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·PÁ·s¶i¤j¡Bavandia¤j´£¨Ñ¸ê°T¡A¥\¼wµL¶q¡AÁÂÁ¡C

¥t¥~¡AMPN Interferon Forum - (Myeloproliferative Neoplasm)¡A¥ç¦³´£¤ÎBESREMI¦b¶ø§Q¦aªº»ù®æ¬° 4000 euros ¸ê°T¡A´£¨Ñºô¤Í°Ñ¦Ò¡C

1.Ropeginterferon alpha 2b by the name BESREMI is becoming available in Austria since august the 1st. Also, very soon in Croatia, but don¡¦t know exact date

2.where did you see this??? So far it is just approved for PV did you see different?. Hopkins says it is the same formula just longer acting and longer acting means less side effects?

3.I gave Angie Information. Bit my englisch is not good, that¡¦ s why Angie wrote...I have a recipe todey geht for this ....I have PMF and no PV ...But i have to wait until 01.08.19. Then in pharmacy.

4.how much does BESREMI cost?

5.Too bad there doesn¡¦t seem to be a pharmaceutical sales rep for Besremi that can tell us what doses are equivalent to comparable Pegasys doses and how Besremi compares in cost to Pegasys.

6.250 micrograms in pen is 4000 euros in austria. Ida is currently using 50 mcg, and pen can be open for at least another 2 weeks. probably more, but not acording to the company that made it.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gavandia10146474  µoªí®É¶¡:2019/8/12 ¤U¤È 10:22:35²Ä 7066 ½g¦^À³
Anna Olsz : Do you know- how much does BESREMI cost?

Ida Idic : Anna Olsz Pharmacy said it costs more than 3000 Euro bot I¡¦m not sure

Anna Olsz : Ida Idic and could you ask please?

Ida Idic : Anna Olsz Yes, I will ask

Anna Olsz :Ida Idic I¡¦m from Poland but I would like buy in Austria

Ida Idic : Anna Olsz But maybe this is with a doctor¡¦s prescription

Pam Pariseau : Thats not just for 1 pen?

Ida Idic : Pam Pariseau One Pen has 250 mg and have dozis 50 mg - 5 times ... but is only 2 needle there at.....pen is for more use

===

¥H¤W¸`¿ý¦Û MPN Interferon Forum - (Myeloproliferative Neoplasm) ªÀ¹Î¯f¤Íªº¹ï¸Ü

===

¤º¤å´£¨ì Ãħ½»¡¤@¤ä¤j·§3000¼Ú¤¸ ¤º§t250mg, ¬Ý¯f±¡¨Ï¥Î½Õ¾ã¥Î¶q»PÀW²v

³o¦ì¯f¤Í¬° MF ¯f±w ¨Ï¥Î¬° 50mg / 2week

The dose is titrated individually with a recommended starting dose of 100 micrograms (or

50 micrograms in patients under another cytoreductive therapy). The dose should be gradually

increased by 50 micrograms every two weeks. The maximum recommended single dose is 500 micrograms injected every two weeks.

¨Ì·Ó¥é³æ©Ò´£¨ì PV «Øij°_©l¶q 100mg / 2 weeks ªºÀW²v ¬ù¤@­Ó¤ë´«¤@¤ä ¤@¦~12¤äªº¸Ü

pv ¯f±w¤@¦~ªá¶O¬ù 36000 ¼Ú¤¸

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¤p¥¿¥¿¤j¡G¤µ¤Ñ¤p§Ì¦³°Ý¹L¤½¥qBesremiÃÄ»ù¡A¥N²zµo¨¥¤H»¡¨º¬O¤£¥¿½Tªº¡ABesremiÃÄ»ù¤ñ5372.88¼Ú¤¸°ª¡A¤]¤ñPegasys°ª¡A¨ãÅé¦h¤Öª÷ÃB¦o¤£²M·¡¡A¤£¹L¬O¤ñPegasysÃÄ»ù°ª.

¦b¼Ú¬w¬O§_¥i¥H¥Î¥é³æ¥~¥ÎÃĥΦb°£¤FPV¥~ªº¨ä¥LMPN±wªÌ?

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¥H¤W³ø§i§¹²¦¡C

·PÁ¤p¥¿¥¿¤j¼ö¤ßªº´£¨Ñ¸ê®Æ¡AÁÙ¦³Alan Liu¤jªºÂ½Ä¶¡A·PÁ¦A·PÁ¡C

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Ropeginterferon alfa-2b(Besremi)

¤@¡B¨C¦ì±wªÌ¨C¦~ªº¹w´Á¶O¥Î¡GPEG¤zÂZ¯À£\¤@¦~¡G£á5,372.88?

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¥H¤W¥¿½T¥G?¦³ºô¤Í¥iÄÀºÃ¶Ü?ÁÂÁ¡C

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www.horizonscangeneesmiddelen.nl/geneesmiddelen/ropeginterferon-alfa-2b-oncologie-en-hematologie-myeloproliferatieve-aandoeningen/versie4

(¥Îgoogleª½±µÂ½Ä¶¡A¥i¯à¤£ºë½T¡A·q½Ðª`·N)¡C(¥t¥~¡A±Æª©·|¶]±¼¡A½Ðª½±µ°Ñ¦Ò­ìºô§}¡A¥¿½Tª©­±)

²Ä¥|ª©2019¦~6¤ë12¤é

Ropeginterferon alfa-2b

Besremi

§÷®Æ¦WºÙ Ropeginterferon alfa-2b

°ì ¸~½F¾Ç©M¦å²G¾Ç

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¼sªxªº«ü¥Ü Besremi¾A¥Î©ó¦¨¤H³æÃĪvÀø¡A¥Î©óªvÀø¯u©Ê¬õ²Ó­M¼W¦h¯g¡AµL¯gª¬©ÊµÊ¸~¤j¡C

1.²£«~

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¯S¼x©M¹ïJAK2¬ðÅܪºµ¥¦ì°ò¦]­t²ü¡]itt hydrea¡^ªº§ó¨ã¿ï¾Ü©Êªº§@¥Î¡A¥¦¹ï©óªvÀø¯u©Ê¬õ

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www.horizonscangeneesmiddelen.nl/geneesmiddelen/ropeginterferon-alfa-2b-oncologie-en-hematologie-myeloproliferatieve-aandoeningen/versie4

versie4(12juni2019)

Ropeginterferon alfa-2b

Besremi

Stofnaam Ropeginterferon alfa-2b

Domein Oncologie en Hematologie

Reden van opname in Horizonscan Nieuw middel (specialité)

Hoofdindicatie Myeloproliferatieve aandoeningen

Uitgebreide indicatie Besremi is indicated as monotherapy in adults for the

treatment of polycythaemia vera without symptomatic

splenomegaly.

1. Product

Merknaam Besremi

Fabrikant AOP Orphan

Werkingsmechanisme Immunostimulatie

Toedieningsweg Subcutaan

Toedieningsvorm Injectie

Bekostigingskader Extramuraal (GVS)

Aanvullende opmerkingen Interferon alpha 2b stimulants

2. Registratie

Registratieroute Centraal (EMA)

Type traject Normaal traject

Datum indiening Maart 2017

Verwachte registratie Februari 2019

Weesgeneesmiddel Ja

Fase registratie Geregistreerd

Aanvullende opmerkingen Positieve CHMP-opinie in december 2018. Geregistreerd in

februari 2019.

3. Therapeutische waarde en behandelschema

Huidige behandelopties Hydrea, PEG-interferon alfa.

Therapeutische waarde Mogelijke meerwaarde

Deze inschatting doet geen uitspraak over de mogelijke opname

in het pakket.

Onderbouwing Slecht 1 maal per 2-4 weken spuiten, gunstig

bijwerkingsprofiel, reductie van allelic burden in polycythemia

vera patiënten. Kan gezien bijwerkingenprofiel en meer

selectiever effect op JAK2 gemuteerde allelic burden (itt

hydrea) wellicht belangrijke plaats gaan krijgen in behandeling

van polycythemia vera, met name bij jongere patiënten.

Behandelduur doorlopend

Toedieningsfrequentie 1 maal per 2 weken

Dosering per toediening 263 £gg

Bronnen Clinical trials NCT01949805, NCT01193699, NCT02523638;

Gisslinger et al, Blood 2015, 126: 1762-1769.

4. Verwacht patiëntvolume per jaar

Patiëntvolume 30 - 400

Marktaandeel wordt in de regel niet meegenomen tenzij anders

vermeld.Aanvullende opmerkingenInschatting blijft moeilijk.

Betreft grotendeels oudere populatie die nu nog hydrea

gebruikt. Zullen niet snel switchen, jonge, nieuw

gediagnostiseerde patiënten en patiënten met bijwerkingen onder

hydrea zullen waarschijnlijk wel behandeld gaan worden met

ropeginterferon.

5. Verwachte kosten per patiënt per jaar

Bronnen Medicijnkosten.nl

Aanvullende opmerkingen Gelijke kosten. Waarschijnlijk vergelijkbaar met PEG

interferon alfa. Volgens medicijnkosten.nl: PEG interferon

alfa voor 1 jaar: £á 5.372,88.

6. Mogelijke totale kosten per jaar

Er is op dit moment niets bekend over de mogelijke totale kosten.

7. Off-label gebruik

Off-label gebruik Ja

Indicaties off-label gebruik Mogelijk incidenteel bij essentiële thrombocytose.

8. Indicatieuitbreiding(en)

Indicatieuitbreiding(en) Ja

Indicatieuitbreidingen Essentiële thrombocytose; Hepatitis B; CLL; Hepatitis C;

Myelofibrose. Essentiële thrombocytose zal waarschijnlijk

de eerste indicatie-uitbreiding worden.

