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.

Geography of innovation

President Barack Obama has asked Congress to appropriate $100 million in fiscal year 2010 to renew economic development efforts at regional innovation hot spots.

A report supports those efforts, saying that areas such as the Silicon Valley, an information technology cluster, and biotech clusters in Boston and the Research Triangle Park area, are critical components of national competitiveness.

The federal government already funds about $150 billion of research and development per year.

North Carolina’s biotech industry, which is concentrated in the Triangle, is considered the third largest by number of companies. But the Triangle is also home to information technology and medical device clusters that together created more than 5,000 jobs between 1998 and 2006, according to the report.

Deals and regulatory actions

Bayer CropScience added a research collaboration to other recent deals aimed at coming up with better genetically modified crop seeds.

The German company, which has its U.S. headquarters in RTP, will partner with Precision BioSciences of San Diego. The deal is the third in a row to improve Bayer CropSciences’ ability to compete in the GM seeds market.

In recent weeks, the company bought rights from Texas Tech to improve the fiber quality from cotton seeds and announced it would buy its RTP-neighbor Athenix.

More about why Bayer CropScience is dealing here.

Other company news:

• Cornerstone Therapeutics, a Cary company specializing in respiratory treatments, received approval to buy the rights to an antibiotic from Oscient Pharmaceuticals, a Massachusetts company that has filed for Chapter 11 bankruptcy.
• The Food and Drug Administration told Pozen that the Chapel Hill drug development company’s request to approve PN400, a painkiller that causes fewer stomach ulcers, is complete. The FDA notice triggered a $10 million milestone payment from British pharma giant Astra-Zeneca, Pozen’s partner. Pozen filed the request in June and the FDA is expected to rule on it in 2010.
• BioDelivery Sciences International will close its research laboratory in Newark and consolidate operations at corporate headquarters in Raleigh. All four positions in Newark will be eliminated to save about $1 million in operating costs per year. More about BDSI here.
• Shares of Icagen get a lift after a mid-stage study shows that the Durham drug development company’s experimental asthma drug eases allergy-related attacks.

Reality shows aim at preventing HIV spread

Family Health International, a Durham organization that aims to improve public health worldwide, is behind two reality shows to prevent the spread of HIV.

“Bongo Star Search” is a competition for would-be pop stars in Tanzania and “You’re the Man” is a competition that challenges stereotypes of what it means to be a man in Cambodia.

Champagne corks popped at BDSI Thursday, the day the Food and Drug Administration let the small Raleigh drug development company know that Onsolis, a potent pain patch for cancer patients, had passed all regulatory hurdles. On Friday, analysts congratulated BDSI CEO Mark Sirgo during a conference call. By Monday, BDSI expected to have about $27 million more in the bank, a payment its Swedish partner Meda promised upon regulatory approval of Onsolis.

“It’s been a long haul,” Sirgo told analysts in the call Friday. “This is a fantastic day for our company.”

So why did BDSI’s stock drop 5 percent on a day when it should have risen?

Product sales are the holy grail for a research and development company that has lived off the good will of investors and partners for years. Revenue lowers the risk that the company will run out of money and indicates that profitability is within reach.

One analyst blamed BDSI’s stock drop on the shareholder base, saying BDSI needs more long-term institutional investors. Another suggested that questions might have arisen about Onsolis’ sales potential and investors bailed after their initial excitement wore off.

In fact, Onsolis will enter a market where three similar products generated about $700 million in annual sales last year. Two of the competitors are versions of Actiq, a fentanyl painkiller that went generic a few years ago. The third is Fentora, an Actiq successor that received regulatory approval in 2006. All three dissolve in the mouth and release fentanyl, a controlled substance.

BDSI’s marketing partner Meda plans to start promoting Onsolis to oncologists, pain specialists and primary care doctors in the fall. The goal is to get about 100,000 patients on Onsolis within two years, Sirgo said. That’s more than three times as many cancer patients as currently receive generic Actiq and Fentora combined for acute, breakthrough pain.

Sirgo acknowledged that’s an aggressive goal, but he said Meda plans educational programs for physicians to convince them to switch patients to Onsolis and to prescribe Onsolis to cancer patients who have not received a fast-acting fentanyl painkiller. He declined to say how much Onsolis will cost.

Study results show that Onsolis delivers more fentanyl in a shorter time than Actiq, according to a presentation BDSI made at a March health care conference for institutional investors. No studies comparing Onsolis and Fentora have been done.

Also, Onsolis delivers fentanyl without taste distortions.

But Onsolis will come to market with more safety requirements, called Risk Evaluation and Mitigation Strategies, than Fentora now has. The FDA is requesting REMS for all opioid pain medications, including fentanyl, morphine and oxycodone, to make sure the drugs’ benefits outweigh their risks, which include death from overdose.

An FDA decision on Fentora’s REMS is due in October, but a delay would put Onsolis at a disadvantage and hurt sales, said Robert Hazlett, a pharmaceutical analyst with BMO Capital.

BDSI shares traded like hotcakes Thursday, going as high as $7.25 when the news on Onsolis’ approval broke. Then they fell, to close at $6.15 Thursday. The drop continued on Friday, when shares lost 5 percent to close at $5.84.