World Leaders in Health Industry Analysis

A Business Monitor International Company

Inhalation & Nasal Spray

Generic Drugs:

Potential Opportunities in the

Respiratory Market

راه اندازی موفق یک کســب و کار در کنار استمرار و ماندگاری این موفقیت، همواره یکی از دغدغه های اصلی سرمایه گذاران و صاحبان هر

کسب و کار است.از طرفی در عصــر حاضر، اطالعات مرتبط، به هنگام و معتبر الزمه موفقیت محســوب می شود. بر این اســاس می توان نتیجه گرفت که ســاماندهی اطالعات و استفاده به موقع از این عنصر حیات بخش، تأثیر به ســزایی در پویایی تصمیمات الزم برای پیشــبرد اهداف راهبردی

شرکت های مختلف خواهد داشت.با درک این حساســیت، مأموریت اصلی گروه تحقیقات بین المللی بیزریپورت، پایش بازار و صنایع بااهمیت در سطح کشور، منطقه و جهان و با هدف ارائه اطالعات صحیح، مرتبط و به هنگام به ســرمایه گذاران اســت که قطعاً می تواند راهنمایی مؤثری در اتخاذ تصمیمات درست

داشته باشد.

گذرنامه ورود به کسب و کارهای

مـاندگــار

ج( گزارش های ادواری

کیزش

ت پیزا

جهو ت

رو دا

World Leaders in Health Industry Analysis

Cancer Blockbusters to 2016The prospects and challenges for 21 US$1 billion oncology products

World Leaders in Health Industry Analysis

A Business Monitor International Company

Trends and Opportunities in the Diabetes Care MarketJanuary 2014

Endo InternationalMedical Device Companies AnalysisAugust 2014

www.esp

icom.com

CardiometabolicDrug News

CMDN Cover.indd 1-2

10/03/2014 15:53:08

BMI View: Switching patients to this follow-up product will help Sanofi to counter the anticipated hit in revenues when cheaper versions of

blockbuster drug Lantus become available. The company will also benefit from continued growth in the diabetes market and high barriers

to biosimilar entry. EC approval will follow in Q215.

The end of February saw Sanofi announce two positive developments for its Lantus successor, Toujeo (insulin glargine [rDNA origin]

injection, 300 U/mL), a once-daily long-acting basal insulin. Firstly, the FDA has approved Toujeo to improve glycaemic control in

adults living with Type I and II diabetes, and the drug is expected to be available in the US at the beginning of Q215; and secondly,

the EMA's CHMP has issued a positive opinion recommending the approval of Toujeo.

Lantus Patent Expiry To Cause Challenges

Insulin glargine is the active ingredient in Sanofi's blockbuster long-acting insulin, Lantus (insulin glargine [rDNA origin] injection,

100 U/mL). Despite reporting an increase in revenues and net income in Q414 and the company projecting a stable or slightly

growing 2015 EPS versus 2014 EPS, recent pricing pressure, notably in the US, has cast some uncertainty on Sanofi's growth

prospects. Additionally, the company has stated that sales at its Diabetes division, which accounts for about 20% of its total revenue,

would be flat in 2015. US patent protection for Lantus, the company's bestselling drug, was lost in February whilst in Europe, the

drug's patent is due to expire in May, however as yet, no other insulin glargine products have been approved by the FDA. In Q414

Lantus sales increased 10.8% to EUR1.77bn (USD2.00bn). In the US, Lantus grew by 10.1% to EUR1.19bn (USD1.35bn) in Q414. Lantus

had 2014 net sales of EUR6.34bn (USD7.09bn), up by 12.1% at constant exchange rates; these sales represented 87.2% of Sanofi's

total for Diabetes, which was EUR7.27bn (USD8.13bn), and 22.9% of the full-year sales for Pharmaceuticals, which were EUR27.7bn

(USD31.0bn).

As Sanofi strives to reduce its reliance on blockbuster drugs such as Lantus and Lovenox (enoxaparin sodium injection) and expand

its presence in biotech, animal health and emerging markets, it is BMI's view that the company's Board will have to be increasingly

transparent regarding company strategy in order to restore investor confidence in the company, particularly as 2015 is set to be a

challenging year for the French drugmaker.

Toujeo Is Sanofi's Lantus Successor

Diabetes is one of Sanofi's seven growth platforms. As noted by the firm, despite basal insulin being a cornerstone treatment

for diabetes for decades, significant unmet medical needs remain a reality, with approximately half of patients on treatment not

reaching their blood glucose level targets. In addition, optimal insulin dose is often not reached during initiation or maintenance

phase. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-

established benefit-risk profile. Its compact subcutaneous depot leads to more stable and more prolonged pharmacokinetic/

pharmacodynamic (PK/PD) profiles. Toujeo has demonstrated a more stable and a prolonged glycaemic control that lasts beyond 24

hours compared with Lantus with low within-individual, within-day blood glucose variability.

The approval of Toujeo was based on FDA review of results from the EDITION clinical trial programme, which was comprised of a

series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse

diabetes populations (Type I and II). In the clinical trial programme leading to approval, once-daily Toujeo was compared to that of

once-daily Lantus in open-label, randomised, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with six

months safety extension. The positive CHMP opinion of Toujeo was also based on results from the EDITION clinical trial programme.

Continued on page 3...

Issue No. 13March 2015

Sanofi's Lantus Successor Will See EC Approval

And US Launch In Q215

Managing Editor Lucy Vann

Conditions of Sale

• Cardiometabolic Drug News must not be reproduced, abstracted, stored in

a retrieval system or transmitted in any form or by any means without the

written permission of the publisher.

• Cardiometabolic Drug News must not be circulated to staff outside the

address to which it is sent.ISSN 2054-8796

©Business Monitor International Ltd. All rights reserved.

www.esp

icom.comDrugDelivery Insight

New DDI Cover Mk3.indd 1-2

02/06/2009 09:06:40

EditorsOmar El Saidi

Managing EditorSophie Bracken

Conditions of Sale

• Drug Delivery Insight must not be reproduced, abstracted, stored in a retrieval system

or transmitted in any form or by any means without the written permission of the

publisher. • Drug Delivery Insight must not be circulated to staff outside the address to which it is

sent.

ISSN 1475-083X

©Business Monitor International Ltd. All rights reserved.

BMI View: As Bayer seems geared for the divestment of its Diabetes Care franchise, the division's underperformance epitomises similar

plights amongst other companies with medical devices targeted for the diabetes market. An unfavourable reimbursement environment

and pricing pressures will continue to weigh on new market entrants.

Bayer has commenced a year-long life sciences reorganisation, which is due to be completed in January 2016, as it prepares to list

its MaterialScience plastics unit on the stock market, according to reports by Bloomberg. The company was cited as stating that its

incentives revolve around enhancing its focus on the more profitable pharmaceuticals and crop chemicals and seeds businesses.

Coupled with Bayer's vocal interest in pursuing acquisitions within the veterinary medicines segment, this latest development is a

key indicator that the company has set its sights on divesting the Diabetes Care business.

The MaterialScience business is estimated to be worth about EUR10.3bn (USD11.7bn) and includes technology geared at reducing

energy costs and other spending in the manufacturing of plastics. Prioritisation of its divestment ahead of the Diabetes Care

business is comprehensible given the latter's lower valuation at EUR2.0bn (USD2.5bn). It serves as a necessary step to improve

overall margins by generating more substantial funds in the near term, which could be redirected at acquisitions within Bayer's

other strong businesses, and leaner organisation.The Diabetes Care business has been underperforming in recent

quarters, with dynamics for a recovery looking unfavourable

stemming from pricing pressures, high competition, and an

unfavourable reimbursement environment. Sales of Bayer

Diabetes Care's primary asset, the Contour series of blood glucose

monitoring systems, has declined from EUR189mn (USD216mn)

in Q312 to EUR167mn (USD191mn) in Q314. The company's total

sales, however, over the same period increased from EUR9,661mn

(USD11.0bn) to EUR10,187mn (USD11.6bn).BMI considers the decision to divest the MaterialSciences business

in a phased manner as favourable for Bayer, as improvements in

bottom-line margins and cost efficiency materialise in the near

term, and help the company realise higher value for its remaining

stake. However, given the Diabetes Care business' lower asset-base

and continued underperformance, the company is unlikely to follow

a similar phased approach and will instead seek a direct divestment.

