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clinicaltrials.gov/ct2/show/NCT01193699?term=P1101&rank=4

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www.bloodjournal.org/content/early/2015/08/10/blood-2015-04-637280

www.bloodjournal.org/content/126/23/4056

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mops.twse.com.tw/nas/STR/644620160620M001.pdf

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*Scientific Agenda

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# ÃÄµØ P1101 ¯S¦â¾ã²z¦p¤U¡G

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# ¥Ø«e¤½¥q¦bP1101¤zÂZ¯Àªº¥¬§½¤W¥D­n²£«~½u¬°¨â¤j°Ï¶ô¡G

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# 2011¦~¦å²G¦~·| (ASH Meeting)µoªí¡G

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Direct-Acting Antiviral Treatment Linked with HCC Recurrence for Patients with Hepatitis C Infection - See more at:

http://www.targetedonc.com/publications/hcc-monitor/2016/june-2016/direct-acting-antiviral-treatment-linked-with-hcc-recurrence-for-patients-with-hepatitis-c-infection?p=2

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Alarm over Cancer

Recurrence after DAA Treatment

Conference Coverage > EASL 2016

Apr 15, 2016 | Gale Scott

Despite all the good news about direct-acting antivirals for treatment of hepatitis C virus (HCV) infection researchers from Italy have sounded a note of alarm.

In a study fast-tracked for publication today in the Journal of Hepatology, a research team found that patients with a prior history of hepatocellular carcinoma (HCC) and treated with DAAs are having a higher than expected rate of cancer recurrence. Further, those cancers came back within a few months.

The recurrence rate in some subgroups has been over 40%.

In their conclusion in the journal article, the researchers said ¡§Our data show an unexpected high rate and pattern of tumor recurrence coinciding with HCV clearance and, though based in a very small cohort of patients, should be taken as a note of caution and prime a large scale assessment that exceeds the individual investigators capacity¡¨.

The study authors believe the recurrences could be a result of having a weakened immune system following DAA therapy.

¡§Something is going here,¡¨ said Jordi Bruix a professor at the Barcelona Clinic Liver Cancer Group, Hospital Clinic Barcelona, discussing the alarming findings in a session today at the International Liver Congress in Barcelona, ¡§But nothing in life is without risk.¡¨

HCC is the most common form of liver cancer worldwide.

According to the World Health Organization, liver cancer accounts for 662,000 deaths and is the third leading cause of cancer-related death, exceeded only by cancer of the lung and stomach.

Approximately 75% to 80% of cases of HCC occur in Asia, however, there is considerable variation within continents.

The overwhelming majority of HCC cases occur in patients with chronic liver disease, where approximately 80% to 90% have cirrhosis and most of the remainder have moderate to advanced fibrosis.

¡§Interferon-free regimens in particular are now being studied in many patient cohorts including those with other pre-existing disease such as HCC. Our data, even though from a relatively small number of patients, are so striking that it clearly signals we must exercise caution in the use of these agents in such patients, at least until data from further large-scale assessments are available,¡¨ Bruix said.

The study included 103 patients across four hospitals who had HCV infection and a prior history of HCC. Of these, 58 patients had achieved complete response after treatment of their cancer and met inclusion criteria for the study. Baseline characteristics, laboratory and radiologic tumor response were registered in all patients before starting antiviral therapy and during the follow-up, according to the clinical practice policy.

After a median follow-up of 57 months. Three patients died and 16 (27.6%) developed tumor recurrence.

Median time between antiviral treatment and detection of recurrence was 3.5 months.

"It is important that hepatologists continue to weigh up the risks and the benefits of DAA treatment for each individual patient, as these drugs are still relatively new.," said Massimo Colombo, Professor of Gastroenterology at the University of Milan, Italy and former Editor-in-Chief of the Journal of Hepatology.

- See more at: http://www.hcplive.com/conference-coverage/easl-2016/alarm-over-cancer-recurrence-after-daa-treatment#sthash.7e4AMQbd.dpuf

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Incyte¡¦s Jakafi Positive in Phase III for Polycythemia Study

by Zacks Equity Research Published on June 10, 2016 |

Incyte Corporation (INCY) announced new 28-week data from a phase III study (RESPONSE-2) on Jakafi for the treatment polycythemia vera (PV).

The multi-center, open-label, randomized study evaluated the safety and efficacy of Jakafi, in comparison to the best available therapy, in patients with PV who are resistant to or intolerant of hydroxyurea, dependent on phlebotomy for hematocrit control and do not have an enlarged spleen.

