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Post by Deleted on Mar 11, 2016 14:33:53 GMT -5
Sanofi cannot terminate the trial without breaking the partnership agreement. The cost for the trial passes to Mannkind once the split happens but Sanofi will have paid for most of the recruitment phase which is expensive. huh? Alirocumab (trade name Praluent ) is Sanofi's... study is on praluent - not Afrezza.. Mannkind should charge current pricing + some to Sanofi where as everyone else should get the reduced pricing
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Post by kc on Mar 11, 2016 14:40:16 GMT -5
I believe that Alirocumab is a Regeneron product.
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Post by kc on Mar 16, 2016 12:52:49 GMT -5
Now this will be very interesting to see how this plays out. Nice to see Sanofi have to deal with this issue. Must have been serious as trading was halted.
Trading Halts, FDA, Corporate News
Regeneron (REGN) and Sanofi Confirm Negative Praluent Ruling, 'Strongly Disagree' with Verdict (AMGN)
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Sanofi (NYSE: SNY) announced that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen (NASDAQ: AMGN) patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment. This decision is the first step in this ongoing litigation and does not impact Praluent® (alirocumab) Injection or our ability to deliver it to physicians and patients at this time.
"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.
Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future.
www.streetinsider.com/Corporate+News/Regeneron+(REGN)+and+Sanofi+Confirm+Negative+Praluent+Ruling,+Strongly+Disagree+(AMGN)/11425728.html
This was another headline:
Added benefit of Praluent not proven, says IQWiG
I wonder if this is why Afrezza was added to the Praluent study?
stkw.it/yMM
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Post by mnkdnewbie on Mar 16, 2016 14:23:04 GMT -5
AMGEN going to use Sanofi's money to buyout Afrezza? that would be hilarious......
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Post by factspls88 on Mar 16, 2016 15:35:44 GMT -5
AMGEN going to use Sanofi's money to buyout Afrezza? that would be hilarious...... Poetic justice on a grand scale.
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Post by jay1ajay1a on Mar 16, 2016 16:22:56 GMT -5
I like the way you think mnkdnewbie.
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Post by compound26 on Oct 19, 2016 8:42:00 GMT -5
Anyone knows what is the status of this trial? It is supposed to end by March 2017. Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778Estimated Enrollment: 500 Study Start Date: October 2015 Estimated Study Completion Date: March 2017 Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure) Drug: ALIROCUMAB SAR236553 (REGN727) Pharmaceutical form:solution for injection Route of administration: subcutaneous Other Name: Praluent
Drug: insulin Pharmaceutical form:solution for injection Route of administration: subcutaneous Other Name: Lantus (insulin glargine) Drug: insulin Pharmaceutical form:powder Route of administration: inhalation Other Name: Afrezza (insulin human) Drug: statin Pharmaceutical form:tablet Route of administration: oral Drug: lipid modifying therapy Pharmaceutical form:tablet Route of administration: oral
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Post by fofos2000i on Nov 17, 2016 4:32:21 GMT -5
Anyone knows what is the status of this trial? It is supposed to end by March 2017. Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778Estimated Enrollment: 500 Study Start Date: October 2015 Estimated Study Completion Date: March 2017 Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure) Drug: ALIROCUMAB SAR236553 (REGN727) Pharmaceutical form:solution for injection Route of administration: subcutaneous Other Name: Praluent
Drug: insulin Pharmaceutical form:solution for injection Route of administration: subcutaneous Other Name: Lantus (insulin glargine) Drug: insulin Pharmaceutical form:powder Route of administration: inhalation Other Name: Afrezza (insulin human) Drug: statin Pharmaceutical form:tablet Route of administration: oral Drug: lipid modifying therapy Pharmaceutical form:tablet Route of administration: oral This study is ongoing, but not recruiting participants, verified Nov 2016clinicaltrials.gov/ct2/show/NCT02585778
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Post by fofos2000i on Nov 17, 2016 4:39:33 GMT -5
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Post by rockstarrick on Nov 17, 2016 5:26:01 GMT -5
Last updated 11/2016, Afrezza is still listed under "assigned interventions" I'm not good at reading these, but from this, I would say yes. clinicaltrials.gov/ct2/show/NCT02585778Anybody see anything I'm missing Thanks in advance
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Post by kc on Jan 4, 2017 10:28:54 GMT -5
Did anybody happen to see this news on January 4th, 2017?
