LONDON, May 12 /PRNewswire/ -- Therapeutic Proteins, Ltd. (“TPL”) has developed generic versions of filgrastim, interferon and erythropoietin, drugs whose branded versions collectively generate approximately $17 billion in annual revenue worldwide.
The expiration of patents on the earliest drugs produced by the biotechnology revolution has created a new market for biogeneric drugs (referred to as “biosimilar” in Europe) and Therapeutic Proteins, Ltd. of the UK will be one of the first entrants.
At this year’s symposium “Biosimilar Medicinal Products A Reality in Europe,” TPL will introduce three products designed to compete with (1) Neupogen(R) (filgrastim or G-CSF), which is used to treat neutropenia, (2) Intron A(R) (interferon), which is used in the treatment of various cancers and for the treatment of chronic hepatitis B and C; and Epogen(R) (erythropoietin), which is used in the treatment of anemia, chronic renal failure and HIV.
Therapeutic Proteins, Ltd. has obtained the TheraGrastim(TM), TheraFeron(TM) and TheraPoietin(TM) trademarks which it will use as brand names for its products.
As a producer of generic drugs, TPL’s intellectual property consists mainly of proprietary know-how that includes the biotechnology and pharmaceutical manufacturing expertise inherent in the methods it has developed. TPL has refined the production process for each of its three products to optimize yield, reproducibility and purity. TPL has also completed a technology transfer to Angel Biotechnology, its MHRA-approved contract manufacturer in the United Kingdom, where the products manufactured are tested by an official UK laboratory for the quality and potency required for release of medicines into the European market.
The company plans to open applications for European marketing approval with the EMEA for all three drugs in 2006 and expects to receive marketing clearance within regulatory guidelines. Prior to EMEA clearance, TPL expects to obtain EDQM product quality certification, after which it intends to sell its API in bulk to drug companies in selected local markets pursuant to contracts it already has in place. TPI plans to file drug applications in the United States after the FDA identifies its requirements for approving biogeneric drugs.
Potential partnering inquires should be addressed to:
Thomas.Flynn@theraproteins.com
Therapeutic Proteins, Ltd.
CONTACT: Thomas L. Flynn III of Therapeutic Proteins, Ltd, UK,+1-312-297-0000, Mobile: +1-312-948-1955, Thomas.Flynn@theraproteins.com
