Daiichi Launches FLOXIN Otic

Business Wire, Feb 19, 1998

FORT LEE, N.J.--(BW HealthWire)--February 19, 1998--Today, Daiichi Pharmaceutical Corporation launched FLOXIN(R) Otic (ofloxacin otic solution) 0.3%, a topical quinolone approved for the treatment of susceptible organisms in the following indications: otitis externa in patients 1 year and older; acute otitis media in pediatric patients with tympanostomy tubes (1-12 years of age); and chronic suppurative otitis media in patients with perforated tympanic membranes (12 years of age and older).

FLOXIN(R) Otic is the first and only drug approved for the treatment of acute otitis media in pediatric patients with tympanostomy tubes and chronic suppurative otitis media in patients with perforated tympanic membrane. FLOXIN(R) Otic is also the first new antibiotic ear drop to be approved in over 20 years.

FLOXIN(R) Otic is applied twice a day. It also has a near-neutral pH, which may minimize patient discomfort.

The launch of FLOXIN(R) Otic is a vital step in the establishment of Daiichi's presence in the United States. It is the first drug developed and marketed under the Daiichi name in the United States.

"We are excited about the launch of FLOXIN(R) Otic as it continues the tradition that Daiichi has established of using science to help meet unmet patient needs. We are particularly pleased that FLOXIN(R) Otic, when used as indicated, will alleviate discomfort for millions of children," said Dr. Nadav Friedmann, President and CEO of Daiichi Pharmaceutical Corporation.

FLOXIN(R) Otic will be co-promoted in the United States by sales representatives from Daiichi Pharmaceutical Corporation, McNeil Consumer Products company and Ortho McNeil Pharmaceutical.

As with all drugs FLOXIN(R) Otic is associated with certain risks. Patients are to discontinue use immediately and contact their physician at the first sign of a rash, an allergic reaction, or if the infection has not improved after one week of treatment. The most common adverse effects associated with the use of FLOXIN(R) Otic in the treatment of otitis externa are pruritus (4%), application site reaction (3%), dizziness (1%), earache (1%), and vertigo (1%); the most common adverse effects associated with the use of FLOXIN(R) Otic in treating acute otitis media in pediatric patients with tympanostomy tubes and in treating chronic suppurative otitis media in patients with perforated tympanic membranes are taste perversion (7%) earache (1%), pruritus (1%), paraesthesia (1%), rash (1%), and dizziness (1%).

Daiichi Pharmaceutical Corporation (DPC) of Fort Lee, New Jersey, was established in 1982. It is the wholly owned subsidiary of Daiichi Pharmaceutical Co., Ltd. (DSK), one of Japan's largest pharmaceutical companies. DSK is renowned for its quinolone R&D, particularly for the discovery of FLOXIN( (ofloxacin) oral and IV, and Levaquin(R) (levofloxacin) oral and IV, which are currently marketed in the U.S. by Ortho McNeil Pharmaceutical.

Full prescribing information can be obtained by calling 1-888-727-2500.

CONTACT: Marvin Wetter, M.D.

Nicholas Marcellos

201/944-4333