Stason Pharmaceuticals, Inc. Company Profile

Background

Founded in 1989, Stason Pharmaceuticals, Inc. is a California-based pharmaceutical company specializing in the development, manufacturing, and commercialization of both generic and branded pharmaceutical products. The company's mission is to provide high-quality, affordable medications, with a primary focus on oncology, central nervous system (CNS) disorders, cardiovascular diseases, and dermatologic conditions. Stason operates a 37,149-square-foot facility in Irvine, California, and maintains strategic alliances with partners in Asia, including Standard Chem. and Pharm. Co., Ltd. in Taiwan.

Key Strategic Focus

Stason's strategic objectives encompass:

• Generic Pharmaceuticals: Since entering the U.S. generic market in 1994, Stason has developed a portfolio of approved Abbreviated New Drug Applications (ANDAs), focusing on high-containment manufacturing and complex formulations.

• Branded Products: The company launched its branded division in 2008, expanding its offerings to include proprietary medications.

• Contract Development and Manufacturing: Through divisions like MPhS and Western PharmSci, Stason provides contract packaging, analytical testing, and contract development and manufacturing organization (CDMO) services, particularly for high-potency products.

Financials and Funding

Stason Pharmaceuticals is a privately held company with estimated annual revenues of approximately $11.9 million and a total of 48 employees across all locations. The company has engaged in strategic collaborations, such as the 2011 agreement with Amerigen Pharmaceuticals for the development of generic oral oncology products, which included upfront fees, development milestones, manufacturing revenues, and royalties.

Pipeline Development

Stason's pipeline focuses on developing generic and branded products in therapeutic areas like oncology and CNS disorders. The company aims to file 4-5 ANDAs annually in these areas, leveraging its high-containment manufacturing capabilities to address complex formulations.

Technological Platform and Innovation

Stason's technological capabilities include:

• High-Containment Manufacturing: The company operates facilities capable of handling highly potent compounds with occupational exposure levels down to 0.1 µg/m³, adhering to SafeBridge® Category 1-4 standards.

• Dosage Form Capabilities: Stason's cGMP manufacturing facilities support production from pilot to commercial scale, with batch sizes ranging from 0.5 kg to 600 kg, and an annual capacity exceeding 2 billion oral doses.

• Analytical Testing and Stability Monitoring: The company offers quality control testing for APIs, intermediates, excipients, and finished products, with stability storage conditions meeting ICH guidelines.

Leadership Team

• Harry T. Fan: Chief Executive Officer

• Jim Fang: Chief Operating Officer

• Diana Wood: Vice President, Corporate Development

These executives have been instrumental in forging strategic alliances and expanding Stason's market presence.

Leadership Changes

As of the latest available information, there have been no significant recent changes in Stason's leadership team.

Competitor Profile

Market Insights and Dynamics:

The pharmaceutical industry, particularly the generic and oncology sectors, is highly competitive and rapidly evolving. Companies are focusing on high-containment manufacturing and complex formulations to address unmet medical needs and regulatory challenges.

Competitor Analysis:

• Amerigen Pharmaceuticals: Specializes in developing and commercializing generic pharmaceuticals, focusing on orally delivered products that require specialized technologies or high containment.

• Unilife Corporation: A U.S.-based medical device company focused on designing and manufacturing proprietary retractable syringes, with which Stason has a distribution agreement for the Unitract™ 1mL safety syringe in Asia.

Strategic Collaborations and Partnerships

Stason has engaged in several strategic collaborations to enhance its market position and capabilities:

• Unilife Corporation: In 2010, Stason signed a five-year agreement to market Unilife's Unitract™ 1mL safety syringe in Japan, China, and Taiwan, with a minimum purchase requirement of one million units per year.

• Amerigen Pharmaceuticals: In 2011, Stason entered into a collaboration agreement for the development of generic oral oncology products, leveraging Stason's specialized containment facilities and formulation expertise.

• Abingdon Life Sciences, Inc.: In 2008, Stason extended its strategic alliance with Abingdon to provide regulatory and clinical support, enhancing business development and IP licensing opportunities in Asia.

Operational Insights

Stason's competitive advantages include:

• High-Containment Manufacturing: Ability to handle highly potent compounds, providing a barrier to entry for competitors.

• Vertical Integration: Control over the supply chain from API development to finished product submission, ensuring quality and cost-effectiveness.

• Strategic Alliances: Partnerships with companies like Unilife and Amerigen expand market reach and product offerings.

Strategic Opportunities and Future Directions

Stason aims to:

• Expand Generic Portfolio: Continue filing multiple ANDAs annually, focusing on oncology and CNS products.

• Enhance Manufacturing Capabilities: Invest in high-containment facilities to handle complex formulations and high-potency compounds.

• Strengthen Global Partnerships: Leverage existing alliances and seek new collaborations to enhance product development and market penetration.

Contact Information

• Website: www.stasonpharma.com

• Headquarters: Irvine, California, USA

Note: Specific contact details such as address, phone number, and email are omitted to maintain privacy.