cp
Newbie
Posts: 7 
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Post by cp on Aug 11, 2014 0:11:43 GMT -5
Just released!
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Post by mapotofu10 on Aug 11, 2014 0:14:04 GMT -5
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 http://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.
Adverse Reactions
The most common adverse reactions associated with Afrezza (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation.
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Post by 4allthemarbles on Aug 11, 2014 0:16:11 GMT -5
Is this true- whoa...
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Post by bradleysbest on Aug 11, 2014 0:17:58 GMT -5
Hope this is true!
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Post by mapotofu10 on Aug 11, 2014 0:20:35 GMT -5
It's on their website. Go for it !!
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Post by 4allthemarbles on Aug 11, 2014 0:24:09 GMT -5
Sanofi or mannkind? It's 1:20 am here- I'm going nuts!
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Post by bradleysbest on Aug 11, 2014 0:24:13 GMT -5
Yep! Legit.. Boom goes the dynamite!
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Post by gamblerjag on Aug 11, 2014 0:24:25 GMT -5
IT IS TRUE.. MNKD SENT EMAIL.. DOESN'T INCLUDE TECHNO.. WHICH IS GREATER NEWS.
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Post by bradleysbest on Aug 11, 2014 0:25:06 GMT -5
Mannkindcorp.com
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Post by 4allthemarbles on Aug 11, 2014 0:26:49 GMT -5
OMG it's true!!!
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Post by gamblerjag on Aug 11, 2014 0:28:17 GMT -5
Sanofi (SAN) agreed to pay MannKind Corp. (MNKD) as much as $925 million for rights to the world’s only available inhaled insulin less than seven weeks after the drug won regulatory approval in the U.S.
Sanofi will take 65 percent of profit or loss related to sales of the drug, Afrezza, while MannKind will get 35 percent, the two companies said in a statement today. Paris-based Sanofi will also advance Valencia, California-based MannKind as much as $175 million in expenses.
The agreement is Sanofi’s second diabetes-related deal in two months after saying in June it would work with Medtronic Inc. on devices to simplify insulin use. The French drugmaker is looking for ways to buttress revenue and fend off competition from Novo Nordisk A/S when its top-selling product, the Lantus insulin, loses patent protection next year.
“Afrezza is a further addition to our growing portfolio,” Pierre Chancel, head of Sanofi’s diabetes division, said in the statement. “It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections.”
Afrezza was approved in late June as a fast-acting insulin for use at meal times for those with both types of diabetes. The U.S. Food and Drug Administration had twice rejected the drug, most recently in 2011, after the company switched inhalers during the review process.
Pfizer Inc. won approval for an inhaled insulin, Exubera, in 2006 but pulled it from the market the following year after sales were lower than expected, according to an FDA staff report. The drug was associated with a higher risk of lung cancer because insulin is directly deposited in the lungs.
Afrezza is a powder delivered through a cartridge and is designed to control blood sugar during meal times in less time than standard injections.
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Post by 4allthemarbles on Aug 11, 2014 0:28:54 GMT -5
I'm going bonkers- I'm on vacation and just got back to the room. Hard to do reach when you can think straight. I went to the Wall Street Journal site
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Post by mapotofu10 on Aug 11, 2014 0:29:41 GMT -5
It's on the Sanofi website also.
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Post by cannon5974 on Aug 11, 2014 0:30:05 GMT -5
Great news about a large company like Sanofi, but terms don't seem as good as I would of expected? Anyone else agree?? Only $150M upfront and 65% goes to Sanofi and 35% to MNKD? There is a potential to receive another $775M. MNKD invested 10 years and 2 Billion to only receive $150M and keep 35% share of sales?
Is anyone else slightly disappointed?
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Post by 4allthemarbles on Aug 11, 2014 0:30:56 GMT -5
Mapotofu10 & CP......
You guys just made my night!!
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