'Pharmaceuticals' Archive
Diabetes patients forever struggling with the burden of daily injections could soon find some relief. Two new therapies under review by the FDA could change the landscape of diabetes treatment. One, MannKind’s AFRESA, delivers insulin through an inhalation device. The other is a once-a-week version of Eli Lilly’s injectable Byetta treatment.
Market optimism over the upcoming release of AFRESA is a major coup for MannKind, which experienced heavy shareholder doubt in 2008 when three other inhalable-insulin players, Pfizer, Novo Nordisk, and Eli Lilly, exited the market. MannKind’s insulin device is touted as easier to use and more effective than its rivals’ versions, as well as potentially faster-acting than some existing injectable insulin therapies.
Byetta is a non-insulin therapy — it is instead based on hormones that trigger the body’s production of insulin. While the daily form of Byetta has faced some safety concerns, Lilly and co-development partners Amylin and Alkermes anticipate that the once-weekly version will be successful. The companies have also submitted the drug for approval to be used as a monotherapy (it is currently used alongside traditional insulin or metformin treatments), and Amylin is developing it in nasal spray form.
Many of the industry’s key players, including Novo Nordisk, GlaxoSmithKline, and MannKind, are also developing hormone-based diabetic therapies. While MannKind currently has the only inhalable insulin program, several companies (including Biocon, Emisphere, Generex, and Biodel) are developing oral formulations of insulin, and additional firms (including Insulet and Medtronic) have wearable insulin pumps on the market.
Hopefully all of these measures will result in fewer diabetics having to undergo daily injections.
Two major drugmakers announced strategic deals last week that look to be directly related to the Obama administration’s health care reform policy regarding generic drugs. While rising competitive pressures in the industry have spurred diversification in recent years, the shifting landscape of America’s health care system is putting the changes into overdrive.
Top drug company Pfizer entered licensing agreements with two generic drug manufacturers based in India, giving Pfizer rights to market over 100 drugs in the US and international markets. Pfizer, which has historically focused on patent-protected drugs, formed a special unit dedicated to off-patent products just last year.
Another major player, Novartis, went the acquisition route by agreeing to pay about $1.2 billion for the specialty generics unit of Ebewe Pharma. While Novartis already has a strong generic presence through subsidiary Sandoz, the purchase will widen Novartis’ offering of generic biotech drugs (also called biogenerics, or follow-on biologics), a field that looks to be ripe for growth in the US market.
While brand-name pharmaceutical companies entering the generic market is not a new trend, President Obama’s goal of reducing health care costs by increasing access to generic products will definitely encourage new players to enter the field, while the existing generic kings bulk up to sustain their positions. If other reform measures in the works prompt similar changes, the drug industry may be a whole new ball game in future years.
Now that the spread and severity of the dreaded swine flu appear to be less extreme than we feared — knock on wood, y’all — federal and international health authorities must decide what resources ($$$) to put into further preventative measures. Investing in the development of an H1N1 vaccine, for example, could ward off what might still become a major health calamity, or it could be a waste of time, money, and energy.
Some are calling the global reaction to the swine flu over the last few weeks an exaggerated response, but I would tend to agree with those who see it as a good thing and a successful practice exercise for what could come in future years. Better safe than sorry, right? (That doesn’t apply to folks who rushed out to buy a box of Tamiflu “just in case,” however.)
Some scientists believe that the swine flu could still turn into a pandemic if it mutates and re-appears in the fall, as it is more contagious than seasonal flu strains that humans have developed immunities against. This analogy likens the current virus to one which caused an estimated 50 million deaths in 1918.
On the pharmaceuticals front, I’m positive that state and federal organizations will make Roche and GlaxoSmithKline (GSK) sing with new orders to replenish depleted Tamiflu and Relenza flu treatment supplies. I’m curious, however, to see how quickly US government and UN officials will go forward with plans to pay for development and production of a swine vaccine.
Usually a new vaccine has to go through the traditional regulatory channels, but exceptions can be made for fast-spreading diseases. For example, companies like GSK, Novartis, and Baxter have developed or are developing bird flu (H5N1) vaccines, but the FDA has not yet approved a bird flu vaccine in the US since the threat is minimal. A rushed vaccine program can also cause harmful or deadly side-effects, as a Ford Administration-era vaccine mishap did in 1976.
While vaccine production technologies are improving, they are still highly time-consuming. It would take months to get a new swine vaccine into production, although that process has already begun. Making vaccine volumes to cover global populations takes even longer, as traditional manufacturing methods use chicken eggs to replicate the virus. Also at issue is the manufacturing companies’ limited capacity, much of which is geared toward seasonal flu vaccine production.
