Vanda Pharma acquires world-wide licence from Eli Lilly to develop & commercialise NK-1 receptor antagonist

WashingtonTuesday, April 17, 2012, 09:00 Hrs  [IST]

Vanda Pharmaceuticals Inc., a biopharmaceutical company, has acquired an exclusive world-wide licence from Eli Lilly and Company (Lilly) to develop and commercialize a small molecule neurokinin 1 receptor (NK-1R) antagonist for all human indications.

NK-1R antagonists have been evaluated in a number of indications including chemotherapy-induced nausea and vomiting (CINV), post-operative nausea and vomiting (PONV), alcohol dependence, anxiety, depression, and pruritus. VLY-686 (formerly known at Lilly as LY686017) has demonstrated proof-of-concept in alcohol dependence in a study published by the NIH (1). In that study VLY-686 was shown to reduce alcohol cravings and voluntary alcohol consumption among patients with alcohol dependence. Merck's Emend (aprepitant) is the only marketed NK-1R antagonist in the United States and is approved for the treatment of CINV and the prevention of PONV.

“The licencing of VLY-686 is an important milestone for Vanda, as we continue to realize our vision of developing treatments to address unmet medical needs,” said Mihael H Polymeropoulos, MD, president and CEO of Vanda.

Under the terms of the agreement with Lilly, Vanda will pay an initial licence fee of $1.0 million and will be responsible for all development costs. Lilly is also eligible to receive additional payments based upon achievement of specified development and commercialization milestones as well as tiered-royalties on net sales at percentage rates up to the low double digits. These milestones include $4.0 million for pre-NDA approval milestones and up to $95.0 million for future regulatory approval and sales milestones.

In 2012, Vanda intends to initiate and complete the technology transfer activities and further examine the clinical and commercial profile of VLY-686. This strategic evaluation will further inform potential indications for an early development clinical programme.

VLY-686 (formerly known at Lilly as LY686017) is an NK-1R antagonist currently at the clinical stage of development, with previous research focusing on the potential as a novel therapeutic in alcohol dependence (1). The patent describing VLY-686 as a new chemical entity expires worldwide in April 2023, except in the United States, where it expires in June 2024, absent any applicable patent term adjustments.

The NK-1R is expressed throughout different tissues of the body, with major activity found in neuronal tissue. Substance P (SP) and NK-1R interactions in neuronal tissue regulate neurogenic inflammation locally and the pain perception pathway through the central nervous system. Other tissues, including endothelial cells and immune cells, have also exhibited SP and NK-1R activity. The activation of NK-1R by the natural ligand SP is involved in numerous physiological processes, including the perception of pain, behavioural stressors, cravings, and the processes of nausea and vomiting. An inappropriate over-expression of SP either in nervous tissue or peripherally could result in pathological conditions such as substance dependence, anxiety, nausea/vomiting, and pruritus. An NK-1R antagonist may possess the ability to reduce this over-stimulation of the NK-1R, and as a result address the underlying pathophysiology of the symptoms in these conditions.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.