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In the Monday order granting the sanctions, Judge Wolf said that PharmaEssentia must foot the bill for a portion of AOP¡¦s legal fees for dodging multiple document requests during discovery.

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According to the order, Judge Wolf will decide the fee amount if the parties can¡¦t agree on a total for sanctions.

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AOP did not immediately respond to requests for comment on Tuesday.

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Counsel for the companies did not immediately respond to requests for comment on Tuesday.

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Taiwanese Pharma Co. Can¡¦t Shake AOP Sanction Bid

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Polycythemia Vera support group

2021/11/03

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My mPn doctor brought up ropeginterferon (besremi)today ,,any thoughts on this ? I was also offered to start pegasys,,I¡¦m thinking of starting the pegasys than when the besremi is given fda approval in the USA I can switch,,I have PV and systemic mastocytosis jak 2 and ckit positive,

§Úªº MPNÂå¥Í¤µ¤Ñ´£¥X¤F¡]besremi¡^¡A¹ï¦¹¦³¤°»ò·Qªk¶Ü¡H§Ú¤]³Q´£Ä³±Ò°Ê pegasys¡A§Ú¥¿¦b¦Ò¼{±Ò°Ê pegasys¡A·í besremi ¦b¬ü°êÀò±o FDA §å­ã®É§Ú¥i¥H¤Á´«¡A§Ú¦³ PV ©M¥þ¨­©ÊªÎ¤j²Ó­M¼W¦h¯g jak 2 ©M ckit ¶§©Ê¡A

FDA has the deadline of November 13th to approve Ropeg. Might be worth waiting a few more days to see if it is approved, if not, start Pegasys¡C

FDA §å­ã Ropeg ªººI¤î¤é´Á¬° 11 ¤ë 13 ¤é¡C¥i¯à­È±o¦Aµ¥´X¤Ñ¬Ý¬Ý¥¦¬O§_³Q§å­ã¡A¦pªG¨S¦³¡A±Ò°Ê Pegasys¡C

I will wait , thank you for the info

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Have no idea of cost and if insurance would pay for?

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Besremi may work slightly better and seems to have a better side effect profile.

Besremi ªº®ÄªG¥i¯àµy¦n¤@¨Ç¡A¦Ó¥B¦ü¥G¦³§ó¦nªº°Æ§@¥Î¡C

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Besremi in Prague

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ª§Ä³ªº®Ö¤ß°ÝÃD¬OÃÄ«~¼ÐÅÒ¤W©M¼ÐÅÒ¥~«ü¥Ü¤§¶¡Ãö«Yªºªk«ß°ÝÃD¡CVZP ÅGºÙ¡A´N«È¤á¦Ó¨¥¡A¤£º¡¨¬¨Ï¥Î Besremi ÃÄ«~ªvÀøªº°ß¤@©Ê±ø¥ó¡A¦]¬°¦³¤@ºØÃÄ«~ Pegasys¡A¬Æ¦Ü¦b¤½¦@ÂåÀø«OÀIÅé¨t¤¤¡C³o¨ÇÂåÃIJ£«~¤§¶¡ªº¥D­nªk«ß°Ï§O¦b©ó¡A®Ú¾Ú²£«~¯S©ÊªºÁ`µ²¡ABesremi ±Mªù¥Î©óªvÀø«È¤áªº¸~½F¯e¯f¡C¥t¤@¤è­±¡APegasys ¤£¾A¥Î©óªvÀø³oºØ¯e¯f¡C´«¥y¸Ü»¡¡A¦b³oºØ±¡ªp¤U¡ABesremi ¬O¤@ºØ¼ÐÅÒ¤ºªvÀø¡A¦Ó Pegasys ¬O¤@ºØ¼ÐÅÒ¥~ªvÀø¡C¦³½ìªº¬O¡A¾¨ºÞ Besremi ªvÀø¬O¹ï«È¤áªº¼ÐÅÒ¤WªvÀø s ¯e¯f¡A¤½¦@ÂåÀø«OÀI¨t²Îªº³ø¾P³Q³]¸m¬°»P Pegasys ªº¼ÐÅÒ¥~ªvÀø¡C¦]¦¹¡A»Ý­n Besremi ªvÀøªº±wªÌ§OµL¿ï¾Ü¡A¥u¯à®Ú¾Ú¡m¤½¦@°·±d«OÀIªk¡n²Ä 16 ±ø­n¨D«OÀI¤½¥q¤ä¥IªvÀø¶O¥Î¡C¡mÃÄ«~ªk¡n³W©w¡A¦pªG±wªÌªºªvÀø¥i¥H¨Ï¥Î¼ÐÅÒ¤WªºªvÀø¡AÂå¥Í¤£±o¨Ï¥Î¼ÐÅÒ¥~ªºªvÀø¡A§Y¨Ï¤w³ø¾P¡C

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www.arbitration.org.tw/upload/publication/pub_Logo3148601643895-2%E5%A7%9A.pdf

