Mannkind, Game-Chancer in Sachen Diabetik? (Seite 546)
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Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin
Paris and Valencia, Calif. - August 11, 2014 - Sanofi (EURONEXT: SAN and NYSE: SNY) and MannKind Corporation (Nasdaq: MNKD) announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015.
Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary.
Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of $175 million.
“Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler,” said Pierre Chancel, Sanofi Senior Vice President Diabetes Division. “Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections.”
“We are so very pleased and honored that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide,” stated Alfred Mann, MannKind’s Chairman and Chief Executive Officer. “Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure. Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs.”
Sanofi’s diabetes solutions portfolio includes medications as well as drug delivery systems and blood glucose monitoring devices. As a leader in diabetes management, the addition of Afrezza to Sanofi’s leading portfolio of pharmaceuticals represents the latest opportunity for the company to bring another insulin option to people with diabetes around the globe.
The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation.
Greenhill & Co. served as exclusive financial advisor to MannKind with respect to this transaction.
MannKind will host a conference call to discuss the collaboration with Sanofi at 8:30 AM (Eastern Time) on August 11, 2014. To view and listen to the webcast, visit MannKind’s website at www.mannkindcorp.com<http://www.mannkindcorp.com> and click on the “MannKind 8/11/14 Conference Call” link in the Webcast section of News & Events. To participate in the live call by telephone, please dial (800) 708-4540 or (847) 619-6397 and use the participant passcode: 37856089.
A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 3785 6089#. A replay will also be available on MannKind's website for 14 days.
The U.S. Food & Drug Administration (FDA) approved Afrezza Inhalation Powder on June 27, 2014, to improve glycemic control in adult patients with diabetes mellitus.
Afrezza (uh-FREZZ-uh) is a rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. The product consists of Afrezza Inhalation Powder delivered using an inhaler. Administered at the start of a meal, Afrezza dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, and decline to baseline by approximately 180 minutes.
Limitations of Use: Afrezza must be used in combination with a long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis and is not recommended for patients who smoke.
Full U.S. Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use is available at Afrezza.com.
Afrezza has been approved with a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA to ensure that the benefits of Afrezza outweigh the potential risk of acute bronchospasm in patients with chronic lung disease.
Important Safety Information about Afrezza (insulin human Inhalation Powder)
The following information is taken from the highlights section of the U.S. Prescribing Information.
Boxed 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.
Contraindications
Afrezza is contraindicated during episodes of hypoglycemia, in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD), or in patients with a hypersensitivity to regular human insulin or any of the Afrezza excipients.
Warnings and Precautions
1.) Acute Bronchospasm: Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV1) in all patients. Do not use in patients with chronic lung disease. 2.) Change in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring. 3.) Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to; insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. 4.) Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms. 5.) Lung Cancer: Afrezza should not be used in patients with active lung cancer. In patients with a history of lung cancer or at risk for lung cancer, the benefit of Afrezza use should outweigh this potential risk. 6.) Diabetic Ketoacidosis: More patients using Afrezza experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated. 7.) Hypersensitivity Reactions: May be life-threatening. Discontinue Afrezza, monitor and treat if indicated. 8.) Hypokalemia: May be life-threatening. Monitor Potassium levels in patients at risk of hypokalemia and treat if indicated. 9.) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
Read more: http://mnkd.proboards.com/thread/1135/pr-sanofi-mannkind#ixz…
Paris and Valencia, Calif. - August 11, 2014 - Sanofi (EURONEXT: SAN and NYSE: SNY) and MannKind Corporation (Nasdaq: MNKD) announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015.
Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary.
Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of $175 million.
“Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler,” said Pierre Chancel, Sanofi Senior Vice President Diabetes Division. “Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections.”
“We are so very pleased and honored that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide,” stated Alfred Mann, MannKind’s Chairman and Chief Executive Officer. “Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure. Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs.”
