Amneal Pharmaceuticals has struck a deal to buy a 98% stake in Kashiv Specialty Pharmaceuticals for $70 million upfront. The takeover will give Amneal control of drug delivery platforms and a pipeline of 505(b)(2) drugs and complex generics. 

Kashiv Specialty is developing a pipeline of treatments for diseases including myasthenia gravis and attention deficit hyperactivity disorder (ADHD). The company plans to use 505(b)(2), an FDA pathway for products that bridge the gap between novel and generic drugs. Products eligible for the pathway include therapies that use a novel drug delivery system to administer an approved molecule.

To support its strategy, Kashiv Specialty has created a portfolio of controlled drug delivery platforms. Amneal is set to gain ownership of the platforms and pipeline by paying $70 million upfront, agreeing to hand over an additional $30 million in one year and committing to up to $8 million in milestones. 

Amneal co-CEO Chintu Patel framed the takeover in the context of his company’s work “to leverage known molecules with novel delivery mechanisms to improve efficacy and reduce side effects for patients.” In the past, Amneal has worked with Kashiv Specialty to develop complex generics. Going forward, Kashiv Specialty and its 80 employees will operate as part of Amneal.

Kashiv Specialty has four publicly disclosed drug delivery platforms. One of the platforms, Grande, is a gastric retention system. Grande products are oral tablets that double in size when they encounter gastric fluids. The expanded tablets stay in the stomach releasing the drug for up to 18 hours, enabling once-daily dosing. 

Kronotec, one of Kashiv Specialty’s other platforms, extends drug release using another mechanism. Using the osmotic oral drug delivery system, Kashiv Specialty can time the release of a molecule. The company is using the platform in an ADHD drug designed to provide early morning symptom control. The child takes the tablet at bedtime but it only releases the active ingredient in the early morning. 

Kashiv Specialty also has formulation technologies to improve the bioavailability of poorly soluble drugs, branded Biomaxx, and a long-acting injectable platform. The long-acting injectable technology, Load, creates depots that gradually break down to provide long-term, sustained release of an active ingredient.