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Replies to #99001 on Biotech Values
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mcbio

07/17/10 10:22 PM

#99007 RE: DewDiligence #99001

EvaluatePharma on anti-coagulant/other markets

[Forecast calls for 2016 Lovenox sales of $2.7B and total worldwide sales of anti-coagulants of ~$14B.]

http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=218193&isEPVantage=yes

Headline Anti-coagulant products set to flow fastest
Source EP Vantage
Company Roche
Related: Bayer, Celgene, Novartis, Pfizer, Sanofi-Aventis
Date July 12, 2010

It comes as no surprise to see cancer therapies ranking as the most valuable group of drugs, now and in six years' time, but which other categories are projected to grow strongly?

The analysis below, taken from EvaluatePharma’s World Preview 2016, reveals that anti-diabetics and anti-rheumatics follow behind oncology, actually with marginally higher growth rates expected. Of the largest therapy areas, however, the fastest annual growth rate is forecast for the anti-coagulants, with significant demand anticipated for newer agents such as Bayer’s Xarelto and Boehringer Ingelheim's Pradaxa more than compensating for the decline in Sanofi-Aventis' huge Lovenox franchise.

Top 15 therapy areas

[See Table in Link]

At the top

Oncology has of course been a major area of research for a number of years now. This group includes a number of therapy types but the main categories, accounting for about 90% of sales, are the monoclonoal antibodies and cytostatic agents.

The latter group includes kinase inhibitors, a significantly growing group of cancer medications, such as Novartis’ Gleevec and Roche’s Tarceva. Antibodies meanwhile are forecast to generate $31.6bn in sales alone by 2016, growing 8% a year until then, making them a large therapy area in their own right.

Roche of course dominates here, owning the three biggest antibody products – Avastin, Rituxan and Herceptin – demand for which will consolidate the Swiss group's position as by far the world’s largest oncology player. The company is seen earning $26.4bn from its cancer portfolio by 2016, giving it a third of the market for branded oncology products, a staggering share of such a large market for one company to control. Novartis, in the number two spot, will come nowhere near competing with only a 9% share of the market and $7.2bn of sales by 2016.

Interestingly, Novartis could well see its number two spot challenged by Celgene, which is rapidly building a strong oncology presence, most recently seen with the acquisition of Abraxis Bioscience. Assuming this goes through and Abraxane becomes the product Celgene believes it can be, there will be little difference between the two companies in terms of sales (Celgene buys Abraxis for $2.9bn but insists premium is earned, June 30, 2010).

Top 5 oncology companies

[See Table in Link]

Fast growing

The anti-coagulant space is expected to find its growth from a raft of new products, although with many similar products slated for launch at similar times, it remains to be seen whether all will be successful commercially. Currently dominating this market is Lovenox, a low molecular weight heparin, which loses patent protection in a couple of years, although sales are not expected to completely drop off a cliff; consensus has sales of $2.7bn in 2016, down from $4.2bn last year.

The new entrants include Bayer’s factor Xa inhibitor Xarelto, which has been approved in Europe and should be re-filed in the US towards the end of this year, having been issued with a complete response letter by the FDA in early 2009. Meanwhile Bristol-Myers Squibb has a similar product in Apixaban, also slated for regulatory filings by year end. Daiichi Sankyo has another, DU-176b, in global phase III trials and already filed for approval in Japan. Going after the same market is Boehringer’s Pradaxa, a thrombin inhibitor already approved in Europe.

The success of Lovenox shows there is huge demand and with all of these newer agents fighting to demonstrate improved efficacy or safety, to justify what will be much higher costs, this is likely to be a fiercely competitive segment of the market over the next few years (Bristol-Myers, Pfizer given reason for cheer with apixaban, June 11, 2010).

Others

Amongst the other big areas, the anti-hyperlipidaemics which includes the huge statin class is set to stay high up the rankings, even with the impending loss of mega-blockbuster Lipitor. And another cardiovascular group, the anti-hypertensives, will also remain a huge area despite the loss of patent protection for almost the entire angiotensis class, mosts notably Novartis' Diovan.

And vaccines, until a few years ago a relatively neglected area of research, continues to prove its worth with both high sales and annual growth rates.

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DewDiligence

08/05/10 5:47 AM

#100790 RE: DewDiligence #99001

What’s New in the Anticoagulant Market?