Reports of Bayer exploring a divestment of its Diabetes Care

business first surfaced in November 2014 [1].Continued on page 3...HighlightsPatent Ruling Edges Pulmicort Respules Toward Lifecycle End

Page 5

Abuse-Deterrent Opioid Market Seeing High Activity

Page 7

CeQur’s Insulin Delivery Device Improves Diabetic Glycaemic Control

Page 10

Issue No. 342

March 4 2015

DiabetesMarketChallengesHighlightedAsBayer

DivestmentEdgesCloser

Omar El SaidiEditorenquiries@espicom.com

Diabetes Care Underperformance Will Instigate Divestment

Bayer and Diabetes Care Revenue, Q312-Q314

Source: Bloomberg, BMI

125

145

165

185

205

225

245

265

285

305

325

9,000

9,200

9,400

9,600

9,800

10,000

10,200

10,400

10,600

10,800

Q312

Q412

Q113

Q213

Q313

Q413

Q114

Q214

Q314

Re

ven

ue (

EU

Rm

n)

Re

ven

ue (

EU

Rm

n)

Diabetes Care (RHS)

Total Bayer (LHS)

Linear (Diabetes Care (RHS))

www.esp

icom.com ardiovascular

Device BusinessC

New CVDB Cover.indd 1-2 06/07/2009 10:12:17

BMI View: The US drug-eluting stent market will garner favourable upward momentum, contrary to recent years, as pricing pressures increase. The rising burden from cardiovascular disease, enhanced public access to healthcare, and competition from new market entrants will lure medium-term demand.

Medtronic has gained significant market share from competitors within the US drug-eluting stent (DES) market, according to data from Bloomberg. In Q414 (calendar period ended December 31 2014), revenue from DES sales in the US exceeded USD330mn, with Medtronic, Abbott Vascular (Abbott Laboratories) and Boston Scientific yielding an overwhelming majority share.

In Q414, Boston Scientific's DES market share declined 40bps to 35.3% compared with the prior year period, as sales decreased 3.2% to USD116.9mn. The company's previous favourable market share has suffered progressive erosion since Q411 due to product introductions from its competitors, in particular Medtronic's Resolute Integrity and Abbott's Xience Alpine.

Abbott also saw its market share decline by 350 bps to 35.2% in Q414 as revenue declined 15.3% to USD116.7mn compared with Q413. This was due in part to Medtronic's market share gains as the company generated USD97.6mn revenue, equivalent to a 14.7% increase compared with Q414. This equated to an increase in market share from 24.6% to 29.5%. Medtronic's capacity to bulk sell appears critical as the company continues to place downward pressures on its competitors.

Downward Pricing Pressures To Continue

Whilst the DES market in the US has been moderately flat in recent years with little upward momentum, BMI forecasts this to alter, as pricing pressures continue. Since Q113, the average price of a DES has declined 9.6% to USD1,400, according to estimates from Bloomberg, with most companies pricing similarly. The rising purchasing power of healthcare institutions is key to this downward trend in price.

Continued on page 3...

Issue No. 290February 2015Pricing Pressures Will Catalyse Drug-Eluting

Stent Market

Omar El SaidiEditor

enquiries@espicom.com

Editor Omar El Saidi

Managing Editor Sophie Bracken

Conditions of Sale• Cardiovascular Device Business must not be reproduced, abstracted, stored in a

retrieval system or transmitted in any form or by any means without the written

permission of the publisher.

• Cardiovascular Device Business must not be circulated to staff outside the address to

which it is sent.

ISSN 1471-0110©Espicom Business Intelligence. All rights reserved.

HighlightsMedical Devices Throne Awaits Medtronic Page 5

Volcano Benefits Playing Out Early For Philips Page 6

Optimistic Outlook For St Jude Despite FY14 Pressures Page 10

Medtronic Gains DES Market ShareDES Market Share By Company

Source: Bloomberg

0

5

10

15

20

25

30

35

40

45

Abbott Vascular Boston Scientific Medtronic

% U

S D

ES

Mar

ket S

har

e

Q413 Q414

- 450 bps - 40 bps

+ 490 bps

utoimmunewww.esp

icom.com

Drug FocusA

New ADF Cover.indd 1-2

27/03/2009 15:51:45

Issue No. 123February 2015

Hyperion Deal Will End DiaPep277 Controversy

Editor

Ian Platts

Managing EditorLucy Vann

Conditions of Sale

• Autoimmune Drug Focus must not be reproduced, abstracted, stored in

a retrieval system or transmitted in any form or by any means without the

written permission of the publisher.

• Autoimmune Drug Focus must not be circulated to staff outside the address

to which it is sent.

ISSN 1746-1243

©Espicom Business Intelligence. All rights reserved.

BMI View: Hyperion Therapeutics is making the best of a bad situation; this agreement allows all of the involved parties to draw a line

under events and move on. Hyperion will need to pick itself up from the Andromeda acquisition and not be daunted by its experience when

considering other potential deals. The fallout also ends what could have been a promising new product; however, new possibilities may yet

emerge from the ashes for another company.

Hyperion Therapeutics has amicably resolved its disputes and entered into a completion of Phase III trial, option and mutual

release agreement with Clal Biotechnology Industries (CBI) and Yeda Research and Development. The agreement is with

regard to DiaPep277, a Type I diabetes product candidate developed by Andromeda Biotech, a company Hyperion acquired from

CBI in June 2014.

As announced in September 2014, Hyperion will complete the ongoing DIA-AID 2 Phase III trial of DiaPep277 to treat new onset

Type I diabetes, but will not take DiaPep277 forward beyond completion of the DIA-AID 2 trial. Hyperion's estimated budget for

completion of the DIA-AID 2 trial remains unchanged at USD10.5mn. Subject to agreed restrictions, a steering committee consisting

of representatives from CBI, Yeda and Hyperion will oversee and direct the completion of the trial, the analysis of its results and

interactions with regulatory authorities.

CBI will have an option to acquire Andromeda, with the option expiring on September 30 2015. CBI will pay a non-refundable option

payment of USD2.5mn at signing, payable in shares of Hyperion stock currently held by CBI. Hyperion intends to use the option

payment to offset any potential increases to the DIA-AID 2 trial budget incurred at the steering committee's direction. Any increases

in this budget beyond USD2.5mn, if incurred at the steering committee's direction, will be reimbursed by CBI. If CBI does exercise its

option, it will pay an option exercise price of USD3.5mn, payable in shares of Hyperion stock currently held by CBI.

If CBI's option is exercised, Andromeda will be obligated to pay Hyperion future contingent payments if and to the extent that it

or its shareholders receive revenues or certain other proceeds, which are capped at USD36.5mn. This amount, along with the

option exercise price that Hyperion may receive, approximates the total amount Hyperion will have invested in Andromeda by the

option exercise date. However, if CBI does not exercise its option, the agreement will see DiaPep277's intellectual property rights

revert to Yeda. Mutual releases of DiaPep277-related claims were exchanged amongst Hyperion, Andromeda, CBI, Yeda and Teva

Pharmaceutical Industries.

Andromeda has also entered into a release agreement with Evotec International, pursuant to which Andromeda has settled its

disputes with Evotec regarding Evotec's assertions that Hyperion's acquisition of Andromeda triggered a EUR3.38mn milestone

payment to it and that it suffered harm from the unravelled situation in relation to DiaPep277. Under the terms of this release, Evotec

is releasing its claims against Andromeda in exchange for a USD500,000 payment from Andromeda.

Continued on page 3...

Highlights

Afrezza’s US Launch Will Test Appetite For New Insulin Delivery Systems

Page 4

Blisibimod On Course To Enter Niche Lupus Arena

Page 15

Salix Acquisition Will Give Valeant A Toehold In Autoimmune Arena

Page 22

Ian Platts

Editor

Pharma_Editorial@espicom.com

www.esp

icom.com

C ancerDrug News

New CDN Cover.indd 1-2

18/02/2009 09:41:14

BMI View: The current definition of an orphan disease cannot be sustained. Personalisation of medicine has led to an increasing number of

diseases being classified as orphan. Oncology and big pharma have dominated the orphan drug market, leaving rare hereditary diseases

lacking treatments. A rethink of orphan medicine will be needed to focus on treatments for rare diseases that do not have the potential to

become blockbusters.Orphan drugs are increasing in popularity among drug developers. This could in part be down to the incentives to develop such

a drug. These include tax credits for qualified clinical testing and extended exclusivity. In addition, a marketing application for a

prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application

includes an indication for other than the rare disease or condition for which the drug was designated.

2014 was a record year for the FDA handing out orphan drug designations (ODDs), and in total, 286 ODDs were granted. The FDA is

not alone in handing out this status, as the EMA gave 172 designations in 2014. However, some drugs have gained numerous ODDs

for different indications. The number of ODDs has risen substantially since 2000, when only 70 were handed out. So far in 2015, 62

ODDs have been granted, and this could lead to another record year in 2015.

The FDA Office of Orphan Products Development (OOPD) pro-

gramme has enabled the development and marketing of more than

400 drugs and biologic products for rare diseases since 1983. In

contrast, fewer than 10 such products supported by industry came

to market between 1973 and 1983. In 2000, a total of 13 drugs with

ODDs were approved by the FDA, and by 2014 this had risen to 40.

It is worth noting that of these, in 2000, three were cancer drugs ap-

proved, and in 2014, 19 were cancer drugs. Hereditary diseases gain

the most designations; however, cancer treatments have the high-

est approval rate. The ODD programme provides orphan status to drugs and

biologics which are defined as those intended for the safe and

effective treatment, diagnosis or prevention of rare diseases/

disorders that affect fewer than 200,000 people in the US, or that

affect more than 200,000 persons but are not expected to recover

the costs of developing and marketing a treatment. The EMA notes

that rare diseases are life-threatening or chronically debilitating

conditions affecting no more than five in 10,000 people in the EU,

equal to fewer than 250,000 people.

Continued on page 3...HighlightsAlvocidib ODD Highlights Increasing Interest In AML

Page 6

Opdivo Set To Become First PD-1 Inhibitor On NSCLC Market Ahead Of Keytruda

Page 8

Pharmacyclics Seeking Potential Suitors

Page 15

Issue No. 622

March 4 2015

Targeted Medicine Increasing Orphan Diseases

Editors

Jessica Wilkinson, Laura Attwood

Managing EditorLucy Vann

Conditions of Sale

• Cancer Drug News must not be reproduced, abstracted, stored in a retrieval

system or transmitted in any form or by any means without the written

permission of the publisher.

• Cancer Drug News must not be circulated to staff outside the address to

which it is sent.

Laura AttwoodEditor

pharma_editorial@espicom.comISSN 1369-7129

©Business Monitor International Ltd. All rights reserved.

Personalisation Of Medicine Leads To Increase In ODDs

Number Of ODDs Granted Versus Orphan Drugs Approved

Source: FDA, BMI.

0

50

100

150

200

250

300

350

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

Orphan Drug Designations

Orphan Drugs Approved فدی

ر

دوره زمانی عنوانانتشار

قیمت فایل انگلیسی )دالر(

1Cardiometabolic Drug News1,095ماهانه

2Americas Pharma & Healthcare Insight1,095موردی

3World Generic Markets1,095دو هفتگی

4CNS Drug News1,095دو هفتگی

5Drug Delivery Insight1,095دو هفتگی

6Cancer Drug News1,095هفتگی

7Key Pharma News1,395دو هفتگی

8Autoimmune Drug Focus1,095ماهانه

9Anti-Infective Drug News 1,095دو هفتگی

10Respiratory Therapy News1,095ماهانه

11Biosimilars Business Review1,095موردی

12Medical Industry Week 1,095هفتگی

13Orthopaedics Business News1,095ماهانه

14Cardiovascular Device Business1,095ماهانه

15Diagnostics Focus1,095دو هفتگی

Cordis

Medical Device Companies Analysis

October 2014

World Leaders in Health Industry AnalysisA Business Monitor International Company

Advances in the Rheumatoid Arthritis

MarketJanuary 2014 Pharma

www.esp

icom.com

NewsKey

New KPN Cover.indd 1-2 29/01/2014 09:28:43

BMI View: The current definition of an orphan disease cannot be sustained. Personalisation of medicine has led to an increasing number of diseases being classified as orphan. Oncology and big pharma have dominated the orphan drug market, leaving rare hereditary diseases lacking treatments. A rethink of orphan medicine will be needed to focus on treatments for rare diseases that do not have the potential to become blockbusters.

Orphan drugs are increasing in popularity among drug developers. This could in part be down to the incentives to develop such a drug. These include tax credits for qualified clinical testing and extended exclusivity. In addition, a marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

2014 was a record year for the FDA handing out orphan drug designations (ODDs), and in total, 286 ODDs were granted. The FDA is not alone in handing out this status, as the EMA gave 172 designations in 2014. However, some drugs have gained numerous ODDs for different indications. The number of ODDs has risen substantially since 2000, when only 70 were handed out. So far in 2015, 62 ODDs have been granted, and this could lead to another record year in 2015.

The FDA Office of Orphan Products Development (OOPD) pro-gramme has enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983. In 2000, a total of 13 drugs with ODDs were approved by the FDA, and by 2014 this had risen to 40. It is worth noting that of these, in 2000, three were cancer drugs approved, and in 2014, 19 were cancer drugs. Hereditary diseases gain the most designations; however, cancer treatments have the highest approval rate.

The ODD programme provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment. The EMA notes that rare diseases are life-threatening or chronically debilitating conditions affecting no more than five in 10,000

people in the EU, equal to fewer than 250,000 people. Most of these people suffer from diseases affecting less than one in 100,000 people. Between 5,000 and 8,000 distinct rare diseases exist, affecting between 6% and 8% of the population in total, equating to between 27mn and 36mn people in the EU. A total of 80% of rare diseases have identified genetic origins, and affect between 3% and 4% of births. Other rare diseases are due to degenerative and proliferative causes.

Continued on page 3...

Issue No. 27March 2 2015

Targeted Medicine Increasing Orphan Diseases

Managing Editor Lucy VannConditions of Sale

• Key Pharma News must not be reproduced, abstracted, stored in a retrieval system or transmitted in any form or by any means without the written permission of the publisher.

• Key Pharma News must not be circulated to staff outside the address to which it is sent.

ISSN 2054-8788©Business Monitor International Ltd. All rights reserved.

Personalisation Of Medicine Leads To Increase In ODDs Number Of ODDs Granted Versus Orphan Drugs Approved

Source: FDA, BMI.

0

50

100

150

200

250

300

350

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

Orphan Drug Designations

Orphan Drugs Approved

World Leaders in Health Industry Analysis

Cancer Blockbusters to 2016The prospects and challenges for 21 US$1 billion oncology products

WORLD GENERICMARKETSw

ww.esp

icom.com

WGM Cover.indd 1-2 06/07/2009 10:10:56

Editor Ian Platts

Managing Editor Lucy Vann

If you have any comments, observations or suggestions, email the editor at:

ian_platts@espicom com

Conditions of Sale•WGM must not be reproduced, abstracted, stored in a retrieval system or transmitted in any form or means without the written permission of the publisher.•WGM must not be circulated to staff outside the address to which it is sent. •An order for additional copies at the same address at reduced rates constitutes an undertaking by the subscriber that such copies will not be distributed so as to avoid taking full price subscriptions elsewhere without the agreement of the publisher.

ISSN 1475-0856 ©Business Monitor International Ltd. All rights reserved.

Volume 14 Number 12 March 6 2015

Highlights...AmericasPatent Ruling Edges Pulmicort Respules Toward Lifecycle End

BMI View: Whilst this latest ruling is unlikely to be the final word, it moves Pulmicort Repsules further toward its product lifecycle end; generic Pulmicort competition will now begin in earnest. AstraZeneca has sought to reinforce its respiratory, inflammation and autoimmunity portfolio...

Continued on page 8____________________

EuropeActavis’ Future Dominated By Brands, But Generics Remain Important

BMI View: Via its merger with Watson Laboratories and subsequent branded expansion, Actavis has come a long way from its Icelandic roots. FY14 represented a tipping point for Actavis with branded revenues overtaking generics for the first time...

Continued on page 14____________________

Asia/PacificComplex Sofosbuvir Relationship Favours Mylan

BMI View: Against the backdrop of licensing agreements in India, Mylan’s opposition to the European sofosbuvir patent paints a complex but potentially advantageous situation...

Continued on page 17____________________

Africa/Middle EastTeva Commences USD1bn Debt Tender Offer

Teva Pharmaceutical Industries has commenced tender offers to purchase for cash for a combined aggregate purchase price of up to USD1bn of the following series of notes issued by finance subsidiaries of Teva and guaranteed by Teva...

Continued on page 19____________________

Editor's NoteRoche Most At Risk From Upcoming Biosimilar Oncology Market

BMI View: Whilst the biosimilar market is still very much in its infancy, biosimilar oncology products represent a lucrative new frontier. No biosimilar oncology products have yet been filed for approval in Western markets, and it remains unclear when there will be any applications. Some companies have already made inroads in less well regulated markets, although these products will require further testing to be acceptable in the US or EU. The potential biosimilar oncology market represents a particular threat for Roche, with a lot of its oncology biologics facing publicly announced biosimilar development programmes.

The biosimilar market is still very much in its infancy. A regulatory pathway now exists in Europe and the US, but in the latter case no biosimilars have yet been approved and only a handful have so far been filed, all since the summer of 2014. The situation in Europe is more advanced, with some biosimilars having now been successfully approved and launched. Although biosimilar versions of biologics indicated to treat conditions arising from therapies such as chemotherapy have been filed in both Europe and the US, these are not strictly oncology products. As yet no biosimilar versions of biologics indicated to treat various forms of cancer have been either filed or approved.

Continued on page 2...

www.esp

icom.com

CnsDrug News

New CNS Cover.indd 1-2 26/01/2009 14:26:10

HighlightsXadago’s Approval Will Not Address Need For Disease-Modifying Parkinson’s Drugs Page 3

Teva Takes Leading Position With Anti-CGRP For Migraine Page 7

Targeted Medicine Increasing Orphan Diseases Page 12

Issue No. 349March 5 2015

BMI View: Dementia is a growing problem with an unmet medical need, but further funding and research is needed. Governments will pay this issue increasing attention; incentives will be a way to counteract the specific challenges faced by pharmaceutical companies.

Britain is to expand its efforts to combat dementia over the next five years, according to Prime Minister David Cameron, who has set out a new, long-term strategy focused on boosting research, improving care and raising public awareness about the condition. The Prime Minister's Challenge on Dementia 2020 is the next phase in the country's effort to combat the condition and includes over GBP300mn (USD463.1mn) invested in UK research, a new global fund on dementia, 1mn NHS staff trained, 3mn more 'Dementia Friends', and faster assessments.

This comes shortly after Alzheimer's Research UK announced a GBP30mn (USD46.3mn) Drug Discovery Alliance, launching three flagship Drug Discovery Institutes at the University of Cambridge, University of Oxford and University College London. The Institutes will see 90 new research scientists employed in state-of-the-art facilities to fast-track the development of new treatments for Alzheimer's disease and other dementias. It also comes after the World Innovation Summit for Health (WISH) published a report set to tackle the global rise in dementia and identify triggers for treatment, care and funding.

An Unmet Medical Need With Growing Numbers And Cost Of Care

Types of dementia include Alzheimer's disease, which accounts for 50-70% of all cases, vascular dementia, and less common forms such as frontotemporal dementia and Parkinson's disease dementia. As yet there is no cure for any dementia due to neurodegeneration. Treatments may delay the progression of symptoms for a short time but do not address the underlying cause of the disease. Finding a cure is a major challenge because it is believed that by the time symptoms appear, significant neuronal loss has already occurred, highlighting the importance of early diagnosis. Indeed, there is currently a focus on mild Alzheimer's disease, with it thought that drugs' efficacy could be improved by giving them earlier in the course of the disease.

Dementia is a growing problem. In ten years it is expected there will be 1mn people living with dementia in the UK. In 2013, approximately 44mn people around the globe were living with some form of dementia. This number is projected to almost double every 20 years, to 76mn in 2030 and to 135mn by 2050, according to Alzheimer's Disease International's 2013 World Alzheimer's Report. Meanwhile, the cost to healthcare is huge, with dementia now one of the greatest pressures on healthcare systems around the world. The cost of care reached an estimated USD604bn worldwide in 2010, equivalent to 1% of global GDP, and costs are expected to exceed USD1trn annually in the US alone by 2050.

Continued on page 3...

UK Government To Invest In Dementia Research

Lucy VannEditor

Pharma_Editorial@espicom.com

Managing Editor Lucy VannConditions of Sale

• CNS Drug News must not be reproduced, abstracted, stored in a retrieval system or transmitted in any form or by any means without the written permission of the publisher.

• CNS Drug News must not be circulated to staff outside the address to which it is sent.

ISSN 1462-656X©Business Monitor International Ltd. All rights reserved.

Rising Burden Of Alzheimer’s And Other Dementias DALYs Lost In Selected Markets

Sources: National Sources/BMI

China - Alzheimer's disease and other dementias, DALYsUnited Kingdom - Alzheimer's disease and other dementias, DALYsUnited States - Alzheimer's disease and other dementias, DALYs

2012 2013 2014 2015 2016 2017 2018 2019 2020

0

1,000,000

2,000,000

3,000,000

4,000,000

www.esp

icom.com edicalMIndustry Week

New MIW Cover.indd 1-2

21/05/2009 11:02:00

HighlightsKenya’s Market Dynamics Favour Foreign Device Manufacturers

Page 3

Women’s Health Business Discontinuation Likely For EndoPage 6

NICE Recommendation Likely For Europe’s First Stem Cell TherapyPage 13

Issue No. 745March 5 2015

BMI View: Further pricing regulation of medical devices will serve Colombia's health system well in the long term, given that the control

of coronary stent prices has the capacity to save upwards of USD5mn annually. Savings can be channelled into modernising the country's

healthcare infrastructure and improving inadequate staffing and hospital bed resources.

On March 5, Colombia's government will begin to regulate the price of certain medical devices within the country, including

coronary stents, cochlear implants, and orthopaedic implants, in an effort to control excessive price mark ups from manufacturers

and suppliers. BMI believes that this measure is part of governmental efforts to guarantee the sustainability of the healthcare

system. Pharmaceutical prices have been strongly regulated in recent years; the Ministry of Health and Social Protection (MinSalud,

Ministerio de Salud y Protección Social)'s extension to medical devices is a logical progression.

A pilot test to assess medical device prices in the country was launched in October 2014, focusing on the price of coronary stents.

MinSalud noted that payments for coronary stents from Fondo de Solidaridad y Garantía (FOSYGA), a public solidarity fund that

covers Colombian health expenses, amounted to COP20,000mn (USD10.7mn) in 2013, which was equivalent to the cost of the most

expensive medicine in Colombia prior to the regulation of pharmaceuticals, eculizumab.

The pilot found that in Colombia, coronary stents cost an average

of COP5,000mn (USD2,007), and an upper limit of COP6,500mn

(USD2,609) while in Canada, the price is around COP2,337mn

(USD938); COP2,466mn (USD990) in Chile; COP2,959mn (USD1,188)

in Spain; and COP2,9902mn (USD1,200) in Uruguay. On average,

this equated to around a 40% mark-up compared with other

nations.

Robust governance, transparency, public consultation and trust are

key to ensure the development of a fairer pricing regulation frame-

work for medical devices in the country. From March 5, the price

of coronary stents will be regulated to not exceed COP3,200mn

(USD1,248), representing a reduction of 36% from the current aver-

age price. This equates to a saving of approximately COP14,000mn

(USD5.6mn) annually for the Colombian health system, given the

volume of around 2,000 annual procedures requiring coronary st-

ents.

Continued on page 3...

Device Price Caps To Save Colombia

Unnecessary Healthcare Costs

Sophie BrackenEditor

enquiries@espicom.com

Contributing Editors: Omar El Saidi/Sophie Bracken

Managing Editor Sophie Bracken

Conditions of Sale

• Medical Industry Week must not be reproduced, abstracted, stored in a retrieval

system or transmitted in any form or by any means without the written permission of

the publisher.

• Medical Industry Week must not be circulated to staff outside the address to which it

is sent.ISSN 1462-8716

©Business Monitor International Ltd. All rights reserved.

Colombia Paying Over The Odds

Disparity Of Coronary Stent Prices In Five Nations (USD)

Source: Ministerio de Salud y Protección Social0 500 1,000 1,500 2,000 2,500 3,000

Canada

Chile

Spain

Uruguay

Colombia

www.esp

icom.com

espiratoryRTherapy News

RTN Cover.indd 1-2

19/03/2014 15:35:55

Issue No. 12

February 2015

BMI View: AstraZeneca's latest addition to its respiratory portfolio will be accretive to its long-term ambitions, despite downbeat investor

sentiment. In particular, Duaklir Genuair will enable the company to fortify its market position.

Actavis and AstraZeneca have entered into a definitive agreement under which the former will divest the rights to its branded

respiratory business in the US and Canada. The initial consideration will be for USD600mn on competition and will exclude low

single-digit royalties above a pre-specified revenue threshold.

Upon the transaction's completion, AstraZeneca will own the development and commercial rights in the aforementioned territories

to Tudorza Pressair (aclidinum bromide), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary

disease (COPD); and Daliresp (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD.

Actavis will also receive an additional USD100mn from AstraZeneca, and has agreed to a multitude of contractual consents and

approvals, including certain amendments to the ongoing collaboration agreements between the two companies.

Growing US COPD Burden According to the World Health Organization (WHO), 64mn

patients are diagnosed with moderate-to-severe COPD globally

(12.7mn in the US), resulting in up to 3mn deaths annually. BMI

forecasts the burden of COPD to increase in the US from 1.64mn

to 1.74mn disability-adjusted life years (DALYs) between 2013

and 2030. Unhealthy lifestyle habits such as smoking, and an

ageing population giving way to a higher burden of chronic

diseases, continue to drive this trend. Canada will also experience

an increase from 87,897 to 93,762 DALYs over the same period,

although the burden is far less compared with the US due to the

former's lower population. Consequently, this rising burden of

disease will continue to facilitate growth of the North American

respiratory market, providing opportunities for revenue gains as

demand increases.AstraZeneca Bolsteing Respiratory Commitment

In November 2014, AstraZeneca acquired Almirall's respiratory business unit [1], which included the European commercialisation

rights to the fixed-dose LABA/LAMA Duaklir Genuair (aclidinium/formoterol). Moreover, and critical to AstraZeneca's long-term

ambitions within the respiratory setting, the company will acquire the development rights for Duaklir Genuair in the US and Canada

as part of the Actavis agreement, where it is being developed under the name LAS40464.

The emergence in the use of LABA/LAMA combination therapies has been driven by extensive clinical data that has demonstrated

their superiority in improving respiratory lung function and reducing COPD exasperations when compared with the conventional

standard use of LABA/inhaled corticosteroid, such as GlaxoSmithKline's Seretide Accuhaler (salmeterol/fluticasone), which

generated USD8.31bn in revenue in 2013.Continued on page 3...

AstraZeneca Further Bolsters Respiratory

Portfolio

Managing EditorLucy Vann

Conditions of Sale

• Respiratory Therapy News must not be reproduced, abstracted, stored in a retrieval

system or transmitted in any form or by any means without the written permission of

the publisher. • Respiratory Therapy News must not be circulated to staff outside the address to which

it is sent.

ISSN 2054-880X ©Espicom Business Intelligence. All rights reserved.

Growing COPD BurdenCOPD Burden in the US and Canada, 2013-2030

Source: WHO, BMI

www.esp

icom.com

rthopaedicsBusinessO

New OBN Cover.indd 1-2

15/09/2009 14:18:29

HighlightsMedical Devices Throne Awaits Medtronic

Page 4

Biomet Will Help Zimmer Weather Economic Headwinds

Page 5

Medtronic Expected To Round Off FY2015 With Covidien Gains

Page 6

Issue No. 177

February 2015

BMI View: Further transactions will take place intended to diversify orthopaedics manufacturers' portfolios across the continuum of care.

To maintain market share and achieve growth targets in the US and other developed markets, orthopaedics manufacturers must continue

to answer the needs of the market by offering innovative, convenient, bundled offerings that serve all aspects of the operating room.

DePuy Synthes (Johnson & Johnson) has become the latest orthopaedics company to diversify its product line, in an effort to

provide expanded portfolio catering to the needs of the operating room. DePuy Synthes has acquired Olive Medical, a Sandy,

UT-based privately held provider of HD visualisation systems for minimally invasive surgery. Olive now operates as a subsidiary of

DePuy Synthes. Founded in 2009, Olive provides affordable HD MIS imaging

equipment to the operating room and physician offices. The

company has 20 employees and its visualisation technology

has been sold in 20 countries throughout the world. Olive's

portfolio enhances the DePuy Synthes Mitek Sports Medicine

arthroscopy line and will enable DePuy Synthes to enter the

arthroscopic visualisation market to serve patients with shoulder,

knee, hip, and small joint pain or injury. This will afford DePuy

Synthes an expansion of its offerings in this market segment,

which is poised for strong growth on the back of increased

demand for arthroscopic procedures and sports medicine repair

surgeries. More poignantly, Olive Medical increases DePuy Synthes' pres-

ence in the operating room, expanding the latter's suite of surgical

products and technologies, yet remaining complementary to the

company's core product lines. This is a tactic being employed by

numerous DePuy Synthes rivals, as demonstrated by the following

recent acquisitions:• Stryker's diversification into hospital and surgical equipment: CHG Hospital Beds (low-height hospital beds and accessories);

Berchtold Holding (surgical infrastructure equipment); Patient Safety Technologies (Safety Sponge system); and Mako

Surgical (robotic-assisted surgery).

• Medtronic: Covidien (substantial hospital product portfolio); NGC Medical (cardiovascular suites, operating rooms and

intensive care unit management).

Continued on page 3...

OrthopaedicsManufacturersExpanding

PresenceInTheOperatingRoom

Sophie BrackenEditor

enquiries@espicom.com

Managing EditorSophie Bracken

Conditions of Sale

• Orthopaedics Business News must not be reproduced, abstracted, stored in a retrieval

system or transmitted in any form or by any means without the written permission of

the publisher. • Orthopaedics Business News must not be circulated to staff outside the address to

which it is sent.

ISSN 1474 - 3426

©Espicom Business Intelligence. All rights reserved.

Significant Opportunities In Sports Medicine Arthroscopy

Global Sports Medicine Market Forecast (USDbn)

Source: Smith & Nephew

Other16%

Mechanical Resection12%

RF Resection8%

Access11%

Video7%

Knees20%

Hips2%

Shoulders24%

Global Market: ~6bn

Joint Repair 7-13% Market Growth

Arthroscopy3-6% MarketGrowth

World Leaders in Health Industry Analysis

The Indian Pharmaceutical

Industry:

Coming of Age in a Global Market

Boston Scientific

Medical Device Companies Analysis

October 2014

www.esp

icom.com iagnostics

FocusD

New DF Cover.indd 1-2

20/02/2009 10:50:56EditorLaura Attwood

Managing EditorSophie Bracken

Conditions of Sale

• Diagnostics Focus must not be reproduced, abstracted, stored in a retrieval system

or transmitted in any form or by any means without the written permission of the

publisher.

• Diagnostics Focus must not be circulated to staff outside the address to which it is sent.

ISSN 1751-5440

©Espicom Business Intelligence. All rights reserved.

BMI View: Precision medicine has the potential to create healthcare savings by ensuring the correct treatment is administered and

avoiding the treatment-resistance that is becoming increasingly commonplace. The seemingly small investment in the Precision

Medicine Initiative will create wider access to genomic data, potentially leading to increasing discoveries of treatable targets in the

oncology field, and the ability to overcome treatment-resistance mechanisms.

President Obama has unveiled details about the launch of a Precision Medicine Initiative, a new research effort to revolutionise

how to improve health and treat disease. The Initiative was launched with a USD215mn investment in the President's 2016

Budget request, and will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries

and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

Most medical treatments have been designed for the 'average patient'. As a result of this 'one-size-fits-all' approach, treatments

can be very successful for some patients but not for others. This is changing with the emergence of precision medicine, an

approach to disease prevention and treatment that takes into account individual differences in people's genes, environments

and lifestyles. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient's

health, disease, or condition, and to better predict which treatments will be most effective.

Advances in precision medicine have already led to new discoveries and several new treatments that are tailored to specific

characteristics of individuals, such as a person's genetic makeup, or the genetic profile of an individual's tumour. This is leading

to a transformation in the way we can treat diseases such as cancer. Patients with breast, lung and colorectal cancers, as well as

melanomas and leukaemias, for instance, routinely undergo molecular testing as part of patient care, enabling physicians to

select treatments that improve chances of survival and reduce exposure to adverse effects.

The potential for precision medicine to improve care and speed the development of new treatments has only just begun

to be tapped. Translating initial successes to a larger scale will require a co-ordinated and sustained national effort. Through

collaborative public and private efforts, the Precision Medicine Initiative will leverage advances in genomics, emerging

methods for managing and analysing large data sets while protecting privacy, and health information technology to

accelerate biomedical discoveries. The Initiative will also engage a million or more Americans to volunteer to contribute their

health data to improve health outcomes, fuel the development of new treatments, and catalyse a new era of data-based

and more precise medical treatment.

Continued on page 3...

The next issue of Diagnostics Focus will be published on March 12 2015

Highlights

Comprehensive Cancer Test Will Lessen Impact Of BRCA Defeat

Page 8

Diagnostics Will Support Roche’s Oncology Sales

Page 9

Low Cost CRC Blood Test Developed

Page 18

Issue No. 216February 12 2015

PrecisionMedicine

InitiativePromotesDa

ta-

DrivenTreatment

Laura Attwood

Editor

enquiries@espicom.com

www.bizreport.ir

World Leaders in Health Industry Analysis

A Business Monitor International Company

Inhalation & Nasal Spray Generic Drugs: Potential Opportunities in the Respiratory Market

در همین راستا تالش چند ساله کانون نهادهای سرمایه گذاری ایران به انتشار گزارش های تحلیلی در صنایع مختلف از جمله صنعت دارو و تجهیزات پزشکی انجامیده است که یکی از نقش آفرینان و عناصر اصلی

اقتصاد در ایران محسوب می شود.

جزئیات گزارش های مورد اشاره: قلمرو موضوعی: بهداشت، درمان، دارو، تجهیزات پزشکی و ...

سطوح مورد بررسی: شرکت، کشور، منطقه، جهان بازه زمانی پیش بینی: 5 تا 10 سال آینده

بازه زمانی انتشار: فصلی، ماهانه، دو هفتگی، هفتگی، موردی فرمت قابل تحویل: فایل پی.دی.اف به زبان انگلیسی، نسخه چاپ

شده به زبان فارسی و ... قیمت هــای اعالمی در جداول این بروشــور، نرخ های مندرج در ســایت اصلی مرجع گزارش می باشد و تهیه گزارش از گروه تحقیقات بین المللی بیزریپورت، با توجه به تعداد گزارش درخواستی و . . . مشمول

تخفیف و شرایط ویژه ای خواهد شد.

الف( گزارش های مربوط به ایران

ب( پایگاه داده شرکت های چندملیتی:این پایگاه داده حاوی اطالعات به روز 1,270 شــرکت چندملیتی و معتبر آفریقایی، آســیایی، آمریکایی، اروپایی، خاورمیانه و شرکت های کلیدی داخلی در ایران است که اطالعات بسیار مفیدی را جهت تأمین امنیت مشتریان جدید، شــرکا و یا تأمین کنندگان مواد اولیه، همچنین

ارزیابی، الگوبرداری تطبیقی و ردیابی رقبا ارائه می نماید.

فدی

ر

قیمت فایل عنوانانگلیسی )دالر(

1Iran Pharmaceuticals & Healthcare Report 1,295

2Iran Medical Devices Report 1,295

3Middle East & Africa Pharma & Healthcare Insight 895

فدی

رقیمت فایل عنوان

انگلیسی )دالر(

1Multinational Companies in Iran Online Database 1,110

د( گزارش های ویژه

DePuy SynthesMedical Device Companies Analysis

November 2014

AnalogicMedical Device Companies Analysis

June 2014

World Leaders in Health Industry AnalysisA Business Monitor International Company

Trends and Opportunities in the Diabetes Care Market

January 2014

آفریقا: الجزایر، آنگوال، بوتسوانا، کامرون، ساحل عاج، مصر، گابن، غنا، کنیا، موریس، تانزانیا، افریقای جنوبی، سودان جنوبی، سودان، نیجریه، نامیبیا، موزامبیک، موراکو،

اوگاندا، زامبیا، زیمبابوه آسیا: استرالیا، بنگالدش، برونئی، کامبوج، چین، هنگ کنگ، هند، اندونزی، ژاپن، الئوس، مالزی، میانمار، نیوزیلند، پاکستان، فیلیپین، سنگاپور، کره جنوبی، سریالنکا،

تایوان، تایلند، ویتنام کارائیب: بلیز، کاستاریکا، کوبا، هندوراس، پورتوریکو

دانمارک، چک، جمهوری کرواسی، بلغارستان، بلژیک، بالروس، اتریش، اروپا: استونی، فنالند، فرانسه، آلمان، یونان، مجارستان، ایرلند، ایتالیا، قزاقستان، لتونی، لیتوانی، اسلونی، اسلواکی، پرتغال، رومانی، روسیه، صربستان، لهستان، نروژ، مولداوی، هلند،

اسپانیا، سوئد، سوییس، ترکیه، اکراین، انگلستان، ازبکستانمکزیک، گواتماال، السالوادور، کلمبیا، شیلی، برزیل، آرژانتین، التین: امریکای

نیکاراگوئه، پاناما، پرو، ونزوئال خاورمیانه: بحرین، ایران، عراق، رژیم صهیونیستی، اردن، کویت، لبنان، عمان، قطر،

عربستان سعودی، امارات متحده عربی امریکای شمالی: کانادا، ایاالت متحده امریکا

در صــورت نیاز به متن ترجمه شــده فارســی، درخواست خود را به صورت مکتوب ارائه نمایید.

جهت کسب اطالعات بیشتر می توانید با شماره www.bizreport.irتلفن88349112 تماس حاصل نمایید.

هـ( گزارش های دارویی و تجهیزات پزشکی سایر کشورهابا توجه به اهداف صادراتــی، وارداتی و نیز تعامالت بین المللی بین شرکت های ایرانی و همپیشگان خارجی، بهره مندی از اطالعات تحلیلی صنعت دارو و تجهیزات پزشــکی سایر کشورها نیز از اهمیت به سزایی برخوردار است. لذا لیست کشورهایی که گزارش آن ها قابل ارائه است،

در ادامه می آید.

