If the rest this year's flu season follows the pattern of the first round of cases, Roche's best-selling antiviral, Tamiflu (oseltamivir), may be next-to-useless against the dominant flu virus, researchers say. The good news for patients-and GlaxoSmithKline-is that the Tamiflu-resistant strain of H1N1 can be treated with GSK's Relenza (zanamivir). 

Tamiflu's firm position in the influenza market weakened when news broke last week that 86 of 88 early-season flu samples tested by the Centers for Disease Control and Prevention (CDC) were resistant to Tamiflu-compared to about 11 percent of samples last year.

"Resistance to Tamiflu has historically been low and is continually monitored," Roche said in an official statement. "The reduced susceptibility observed had no apparent relationship to oseltamivir use or exposure. A spokesperson for Roche told Pharm Exec on Wednesday that - "at this time - only one currently circulating strain of influenza, A (H1N1), is showing resistance to Tamiflu. No resistance to Tamiflu has been identified among other circulating viruses [A(H3N2) and B viruses]."

A CDC advisory released in mid-December recommended GSK's Relenza as treatment for the resistant strain. Because there is no timely way to test for individual strains of flu in a clinic, Relenza may become the drug of choice this year. However, doctors and nursing homes could be less than satisfied with the alternative, as Relenza is an inhaled drug, making it difficult to administer to older and institutionalized patients-a key segment of the flu market.

"There are [several] flus in circulation and one of the strains is resistant to Tamiflu. Luckily we have other treatments," said Tom Skinner, a spokesman for the CDC. "Antiviral-resistant flu is not unheard of. Thankfully, we have a vaccine that seems a good match for this year."

Does this mean Tamiflu is on the ropes? Hardly, say experts. In the long run, CDC and physicians expect to be using Tamiflu again.

Tina Tan, associate professor of Pediatrics at the Feinberg School of Medicine at Northwestern University, said the Tamiflu news is nothing to panic about. "We know that this particular strain was a spontaneous mutation, so it may not happen again," she said. "I still think that Tamiflu is going to remain the drug of choice in most cases." 

Tamiflu will still be an important part of government stockpile programs designed to guard against potential outbreaks. "No one can predict what strain will cause a pandemic, said Skinner. "[Tamiflu] still is an effective antiviral against other strains of the flu. It's still a part of our stockpile, and will be until we feel we need to reevaluate." 

Even if this is a one-time incident, GlaxoSmithKline is using the gap in the market to their advantage. In a press release issued in response to the CDC's announcement, GSK assured customers that they have a sufficent supply of Relenza to meet the needs of the 2008–09 influenza season.

"Our major strategy is to make sure the pharmacies have the stock they need as people increase prescriptions of Relenza to address concerns," said Judith Ng-Cashin, vice president of Global Clinical Development for Infectious Diseases at GlaxoSmithKline. "We're committed to making sure that enough Relenza is available to the public." 

Articles

News Analysis

The Tamiflu-resistant flu strain means increased sales for GSK's Relenza, but doesn't mean the end for the number-one antiviral.

Latest Flu Season Sets Tamiflu Back but Doesn't Knock It Down

Pfizer, this week, quietly began releasing approximately 5 to 8 percent if its global research and development workforce. While the company has only reported the percentage of positions being eliminated, estimates are that up to 800 researchers could be affected. 

 that the layoffs are R&D-specific, and that the restructuring will affect every site around the world. 

“We have not given a breakdown as to site-by-site cuts,” said Ray Kerins, Pfizer’s head of global media relations. “What we’ve tried to do is look at staffing in a methodical way, and, based on the plan 

 has put in place, try to make staffing decisions based on the scientific expertise we will need in the future.”

Mackay, Pfizer’s head of R&D, is focusing on Phase II and III drugs and prioritizing the company’s portfolio. This means that Pfizer will be exiting areas where it hasn’t had much success, while keeping research staff in positive areas such as pain, Alzheimer’s, and oncology. 

“The idea here is to focus on the scientific expertise that we need, based on the plan that [Mackay] put in place about a year ago,” Kerins said. “From our standpoint, this announcement is clearly indicative of the plan.” 

, Pfizer restructured its R&D program into a therapeutic-centered model, focusing on “best win” areas where Pfizer has had success. As part of the plan, development was moved from R&D into the business unit. The premise is that if the business unit is working with development in the creation of new drugs, then decisions can be made earlier on as to whether a compound will advance to later stage development or be shelved.

“Like everyone else, Pfizer has been rationalizing their portfolio towards those areas that will have the greatest value and return,” said Deutsche Bank analyst Barbara Ryan. “The restructuring is positive and needs to happen. The industry has to continue to innovate in order to have revenue growth as they lose patent protection.”

At this week’s JP Morgan conference in San Francisco, Mackay said that Pfizer now-for the first time-has the option of out-licensing the compounds that the business unit decides not to invest in. 

“In the past, they might not have gone anywhere, and just sit on a shelf,” Kerins said “Now we’re saying that we are going to take those assets and license them to maximize their potential.” 


  In other Pfizer news, the company on Wednesday elected Stephen W. Sanger to its board of directors. He is a veteran executive of General Mills and serves as board director of Target and Wells Fargo.

Sales reps aren't the only ones heading for the unemployment line - Pfizer is eliminating researcher positions as fewer drugs are making it to development. But could streamlining the crux of drug R&D cause more harm than good?

