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July 30, 2015 7:26 PM ET

Pharmaceuticals

Company Overview of Catalent Pharma Solutions, Inc.

Company Overview

Catalent Pharma Solutions, Inc. provides development solutions and delivery technologies for drugs, biologics, and consumer health products. The company’s Development and Clinical Services segment offers manufacturing, packaging, storage, and inventory management services for drugs and biologics in clinical trials. This segment also provides analytical chemical and cell-based testing and scientific services; respiratory products formulation and manufacturing; regulatory consulting; and bioanalytical testing for biologic products. Its Oral Technologies segment offers oral delivery technologies, including formulation, development, and manufacturing services for the oral dose forms comprising p...

14 Schoolhouse Road

Somerset, NJ 08873

United States

8,300 Employees

Phone:

732-537-6200

Fax:

732-537-6480

Key Executives for Catalent Pharma Solutions, Inc.

Chief Executive Officer, President and Director
Age: 51
Chief Financial Officer, Principal Accounting Officer and Executive Vice President
Age: 48
Senior Vice President of Global Operations
Age: 53
Group President of Clinical Supply Services
Age: 48
President of Oral Technologies - Modified Release Technology
Age: 49
Compensation as of Fiscal Year 2015.

Catalent Pharma Solutions, Inc. Key Developments

Amarantus Bioscience Holdings, Inc. Announces Manufacturing Agreement with Catalent Pharma Solutions

Amarantus BioScience Holdings, Inc. announced that it has entered into a manufacturing agreement with Catalent Pharma Solutions (CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor). Under the agreement, Catalent will provide all cell line engineering, process development and clinical Good Manufacturing Practices (cGMP) biomanufacturing activities necessary for the rapid development of a high performance cell line expressing MANF protein that will thereafter be advanced into scale up for cGMP production. The project will utilize Catalent's proprietary GPEx technology, which creates high-expression, extremely stable cell lines with speed and efficiency, typically capable of getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing and commercial scale production. MANF is a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease. Amarantus is developing MANF for the treatment of orphan ocular indications, including retinitis pigmentosa (RP), and recently received orphan drug designation for MANF for the treatment of RP in the United States and in Europe. In addition, MANF proteins have demonstrated proof-of-concept in animal pre-clinical models to treat a wide range of conditions including retinal artery occlusion, glaucoma, Parkinson's disease (PD), diabetes and ischemic heart disease, among others. With this announcement, Amarantus is initiating Investigational New Drug enabling (IND-enabling) studies to support a first-in-man clinical study with MANF. The Company has retained regulatory expertise to identify the fastest path to human proof-of-concept data by evaluating well-respected regulatory pathways available worldwide, and will be working judiciously towards this objective. Amarantus is targeting the initiation of first-in-man clinical studies for MANF in 2016.

Catalent Pharma Solutions Expands Manufacturing Facility in Winchester, Kentucky

Catalent Pharma Solutions has expanded its manufacturing facility in Winchester, Kentucky. The expansion has seen the doubling of its footprint to 180,000sq.ft. The expansion features newly installed fluid bed capacity, expanded analytical laboratories, and an advanced, open facility design that provides flexibility in supporting the requirements of new customer programs. The expansion was completed in response to increased customer demand for the manufacture of complex, oral solid formulations.

Biohaven Pharmaceutical Holding Company Limited Enters into Exclusive Formulation Agreement and Global License with Catalent for Lead Product

Portage Biotech Inc. announced that Biohaven Pharmaceutical Holding Company Limited has entered into an exclusive world-wide agreement with Catalent Pharma Solutions to provide Catalent's Zydis® Orally Disintegrating Tablet (ODT) technology for Biohaven's lead drug development candidate, BHV-0223. Catalent's proprietary Zydis® technology is a unique, freeze-dried, oral solid dosage form that disperses instantly in the mouth - no water is required. Catalent has been working with Biohaven over the last six months to optimize Biohaven's formulation of BHV-0223 utilizing Zydis® ODT. Prototype development has been completed and manufacturing of clinical drug supplies is being initiated to support the formal IND filing for BHV-0223 as well as initiation of a pharmacokinetic study.

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