Data from the study demonstrated that 62% of patients treated with Jakafi achieved hematocrit control without phlebotomy, compared to the 18% of patients treated with the best available therapy. Results were presented at the Congress of the European Hematology Association.

Jakafi was generally well tolerated. Results from the RESPONSE-2 study were consistent with data from the RESPONSE study, which evaluated patients suffering from inadequately controlled PV with an enlarged spleen.

We note that Jakafi is currently approved in the U.S. for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF, and post-essential thrombocythemia MF. The company recorded Jakafi sales of $183.3 million in the first quarter of 2016, up 58.9% year over year.

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CTI BioPharma Reports Mixed Pacritinib Study Data, Stock Up

by Zacks Equity Research Published on August 30, 2016 |

CTI BioPharma Corp.¡¦s (CTIC) shares gained 14.9% after the company announced top-line results from a phase III study (PERSIST-2) on pacritinib, wherein the study met one of the co-primary endpoints.

The PERSIST-2 study evaluated pacritinib in comparison to the best available therapy (BAT), including Incyte Corporation¡¦s (INCY) Jakafi (ruxolitinib), for the treatment of myelofibrosis in patients whose platelet counts were less than 100,000 per microliter.

Results from the study demonstrated a statistically significant improvement in spleen volume reduction (SVR) in patients treated with pacritinib, thereby meeting one of the co-primary endpoints. Although the study failed to meet the co-primary endpoint of greater than 50% reduction in Total Symptom Score (TSS), its preliminary analysis approached marginal significance in comparison with BAT.

The most common adverse events associated with pacritinib were diarrhea, nausea and vomiting, which were found to be generally manageable.

Note that in Aug 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high-risk myelofibrosis, including but not limited to patients with disease-related thrombocytopenia, patients experiencing treatment-emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy.

We remind investors that in Feb 2016, the FDA had placed the company¡¦s Investigational New Drug (IND) application for pacritinib on a full clinical hold. The company is currently working with the FDA to seek to address their recommendations for getting pacritinib off the hold.

CTI BioPharma currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK) and ANI Pharmaceuticals, Inc. (ANIP) . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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¦pªG§A¦³¨º¼Ëªº¿ï¶µ¡A¨º»ò§A¯d¦b§É¤W¡A§Ô¨üÃĪ«¡A¦ý³o¬O¥i¯àªº¡A±w¦³°©Åè¼W¥Í©Ê¯e¯f¡C¬Û¤ñ¤§¤U¡A§Ú­Ì¥Î«Ü¤pªº¾¯¶q¡A¨C¶g45·L§J¡A©Ò¥H³o¬O¤@­Ó·L¤£¨¬¹Dªº¾¯¶q¡A§Ú­Ì¥i¥Hªø®É¶¡ªvÀø¯f¤H¡C

Andrew Schorr¡G

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Dr. Richard Silver¡G

¦A¦¸¡A³o¬O¤@­Ó«D±`¦nªº°ÝÃD¡C­«­nªº¬O­n±j½Õ¡A§Ú­ÌªºÆ[²³¡A©Ò¦³ªº¤zÂZ¯À©w©Ê¬O«D±`­«­nªº¡A³o·N¨ýµÛ¥¦­Y¦P¤@¾÷ºc¥XªºÃĪ«ªº¬O¬Û¦Pªº¡C

¦³´XºØ²£«~¥«°â¡A¨ä¤¤¤§¤@¥Ñ¥ýÆF¸¶¶®´£¥X¡A³o¬O¤zÂZ¯À£\-2b¡A²{¦b¥s°µ¡A¥ýÆF¸¶¶®Àq§J¡CÁÙ¦³¤@­Ó¥Ñù¤ó´£¥Xªº¡A³o¬OPegasys¡A¨Ã¦³¤@­Ó·sªº¡A²{¦b¥¿¥ÑAOP©MPharmaEssentia»s³y¡A«ùÄò®É¶¡§óªø¡C

¦pªG§Ú­Ì¥i¥Hµ¹«ùÄò®É¶¡¸ûªø»Pª`®gÃĪ«¡A¦Ó¤£¬O¨C¶g¤T¦¸¡A¨Ã¨Ï¨ä¨C¤ë¤@¦¸¡A³oµ¹±wªÌ«D±`¦³§l¤Þ¤O¡C