Pfizer Sheds More Staff

2009 sees Håkan Björklund enter his eleventh year as CEO of Nycomed. When he  came on board in 1999, the company was a small, primarily Scandinavian  operation. With the acquisition of Altana in 2006, it was propelled into the  major league, becoming one of the world’s 25 biggest pharma companies. Now  headquartered on the outskirts of Zurich, Switzerland, the company employs  over 12000 people worldwide and in 2007 boasted a net turnover of E3.5  billion.

 But after a decade of this remarkable growth and buoyant ambition, is it now  time-as it clearly is for many industries-for Nycomed to endure a  downhill slope? Certainly, the economic crisis has made the company, which  is privately owned by a consortium including Nordic Capital and Credit  Suisse DLJMB, think twice about its tentative plans to go public. Björklund  isn’t unduly worried about the credit crisis, however: “Over the 23 years  I’ve been in the industry, I’ve never really seen pharma sales being  affected by an economic downturn in the western world,” he says. “We’re  probably one of the industries that will be affected the last and the  least.” But he does concede that this downturn is unprecedented and “you  cannot go public in a situation where the stock market is down 10 percent one day  and up 8 percent the other. The current volatility of the market makes it very  difficult and very unattractive.”

 His bigger concern is the imminent patent expiry, in the US and Europe, of  Nycomed’s best-selling product, the gastroenterological treatment  pantoprazole. By 2007, pantoprazole (Protonix in the US), a product  inherited from the Altana acquisition, was the leader in 22 proton pump  inhibitor (PPI) markets, bringing in sales of E1.7 billion. But at the end  of that year, Teva and Sun Pharmaceuticals muscled in with a generic  version, dealing a blow to Nycomed’s US sales. Nycomed sued-the US patent  on Protonix isn’t due to expire until 2010-but the episode served as a  stark indication of what lies ahead for the drug.

 In the major European markets, pantoprazole’s patent expires later this year  and Björklund admits that “this will certainly have a bigger impact on our  sales than the credit crisis.”  Nycomed and its partner Wyeth have now  initiated its own generic version in the US, and, for the moment, continues  to see better-than-expected sales in other territories. Also, Björklund  reminds us, “a large part of pantoprazole’s sales-over 40 percent-is in markets  where the patent has already expired or where there never was a meaningful  patent.” But it is clearly time to look towards new products and new models  to secure Nycomed’s future fortunes.

 One of the most promising products in the company’s pipeline is Daxas  (roflumilast), a chronic pulmonary obstructive disease (COPD) treatment that  showed very positive results in Phase III trials last year. Björklund  explains: “We’re all very excited about Daxas because it is the first oral  anti inflammatory treatment for COPD; it’s one of first new drugs developed  for the disease in many, many years.” If it lives up to expectations, Daxas  could indeed be huge-COPD is the fifth biggest killer disease in the  world. Nycomed is planning to submit Daxas to the US and European regulatory  authorities by the middle of 2009. “It’s not going to be as big as  pantoprazole, but it will be a very big drug for us,” Björklund says.


  Nycomed’s ambitions are no longer focused on growing significantly larger.  Indeed, in the present end-of-the-blockbuster climate, it looks like the  smaller (and specialist) companies are better placed for survival. Björklund  says that while the Altana acquisition gave Nycomed access to new  territories and to a much larger R&D portfolio, he is well aware that “it’s  actually an advantage not to be too big.”

 All the same, the company is now four times as big as it was four years ago,  and, as CEO, he must have felt the challenges of that expansion as keenly as  he saw the opportunities. “It has of course changed things,” he says. “The  sheer size of it is different and the number of subsidiaries we have today  is much larger, which of course means that my travelling has increased  significantly.” He also realised that moving from managing 3000 to 12000  people in one leap involves putting a lot more faith in delegation. “It’s  important to give managers the freedom to run the business. You could say  that, inevitably, you have to be a little bit less involved in the details.”

 Björklund has always taken pride, however, in allowing Nycomed employees to  take as much responsibility as they can. “I strongly believe that part of  our success has been our culture of giving people the freedom to do what  they’re supposed to do, the responsibility to take their own decisions,  wherever they are in the organisation,” he says. “And if you can motivate  people this way, they become more enthusiastic, more efficient. If we have  12000 people in the company and we get them so motivated that they are 10 percent  more efficient-and that doesn’t mean they spend 10 percent more time at work-then we have effectively added 1200 people to the company at no extra cost.  And they will be  happy people!”

 After ten years at the helm of one company-a pretty good innings in  anyone’s book, whatever the industry-there is also the question of how  Björklund keeps himself motivated. “What really excites me is getting new  products on to the market,” he says. “I have a great interest in both the  R&D and the sales side. I also find the emerging markets very exciting.”  Indeed, in 2007, the company saw its strongest sales growth (20.9 percent) in  Russia and the Commonwealth of Independent States (CIS), with good progress  also made in Latin America, Canada and Australia, (territories whose doors  were opened by the Altana acquisition). Expansion in Asia is now on the  cards, too.

 But it seems to be as much the looming uncertainty of pharma’s (and the  global economy’s) future as the day-to-day challenges of drug development  and marketing that continues to fuel Björklund’s passion for his work.“We’re living in interesting times, and even before all this, it was clear  that the pharma market was changing,” he says. “It’s pretty exciting to be a  part of that.”

This article was originally published in Pharmaceutical Executive Europe's digital edition. 

Long-standing Nycomed CEO Håkan Björklund tells Pharm Exec Europe how the company is looking to new products, and new territories, to combat the patent expiry of its biggest product.

Pharmaceutical Executive-01-15-2009

Latest Flu Season Sets Tamiflu Back but Doesn't Knock It Down

Pfizer Sheds More Staff

Nycomed's New Horizons