Psychiatry - August 2008 - (Page 59)

[research to practice] Many in senior management, however, believed that a fourth or fifth atypical antipsychotic medication would not be profitable in the marketplace. A pivotal step for the planning team’s ultimate decision to support Seroquel was the effective partnering with the CNS discovery team so that we and senior management could be educated about the drug’s real potential. We learned that not all atypical antipsychotics were the same, unlike some classes of antihypertensive agents, which we understood to be difficult to differentiate in the marketplace, and we were convinced by the sustained belief of the CNS group that clozapine would have been a blockbuster had it not been for the risk of agranulocytosis. Clearly, the successful results for Seroquel in the marketplace have shown that they were right. HOW DID YOU CHOOSE A DRUG NAME? Mr. Milbauer: We worked with an independent branding company who would assure that a potential drug name was memorable, available globally, and did not contain some inadvertent meaning in another language. Our company chose, for example, in oncology to use “dex” as the last syllable in our family of products, e.g. Nolvadex, Zoladex, Casodex, etc. I did not always like chosen drug names when they were first suggested, but usually got used to them. One drug, Zestril, an antihypertensive drug, turned out to have a great brand name, which may have been responsible for its success in the marketplace. We had with existing treatments for the disease, the market need, and our costs for development. We generally determined a “value” for the product in terms of the benefit to be derived by patients when compared to existing therapies or other types of interventions, e.g. surgery, hospitalization. Over the past 15 to 20 years, there are many new “payors” to consider when pricing a new medication. WHAT IS THE EXPECTED RETURN ON INVESTMENT WHEN A DRUG IS INTRODUCED TO THE MARKET? HOW DID YOU DETERMINE IF YOU HAD A SUCCESSFUL LAUNCH? Mr. Milbauer: It’s important to appreciate that we set goals for HOW DID YOU INTERACT WITH THE FDA? Mr. Milbauer: I led a group of professionals representing a number of scientific disciplines, like chemistry, pharmacy, pharmacology, and law, who acted as the primary liaisons with FDA reviewers and administrators with respect to drugs in development and those already in the market. It was our job to interpret FDA’s requirements while advocating the company position on the many issues FDA considers during a drug product’s life-cycle. We were also the group that assembled the vast amount of data on clinical safety and effectiveness, chemistry, and manufacturing into a dossier that would be accurate and result in FDA’s approval of each step along the way. With each new drug’s approval and introduction to the US market, there were other drugs that had failed to make it through development. So, when we calculated our return on investment, we included costs for all of the drugs in our development programs. a license agreement with another company who was marketing the same molecule under a different name. We achieved greater than 60-percent market share by using the Zestril brand name and bright red advertising in medical journals. Sometimes, the FDA would ask us to change a name after product launch because pharmacists found the name confusing or too similar to other prescribed drugs. After the extensive planning process, a name change was an expensive and frustrating ordeal for us. each newly launched product, such as volume of new prescriptions, formulary acceptance, refill rates, and ultimately sales from our factories. We did not evaluate success based solely upon one drug. With each new drug’s approval and introduction to the US market, there were other drugs that had failed to make it through development. So, when we calculated our return on investment, we included costs for all of the drugs in our development programs. Historically, 20 percent of a company’s revenue goes back into research and development. A drug launch is expected to recover the investment for both the specific drug and the failed drugs that did not get approved. Regarding success, not every drug is expected to be a breakthrough drug. [AUGUST] HOW DID YOU CHOOSE AN APPROPRIATE PRICE? Mr. Milbauer: Well, a drug company is a for-profit business and we obviously sought to make a profit. We would compare our drug Psychiatry 2008 59

Table of Contents Feed for the Digital Edition of Psychiatry - August 2008

Psychiatry - August 2008 Editor’s Message Editorial Advisory Board Contents Borderline Personality Disorder: Are Proliferative Symptoms Characteristic? Short-acting versus Long-acting Medications for the Treatment of ADHD Baby Stimuli and the Parent Brain: Functional Neuroimaging of the Neural Substrates of Parent-Infant Attachment These Boots Are Made for Stalking: Characteristics of Female Stalkers Managing Attention Deficit Hyperactivity Disorder in the Emergency Department Obstructive Sleep Apnea, Hypoxia, and Metabolic Syndrome in Psychiatric and Nonpsychiatric Settings Improving the Quality of Life in Patients with Alzheimer’s Disease The Process of Getting New Drugs to Market Journal Watch Classified Advertising Information for Authors

Psychiatry - August 2008

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