ALK Acquires OTIPRIO® (ciprofloxacin otic suspension), Broadening Treatment Solutions for Healthcare Providers and Patients

ROUND ROCK, Texas, June 3, 2021 /PRNewswire/ -- ALK (ALKB:DC / OMX:ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced today that it has acquired OTIPRIO^® (ciprofloxacin otic suspension) from Otonomy, Inc. OTIPRIO is a prescription fluoroquinolone antibacterial approved to treat pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP), and to treat acute otitis externa (AOE), also known as swimmer's ear, in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus. The acquisition will strengthen ALK's expansion into ear, nose and throat (ENT) and pediatrics. In June 2020, ALK signed an exclusive agreement with Otonomy for the co-promotion of OTIPRIO, which included exclusive rights to market OTIPRIO for AOE to office-based health care professionals in the U.S.

"ALK is excited to expand our portfolio to offer more innovative solutions to healthcare providers, including ENTs, primary care physicians and pediatricians, as well as their patients," said Jorge Alderete, President, ALK, Inc. "OTIPRIO is a great fit with our existing portfolio and supports our business strategy to broaden our commercial footprint in the U.S. with novel first-in-class products that can help improve patient outcomes via physician provided in-office procedures. Additionally, ALK will also now offer our other allergy immunotherapy products and penicillin allergy testing to an expanded set of healthcare provider specialties."

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. For AOE, OTIPRIO is administered as a single 0.2 mL (12 mg) administration to the external ear canal of each affected ear.

About Bilateral Otitis Media with Effusion in Tympanostomy Tube Placement
According to the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement (TTP) surgery is the most common ambulatory surgery performed on children. Overall, there are approximately one million TTP procedures performed each year in the United States, of which 85% are in pediatric patients who typically have middle ear effusion and receive tubes in both ears (bilateral). The tubes are placed for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear). Placement of the tube helps to ventilate the middle ear and enables the administration of topical antibiotics to treat the infection.

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."

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.

About ALK
ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company employs around 2,500 people worldwide and is listed on Nasdaq Copenhagen. To learn more about ALK and allergies, visit www.alk.net.

For further information, please contact:

ALK:
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

SOURCE ALK, INC.

Related Links

https://www.alk.net/