9. Overige informatie

Er is op dit moment geen overige informatie.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAlan Liu10136094  µoªí®É¶¡:2019/8/9 ¤U¤È 10:59:40²Ä 7061 ½g¦^À³
ÁÂÁ¤p¥¿¥¿¤j¤À¨É, ¤å³¹Â½Ä¶µy§@½Õ¾ã¨Ñ¦U¦ì§ë¸ê¥ý¶i­Ì°Ñ¦Ò¡C

COMPASSIONATE USE OF ROPEGINTERFERON TO TREAT MYELOPROLIFERATIVE NEOPLASMS IN TAIWAN

®¦·OÀøªk¹B¥Î (6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀROPEGINTERFERONªvÀø¥xÆW°©Åè¼W¥Í©Ê¸~½F¯f±w

HemaSphere: June 2019 - Volume 3 - Issue - p 999

2019¦~6¤ë´Á¥Z

Publication Only: Myeloproliferative neoplasms ¡V Clinical

µoªí¥Î¡G°©Åè¼W¥Í©Ê¸~½F-Á{§É

# Background:

¬ã¨s­I´º

There is a high unmet medical need for therapeutic options for patients suffering from myeloproliferative neoplasms (MPN), who have failed or are not eligible to available treatment options. Ropeginterferon-alfa-2b (P1101) is a novel, third generation pegylated interferon-alfa, recently approved by EMA to treat polycythemia vera (PV). Ropeginterferon-alfa-2b is also in the late stages of development in several countries for treatment of PV and other MPNs.

¹ï©óªvÀø¥¢±Ñ¥H¤Î¨S¦³¾A·íªºªvÀø¿ï¶µªº°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^ªº¯f±w¦Ó¨¥¡A³o¤´¦s¦b°ª«×¥¼º¡¨¬ªºÂåÀø»Ý¨D¡C(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀROPEGINTERFERON¡]P1101¡^¬O·s«¬¡B²Ä¤T¥Nªºªø®Ä«¬¤zÂZ¯À¡A³Ìªñ³Q¼Ú·ùEMA§å­ã¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¦h¯g¡]PV¡^¡C Ropeginterferon-alfa-2b¦b¬Y¨Ç°ê®a¤]¤w¶i¦æ¨ì¬ãµoªº³Ì«á¶¥¬q¡A¥D­n¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¦h¯g¡]PV¡^¥H¤Î¨ä¥L°©Åè¼W¥Í©Ê¸~½F(MPNs)¡C

# Aims:

¬ã¨s¥Øªº¡G

Ropeginterferon-alfa-2b is a new and attractive treatment option for patients suffering from MPN who have exhausted all therapeutic options and require treatment. The Compassionate Use Program (CUP) was approved and initiated in Taiwan with the purpose of granting access to P1101 to patients with MPN disease with no therapeutic options who are not eligible to enroll in existing clinical trials for their disease.

(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀRopeginterferon-alfa-2b¹ï©ó¥²¶·µLÃÄ¥iÂå¥B»Ý­nªvÀøªº°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^ªº¯f±w¬O¤@ºØ·¥¨ã§l¤Þ¤OªºªvÀø¿ï¾Ü¡C

®¦·OÀøªk(Compassionate Use Program)¦b¥xÆW¤wÀò±o§å­ã¨Ã¤w¶}©l¶i¦æ¡C¥D­n±NP1101¥Î©óªvÀøµLÃÄ¥iÂå¥H¤Î¨S¦³¸ê®æ°Ñ¥[Á{§Éªº°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^¯f±w¡C

# Methods:

¬ã¨s¤èªk¡G

Patients were identified that had the potential to benefited from P1101 therapy and were eligible according to the protocol. Patients were treated at a starting dose of 250 ug with subsequent dose escalation every 2 weeks over a 6-week period to 350 ug, 450 ug and 500 ug. Dose adjustments were permitted based on tolerability and efficacy.

¬°¤FÅý¯f±w¥i¥H±q (6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101ªvÀø¤¤¨ü¯q¡A¦]¦¹®Ú¾Ú­pµe®Ñ¡A¯f±wªì´Á¥H250ugªº¾¯¶q¶}©l¶i¦æªvÀø¡AÀH«á¦b6¶gªºªvÀø®É¶¡¤º¨C2¶g½Õ¾ã¾¯¶q¤À§O¦Ü350ug¡B450 ug©M500 ug¡C¾¯¶q·|°w¹ï­@¨ü«×©MÀø®Ä¶i¦æ½Õ¾ã¡C

# Results:

¬ã¨sµ²ªG¡G

The CUP currently contains 15 patients from two academic hospitals: 9 with PV, 2 with post-PV myelofibrosis (MF), two with pre-fibrotic MF, one with primary MF, and one essential thrombocythemia patient. The driver mutation was JAK2 in 13 patients, CALR in one, and another one was triple negative. Pre-treatment with hydroxyurea and/or anagrelide was reported in 13 patients. P1101 was given for > 12 weeks to 14 patients (range 4 - 64 weeks). The highest administered dose of P1101 was: 500 ug in 11 patients (time to highest dose - 6 weeks in 9 patients, 10 weeks - in 1 and 20 weeks in another patient); 250 ug, 350 ug and 450 ug in three other patients.

®¦·OÀøªk15¦ì¯f±w¨Ó¦Û©ó¨â¶¡¾Ç³NÂå°|¡F¥]§t9¦WPV¯f±w¡B2¦W¬°PV´c¤Æ¦Ü°©ÅèÅÖºû¤Æ(MF)¯f±w¡A2¦W¬°ÅÖºû¤Æ«eªºMF¯f±w¡A1¦W¬°PMF¯f±w¡A¥H¤Î1¦W

­ìµo©Ê¦å¤pªO¼W¦h¯g¯f±w¡C

13¦W¯f±wÀËÅç¥XJAK2 ¬ðÅÜ¡A¨ä¤¤1¦W¬°CALRÅܲ§¡A1¦W¬°¤T³±©Ê¡C13¦W¯f±w¹w¥ý´£¨ÑHU©Î ¦w»ÕÆF(anagrelide) ¶i¦æªvÀø¡C¦³14¦W¯f±w¨Ï¥ÎP1101 ¶i¦æªvÀø¶W¹L12©P (ªvÀø®É¶¡¬O4-64©P)¡C11¦W¯f±w¤¤¥ÎP1101ªvÀø¹F³Ì°ª¾¯¶q500 ug (½Õ¾ã¨ì³Ì°ª¾¯¶q®É¶¡¡G9¦W¯f±w©ó¤»©P½Õ¾ã¨ì³Ì°ª¾¯¶q¡B1¦W¯f±w©ó10©P½Õ¾ã¨ì³Ì°ª¾¯¶q¡B1¦W©ó20©P½Õ¾ã¨ì³Ì°ª¾¯¶q)¡F¥t¥~¤T¦W¾¯¶q«h¤À§O¬°250 ug¡B350 ug¥H¤Î450 ug¡C

The need to decrease or temporarily interrupt P1101 therapy occurred in 4 patients, all due to transaminase(s) elevation. Notably, these events did not require permanent discontinuation of therapy and could be alleviated by appropriate dose modifications. The majority of observed adverse events were of grade 1 and included fatigue, arthralgia, myalgia, chills and dizziness. Grade 2 events included elevation of transaminases (in 3 patients), dizziness, pruritus and lower limbs pain (in 1 patient each). One patient developed elevation of transaminases of grade 3.

Normalization of blood parameters within complete hematologic response range was observed in 3 PV and 2 post-PV MF patients. Two PV patients fulfilled the partial response criteria. In other patients, decrease of platelet count (even in previously treatment-resistant thrombocytosis) and symptomatic improvement were also observed. No major cardiovascular events were recorded. One pre-PMF patient transformed into MF (grade 5). No patients progressed to acute myelogenous leukemia (AML) during the observation.

4¦W¯f±w´î¤Ö©Î¼È®É¤¤Â_P1101ªvÀø¡A¥D­n¦]¨x«ü¼Æ(transaminase(s)¤É°ª¾É­P¡C

µM¦Ó¡A³o¤£»Ý­n¥Ã¤[°±¤îªvÀø¡A¥i¥H³z¹L½Õ¾ã¾A·í¾¯¶q¨Ó³B²z¡C¤j¦h¼ÆÆ[¹î¨ìªº¤£¨}¤ÏÀ³§¡¬°1¯Å¡A¥]¬A¯h³Ò¡BÃö¸`µh¡B¦Ù¦×µmµh¡A¬È´H©MÀY·w¡C

2¯Å¤£¨}¤ÏÀ³¥]¬A3¦W¯f±w¨x«ü¼Æ¤É°ª¡B1¦W¯f±wÀY·w¡B1¦W¯f±wæ±Äo¥H¤Î1¦W¤UªÏ¯kµh¡C¨ä¤¤¦³1¦W¯f±wµo¥Í¤£¨}¤ÏÀ³3¯Åªº¨x«ü¼Æ¤É°ª¡C

¦³3¦WPV¯f±w¥H¤Î2¦WPV´c¤Æ¦Ü°©ÅèÅÖºû¤Æ(MF)¯f±w¤¤Æ[¹î¨ì§¹¥þ¦å²G¾Ç¤ÏÀ³¦^¨ì¥¿±`¼Æ¦r¡C2¦WPV¯f±w²Å¦X³¡¤À¦å²G¾Ç¤ÏÀ³¼Ð·Ç¡C¦b¨ä¥L¯f±w¨­¤WÆ[¹î¨ì¦å¤pªO¼Æ¶q´î¤Ö¡]³o¬Æ¦Ü¥]§t¥ý«eªvÀø¦å¤pªO¼W¦h¯gµL®Ä¯f±w¡^¥H¤Î¯gª¬§ïµ½¡C¨S¦³µo¥Í¥ô¦ó­«¤j¤ß¦åºÞ¨Æ¥ó¡C¤@¦Wpre-PMF¯f±w´c¤Æ¨ìµ¥¯Å5ªº°©ÅèÅÖºû¤Æ¡CÆ[¹î´Á¶¡¨S¦³¥ô¦ó¯f±w´c¤Æ¨ì«æ©Ê°©Åè²Ó­M¥Õ¦å¯f¡]AML¡^¡C

# Summary/Conclusion:

ºK­n/µ²½×¡G

In this cohort of MPN patients, not amenable for established treatment options, P1101 demonstrated good tolerability and substantial efficacy. The dose administration schema with a starting dose of 250 ug and escalation to the highest dose of 500 ug within the first 6-8 weeks was feasible, tolerated and allowed rapid control of blood parameters. The observed efficacy demonstrate P1101 as a promising treatment option for patients with MPNs with limited or no alternate therapeutic option. These results mandate access to P1101 at earlier stages of disease as recommended by international MPN treatment guidelines.

