Teva seeks to minimize risk exposure and to achieve an effective deployment of resources in its research endeavors. Therefore, Teva does not engage in the discovery phase of the R&D process. Through its TIV (Teva Innovative Ventures) group, Teva operates a global sourcing program to identify molecules with a preliminary proof of principle and invests in companies with promising products and technologies at the drug discovery phase.

Proceeding to the next stage- pre-clinical studies- will be initiated only after the following issues have been considered:

• Is the new molecule (structure and/or synthesis and/or use, etc.) patentable?
• What is the projected market environment upon approval?

Teva puts great emphasis on CMC development, to ensure the development process meets the highest quality standards and is performed in a timely manner.

Pre-clinical trials assess the compound’s safety (toxicity), ADME (absorption, distribution, metabolism, elimination) and PK (pharmacokinetics). During this stage, the drug substance is manufactured on a pilot scale, in compliance with Good Laboratory Practice (GLP) standards.

The company’s "go ahead" decision is followed by the preparation of a Clinical Trial Application and its submission to the relevant regulatory authority. The non-clinical program continues to run in parallel to the clinical program, in order to evaluate the drug’s carcinogenicity and reproduction toxicity.

Clinical trials are usually conducted in three main phases. Each phase addresses different questions that determine whether the testing of the new drug can proceed to the next stage.

Teva's Clinical Quality Management  system monitors the different phases of clinical development, to ensure the safety and rights of our participants, the reliability of data and compliance with Good Clinical Practice (GCP) standards.

 

Phase 1 studies are designed to determine the new drug's safety and recommended dosage.

The study aims to determine whether the new drug is effective for treating the disease as well as to determine the safety and tolerability profile of the compound. It should furthermore verify the dosing size and frequency needed to achieve maximal results and minimal side effects.

Proceeding to Phase 2 will depend on:

• Whether Phase 1 trial results demonstrated a reasonable level of safety
• Whether Phase 1 trials provided conclusive information on the drug's pharmacokinetics and side effects
• Whether Phase 1 results demonstrated reasonable drug tolerability
• The resources required for future development

 

Phase 2

During Phase 2, the new drug is administered to a selected group of patients (typically 100-300 people), who have the disease that the new drug treats. The study aims to determine whether the new drug is effective for treating the disease. It should furthermore verify the dosing size and frequency needed to achieve maximal results and minimal side effects.

Proceeding to Phase 3 will depend on:

• Whether evidence of effectiveness has been obtained in Phase 2
• The severity of common short-term side effects, as determined in Phase 2
• The safety data accumulated to date
• Market changes to date
• The options available for increasing the chance of success in Phase 3 (for example, number and types of patients, study end points, etc.)

 

Phase 3

Phase 3 study is the longest of all stages. During this stage the new drug is typically administered to 1,000-3,000 patients around the world. It is designed to confirm efficacy and monitor long-term side effects.

Proceeding to regulatory submission will occur once:

• Conclusive results show significant proof that projected end points were reached or, at least, met with satisfactory proximity
• Accumulated safety data to date shows that the tested drug may be considered safe
• Experts concur on the likelihood of the drug’s approval by the regulatory authorities

Should the company decide to proceed to submission, a regulatory packagewill be prepared for every market in which the company wishes to have the product marketed.

The regulatory authority- such as FDA or EMA- may need as long as a year to review the regulatory package and reach a final decision.

A successful launch of a new product, once approved, includes the following marketing activities:

• A marketing support study
• A Complete communication plan
• Trademark generation and registration
• Publication and education plans

Production process and validation methods for drug substance (API) and drug product are developed early in the development stages and are later forwarded to the production facility. Three validation batches are produced and drug is tested for stability in different storage conditions.

 

Production commences in compliance with Good Manufacturing Practice (GMP) regulations. Once production is completed, a new innovative drug is launched.

 

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Once a drug has been approved by a regulator, Teva’s Pharmacovigilance unit continues to monitor its safety based on market reports. The purpose of safety surveillance is to detect Adverse Drug Reactions (ADR's) over a wide population of patients and long periods of use. This activity is crucial for the protection of public health, since the safety data collected during the clinical studies are based on a restricted number of patients and therefore might not provide an accurate indication of future safety. Post marketing activities include:

• Ongoing surveillance of safety and adverse reactions or side effects
• Observation of long-term risks and benefits
• Continuous monitoring of drug's safety and efficacy when widely used