Research and development spending dollars reached a record $67.4 billion in 2010, a $1.5 billion increase compared with 2009.
North Carolina’s life science companies are certainly part of that mix. A look at the annual reports from public companies in the state shows that many of them are indeed pouring money into R&D.
The U.S. R&D figures were calculated by the Pharmaceutical Research and Manufacturers of America, the trade group known as PhRMA, along with life sciences merchant bank Burrill & Company. The Burrill analysis shows that over the past decade, U.S. biopharmaceutical research companies have consistently invested about 19 percent of domestic sales into R&D. Last year, that figure climbed to 20.5 percent.
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Most of the North Carolina companies don’t have commercialized products and instead get their revenue from grants, milestone payments and licensing agreements. It’s difficult to find any discernible trend from a snapshot frozen in time. At any given moment, companies might be ramping up or winding down development programs depending on the progress they’ve made and the success or failures they’ve experienced in their efforts to bring to market the next medical breakthrough.
Here’s a look at the R&D spending from 13 public life science companies either headquartered in North Carolina or with major operations in the state.
BioDelivery Sciences International (NASDAQ: BDSI)
R&D spending 2010: $10.6 million
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R&D spending 2009: $10.4 million
Where the money went: The Raleigh, North Carolina pharmaceutical development company develops products that distributes medicine through a small piece of film that dissolves when placed inside the cheek. Most of BDSI’s 2010 R&D spending went to work on BEMA Buprenorphine, which will deliver the drug bupenorphine to patients with chronic pain. BEMA Buprenorphine is currently in late stage clinical trials. The company recently secured commitments for an additional $15 million for pipeline development.
BioCryst Pharmaceuticals (NASDAQ:BCRX)
R&D spending 2010: $82.4 million
R&D spending 2009: $72.3 million
Where the money went: The Durham, North Carolina drug developer is now in phase 3 clinical trials for its lead candidate, Peramivir, a flu treatment. The drug candidate is being developed under a $180 million contract with the U.S. Department of Health & Human Services, which recently modified the agreement to award another $55 million for late stage clinical trials.
Chelsea Therapeutics (NASDAQ: CHTP)
R&D spending 2010: $30.8 million
R&D spending 2009: $23.9 million
Where the money went: The Charlotte, North Carolina drug developer has been in late-stage clinical trials for droxidopa, a compound being developed for the treatment of neurogenic orthostatic hypotension associated with Parkinson’s disease. Chelsea recently raised $35 million through a stock offering; proceeds will go toward commercialization efforts of droxidopa and compounds in its pipeline.
Cornerstone Therapeutics (NASDAQ:CRTX)
R&D spending 2010: $4.5 million
R&D spending 2009: $3.6 million
Where the money went: The Cary, North Carolina specialty pharmaceutical company has been developing a compound that for now is called CRTX 067, which will be a generic version of the cough drug Tussionex. The compound is currently under Food and Drug Administration review and the company said that most of the increase in R&D expense was related to the FDA filing and scale-up activities with contract manufacturers.
DARA Biosciences (NASDAQ:DARA)
R&D spending 2010: $69.6 million
R&D spending 2009: $71.2 million
Where the money went: The Raleigh company started a phase 1 study for DB959, a compound being developed to treat type 2 diabetes and continued work on KRN5500, a compound being developed to treat chemotherapy induced peripheral neuropathy. DARA recently updated a shelf filing leaving the company the option to raise up to $30 million if needed.
Furiex Pharmaceuticals (NASDAQ:FURX)
R&D spending 2010: $50.1 million
R&D spending 2009: $11.8 million
Where the money went: The Morrisville, North Carolina-based drug development company, spun out from clinical research organization PPD (NASDAQ:PPDI) last year, said R&D expenses were incurred for pre-clinical and clinical-stage drug candidates including a new statin drug candidate called PPD-10558. A phase II clinical trial on the compound is expected to start in early 2011. The company estimates the cost of development could be $15 to $20 million over the next two years.