The little piggy went where?
Eschewing going to market, staying home, having roast beef or none, this little piggy will make you sick, might even kill you.
This thought is what the pork industry is up in arms about. Calling the latest influenza outbreak “swine flu” has pork farmers crying foul (a “fowl” nod to Tyson, which sells pork as well as poultry).
This latest flu virus has nothing whatsoever to do with eating pork or any porcine products. The disease is spread through human contact, not food consumption. It ain’t peanut butter making us sick this time, folks. The cause is coughing, sneezing people. They spread the Influenza A (H1N1) virus.
Pork producers, including the US’s über ovine supplier, Smithfield Foods and Brazil’s JBS, which owns Swift, are issuing press releases saying their meats are safe faster than the racing piglets at the county fair. The meat industry blogs are bristling with posts about the damage this will do to pig producers everywhere. And rightly so. Frightened people, fanned by the alarming media coverage that is going on 24/7, can’t be counted on to think in a calm logical ways.
Facebook has some 100 group pages dedicated to “swine flu” where one can read posts like, “MmMmM BACON. & all you have to deal with is a little fever nausea and diarrhea and a chance of death but other than that your cool!”
Enter Homeland Security and the USDA
In response, the US Department of Homeland Security has announced that the name of the virus will be changed to the “Influenza A (H1N1) virus.” If you are a news nerd (like me), you’ve noticed (cue the tapes, guys) that Janet Napolitano, Homeland Security secretary, has taken to referring to this strain and its outbreak as H1N1. The US Department of Agriculture secretary Tom Vilsack has also recommended the name be changed to eliminate public confusion and to accurately characterize the flu virus as being transmitted human to human.
Never kiss a pig
The problem, the agencies point out is that the name “swine flu” implies that the source of the illness is pigs. However, this new variant of H1N1 influenza, they point out, has not been identified in any North American swine. The Centers for Disease Control and Prevention, which still has a link called Swine Flu on its Web site, reports that it has found no evidence to indicate that any of the reported illnesses have come as a result of contact with pigs.
The damage begins
Several countries, among them Russia, Ukraine, China, Thailand, and the United Arab Emirates, have already halted or restricted the import of US pork products; Russia has, in fact, restricted all US meat products, including beef and poultry. (Fortunately, Japan, the #1 buyer of US pork products, has not.)
In reaction, the Office of the US Trade Representative stated that banning US pork is uncalled for and might create further trade challenges (a little diplomatic raise of the eyebrow never hurts). Vilsack said at a news conference that he is concerned that misunderstandings could have a negative impact on US farmers who supply pork products to people around the world. He emphasized that US pork herds are sound and that consumers everywhere need to know that US pork products are safe.
No happy ending
All these governmental officials are correct in their assessments, of course. But Influenza A (H1N1) virus is a real mouthful. (No pun intended.) Can’t imagine Katie Couric breezing through multiple mentions of this new and improved (albeit more cumbersome) name. And for all of us bloggers out here in etherland, typing Influenza A (H1N1) virus is no picnic either.
Damage control on this issue, I’m afraid, has come too late. But I, for one, am serving stuffed pork chops for supper.
Preventative measures taken to stem fears over a possible avian flu pandemic in recent years are proving beneficial during the current North American outbreak of swine flu, as officials mobilize efforts to contain and eliminate the illness before it broadens its scope.
The bird flu paranoia has caused international governments and the World Health Organization to create a massive stockpile of seasonal flu medications, including Roche’s Tamiflu and GlaxoSmithKline’s Relenza, and US officials are now working to parcel out portions of their medicine stockpile to locations where confirmed or suspected cases of swine flu have been reported, including Texas, New York, and California. In addition to the US, Mexico, and Canada, there have also been reports of possible cases in Europe and New Zealand.
Many countries have also developed pandemic preparedness plans, which are helpful for officials and health workers trying to contain newly discovered flu strains. The situation in Mexico is the most severe, but health inspections for travelers at airports and border crossings are being conducted in nations worldwide to prevent the spread of the virus.
Depending on how widespread the swine flu becomes, drugmakers Roche and GSK could be requested to step up current production of their flu medications. Vaccine makers may also gain new government contracts through the outbreak, although the process of developing and producing a vaccine for a new flu strain is time-consuming.
The US Centers for Disease Control (CDC) is already starting work on a potential vaccine. Major drug companies specializing in vaccination research and development that may be brought in on the process include Sanofi-Aventis, GlaxoSmithKline, Novartis, and Baxter International.