet.com TV and The Wall Street Transcript in the past two weeks.

The effort hasn’t helped the stock – it’s down below $5 per share from a high of near $7 per share in June. But at least one analyst says he’s impressed. Matthew Kaplan, managing director of the health care group at Ladenburg Thalmann, told The Wall Street Transcript that he liked BDSI.

In other company news:

• Shareholders of Oxygen Biotherapeutics approve a 15-1 reverse stock split. The Durham drug development company hopes to get listed on a major exchange now that it boosted its stock price.
• A Korean company offered about $80 million to buy Trimeris, a Durham company that has shut down its lab and laid off all but a handful of employees. Sales of Trimeris’ AIDS drug Fuzeon continued to drop in the third quarter.
• Quintiles Transnational, a Durham company that helps drugmakers test and sell new medicines, launched a Web site, ClinicalResearch.com, to make it easier for patients to find a clinical trial.

Kennedy’s job duties will receive much attention at public education workshops Saturday at N.C. Central University in Durham. The workshops are hosted by the Center for Information and Study of Clinical Research Participation as part of the nonprofit’s East Coast campaign to get more people, particularly more minorities, interested in participating in clinical trials.

About 25 percent of all clinical trials are run by contract research organizations such as Quintiles, but over the next few years drugmakers are expected to farm out as many as 35 percent of all trials.

North Carolina’s Research Triangle area is home to more CROs than any other place in the U.S. Quintiles, which is based in Durham, is the largest CRO in the world and a strong supporter of CISCRP. Kara Lemons, a quality assurance manager at Quintiles, will participate on one of the workshop panels.

Kennedy told Science in the Triangle why the workshops, billed as Clinical Research Education Day, are so important.

Q: How big a problem is patient recruitment for clinical trials?

A: Difficulties in recruiting enough patients to enroll in clinical trials is the main reason why trials don’t start on time and trial results are delayed.

A lot of scary stories have been published about what can go awry in clinical trials. “I don’t want to give the impression that this doesn’t happen. But the scary stories aren’t always balanced. Controls are in place to govern clinical trials.”

There isn’t one big solution to make patient recruitment easier. The workshops are aimed at providing information about who oversees and monitors clinical trials and about patients’ rights to make people more comfortable about participating in clinical trials.

Q: What do you hope people will take away from the workshops?

A: “I would love to see the clinical trial experience demystified. If they want to participate in a clinical trial, there is so much information out there.”

Multiple regulatory layers exist to ensure patients’ safety and to protect their rights and their welfare. The layers include Food and Drug Administration inspectors, independent review boards and internal auditors at clinical research companies.

I hope the workshops raise public awareness about what it means for patients to have the right of informed consent. “So many people think of informed consent as a document you sign. It’s really a process that includes a lot of dialog.”

As part of that dialog, patients should be able to ask questions – What procedures will they undergo during the trial? What is the chance of getting the experimental medicine? What are the known or potential side effects of the drug? – and receive answers.

As a patient, “you must be able to make a decision without coersion.”

Q: Two studies published in the past week raise concerns that clinical research still lacks transparency. One study found that the results of fewer than half of the clinical trials sponsored by the pharmaceutical industry are published. Another study found that the published results of clinical trials oftentimes are different from what the trial was supposed to show. Any comments?

A: I haven’t read the studies and can’t comment on them. What I can say is that Quintiles follows all the requirements of publication of clinical trials.

Q: Why do people participate in clinical trials?

A: Some people feel it’s the only way to gain access to a new treatment. Others do it to serve the greater good, to help other patients. I participated in a clinical trial because I wanted to learn what it is like to be a patient.

“Everybody is doing it for different reasons. But you have to make sure it’s right for you.”

Purdue seized the grand opening of Quintiles Transnational’s new global headquarters in Durham to talk about a founder’s tax credit and small innovation research grants she said she wants legislators to pass during the ongoing session.

Quintiles Plaza, a 10-story-tall, environmentally friendly building befitting a company with nearly $3 billion in annual revenue, made for a good backdrop. Conceived in a trailer on the University of North Carolina Chapel Hill campus 27 years ago, Quintiles has become the largest contract research organization in the world. Of 23,000 Quintilians, as co-founder Dennis Gillings calls employees, about 1,700 work in the Triangle.

“There’s nothing that could have kept me away from this,” Perdue told a crowd of hundreds that had gathered for the grand opening. “This is the kind of company we want.”

Located at the gateway to Research Triangle Park, a North Carolina economic engine that was nothing but scrub pines and possums 50 years ago, Quintiles embodies the entrepreneurship that Perdue said she wants to foster with the proposed incentives. The tax credit, for example, would allow successful company founders to sell their stock without getting penalized for capital gains.

Especially biopharma research and nanotechnology are expected to spawn possible Quintiles of the future and North Carolina is dotted with research hubs in both fields from the Triangle to Charlotte.

As for Quintiles, the company that started as a small consulting business in 1974 grew quickly as pharmaceutical companies farmed out more and more of their drug testing. “We thought we hit it big time when we moved into a small house in Carrboro,” Gillings told the crowd at the grand opening.

Quintiles’ business continued to increase and the company has had a hand in the development of the 30 best selling pharmaceutical medicines and nine of the 10 best selling biotech drugs.

In 2006, about $25 million in state and local incentives convinced Quintiles to expand in Durham and move into a new  headquarters building. The expansion was projected to create 1,000 new jobs in the Triangle by 2012.

So far, more than 400 employees have been added, Gillings said. “We’ve come a long way, baby, from that trailer.”