.Johnson & Johnson
.Johnson & Johnson
.Johnson & Johnson
Alberto BACCHIEGA, Stphane DIONNET and Mario TODINO, unit E-3, and
Chlo MACEWEN, unit A-2, Directorate-General Competition
1. Introduction
Following an in-depth investigation, on 25 August
2005 the European Commission authorised under
the Merger Regulation the planned $24 billion
(around 18 billion) acquisition by US healthcare
group Johnson & Johnson (J&J) of its competitor
Guidant, a US company specialised in cardiovascular medical products, subject to a number of
conditions designed to address the competition
concerns identified in the course of the investigation.
Both J&J and Guidant are active worldwide in
the development, production and sale of vascular
medical devices. Their products are used by physicians in procedures to treat vascular diseases both
in the heart (coronary arteries) and in peripheral
parts of the human body (e.g. carotid, renal, femoral arteries). The firms are direct competitors in
respect of a number of vascular devices and are
among a limited number of leading companies in
this field in Europe and worldwide.
The case presents a number of noteworthy aspects
both of a substantive and procedural nature.
To begin with, the investigation confirms the gradual shift in emphasis in the Commissions analysis
when it comes to mergers between differentiated
products. Consistent with the new Commission
guidelines on horizontal mergers, in the assessment of the effects of the merger more emphasis
was put on the issue of closeness of substitution
and the relevance of the competitive constraint
being removed, rather than on the conventional
concepts of single dominance and market definition.
The decision, in line with the most recent precedents such as Procter/Gillette and GE/Amersham,
also confirms that the Commission is adopting a
cautious attitude when assessing the risk of foreclosure effects stemming from bundling strategies.
As in past cases, the key questions the Commission had to address were: is it feasible and rational
to engage in bundling strategies, having regard to
the features of the market-place (the characteristics of the products and the possibility to bundle
them, the purchasing practices of customers and
their bargaining power, etc.)? And if so, can a bunNumber 3 Autumn 2005
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Against this background, in its market investigation the Commission first carefully scrutinised the
position of the two incumbent players in the DES
market to see whether the current market situation
adequately reflected each players real strength. In
this respect, the investigation revealed that BSXs
leadership in DES was likely to be more robustly
challenged in the short/mid run, primarily by J&J,
as well as by other new entrants.
Secondly, the Commission had to assess the prospect of success of the various new entrants in the
DES market. This was essentially done by reviewing the clinical evidence available with respect to
each new entrants ongoing DES programme. To
this end, the Commission relied upon the assistance of a small number of eminent physicians,
selected from a list of names provided by the parties and the competitors, involved at the highest
level in clinical trials of DES. Significant weight
was also given to the large number of studies prepared by specialised consultants as well as to the
periodic reports published by the major financial
analysts.
With respect to Guidant the investigation proved
that the merger removed one of the new entrants
with the best prospect of success in the market for
DES. In particular, Guidant could rely on the following assets: i) excellent stent platform, already
established on the market; ii) good drug: Guidants
Everolimus drug belongs to the same family as
J&Js sirolimus compound; iii) promising results of
the first clinical trials on its DES; iv) great reputation of innovator; v) excellent sales forces; vi)
strong customer base in BMS and accessories; and
vii) strong product portfolio. The investigation also
revealed that there were not yet compelling clinical
data showing Guidants drug efficacy as the sample
of patients having been treated with Everolimus
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was too small. Furthermore, Guidants DES clinical trials were still at an early stage, and the availability of only indirect parameters (angiographic
parameters) proving Guidants stent efficacy.
The Commission concluded that, on balance,
according to the prevailing view in the scientific
and business community, Guidant would have
been likely to become one of the key players in
the market for DES, acting as a major competitive
constraint vis--vis the two current competitors
J&J and BSX.
However, the evidence collected in the investigation also showed that the other new entrants, above
all Medtronic and Abbott, would be likely to exert
a sufficient competitive constraint on the market
for DES, compensating for the loss of competition
resulting from J&Js acquisition of Guidant.
First, the evidence collected in the investigation
indicated that Medtronic, together with Guidant,
was well placed to enter the DES market successfully and gain a significant share in Europe. In particular, the investigation confirmed that Medtronic
could rely upon the following assets: i) excellent
stent platform already established on the market;
ii) good drug; iii) imminent entry in the European
DES market (which took place in July 2005); iv)
good customer base, strong foothold in old generation stents (it is together with Guidant market
leader in BMS in Europe) and accessories; v) excellent sales forces; and vi) strong product portfolio.
Moreover, Medtronics trials were very advanced,
had been undergone on a large sample of patients,
and their results were positive based on clinical parameters which are more direct predictors
of success. The market also signalled as a potential problem the issue of Medtronic DES poorer
performance than its competitors DES as regards
a specific angiographic parameter generally connected to the risk of restenosis (late lumen loss).
