Grifols, S.A. and Talecris Biotherapeutics Holdings Corp.; Analysis of Agreement Containing Consent Orders to Aid Public Comment, 33298-33301 [2011-14082]
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Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
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[FR Doc. 2011–14065 Filed 6–7–11; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL TRADE COMMISSION
[File No. 101 0153]
Grifols, S.A. and Talecris
Biotherapeutics Holdings Corp.;
Analysis of Agreement Containing
Consent Orders to Aid Public
Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
ACTION:
The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair or
deceptive acts or practices or unfair
methods of competition. The attached
Analysis to Aid Public Comment
describes both the allegations in the
draft complaint and the terms of the
consent order—embodied in the consent
agreement—that would settle these
allegations.
SUMMARY:
Comments must be received on
or before July 1, 2011.
ADDRESSES: Interested parties may file a
comment online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘Grisfols-Talecris, File No.
101 0153’’ on your comment, and file
sroberts on DSK5SPTVN1PROD with NOTICES
DATES:
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your comment online at https://
ftcpublic.commentworks.com/ftc/
grifols-talecris, by following the
instructions on the web-based form. If
you prefer to file your comment on
paper, mail or deliver your comment to
the following address: Federal Trade
Commission, Office of the Secretary,
Room H–113 (Annex D), 600
Pennsylvania Avenue, NW.,
Washington, DC 20580.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Perry (202–326–2331), FTC,
Bureau of Competition, 600
Pennsylvania Avenue, NW.,
Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 2.34 the Commission Rules
of Practice, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing a consent
order to cease and desist, having been
filed with and accepted, subject to final
approval, by the Commission, has been
placed on the public record for a period
of thirty (30) days. The following
Analysis to Aid Public Comment
describes the terms of the consent
agreement, and the allegations in the
complaint. An electronic copy of the
full text of the consent agreement
package can be obtained from the FTC
Home Page (for June 1, 2011), on the
World Wide Web, at https://www.ftc.gov/
os/actions.shtm. A paper copy can be
obtained from the FTC Public Reference
Room, Room 130–H, 600 Pennsylvania
Avenue, NW., Washington, DC 20580,
either in person or by calling (202) 326–
2222.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before June 10, 2011. Write ‘‘GrifolsTalecris, File No. 101 0153’’ on your
comment. Your comment—including
your name and your state—will be
placed on the public record of this
proceeding, including, to the extent
practicable, on the public Commission
Web site, at https://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’s Social
Security number, date of birth, driver’s
license number or other state
identification number or foreign country
equivalent, passport number, financial
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account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment does
not include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is obtained
from any person and which is privileged
or confidential,’’ as provided in Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2).
In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).1 Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
grifols-talecris by following the
instructions on the web-based form. If
this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Grifols-Talecris, File No. 101
0151’’ on your comment and on the
envelope, and mail or deliver it to the
following address: Federal Trade
Commission, Office of the Secretary,
Room H–113 (Annex D), 600
Pennsylvania Avenue, NW.,
Washington, DC 20580. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Visit the Commission Web site at
https://www.ftc.gov to read this Notice
and the news release describing it. The
FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
1 In particular, the written request for confidential
treatment that accompanies the comment must
include the factual and legal basis for the request,
and must identify the specific portions of the
comment to be withheld from the public record. See
FTC Rule 4.9(c), 16 CFR 4.9(c).
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Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before July 1, 2011. You can find more
information, including routine uses
permitted by the Privacy Act, in the
Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
Analysis of Agreement Containing
Consent Order to Aid Public Comment
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I. Introduction
The Federal Trade Commission
(‘‘Commission’’) has accepted from
Grifols, S.A. (‘‘Grifols’’) and Talecris
Biotherapeutics Holdings Corp.
