Danube Pharmaceuticals Taps Aptuit for Integrated Phase II Drug Development Project.

Danube Will Draw on Full Range of Aptuit Resources Across Its Global Network, From API Development Through to Qualified Person Release and Manufacture for Clinical Trial Materials

GREENWICH, Conn. -- Aptuit, Inc. announced today that it has secured its first integrated drug delivery contract from Danube Pharmaceuticals. Aptuit will provide the company with a full range of drug development services and employ five of its global facilities to develop and manufacture Danube's investigational compound in support of upcoming Phase II clinical trials. This project will include a wide range of Aptuit's services including: API process development, cGMP API delivery, clinical manufacture, analytical services, clinical packaging and labeling, and Qualified Person (QP) release.

"This partnership is an end result of what we have worked to build since Aptuit's inception two years ago - a company that offers clients a fully integrated, global service offering that addresses the scientific and regulatory challenges, as well as redundancies, that make the current drug development process prolonged and expensive," said Michael A. Griffith, CEO of Aptuit.

Mr. Griffith added, "The Aptuit model provides a comprehensive, tailored approach to drug development, backing our services with hands-on project management. This contract underscores Danube's confidence that Aptuit can deliver what it needs to get through Phase II more efficiently and effectively than they could on their own."

With its full suite of global services, from API development through to commercial manufacture, as well as horizontal project management, Aptuit can execute upon complex projects at all stages of development and minimize intelligence transfer obstacles across technology and processes. The Danube project will utilize Aptuit's specialized teams and facilities in Harrisonville and Kansas City, Missouri; Bathgate and Riccarton, Scotland; and Deeside, Wales, and will be coordinated by a central Aptuit project manager responsible for full integration of services.

"Aptuit's wide range of services, sophisticated manufacturing facilities, and tailored project management were attractive features in our decision to engage the company," said David Tanen, President of Danube Pharmaceuticals. "With tight timelines for an anticipated Phase II clinical trial this summer, we felt that Aptuit presented the best service offering that would move our project forward efficiently and seamlessly, and more importantly, deliver a quality product on time."

Having recently completed its sixth major acquisition, Aptuit has established competencies across all aspects of drug development, including: API development and manufacture, preclinical technologies, analytical chemistries, informatics and information management, clinical packaging and logistics, and industry-leading consulting expertise. To date, Aptuit has invested more than $30M internally to align its global operations and has embarked on a further $100M expansion program to increase capacity and add additional services. Aptuit now operates in 14 facilities globally, complemented by a clinical trial distribution network of 27 supply depots, accessing more than 70 countries worldwide.

About Aptuit:

Aptuit, Inc. is a global company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. The company was founded by a group of industry experts with extensive market experience who have a track record of building a similar, highly successful company through acquisitions and investment. Aptuit provides a comprehensive suite of product development services and competencies to more than 500 biotechnology and large, fully integrated pharmaceutical innovators worldwide. Currently, the company has more than 2,000 employees, 14 global facilities, and resources to reach 70 countries. Aptuit's mission is to engineer a better drug development process, and is partnered with Welsh, Carson, Anderson & Stowe, one of the world's largest private equity investors. For more information about Aptuit, please visit aptuit.com.

About Danube:

Danube Pharmaceuticals, Inc. is a privately held biopharmaceutical company created in 2005 by Two River Group Holdings, LLC. Danube acquires the rights to commercially develop therapeutic technologies to address unmet medical needs. Danube is developing DNB-001, an oral therapy currently in phase II clinical development as a treatment of glaucoma, and beginning phase II development as a treatment for ischemic cardiac and kidney damage. The company's mission is to efficiently move its technologies through the various stages of clinical development in order to meet the need for safe and effective treatments of human illnesses.