New chemical entity

Anew chemical entity(NCE) is, according to theU.S. Food and Drug Administration,a novel, small, chemical moleculedrugthat is undergoing clinical trials or has received a first approval (not a new use) by the FDA in any other application submitted under section 505(b) of theFederal Food, Drug, and Cosmetic Act.

Anew molecular entity(NME) is a broader term that encompasses both an NCE or an NBE (New Biological Entity).

Definition

Anactive moietyis amoleculeorion,excluding those appended portions of the molecule that cause the drug to be anester,salt(including a salt withhydrogenorcoordination bonds), or othernoncovalentderivative (such as acomplex,chelate,orclathrate) of the molecule, responsible for thephysiological or pharmacological actionof the drug substance.

An NCE is a molecule developed by the innovator company in the earlydrug discoverystage, which after undergoingclinical trialscould translate into a drug that could be a treatment for some disease.Synthesisof an NCE is the first step in the process ofdrug development.Once the synthesis of the NCE has been completed, companies have two options before them. They can either go for clinical trials on their own or license the NCE to another company. In the latter option, companies can avoid the expensive and lengthy process of clinical trials, as the licensee company would be conducting further clinical trials and subsequently launching the drug. Companies adopting this model of business would be able to generate high margins as they get a huge one-time payment for the NCE as well as entering into a revenue sharing agreement with the licensee company.

Under theFood and Drug Administration Amendments Act of 2007,all new chemical entities must first be reviewed by an advisory committee before the FDA can approve these products.

See also

• Molecular/chemical entity
• Medicinal chemistry
• Drug development

External links

• NME's worldwide and in Germany
• CDER Drug and Biologic Approval Reports