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PharmEng International Inc., Toronto On, TSX .V : PII
CORPORATE OVERVIEW
PharmEng International Inc. wholly-owns:
PharmEng is engaged in two businesses:
Through Keata, the Company provides contract manufacturing services in drug formulation, manufacturing scale up, and commercial production of both solid and liquid pharmaceuticals.
Keata operates through two pharmaceutical manufacturing facilities - a newly constructed facility located in Sydney, Nova Scotia (46,400 sq. ft.) and a newly acquired facility located in Arnprior, just outside of Ottawa, Ontario (85,000 sq. ft.).
In these two facilities, Keata provides high quality services under current Good Manufacturing Practices in the following areas:
PTI is recognized as a respected consulting practice in the pharmaceutical, biotechnology and medical device sectors, and is emerging as a leader with its complete service offerings to assist clients in the rapid commercialization of new products, from strategic planning to process scale up.
PTI’s consulting services include regulatory audits and compliance, project management, engineering, quality systems development and audits, GMP (Good Manufacturing Practice) audits, SOP (Standard Operating Procedures) development, process validation, calibration, medical device investigative testing (clinical trials), medical device product licenses and establishment licenses, mandatory problem reporting and certified training in the medical device, pharmaceutical and biotechnology fields.
PTI is also active in delivering the Biotechnology and Pharmaceutical Technology Certificate Program in partnership with universities in Canada and abroad by providing course materials and instructors.
Recent Highlights
PharmEng will receive $3.0M over 3 years from the Atlantic Canada Opportunities Agency ("ACOA") for research and eventual commercialization of a daffodil derived extract for the treatment of Alzheimer's disease.
ACOA's Atlantic Innovation Fund will distribute the $3.0M based on the project meeting certain conditions that will include $1.0M of private sector financial participation.
The project involves formulation development, extraction of the active pharmaceutical ingredient (galanthamine), purification and final dosage finishing. Access to Government funding is expected as the project meets certain deliverables over the 3 year period.
Keata's pharmaceutical manufacturing facility located in Sydney, N.S. will provide the eventual commercial manufacturing for the North American market once research has been successfully completed and all the necessary regulatory approvals have been obtained, a process that could take 3 to 5 years.
STRATEGY AND OUTLOOK
PharmEng’s vision is to be a leader and preferred supplier to the pharmaceutical sector, offering a fully integrated suite of high-quality consulting services and commercial manufacturing, from strategic planning and process scale up to final production.
PharmEng’s strategy is to provide strategic benefits and advantages to its clients through access to comprehensive quality products and services. This strategy includes:
The pursuit of this vision led the Company to a major acquisition of a Pfizer manufacturing facility located in Arnprior, Ontario. This acquisition was completed December 31, 2007
OVERVIEW OF THE PHARMACEUTICAL INDUSTRY
The global pharmaceutical industry comprises global, regional and national pharmaceutical manufactures, developers, distributors, biotechnology companies, and specialty companies in drug formulation, testing, clinical trials, engineering, and compliance.
There is a trend by major pharmaceutical companies towards outsourcing of drug development, commercial manufacturing, and consulting services to meet growing demand and bring products to market quickly. In addition, the growth of biotechnology companies, generic drug companies, and nutraceutical companies, whose principal focus is on efficient product development as opposed to incurring considerable investment for non-recurring resources and manufacturing.
PharmEng management believes that growth in pharmaceutical industry outsourcing will continue to :
COMPETITORS
Pharmaceutical Consulting and Development
The pharmaceutical consulting and development market is composed of a number of small competitors who specialize in one or a few areas of the technical areas where PharmEng operates. With respect to drug development, there are small laboratories in most major centers that provide limited development services on a small scale. On the other hand there are competitors with much larger operations and geographic coverage. In most cases these larger competitors are not focused solely on the pharmaceutical sectors, and the pharmaceutical business only comprises a fraction of their overall consulting business. There are a few integrated companies that can provide the full complement of consulting services to develop and manufacture a wide range of pharmaceutical products.
Contract Manufacturing
The contract manufacturing organization (“CMO”) industry is fragmented, highly competitive with numerous private and public firms. Players range from small specialty companies to large diversified pharmaceutical manufacturers. CMO companies not only compete against one another, but also against major pharmaceutical companies, which have in-house manufacturing capabilities and seek to sell excess capacity on a contract basis.
Intellectual Properties Valuation
The Company has capitalized intellectual properties related to the development, formulation, and clinical and stability testing, for certain company owned pharmaceutical products referred to as drug identification numbers (DIN’s). The Company has received Health Canada approval for the manufacture and distribution of these products. These assets are considered to have indefinite lives and the Company tests these assets for impairment at least annually, to determine whether the carrying value exceeds its fair value. If it is determined that impairment exists, such impairment is recognized in net income at the time.