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Thursday, November 06, 2014 2:24:48 AM
Zogenix, Purdue ink hydrocodone pact
By Bradley J. Fikes1:34 P.M.OCT. 31, 2014
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Zogenix provides combination-locking pill bottles for Zohydro ER. — Zogenix
Opioid painkiller maker Zogenix will get $10 million from competitor Purdue Pharma in a deal that eliminates a potential conflict in selling their respective hydrocodone drugs.
The companies waive regulatory exclusivity on each other's extended-release hydrocodone products under the deal, announced Friday. The companies can still claim the exclusivity against other companies.
Purdue's first payment of $5 million is due within 15 days and the balance on July 1, 2015. Zogenix may also be eligible to receive royalties on sales of Purdue's extended-release hydrocodone product for a limited period of time.
Zogenix has a three-year exclusivity period for selling Zohydro, its extended-release hydrocodone without acetaminophen, the company told U-T San Diego in April.
If that exclusivity period had been enforced, it would have interfered with the plans of Stamford, Conn.-based Purdue Pharma plans to launch its own extended-release version of pure hydrocodone.
Unlike other forms of hydrocodone, Zohydro doesn't contain acetaminophen, which can damage the liver in large doses. Providing the drug in an extended-release form means that chronic pain patients can get relief for up to 12 hours. This is more convenient for those who are active during the day, such as those who are working.
However, critics say an extended-release form, which contains a greater amount of hydrocodone than immediate-release versions, is vulnerable to abuse. Massachusetts Gov. Deval Patrick tried to ban Zohydro this spring. But a court struck down that ban as an unconstitutional interference by a state in drug approval, which is controlled by federal law.
Purdue plans to sell its own extended-release hydrocodone without acetaminophen, which will include a technology intended to deter abuse.
On Oct. 1, Zogenix said it had submitted a marketing approval request for an abuse-deterring form of Zohydro to the U.S. Food and Drug Administration.
"We're pleased that this agreement enables us to continue focusing on what we do best, which is bringing innovative abuse-deterrent formulations to the market," said Todd Baumgartner, M.D., Purdue's head of research & development.
TRUTH
By Bradley J. Fikes1:34 P.M.OCT. 31, 2014
Click For Link
Zogenix provides combination-locking pill bottles for Zohydro ER. — Zogenix
Opioid painkiller maker Zogenix will get $10 million from competitor Purdue Pharma in a deal that eliminates a potential conflict in selling their respective hydrocodone drugs.
The companies waive regulatory exclusivity on each other's extended-release hydrocodone products under the deal, announced Friday. The companies can still claim the exclusivity against other companies.
Purdue's first payment of $5 million is due within 15 days and the balance on July 1, 2015. Zogenix may also be eligible to receive royalties on sales of Purdue's extended-release hydrocodone product for a limited period of time.
Zogenix has a three-year exclusivity period for selling Zohydro, its extended-release hydrocodone without acetaminophen, the company told U-T San Diego in April.
If that exclusivity period had been enforced, it would have interfered with the plans of Stamford, Conn.-based Purdue Pharma plans to launch its own extended-release version of pure hydrocodone.
Unlike other forms of hydrocodone, Zohydro doesn't contain acetaminophen, which can damage the liver in large doses. Providing the drug in an extended-release form means that chronic pain patients can get relief for up to 12 hours. This is more convenient for those who are active during the day, such as those who are working.
However, critics say an extended-release form, which contains a greater amount of hydrocodone than immediate-release versions, is vulnerable to abuse. Massachusetts Gov. Deval Patrick tried to ban Zohydro this spring. But a court struck down that ban as an unconstitutional interference by a state in drug approval, which is controlled by federal law.
Purdue plans to sell its own extended-release hydrocodone without acetaminophen, which will include a technology intended to deter abuse.
On Oct. 1, Zogenix said it had submitted a marketing approval request for an abuse-deterring form of Zohydro to the U.S. Food and Drug Administration.
"We're pleased that this agreement enables us to continue focusing on what we do best, which is bringing innovative abuse-deterrent formulations to the market," said Todd Baumgartner, M.D., Purdue's head of research & development.
TRUTH
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