¦b³o¨Ç¨S¦³¦X¾AªvÀø¿ï¶µªº°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^ªº¯f±w¦Ó¨¥¡A¦b¨Ï¥ÎÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101¶i¦æªvÀø«á¡AÅã¥Ü¥X¨}¦nªº­@¨ü©Ê©MÀø®Ä¡C¾¯¶q¥Ñ³Ìªìªº250ug¦b¯f±wªvÀø6-8¶g¤º½Õ¾ã¨ì³Ì°ª500ugªº¾¯¶qÃÒ©ú¬O¥i¦æªº¡B¯f±w­@¨ü«×¨Î¦Ó¥B¯à°÷§Ö³t±±¨î¯f±w¦å²G¼Æ¦r¡CÆ[¹î¥iµo²{¡AÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101°w¹ïªvÀø¤è¦¡¦³­­©ÎµLÃÄ¥iÂ媺°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^ªº¯f±w¦Ó¨¥¡A¬O·¥¦³§l¤Þ¤OªºªvÀø¿ï¶µ¡C®Ú¾Ú°ê»Ú°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^ªvÀø«ü«n¡A³o¨Çµ²ªG±j¯P«Øij¦­´Á¨Ï¥ÎÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101¶i¦æªvÀø¡C

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journals.lww.com/hemasphere/Fulltext/2019/06001/COMPASSIONATE_USE_OF_ROPEGINTERFERON_TO_TREAT.2094.aspx

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COMPASSIONATE USE OF ROPEGINTERFERON TO TREAT MYELOPROLIFERATIVE NEOPLASMS IN TAIWAN

ROPEGINTERFERON¥Î©óªvÀø¥xÆW°©Åè¼W¥Í©Ê¯e¯f

Chen, C.-C.1; Kuo, M.-C.2, 3; Su, Y. -.-J.2; Huang, C.-E.4; Hsu, C.-C.4; Wu, Y.-Y.4; Chen, Y.-J.4; Shih, L.-Y.2, 3

HemaSphere: June 2019 - Volume 3 - Issue - p 999

doi: 10.1097/01.HS9.0000567388.41296.09

Publication Only: Myeloproliferative neoplasms ¡V Clinical

Background:

­I´º

There is a high unmet medical need for therapeutic options for patients suffering from myeloproliferative neoplasms (MPN), who have failed or are not eligible to available treatment options. Ropeginterferon-alfa-2b (P1101) is a novel, third generation pegylated interferon-alfa, recently approved by EMA to treat polycythemia vera (PV). Ropeginterferon-alfa-2b is also in the late stages of development in several countries for treatment of PV and other MPNs.

¹ï©ó±w¦³°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^ªº±wªÌ¡AªvÀø¿ï¾Ü¦s¦b°ª«×¥¼º¡¨¬ªºÂåÀø»Ý¨D¡A³o¨Ç±wªÌ¤w¸g¥¢±Ñ©Î¨S¦³¸ê®æÀò±o¥i¥ÎªºªvÀø¿ï¾Ü¡C Ropeginterferon-alfa-2b¡]P1101¡^¬O¤@ºØ·s«¬ªº²Ä¤T¥N»E¤A¤G¾J¤Æ¤zÂZ¯À-£\¡A³Ìªñ³QEMA§å­ã¥Î©óªvÀø¯u©Ê¬õ²Ó­M¼W¦h¯g¡]PV¡^¡C Ropeginterferon-alfa-2b¦b¤@¨Ç°ê®a¤]³B©óµo®iªº«á´Á¶¥¬q¡A¥Î©óªvÀøPV©M¨ä¥LMPN¡C

Aims:

¥Øªº¡G

Ropeginterferon-alfa-2b is a new and attractive treatment option for patients suffering from MPN who have exhausted all therapeutic options and require treatment. The Compassionate Use Program (CUP) was approved and initiated in Taiwan with the purpose of granting access to P1101 to patients with MPN disease with no therapeutic options who are not eligible to enroll in existing clinical trials for their disease.

Ropeginterferon-alfa-2b¹ï©ó±w¦³MPN¥B¤w¸g¥ÎºÉ©Ò¦³ªvÀø¿ï¾Ü¨Ã»Ý­nªvÀøªº±wªÌ¦Ó¨¥¬O¤@ºØ·sªº¥B¦³§l¤Þ¤OªºªvÀø¿ï¾Ü¡CÅé«ò¨Ï¥Î­p¹º¡]CUP¡^¦b¥xÆWÀò±o§å­ã¨Ã±Ò°Ê¡A¥Øªº¬O¦V¨S¦³ªvÀø¿ï¾ÜªºMPN¯e¯f±wªÌ±Â¤©P1101¨Ï¥ÎÅv¡A³o¨Ç±wªÌ¨S¦³¸ê®æ°Ñ¥[²{¦³ªº¯e¯fÁ{§É¸ÕÅç¡C

Methods:

¤èªk¡G

Patients were identified that had the potential to benefited from P1101 therapy and were eligible according to the protocol. Patients were treated at a starting dose of 250 ug with subsequent dose escalation every 2 weeks over a 6-week period to 350 ug, 450 ug and 500 ug. Dose adjustments were permitted based on tolerability and efficacy.

½T©w±wªÌ¦³¥i¯à±qP1101ªvÀø¤¤¨ü¯q¨Ã¥B®Ú¾Ú¤è®×²Å¦X±ø¥ó¡C±wªÌ¥H250ugªº°_©l¾¯¶q¶i¦æªvÀø¡AÀH«á¦b6¶g®É¶¡¤º¨C2¶g¼W¥[¾¯¶q¦Ü350£gg¡A450£gg©M500£gg¡C°ò©ó­@¨ü©Ê©M¥\®Ä¤¹³\¾¯¶q½Õ¾ã¡C

Results:

µ²ªG¡G

The CUP currently contains 15 patients from two academic hospitals: 9 with PV, 2 with post-PV myelofibrosis (MF), two with pre-fibrotic MF, one with primary MF, and one essential thrombocythemia patient. The driver mutation was JAK2 in 13 patients, CALR in one, and another one was triple negative. Pre-treatment with hydroxyurea and/or anagrelide was reported in 13 patients. P1101 was given for > 12 weeks to 14 patients (range 4 - 64 weeks). The highest administered dose of P1101 was: 500 ug in 11 patients (time to highest dose - 6 weeks in 9 patients, 10 weeks - in 1 and 20 weeks in another patient); 250 ug, 350 ug and 450 ug in three other patients.

CUP¥Ø«e¥]§t¨Ó¦Û¨â©Ò¾Ç³NÂå°|ªº15¦W±wªÌ¡G9¦W±w¦³PV¡A2¦W±w¦³PV«á°©ÅèÅÖºû¤Æ¡]MF¡^¡A2¦W±w¦³ÅÖºû¤Æ«eMF¡A1¦W±w¦³­ìµo©ÊMF¡A¥H¤Î1¦W­ìµo©Ê¦å¤pªO¼W¦h¯g±wªÌ¡CÅX°Ê¬ðÅܬO13¨Ò±wªÌªºJAK2¡A¨ä¤¤¤@¨Ò¬OCALR¡A¥t¤@¨Ò¬O¤T³±©Ê¡C¦b13¦W±wªÌ¤¤³ø¾É¤F¥Îßm°ò脲©M/©Îªü¨º®æ¹p¹w³B²z¡C¹ï©ó14¦W±wªÌ¡]½d³ò4-64¶g¡^µ¹¤©P1101> 12¶g¡C P1101ªº³Ì°ªµ¹Ãľ¯¶q¬°¡G500£gg¡A11¦W±wªÌ¡]³Ì°ª¾¯¶q®É¶¡ - 9¦W±wªÌ¬°6¶g¡A10¶g¬°¥t¤@¦W±wªÌ¬°1©P©M20¶g¡^;¨ä¥L¤T¦W±wªÌ250·L§J¡A350·L§J©M450·L§J¡C

The need to decrease or temporarily interrupt P1101 therapy occurred in 4 patients, all due to transaminase(s) elevation. Notably, these events did not require permanent discontinuation of therapy and could be alleviated by appropriate dose modifications. The majority of observed adverse events were of grade 1 and included fatigue, arthralgia, myalgia, chills and dizziness. Grade 2 events included elevation of transaminases (in 3 patients), dizziness, pruritus and lower limbs pain (in 1 patient each). One patient developed elevation of transaminases of grade 3. Normalization of blood parameters within complete hematologic response range was observed in 3 PV and 2 post-PV MF patients. Two PV patients fulfilled the partial response criteria. In other patients, decrease of platelet count (even in previously treatment-resistant thrombocytosis) and symptomatic improvement were also observed. No major cardiovascular events were recorded. One pre-PMF patient transformed into MF (grade 5). No patients progressed to acute myelogenous leukemia (AML) during the observation.

