AAIPHARMA INC

AAIPHARMA INC

Previous company name
APPLIED ANALYTICAL INDUSTRIES INC
Name change date
4/30/1996
Company Overview
AAIPharma Inc., based in Wilmington, North Carolina, is a global provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. The company was founded in 1979 as an analytical laboratory providing testing services to pharmaceutical clients.
AAIPharma has a broad array of scientific skills to meet customer’s drug development needs worldwide, from simple to complex, spanning the spectrum from pharmaceutical to clinical. Its full development capabilities, includes pharmaceutics, analytical, bioanalytical, clinical, and regulatory services, which help conduct studies necessary to support all phases of product development.
AAIOncology (formerly CAC), a full-service clinical unit of AAIPharma, is dedicated to oncology drug development and clinical trial management. AAI Infectious Diseases is an integrated full-service unit for drug and vaccine development offering expert medical advice, regulatory strategy and clinical trial management for products combating a broad spectrum of human pathogens. AAIPharma’s Generic Solutions Group is dedicated to providing ANDA development resources to meet customer’s product needs. AAIPharma’s Biotech Solutions Group combines deep experience, skills and flexibility in product development with special qualities of collaborative team chemistry. In addition, AAIPharma, through its AAI International division, is a leader in providing contract pharmaceutical development services.
AAIPharma mission is to create value for its customers by providing worldwide professional drug development services that translate leading edge technological and scientific advances into practice.
The company is active in North America, Europe, South America, and in Asia.
Business Summary
aaiPharma Inc. (aaiPharma) is a science-based pharmaceutical company offering pharmaceutical development capabilities primarily in the United States and Europe. aaiPharma offers laboratory services, clinical trials material manufacturing, microbiological testing, regulatory and quality consulting, and bioanalytical, biotechnical, commercial manufacturing and human clinical trials-management services. During the year ended December 31, 2004, the Company operated through three businesses: Product Sales (the Pharmaceuticals Division), Development Services (the AAI Development Services Division) and Product Development (Research and Development). In March 2005, aaiPharma reorganized its operating structure and now operates in only two business segments: pharmaceutical product development and sales through its Pharmaceuticals Division, and development services offered to third parties through its AAI Development Services Division.
Description and history
aaiPharma Inc. (aaiPharma), incorporated in 1986, is a science-based pharmaceutical company offering pharmaceutical development capabilities primarily in the United States and Europe. aaiPharma offers laboratory services, clinical trials material manufacturing, microbiological testing, regulatory and quality consulting, and bioanalytical, biotechnical, commercial manufacturing and human clinical trials-management services. During the year ended December 31, 2004, the Company operated through three businesses: Product Sales (the Pharmaceuticals Division), Development Services (the AAI Development Services Division) and Product Development (Research and Development). In March 2005, aaiPharma reorganized its operating structure and now operates in only two business segments: pharmaceutical product development and sales through its Pharmaceuticals Division, and development services offered to third parties through its AAI Development Services Division.

Pharmaceuticals Division

The Pharmaceuticals Division markets and commercializes the pharmaceutical products that aaiPharma has acquired or developed. The Pharmaceuticals Division also manages the development of the Company’s pipeline products. aaiPharma commercializes products in the pain and critical care therapeutic areas. Its pain products include Duraclon (clonidine hydrochloride), Drug Enforcement Administration (DEA) Schedule IV products (Darvon/Darvocet) and DEA Schedule II products (Methadone injectable, Roxicodone (oxycodone hydrochloride tablets), Roxanol (morphine sulfate) and Oramorph SR (morphine sulfate)). Its critical care products are used to treat organ rejection in kidney transplants (azathioprine) and severe asthma (Brethine).

The Roxicodone, Oramorph SR, Roxanol and Duraclon product lines are meant to treat moderate-to-severe pain. Roxicodone immediate-release oral solutions, Oramorph SR sustained-release tablets and Roxanol immediate release oral solutions are DEA Schedule II (CII) pain products. Duraclon injection is a non-scheduled, pain-management product.

The Darvon and Darvocet products, which were acquired from Eli Lily, are prescribed for the treatment of mild-to-moderate pain. The acquired products include Darvon (propoxyphene hydrochloride), Darvocet-N (propoxyphene napsylate and acetaminophen), Darvon-N (propoxyphene napsylate) and Darvon Compound-65 (propoxyphene hydrochloride, aspirin and caffeine). aaiPharma acquired a product, which it subsequently branded as Darvocet A500 from Athlon Pharmaceuticals in July 2003. Darvocet A500 contains 500 milligrams (mg) of acetaminophen, compared to 650 mg in Darvocet-N 100.

