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Case Study 2:
Resurrecting a Product from a Study That Failed to Achieve its Primary Endpoint

When this client's lead compound failed to achieve its primary endpoint in a pivotal Phase 3 trial, they asked Umen & Co. to help determine whether continued development was warranted, and if so, how the company should proceed.

Our team and an independent group of medical consultants reviewed all of the available data to gain a full understanding of the drug's efficacy and safety profile. During the review, it became apparent that the data, including the Phase 3 trial, suggested that the drug was intrinsically effective and devoid of any significant safety signals. Based on these favorable trends, the client was advised that further development should be considered. We subsequently helped construct a new clinical development plan aimed at gaining marketing approval.

From a strategic regulatory standpoint, it was critical to bolster the application with respect to efficacy as much as possible given that the previous Phase 3 trial had not achieved its primary endpoint. Consequently, we developed a regulatory strategy that had the potential of providing the substantial evidence of effectiveness necessary for approval in the shortest time frame possible. In addition to conducting additional Phase 3 trials, this strategy positioned select Phase 2 trials and an alternate analysis of the previous Phase 3 trial as confirmatory evidence of effectiveness.

When the new Phase 3 trials yielded positive results, we provided the medical writing services to complete the clinical study reports, the ISE, the ISS, and the Application Summary in a manner that integrated the regulatory strategy into each of these key NDA documents. We also worked with the client's multidisciplinary team to draft and annotate the PI.

The NDA was ultimately approved and the drug became the company's first marketed product. What was once a doomed drug now benefits countless patients and delivers considerable value to our client.






Umen & Co.  The Leader in NDA Preparation Since 1981