Early growth in manufacturing.In 1946, United Research Laboratories (URL) was founded by Albert Roberts, a bench chemist with a degree from the University of Pittsburgh. Initially, the company manufactured and sold ACTH directly to physicians to treat arthritis. From this, the Company developed a significant pharmaceutical distribution business which sustained the Company for the ensuing 40 years.
In 1984, seeing that their manufacturers were starting to bypass distributors like URL, Mr. Roberts and his brother, Theodore Roberts, Ph.D., established Mutual Pharmaceutical Company to develop and manufacture generic pharmaceutical products.
In 1988, Albert Roberts’ son, Richard H. Roberts, M.D., Ph.D., left the Brigham and Women’s Hospital, of Harvard Medical School, to join the Company. Dr. Richard Roberts became the Chief Operating Officer in 1989, assuming control of the operations and leading the company to profitability.
In 1997, venture capital investors (Elliott Associates and Momar Corporation) purchased a majority of the company. Dr. Richard Roberts, the only remaining member of the founding Roberts family, maintained a minority interest and became President, CEO and Chairman of the Board.
From generic excellence to branding expertise.By 2001, URL Pharma had achieved significant growth with net sales exceeding $100 million. Additionally, the Company’s R&D budget had increased to $12 million, and an annual production of two billion tablets and capsules. The Company was also manufacturing 35 products, had 14 Abbreviated New Drug Applications (ANDAs) pending FDA approval, and distributed third-party tablets, capsules, liquids, creams, ointments, and injectables.
In 2004, foreseeing that the profitability of the generic pharmaceutical marketplace would deteriorate over the next 5 years as Asian manufacturers gained FDA approvals of generic drugs, URL Pharma embarked upon an ambitious plan to transform the Company into a medically and scientifically focused branded product and technology business. As part of this effort, R&D spending was greatly expanded, transitioning from commodity generic products to first-to-file, patent-challenge generics, branded product development, and technology development. The company also established a branded label business (AR Scientific, Inc.), which currently markets 4 NDA products: COLCRYS®, FIBRICOR®, Qualaquin®, and Bactrim™ (a trademark of Hoffman-La Roche Inc.). The Company also launched felodipine ER and remained the exclusive generic provider for nearly 4 years.
In 2006, URL launched Qualaquin® (quinine sulfate), the Company’s first internally developed branded product and the only FDA-approved version of quinine sulfate. Qualaquin® has Orphan Drug Exclusivity for the treatment of malaria until August 2012.
By 2007, the Company had annual sales of $483 million, more than 250 approved ANDAs, 4 approved NDAs, licensing deals, multiple high-barrier ANDAs, and a broad portfolio of proprietary products under development.
In 2008, the Company changed its name to URL Pharma, Inc. URL Pharma has developed multiple pharmaceutical technologies such as PRISM™,NanoBurst™,MultiBurst™ and Z-Burst™, and continues to progress the development of its proprietary pipeline.
In 2009, URL Pharma received FDA approval of its NDAs for COLCRYS® and FIBRICOR® and commercially launched these products in the third quarter of the year, continuing the Company’s evolution into a specialty pharmaceutical provider.
On June 4, 2012, Takeda Pharmaceuticals U.S.A., Inc., completed its acquisition of URL Pharma, Inc. Takeda Pharmaceuticals U.S.A., Inc. is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions.