药业新观察第1季度英文_精品文档资料下载.pdf

1、AWARDED TO THOMSON SCIENT FIC LIMITED（THE SCIENTIFIC BUS NESS OF THOMSON REUTERS）Expert review from Thomson Reuters of the most promising drugs changing clinical phase,receiving approval and launched this quarter,based on the strategic data and insight of Thomson Reuters Pharma,the worlds leading ph

2、armaceutical competitive intelligence solution.THE ONES TO WATCHA PHARMA MATTERS REPORT.A REviEw of JAnuARy-MARch 2011.PublishEd JunE 2011.Image CopyrIght:#Alessandro bianchiPHARMA MATTERS|THE ONES TO WATCHFor more information on Thomson Reuters Pharma visit or email PHARMA MATTERS|THE ONES TO WATCH

3、In the face of external pressures such as a continuing poor economy,the impending patent cliff,and an increasingly tough regulatory environment,Pharma companies are seeking more partnership opportunities than ever before,especially at an R&#D level.By sharing the risks,businesses are hoping to avoid

4、 the costs of early or late stage failure.Partnering can also allow companies to access innovative new technologies,and the pharma industry is increasingly recognizing how important innovation is in all areas,not just R&#D.However,while partnering certainly can be a rewarding method of ushering a pr

5、oduct through the pipeline,due consideration should go into every deal.Overall,the industry is expecting growth due to the increasing healthcare needs of an aging population and higher incidence of chronic disease.This edition of The Ones to Watch contains examples of companies joining forces to adv

6、ance their products through the R&#D process,including Hologic and KV Pharmaceuticals Makena,Baxter and DynPorts PerFluCel and GlaxoSmithKline and ChemoCentryxs CCX-832.Anti-cancer agents also feature heavily in this issue,as in previous quarters,with the most significant being Yervoy,the first ther

7、apy approved in the U.S.for unresectable or metastatic melanoma in over 10 years.Lorus Therapeutics LOR-253 and BioMarin Pharmaceuticals BMN-110 both entered phase I trials this quarter and offer interesting innovative approaches in tackling cancer.Partnering is one of the major initiatives drug dev

8、elopers are utilizing to change the way resources are allocated for portfolio management and business growth,and in this issue we examine some of those partnering success stories.Lets take a closer look at the five most promising drugs launched or receiving approval,and then move through each clinic

9、al phase,between January and March 2011.PHARMA MATTERS|THE ONES TO WATCHThE fivE MosT PRoMising dRugs lAunchEd oR REcEiving APPRovAlDRUGDISEASECOMPANYMakenaPremature laborHologic/KV Pharmaceutical GraliseNeuralgiaDepomedYervoyMelanomaMedarexPREFLUCELInfluenza virus infectionBaxter/DynPortEdirolOsteo

10、porosisChugai/TaishoWe begin this edition of The Ones to Watch with Hologic and KV Pharmaceuticals makena,which in February 2011 became the first and only FDA-approved therapy designed to reduce the risk of premature labor（preterm birth）in women with a history of singleton spontaneous preterm birth.

11、The drug was launched in March 2011.Makena（formerly known as Gestiva）is a long-acting injectable form of the naturally-occurring progesterone 17 alpha-hydroxyprogesterone caproate（17P）and according to its makers and healthcare providers,offers a breakthrough in the fight against preterm birth,giving

12、 hope to thousands of women affected by preterm birth.US statistics for preterm birth,defined as a birth at less than 37 completed weeks of pregnancy,reveal that one in eight babies is born prematurely and cost the country$26 billion per year.Furthermore,the last quarter of a century has seen a 35 p

13、ercent increase in the rate of premature births.While the cause of premature labor is as yet unknown,recent research showed that supplementing progesterone levels in pregnant women with a history of spontaneous preterm birth enabled them to prolong their gestation period and reduce complications for

14、 themselves and their babies.Makenas approval was based on a multicenter,double-blind,placebo-controlled NIH-funded study in which 463 women between week 16 and 21 of pregnancy and with a history of preterm birth received weekly injections of the drug or placebo until delivery or 37 weeks gestation.

15、A 34 percent reduction in preterm birth rate was seen in Makena-treated women,with resulting children having significantly lower rates of necrotizing enterocolitis,intraventricular hemorrhage,use of supplemental oxygen and mean number of days of respiratory therapy.The drug is currently indicated on

16、ly in women with a prior spontaneous singleton preterm birth and not intended for use in women with multiple gestations or other risk factors for preterm birth.gralise,a controlled-release tablet formulation of the anticonvulsant analgesic gabapentin（Neurontin）is the second approved/launched drug of interest in this issue of The Ones to Watch.Depomed used its AcuForm gastric retention delivery technology to develop Gralise for the treatment of postherpetic neuralgia（PHN）,a persistent neuropathic pai