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www.yypharm.com/?p=10547

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BMS986168¬O°ò©óTau³J¥Õ°²»¡ªºªvÀøªk¡A¥Î©ó¥@¬ö´cÅ]AD¡A»P¤§Ãþ¦üªº´N¬O¾ý¯»´³°²»¡¡]¾ý¯»¯Z°²»¡¤w¸g¦º¤F¤@¤j²¼ªºÁ{§É¡^¡A¦ÓBMS986168¥Ø«e¶i«×¥u¹L¤F¤@´Á¡A³o­Ó¥æ©ö»ù¦ì¥i¥H¥YÅã·~¬É¹ï©óADÀøªkªº­«µø

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Bristol-Myers Squibb Enters into Separate Agreements with Biogen and Roche to License Anti-eTau and Anti-Myostatin Compounds, Respectively

http://investor.bms.com/iframes/press-releases/press-release-details/2017/Bristol-Myers-Squibb-Enters-into-Separate-Agreements-with-Biogen-and-Roche-to-License-Anti-eTau-and-Anti-Myostatin-Compounds-Respectively/default.aspx

APR 13, 2017

Bristol-Myers Squibb to receive a combined $470M upfront, along with potential milestone payments and tiered double-digit royalties from each company

Under the agreement to license BMS-986168, Biogen will pay to Bristol-Myers Squibb an upfront payment of $300 million with potential milestone payments of up to $410 million. Biogen also will assume all remaining obligations to the former stockholders of iPierian, Inc. related to Bristol-Myers Squibb¡¦s acquisition of the company in 2014. Under the agreement to license BMS-986089, Roche will pay to Bristol-Myers Squibb an upfront payment of $170 million with potential milestone payments of up to $205 million. Bristol-Myers Squibb will receive tiered double-digit royalties if either asset is approved and commercialized. These agreements are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and are expected to close in the second quarter of 2017.

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www.most.gov.tw/la/ch/detail?article_uid=0c39a4b5-2065-11e7-bed9-005056826649&menu_id=2f9e8a7e-65a8-4a6b-a202-eea9c75350ca

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9.2.3.2 The standardized mean difference

http://handbook.cochrane.org/chapter_9/9_2_3_2_the_standardized_mean_difference.htm

¡u Effect sizes typically, though not always, refer to versions of the standardized mean difference. ¡v

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http://terms.naer.edu.tw/detail/1308366/

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¡ua small SMD for a fatal disease is more important than a large SMD for a transitory rash. ¡v

¡uEffect sizes of general medicine medication are presented on the left-hand side (median 0.37, mean 0.45, 95% CI 0.37¡V0.53) and

psychiatric drugs on the right-hand side (median 0.41, mean 0.49,95% CI 0.41¡V0.57).¡v

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Putting the efficacy of psychiatric and general medicine medication into perspective: review of meta-analyses

http://www.antoniocasella.eu/archipsy/Leucht_2012.pdf

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"Cohen¡¦s rule that an SMD of 0.2 is a small effect size, 0.5 medium and 0.8 a large effect size is often used,

but Cohen hastened to say that the interpretation depends on the

context;

a small SMD for a fatal disease is more important than

a large SMD for a transitory rash. "

¤S±q Fig. 1 Summary of effect sizes , ¥i¬Ý¨ìÃÄ«~effect size­Èªº¤À¥¬

Effect sizes of general medicine medication are presented on the left-hand side (median 0.37, mean 0.45, 95% CI 0.37¡V0.53) and

psychiatric drugs on the right-hand side (median 0.41, mean 0.49,95% CI 0.41¡V0.57).

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Pharma Broadroom ½Ķ Part 2

Q: ÁöµM¥H¤¤¼Ï¯«¸g»â°ì¦Ó¨¥¬O¬Û·í¯S§O¤Ö¨£ªº¡A±zªº¨â­Ó²£«~ (SND 13 ¤Î SND 12¡AªvÀøºë¯«¤Àµõ¯g (schizophrenia) ) ¤À§O¦b2014¦~12¤ë¤Î2015¦~11¤ë±o¨ì¬ü°ê­¹«~»PÃĪ«ºÞ²z§½ªº¬ð¯}©ÊÀøªk»{©w¡C±z²{¦b¤]­p¹º±N±j¤ÆNMDAªºÀøªkÀ³¥Î¦b§ó¼sªxªº¸£¥¢½Õªº¯e¯f¡C±z¯à§_·§²¤¤¶²Ð±j¤ÆNMDAÀøªkªº¾÷Âà¡A¦Ó¬°¦ó¹ïªvÀø¤¤¼Ï¯«¸g¨t²Î¯e¯f¦p¦¹¦³®Ä¡H

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NaBen(¶u­f)³o­Ó¤ß®®ªº·sÃÄ¡A¤p§Ì¤µ¤Ñ¤~ª¾¹D¥¦¦³µÛ­f¥Ò»Ä¶u ( Sodium benzoate¡ANaC6H5CO2)ªºÁY¼v

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Åý¤ß®®®³¨ìFDA BTDªº½×¤å¼Æ¾Ú

http://jamanetwork.com/journals/jamapsychiatry/fullarticle/1746121

http://www.cadencetrials.com/sites/default/files/pdf/Lane2013.pdf

2015/4/24 FDA¬ã°Q·|¡¨Breakthrough Therapy Designation: Exploring the Qualifying Criteria¡¨¤Û¿O¤ù

