About Spear Pharmaceuticals
For more than 15 years, Spear Pharmaceuticals has been committed to making FDA-approved bioequivalent products—and more recently, branded drugs—accessible to the public. The Spear doctrine for bioequivalent drugs is to utilize the same active and inactive ingredients, as well as the same texture, look and consistency, as the branded product. Our commitment to quality has resulted in FDA approval for seven (7) first-to-market bioequivalent dermatologicals, with several more in the pipeline.
Company History
Spear Pharmaceuticals, founded by K.L. Spear, M.D., in 1993, is a company that develops specialty dermatological products to fulfill market needs. Dr. Spear started the firm after 20 years working with patients and seeing firsthand the improvement he could effect in their skin and how that change for the better could enhance their lives. He believed that helpful, effective medications should be kept available for all patients. By combining his formal training at the Mayo Clinic with his practical experience, Dr. Spear now helps thousands of patients at a time by making and marketing the bioequivalent and branded products people need.
Dr. Spear's mission was formed when he realized there was no generic bioequivalent for one of dermatology's biggest products. He knew from his everyday medical practice the kind of positive impact he could provide to his patients, and believed from his clinical trial experience at the Mayo clinic that it would be possible to develop an affordable alternative to Retin-A. And, of course, he knew what kind of benefits he could provide, not only to the patients who came to his office, but to people everywhere.
That was the genesis of the DermIdentical™ process, which designs and develops bioequivalent drugs that have the same active and inactive ingredients, the same texture, look and consistency as the branded product. The Spear doctrine is to produce quality bioequivalent products with characteristics that meet a dermatologist's demanding specifications. We prefer the term bioequivalent over generic because it better explains our process.
After the team identifies a market need for a bioequivalent to a branded prescription dermatology product, we develop it, perform the clinical trials, file with the FDA and once approved, market through drug wholesalers and retail pharmacy chains. We perform large clinical trials of the product proving safety, efficacy, and bioequivalence. That data is then filed with the FDA for their review and approval.
Spear has extensive experience with dermatologic compounds from both the clinical and technical perspectives. Tretinoin is one such compound, for which Spear introduced first-to-market bioequivalent versions of Retin-A and Renova. Since 2001, pharmacies around the country have dispensed over a million prescriptions containing Spear's tretinoin. The Retin-A equivalent products are no longer marketed by Spear, as they were divested (sold to Triax Pharmaceuticals in 2005). Spear continues to market Tretinoin Cream Emollient 0.05%, the bioequivalent generic to Renova 0.05%.
Working with seasoned drug industry professionals covering the disciplines of research and development, quality, manufacturing, regulatory, sales and marketing, Dr. Spear has fulfilled his vision of making FDA-approved bioequivalent drugs accessible to the public. In 1998 after only 5 years, Spear obtained its first approvals, becoming the smallest pharmaceutical company ever to receive an FDA approval. To date, Spear has earned FDA approval for seven (7) first-to-market bioequivalent dermatologicals, and has several more in the pipeline — including some branded products.
Spear Pharmaceuticals is responsible for all technical aspects of the corporation, including manufacturing, regulatory, quality control, and research and development. Dr. Spear has combined his clinical and professional experience with the extensive pharmaceutical industry experience of Bob Sarrio and David Christ.
Spear Dermatology Products is the sales and marketing arm responsible for all commercial operations (Click here to learn more on SDP).
K.L. Spear, M.D.
President and Dermatologist
K.L. Spear, M.D., founded Spear Pharmaceuticals after more than 20 years of work in the field of dermatology. His experience led him to believe that by helping people improve the condition of their skin, he could also have a positive impact on their lives. And by understanding the pharmaceutical market, he knew that he could provide that kind of help to thousands of patients around the country. Dr. Spear attended the University of Illinois as an undergraduate and attended Medical School there as well. He graduated from the prestigious Mayo Clinic as a Dermatologist in 1983 and he practiced Dermatology in Florida for 18 years until 2001. In 1993 he founded Spear Pharmaceuticals with this mission: To develop Bioequivalent Dermatologic Drugs that are off patent, giving patients identical, affordable alternatives through the patented DERMIDENTICAL™ process.
Past positions:
President of Lee County Medical Society 1990-1991
President of Mayo Dermatology O'Leary Society 2004-2006
American Academy of Dermatology Therapeutics/FDA Liaison Task Force 1998-2002
Stephen Basile
Senior Vice President, Sales & Marketing
Stephen Basile is a thirty year veteran of the pharmaceutical industry. He holds a bachelors degree in Marketing, and an MBA. His experience spans the generic industry as well as big pharma. After spending a decade in selling pharmaceutical products for leading pharmaceutical companies, Mr. Basile joined Schein Pharmaceutical, a manufacturer and marketer of generic drugs, in 1985, the goal being the creation of a premier sales and marketing organization. In addition to leading the sales and marketing effort for Spear, Mr. Basile is responsible for managing relationships with Spear Pharmaceuticals' current and future business partners.
Bob Sarrio
VP Q/A and Scientific Affairs
Bob Sarrio joined Spear in 1998 as the lead scientist and quality expert. Bob's drug product experience spans all dosage forms (including radiopharmaceuticals) as well as biotechnologically derived products from conception through commercial production. His experience includes facilities engineering and design, analytical methods development and all types of validations. Subsequent to working in the pharmaceutical arena Bob spent years as an international regulatory and CGMP consultant prior to joining Spear. Bob's formal studies include a full doctoral education (all but dissertation) in physical chemistry. Thesis work was done at Oak Ridge National Laboratory in the facility's Transuranium Research Lab (TRL) studying the chemistry and physics of the man-made elements.
David Christ
VP Regulatory
David Christ joined the Spear Team in February 2003 to support the company's growing number of ANDA approvals and R&D pipeline. David brings a breadth of experience in both private industry (10 years plus) and as an industry consultant (5 years plus), working alongside former prominent FDA officials at Lachman Consultant Services to understand the FDA perspective. He has worked as a chemical compounder in Manufacturing, QC Chemist, formulation chemist, project leader, and primarily in Regulatory Affairs. Much of that work has involved topical products and semisolid formulations, especially in generics. His formal education includes a B.S. in Chemistry (Fairfield University) and an MBA (Hofstra University).