4¦W±wªÌ»Ý­n´î¤Ö©Î¼È®É¤¤Â_P1101ªvÀø¡A³o³£¬O¥Ñ©óÂà®ò酶¤É°ª©Ò­P¡C­È±oª`·Nªº¬O¡A³o¨Ç¨Æ¥ó¤£»Ý­n¥Ã¤[°±¤îªvÀø¡A¨Ã¥B¥i¥H³q¹L¾A·íªº¾¯¶q­×§ï¨Ó½w¸Ñ¡C¤j¦h¼ÆÆ[¹î¨ìªº¤£¨}¨Æ¥ó§¡¬°1¯Å¡A¥]¬A¯h³Ò¡AÃö¸`µh¡A¦Ùµh¡Aµo§N©MÀY·w¡C 2¯Å¨Æ¥ó¥]¬AÂà®ò酶¤É°ª¡]3¦W±wªÌ¡^¡AÀY·w¡Aæ±Äo©M¤UªÏ¯kµh¡]¨C¦W1¦W±wªÌ¡^¡C¤@¦W±wªÌµo¥Í3¯ÅÂà®ò酶¤É°ª¡C¦b3¦WPV±wªÌ©M2¦WPV«áMF±wªÌ¤¤Æ[¹î¨ì¦å²G°Ñ¼Æ¦b§¹¥þ¦å²G¾Ç¤ÏÀ³½d³ò¤ºªº¥¿±`¤Æ¡C¨â¦WPV±wªÌ²Å¦X³¡¤À¤ÏÀ³¼Ð·Ç¡C¦b¨ä¥L±wªÌ¤¤¡AÁÙÆ[¹î¨ì¦å¤pªO­p¼Æ´î¤Ö¡]¬Æ¦Ü¦b¥ý«eªºªvÀø§Ü©Ê¦å¤pªO¼W¦h¯g¤¤¡^©M¯gª¬§ïµ½¡C¨S¦³°O¿ý¨ì­«¤j¤ß¦åºÞ¨Æ¥ó¡C¤@¦W«ePMF±wªÌÂàÅܬ°MF¡]5¯Å¡^¡C¦bÆ[¹î´Á¶¡¨S¦³±wªÌµo®i¬°«æ©ÊÅè©Ê¥Õ¦å¯f¡]AML¡^¡C

Summary/Conclusion:

ºK­n/µ²½×¡G

In this cohort of MPN patients, not amenable for established treatment options, P1101 demonstrated good tolerability and substantial efficacy. The dose administration schema with a starting dose of 250 ug and escalation to the highest dose of 500 ug within the first 6-8 weeks was feasible, tolerated and allowed rapid control of blood parameters. The observed efficacy demonstrate P1101 as a promising treatment option for patients with MPNs with limited or no alternate therapeutic option. These results mandate access to P1101 at earlier stages of disease as recommended by international MPN treatment guidelines.

¦b³o²ÕMPN±wªÌ¤¤¡AP1101¤£¾A¦X½T©wªºªvÀø¤è®×¡AP1101ªí²{¥X¨}¦nªº­@¨ü©Ê©M¹ê½è©ÊÀø®Ä¡C¾¯¶q¬I¥Î¤è®×¨ã¦³250ugªº°_©l¾¯¶q¨Ã¥B¦b³Ìªìªº6-8¶g¤º¤É°ª¦Ü500ugªº³Ì°ª¾¯¶q¬O¥i¦æªº¡A­@¨üªº¨Ã¥B¤¹³\§Ö³t±±¨î¦å²G°Ñ¼Æ¡CÆ[¹î¨ìªºÀø®ÄÃÒ©úP1101§@¬°¨ã¦³¦³­­©ÎµL´À¥NªvÀø¿ï¾ÜªºMPN±wªÌªº¦³§Æ±æªºªvÀø¿ï¾Ü¡C®Ú¾Ú°ê»ÚMPNªvÀø«ü«nªº«Øij¡A³o¨Çµ²ªG­n¨D¦b¯e¯fªº¦­´Á¶¥¬qÀò±oP1101¡C

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¨Ì¾Ú¥L¤À¨É¸ê°T¥H¤Î¥L¦P®É¥ç¦b¥t¤@¯f¤Í¹ÎÅé ¡§ET & MF/ CARL mutation patients support group ¡¨ ¤À¨É¸Ó°T®§±¡ªp¤U¡A§Ú¥Ø«e²z¸Ñ¬O¨«¥é³æ¥~ªvÀø¡]off-label use) ¤è¦¡´£¨Ñµ¹¸ÓPMF¯f¤ÍBesremi ³B¤è¡C

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¤@¡B¦³Ãö¤À¨É¯f¤Í¹ÎÅé MPN Interferon Forum - (Myeloproliferative Neoplasm) ¶ø¦a§Q¯f±w¨ú±o (6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi «á¬ÛÃö°Q½×¡A·í¤¤°T®§¡u

§Ú¨Ó¦Û¶ø¦a§Q¡A¦Ó§Ú¨C¨â©P¨Ï¥Î50mg¾¯¶q¡C¶}©l(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi ªºªvÀø, ÃĪ«­@¨ü«×«D±`¦n¡C§Ú¬OGisslingerÂå¥Íªº¯f±w¡C§Ú¬O CALR Åܲ§¶§©Êªº PMF ¯f±w¡C¡v

¤G¡B¨ä¤¤¡A¡uCALR Åܲ§¶§©Êªº PMF ¯f±w¡C¡v¬OÄÝ©óPV±wªÌ¡H­Y¤£¬O¡A¬OÄÝ©óMF±wªÌ¡A¬°¦ó¥i¨Ï¥ÎBesremi¡A¬OÄÝ©óÃĵØMF¼Ú¬w¤G´ÁÁ{§É¸ÕÅç?©Î¬O¼ÐÅÒ¥~¨Ï¥Î¡]Off-Label Use¡^?¤£¸Ñ¡C

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¤À¨É¯f¤Í¹ÎÅé MPN Interferon Forum - (Myeloproliferative Neoplasm) ¶ø¦a§Q¯f±w¨ú±o (6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi «á¬ÛÃö°Q½×¡A½Ķ¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò¡AÁÂÁ¡C

Ida Idic

Hi everyone, I have yesterday begin with therapy Besremi. Very will I tolerate medication.

Hi ¦U¦ì, §Ú¬Q¤Ñ¶}©l(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi ªºªvÀø, ÃĪ«­@¨ü«×«D±`¦n¡C

Mecky Rennebaum-González

I¡¥m still waiting - but it may take a while before Besremi becomes available in Switzerland.

§ÚÁÙ¦bµ¥«Ý¡A¦ý¦b(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi¦b·ç¤h¤W¥«¤§«e¥i¯àÁٻݭn¤@¬q®É¶¡¡C

Ida Idic

Mecky Rennebaum-González I believe this month come in Switzerland.

Mecky Rennebaum-González¡A§Ú¬Û«H³o­Ó¤ëBesremi·|¶i¨ì·ç¤h¡C

Katarzyna Rola¡G

Where are you from and how often do you take it?

§A¨Ó¦Û­þ¸Ì¥H¤Î§A¦h¤[¨Ï¥Î¤@¦¸¡H

Ida Idic¡G

Katarzyna Rola I live in Austria and I take 2¡Ñ 50 mg in month. ...every 2 weeks.

Katarzyna Rola¡G§Ú¨Ó¦Û¶ø¦a§Q¡A¦Ó§Ú¨C¨â©P¨Ï¥Î50mg¾¯¶q¡C

Katarzyna Rola

I am from Poland and we don¡¦t now when besremi will be available

§Ú¨Ó¦ÛªiÄõ¡A¦ý§Ú¤£ª¾¹D¦ó®É¯à¨Ï¥ÎBesremi¶i¦æªvÀø

Gabriele Ahern

Good Luck Ida.

Let us know how you feel on it and how it works for you....please.😊❤❤❤❤

Ida, ¯¬§A¦n¹B¡C½ÐÅý§Ú­Ìª¾¹D§A¹ï¥¦ªvÀø·P¨ü¥H¤Î¥¦¹ï§Aªº¼vÅT¡C

Ida Idic

Katarzyna Rola I think that¡¦s this month will be in EU

Katarzyna Rola¡A§Ú·Q¬O³o­Ó¤ë·|¦b¼Ú·ù¾P°â

Ida Idic Gabriele Ahern Thank you ....I wìll inform you

Gabriele Ahern¡AÁÂÁ¡A§Ú·|¸ò§A­Ì»¡¡C

Katarzyna Rola

Good Luck Ida Idic!

Ida, ¯¬§A¦n¹B¡C

Marcy Worthington

Congratulations! You¡¦re the first person I¡¦ve heard of who is using Besremi outside of a medical trial.

I¡¦ve used Pegasys for over ten years and have had excellent results. I hope Besremi is as good for you as Pegasys has been for me!

®¥³ß¡I§A¬O§ÚÅ¥¨ì²Ä¤@­Ó¦bÁ{§É¸ÕÅ礧¥~¨Ï¥Î(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀBesremiªº¤H¡C

§Ú¥Îù¤ó¤zÂZ¯À PegasysªvÀø¶W¹L¤Q¦~¡A¨Ã¨ú±o¤F«Ü¦nªº¦¨ÁZ¡C§Ú§Æ±æ§A¨Ï¥ÎBesremiªvÀø«á¦¨®Ä¤]¯à¹³Pegasys¹ï§Ú¤@¼Ë¡I

Ida Idic

Marcy Worthington

Thank you ...I am a patient from doctor Gisslinger, that¡¦s why it went fast.

Marcy WorthingtonÁÂÁ¡A§Ú¬OGisslingerÂå¥Íªº¯f±w¡A³o¤]¬O§Ú¬°¦ó³o»ò§Ö¨ú±oªº­ì¦]¡C

Marcy Worthington

You are very fortunate to be treated by an excellent MPN expert!

§A«Ü©¯¹B¯à±o¨ì³Ì³»¦yªºMPNÅv«ÂÂå¥ÍªºªvÀø¡I

Kim Christian Hvidkjær

Interesting Ida Idic - as i read it, Besremi is RoPegulated Interferon. Is this PV-specific, or also applicable to other MPN variations?

Ida Idic¡A³o«Ü¦³½ì¡C§Ú¬Ý¤F¤@¤U¸ê®Æ¡ABesremi ¬Oªø®Ä«¬¤zÂZ¯À¡A±MÄÝ©óPV ¾AÀ³¯g¡A¦³¾A¥Î©ó¨ä¥Lªº MPN ¾AÀ³¯g¶Ü¡H

Ida Idic

Kim Christian Hvidkjær My diagnosis is PMF CALR +

Kim Christian Hvidkjær¡A§Ú¬O CALR Åܲ§¶§©Êªº PMF ¯f±w¡C

Greg Giarratana

Is it available in Australia

½Ð°Ý³o¦b¿D¬w¦³¶Ü¡H

Ida Idic

Greg Giarratana I do not know

Greg Giarratana¡A§Ú¤£ª¾¹D¡C

David Cray

Ropeg is not on our pharmaceutical benefit system yet but Pegasus is in pre loaded syringes which costs me A$ 39.00 for a four pack.

