Upsher-Smith Laboratories, Inc. (Private)

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September 10, 2012 Issue

The Most Powerful Name In Corporate News and Information


With Branded, Branded-Generic and Generic Pharmaceuticals for Women’s Health, Dermatology and Cardiology and Therapy Development in Central Nervous System Diseases, Upsher-Smith Laboratories, Inc. is Focused on Improving Patients’ Lives

Company Profile:

Upsher-Smith, founded in 1919, is an independent and privately-owned specialty pharmaceutical company headquartered in Maple Grove, Minnesota that focuses on product growth and innovation for branded, branded-generic and generic pharmaceuticals.


Upsher-Smith markets products in the fields of women’s health, dermatology and cardiology. In addition to products currently marketed, Upsher-Smith has a particular focus on developing therapies to assist people suffering from central nervous system diseases (including epilepsy, Parkinson’s disease and Alzheimer’s disease) and has an emerging neurology pipeline with a number of products in development, two of which are in Phase III clinical trials.

On August 14, 2012, the company completed its acquisition of UK-based Proximagen Group plc, a European biotechnology company focused
on the development and commercialization of novel therapeutics for diseases of the central nervous system and inflammation. 


Upsher-Smith also has offices in Plymouth, MN, Denver, CO, Morristown, NJ in the U.S., and in London and Cambridge in the UK.


For more information, visit

Thomas W. Burke

Chief Operating Officer

Upsher-Smith Laboratories, Inc.

Minneapolis, Minnesota

As chief operating officer, Tom Burke is responsible for executing the strategic vision of Upsher-Smith Laboratories. In his role as COO, Tom is responsible for the sales, marketing, business development, operations and strategic portfolio management functions.


Since beginning his career as a territory sales representative at Upsher-Smith in 1983, Tom has been instrumental in driving the strategic growth of sales and commercial operations.


Prior to being named COO, Tom served as executive vice president of commercial operations for six years. Under his direction, the company consistently achieved consecutive years of record sales and profit growth and became recognized as a top manufacturer and marketer of high-quality, economically priced, alternative brand pharmaceutical products. Tom’s earlier roles at Upsher-Smith include vice president of corporate development, and national director of sales.


First-hand knowledge of all aspects of the company’s operations allows Tom to identify critical elements for success when developing key strategies and forging new customer relationships. He encourages the team at Upsher-Smith to focus on service, good communication and “speed” –– knowing that responsiveness is the key to creating valuable customer relationships and competitive advantage over significantly larger pharmaceutical companies.


Tom holds a BA in Marketing from the University of Minnesota, and an MBA in marketing from the University of St. Thomas.

Specialty Pharmaceutical

Upsher-Smith Laboratories, Inc.
6701 Evenstad Drive
Maple Grove, MN 55369
Phone: 800-654-2299

Upsher-Smith Laboratories, Inc.
Print Version


Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 10, 2012

Mr. Burke, would you tell us about Upsher-Smith?

Mr. Burke: Upsher-Smith is a privately-owned pharmaceutical company that was founded in 1919. We are headquartered in Maple Grove, Minnesota. We market a number of branded products in women’s health, dermatology, and cardiology, and also have a strong generics business. We have an emerging focus in the area of central nervous system diseases focusing on therapies for people suffering from epilepsy, Parkinson’s disease, and Alzheimer’s disease. This is where we are developing the majority of our products. We have a number of products that are in the development stage from pre-clinical to Phase III trials.

CEOCFO: Why the decision to go heavily into the CNS (central nervous system) area?

Mr. Burke: We identified a number of unmet needs of the patient population in those disease areas where we are focused. We believe that we have the capability and the wherewithal to deliver products that would meet the needs of those patients. Epilepsy, Parkinson’s disease and Alzheimer’s disease are all areas where we feel there are opportunities to help improve patients’ lives.

CEOCFO: What is it that Upsher-Smith knows or understands that will allow you to create or develop products that others cannot?