Andrew Schorr¡G

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Dr. Richard Silver¡G

­@¨ü©Ê¨}¦n¡C²{¦b¡A²Ä¤G¥ó¨Æ±¡¬O¡A¥¦¤£¶È¬O§ó¦nªº­@¨ü©Ê¡A¤zÂZ¯Àºû«ù¤@©w¿@«×¥i¤¹³\¦³¸û¦nªºªvÀø®ÄªG(ª`:P1101¥iºû«ù¨â¬P´Á¡A¬Æ©Î¤@¤ëªºÃ­©w¿@«×)¡A¦Ó¤£¬O§A¬Ý¨ìªº¡A¨C¶g¥´¤T¦¸ªºÃÄ¡A¿@«×©¿°ª©¿§C¡C

Andrew Schorr¡G

¦nªº¡C²{¦b¡A§A´£¨ìªº´£¨Ñµ¹PV¡C¥i¯à³o¤]¦³¨ä¥LªºMPNªvÀø¡AÅý§Ú­Ì»¡¡A°©ÅèÅÖºû¤Æ©O¡H¡K¡K¡K.

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辉·ç140¬ü¤¸¦¬购Medivation

来·½¡G¬ü¤¤药·½ 2016-8-23

¤µ¤Ñ辉·ç¥H¨CªÑ81.5¬ü¤¸¡A总­È140亿¬ü¤¸¦¬购¤FMedivation¡C这个¤L个¤ë¥H来¨î药¬É³Ì热门©ç卖¥H¤g»¨ªº¤j¤â笔¤¶¤J¦Ó结§ô¡C¤µ¤Ñªº¦¬购¤£仅¥O©Ò¦³¦³PARP项¥Øªº¤½¥qªÑ²¼³£¤£¦Pµ{«×¤W扬¡A¦Ó¥B¦]为§ë资ªÌ¬Ý¨ì¤j药ÉD¦³钱无产«~ªº现实¥i¯à会诱发¤U¤@轮©ç卖¦Ó¥O¾ã个¥Íª«¨î药´¶¹M¤W涨¡C

Medivation¨Æ¥ó¦b¥Íª«¨î药¥v¤W³£¤£¦h见¡A赛诺µá¡B¦w进¡B辉·ç¡B¦N§Q±o¡B赛尔°ò¦]¡Bªü´µ¦C±d¡B诺华¡BÀq¨F东¡Bªü´µ¯S©Ôµ¥药¥ø¤L¥G¦P时ªí¥Ü±ý¦¬购这个¥u¦³¤@个产«~ªº¤½¥q¡C³Ì¦Z辉·ç¥H辉·ç¬£头¦¨为³Ì¦Z赢®a¡A¥HMedivation销°â额11­¿ªºÉ²®æ¦¬购¦¨¥\¡A¦Ó辉·ç¥«­È¥u¦³¦Û¤v销°â额ªº4.5­¿¡C虽µM¥Íª«§Þ术¤½¥q©M药ÉDªÑɲ¦³区别¡A¦ý还¬O¦³¤H质ºÃ辉·ç¥Xɲ¤Ó°ª¡CMedivation°£¤FXtandi¥h¦~¦¬¤J22亿¡]ÉOªü´µ¯S©Ô¦@¨É¡^¡A还¦³PARP§í¨î剂talazoparib©MIO产«~pidilizumab¡C现¦b¥t¥~两个PARPÉD®aTesaro¡BClovis¥«­È¬Û®tªñ10­¿¡A¤À别为50亿©M6亿¡A©Ò¥H«Ü难­ãÚ̦ôɲtalazoparib¡C

辉·ç现¦b«æ»Ý­«­n产«~扩¥R产«~线¡A过¥h两¦~´¿¥ý¦Z试图¦¬购ªü´µ¦C±d©M¦ã尔«Ø¡A¦ý§¡¥¼±o¤â¡C获±oMedivation¦Z辉·ç将拥¦³¥¼来¤L¦~10¤j§ÜÀù药ªº两个¡]Ibrance©MXtandi¡^¡A©Ò¥H会¦b肿½F这个³Ì­«­n竞争领°ì¥e¦³¤@®u¤§¦a¡C¥t¥~这个¦¬购对辉·ç¤]¦³¤@©w战²¤¨¾±s·N义¡C¦pªGÀq¨F东©Î赛诺µá赢±o竞©ç¡A¦Ó³Ì¦ZXtandiÓì应¯g扩¤j¨ì«e¦C¸¢Àù¥H¥~¡A©Îtalazoparib¯u¦¨为best in class¡A辉·ç¦b肿½F领°ì¤S±o¸¨¦Z10¦~¡C辉·ç¤w经错过¤F§K¬Ì疗ªk¤j¼é¡A¦A错过PARPªºÉó会¦¨¥»«Ü°ª¡C¥t¥~«e¦C¸¢Àù¬O¤Ö数­ï¥d§í¨î剂无®Äªº¤j¯fÏú¡A©Ò¥HXtandi¨üO¡BK挤压¤L²v较§C¡C

