GemVax licenses Alzheimer's disease treatment GV1001 to Samsung Pharm

Domestic Licensing Contract Worth 120 Billion KRW... Separate Royalties Based on Sales

GemVax & Kael announced on the 26th that it has signed a technology transfer agreement with Samsung Pharm regarding the domestic clinical development and commercialization rights of the Alzheimer's disease treatment GV1001.

The contract is valued at 120 billion KRW. Under the agreement, GemVax will receive an upfront payment of 12 billion KRW from Samsung Pharm and milestone payments totaling 108 billion KRW upon product approval. Royalties based on sales will be separate. The rights pertain only to the domestic market, with GemVax retaining the rights to GV1001 for Alzheimer's disease in global markets excluding Korea.

GemVax has secured the budget for various ongoing clinical trials both domestically and internationally. By transferring the technology to Samsung Pharm, which has GMP-certified manufacturing facilities, all processes including production, management, distribution, marketing, and sales following phase 3 clinical trial approval can proceed smoothly.

Samsung Pharm, by acquiring GV1001 as a key clinical pipeline with proven potential as an Alzheimer's disease treatment, has secured the rights to conduct domestic phase 3 clinical trials and commercialization in Korea. This is expected to enhance new drug development capabilities and improve performance at the newly built state-of-the-art manufacturing plant.

GV1001 is undergoing clinical trials simultaneously in Korea, the United States, and seven European countries. A phase 2 clinical trial conducted in Korea on patients with moderate to severe Alzheimer's disease demonstrated efficacy and safety. The phase 3 clinical trial plan (IND) has been approved, and preparations for the trial are underway.

The global phase 2 clinical trial ongoing in the U.S. and seven European countries is being conducted on patients with mild to moderate Alzheimer's disease following the FDA's suggestion to expand indications. The trial is recruiting 77 patients in the U.S. and 108 in Europe, totaling 185 participants.

A GemVax representative stated, "The license agreement is significant as it was made after discovering a new indication for Alzheimer's based on the compound's characteristics and proving its potential as a treatment through actual clinical trials." They added, "GemVax will focus all its capabilities on global Alzheimer's clinical trials and Korea's first progressive supranuclear palsy clinical trial to achieve results across neurodegenerative diseases."

A Samsung Pharm representative said, "This is part of our efforts to transform into a high value-added pharmaceutical company centered on new drugs," adding, "We will actively enhance competitiveness as a pharmaceutical company by securing new pipelines and introducing new projects to strengthen new drug development capabilities."