Sanofi US to Return Auvi-Q® (epinephrine inj) Right to kaleo
Feb 23, 2016 17:16:14 GMT -5
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Post by lakers on Feb 23, 2016 17:16:14 GMT -5
www.keyc.com/story/31295473/sanofi-us-to-return-auvi-q-epinephrine-injection-usp-rights-to-kalo
BRIDGEWATER, N.J., Feb. 23, 2016 /PRNewswire/ -- Sanofi announced today that the license and development agreement between Sanofi and kaléo, formerly Intelliject Inc., the developer of Auvi-Q® (epinephrine injection, USP), will terminate later this year. At that time, all U.S. and Canadian rights will be returned to kaléo. Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. Kaléo will evaluate timing and options for bringing Auvi-Q back to market.
The decision to return rights for Auvi-Q aligns with Sanofi's ongoing transformation to focus on critical therapeutic areas in its five global business units: Diabetes & Cardiovascular, General Medicines & Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi US will complete the return and reimbursement process associated with the October 28, 2015, voluntary nationwide recall of Auvi-Q. For more information on the recall, please visit www.Auvi-Q.com.
Indication
Auvi-Q® (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions.
Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Sanofi abandoning Auvi-Q after dosage problems led to total recall
By Dan Stanton+, 23-Feb-2016
Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.
www.in-pharmatechnologist.com/Processing/Sanofi-abandoning-Auvi-Q-after-dosage-problems-led-to-total-recall
12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind
13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential
14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency Trials
Former Mylan CMO, current Mnkd CMO Ray said,
"The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around.
They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option.
Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need."
Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz411J1bXsH
Mylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi's Auvi-Q® (epinephrine injection, USP) Recall
www.prnewswire.com/news-releases/mylan-confirms-availability-of-epipen-epinephrine-injection-auto-injector-for-us-patients-affected-by-sanofis-auvi-q-epinephrine-injection-usp-recall-300168925.html
According to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences.
[Imagine Mnkd partners with Mylan for inhaled Epinephrine]
BRIDGEWATER, N.J., Feb. 23, 2016 /PRNewswire/ -- Sanofi announced today that the license and development agreement between Sanofi and kaléo, formerly Intelliject Inc., the developer of Auvi-Q® (epinephrine injection, USP), will terminate later this year. At that time, all U.S. and Canadian rights will be returned to kaléo. Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. Kaléo will evaluate timing and options for bringing Auvi-Q back to market.
The decision to return rights for Auvi-Q aligns with Sanofi's ongoing transformation to focus on critical therapeutic areas in its five global business units: Diabetes & Cardiovascular, General Medicines & Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi US will complete the return and reimbursement process associated with the October 28, 2015, voluntary nationwide recall of Auvi-Q. For more information on the recall, please visit www.Auvi-Q.com.
Indication
Auvi-Q® (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions.
Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Sanofi abandoning Auvi-Q after dosage problems led to total recall
By Dan Stanton+, 23-Feb-2016
Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.
www.in-pharmatechnologist.com/Processing/Sanofi-abandoning-Auvi-Q-after-dosage-problems-led-to-total-recall
12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind
13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential
14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency Trials
Former Mylan CMO, current Mnkd CMO Ray said,
"The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around.
They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option.
Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need."
Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz411J1bXsH
Mylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi's Auvi-Q® (epinephrine injection, USP) Recall
www.prnewswire.com/news-releases/mylan-confirms-availability-of-epipen-epinephrine-injection-auto-injector-for-us-patients-affected-by-sanofis-auvi-q-epinephrine-injection-usp-recall-300168925.html
According to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences.
[Imagine Mnkd partners with Mylan for inhaled Epinephrine]