Medivation¤L¦~«e´¿从«X罗´µ¦¬购¤F¤@个诡Éݪºªü尔¯ý®üÀq药ª«dimebon¡A¦}¦¨¥\获±o辉·ç2亿¦h¬ü¤¸¦@¦P开发¡C³Ì¦Zdimebon¯»¨­¸H°©¡A¦ýMedivation¥Î这笔钱¦¬购¤FXtandi¡A¦}¤j获¦¨¥\¡C¦Z来从BioMarin¥H5亿¬ü¤¸¦¬购¤Ftalazoparib¡A¦p¤µ³Q¦ôɲ40-50亿¡C¦Ó辉·ç则§â¦Û¤vªºPARP卖给Clovis¡A现¦b¥«­È¥u¦³6亿¬ü¤¸¡C©Ò¥H净结ªG¬O辉·ç8¦~«e­É给Medivation 2亿¬ü¤¸¥h赌³Õ¡AµM¦Z¤µ¤Ñªá140亿§âMedivation赢ªº资产买¤U¡C

现¦b«Ü¦h药ÉD³£ªZ¥\¤£济¡A«æ»Ý¯«©_§L¾¹¥ß¨¬¦¿´ò¡C¤µ¤Ñ辉·ç°ªÉ²夺¨ì¡§­Ê¤Ñ剑¡¨¡A³Ñ¤U¨º¨Ç´¿参ÉOMedivation竞©çªº¥ø业»Ý­n¥h§ä¡§±O龙¤M¡¨¡CBioMarin¡B¦A¥Í¤¸¡B¦Ê«Ø³£³Q¦C为¦¬购对¶H¡CMedivation¨Æ¥ó¤j®aªº¦@识¬O当ªì赛诺µá¥Xɲ¤£够ªG断¡A©Ò¥H¥i¥H预测¤U¤@轮¦¬购¥Xɲ会°¾°ª¡A这¤]¬OIBB¤µ¤Ñ¤W扬ªº­ì¦]¡C¦Ü¤_CEO David Hung则¦¨¤F§ë资ªÌ¤ß¤¤ªº­^¶¯¡C药ÉD¦³钱¯Ê产«~ªº§½­±µu´Á内¤£会§ï变¡A©Ò¥H专®a预测Hung«Ü§Ö会­«¥X¦¿´ò¡A¤â«ù¤@§â±O龙¤M¡C

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½÷·ç°ª»ùÁʨ֡AMedivation¶g¤@ªÑ»ùötº¦ªñ¨â¦¨

2016/08/23 08:50 °]°T§Ö³ø ½±©{¦p

¬ü°ê»sÃÄ¥¨À¼½÷·ç(Pfizer Inc.)22¤é«Å¥¬¥¸¸ê140»õ¬ü¤¸¨ÖÁʪ¾¦W«e¦C¸¢ÀùÀøªk¿W¥ßÃļtMedivation Inc.¡A³o¶µ®ø®§¿EÀyMedivationªÑ»ù¶g¤@¦¬½L¤@¤f®ðötº¦19.74%¡A¦¬80.42¬ü¤¸¡A½l³y¦¬¥«·s°ª¬ö¿ý¡A¤µ¦~¨Óº¦´TÂX¤j¨ì66.36%¡C

Who¡¦s Next After Medivation?

Pfizer¡¦s (PFE) $14bn takeout of Medivation (MDVN) sent the Nasdaq biotech index up 2% yesterday, supposedly presaging a buying spree among big pharma groups desperate to restock pipelines. At least that¡¦s what deal bankers and biotech bulls will be hoping for.