27The Indian Pharmaceutical Industry: New strategies in a changing world 1,390

28Generic Drugs: Global Collaboration Opportunities 1,250

29The Worldwide Guide to PharmaceuticalPricing & Reimbursement 2014 1,110

30Advances in the Biologics Market 2014 995

31Recent Developments in the CNS Drugs Market 995

32The World Prescription Drug Market Report 995

33World Generic Market Report 2014Volume II: National Markets 995

34The CNS Pipeline Fact Book: Whats in Clinical Development? 690

3510 Hidden Risks To The Global Economy 580

362014 Pharmaceutical & Healthcare Industry Trends 580

37AEC: Assessing The Regional Impact 580

38Blockbusters Of The Future:The Most Promising New Pharmaceuticals 580

39Cuba’s Next Revolution: Emerging from Decades Of Isolation 580

40Eurozone Debt Crisis:Effects on PIIGS Pharmaceuticals Market 580

41Molybdenum-99: Privatising Nuclear Medicine 580

42Pharmaceutical Pricing: Dynamics In A Global Market 580

43Pharmaceuticals & Healthcare Q214 Round-Up 580

44Telecare: Bringing Healthcare To The Next Billion 580

45The 2014 Outlook For The Pharmaceutical Industry:A Regional Focus 580

46The Opportunities Of African Healthcare:What China’s Entry Means For Multinationals 580

47US Regulatory Trends During 2010:A Rapidly Changing Environment 580

www.esp

icom.com

ardiovascularDevice Business

C

New CVDB Cover.indd 1-2

06/07/2009 10:12:17

BMI View: The US drug-eluting stent market will garner favourable upward momentum, contrary to recent years, as pricing pressures

increase. The rising burden from cardiovascular disease, enhanced public access to healthcare, and competition from new market entrants

will lure medium-term demand.

Medtronic has gained significant market share from competitors within the US drug-eluting stent (DES) market, according to data

from Bloomberg. In Q414 (calendar period ended December 31 2014), revenue from DES sales in the US exceeded USD330mn, with

Medtronic, Abbott Vascular (Abbott Laboratories) and Boston Scientific yielding an overwhelming majority share.

In Q414, Boston Scientific's DES market share declined 40bps to 35.3% compared with the prior year period, as sales decreased

3.2% to USD116.9mn. The company's previous favourable market share has suffered progressive erosion since Q411 due to product

introductions from its competitors, in particular Medtronic's Resolute Integrity and Abbott's Xience Alpine.

Abbott also saw its market share decline by 350 bps to 35.2% in

Q414 as revenue declined 15.3% to USD116.7mn compared with

Q413. This was due in part to Medtronic's market share gains as

the company generated USD97.6mn revenue, equivalent to a

14.7% increase compared with Q414. This equated to an increase

in market share from 24.6% to 29.5%. Medtronic's capacity to bulk

sell appears critical as the company continues to place downward

pressures on its competitors.

Downward Pricing Pressures To Continue

Whilst the DES market in the US has been moderately flat in

recent years with little upward momentum, BMI forecasts this to

alter, as pricing pressures continue. Since Q113, the average price

of a DES has declined 9.6% to USD1,400, according to estimates

from Bloomberg, with most companies pricing similarly. The

rising purchasing power of healthcare institutions is key to this

downward trend in price.Continued on page 3...

Issue No. 290

February 2015

Pricing Pressures Will Catalyse Drug-Eluting

Stent Market

Omar El SaidiEditor

enquiries@espicom.com

Editor

Omar El Saidi

Managing EditorSophie Bracken

Conditions of Sale

• Cardiovascular Device Business must not be reproduced, abstracted, stored in a

retrieval system or transmitted in any form or by any means without the written

permission of the publisher.

• Cardiovascular Device Business must not be circulated to staff outside the address to

which it is sent.

ISSN 1471-0110

©Espicom Business Intelligence. All rights reserved.

HighlightsMedical Devices Throne Awaits Medtronic

Page 5

Volcano Benefits Playing Out Early For Philips

Page 6

Optimistic Outlook For St Jude Despite FY14 Pressures

Page 10

Medtronic Gains DES Market Share

DES Market Share By Company

Source: Bloomberg

0

5

10

15

20

25

30

35

40

45

Abbott Vascular

Boston Scientific

Medtronic

% U

S D

ES M

arke

t Sha

re

Q413Q414

- 450 bps

- 40 bps

+ 490 bps

فدی

ر

قیمت فایل عنوانانگلیسی )دالر(

1 Worldwide Pharmaceutical Market Forecasts to 2019 3,295

2Breast Cancer Drug Discoveries - What the future holds 3,145

3Gastric Cancer Drug Discoveries - what the future holds 2,615

4Will Anyone Crack the Obesity Drug Market? 2,615

5Biosiomilars: A Return to Optimism? 2,265

6Cancer Blockbusters to 2016 2,265

7Emerging Drug Delivery Technologies & Strategies:Players, Pipelines & Partnerships 2,265

8Evolution in the Pain Therapy Market:Nociceptive and Neuropathic Drug Development 2,265

9Global Causes of Death to 2020 2,265

10Ophthalmology Drug Futures 2,265

11Targeted Cancer Drugs: The Launch Landscape to 2018 2,265

12World Generic Market Report 2014Volume I: Company Profiles 1,995

13Advanced Oral & Parenteral Drug Delivery Technologies 1,740

14Inhalation & Nasal Spray Generic Drugs 2013 1,740

15Injectable Generic and Biosimilar Drugs:Potential Opportunities for Developers 2013 1,740

16Multi-therapy Drugs:Opportunities for Generics & Biosimilars 1,740

17The Complete Guide to Companion DiagnosticsMarket Environment, Products and Companies 1,740

18The World OTC Medicine Market Report 1,595

19World Pharmaceuticals Factbook 2014 1,595

20Advances in the Rheumatoid Arthritis Market 1,545

21Trends and Opportunities in the Diabetes Care Market 1,545

22Advances in the Obesity Market 1,495

23Biosimilar Opportunities in an Evolving Market 1,495

24Central & Eastern Europe Pharmaceutical Market Forecasts to 2019 1,495

25The Silent Killer - Advances in Cardiovascular Disease 1,495

26The Complete Guide to Orphan DrugsMarket Environment, products and companies 2012 1,390

World Leaders in Health Industry Analysis

A Business Monitor International Company

Advances in the

Rheumatoid Arthritis

Market

January 2014

Boston Scientific

Medical Device Companies Analysis

October 2014

BIOSIMILARSBUSINESS REVIEW

www.espicom.com

Policy l Products l Players l Prospects

Espico

m

Issue: 29

December 2014

US Biosimilar Market Edged Closer In 2014,

Intensifying Key Debates

BMI View: The filing of the first two biosimilar applications in

the US marked a watershed moment for the emerging global

biosimilar business. Whilst the issues raised in 2014 are not

new, the two applications have created additional emphasis.

Having been on the back foot over state-level legislation,

the Generic Pharmaceutical Association looks set to regain

the initiative. The key theme to emerge in 2014 has been

education, a need that will continue far beyond 2015.

Without doubt, 2014 will be remembered as a

breakthrough year for biosimilars. In July, Sandoz

(Novartis) became the first company to test the FDA's

biosimilar regulatory approval pathway created by the

Biologics Price Competition and Innovation Act of 2009

(BPCIA). The company filed for approval of a BLA for

filgrastim, a proposed biosimilar version of Amgen's

Neupogen. Filgrastim is indicated to decrease the incidence

of infection, as manifested by febrile neutropenia, in

patients with non-myeloid malignancies receiving

myelosuppressive anticancer drugs associated with a

significant incidence of severe neutropenia with fever.

Sandoz' filgrastim has been marketed under the brand

name Zarzio in more than 40 countries outside of the

US, generating nearly 6mn patient-exposure days of

experience. Sandoz claims Zarzio is the number one

biosimilar filgrastim globally and is the leading G-CSF

in Europe with 30% volume market share. The firm

further claims to have over a 50% share of all biosimilars

approved in the markets of Canada, Europe, Japan and

Australia. Sandoz currently markets three biosimilars

outside of the US, and its biosimilars are sold in over 60

countries; they have generated over 200mn patient-

exposure days in experience.

Continued on page 2...

Highlights...

ASBM Biosimilars Survey Reveals

Education Need

The Alliance for Safe Biologic Medicines (ASBM) presented

results from a survey of European physicians at the 1st

EuropaBio-ASEBIO Meeting on Innovation and Biological

Therapies at the Spanish Ministry of Health, Social Services

and Equality...

Continued on page 5

Amgen’s Biosimilar Programme

Progresses

BMI View: Whilst it may seem surprising that Amgen is

pursuing a biosimilar strategy given its notable opposition

to a biosimilar market, the programme...

