Why the trend towards biologics?

When sanofi-Aventis sold its share of Exubera to Pfizer for $1.3 billion in 2005, they must have known what they were doing. Exubera which offers diabetes patients an alternative to injected insulin via inhalation of powdered form of the insulin has been made light of due to its resemblance to a marijuana bong. While comical, I don’t think that’s why Pfizer has canceled it’s agreement to market and distribute the drug. I imagine it has something to do with its lack luster performance this year of $12 million dollars and if I can venture a guess the unknown efficacy profile. Regardless of Exubera’s poor performance pulling a compound off the market that does not possess a poor safety profile is unprecedented. Abbott and NovoNordisk beware.
Form your opinion and say what you will about Exubera, one point is clear…even the big boys are focusing on developing biologics as opposed to traditional compounds. Certain analysts have called the failure of Exubera the largest failure in pharmaceutical history. Pfizer is no dummy, why would they risk so much on a biologic?


They wanna be like Mike
Michael Jordan was arguably the greatest NBA player of all time. Baseball is another story. MJ established a brand that provides automatic patent protection because of what he did and how he did it Do you think his performances will ever be duplicated or his compensations for that matter? You couldn’t just take any old players silhouette and put it on a sneaker that was not Nike. Who would buy it? Let me rephrase…who would want it? Biotech companies are similar to MJ, where they have innovative products to which the process for creating and duplicating them is way too complicated for generic manufacturers.


The biotechnology industry has always felt a need to break free of patterns set by traditional pharmaceutical firms since most products run into patent expiration after 8-10 years. Now the industry is trying to avoid the usual fate big drug companies suffer (aka MJ scoring 50 on them) when their top-selling drugs lose patent protection. Currently there are no laws to allow manufacturers to create generics for biologic drugs and a debate is percolating regarding this issue (stay tuned).


They’re trying to do the right thing…
Pharmaceutical organizations are so often accused of doing just enough for patients even though there mission statements are patient focused. Often comedians and analysts compare big pharma to drug dealers…stating that there is “more money in treatment as opposed to the cure”. Biologics allow a company to focus on the root causes of a disease, as opposed to flare ups and indications created by a disease. So what of the pundits? Of course pharma and biotech companies are trying to make money…it’s a business, however they are trying to also help physicians to effectively treat diseases which have been untouchable by traditional therapeutics. So can we all hold hands on this issue? Probably not…the treatment costs for biologic drugs are 10, 15 or even 20x greater than non-biologic drugs. Who’s gonna take care of those bills?


Times are a changing…
It’s hard to change on a dime especially when you are instituting change within a large drug organization. Different organizations such as Lilly have taken a path of creating in house biotech innovations centers while others such as sanof-Aventis have went on purchasing sprees gobbling up biotech left and right. Regardless of the strategy the time for biotech is now and traditional methodologies for sales representatives are changing due to marketplace demands. Did someone say e-Detailing?


Physicians are inundated day in and day out with messages, education, health care reform etc etc. The bandwidth for a physician is diminishing; therefore the traditional pharmaceutical sales rep faces challenges to keep a physician’s attention. (Side Bar: Honey please take note of this section). Physicians look primarily to increase their knowledge with continuing medical education (CME) and they often get this through highly knowledgeable biotech representatives. There is a rep of the future which is more knowledgeable and more scientific than today’s rep. That’s the rep that physicians will speak to because they get better educated not only a drug’s mechanism, but more importantly they gain information on disease state and emerging research trends which the may not have picked up in the literature.
Other reasons or comments? Please post.

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