[Added Xarelto entry in acute DVT.]

See MNTA ReadMeFirst for info on Lovenox and M118.


General
#msg-51227061 How large is the anticoagulant market?
#msg-26451612 VTE is a big, big problem (Lancet 2008)
#msg-26701803 Technical information on traditional anticoagulants


Pradaxa (dabigatran)
#msg-51498625 Musings on Pradaxa and competitive landscape
#msg-27956748 EU approves Pradaxa for VTE prevention
#msg-32382343 NICE approves reimbursement for VTE prevention
#msg-41018490 Pradaxa bests warfarin in AF/stroke prevention (Reuters)
#msg-41014644 Pradaxa bests warfarin in AF/stroke prevention (WSJ)
#msg-41024424 Pradaxa bests warfarin in AF/stroke prevention (Forbes)
#msg-44244839 Phase-3 Pradaxa data in acute VTE (ASH 2009)
#msg-51315844 Non-inferior to Lovenox in VTE prevention (RE-NOVATE 2)
#msg-21155926 Non-inferior to Lovenox in VTE prevention (RE-NOVATE)
#msg-25152872 BI starts phase-2 trial in ACS


Xarelto (rivaroxaban)
#msg-52987231 Xarelto matches Lovenox in acute DVT
#msg-47110232 Response to FDA’s CRL is due in 2H10
#msg-44245112 Troublesome bleeding in VTE extension study
#msg-30972846 EMEA approves Xarelto for VTE prevention
#msg-34103973 Phase-3 data in VTE prevention (JNJ PR)
#msg-29661234 Phase-3 data in VTE prevention (Reuters)
#msg-31857009 Bayer accelerates Xarelto development in ACS, but…
#msg-39151366 ...Xarelto still has a long way to go in ACS!
#msg-33517140 Phase-2 data in ACS
#msg-29662519 Checklist rationale for Xarelto program


Apixaban
#msg-51162505 Phase-3 succeeds in warfarin-free AF/stroke prevention
#msg-47461590 ADVANCE-2 in VTE prevention succeeds, but…
#msg-31742223 ADVANCE-1 in VTE prevention fails
#msg-29928836 Phase-3 trials begin for VTE treatment
#msg-32024540 Tepid phase-2 results in ACS
#msg-19134406 PFE, BMY ink $1B deal to co-develop Apixaban


Edoxaban
#msg-48661173 Daiichi Sankyo files for approval in Japan
#msg-46218043 Largest-ever phase-3 begins in VTE prevention
#msg-34100821 Phase-3 begins in AF
#msg-34100787 Comparable safety to warfarin in AF (phase-2)
#msg-31950663 Phase-2 data in VTE prevention after hip surgery


Betrixaban
#msg-39418241 MRK licenses betrixaban (WSJ)
#msg-39388813 MRK licenses betrixaban (MRK/Portola PR)
#msg-47847796 Phase-2 safety data vs warfarin in AF
#msg-21106352 Phase-2 data vs Lovenox in VTE prevention


Miscellaneous (in alphabetical order)
#msg-41143344 Ablynx starts phase-2 of ALX-0081 in PCI
#msg-40720487 Ablynx phase-1 ALX-0681 results in healthy volunteers
#msg-10569101 Arixtra bests Lovenox in ACS
#msg-27043616 ART-123 from Artisan Pharma
#msg-39348082 ARYX’s Tecarfarin whiffs in phase-3
#msg-36811828 AZN reports phase-2 data for AZD0837
#msg-30965016 LLY terminates FXa program
#msg-30353872 MYRX MPC-0920 begins phase-1
#msg-31461171 NUVO reports phase-1b data for NU172
#msg-46648382 Otamixaban ho-hum in phase-2 ACS study
#msg-27187973 Paion’s Solulin completes phase-1
#msg-28742653 Paion acquires flovagatran rights
#msg-50887012 PYMX phase-1b PMX-60056 data for Lovenox reversal
#msg-49561036 PYMX starts 2nd phase-1/2 trial for heparin reversal
#msg-32171800 Regado reports phase-1 data for aptamer
#msg-46648462 Sanofi’s stable of anticoagulant aspirants
#msg-52169431 TB-402 (FVIII inh) bests Lovenox in VTE prevention
#msg-37562465 Warfarin genetic test rejected by Medicare