(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi ©|¥¼¯Ç¤JÃÄ«~ºÖ§QºÞ²z¨t²Î¡A¦ýù¤ó¤zÂZ¯À Pegasus «h¬O¹w¸Ëª`®g¾¹¡A¥|¥]¸Ë°â»ù¬°39.00 ¿D¤¸¡C

Marcy Worthington

I think Besremi, Ropeginterferon, is only available in parts of Europe at this time. David, is Peg Intron available in Australia?

§Ú·Q(6446) ÃĵØÃÄ·s¤@¥N¤zÂZ¯À Besremi¡ARopeginterferon ¥Ø«e¥u¦b¼Ú¬w³¡¤À¦a°Ï¦³¾P°â¡C David¡A½Ð°Ý¿D¬w¬O§_¦³ Peg Intron ¤W¥«¡H

Rosanne Romeo

That means years for it to be available for us in the US.

³o·N¨ýµÛ³o§Y±N¦b¬ü°ê¤W¥«´£¨Ñ§Ú­Ì¨Ï¥Î¡C

Ida Idic

Rosanne Romeo Ich hope that comes fast to you.

§Æ±æ³o¾¨§Ö´£¨Ñ§A­Ì¨Ï¥Î

Rosanne Romeo

Ida Idic Thank you. I hope this new drug works well for you.

Ida Idic ÁÂÁ¡A§Ú§Æ±æ³oÃĪ«¹ï§A¦¨®Ä¨}¦n¡C

Karrie Schwartz

I¡¦ve been on Pegasys for a decade. Funny the things that make one jealous when you get old! Congratulations.

§Ú¤w¸g¨Ï¥Îù¤ó¤zÂZ¯À Pegasys ªvÀø¤Q¦~ªº®É¶¡¡C³o¥ó¨Æ¯uÅý¤H¶ú§ª¡I®¥³ß¡C

Eva Glud

Ida Idic Have you been on Pegasys before? I am also CALR+ MF and did not have any results on PegIntron ie RopInterfron alfa-2b but excellent results with Pegasys ie the 2a version. So how much I would like to space the injections to every second week- I am concerned to change. Have you discussed this with Prof Gisslinger?

Ida Idic¡A½Ð°Ý§A¥ý«e¬O§_¥Î¹Lù¤ó¤zÂZ¯ÀPegasys¡A§Ú¤]¬O CALR Åܲ§¶§©Êªº PMF ¯f±w¡A¥ý«e¨S¦³¥ô¦óRopInterfron alfa-2bªº¦¨ªG¡A¦ý¦bù¤ó¤zÂZ¯ÀPegasys ¤W¦¨®Ä¨}¦n¡C

§Ú·Q­n§ï¦¨¨C¨â©P¤@°w¡A§A¬O§_©M Gisslinger ±Ð±Â°Q½×¹L¦¹¨Æ¡H

Ida Idic

Eva Glud No, i did not try pegasys before. Only this

¤£¡A§Ú¨S¨Ï¥Î¹Lù¤ó¤zÂZ¯ÀPegasys¡A¥u¥Î¹L³o­Ó¡C

Rina Straßl

Wow, it¡¦s actually a pen! Must be more convenient. 😮 Ich hoffe, du verträgst es gut! Viel Glück!

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MPN Interferon Forum - (Myeloproliferative Neoplasm)

Hi everyone, I have yesterday begin with therapy Besremi. Very will I tolerate medication

I¡¥m still waiting - but it may take a while before Besremi becomes available in Switzerland.

I believe this month come in Switzerland.

Where are you from and how often do you take it?

I live in Austria and I take 2¡Ñ 50 mg in month. ...every 2 weeks.

I am from Poland and we don¡¦t now when besremi will be available

Congratulations! You¡¦re the first person I¡¦ve heard of who is using Besremi outside of a medical trial. I¡¦ve used Pegasys for over ten years and have had excellent results. I hope Besremi is as good for you as Pegasys has been for me!

Thank you ...I am a patient from doctor Gisslinger, that¡¦s why it went fast.

You are very fortunate to be treated by an excellent MPN expert!

Interesting Ida Idic - as i read it, Besremi is RoPegulated Interferon. Is this PV-specific, or also applicable to other MPN variations?

My diagnosis is PMF CALR +

I¡¦ve been on Pegasys for a decade. Funny the things that make one jealous when you get old!

Have you been on Pegasys before? I am also CALR+ MF and did not have any results on PegIntron ie RopInterfron alfa-2b but excellent results with Pegasys ie the 2a version. So how much I would like to space the injections to every second week- I am concerned to change. Have you discussed this with Prof Gisslinger?

No, i did not try pegasys before. Only this

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www.aoporphan.com/global_en/individual-treatments

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Jakafi¦bMyelofibrosis(¤@½u¥ÎÃÄ)»P Polycythaemia vera(¤G½u¥ÎÃÄ)ªº¾P°â¹w´ú

www.evaluate.com/vantage/articles/news/eha-least-incyte-can-still-count-jakafi

Global sales ($m)

Indication Status 2017 2024e Trial ID

Myelofibrosis Marketed 1,266 1,962 NCT00952289

Polycythaemia vera Marketed 644 1,854 NCT01243944

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Well we will have this discussion again in 5 years and then again 10 years and see where we are at. My guess is nothing major will have changed; i.e. ET, PV and primary MF patients will still routinely be diagnosed late and the patients diagnosed early will still be told by the major cancer centers like by Mt. Sinai, MD Anderson, Mayo, Moffat, Stanford, etc., to Watch & Wait for their counts to get worse instead of being prescribed Ropeginterferon immediately.

If a new disease progression inhibiting therapy becomes available for use at the time of diagnosis of ET, PV and primary MF, such as an affordable vaccine, I believe the europeans or asians will discover and pioneer it¡¦s use and the Americans will view it as a threat to their advanced disease business just like they currently view early treatment with interferon as a threat.

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have read articles by Silver & Hasselbalch that they believe MPNs should be treated like prostate cancer - catch it early and treat immediately. I know many doctors like Watch & Wait but think treating early with interferon of some kind

is our best chance for a remission. I am in the 20-25% of people intolerant to Pegasys but even so, I think it¡¦s the best treatment available now. But we need new meds for people like me. My platelets have been between 425 & 500 since I stopped Peg in Jan.2016 but that won¡¦t last forever and at almost 73, will have to go back to HU. I was having stomach issues after 4 years on it so just hope it will take another 4 years to start having problems. Or, someone will come up with another drug I can take. It¡¦s a real problem for those of us that can¡¦t take Pegasys.

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dört aydır haftada üç roferon aşı ve günde bir hidra kullanıyordum. bu gün kontrolde çıkan sonuçlar : HGB 16,6 (12-18), HCT 49,3 (36-52), PLT 228 (150-450). hidrea kullanımını kestik. olağandışı bir şey olmazsa üç ay sonra kontrol. almanyadaki arkadaşla bu günkü yazışmalarımız : ( 1 ağustostan itibaren avusturya basta olmak uzere avrupada ropeginterferon receteli satis ile eczanelerde olacakmis yakinda bize de gelir selamlar. yeni ilacin adi ropeginterferon besremi diye geciyor .adi Besremi hazir siringa. Her vucut farkli insallah bize uygun olur 10.kullanicidan 8 i cok memnun mutasyonu durduran ve yuzde 30 iyilesme gosteren bir igne 2 hafta sonra eczanelerde insallah yakinda bizde turkiyedede cikar diye dusunuyorum selamlar.. bu konuda doktorum : yeni ilaç uzun süreli etkiye sahip, kullandığım roferonla aynı etkiye sahip, sadece roferon kısa süreli etkiye sahip olduğundan haftada üç tane yapıyorsun. dedi. hepinize geçmiş olsun. selamlar..

Besremi hazir siringa

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PHARMAESSENTIA ¡V On the road to product launch

www.forbes.com/custom/2019/07/15/taiwan-a-bright-future/#pharmaessentia-on-the-road-to-product-launch

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Since 1984, the number of biotechnology companies listed on the Taiwan Stock Exchange has gone from precisely zero to more than 100, with a combined value of US$25 billion.

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The government in Taipei can take some of the credit for this after identifying the industry as the next Big Thing to promote after its success in establishing the island as a center of excellence and innovation for the semiconductor manufacturing sector; but so too can the cohort of scientists and entrepreneurs who have provided the skill and the commercial acumen that has seen Taiwan established as an engine room for an industry that is not just making a significant contribution to the island¡¦s economy but is also helping improve the health and the quality of life of millions of people around the world.

¥xÆW¬F©²¦b¦¨¥\±N¥xÆW¥´³y¦¨¥b¾ÉÅé»s³yªº¨ô¶V©M³Ð·s¤¤¤ß¤§«á¡A±N¥Í§Þ²£·~½T©w¬°¤U¤@­Ó¤j«¬±À¼s²£·~¡C³o¨Ç¾Ö¦³§Þ³N©M°Ó·~ÀY¸£ªº¬ì¾Ç®a©M¥ø·~®a¤]¬O¦p¦¹¡A¥L­Ì¤w¸g±N¥xÆWµø¬°²£·~ªºµo®i¤ÞÀº¡A¥Í§Þ²£·~¤£¶È¹ï¥xÆWªº¸gÀÙ°µ¥X¤F­«¤j°^Äm¡A¦Ó¥BÁÙ¦³§U©ó§ïµ½°·±dª¬ªp¥H¤Î¥þ¥@¬É¼Æ¦Ê¸U¤Hªº¥Í¬¡«~½è¡C

One of the Taiwanese diaspora to respond to Taipei¡¦s clarion call was PharmaEssentia¡¦s CEO Ko-Chung Lin. In 2003, he joined a team of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies who decided to come back home to launch a company dedicated to the development of drugs designed to treat myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV), essential thrombocythemia (ET), myeloid fibrosis (MF) and chronic myeloid leukemia (CML), as well as hepatitis and cancer.