Continued on page 6

WHO BQ Proposal Gains Traction,

But EGA Response Delivers

Stumbling Block

BMI View: The issue of naming biosimilars is a contentious

one and a key battleground in establishing a market. The

World Health Organization’s proposal for a Biological

Qualifier has the potential to strike a balance...

Continued on page 8

GPhA Seeks To Retake Biosimilar

Initiative In 2015 Legislation

BMI View: The Generic Pharmaceutical Association’s

compromise language for state-level biosimilar legislation

returns the initiative to the generic industry in the US

debate over biosimilars...

Continued on page 12

If you have any comments, observations or suggestions,

email the editor at:Ian_Platts@espicom com

nti-Infective

www.esp

icom.com

ADrug News

New AIDN Cover.indd 1-2

05/03/2009 14:34:37

BMI View: The HIV market is expected to grow gradually yet indefinitely as the number of new cases continues to rise. The number of deaths

from HIV is more likely to be reduced as nations focus efforts on wider antiretroviral drug coverage. ViiV Healthcare has the opportunity to

be a serious competitor for leader Gilead Sciences, yet Gilead is seeking an approval for its tenofovir alafenamide-based regimen to combat

this threat. The global HIV infected population is expected to increase from 1.23mn in 2013 to approximately 1.4mn in 2022. The combined

sales value of antiretroviral (ARV) drugs in the seven major markets including, US, Japan, UK, France, Germany, Italy and Spain, is

expected to increase from USD11.9bn in 2013 to approximately USD16.8bn in 2022. Within the market, growth will be primarily

driven by the increased use of single-dose, multi-class, once-daily combination drugs such as Gilead Sciences' Atripla (efavirenz/

emtricitabine/tenofovir disoproxil fumarate [TDF]) or ViiV Healthcare's Triumeq (dolutegravir/abacavir/lamivudine). In addition,

national coverage of ARV therapy in countries with the highest HIV/AIDS burdens is increasing due to government intervention as

well as the emergence of ARV generics at more affordable prices.

Market LeadersGilead, despite being a late-comer to the HIV market, has become the market leader with a wide ARV portfolio including once-

daily, combination regimens including Atripla, Stribild (elvitegravir/cobicistat/emtricitabine/TDF) and Truvada (emtricitabine/TDF).

Pfizer/GlaxoSmithKline's joint venture, ViiV Healthcare possesses the single-dose combination regimen, Triumeq as well as Tivicay

(dolutegravir), which is expected to jump to the forefront of the market, certainly to become the highest selling integrase inhibitor,

above that of competitor Isentress (raltegravir) from Merck. Gilead's Stribild is expected to overtake single-tablet combination

regimens Atripla and Truvada, forecast to increase to USD3,439.1mn in 2018 from USD1,197mn in 2014. However, ViiV's Triumeq was

approved in August 2014 which uses Tivicay as a component, it is therefore a direct threat to Stribild. Tivicay appears to have a higher

barrier to resistance than the other two integrase inhibitors, Isentress and Gilead's Viteka (elvitegravir); to date, no resistance has been

seen in people starting Tivicay as an initial regimen. Viteka is contained in Stribild, which could have a positive impact for Triumeq

sales. Other participant companies in the HIV market include Bristol-Myers Squibb, AbbVie, Janssen (Johnson & Johnson) and Merck.

In January 2015, the FDA approved BMS' Evotaz (atazanavir/cobicistat) in combination with other ARV agents for the treatment of

HIV-1 infection in adults. More importantly, in November 2014, Gilead submitted an NDA to the FDA for an investigational, once-

daily, single-tablet regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (TAF) 10mg (E/C/F/

TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult

and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal

impairment. If approved, E/C/F/TAF would be Gilead's first single tablet regimen to contain TAF.

Continued on page 3...HighlightsUS And Canada Experience Measles Cases And Outbreaks

Page 7

Sofosbuvir+ACH-3102 Six Week Combination Achieves 100% SVR12 In Phase II HCV Trial

Page 10

GSK Strengthens Early Stage Vaccine Pipeline With GlycoVaxyn Acquisition

Page 12

Issue No. 324

February 24 2015

HIV Market Set To Expand Gradually; Gilead To

Uphold Leadership Despite ViiV

Editor

Jessica Wilkinson

Managing EditorLucy Vann

Conditions of Sale

• Anti-Infective Drug News must not be reproduced, abstracted, stored in

a retrieval system or transmitted in any form or by any means without the

written permission of the publisher.

• Anti-Infective Drug News must not be circulated to staff outside the address

to which it is sent.

ISSN 1471-8294

©Espicom Business Intelligence. All rights reserved.

Jessica WilkinsonEditor

Pharma_Editorial@espicom.com

Baxter InternationalMedical Device Companies AnalysisOctober 2014

www.esp

icom.com edicalMIndustry Week

New MIW Cover.indd 1-2

21/05/2009 11:02:00

HighlightsKenya’s Market Dynamics Favour Foreign Device Manufacturers

Page 3

Women’s Health Business Discontinuation Likely For EndoPage 6

NICE Recommendation Likely For Europe’s First Stem Cell TherapyPage 13

Issue No. 745March 5 2015

BMI View: Further pricing regulation of medical devices will serve Colombia's health system well in the long term, given that the control

of coronary stent prices has the capacity to save upwards of USD5mn annually. Savings can be channelled into modernising the country's

healthcare infrastructure and improving inadequate staffing and hospital bed resources.

On March 5, Colombia's government will begin to regulate the price of certain medical devices within the country, including

coronary stents, cochlear implants, and orthopaedic implants, in an effort to control excessive price mark ups from manufacturers

and suppliers. BMI believes that this measure is part of governmental efforts to guarantee the sustainability of the healthcare

system. Pharmaceutical prices have been strongly regulated in recent years; the Ministry of Health and Social Protection (MinSalud,

Ministerio de Salud y Protección Social)'s extension to medical devices is a logical progression.

A pilot test to assess medical device prices in the country was launched in October 2014, focusing on the price of coronary stents.

MinSalud noted that payments for coronary stents from Fondo de Solidaridad y Garantía (FOSYGA), a public solidarity fund that

covers Colombian health expenses, amounted to COP20,000mn (USD10.7mn) in 2013, which was equivalent to the cost of the most

expensive medicine in Colombia prior to the regulation of pharmaceuticals, eculizumab.

The pilot found that in Colombia, coronary stents cost an average

of COP5,000mn (USD2,007), and an upper limit of COP6,500mn

(USD2,609) while in Canada, the price is around COP2,337mn

(USD938); COP2,466mn (USD990) in Chile; COP2,959mn (USD1,188)

in Spain; and COP2,9902mn (USD1,200) in Uruguay. On average,

this equated to around a 40% mark-up compared with other

nations.

Robust governance, transparency, public consultation and trust are

key to ensure the development of a fairer pricing regulation frame-

work for medical devices in the country. From March 5, the price

of coronary stents will be regulated to not exceed COP3,200mn

(USD1,248), representing a reduction of 36% from the current aver-

age price. This equates to a saving of approximately COP14,000mn

(USD5.6mn) annually for the Colombian health system, given the

volume of around 2,000 annual procedures requiring coronary st-

ents.

Continued on page 3...

Device Price Caps To Save Colombia

Unnecessary Healthcare Costs

Sophie BrackenEditor

enquiries@espicom.com

Contributing Editors: Omar El Saidi/Sophie Bracken

Managing Editor Sophie Bracken

Conditions of Sale

• Medical Industry Week must not be reproduced, abstracted, stored in a retrieval

system or transmitted in any form or by any means without the written permission of

the publisher.

• Medical Industry Week must not be circulated to staff outside the address to which it

is sent.ISSN 1462-8716

©Business Monitor International Ltd. All rights reserved.

Colombia Paying Over The Odds

Disparity Of Coronary Stent Prices In Five Nations (USD)

Source: Ministerio de Salud y Protección Social0 500 1,000 1,500 2,000 2,500 3,000

Canada

Chile

Spain

Uruguay

Colombia

World Leaders in Health Industry Analysis

The Complete Guide to Orphan Drugs

Market environment, products and companies