London, 1 May 2019 – Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) the multinational pharmaceutical company, today launched its 100th injectable medicine in the United States with the introduction of Vancomycin Hydrochloride for Injection, USP, 5g, 10g and 750mg, through its US affiliate, Hikma Pharmaceuticals USA Inc.
“Vancomycin Hydrochloride for Injection is an essential antibiotic used by hospitals to treat patients who have failed to respond to a number of other antibiotics, and it’s another important addition to our growing US portfolio,” said Dan Motto, Executive Vice President, Commercial and Development, Injectables. “This launch marks a great milestone – Hikma’s 100th injectable medicine in the US – and it demonstrates our commitment to providing doctors and hospitals with a broad range of high-quality medicines needed to treat the current and future needs of patients.”
Hikma’s Vancomycin Hydrochloride for Injection, USP is indicated for:
- the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam- resistant) staphylococci;
- patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by Vancomycin-susceptible organisms that are resistant to other antimicrobial drugs;
- initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly;
- the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures;
and has been:
- reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), has been reported to be effective only in combination with an aminoglycoside;
- reported to be effective for the treatment of diphtheroid endocarditis;
- used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The parenteral form of Vancomycin Hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of Vancomycin Hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.
According to IQVIA, US sales of Vancomycin Hydrochloride for Injection, USP, 5g, 10g and 750mg were approximately $247 million in the 12 months ending February 2019.
“Our portfolio of 100 injectable medicines now covers many vital, large and growing therapeutic areas including oncology, anti-infectives, anaesthesia and pain management,” continued Mr. Motto. “We are expecting to launch 15 additional products this year, further strengthening Hikma’s position as a top manufacturer and supplier in the US generic injectable market with a strong portfolio that can’t easily be replicated.”
“Our customers prefer to work with manufacturers that have a large product portfolio and a long record of successful FDA inspections,” said Riad Mechlaoui, Hikma’s President of Injectables. “Over the years Hikma has established a strong reputation for quality products and reliability. We have made significant investments to build flexible manufacturing capabilities allowing us to shift capacity to where it is needed most, and enabling us to quickly address changing market demands, including US drug shortage situations as they arise.”
Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.