What makes this interesting is that Stuart Tross left Amgen very suddenly since they have not even replaced him on the Amgen Leadership page on their web site.
Afrezza was still being used by SNY and Regeneron in a study in 2016 on the Praluent product. No Sanofi and Regeneron have to stop selling their blockbuster drug Praluent or make a deal with Amgen. What is thedate at Sanofi needs to make the final divorce payment to MannKind? Is that Around January 9th? Lets hope that the stars align in the right direction for MannKind.
in.reuters.com/article/us-sanofi-fr-amgen-idINKBN14N1VD
Sanofi, Regeneron lose bid to overturn Amgen win in patent case
By Brendan Pierson
A federal judge on Tuesday refused to throw out a court verdict upholding two Amgen Inc patents related to the company's cholesterol drug, a defeat for Sanofi SA and Regeneron Pharmaceuticals Inc, which make a rival drug.
In an October 2014 lawsuit, Amgen had sought to stop Paris-based Sanofi and Tarrytown,New York-based Regeneron from selling Praluent, a drug intended to lower bad LDL cholesterol by blocking a protein known as PCSK9.
Amgen makes a rival drug called Repatha, and it said Praluent infringed the Thousand Oaks, California-based company's patents related to the protein. A jury found Amgen's patents valid in March.
Following that verdict, Sanofi and Regeneron moved for U.S. District Judge Sue Robinson, who is presiding over the case, to overturn the verdict and order a new trial. She denied that motion on Tuesday.
Regeneron shares were down 2.6 percent in after-hours trading, and Amgen shares rose 1.6 percent.
"The court's ruling today is an important step in this case and confirms the jury's finding that the patents which protect Repatha are valid and infringed by Sanofi," Amgen spokeswoman Kristen Davis said in an email.
Sanofi spokeswoman Ashleigh Kosssaid in an email that the company was disappointed with the ruling.
"It is our longstanding position that Amgen's asserted patent claims are invalid, and we intend to appeal today's ruling," she said.
Regeneron, which developed Praluent in partnership with Sanofi, could not immediately be reached for comment.
Damages have yet to be set, and Robinson has not decided whether to block Sanofi and Regeneron from selling Praluent. The defendants said after the verdict that they planned to appeal to the U.S. Federal Circuit Court of Appeals, which reviews patent disputes.
The U.S. Food and Drug Administration approved Praluent and Repatha to reduce bad cholesterol in 2015.
The drugs are more costly than other treatments targeting bad cholesterol, with a list price topping $14,000 annually.
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Post by kc on Jan 5, 2017 18:23:56 GMT -5
Bad Karma? or just the Devil getting his due from Sanofi.
www.reuters.com/article/us-sanofi-fr-amgen-idUSKBN14P2IY
Seems that Sanofi gets a good judgment.
U.S. judge blocks Sanofi, Regeneron from selling cholesterol drug
A federal judge on Thursday blocked Sanofi SA and Regeneron Pharmaceuticals Inc from selling their cholesterol drug Praluent, a victory for Amgen Inc, which had accused them of infringing its patents.
U.S. District Judge Sue Robinson in Delaware ordered that the ban not take effect for 30 days to give Sanofi and Regeneron time to appeal.
Amgen was up 4.9 percent in after hours trading, while Sanofi's U.S. shares and Regeneron were down 4 and 1.1 percent, respectively.
More at link above Reuters link.
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