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM447162.pdf

NaBen ªº¤¶²Ð¦bS103 ~ S111

½²±Ð±ÂÀòÁÜ°Ñ¥[¬ã°Q·|ªº¦Û«H¤¥ªö (¬ù¦b9¤À ~ ¡F45¤À ~ ¡F 58¤À ~ )

https://www.youtube.com/watch?v=pEpUoj2rfoo

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New Schizophrenia Treatments Address Unmet Clinical Needs

https://www.ptcommunity.com/journal/article/full/2017/2/130/new-schizophrenia-treatments-address-unmet-clinical-needs

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¨ä¤¤Ãö©ó¤ß®®NaBen

NaBen (sodium benzoate, SyneuRx International [Taiwan] Corp.) is a D-amino acid oxidase inhibitor under clinical development as a schizophrenia treatment.6 It was granted orphan drug status for the treatment of schizophrenia patients with refractory disease in combination with clozapine in December 2011 and for the treatment of schizophrenia in pediatric patients in July 2012.41 In December 2014, NaBen also won a breakthrough therapy designation as an adjunctive treatment for schizophrenia in adults.

A phase 2, randomized, double-blind, placebo-controlled trial was conducted in Taiwan to determine the clinical and cognitive efficacy of add-on treatment with sodium benzoate in patients with schizophrenia who had been stabilized with antipsychotic medications for at least three months. Fifty-two patients received six weeks of add-on treatment with 1 g daily of sodium benzoate or placebo. Sodium benzoate was associated with a 21% improvement in the PANSS total score compared with placebo. Significantly greater improvements were also observed in Scales for the Assessment of Negative Symptoms¡V20 items, the Global Assessment of Function, the Quality of Life Scale, and the Clinical Global Impression in patients receiving add-on sodium benzoate treatment compared with placebo treatment.

SyneuRx filed a proposed phase 2b/3 study of sodium benzoate with the National Institutes of Health in September 2014, but as of December 2016, no subjects have been recruited. The multicenter, prospective, randomized, placebo-controlled, sequential parallel comparison design trial is expected to enroll an estimated 240 adults with schizophrenia. The study will consist of a 19-week double-blind phase followed by a 26-week open-label extension phase.

³Ì«á¤@¬q¤ß®®¤w¸g°µ¤FÅܧó ¡A¨Ã©ó2017/4/6¶}©l©Û¶Ò±wªÌ

In summary, several products are being developed to address the significant unmet needs that exist in the schizophrenia marketplace. For example, three potential treatments¡XITI-007 (Intra-Cellular Therapies), MIN-101 (Minerva Neurosciences), and NaBen (SyneuRx)¡Xare aimed at managing the negative symptoms of the disease¡K¡K.

Á`µ²¤¤°w¹ï­t©Ê¯gª¬ªºÃÄ ¡A °£¤FNaBen ¡AÁÙ¦³ITI-007¡B MIN-101

ITI-007:

http://ir.intracellulartherapies.com/releasedetail.cfm?releaseid=991333

MIN-101:

http://www.minervaneurosciences.com/innovation-pipeline/min-101/

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Breakthrough Therapies: Market Dynamics and Investment Opportunities

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http://www.prnewswire.com/news-releases/global-market-for-breakthrough-therapy-designation-drugs-should-reach-992-billion-by-2022-from-488-billion-in-2017-at-a-cagr-of-152---research-and-markets-300410084.html

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Acadia Pharmaceuticals Inc.

Adaptimmune Therapeutics Plc

Aduro Biotech Inc.

Aimmune Therapeutics Inc.

Alexion Pharmaceuticals Inc.

Allergan Plc

Amgen Inc.

Anatara Lifesciences Limited

Ariad Pharmaceuticals Inc.

Astrazeneca Plc

Avexis Inc.

Boehringer Ingelheim Gmbh

Celldex Therapeutics Inc.

Clovis Oncology Inc.

Daiichi Sankyo Company, Limited

DBV Technologies

Eisai Co. Ltd.

Eli Lilly And Company

Exelixis Inc.

F. Hoffmann-La Roche Ltd.

Gilead Sciences Inc.

Glaxosmithkline Plc

Immunomedics Inc.

Individor Plc

Jazz Pharmaceuticals

Johnson & Johnson

Juno Therapeutics Inc.

Kite Pharma Inc.

Merck & Co. Inc.

Merck Kgaa

Novartis AG

Pfizer Inc.

Pharmacyclics Inc.

Progenics Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc.

Rhythm Pharmaceuticals Inc.

Syndax Pharmaceuticals Inc.

Syneurx International Corporation

Teva Pharmaceuticals Inc.

Trevena Inc.

Vertex Pharmaceuticals Inc.

Vtesse Inc.

Wellstat Therapeutics Corporation

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Detailed Description:

This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled study, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, and 8 week double-blind treatment part, and a 52 week Open-Label Extension part.

Screening part of the study:

The subjects will be evaluated for eligibility during the Screening part of the study.

Enrichment run-in part of the study:

Subjects who are determined to be eligible will enter the Run-in part of the study. A total of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBenR or Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both groups (NaBenR or Placebo) will be assessed and categorized intoresponders and non-responders, based on 20% or more reduction from baseline in their PANSS total scores as per the evaluations at Visit 2 and Visit 4.

Double-Blind treatment part of the study :

Subjects who have successfully completed the Enrichment Run-in part will enter the Double- Blind treatment part of the study per below: NaBenR treated subjects: Subjects will continue receiving NaBenR for another 8 weeks.

Placebo treated subjects:

Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks.

Placebo Non-responders: Subjects will be re-randomized to receive NaBenR or Placebo in a 1:1 ratio for another 8 weeks.

Open-Label Extension part of the study:

All subjects who have completed the Double-Blind part of the study will continue with the Open-Label Extension part of the study to receive NaBenR for an additional 52 weeks, plus a 2 week follow-up.

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