R&D spending 2010: $5.96 billion
R&D spending 2009: $5.93 billion
Where the money went: The figures represent R&D spending across London-based GSK global footprint. The company, which has its U.S. headquarters in Research Triangle Park, North Carolina, announced in 2010 it would expand a previously announced restructuring program by reducing R&D infrastructure costs in an effort to reach $785 million in savings by 2012. The pharmaceutical company has numerous compounds in various stages of development, some of them being developed by partners. About half of GSK’s early stage drug pipeline is partnered in some form or another.
R&D spending 2010: $13.2 million
R&D spending 2009: $18.1 million
Where the money went: The Durham drug developer’s lead drug candidate, ICA-105665, is being developed as a treatment for epilepsy and pain in partnership with Pfizer (NYSE:PFE). That compound is in phase 2 clinical trials. Under the agreement, Pfizer paid Icagen an upfront fee of $12 million and will also fund R&D for ICA-105665 and other compounds in Icagen’s pipeline.
Inspire Pharmaceuticals (NASDAQ:ISPH)
R&D spending 2010: $46.1 million
R&D spending 2009: $51.1 million
Where the money went: The Raleigh pharmaceutical company was developing a cystic fibrosis drug candidate that failed in phase 3 clinical trial results released earlier this year. Shortly afterward, Inspire announced a restructuring that discontinued its work in pulmonary therapies and refocused the company on its eye care business. “This restructuring resulted in a substantial reduction of resources devoted to future research and development,” the company said in its annual report.
R&D spending 2010: $17.6 million
R&D spending 2009: $16.0 million
Where the money went: The Chapel Hill, North Carolina company is developing its PA drug platform, which centers on aspirin products. Pozen is in phase 3 trials for PA 32450, a compound developed to offer patients the cardiovascular benefits of aspirin in a form that is safer on the stomach. The company expects to file a new drug application with the FDA in the second half of 2012.
Salix Pharmaceuticals (NASDAQ:SLXP)
R&D spending 2010: $73.3 million
R&D spending 2009: $89.5 million
Where the money went: Most of Morrisville-based Salix’s 2010 R&D expenses were for rifaximin, a drug marketed as Xifaxan. The drug is approved for traveler’s diarrhea and hepatic encephalopathy, a brain disorder associated with severe liver disease. The company has been developing the drug for irritable bowel syndrome. The FDA in February told the company that the agency would not approve the company’s application in its current form. Salix is reviewing the FDA’s comments and the company might need to spend more money on additional trials in order to win approval.
Talecris Biotherapeutics (NASDAQ:TLCR)
R&D spending 2010: $69.6 million
R&D spending 2009: $71.2 million
Where the money went: The Research Triangle Park, North Carolina-based blood therapeutics company’s pipeline includes work developing its blood clot treatment Plasmin for acute peripheral arterial occlusion, or aPAO. The compound is in phase 2 clinical trials and this year received an orphan drug designation from European regulators. Plasmin received orphan drug designation from the FDA in 2009.
R&D spending 2010: $64.5 million
R&D spending 2009: $40.1 million
Where the money went: The Winston-Salem drug development company attributed the higher R&D spending to higher expenses related to its clinical-stage product candidates, including costs for clinical trials. Targacept, which is partnering with AstraZeneca (NYSE:AZN), is in phase 2 clinical trials for TC-5619, a compound the company is developing as a treatment for patients with cognitive dysfunction in patients with schizophrenia.
The compound failed in a separate trial studying the compound in attention deficit hyperactive disorder. In the second quarter, AstraZeneca is expected to determine whether it will license TC-5619. At that point, AstraZeneca would take over responsibility for funding development and commercialization of the compound.
Related articles
- N.C. pharma DARA BioSciences updates $30M stock filing (medcitynews.com)
- GSK’s stock rises is good for investors but may not be good for patients (medcitynews.com)
- GSK seeking more pharma partnerships to fill early stage pipeline, executive says (medcitynews.com)
- NC pharma BioDelivery Sciences gets patent extension in Canada (medcitynews.com)
