AbbVie 2014 Annual Report Download - page 9

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Other products. AbbVie’s other products include the following:
Duopa and Duodopa. AbbVie’s levodopa-carbidopa intestinal gel for the treatment of advanced
Parkinson’s disease is marketed as Duopa in the United States and as Duodopa outside of the United
States.
Anesthesia products. Sevoflurane (sold under the trademarks Ultane and Sevorane) is an
anesthesia product that AbbVie sells worldwide for human use.
Dyslipidemia products. AbbVie’s dyslipidemia products (TriCor, Trilipix, Niaspan, Simcor and
Advicor) address the range of metabolic conditions characterized by high cholesterol and/or high
triglycerides.
Zemplar. Zemplar is a product sold worldwide for the treatment of secondary
hyperparathyroidism associated with Stage 3, 4, and 5 chronic kidney disease (CKD).
Research and Development Activities
AbbVie has numerous compounds in clinical development, including potential treatments for complex,
life-threatening diseases. AbbVie’s ability to discover and develop new compounds is enhanced by the
company’s use of integrated discovery and development project teams, which include chemists, biologists,
physicians, and pharmacologists who work on the same compounds as a team.
The research and development process generally begins with discovery research which focuses on the
identification of a molecule that has a desired effect against a given disease. If preclinical testing of an
identified compound proves successful, the compound moves into clinical development which generally
includes the following phases:
• Phase 1—involves the first human tests in a small number of healthy volunteers or patients to
assess safety, tolerability and potential dosing.
• Phase 2—tests the drug’s efficacy against the disease in a relatively small group of patients.
• Phase 3—tests a drug that demonstrates favorable results in the earlier phases in a significantly
larger patient population to further demonstrate efficacy and safety based on regulatory criteria.
The clinical trials from all of the development phases provide the data required to prepare and submit
a New Drug Application (NDA), a Biological License Application (BLA) or other submission for regulatory
approval to the FDA or similar government agencies outside the United States. The specific requirements
(e.g., scope of clinical trials) for obtaining regulatory approval vary across different countries and geographic
regions.
The research and development process from discovery through a new drug launch typically takes 8 to
12 years and can be even longer. The research and development of new pharmaceutical products has a
significant amount of inherent uncertainty. There is no guarantee when, or if, a molecule will receive the
regulatory approval required to launch a new drug or indication.
In addition to the development of new products and new formulations, research and development
projects also may include Phase 4 trials, sometimes called post-marketing studies. For such projects, clinical
trials are designed and conducted to collect additional data regarding, among other parameters, the
benefits and risks of an approved drug.
AbbVie spent approximately $3.3 billion in 2014, $2.9 billion in 2013, and $2.8 billion in 2012 on
research to discover and develop new products, indications and processes and to improve existing products
and processes. These expenses consisted primarily of salaries and related expenses for personnel, license
fees, consulting payments, contract research, clinical drug supply manufacturing, the costs of laboratory
equipment and facilities, clinical trial costs, and collaboration fees and expenses.
2014 Form 10-K 3