Looking for the next Medivation: mid caps* reliant on a single, marketed drug

Company Market cap Top drug¡¦s share of 2015 sales Top drug Top drug¡¦s 2015 sales Top drug¡¦s 2015-22 CAGR

Incyte $15.4bn 100% Jakafi $601m 17%

2016 Financial Guidance Current Previous

Jakafi net product revenues $825-$835 million $815-$830 million

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¡]Biologics Manufacturing Asia 2017¡^³qª¾¡A³Q´£¦W¬°

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APAC Bioprocessing Excellence Awards

15th February, 2017 Singapore held in conjunction with the pre-eminent 4th Biologics Manufacturing Asia 2017

APAC Bioprocessing Excellence Awards aims to recognize outstanding bioprocessing people, organizations and technologies that facilitate biomanufacturing excellence at enhanced speed, reduced cost and superior quality. Featuring top bioprocessing and biomanufacturing experts in the industry, along with the latest advances in technologies and bets practices in manufacturing, Asia¡¦s Bioprocessing Excellence Awards aims to recognize outstanding leaders & trend-setters of today, and inspire innovators of tomorrow.

APAC Bioprocessing Excellence Awards¡B2017

Best Bioprocessing Excellcnce Award;

Shortlisted Nominees;

Taiwan;

Pharmaessentia

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Incyte Reports 2016 Second-Quarter Financial Results and Updates Key Clinical Programs

• $208 million of 2016 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 46 percent growth over the same period last year

• ECHO-301, the first Phase 3 trial evaluating epacadostat, now underway in combination with pembrolizumab as first-line treatment of patients with advanced or metastatic melanoma

• New Phase 3 clinical data from COMFORT-I in myelofibrosis and RESPONSE-2 in polycythemia vera reinforce the leadership position of Jakafi in the treatment of patients with these myeloproliferative neoplasms (MPNs)

• Ruxolitinib granted Breakthrough Therapy Designation by the FDA for the treatment of patients with acute graft-versus-host disease (GVHD)

Conference Call and Webcast Scheduled Today at 10:00 a.m. ET

WILMINGTON, Del.--(BUSINESS WIRE)--Aug. 9, 2016-- Incyte Corporation (Nasdaq: INCY) today reports 2016 second-quarter financial results, including strong revenue growth driven by increased sales of Jakafi® (ruxolitinib) in the U.S. as well as continued growth in the royalties from ex-U.S. sales of Jakavi® (ruxolitinib) by Novartis.

The long-term clinical profile of Jakafi was reinforced by the presentation of five-year overall survival data from the COMFORT-I trial in patients with myelofibrosis at the recent American Society of Clinical Oncology (ASCO) meeting and the successful results from the RESPONSE-2 Phase 3 trial in patients with uncontrolled polycythemia vera highlighted at the European Hematology Association (EHA) congress. Additionally, ruxolitinib has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute GVHD.

Baricitinib, currently under global regulatory review for the treatment of patients with rheumatoid arthritis, may provide Incyte with a further valuable source of revenue, given the potential for milestones and royalties under the Company¡¦s license agreement with Eli Lilly and Company. The first regulatory approval for baricitinib is anticipated in the first quarter of next year.

Incyte has a growing international footprint, which was accelerated by the recent ARIAD transaction in Europe, and now has a development, medical and commercial organization in Europe to complement its fully-integrated U.S. business. The expanded European team is fully operational, and will continue to grow the Iclusig® (ponatinib) brand as well as contribute to the clinical development of Incyte¡¦s portfolio of 14 product candidates.

Within the R&D group, and during the second quarter of 2016, Incyte initiated the first pivotal Phase 3 trial of epacadostat, added a new clinical program with the initiation of a first-in-man trial of INCAGN1876, an anti-GITR agonist antibody, and signed a drug discovery alliance with the Moffitt Cancer Center ¡V collectively illustrating the depth and breadth of Incyte¡¦s discovery and development programs.

¡§Incyte is in an excellent position both financially and operationally as we enter the second half of the year,¡¨ stated Hervé Hoppenot, Incyte¡¦s Chief Executive Officer. ¡§Jakafi continues to grow rapidly in the U.S., and we have successfully incorporated our expanded European team. The recent initiation of the first Phase 3 trial of epacadostat was a significant milestone for Incyte, and we are preparing to launch the pivotal program for ruxolitinib in GVHD.¡¨

2016 Second-Quarter Financial Results

Revenues For the quarter ended June 30, 2016, net product revenues of Jakafi were $208 million as compared to $142 million for the same period in 2015, representing 46 percent growth. For the six months ended June 30, 2016, net product revenues of Jakafi were $391 million as compared to $258 million for the same period in 2015, representing 52 percent growth. For the quarter and six months ended June 30, 2016, net<

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