¨ä¤¤¤@¦ì±a°Ê¥Í§Þ²£·~¸¹¨¤ªº¬O±q®ü¥~¦^¥xªºÃĵØÃÄ°õ¦æªøªL°êÄÁ³Õ¤h¡C2003¦~¡A¥L»P¤@¸s¬ü°ê­º©}¤@«üªº¥Í§Þ¤½¥q¥xÆW¸Ç°ª¶¥¥DºÞ©M°ª¯Å¬ì¾Ç®a¹Î¶¤¡A¨M©w¦^°ê³Ð¿ì¤@®a±Mªù¬ãµoªvÀø°©Åè¼W¥Í©Ê¸~½F¡]MPNs¡^ªºÃĪ«ªº¤½¥q¡A³oÃþ¯e¯f¥]§t¯u©Ê¬õ¦å²y¼W¦h¯g(PV¡^¡A­ìµo©Ê¦å¤pªO¼W¦h¯g¡]ET¡^¡A°©ÅèÅÖºû¤Æ¡]MF¡^©MºC©Ê°©Åè²Ó­M¥Õ¦å¯f¡]CML¡^¡A¥H¤Î¨xª¢©MÀù¯g¡C

¡§I chose to set up the company here rather than in the U.S. because Taiwan is probably the best place in the world in which to raise capital for a biotech company,¡¨ Ko-Chung explains. It was the right call. The company¡¦s 2016 IPO raised more than US$100 million and immediately propelled PharmaEssentia into the top half of Taiwan¡¦s league of biotech companies.

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That could be just the beginning. Earlier this year, the European Commission (EC) announced that it had given marketing approval for Besremi® (ropeginterferon alfa-2b). Developed in conjunction with AOP Orphan Pharmaceuticals, Besremi® is indicated as monotherapy in adults for the treatment of polycythemia vera without splenomegaly. Following the EC ruling, it is now the only such treatment available to PV sufferers across most of Europe.

¨º¶È¶È¥u¬O­Ó¶}©l¡C¤µ¦~¦~ªì¡A¼Ú¬w©e­û·|¡]EC¡^«Å¥¬¤w¸g§å­ã¤FBesremi®¡]ropeginterferon alfa-2b¡^ªº·sÃĤW¥«³\¥i¡C Besremi®»PAOP Orphan Pharmaceuticals¦@¦P¶}µo¡A¥i§@¬°¾A¥Î©ó¦¨¤H³æ¤èªvÀø¡A¥Î©óªvÀøµLµÊŦ¸~¤j¯gª¬ªº¬õ¦å²y¼W¥Í¯g¡C¦b¼Ú¬w©e­û·|¡]EC¡^¨Mij¤§«á¡A¥¦²{¦b¬O¼Ú¬w¤j³¡¤À¦a°ÏPV¯f±w°ß¤@¥i¥ÎªºªvÀø¤èªk¡C

For Ko-Chung, it makes all the blood, sweat and occasional tear that he and his colleagues have shed on the way worthwhile. ¡§We have conceptualized an idea and turned it into a reality,¡¨ he beams. ¡§I have been a scientist for 40 years and it is the dream of anybody in my profession to find themselves in this position. It is very rewarding.¡¨

¹ï©óªL°êÄÁ³Õ¤h¦Ó¨¥¡A³o¬O¥L©M¥Lªº¦P¨Æ­Ì¤@¸ô¤W¥Î¦½¤ô¡B¦å²\¨ú±oªº¦¨´N¡C ¡§§Ú­Ì¤w¸g±N¤@­Ó·§©À¤Æªº·Qªk¤Æ¬°²{¹ê¡A¡¨¥L´£¨ì¡C ¡§§Ú40¦~¨Ó¤@ª½¬O¤@¦W¬ì¾Ç®a¡A§Ú­Ì³o­Ó¾·~¡A¨C­Ó¤H³£¦³µÛ¹Ú·Q¡C³o¹ê¦b¥O¤H¹ª»R¡C¡§

Ko-Chung is only too aware, however, that the hard work has only just begun. ¡§The challenge for us now is to explain to our investors that even having met the milestone of gaining EC approval for Besremi®, making money from it will not happen overnight, and we still need their support to carry us through the initial marketing stages. Two other firms in this sector found themselves in a similarly great position of having an approved drug with a lot of potential recently, but their shares plunged because their cashflow did not immediately rise. I learned a lot from their experiences, and we try to give our shareholders as much precise information as possible so that they understand our plan and potential.¡¨

µM¦Ó¡AªL°êÄÁ³Õ¤h·NÃѨì¡AÁ}­Wªº¤u§@¤~­è­è¶}©l¡C ¡§§Ú­Ì²{¦b­±Á{ªº¬D¾Ô¬O¦p¦ó¦V§Ú­Ìªº§ë¸êªÌ¸ÑÄÀ¡A§Y¨Ï¤w¸g¨ú±o¼Ú¬w©e­û·|¡]EC¡^§å­ãBesremi®·sÃij\¥iªº¨½µ{¸O¡A¤]¤£·|¦b¤@©]¤§¶¡ÁÈ¿ú¡A§Ú­Ì¤´»Ý­n§ë¸êªÌªº¤ä«ù¤~¯à±a»â§Ú­Ì«×¹L³Ìªìªº¾P°â¶¥¬q¡C¥t¥~¨â®a¥Í§Þ¤½¥q³Ìªñ¤]¬O¤@¼Ëªºª¬ªp¡A¦b¦³¼ç¤OªºÃĪ«¨ú±o¾P°â³\¥i«á¡A¦]¬°¥L­Ìªº²{ª÷¬y¨S¦³¥ß§YÃk¤É¡A¾É­PªÑ»ù¼É¶^¡C§Ú±q¥L­Ìªº¸g¾ú¤¤¾Ç¨ì¤F«Ü¦hªF¦è¡A§Ú­Ì§V¤O¬°ªÑªFºÉ¥i¯à´£¨Ñ·Ç½Tªº¸ê°T¡A¥H«K¥L­Ì¤F¸Ñ§Ú­Ìªº­p¹º©M¼ç¤O¡C¡§

The next step for PharmaEssentia is to strengthen its U.S. presence. The company already has a second-line PV reference drug (given to patients after they have been previously treated with another drug) and is looking for FDA approval to be classified as a first-line option. According to Ko-Chung, the PharmaEssentia¡¦s product has the potential to treat 4.5 times more patients than the current drug of official choice.

ÃĵØÂåÃĤU¤@¨B¬O±j¤Æ¦b¬ü°êªº¥¬§½¡C¸Ó¤½¥q¤w¸g¾Ö¦³PV¤G½u¥ÎÃĪº¥ÎÃÄJAKAFi¤W¥«°Ñ¦Ò¡]¸ÓÃĬ°©ó¯f±w¤§«e´¿±µ¨ü¹L¨ä¥LÃĪ«ªvÀø«áµ¹¤©¡^¡A¥Ø«e¥¿¦b´M¨DFDA§å­ã¬°¤@½u¥ÎÃÄ¡C®Ú¾ÚªL°êÄÁ³Õ¤hªº»¡ªk¡AÃĵØÃĪº·sÃįf±w¸s¤ñ©x¤è§å­ãªºÃĪ«ªvÀø¯f±w¦h¥X4.5­¿¡C

With the assistance of its office in Boston, the company is going to expand indication for BESREMI® to include ET and is currently in talks with the FDA to conduct a Phase 3 clinical trial. Ko-Chung expects development and rollout to take another three years or so, giving it access to a segment of the healthcare worth between US$5 billion and US$10 billion. It will also be marketed in Taiwan, Japan, Korea and China.

¦bªi¤h¹y¿ì¨Æ³Bªº¨ó§U¤U¡A¸Ó¤½¥q±NÂX¤jBESREMI®ªº¾AÀ³¯g½d³ò¥]¬AET¡A¥Ø«e¦å¤pªO¼W¦h¯g(ET)¥¿¦b»PFDA¶i¦æ°Q½×¥H¶i¦æÁ{§É¤T´Á¸ÕÅç¡C ªL°êÄÁ³Õ¤h¹w­p¬ãµo¨ì¾P°â±À¼s»Ý­n¤T¦~¥ª¥kªº®É¶¡¡A³o¥«³õ¼ç¤O¦³50»õ¦Ü100»õ¬üª÷ªº»ù­È¡C¸ÓÃĪ«¤]±N¦b¥xÆW¡B¤é¥»¡BÁú°ê©M¤¤°ê¾P°â¡C

Another drug for Hepatitis B patients is also in the later stages of development and more innovations and discoveries will surely follow. ¡§We are humble and we continue to learn. This is why our success rate in discovering new drugs is so high,¡¨ says Ko-Chung.

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The next step for PharmaEssentia is to strengthen its U.S. presence.

The company already has a second-line PV reference drug (given to patients after they have been previously treated with another drug) and is looking for FDA approval to be classified as a first-line option.

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www.forbes.com/custom/2019/07/15/taiwan-a-bright-future/

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The next step for PharmaEssentia is to strengthen its U.S. presence. The company already has a second-line PV reference drug (given to patients after they have been previously treated with another drug) and is looking for FDA approval to be classified as a first-line option. According to Ko-Chung, the PharmaEssentia¡¦s product has the potential to treat 4.5 times more patients than the current drug of official choice.

With the assistance of its office in Boston, the company is going to expand indication for BESREMI® to include ET and is currently in talks with the FDA

to conduct a Phase 3 clinical trial. Ko-Chung expects development and rollout to take another three years or so, giving it access to a segment of the healthcare worth between US$5 billion and US$10 billion. It will also be marketed in Taiwan, Japan, Korea and China.

