Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler® Family of Inhalers to Support Asthma Management

Via the PhilRx Patient Access Platform, patients can now access Teva Pharmaceuticals’ Digihaler® family of inhalers

SAN FRANCISCO--(BUSINESS WIRE)-- Phil Inc., a patient access platform company that revolutionizes life science product commercialization, today announced an agreement with Teva Pharmaceuticals that will make Digihaler® products available for prescription using the PhilRx Patient Access Platform. Teva’s Digihaler system is the first and only smart inhaler system that can provide objective inhaler data to help patients and their doctors have informed treatment discussion in support of asthma management.

The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably. Using the PhilRx Patient Access Platform, patients can fill their prescription, review prescription records and obtain assistance navigating insurance benefits.

The PhilRx Patient Access Platform provides end-to-end visibility into the entire prescription life cycle, starting when the physician writes the prescription. Physicians can select the PhilRx Patient Access Platform directly from an electronic medical record (EMR) to submit a prescription for a Digihaler product. Then, physicians can determine if a prescription was filled and have the option to develop a personalized care plan based on the data provided.

“As a global leader in generics and biopharmaceuticals, we are continually striving to improve and innovate around care delivery to help patients access their medication simply and affordably,” said Manny Montalvo, SVP, Digital Health & Innovation, Teva Pharmaceuticals. “With our integrated inhaler we are always looking for ways to enhance consumer experience as technology evolves, and Phil’s technology solution will help us build upon our efforts in a significant and meaningful way.”

“There is incredible opportunity for pharma brands and physicians to better align outcomes, and Phil’s technology solution is patient-centric while seamlessly integrating into users’ workflows,” said Deepak Thomas, Founder and Chief Executive Officer, Phil. “We are pleased to work alongside Teva Pharmaceuticals to better meet consumers where they are in the health journey and improve access to medication.”

Learn more about the PhilRx Patient Access Platform.

ProAir Digihaler Indications and Usage

ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information About ProAir Digihaler

• Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
• Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs
• Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
• Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
• Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
• Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler
• Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines
• Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
• Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
• Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
  • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
  • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
  • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
  • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

Please see full Prescribing Information for ProAir Digihaler.

AirDuo Digihaler Indications and Usage

• AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
• AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.

AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.

Important Safety Information About AirDuo Digihaler

• AirDuo Digihaler contains salmeterol. Long-acting beta₂-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems
• Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms
• Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure
• Do not use AirDuo Digihaler more often than prescribed
• Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason
• Tell your healthcare provider about all the medicines you take and about all of your health conditions
• AirDuo Digihaler can cause serious side effects, including:
  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush
  • Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur
  • Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away
  • Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • Effects on heart
    • increased blood pressure
    • a fast or irregular heartbeat
    • chest pain
  • Effects on nervous system
    • tremor
    • nervousness
  • Bone thinning or weakness (osteoporosis)
  • Slowed growth in children. A child's growth should be checked often
  • Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler
  • Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)

• Common side effects of AirDuo Digihaler include:
  • Infection of nose and throat (nasopharyngitis)
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • back pain
  • headache
  • cough
• These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects.
• 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.

Please see full Prescribing Information for AirDuo Digihaler.

ArmonAir Digihaler Indications and Usage

ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

ArmonAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile App. Use of the App is not required for administration of medication to the patient.

Important Safety Information for ArmonAir Digihaler

Contraindications: ArmonAir Digihaler is contraindicated in:

• Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
• Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler
• Deterioration of Disease and Acute Episodes: ArmonAir Digihaler is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta₂-agonist, not ArmonAir Digihaler, should be used to relieve acute symptoms such as shortness of breath
• Oropharyngeal Candidiasis has occurred in patients treated with ArmonAir Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation
• Immunosuppression and Risks of Infections: Patients who use corticosteroids, such as found in ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
• Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler
• Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler slowly
• Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur.
• Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. if bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue ArmonAir Digihaler and institute alternative therapy
• Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler. Discontinue ArmonAir Digihaler if such reactions occur
• Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler
• Effect on Growth: ICS may cause a reduction in growth velocity. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler
• Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
• Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur when using ArmonAir Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
• Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (greater than or equal to 3%) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough

Please see full Prescribing Information for ArmonAir Digihaler.

About Phil, Inc.

Phil, Inc. revolutionizes life science product commercialization with technology to improve prescription access. Our patient access platform removes barriers to medication access and ensures patients can seamlessly start and adhere to therapy. Providing end-to-end visibility into the prescription life cycle, we unlock coverage and maximize reimbursement for brands while integrating into the lives and workflows of patients and providers. We combine a Silicon Valley mindset and deep pharma expertise with data insights and software-driven platform customization to improve provider experience and elevate brand value.

About Teva Pharmaceuticals

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative medicines research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.

About Digihaler®

Asthma is caused by chronic inflammation of the lung airways and causes coughing, chest tightness, wheezing and shortness of breath. According to the Centers for Disease Control and Prevention (CDC), over 25 million Americans have asthma. Clinical data demonstrate the impact of the Digihaler System on asthma management resulting in a reduction in SABA use and increase in SABA-free days. The objective data support more timely patient-physician interactions versus standard of care. Patients may connect their inhaler to an app, which records inhalation data, and allows patients to securely share the data with a physician or care team to establish more personalized treatment plans.

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Media Contact

Katie Beach

Evoke Canale for Phil

Katherine.Beach@canalecomm.com

PR Contacts

Teva Pharmaceuticals

Kelley Dougherty, (973) 832-2810

Yonatan Beker, (973) 264-7378

Source: Phil Inc.