Sanofi’s diabetes solutions portfolio includes medications as well as drug delivery systems and blood glucose monitoring devices. As a leader in diabetes management, the addition of Afrezza to Sanofi’s leading portfolio of pharmaceuticals represents the latest opportunity for the company to bring another insulin option to people with diabetes around the globe.
The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation.
Greenhill & Co. served as exclusive financial advisor to MannKind with respect to this transaction.
MannKind will host a conference call to discuss the collaboration with Sanofi at 8:30 AM (Eastern Time) on August 11, 2014. To view and listen to the webcast, visit MannKind’s website at www.mannkindcorp.com<http://www.mannkindcorp.com> and click on the “MannKind 8/11/14 Conference Call” link in the Webcast section of News & Events. To participate in the live call by telephone, please dial (800) 708-4540 or (847) 619-6397 and use the participant passcode: 37856089.
A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 3785 6089#. A replay will also be available on MannKind's website for 14 days.
The U.S. Food & Drug Administration (FDA) approved Afrezza Inhalation Powder on June 27, 2014, to improve glycemic control in adult patients with diabetes mellitus.
Afrezza (uh-FREZZ-uh) is a rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. The product consists of Afrezza Inhalation Powder delivered using an inhaler. Administered at the start of a meal, Afrezza dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, and decline to baseline by approximately 180 minutes.
Limitations of Use: Afrezza must be used in combination with a long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis and is not recommended for patients who smoke.
Full U.S. Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use is available at Afrezza.com.
Afrezza has been approved with a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA to ensure that the benefits of Afrezza outweigh the potential risk of acute bronchospasm in patients with chronic lung disease.
Important Safety Information about Afrezza (insulin human Inhalation Powder)
The following information is taken from the highlights section of the U.S. Prescribing Information.
Boxed 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.
Contraindications
Afrezza is contraindicated during episodes of hypoglycemia, in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD), or in patients with a hypersensitivity to regular human insulin or any of the Afrezza excipients.
Warnings and Precautions
1.) Acute Bronchospasm: Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV1) in all patients. Do not use in patients with chronic lung disease. 2.) Change in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring. 3.) Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to; insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. 4.) Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms. 5.) Lung Cancer: Afrezza should not be used in patients with active lung cancer. In patients with a history of lung cancer or at risk for lung cancer, the benefit of Afrezza use should outweigh this potential risk. 6.) Diabetic Ketoacidosis: More patients using Afrezza experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated. 7.) Hypersensitivity Reactions: May be life-threatening. Discontinue Afrezza, monitor and treat if indicated. 8.) Hypokalemia: May be life-threatening. Monitor Potassium levels in patients at risk of hypokalemia and treat if indicated. 9.) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
Read more: http://mnkd.proboards.com/thread/1135/pr-sanofi-mannkind#ixz…
NEWS:
MannKind has added a news release to its Investor Relations website.
Title: Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin
Date(s): 11-Aug-2014 9:04 PM
For a complete listing of our news releases, please click here
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=ir…
NASDAQ OMX 325 Donald J. Lynch Blvd, Marlborough, MA 01752 | 800/990-6397
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MannKind has added a news release to its Investor Relations website.
Title: Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin
Date(s): 11-Aug-2014 9:04 PM
For a complete listing of our news releases, please click here
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=ir…
NASDAQ OMX 325 Donald J. Lynch Blvd, Marlborough, MA 01752 | 800/990-6397
Click Here to unsubscribe from this JoinMail list.
Buona sera...
Bin gespannt auf den morgigen Tag und auf die Neuigkeiten, die uns erwarten werden ;-)
Sonnige Grüße aus bella Italia
Bin gespannt auf den morgigen Tag und auf die Neuigkeiten, die uns erwarten werden ;-)
Sonnige Grüße aus bella Italia
wer lesen kann ist klar im vorteil. ich habe nicht gesagt, dass ich davon ausgehe, dass mnkd nicht seigt, sondern, dass der zeitpunkt m.m.nach von den shorties bestimmt wird.