In April 2003, aaiPharma acquired rights to a parenterally administered Methadone injectable product, formerly branded as Dolophine Hydrochloride Injection, from Roxane. This product is indicated for the treatment of moderate-to-severe pain not responsive to non-narcotic analgesics, and for use in temporary treatment of opioid dependence in patients unable to take oral medication.

The Brethine-branded product line was acquired from Novartis Pharmaceuticals Corporation and Novartis Corporation. On April 19, 2004, the United States Food and Drug Administration (FDA) approved the Company’s supplemental new drug application for a vial presentation of the injectable form of this product. On November 1, 2004, aaiPharma launched its Brethine vial presentation into the United States market.

During the year ended December 31, 2003, aaiPharma received FDA approval to market three internally developed line extensions of additional strengths to its 50-mg generic azathioprine tablet product, 25 mg, 75 mg and 100-mg tablets. The Company began selling the 75 mg and 100-mg products during 2003. In November 2003, aaiPharma granted Salix Pharmaceuticals (Salix) a license to market the additional strengths of Azasan (azathioprine) and licensed its Azasan trademark to Salix. On April 26, 2004, the Company sold its the M.V.I. and Aquasol-branded lines of critical care injectable and oral nutritional products to Mayne Pharma (USA) Inc.

AAI Development Services

AAI Development Services provides a variety of pharmaceutical services to its customers, including drug formulation development and small-scale manufacturing, as well as storage and distribution of clinical trial supplies. AAI Development Services provides integrated formulation development services for customers’ pharmaceutical products to develop safe and stable products with desired characteristics. It provides services during each phase of the drug development process, from new compounds to modifications of existing products. It manufactures clinical trial materials for Phase I through IV drug-product clinical trials.

AAI Development Services provides a variety of analytical services, as well as services pertaining to method development and validation, drug product and active pharmaceutical ingredient characterization and control, microbiological support, stability storage and studies, technical support and problem solving. Its analytical services include method development and validation, product characterization, raw materials and product release testing, and stability studies.

AAI Development Services integrates a Phase-I clinical study capability with bioanalytical and biotechnology expertise to provide biopharmaceutical services to its customers. Its biopharmaceutical services include phase I clinical services from an 88-bed, Phase-I clinical trial facility located in Research Triangle Park, North Carolina, and a 72-bed facility in Neu-Ulm, Germany, and microbiological testing, bioanalytical testing and biotechnology analysis.

AAI Development Services provides a range of Phase I through IV clinical services to customers in the pharmaceutical, biotechnology and medical device industries for assistance in the drug development and regulatory approval process in North America and Europe. The clinical services include clinical protocol and program development, global clinical strategy consulting, investigator/site management, clinical trial management and monitoring, project management, site selection, medical affairs, data management and biostatistics.

AAI Development Services provides consulting services with respect to regulatory affairs, quality compliance and process validations. It assists in the preparation of regulatory submissions for drugs, devices and biologics, audits clients’ vendors and client operations, conducts seminars, provides training courses and advises clients on applicable regulatory requirements.

Research and Development

aaiPharma’s research and development efforts are focused on three products in development. aaiPharma is working on a modified release Darvocet product. Other products being developed include Lynxorb, a formulation of diclofenac that utilizes the Company’s ProSorb drug delivery technology to enhance the amount and speed of absorption of this inhibitor of cyclooxygenase one (COX1) and cyclooxygenase two (COX2) enzymes, and an aaiPharma formulation of a generic proton pump inhibitor.

Was founded as an analytical laboratory providing testing services to pharmaceutical clients

Business Line
A global provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries
Subsidiary
INSTITUTO DE PESQUISA CLINICA DE SAO PAULO LTD
Advisor
ERNST & YOUNG LLP
IPO date
9/1996
US SIC Code
2833
Company Address
2320, Scientific Park Drive

City province or state postal code
28405, WILMINGTON, NC
Phone: +1 910 254 7000
Fax: +1 910 815 2287
Country address: UNITED STATES OF AMERICA
Website url: www.aaipharma.com