Another drug for Hepatitis B patients is also in the later stages of development and more innovations and discoveries will surely follow. ¡§We are humble and we continue to learn. This is why our success rate in discovering new drugs is so high,¡¨ says Ko-Chung.

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I have just been told by Roche that they are phasing our Pegasys in Europe due to ¡¥lower demand and new and better treatment options¡¦. In Estonia, where I live, they have already stopped selling Pegasys and in other European countries Roche will stop when stocks run out. This is what I was told by Roche Estonia - have also contacted their Swiss headquarters for comments. Has anyone come across this? What have your doctors said/suggested? Is anyone using Jakafi/Roferon A combo as alternative to Pegasys?

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www.patientpower.info/video/asco-noted-mpn-expert-shares-key-takeaways-for-patients?autoplay=1&utm_source=health-topic-alert&utm_medium=email&utm_campaign=MPN62619

ASCO 2019: Noted MPN Expert Shares Key Takeaways for Patients

Published on June 21, 2019

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Finally, presenting another trial in progress as it relates to the design of a trial for the interferon, pegylated interferon recently approved in Europe for polycythemia vera, which Dr. Verstovsek and I hope to colead a study here in the US for patients with essential thrombocythemia. So a lot of exciting things regarding MPNs here at ASCO 2019.

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·|­û¡GAlan Liu10136094  µoªí®É¶¡:2019/6/27 ¤W¤È 10:19:44²Ä 6970 ½g¦^À³
¤p¤ß ¤j±z¦n, ·sÃĪѤ£¦P©ó¤@¯ë¹q¤l·~, §ë¸ê¦^³ø°ª¡A¦ý¦P®É¤]¨ã¦³°ª­·ÀI¡B¬ãµo©P´Áªøµ¥¯S©Ê, §ë¸ê­n­°§C­·ÀIµL±¶®|, °ß¦³¹ï©ó§ë¸ê¼Ðªº²`¤J¤F¸Ñ, ¥Î¤ß¬ã¨s¤½¥q°ò¥»­±, ¹B¥Î¶¢¸m¸êª÷¥B¥Îªø´Á§ë¸êªº¤ßºA¨Ó§ë¸ê, ¦@«j¤§, ÁÂÁ¡C
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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2019/6/26 ¤U¤È 10:43:17²Ä 6968 ½g¦^À³
Access 2019 ASCO Annual Meeting Proceedings Hematologic Malignancies Abstracts

ascopubs.org/jco/abstracts-hematologic-malignancies-19

Proposal of an endpoint for a phase III clinical study of essential thrombocythemia: Balancing between short term effects and long term benefits.

ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.7055

Ruben A. Mesa, Craig Zimmerman, Lih Lisa Kang, Albert Qin, Chungwei Lee, Weichung (Joe) Shih, Oleh Zagrijtschuk, Norio Komatsu, Zhi-Jian Xiao, Hsin-An Hou, Chih-Cheng Chen, Srdan Verstovsek

UT Health San Antonio Cancer Center, San Antonio, TX; PharmaEssentia Corp., Boston, MA; PharmaEssentia Corp., Taipei, Taiwan; Biostatistics School of Public Health, Rutgers, The State University of New Jersey, New Jersey, NJ; Juntendo University School of Medicine, Tokyo, Japan; Tianjin Blood Disease Hospital, Chinese Academy of Medical Sciences, Tianjin, China; Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Chang-Gung Memorial Hospital, Chiayi, Taiwan; The University of Texas MD Anderson Cancer Center, Houston, TX

Abstract

Background:

Essential thrombocythemia (ET) is a chronic myeloproliferative neoplasm (MPN), covering broad spectrum of clinical scenarios, from asymptomatic patients with only isolated high platelets to highly morbid patients in late stage disease. Due to heterogenous patient population, designing clinical studies in ET is difficult, and after anagrelide there was no new drug approval to treat ET during the past 15 years, thus, high unmet medical to treat patients with ET remains. Interferons alpha (IFNa) are known to have beneficial effects in MPN (Kiladjian et al, 2016). P1101 is a next generation monopegylated IFNa, developed specifically to treat MPNs, including ET. Methods: External published clinical data in ET were analyzed to design optimal clinical study. Proposed endpoints are meant to cover all relevant clinical aspects of ET, and suffice for a regulatory relevant pivotal clinical study. Results: Composite primary endpoint scale is based on modified ELN criteria. Short term study endpoints should have clinical meaningfulness at time of measurement but also predict the later outcomes. The scale consists of: normalization of platelets (<400 G/L) and leukocytes (<9.5 G/L); normalization in size or non-progression of palpable spleen; lack of major cardiovascular event during the observation period; and improvement of Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (MPN-SAF TSS). MPN-SAF TSS is a 10 items questionnaire, allowing concise, valid, and accurate assessment of MPN symptom burden over time (Emanuel et al, 2012). For TSS-10 score, to qualify for response, following rules were elaborated: 10 points or higher reduction for patients with baseline score of ≥20, for patients with baseline score 15-19 ¡V 5 points reduction, baseline scores 10-14 ¡V reduction below 10 points, and for TSS baseline score <10 ¡V stay <10. Bone marrow analysis is not to be a mandatory test for assessment of overall benefit of therapy. Extensive genetic workup is planned to document any change in observed genetic and chromosomal abnormalities, including level of circulating mutant CALR. This would allow for objective evaluation of IFNa¡¦s ability to modify the disease. Long term observation, going beyond the 12 month of initial observation, is planned.

Conclusions:

Authors conclude that proposed endpoint scale covers well all clinically relevant aspects of ET, in order to make clinically relevant conclusions on durable benefits and risks of P1101 therapy.

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FDA Makes New Cancer Treatments Easier to Get

www.webmd.com/cancer/news/20190603/fda-makes-new-cancer-treatments-easier-to-get?fbclid=IwAR2auqr_ZaxZj58Zz76obT80-Ohf_alEY7DC8nDX4HiFoxCU4xid6bvXrhU

June 3, 2019 -- Each year, thousands of cancer patients seek access to drugs that have shown promise, but haven¡¦t be approved. Now they may have a better shot at getting them under a new initiative from the U.S. Food and Drug Administration, the Associated Press reported.

A case in point is that of Sally Atwater whose doctor spent two months calling and filling out forms to get an experimental drug to treat her lung cancer that had spread to her brain and spine.

And then there¡¦s Nancy Goodman, who unsuccessful pleaded with eight companies for a drug to treat her child¡¦s brain tumor, which ultimately killed him.

Rather than making doctors beg for these drugs, if the company approves, the FDA will intercede and help the process along, the agency announced at the meeting of the American Society of Clinical Oncology in Chicago.

We are here to help. We are not here to make a drug company give a specific drug to a patient. We don¡¦t have that authority, Dr. Richard Pazdur, who is leading the FDA program, told the AP.

We do not want to have the situation where somebody who screams loudest gets the drug while others don¡¦t, he said.

Goodman, who started the group Kids v Cancer, told the AP that the FDA was never the problem, it was drug companies¡¦ refusals. But the FDA¡¦s new program is absolutely going to change things, she said.

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www.nice.org.uk/guidance/indevelopment/gid-ta10497

Ropeginterferon alfa-2b for treating polycythaemia vera without symptomatic

splenomegaly ID1596: May 2019

Draft scope for the appraisal of ropeginterferon alfa-2b for treating polycythaemia vera without symptomatic splenomegaly

Issue Date: May 2019 Page 1 of 5

© National Institute for Health and Care Excellence 2019. All rights reserved.

¥Î©óªvÀøµL¯gª¬©ÊµÊ¸~¤jªº¬õ²Ó­M¼W¦h¯gªºropeginterferon alfa-2bµû¦ô½d³ò¯ó®×¡Cµo¦æ¤é´Á¡G2019¦~5¤ë²Ä1­¶¡A¦@5­¶¡C©°ê®a°·±d»PÅ@²z¨ô¶V¬ã¨s©Ò2019.

³¡¤À¤º®e¡G

Polycythaemia vera is a rare condition, with an estimated prevalence in the

UK of 6.05 per 100,000.If these prevalence figures are applied to the midyear 2017 population estimate of 66 million, there are around 4,000 individuals with polycythaemia vera in the UK. According to Hospital Episodes Statistics for England, there were 11,571 admissions in 2017-18 for¡¥polycythaemia vera¡¦. The median age of people presenting with polycythaemia vera is 60 years and the estimated median survival is around 14 years.The aim of treatment is to reduce the risk of thrombosis and haemorrhage,minimise the risk of transformation to acute leukaemia and myelofibrosis and manage complications such as thrombosis and pruritus. The British

Committee for Standards in Haematology recommends a range of treatments

including periodic venesection (bloodletting), interferon, hydroxycarbamide,

anagrelide, radioactive phosphorus or low dose busulfan. In addition,

melphalan has a license for treating polycythaemia vera in the UK.

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healthunlocked.com/mpnvoice/posts/140977199/miracle-of-pegasys

Miracle of Pegasys

Pegasysªº©_ÂÝ

Hi everyone

I had my latest appointment today and I¡¦ve been on Pegasys for about eight weeks gradually inceeasing to 90mg fortnightly and already my platelet count has dropped from over 900 to 640! I¡¦m so pleased and so grateful for this on the NHS.

¶Ù¡A¤j®a¦n

§Ú¤µ¤Ñ¦³³Ìªñªº¬ù·|¡A§Ú¤w¸g¦bPegasys¤u§@¤F¤j¬ù¤K­Ó¬P´Á¡A¨C¨â¶g³vº¥´î¤Ö¨ì90mg¡A§Úªº¦å¤pªO­p¼Æ¤w¸g±q900¦h­Ó´î¤Ö¨ì640­Ó¡I ¦bNHS¡A§Ú«Ü°ª¿³¤]«Ü·P¿E¡C

Brilliant news. Yep these drugs can be real miracle workers. Long may they continue to do their best!