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·|­û¡G§ë¸ê¬ö«ß10145266  µoªí®É¶¡:2020/12/17 ¤W¤È 12:52:58²Ä 9788 ½g¦^À³
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·|­û¡G©ú¤ß¨£©Ê10141540  µoªí®É¶¡:2020/12/13 ¤W¤È 10:40:40²Ä 9787 ½g¦^À³
Dr. Ruben Mesa ¦bASH Ask Me Anything Session ªº³X½Í¡A¥]§t¤p´²¤á¤j¸`¿ýªº¨º¬q¡C

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patientpower.info/mpn-ask-me-anything-new-medications-clinical-trials-and-more/?fbclid=IwAR3LdDq7e1RbaLtNKCm0Yt3n1bg16pyIGIb5vnO10mnj0yT3RtwlUhNyX3A

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¥H¤U¬°¬ü°êDr. Ruben Mesa (MPN ¬Û·í­«­nªºKOL)°Ñ¥[ ¡uASH 2020 MPN Ask Me Anything program.¡v¤¤µoªí¦³ÃöPegasys»PRopeginterferon(§YÃĵØP1101©ÎBESREMi)¤§®t²§»¡©ú¡A¥ç¥]§tRopeg¬ü°êÃÄÃÒ¨úªº®É¶¡µ¥¡A½Ð¦U¦ì¤j¤j°Ñ¦Ò¡A©Î³\³z¹L¨¦ºq¤j¯«Â½Ä¶¡C

Esther Schorr: Okay. All right. Let¡¦s switch gears just a little bit. You talked about that one of the themes at ASH was that, there were new treatments for these different categories of MPNs.

And one person wrote in and said, What is the difference in the effectiveness of Pegasys versus, now this is one I¡¦m not familiar with, Ropeginterferon for PV patients? And do you expect ropeg to be approved for use for PV patients in the US? And if so, when? You¡¦ll have to educate me, is ropeg a new one that is about to be approved?

Dr. Mesa: Interferons are a biological molecule that the body can make that does a range of different things. And the genetically engineered interferons can be used as a range of different therapies. PEGylation is adding a carbohydrate molecule onto interferon so, when they¡¦re injected, they last in the body longer because they sit and they only slowly leak into circulation. Pegasys is PEGylated interferon alpha-2a and it is produced by Roche and Genentech, its subsidiary Genentech. It¡¦s approved for hepatitis C but it¡¦s the main one that we have used, because it was commercially available, and that¡¦s the main one that¡¦s been used in many trials and many US patients. If they receive interferon, that¡¦s likely the one that they receive, but it¡¦s not approved for P vera.

It¡¦s not to say it¡¦s not helpful for P vera, the companies who own the drug have never pursued the path to do the trials or do the work with the FDA, to get it formally approved. There are many things that we do that are helpful, that are not approved, approved is a very specific set of regulatory steps to go through. Ropegylated interferon is a different PEGylation, it¡¦s a slightly different molecule but with the same intent. It¡¦s produced by two companies, AOP, in Europe, and PharmaEssentia in Taiwan. And in the US, it¡¦s PharmaEssentia that has the rights to the drug in the US.

There are studies and they were presented at ASH, showing the longer-term outcomes with ropegylated interferon in P vera, compared to hydroxyurea. And the data do look very favorable, in terms of ability to control the blood counts, improve the risk of blood clots or bleeding. In other studies, in low-risk PV, helped to improve symptoms. There is no trials yet that have directly compared or randomized people between Pegasys and ropegylated interferon.

One very practical thing is that, if ropegylated interferon becomes approved, it would be approved for an MPN. One of the biggest differences is that the company sponsor is trying to go through these regulatory steps, to get it approved in P vera or in ET. Dr. Srdan Verstovsek and I are leading the global phase three study, looking at that agent in patients with ET, who have failed hydroxyurea and they¡¦re being randomized between that drug and anagrelide, and they can cross over to interferon after a period of time.

It¡¦s a good drug, it is probably as good as Pegasys. Is it better? It¡¦s again, comparing two things that have not been compared directly, it¡¦s a bit like you¡¦re hearing about there are two vaccines, the Moderna vaccine and the Pfizer vaccine, and they both say they have 95% effectiveness. Can I say which one is better? I cannot, because until... If we randomize people. Now, in that circumstance, it may not make any sense to bother randomizing people between two very effective vaccines anyway. And likewise, there may not end up making sense to do a comparison trial between Pegasys and ropeg. Because with ropeg, you have a company who went through the steps and then there is an FDA-approved drug, it¡¦ll immediately become preferred because it¡¦s approved. Insurance companies much prefer to cover an approved drug, physicians would much rather prescribe an approved drug, if there¡¦s a good one.

I think there likely would be studies in people who are on Pegasys, to see how well people transition from one drug to the other. It¡¦s not that we would switch people willy-nilly, but it likely would become the dominant interferon. But it¡¦s a very good takeaway because, again, the data looks very positive, they are working with both existing trial data and plan trials with the FDA, to try to obtain an approval. I don¡¦t know when that likely will be available in the United States, but certainly every effort is being made to try to do it so.

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