Hikma Pharmaceuticals Regulatory News (HIK)

London, 17 December 2020 - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has received FDA approval for and launched its generic version of GlaxoSmithKline's Advair Diskus®1 (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.

Hikma worked with Vectura Group, a UK based provider of innovative inhaler drug delivery solutions, to develop the proprietary dry powder inhaler and formulation technology.

According to IQVIA, US sales of Fluticasone Propionate and Salmeterol Inhalation Powder USP, 100mcg/50mcg and 250mcg/50mcg, were approximately $2 billion in the 12 months ending September 2020.

Siggi Olafsson, Chief Executive Officer of Hikma, said "The approval of our generic version of Advair Diskus® marks an important milestone in our strategy to develop more complex respiratory products. Through the unwavering dedication of our employees and close collaboration with the Vectura team, we have developed a high quality and substitutable generic product for Advair Diskus® that will improve availability of this critical medicine. We are very pleased to have now launched this product and will leverage the investments we have made and the experience we have gained through this process to develop a range of respiratory and other complex treatment options for patients and healthcare providers, helping us to continue to put better health, within reach, every day."

1 Advair® and Advair Diskus® are registered trademarks of GSK group of companies.

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Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

Important Safety Information for Fluticasone Propionate and Salmeterol Inhalation Powder USP, 100mcg/50mcg, 250mcg/50mcg:

Contraindications

The use of fluticasone propionate and salmeterol inhalation powder is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) where intensive measures are required.

• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol or any of the excipients.

Warnings and Precautions

Warnings While Using This Medicine:

Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, cataracts, diabetes, glaucoma, heart disease, high blood pressure, heart rhythm problems, thyroid problems, seizures, or osteoporosis. Tell your doctor about any immune system problems or infections, including herpes simplex in your eye, tuberculosis, or parasites. Tell your doctor if you have been exposed to chickenpox or measles.

This medicine may cause the following problems:

Increased risk of asthma-related hospital stays, intubations, and deathIncreased trouble breathing right after use (paradoxical bronchospasm)Increased risk of pneumonia in people who have COPDIncreased risk of infection, including fungus infection in the mouth (thrush)Low bone mineral density, which may lead to osteoporosisCataracts, glaucoma, or other vision problemsSlow growth in childrenAdrenal gland problems

This medicine will not stop an asthma attack that has already started. You should have another medicine to use in case of an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.Tell any doctor or dentist who treats you that you are using this medicine.Call your doctor if your symptoms do not improve or if they get worse.Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:Call your doctor right away if you notice any of these side effects:

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathingChanges in skin color, dark freckles, easy bruising, muscle weakness, round or puffy faceChest pain, trouble breathingDry mouth, increased thirst, muscle cramps, nausea, vomitingEye pain or trouble seeingFast, pounding, or uneven heartbeatFever, chills, cough, runny or stuffy nose, sore throat, body achesTremors, nervousness, or shakingUnusual tiredness or weaknessWorsening of breathing problems

If you notice these less serious side effects, talk with your doctor:

HeadacheHoarseness, voice changesWhite patches inside the mouth or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.

Fluticasone propionate and salmeterol inhalation powder contains salmeterol. Long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. Fluticasone propionate and salmeterol inhalation powder contains an inhaled corticosteroid (ICS) and a LABA. When a fixed-dise combination ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems compared with ICS alone.

Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

Do not use fluticasone propionate and salmeterol inhalation powder to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use fluticasone propionate and salmeterol inhalation powder if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

Do not use fluticasone propionate and salmeterol inhalation powder if you are allergic to fluticasone propionate, salmeterol or any of the ingredients in fluticasone propionate and salmeterol inhalation powder. Ask your healthcare provider if you are not sure.

Do not use fluticasone propionate and salmeterol inhalation powder more often or at a higher dose than prescribed.

Rinse your mouth with water without swallowing after each dose of fluticasone propionate and salmeterol inhalation powder.

Call your healthcare provider or get medical care right away if:

- your breathing problems get worse. o you need to use your rescue inhaler more often than usual.

- your rescue inhaler does not work as well to relieve your symptoms.

- you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.

- you use 1 whole canister of your rescue inhaler in 8 weeks.

- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

- you have asthma and your symptoms do not improve after using regularly for 1 week

Fluticasone propionate and salmeterol inhalation powder can cause serious side effects, including:

• Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after each dose of fluticasone propionate and salmeterol inhalation powder.

• Pneumonia. People with COPD have a greater chance of getting pneumonia. Fluticasone propionate and salmeterol inhalation powder may increase this risk. Call your healthcare provider right away if you have an increase in mucus (sputum) production, change in mucus color, fever, chills, increased cough or increased breathing problems.

• Weakened immune system and greater chance of getting infections (immunosuppression). Fluticasone propionate and salmeterol inhalation powder may make you more prone to infection. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults using corticosteroids.

• Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines (like prednisone) and start taking a medicine containing an inhaled steroid (like fluticasone propionate and salmeterol inhalation powder). During this transition period, when your body is under stress such as fever, trauma, infection, surgery or more severe COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include feeling tired, lack of energy, weakness, nausea and vomiting and low blood pressure.

• Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using fluticasone propionate and salmeterol inhalation powder and call your healthcare provider right away.

• Serious allergic reactions. Call your healthcare provider or get emergency medical care right away if you have any of the following symptoms of a serious allergic reaction: rash; hives; swelling of the mouth, face and/or tongue; breathing problems.

• Effects on the heart. Call your healthcare provider if you have an increase in blood pressure, fast or irregular heartbeat or chest pain.

• Effects on the nervous system. Call your healthcare provider if you have tremor or nervousness.

• Bone thinning or weakness (osteoporosis). Get regular bone density screenings if you have or are at risk for osteoporosis treated with established standards of care.

• Slowed growth in children. Have your child's growth checked regularly by a healthcare provider while using fluticasone propionate and salmeterol inhalation powder.

• Eye problems. Tell your healthcare provider if you have glaucoma, increased pressure in your eye, cataracts or other changes in vision. Get regular eye exams while using fluticasone propionate and salmeterol inhalation powder.

• Changes in laboratory blood levels (sugar, potassium, certain types of white blood cells). Get blood tests at your healthcare provider's recommendation.

Common Side Effects

· Common side effects for asthma include upper respiratory tract infection, throat irritation, hoarseness and voice changes, thrush in your mouth or throat, bronchitis, cough, headache, and nausea and vomiting. In children with asthma, infections in the ear, nose, and throat are common.

· Common side effects for COPD include thrush in your mouth or throat, throat irritation, hoarseness and voice changes, viral respiratory infections, headache, and muscle and bone pain.

Common side effects of fluticasone propionate and salmeterol inhalation powder in patients with COPD include thrush in the mouth or throat, throat irritation, hoarseness and voice changes, viral respiratory infections, headache and muscle and bone pain.

These are not all the possible side effects of fluticasone propionate and salmeterol inhalation powder. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Interactions

Tell your healthcare provider about all of your medical conditions and about all the medicines you take, as fluticasone propionate and salmeterol inhalation powder can interact with other medicines and may cause side effects, in some cases severe:

Drugs and Foods to Avoid:Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Some foods and medicines can affect how fluticasone/salmeterol works. Tell your doctor if you are using any of the following:

Blood pressure medicineDiuretic (water pill)Medicine to treat depression or an MAO inhibitor within the past 2 weeks (including nefazodone)Medicine to treat HIV or AIDS (including atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)Medicine to treat an infection (including clarithromycin, itraconazole, ketoconazole, telithromycin)Seizure medicine

Pregnancy and Breastfeeding

Tell your healthcare provider if you are pregnant, plan to become pregnant or are breastfeeding.

Dosage and Administration

Fluticasone propionate and salmeterol inhalation powder should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

More frequent use or taking more than 1 inhalation twice daily of the prescribed strength of fluticasone propionate and salmeterol inhalation powder is not recommended.

Do not use additional LABA for any reason.

Indications and Usage

Treatment of Asthma

Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older.

Important Limitation of Use:

Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment of COPD

Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Important Limitation of Use:

Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.

For more information about fluticasone propionate and salmeterol inhalation powder, please see the full Prescribing Information and Medication Guide, which you can find in the full press release published on our website at https://www.hikma.com/newsroom/#pageRS=1.

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

Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228

Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ, 07922

Document identification number: WW40040