70 Mio shares short sind eine waffe! und weder ein überragendes adcom voting noch ein vorzeitiges approval durch die fda haben dieses geschütz auch nur einen millimeter aus der richtung gebracht - im gegenteil: das shortinterest hat noch locker um 10% zugenommen. d.h. für mich liegt die vermutung nahe, dass die macht dieser bande sehr stark ist... wenn die nur 10% ihrer aktien in einer konzertierten aktion auf den markt abfeuern - geht das teil locker um 2$ in den süden - und das sind nurmal 10% ihres pulvers!!
ich denke, dass die diese waffe nicht zu abwehr, sondern zum angriff nutzen werden. meine antwort: mehrere "trittbrett" SL-fishing-orders bis runter zu 6,5 $ ...
70 Mio shares short sind eine waffe! und weder ein überragendes adcom voting noch ein vorzeitiges approval durch die fda haben dieses geschütz auch nur einen millimeter aus der richtung gebracht - im gegenteil: das shortinterest hat noch locker um 10% zugenommen. d.h. für mich liegt die vermutung nahe, dass die macht dieser bande sehr stark ist... wenn die nur 10% ihrer aktien in einer konzertierten aktion auf den markt abfeuern - geht das teil locker um 2$ in den süden - und das sind nurmal 10% ihres pulvers!!
ich denke, dass die diese waffe nicht zu abwehr, sondern zum angriff nutzen werden. meine antwort: mehrere "trittbrett" SL-fishing-orders bis runter zu 6,5 $ ...
Wenn Al-Man den Abgang machen sollte, gibt es sicherlich hier schon eine Nachfolgeregelung! Somit gehst Du eigentlich davon aus, dass Mannkind niemals ordentlich steigen wird. Also ich als großes Pharmaunternehme würde mir Mannkind eher schnappen und halt dann mit Afreeza Umsätze generieren! Somit bleibt der Große im Insulinmarkt Platzhirsch! Es sind doch fast bei allen kleineren BioBuden extrem viele Short unterwegs. Also können wir ja getrost verkaufen - Mannkind bleibt bei 8-10$
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Antwort auf Beitrag Nr.: 47.450.506 von thozo am 06.08.14 21:20:01nochmal für alle zum mitschreiben: hier haben finstere mächte - vielleicht ein konsortium von großen pharmabuden - über ein paar hedgefonds oder weiß der geyer was, über 70 MILLIONEN aktien short!! und die kauft kein thozo, sunny, tippse mit hier&da mal ein paar hundert stück nach oben. vielleicht haben die einen so richtig langen atem und spekulieren darauf, dass al mann - immerhin ist der mann 89 alt - den finalen abgang macht... klingt zynisch, aber der kapitalmarkt ist leider kein ponyhof 
schaut nur in euer depot. das ding steigt, wenn es die finsteren mächte zulassen und nicht ob die einen partner bekannt geben oder das insulin bei x oder y einkaufen ...
schaut nur in euer depot. das ding steigt, wenn es die finsteren mächte zulassen und nicht ob die einen partner bekannt geben oder das insulin bei x oder y einkaufen ...
Buona sera a tutti ;-)
Hat jemand von euch eine Ahnung, warum sich bei MNKD kurstechnisch Richtung Norden immer noch nichts bewegt?? Im PM hat es doch noch ganz gut ausgesehen und nun zum Ende des Tages können wir hoffen, dass es nicht wieder in den roten Bereich rutscht...
Herzliche Grüsse aus bella Italia
Hat jemand von euch eine Ahnung, warum sich bei MNKD kurstechnisch Richtung Norden immer noch nichts bewegt?? Im PM hat es doch noch ganz gut ausgesehen und nun zum Ende des Tages können wir hoffen, dass es nicht wieder in den roten Bereich rutscht...
Herzliche Grüsse aus bella Italia
i-afrezza :P
http://mobihealthnews.com/35489/apple-adds-spirometry-data-tracking-to-health-app/
etwas Phantasie gefällig?
etwas Phantasie gefällig?
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Mannkind, Game-Chancer in Sachen Diabetik?