However, the prevailing view was that this issue
might ultimately have only modest negative implications, and essentially in the long term.
According to the findings of the investigation,
Abbott, a big US pharmaceuticals company with
significant financial strength, a deep expertise in
pharmaceuticals (an important asset for the development of the next generation DES), and commercial experience with hospitals, was also considered
a credible entrant with a very promising DES programme capable of exerting a non negligible competitive constraint in the marketplace.
Based on the above, it was concluded that the concentration would not significantly impede effective
competition in the Common market and the EEA
for DES.
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distinguished. In the top tier, to which the merging parties belong, there is only a small number of
large global companies competing on a worldwide
level and having the following assets: top quality
devices, primarily the stents, supported by good
and abundant clinical data; strong relationships
with customers and a good reputation as well as
support from prestigious medical institutions and
key opinion leaders; vast financial capabilities to
finance massive R&D programmes; wide geographic reach that is a strong and widespread
presence in the three most lucrative markets, the
US, Japan and Europe; a strong patent portfolio and
broad product range. To date, the only firms which
can rely upon the above assets are J&J, Guidant,
Medtronic and BSX. In addition, Abbott, a big
pharmaceutical company, has recently entered the
market with the ambition to become a key player
in vascular devices.
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geneous as for interventional cardiology. Therefore, demand is more diversified and the expected
return from investments in innovation lower.
3.1.3. Market share and concentration
Many European markets for endovascular stents
are highly concentrated (). Although the number
of active competitors is significant, not all players
have the same strength or are present in all product or geographic markets. In a number of national
markets, the first three suppliers accounted for
between 70% and 95% of the market in 2004, and
the first four between 85% and 99%. () Three companies represent the lions share of the endovascular stents markets: J&J, BSX and Guidant. Guidants
market shares have consistently increased over the
past five years, albeit from a relatively low base,
while J&Js remained stable.
The merger would reduce the number of most significant competitors from three to two in a number
of national markets. At the EEA level, the 2004
combined market share of the merging parties
would exceed 60% for BX stents (HHI of around
4500 with a delta in excess of 2000), reach around
50% for carotid stents (HHI of around 3700 with
a delta in excess of 1000) and above 35% for noncarotid stents (HHI of around 2700 with an increment of 600).
3.1.4. Closeness of substitution
As mentioned above, endovascular stents markets
are characterised by a high degree of product differentiation. Clinical trials funded by stent suppliers as well as by independent bodies regularly
compare the characteristics of different products
along a number of dimensions that include efficacy and ease of use. These studies are carefully
examined by practitioners (who most often decide
which model the hospital purchases), who may
also have strong personal preferences. In order to
inquire on the closeness of substitution between
J&Js and Guidants stent, the market investigation
asked physicians to indicate the closest alternative
to the product they actually use. The investigation
highlighted that the disappearance of Guidant
would eliminate the competitor that was considered the closest substitute to J&Js stents across the
whole range of products. The closeness of substi(1) The Commission has carried out its analysis at national
level, coherently with the relevant geographic market
definition. The EEA level figures quoted in this article at
nevertheless a good summary of the competitive situation
in most Member States, and have the advantage of being
more easily presentable.
(2) The most affected countries included Austria, Belgium,
France, Germany, Italy, The Netherlands, Portugal and
Spain.
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3. Endovascular stents
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6. The remedies
In order to make the concentration compatible
with the common market, the parties have committed to divest Guidants EEA endovascular business (including stents and accessories), J&Js EEA
Steerable Guidewires business. ()
The EEA endovascular and steerable guidewires
businesses consist of the inventories and the customer lists, the assignment of rights for use of
trademarks, the license of IP rights, and the transfer of specifications relating to the design of the
products. The business to be divested does not
include any manufacturing or research facilities,
because the production of J&J steerable guidewires
is done by a third party on the basis of an OEM
contract, and the production of Guidant endovas(1) The parties also committed to divest either J&J or Guidant Endoscopic Vessel Harvesting products in cardiac
surgery. As noted above, the remedy in cardiac surgery
results from fairly straightforward competition concerns
and does not raise any particularly significant competition issues. As such, it is not discussed in this article.
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Combined market shares for accessories varied significantly across countries, reaching in some cases
very high levels (above 70%). This notwithstanding the Commission concluded that the merger
would not pose a threat to effective competition.
Unlike stents, accessories have very little specific
IP content and are offered by a number of international and local suppliers. They are increasingly
homogeneous and interchangeable products for
which there are low barriers to entry and production scale-up. Finally, doctors customarily use different brands and can switch easily between them.
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