New Topical Solution Addresses Parents' Concerns with Ear Infections

Business Wire, Feb 19, 1998

FORT LEE, N.J.--(BW HealthWire)--Feb. 19, 1998--

--First Antibiotic Ear Drop in Over 20 Years to Earn FDA Approval--

Today, Daiichi Pharmaceutical Corporation launched FLOXIN(R) Otic, which marks the first time in over two decades that a new antibiotic ear drop has been approved by the U.S. Food and Drug Administration.

The arrival of FLOXIN(R) Otic will vastly aid in the treatment of approximately 5 million people in the United States suffering from specific middle and outer ear infections. FLOXIN(R) Otic will be particularly beneficial to children 1-12 years of age with tympanostomy tubes who develop middle ear infections (acute otitis media with tympanostomy tubes) and patients 12 years and older who suffer from middle ear infections associated with perforated eardrums (chronic suppurative otitis media). For these two groups, FLOXIN(R) Otic stands alone as the first and only drug approved for their treatment.

FLOXIN(R) Otic may be used alone without oral antibiotic therapy. This may help to alleviate some parental concerns over the frequent use of oral antibiotics in their children. In addition the twice-daily dosing of FLOXIN(R) Otic allows for greater flexibility in coordinating daily applications avoiding school and work hours.

Of the approximately 5 million people annually who suffer from ear infections that can be treated with FLOXIN(R) Otic, about 4 million suffer from swimmer's ear, or outer ear infections (medically referred to as otitis externa). This infection generally occurs during the summer months. Topical treatment is standard therapy for outer ear infections. FLOXIN(R) Otic is the first twice daily topical therapy approved for the treatment of these infections and, with its near neutral pH level, it may minimize the patient's discomfort. It is the first new topical solution in 20 years approved by the FDA for treatment of outer ear infections.

The development of FLOXIN(R) Otic reflects Daiichi's company credo --`science meeting patient needs'-- by making it possible to treat these ear conditions in children and adults with a topical solution rather than an oral antibiotic, reducing the risk of resistance and unwanted side effects.

The most commonly reported adverse reactions in clinical trials in otitis externa patients treated with FLOXIN(R) Otic (n=229): pruritis (4%) application site reaction (3%); dizziness (1%); and vertigo (1%); in acute otitis media patients with tympanostomy tubes and in CSOM patients with perforated membranes treated with FLOXIN(R) Otic (n=656): taste perversion (7%); earache (1%), pruritis (1%); paraesthesia (1%); rash (1%); and dizziness (1%).

FLOXIN(R) Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or other ingredients of the medication, and should be discontinued at the first sign of allergic reaction. Patients who have not improved after one week of treatment should be evaluated by their doctor.

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 representation from Daiichi Pharmaceutical Corporation, McNeil Consumer Products company and Ortho McNeil Pharmaceutical.

FLOXIN(R) Otic (ofloxacin otic solution) 0.3%, a topical quinolone, was approved by the F.D.A. for 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).

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(R)(ofloxacin) oral and IV, and Levaquin(R) (levofloxacin) oral and IV, which are currently marketed in the U.S. by Ortho McNeil Pharmaceutical. -0-

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

CONTACT: Daiichi Pharmaceutical Corp.

Marvin Wetter, M.D.

Nicholas Marcellos

201/944-4333