Mr. Burke: I would say that we are ideally positioned from the standpoint of having good knowledge and thought leaders to draw upon. We are well connected with many of the thought leaders who are dealing with these disease states. As a result, we have an ability to understand where their patients are suffering most and are working to develop products through good research and good pharmaceutical development in order to meet those needs.

CEOCFO: Upsher-Smith recently acquired Proximagen; what does that add to the table and are acquisitions part of your corporate strategy?

Mr. Burke: Acquisitions are part of our corporate strategy, along with licensing opportunities, co-development projects with other companies, and our own internal development. Those are among the ways that we look to grow our portfolio, particularly in CNS. UK-based Proximagen Group plc adds a great deal to our organization and actually complements our organization quite well. In the area of research and development, Proximagen is, and has been, very strong on the research side. Upsher-Smith has a strong track record in the area of development, so bringing the two companies together helps us to form an organization that is strong in the research area and strong in the pharmaceutical development area in order to be successful in the marketplace.

CEOCFO: Is it strictly opportunistic on how you approach a particular problem or do you have a certain balance you would like between acquisitions and in-house development, partnerships, and other strategies?

Mr. Burke: From a partnership standpoint, it needs to be more than just opportunistic, you have to feel it is the right chemistry between the organizations both at the management level and the scientific level. It is very important that there is a strong cultural fit between the two organizations and in this situation, we feel that this is the case as Upsher-Smith and Proximagen have been working together since 2008. We feel that there is a good understanding of the culture and a good mutual respect for the abilities that exist at both organizations.

CEOCFO: What specifically are you working on; what is the lead focus for you now?

Mr. Burke: In the pipeline at Upsher-Smith, we have products that are further along than most of those at Proximagen. Most of the programs at Proximagen are in earlier stages of development. Upsher-Smith’s central nervous system (CNS) pipeline in clinical development includes USL255, an investigational extended-release topiramate for the management of epilepsy in adults, which is being studied in an ongoing international Phase III clinical trial (PREVAIL). We are also developing USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients on stable anti-epileptic drug regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted orphan drug designation for this use by the U.S. Food and Drug Administration and is currently in Phase III of development.

We then have a third program within Upsher-Smith that is actually a partnership with Proximagen prior to our acquisition and that is USL260 which is a drug called tonabersat. It is an investigational drug in Phase I of development that is a potential first-in-class neuronal gap junction modulator that is also being explored as a potential treatment for epilepsy.

CEOCFO: Drug development is always expensive; what is the financial picture like for the company today?

Mr. Burke: We have been fortunate to have a very strong commercial business generating strong revenue. Financially, we are in quite a sound position. Strong profits will help us to reinvest into the areas of epilepsy and Parkinson’s disease as we look to further develop our pipeline.

CEOCFO: What do you see for the next year or two?

Mr. Burke: I really see more of the same in terms of where we are today, we have had, and will continue to have, successful business operations in the area of women’s health and generics. What is different for us over the last several years, and what we will continue to build upon, is bringing forth a pipeline of products in the areas of epilepsy and Parkinson’s disease that we feel will help improve the lives of patients. We continue to look for more opportunities to meet patients’ needs, and work with both investigators and physicians to better understand what those needs are and to continue to shape our pipeline to meet those needs.

CEOCFO: Our readers are primarily in the investment community, always interested in early opportunities. Why pay attention to Upsher-Smith?

Mr. Burke: We are a family-owned, privately-held company, yet we are very focused on areas that are important to the medical community, the patients they serve, and important to US society in general in terms of looking for ways to improve patients’ lives. I believe that is something that is certainly important. Our entire leadership believes that working toward trying to deal with disease and to improve those patients’ lives is very important. That is something that people would want to pay attention to, and see what types of improvements we are able to bring to the marketplace.


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We are very focused on areas that are important to the medical community, the patients they serve, and important to US society in general in terms of looking for ways to improve patients’ lives. - Tom Burke


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