King Pharmaceuticals Announces FDA Approval of New Bicillin Manufacturing FacilityBRISTOL, Tenn.--(BUSINESS WIRE)--Feb 21, 2007 - King Pharmaceuticals, Inc. (NYSE: KG) announced today the U.S. Food and Drug Administration (FDA) approval of the Company's new state-of-the-art manufacturing and production facility in Rochester, Michigan for its Bicillin(R) product line. Bicillin(R) L-A (penicillin G benzathine injectable suspension) is the first product available from this facility.
The recent Sexually Transmitted Diseases Treatment Guidelines issued in 2006 by the Centers for Disease Control and Prevention (CDC) recommends penicillin G as the preferred treatment of all stages of syphilis. Bicillin(R) L-A, administered via deep intramuscular injection, has been used effectively for more than 60 years to cure syphilis and prevent sexual transmission.
"This modern facility demonstrates King's commitment to the continued importance of treating and controlling infectious diseases," stated Eric J. Bruce, Chief Technical Operations Officer, King Pharmaceuticals, Inc. "With syphilis on the rise in major cities across the U.S., the new facility expands our production capacity to ensure continued availability of Bicillin(R) L-A to healthcare providers and patients."
New Packaging/Delivery System
To streamline the ease and use of Bicillin(R) L-A, King is now using the Becton Dickinson Hypack(TM) Luer-Lok(TM) syringe system with the Eclipse(TM) safety-cover needle. The Bicillin(R) L-A package carton contains five prefilled syringes per thermoform tray, two trays per carton and 10 needles individually sterilized and packaged.
Bicillin(R) L-A is available in 1mL Pediatric (600,000 units), 2mL (1,200,000 units) and 4mL (2,400,000 units). The average dose to treat primary, secondary and latent syphilis is 2,400,000 units in one single dose. Bicillin(R) L-A is also indicated for mild-to-moderate infections of the upper respiratory tract due to susceptible streptococci, including streptococcal pharyngitis, and has been used for prophylaxis to prevent recurrence of rheumatic fever and/or chorea.
Alarming Increase in Syphilis
Syphilis shows a significant increase in cities across the country. There were 8,852 new cases of primary and secondary syphilis reported at the end of 2006.
"The overall increase in syphilis infections among adults and adolescents was driven by increases among at-risk males. The rates increased by 8.5 percent in 2005 -- 4.7 per 100,000 population in 2004 to 5.1 in 2005. And, for the first time in over a decade, the rate of syphilis has increased in women, underscoring the need for ongoing, effective medical prevention and treatment using penicillin G benzathine," said Jeffrey D. Klausner, M.D., M.P.H. Director, STD Prevention and Control Services, San Francisco Department of Public Health and Associate Clinical Professor of Medicine, University of California, San Francisco.
Syphilis is a sexually transmitted disease (STD) caused by the bacterium T. pallidum. It is passed from person to person through direct sexual contact with syphilis sore, or chancre, which is painless and disappears in about three weeks.
Many people infected with syphilis may not have any symptoms for years, or do not recognize a sore or rash during the early stages of the disease. As such, most transmission is from persons who are unaware of their infection. Left untreated, the disease may progress leading to organ damage and potentially, death.
"As the only manufacturer of Bicillin(R) L-A in the U.S., King recognizes its responsibility to healthcare clinicians and their patients. Through ongoing educational efforts, including audio conferences, newsletters and a new Web site, we will endeavor to keep clinicians up-to-date on prevention and treatment issues," said Charles L. Pamplin, III, M.D., Vice President of Medical Affairs for King Pharmaceuticals.
About Bicillin(R) L-A
Bicillin(R) L-A (penicillin G benzathine injectable suspension) is indicated for the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels provided by this particular dosage form including: syphilis, yaws, bejel and pinta.
Penicillin G benzathine is contraindicated in individuals with hypersensitivity to any penicillin-type antibiotic. Use with caution in individuals with histories of significant allergies and/or asthma. Give only by deep intramuscular injection. Do not inject by any other route, such as intra-arterial or intravenous. Do not inject into or near nerves or blood vessels, since such injection might produce neurovascular or other damage.
WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.
Please see full Prescribing Information which may be obtained at www.bicillin.net.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management. For more information about Bicillin(R) L-A and syphilis, visit www.bicillin.net.
King Pharmaceuticals, Inc., Bristol
James E. Green, 423-989-8125
Executive Vice President, Corporate Affairs
David E. Robinson, 423-989-7045
Senior Director, Corporate Affairs
Posted: February 2007