MannKind Announces Launch of New Titration Pack and Field...
Feb 1, 2017 9:04:42 GMT -5
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Post by sla55 on Feb 1, 2017 9:04:42 GMT -5
investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1009952
VALENCIA, Calif., Feb. 01, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD), a fully integrated biopharmaceutical company focusing on the discovery and development of therapeutic products for patients with diseases such as diabetes, announced today the launch of a new Titration Pack containing 60 — 4 unit cartridges, 60 — 8 unit cartridges and 60 — 12 unit cartridges of Afrezza (insulin human) Inhalation Powder.
This new package is intended to simplify physician prescribing of Afrezza and allow patients greater dose flexibility in managing their diabetes, while potentially reducing the cost burden of multiple copays.
Michael Castagna, Chief Commercial Officer of MannKind Corporation, stated, "We are excited to see our new Titration Packs entering the supply chain this week. This new titration box along with our new sample program will enable higher dose mealtime insulin patients to dose Afrezza appropriately and manage their disease in as few inhalations as possible."
The new titration package compliments a similar Titration Pack with 90 — 4 unit and 90 — 8 unit cartridges that launched in July 2016 and now makes up almost 25% of weekly Afrezza units dispensed.
Additionally, the Company is transitioning its sales force from a contract sales organization to an expanded team fully staffed by MannKind employees. The new team is expected to be trained and in the field over the next two weeks. The expanded sales force will be able to reach approximately 75% of the total Rapid Acting Insulin Market. The Company is also changing its diabetes nurse educator model, going from a small dedicated team to a much larger nurse team operating on a per diem basis. These efforts are expected to enhance the education and training of patients initiating Afrezza therapy, thereby increasing compliance and persistence.
"The new package, along with our new sales force expansion and nurse educator model, will enable us to make a stronger impact in how we market Afrezza without dramatically increasing our cost structure. Additionally, our Commercial organization has several direct-to-consumer and digital media initiatives deploying in the next few months that will further expand our promotional efforts," said Matthew Pfeffer, Chief Executive Officer.
INDICATION
Prescription Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin used to treat adults with diabetes for the control of high blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for long-acting insulin; Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza.
Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your doctor will take a medical history and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.
You must test your blood sugar levels while using insulin such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.
The most common side effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.
Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breastfeeding or planning to breastfeed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea. Please see full Prescribing Information for Afrezza, including Boxed WARNING and www.afrezza.com.
ABOUT AFREZZA®
Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of 4-unit, 8-unit and 12-unit cartridges. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.
VALENCIA, Calif., Feb. 01, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD), a fully integrated biopharmaceutical company focusing on the discovery and development of therapeutic products for patients with diseases such as diabetes, announced today the launch of a new Titration Pack containing 60 — 4 unit cartridges, 60 — 8 unit cartridges and 60 — 12 unit cartridges of Afrezza (insulin human) Inhalation Powder.
This new package is intended to simplify physician prescribing of Afrezza and allow patients greater dose flexibility in managing their diabetes, while potentially reducing the cost burden of multiple copays.
Michael Castagna, Chief Commercial Officer of MannKind Corporation, stated, "We are excited to see our new Titration Packs entering the supply chain this week. This new titration box along with our new sample program will enable higher dose mealtime insulin patients to dose Afrezza appropriately and manage their disease in as few inhalations as possible."
The new titration package compliments a similar Titration Pack with 90 — 4 unit and 90 — 8 unit cartridges that launched in July 2016 and now makes up almost 25% of weekly Afrezza units dispensed.
Additionally, the Company is transitioning its sales force from a contract sales organization to an expanded team fully staffed by MannKind employees. The new team is expected to be trained and in the field over the next two weeks. The expanded sales force will be able to reach approximately 75% of the total Rapid Acting Insulin Market. The Company is also changing its diabetes nurse educator model, going from a small dedicated team to a much larger nurse team operating on a per diem basis. These efforts are expected to enhance the education and training of patients initiating Afrezza therapy, thereby increasing compliance and persistence.
"The new package, along with our new sales force expansion and nurse educator model, will enable us to make a stronger impact in how we market Afrezza without dramatically increasing our cost structure. Additionally, our Commercial organization has several direct-to-consumer and digital media initiatives deploying in the next few months that will further expand our promotional efforts," said Matthew Pfeffer, Chief Executive Officer.
INDICATION
Prescription Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin used to treat adults with diabetes for the control of high blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for long-acting insulin; Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza.
Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your doctor will take a medical history and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.
You must test your blood sugar levels while using insulin such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.
The most common side effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.
Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breastfeeding or planning to breastfeed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea. Please see full Prescribing Information for Afrezza, including Boxed WARNING and www.afrezza.com.
ABOUT AFREZZA®
Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of 4-unit, 8-unit and 12-unit cartridges. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.
