The Menarini Group Announced Marketing Authorization Application for Delafloxacin

Food and Healthcare Press Releases Monday March 12, 2018 13:22
FLORENCE, Italy--13 Mar--PRNewswire/InfoQuest

The Menarini Group announced today that on March 6th 2018 it submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix. The proposed indication for delafloxacin in Europe is the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and the conclusion of the European regulatory process is expected in IIQ 2019.

(Logo: https://mma.prnewswire.com/media/652491/MENARINI_Group_Logo.jpg )

Delafloxacin (marketed as Baxdela(TM) in the US) is a novel anionic fluoroquinolone licensed in February 2017 to the Menarini Group from Melinta Therapeutics, Inc., a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections. As part of the development and commercialization agreement, Melinta granted the Menarini Group exclusive rights to commercialize Delafloxacin in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia.

"The regulatory submission of delafloxacin in Europe, after one year from the signature of the agreement, represents an important strategic milestone for Menarini. ABSSSIs are among the most common human bacterial infections and are associated with considerable morbidity, especially in subjects with underlying diseases. Delafloxacin, with its broad in vitro spectrum of activity against Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative and as well as atypical and anaerobe organisms, stands out as a new therapeutic option in this setting. Thanks to this new molecule, we will keep contributing to the health of patients all over the world with the high quality standards that distinguishes Menarini," says P.Mei General Manager of The Menarini Group .

Delafloxacin offers physicians the flexibility of fixed dose intravenous and/or oral dosage formulations, does not require therapeutic drug monitoring, can be taken with food, has a minimal potential for drug interactions, and does not require therapeutic drug monitoring. These factors, in concert with its favorable safety profile, would support the addition of delafloxacin to the ABSSSI armamentarium as an important treatment option.

About the Menarini Group

The Menarini Group is an Italian pharmaceutical company, 12th in Europe out of 5,255 companies, and 36th company in the world out of 20,862 companies, with a turnover of more than 3,5 billion Euro and more than 16,700 employees. The Menarini Group has always pursued two strategic objectives: Research and Internationalisation and is present in the most important therapeutic areas including products for cardiology, gastroenterology, pneumology/antibiotics, diabetology, anti-inflammatory agents/analgesics. With 16 production sites and 6 Research and Development centers, the Menarini Group has a strong presence throughout Europe and Asia, Africa, Central and South America. Menarini's products are available in 136 countries worldwide. For further information, please visit http://www.menarini.com

Source: Menarini Group

Latest Press Release

Novo Nordisk (Thailand) is hosting a press conference for the topic of Rethink Obesity.

Mr. John Dawber, Vice President and General Manager at Novo Nordisk (Thailand) is hosting a press conference for the topic of "Rethink Obesity". The event will be chaired by His Excellency Mr. Uffe Wolffhechel, Ambassador of Denmark to Thailand, and will...

Brain Health Supplements Market Expecting an Outstanding Growth Till 2025

The global brain health supplements market size is expected to reach USD 10.7 billion by 2025, according to a new report by Grand View Research, Inc., expanding at a CAGR of 8.2% over the forecast period. Growing health concerns over depression, anxiety,...

Menarini Silicon Biosystems Launches VRNxT Volume Reduction Instrument

Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, announced that it will launch the new VRNxT(TM), a volume reduction instrument optimized to remove manual sample volume reduction steps in cellular biology...

BREASTFEEDING CAMPAIGN SETS A NEW REGIONAL STANDARD FOR SUSTAINABLE COMMUNICATION

The "6 months mother's milk is all you need" campaign has been awarded South East Asia PR Campaign of the year and Cause related public awareness campaign of the Year by Campaign Asia at the PR awards in Hong Kong last month. Initiated by Save The...

Daewoong Pharmaceutical participated in the IMCAS Asia 2019 to introduce the excellence of NABOTA

Daewoong Pharmaceutical Co., Ltd, a world-leading botulinum toxin manufacturer in Korea, announced its participation in IMCAS Asia 2019 held in Bali, Indonesia July 5-7, 2019 to introduce the excellence of NABOTA(R) (Prabotulinumtoxin A). The 13th year...

Related Topics