ALK Enters into Co-Promotion Agreement with Otonomy for OTIPRIO® (ciprofloxacin otic suspension), the First and Only Single-Dose Treatment for Acute Otitis Externa (Swimmer's Ear)

- ALK gains exclusive rights to market OTIPRIO in U.S. for acute otitis externa including to ear, nose and throat (ENT) physicians, pediatricians and select primary care physicians -

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ALK, INC.

Jun 17, 2020, 10:23 ET

ROUND ROCK, Texas, June 17, 2020 /PRNewswire/ -- ALK (ALKB:DC / OMX:ALK B / AKABY / AKBLF) a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced today the signing of an exclusive agreement with Otonomy, a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, for the co-promotion of OTIPRIO^® (ciprofloxacin otic suspension) for acute otitis externa (AOE) in the U.S. in patients six months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.

"We are excited for this collaboration with Otonomy, the company that pioneered drug delivery technology to provide sustained exposure to the ear," said Jorge Alderete, President, ALK, Inc. "OTIPRIO is already commercially available with an established J code to support buy-and-bill reimbursement. It also complements our existing allergy portfolio and supports our ongoing expansion into ENT and pediatrics, which uniquely positions us to effectively educate healthcare providers that seek to provide a single-dose treatment option to their patients."

Under the terms of the agreement, ALK will have exclusive rights to promote OTIPRIO for AOE to office-based healthcare professionals in the U.S. including ENT physicians, pediatricians and select primary care physicians. During the multi-year agreement, Otonomy will retain responsibility for supply chain, distribution, order-handling, the customer call center, pharmacovigilance and maintaining the NDA for OTIPRIO, while ALK will handle promotion of the product to healthcare professionals for AOE. ALK plans to begin promotional activities in support of the product in early July.

"The arrival of summer signals an increase in the number of swimmer's ear infections we treat as people spend more time in the water for recreation," said John Ansley, M.D., Carolina Ear Nose & Throat Clinic. "OTIPRIO provides an important option to treat patients, as young as six months old, with a single-dose antibiotic administered right in the doctor's office."

About Acute Otitis Externa
Acute otitis externa (AOE), also known as swimmer's ear, is a common condition involving infection and inflammation of the external ear canal typically caused by bacterial infection. According to market data, there are approximately 4 million episodes of AOE each year in the United States. Symptoms include itchiness, redness, swelling, pain and pus draining from the infected ear. Topical antibiotics are considered the standard of care treatment for AOE with the typical regimen of ear drops requiring several administrations to the affected ear each day for up to 10 days. In a study of the accuracy of patient self-medication with topical eardrops, England et al. observed that "Compliance patterns were extremely poor, in that only 40 percent of patients were managing to self-medicate within a 25 percent error margin by the end of day 3."

About OTIPRIO
OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

For bilateral otitis media with effusion, OTIPRIO is administered during ear tube surgery as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p < 0.001).

For AOE, OTIPRIO is administered as a single 0.2 mL (12 mg) administration to the external ear canal of each affected ear. In a single Phase 3 trial, OTIPRIO demonstrated statistically significant clinical response defined as the complete absence of signs and symptoms of AOE (i.e., tenderness, erythema, edema and otorrhea) compared to sham (p < 0.001).

Approved Indications for OTIPRIO

OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for

The treatment of pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing tympanostomy tube placement and
The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.

Important Safety Information for OTIPRIO

Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

Warnings and Precautions - Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.

Adverse Reactions - Bilateral otitis media with effusion clinical trials: Adverse reactions (incidence at least 3%) with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%). Acute otitis externa clinical trial: Adverse reactions (incidence at least 2%) with OTIPRIO vs sham were: ear pruritus (2% vs 2%), headache (2% vs 1%), otitis media (2% vs 1%), and ear discomfort (2% vs 0%).

Use in Specific Populations - Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement and acute otitis externa.

Full prescribing information can be found at www.OTIPRIO.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838

About ALK
ALK is a global specialty pharmaceutical company focused on allergy. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,400 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs, including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

SOURCE ALK, INC.