AIMM Trial Expected to End on January 31 (NASDAQ:VICL)
On December 28, 2009, Vical Incorporated (NASDAQ: VICL) disclosed that an independent organization – called the Safety Monitoring Board (SMB) – had been analyzing the safety issues of the company’s Phase 3 AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) trial. This was the third time the SMB had analyzed the Phase 3 AIMM trial of Allovectin-7(R). After analyzing, the SBA suggested that Vical should continue the trial “per the protocol”. Allovectin – 7(R) is a drug that has been developed by Vical for treating patients suffering from metastatic melanoma. A total of 375 subjects, who are suffering from Stage III or IV metastatic melanoma and have never used chemotherapy, will be participating in the AIMM trial. Vical has a estimated primary data collection date of January 2010 according to the clinical trials FDA website.
The AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) trial represents a crucial point in the Phase 3 trial of Allovectin-7(R). The trial would check the efficiency and the effectiveness of the drug for treating Stage III or IV metastatic melanoma. The trial would also compare the efficacy of the drug with that of chemotherapy. The AIMM trial has so far been conducted with a Special Protocol Assessment (SPA) agreement with the United States of America’s toughest regulator the Food and Drug Administration (FDA). The SPA mentions the objectives of the AIMM trial, how the trial would be carried out, what objectives and goals (more specifically, “clinical endpoints”) the trial aimed to achieve. In short, the SPA states all the functions that must be carried out for Allovectin-7® to get the FDA’s approval. At present, the AIMM trial is being conducted by the multiple centers of Vical that can be found throughout the world. The trial is taking place only in clinics.
However, conducting the trial had not been easy for Vical. The main reason is the high cost involved with conducting such a trial. That is why it the company had to enter a “collaborative agreement” with AnGes MG, Inc. Under the agreement, the AnGes MG would be “funding the AIMM trial through a series of cash payments and equity investments”. Already, AnGes MG gas paid the full cost – $22.6 million to be exact – of the trial.
So, what would AnGes MG get in return? The company would get the exclusive rights to market Allovectin-7(R) in many countries of Asia, including Japan. In addition, it would get “tiered royalties” (not fixed) from the sales of Allovectin-7(R) in the USA, and “fixed royalties” from the sales of other parts of the world.
Also, Vical would receive royalties from the sales of Allovectin-7(R) by AnGes MG in the countries of Asia. Vical would “sales-based milestone payments” if AnGes MG reach expected levels of sales of Allovectin-7(R) in those countries.
Although both companies plan to share their sales in every country, getting the approval of the regulator, such as the FDA in the USA, in a certain country would be the sole responsibility of the company who is marketing Allovectin-7(R) there.
Tags: VICL
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