¦n®ø®§¡C ¬Oªº¡A³o¨ÇÃĪ«¥i¥H¦¨¬°¯u¥¿ªº©_Âݤu§@ªÌ¡C ¥L­Ì¥i¯à·|Ä~ÄòºÉ¤O¦Ó¬°¡I

And long term they are even better

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If we must take meds, it¡¦s great news they are doing what they are supposed to!

¦pªG§Ú­Ì¥²¶·ªA¥ÎÃĪ«¡A¨º»ò¥L­Ì¥¿¦b°µ¥L­ÌÀ³¸Ó°µªº¨Æ±¡ªº¦n®ø®§¡I

That¡¦s excellent news, I am very pleased for you, for some people Pegasys seems to work really well. I started Pegasys in March 2019 at 45mcg weekly, increasing to 65mcg, within 8 weeks my platelets reduced from 1220 to 395, brilliant result and no side effects. Unfortunately, Roche, the company that produces Pegasys will discontinue production by 2026. Hopefully by then the new Interferon (Ropeginterferon - Besremi) will be available to us or may be an even better treatment.

³o¬O­Ó¦n®ø®§¡A§Ú¬°§A·P¨ì°ª¿³¡A¦]¬°¦³¨Ç¤HPegasys¦ü¥G¤u§@±o«D±`¦n¡C §Ú©ó2019¦~3¤ë¶}©lPegasys¨C¶g45mcg¡A¼W¥[¨ì65mcg¡A8¶g¤º§Úªº¦å¤pªO±q1220´î¤Ö¨ì395¡Aµ²ªG«D±`¦n¡A¨S¦³°Æ§@¥Î¡C ¤£©¯ªº¬O¡A¥Í²£Pegasysªº¤½¥qRoche±N¦b2026¦~°±²£¡C§Æ±æ©¡®É·sªº¤zÂZ¯À¡]Ropeginterferon - Besremi¡^±N¥i¨Ñ§Ú­Ì¨Ï¥Î¡A©ÎªÌ¥i¯à¬O§ó¦nªºªvÀø¤èªk¡C

Hi, that is worrying. Where did you hear this? X

¶Ù¡A³o«Ü¥O¤H¾á¼~¡C §A¦b­þ¸ÌÅ¥¨ì³o­Ó¡H

I worked for Roche in Clinical Research for 15 years before taking early retirement 4 years ago. I also did some occasional consultancy work for Roche, so I still have many contacts in the company. Pegasys was originally approved for the treatment of Hep C. I understand Sales in that indication have been declining over the past few years as newer, non-intererfon treatments have been developed. Pegasys for the treatment of MPNs is prescribed ¡¦off-label¡¦ , and I suspect accounts for a relatively small percentage of sales. Pegasys is very expensive to produce and with the new & better interferon Ropeginterferon shortly to become available, I assume this has also influenced the Roche decision to phase out Pegasys by 2026.

§Ú¦bù¤óÁ{§É¬ã¨s¤u§@¤F15¦~¡AµM«á¦b4¦~«e´£«e°h¥ð¡C §ÚÁÙ¬°Ã¹¤ó°µ¤F¤@¨Ç¤£©w´Áªº¿Ô¸ß¤u§@¡A©Ò¥H§Ú¦b¤½¥q¸Ì¤´µM¦³«Ü¦hÁpô¤H¡C Pegasys³Ìªì³Q§å­ã¥Î©óªvÀøHep C.§Ú²z¸Ñ¡AÀHµÛ·sªº«D¤¶¤JªvÀøªº¶}µo¡A¸Ó«ü¼xªº¾P°â¦b¹L¥h´X¦~¤¤¤@ª½¦b¤U­°¡C ¥Î©óªvÀøMPNªºPegasys³Q³W©w¬°¡§¼ÐÅÒ¥~¡¨¡A§ÚÃhºÃ¦û¾P°âÃBªº¤ñ¨Ò¬Û¹ï¸û¤p¡C Pegasysªº¥Í²£«D±`©ù¶Q¡A¦Ó¥B·sªº©M§ó¦nªº¤zÂZ¯ÀRopeginterferon«Ü§Ö´N·|¤W¥«¡A§Ú»{¬°³o¤]¼vÅT¤Fù¤ó¨M©w¦b2026¦~³v¨B²^¨OPegasys¡C

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ÃĵØÂåÃĪѥ÷¦³­­¤½¥q (¥N¸¹ 6446) ¬O¤@®a¥þ²y¥Íª«»sÃĤ½¥q¡A¬°ªvÀø¤HÃþ¯e¯f´£¨Ñ¦³®Ä¡B¦w¥þ©M¨ã¦³¦¨¥»®Ä¯qªºªvÀø薬«~¡F Athenex, Inc ¡]NASDAQ ¥N¸¹ ATNX)¡A¬°¤@®a¥þ²y¥Íª«»sÃĤ½¥q¡A­P¤O©óµo©ú¡B¶}µo©M°Ó·~¤ÆÃö©óªvÀøÀù¯g»P¨ä¬ÛÃö¯e¯fªº·sªvÀø¤èªk¡C¨â®a¤½¥q¤µ¤Ñ¦@¦P«Å§G¦b¥xÆW©Ò°õ¦æ¤§²Ä¤@´ÁÁ{§É¸ÕÅ礤¡A¤û¥ÖÅ~ ¡]¤SºÙ»È®h¯f) ±wªÌ KX2-391 ¡]¦b¥xÆW KX01¡AINN¡Gtirbanibulin) 1¢H ³n»I¡A¸g¨C¤é 1 ¦¸¡B«ùÄò 5 ¤ÑªvÀø¡AÁ{§É¤W¤wÆ[¹î¨ìªì¨B¥¿­±ªºµ²ªG¡C

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ATNX along with Taiwan¡¦s PharmaEssentia Corp announced positive preliminary data from a phase I study on its pipeline candidate, KX2-391 (tirbanibulin) ointment. Positive early clinical signals were observed in a small cohort of patients with psoriasis, having undergone treatment with the ointment in a phase I study.

The World Health Organization has suggested tirbanibulin as the International Nonproprietary Name (INN) for KX2-391.

Shares of Athenex were up almost 10.5% following this news on Friday. In fact, the stock has surged 32.1% so far this year outperforming the industry¡¦s increase of 1.8%.

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Amanda L. Renzi¡GWhat is the difference between Ropeginterferon and Pegasys?

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Kevin Walsh It¡¦s my understanding that Ropeg is only administered every other week or late one is monthly. I believe it¡¦s just a different form of interferon, but I may be wrong but I think the main difference is the middle aspect of it. Personally, if Pegasys is working well for me, I¡¦m not sure I would change meds unless I had to.

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Dennis Zabel¡GPegasys is an a2a interferon where Ropeg is an a2b interferon. I do not think there is much of a difference between alpha and bravo versions. What is different is the pegylation process which allows one injection to last for 14 days as opposed to seven. Based upon ongoing clinical trials ROPEG has been shown to have less side effects than PEG and has been shown to be superior to HU on all fronts.

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Pia Hartvigsen Hi Dennis, do you have any links to research that documents less sideeffects with Ropeg? Im interested as i might start one of them soon

Dennis, §A¦³¥ô¦ó´£¨ì¨ìÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101°Æ§@¥Î¤ñ¸û¤Öªº³sµ²¶Ü¡H§Ú¦³¿³½ì¬O¦]¬°§Ú«Ü§Ö¥i¯à´N·|¦b¨ä¤¤¤@ºØÃĪ«¤¤¶}©l¶i¦æªvÀø

Jill Zaitchick Pia Hartvigsen --Ropeg is not yet available in the USA--only in Europe.

Pia Hartvigsen¡AÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101ÁÙµLªk¦b¬ü°ê¨Ï¥Î¡A¥u¯à¦b¼Ú¬w

Amanda L. Renzi Jill Zaitchick I wonder why that is.

Jill, ¬°¤°»ò¡H

Dennis Zabel Pia Hartvigsen I will look tomorrow to see if I can find the link. I heard MPN specialist Dr Gisslinger from Austria present the findings last year at a conference. They were also presented at ASH in 2018.

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David Katz Amanda L. Renzi the FDA is extremely rough. Always has been. That¡¦s something that President Trump has been fighting. He believes that cancer drugs should not be regulated because it cannot hurt relative to the nature of the diseases themselves. Trump believes that these FDA restrictions are wasting valuable time for cancer patients. Hopefully, he makes some headway.

FDA¤@ª½³£«ÜÁV¿|¡C³o¬O¤t´¶Á`²Î¤@ª½¦b¤Ï¹ïªº¨Æ¡A¥L»{¬°¤£À³¸Ó¹ï§ÜÀùÃĪ«¶i¦æºÊºÞ¡A³o¨ÇÃĪ«¤£·|¹ï¯e¯f¥»¨­³y¦¨¶Ë®`¡C¤t´¶»{¬°¡A³o¨Ç FDA ­­¨î¥¿¦b®ö¶OÀù¯g¯f±wªºÄ_¶Q®É¶¡¡C§Æ±æ¥L¯à¦³¤@¨Ç¶i®i¡C

Pia Hartvigsen Jill i know, im in Europe

Jill, §Úª¾¹D, §Ú¤H¦b¼Ú¬w

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Polycythemia Vera support group

Unfortunately, not many local hematologists are experienced with using interferon to treat MPNs. Some experts use Pegasys, a long-acting form of interferon, as the first line of treatment. A new type of long-acting interferon, called Ropeginterferon (Besremi) has been approved specifically to treat MPNs in Europe. Once it¡¦s approved in the U.S., I think interferon with be offered to more people who have MPNs. I switch from hydroxyurea to Pegasys in 2009 and have had wonderful results. Although I have PV, not ET, my platelets run high without medication. Due to using Pegasys, they have consistently stayed at about 300K for years.

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¥|¡B2019 Conference 11TH JOYCE NIBLACK MEMORIAL CONFERENCE ON MYELOPROLIFERATIVE NEOPLASMS March 2 & March 3, 2019

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(¤@) Jean Jacques Kiladjian MD PhD The Future of Interferon in MPNs

(¤G) Richard Silver MD PhD Managing PV in 2019

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