Research & Development

Our Approach to R&D
- Mitigate risks and reduce the cost and time to develop products
- Commercialize therapies which address significant unmet needs to improve patients’ lives

Our novel development approach has been designed to reduce the cost and time associated with the development and commercialization of new therapies which address patient needs and result in significant market opportunities. The focus of our development activities is to bring to market products that improve patients’ lives. Once products are approved, our goal is to promote them through our specialty sales force. Our portfolio is built through internally-identified product concepts and focused acquisition and in-licensing activities.

Significant unmet therapeutic needs similarly exist for a wide range of neurological and psychiatric disorders. An estimated 26 percent of Americans 18 years and older suffer from a diagnosable mental disorder in a given year, which translates into nearly 58 million people and makes it more than the disease burden caused by all types of cancers. Up to 70 million Americans suffer from debilitating sleep conditions, the majority of which are neither diagnosed nor appropriately treated, according to the National Heart, Lung and Blood Institute.

>Our Pipeline

Product Development Process
Our process for identifying and developing product candidates draws on market research, new product planning activities, interactions with thought leaders in neurology and psychiatry, and research and development. Jazz Pharmaceuticals selects not only the most promising compounds, but also the drug delivery technology that will optimize that promise. Once a potential product candidate is identified, we conduct feasibility activities to help us determine whether a product candidate has the requisite pharmacological activity, would be valuable to patients and healthcare providers, and could be developed within an acceptable timeframe and budget.

Our JZP-7 and JZP-8 product candidates resulted from our in-house program to identify product candidates. Several other product candidates identified through this process are in various stages of development.

Lowering Risk, Speeding Development –
- Obtain proof-of-concept before incurring significant development expenses
- Identify activities and milestones at each development stage to reduce risk
- Shorten development cycle by working with well-proven drug molecules and new substances with known mechanisms of action

We focus our early-stage activities on obtaining proof-of-concept for each product candidate at a relatively low cost to identify and lessen risk before we incur significant development expenses.

Activities and milestones at each stage of development are designed to further reduce risk, so that as a product candidate moves through the stages of development we can confidently allocate additional resources. If a product candidate does not successfully meet our requirements at any stage of development, we terminate the project.

Our program is also designed to shorten the development cycle for our product candidates compared with that for most new chemical entities. Because we generally work with known drug compounds, or compounds with a mechanism of action or chemical structure that is the same as or similar to that of marketed products, we can often move from a proof-of-concept study directly into pivotal clinical trials.

If we are able to complete product development with fewer clinical trials than are required for a new chemical entity, we may have lower costs of development and shorter development timelines.

We review our portfolio periodically to ensure that we have a balanced mix of product candidates moving into development.

Science & Technology –
Our R&D staff is an interactive team of formulation, preclinical and pharmacokinetic experts. Once an unmet medical need is identified, the team determines the best compound and the optimal drug delivery and pharmacokinetic profile. Our goal is to maximize efficacy and patient compliance while minimizing side effects. The best delivery technology and route of administration to meet this target product profile is selected and optimized for patient use and commercial development. Jazz Pharmaceuticals is not constrained or committed to any specific delivery technology, but seeks collaborations that will result in the most beneficial outcomes for patients. Jazz Pharmaceuticals scientists apply creative and innovative solutions when developing novel approaches to delivery technologies and product development including but not limited to transdermal, intranasal, immediate and controlled release oral formulations.