A Gift Indeed

Thank you Pharma for making the holiday season brighter for everyone

By Steven E. Kuehn, Editor in Chief

Over the Thanksgiving holiday my family had an encounter with a new (to us) pharmaceutical. You see, my mother has COPD, complicated by emphysema, bronchitis and asthma — the result of years of smoking. After about two years of witnessing less-than-promised symptomatic relief from the other most commonly prescribed inhalable COPD therapy, I convinced my Mom to ask her doctor about switching to one of the newer alternatives — something that wasn’t as straightforward as it might seem. My Mom comes from an era where the physician’s medical opinion is sacrosanct, not to be questioned. However, after much prompting from me, she finally asked the doctor if she could try something different: “One of the new one’s my son keeps talking about,” is basically what she said. The doctor nonchalantly agreed and provided her with a prescription to Symbicort, AstraZeneca’s well-known, but not-so-new, budesonide/formoteral COPD/asthma treatment.

Long story short, my mother took her first two-puff dose off a very familiar pressurized metered dose inhaler (pMDI) and within about five minutes (as advertised I might add) began experiencing real symptomatic relief for the first time in years. Soon, we were all, literally, breathing easier. The affect was dramatic and within days Mom started feeling better. With increasing confidence, she resumed her normal routines without having to stop every 10 feet to catch her breath. After thanking a higher power I started thinking about who else I might thank for the truly transcendent boost to my mother’s quality of life. Naturally, my thoughts turned to the pharmaceutical industry.

So I started doing a little digging. AstraZeneca, of course, deserves great credit, responsible for investing the hundreds of millions of dollars to develop the budesonide/formoteral combo and then winning its regulatory approval in Europe for it in 2000. Eventually (2006) the U.S. Food and Drug Administration approved the pMDI version for Americans. Given that the compounds’ efficacy was so overwhelmingly well demonstrated I pondered the significant lag time, but didn’t dwell on it for long because I think we all know why. Regardless, knowing the complexities of drug development, supply chain resources and subsequent commercial manufacture, I knew there were many more people to thank for the Kuehn family’s holiday “miracle.”

But where does one start? AstraZeneca has 65,000 employees, many of whom work at the company’s 26 or so manufacturing sites. Granted not all of them make Symbicort, but I thank them nonetheless. Then there’s Minakem Group, who acquired AstraZeneca’s Dunkirk, France API facility in 2009, bolstering global supply with their operational acumen. In its press announcement Minakem mentioned the long-term contract it signed to manufacture budesonide for AstraZeneca. According to an industry report, a few years prior AstraZeneca invested a bunch of capital ($25 million) to develop the facility’s production infrastructure and accomplish the apparently tricky fill and finish processes for Symbicort’s pMDIs. Jacobs Engineering was responsible for that project, which also included a clean room environment delivered by Carmetec. Apparently Werum was active in bringing contemporary manufacturing data and operational informatics technologies into the mix as well. More digging revealed that at the heart of it are Pamasol’s HCA pMDI filling systems and 3M Drug Delivery’s dose counter enabled pMDI devices. I’m not sure who supplied the Turbuhaler devices AstraZeneca innovated with the original approval, but that technology was instrumental to Symbicort’s overall popularity and effectiveness. According to AstraZeneca’s 2011 Annual report, after FDA approval Symbicort garnered $3.1 billion in sales worldwide, of which $846 million came from the U.S. alone.

Alas, my “Nice” list is likely not complete, but my point is this: Yes, there are plenty of individuals who contributed specifically to bring Symbicort to market and deliver its therapeutic and market success, but in the end, it’s all of Pharma who put this therapy into my Mom’s hands, as well as into the hands of millions of others struggling just to breath during the holiday season. That is a gift indeed and I’ll be forever grateful. Thank you.

 

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