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Generating Pharmaceutical Sales before Marketing Authorization


When a patient has a serious illness and there is no approved drug available, the physician can try one which has not yet been authorized for marketing.

When a patient has a serious illness and there is no approved drug available, the physician can try one which has not yet been authorized for marketing.

When a patient has a serious illness and there is no approved drug available, the physician may want to try one which has not been authorized for marketing by national health authorities but has shown promise in clinical trials. European Named Patient Programs, like US compassionate use programs, offer physicians access to pharmaceuticals which have not yet been licensed. However, there is one important difference: in Europe an unlicensed drug can be reimbursed. This presents drug-makers with an opportunity to generate revenues while development is still in-progress. 

Significant Revenues Are Possible 

The additional revenues can be considerable. For example, Pharmion, a US based company focusing on Oncology and Hematology reported dramatic increases in its Thalidomide sales from $1.9 million in 2Q 03 to $15.3 million in 2Q 04, primarily due to named patient sales in Europe for Multiple Myeloma.  Thalidomide sales accounted for approximately 75% of Pharmions total revenues for the first half of 2004, according to company sources, and were generated while the product awaits marketing approval for this indication. Before receiving European Marketing Approval, Shires Argylin for essential thrombocythaemia generated about 5% of its total sales from its European named patient program 

Other Benefits of Named Patient Programs 

A named patient program can speed uptake after official launch. Physicians, who have had experience before launch, via clinical trials or named patient programs, often become early adopters and references for other physicians once the drug is freely circulating.  

Named patient programs, like US compassionate use programs, can increase good-will toward the company because they simplify the process of gaining access for patients in critical need. Smaller companies often can not afford the administrative time and costs of shipping drugs around the world before launch. This can lead to frustration and resentment towards a company that many physicians will remember long after a drug is officially on the market. Creating a formal channel eliminates the unfortunate need of denying requests and risking ill-will later. 

A named patient program should be considered an important part of a pre-launch program. It increases awareness to a pharmaceuticals existence, creates excitement, generates good-will and speeds penetration of the product after launch. 

Frequent Communication is Necessary 

If one of the objectives is to generate revenues, setting up a named patient program is just the beginning. In order to achieve success, physicians need to be aware of the product and what they need to do to get it. Typical methods of informing physicians, such as sales rep visits and ads, may not be appropriate because a license is necessary to market a drug. While physicians are used to simply writing a prescription and being done with it, named patient programs require paper-work that some find tedious. Therefore the company needs to create an appropriate communication plan and work closely with the targeted medical community to keep them informed and simplify the process.

Issues to Consider 

You have decided to make a named patient program part of your pre-marketing plan, what now? If you do not have an experienced European marketing group, an organization that is familiar in sales and marketing of pharmaceuticals in Europe can help you to maximize participation in the named patient program.  A communication plan, if properly developed and implemented can increase product awareness, but communication concerning an unlicensed product must be done appropriately.  This plan should ensure that your entire target group: 

• Is fully aware of the product AND the program
• Knows what needs to be done to take advantage of the program
• Has an advocate available to guide them through the process

ABOUT THE AUTHOR

Dr Gene Emmer, is President of Med Services Europe B.V., and conducts business development for Pharmaceutical, Diagnostic, Biotech and Medical Equipment manufacturers. www.MedServicesEurope.com

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eSpring® Water Purifier Countertop Unit

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PlayStation 2 NASCAR Racing Wheel

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It's worth the money.

The Legend of Bruce Lee

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Customer Review: A Classic

One of my good friends showed me this as a joke but the fighting is good in it. It is nothing like the real life of Bruce Lee but who cares it's very entertaining. Some of the crappy elements of this make it very funny if you like bad movies. My friends and I quote this movie often especially the reference to 'college'

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This is yet another Bruceploitation flick that I choose not to give a whole paragraph to, HOWEVER, while the film has little or nothing to do with Bruce's SHORT but TRAGIC life as suggested by the cover, Bruce Le does prove himself to be quite a martial arts entertainer...and I'm convinced that between him and Bruce Li, he bares the strongest resemblance to Bruce Lee in appearance, physical conditioning, and speed. However, while the movie is fast-paced and features everyone from Bolo to Hahn from Enter the Dragon...there's a little too much fiction and THIS AINT NO BRUCE LEE STORY...it pretty much attempts to dramatize his urban youth in Hong Kong. But again, it's a keeper for the action alone.

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