(‘‘Talecris’’), subject to final approval, an
Agreement Containing Consent Orders
(‘‘Consent Agreement’’) and Decision
and Order, and has issued a Complaint
and the Order to Maintain Assets
(‘‘OMA’’) contained in the Consent
Agreement. The Consent Agreement is
designed to remedy the anticompetitive
effects resulting from Grifols’ proposed
acquisition of Talecris (the
‘‘Acquisition’’). Under the Consent
Agreement, Grifols will: (i) Divest the
fractionation facility currently owned by
Talecris in Melville, New York, to
Kedrion S.p.A. (‘‘Kedrion’’); (ii) divest
plasma collection centers to Kedrion;
(iii) divest to Kedrion Talecris’ Koate
DVI plasma-derived Factor VIII
(‘‘pdFVIII’’) business, including the
Koate brand name, in the United States;
and (iv) for a seven-year period,
manufacture immune globulin (‘‘Ig’’),
albumin, and Koate for Kedrion to sell
in the United States.
The proposed Consent Agreement has
been placed on the public record for 30
days to solicit comments from interested
persons. Comments received during this
period will become part of the public
record. After 30 days, the Commission
will again review the proposed Consent
Agreement and will decide whether it
should withdraw from the proposed
Consent Agreement, modify it, or make
it final.
On June 6, 2010, Grifols entered into
an agreement to acquire Talecris for
approximately $3.4 billion in cash and
stock. The Commission’s Complaint
alleges that the Acquisition violates
Section 5 of the FTC Act, as amended,
15 U.S.C. 45, and if consummated,
would violate Section 7 of the Clayton
Act, as amended, 15 U.S.C. 18, and
Section 5 of the FTC Act by lessening
competition in the U.S. markets for Ig,
albumin, and pdFVIII (the ‘‘Relevant
Products’’).
II. The Parties
Grifols is a public company,
headquartered in Barcelona, Spain. Its
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bioscience division develops and
manufactures human blood plasmaderived products with manufacturing
facilities in Barcelona and Los Angeles,
California. Grifols entered the U.S.
market in 2002, when it acquired the
assets of a U.S. manufacturer, Alpha
Therapeutics Corporation, and 42
plasma collection centers from
SeraCare. Since then, Grifols has
acquired additional plasma centers and
is now vertically integrated, making it
the second largest plasma collector in
the world. Grifols employs
approximately 6,000 people worldwide
and had global 2009 revenues of $1.3
billion.
Talecris is also a public company—
owned in part by the private investment
firm Cerberus Capital Management, L.P.
(‘‘Cerberus’’)—that specializes in the
development, manufacture, and
worldwide sale of human blood plasmaderived products. Talecris began its U.S.
operations in 2005, when Cerberus
acquired Bayer AG’s global plasma
business and Precision Pharma in the
same year. Talecris is headquartered in
Research Triangle Park, North Carolina,
with additional regional headquarters in
Canada and Germany. Like Grifols,
Talecris is a vertically integrated
company, owning numerous plasma
collection centers, as well as
manufacturing facilities in Clayton,
North Carolina, and Melville, New York.
It employs approximately 5,000 people
worldwide and had global 2009
revenues of approximately $1.5 billion.
III. Market Structure and Relevant
Products
A. Relevant Geographic Market
The relevant geographic market in
which to analyze the Acquisition’s
effects is the United States. Plasmaderived products must be FDAapproved for sale in the United States,
which requires that these products be
made solely from plasma collected in
the United States in FDA-approved
collection centers and manufactured in
FDA-approved plants. Thus, plasma
products not approved for sale in the
United States do not provide viable
competitive alternatives for U.S.
consumers in the face of an increase in
price for U.S. products.
B. Relevant Product Markets
i. Ig
Ig is a plasma protein replacement
therapy largely used to treat immune
deficient patients. The relevant product
market for Ig includes all brands,
concentrations (i.e., 5% and 10%),
formulations (i.e., liquid and
lyophilized/powder), and means of
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administration (i.e., intravenous and
subcutaneous). Because intravenous Ig
(‘‘IVIG’’) accounts for the overwhelming
majority of Ig sales in the United States,
industry participants often refer to the Ig
market as the IVIG market. Although
IVIG is available in two concentrations
(5% and 10%), they are therapeutically
equivalent. The main difference is one
of convenience: A 10% IVIG requires
less volume, meaning treatment
typically takes less time. Ig has
numerous FDA-approved indications
(e.g., primary immunodeficiencies and
Chronic Inflammatory Demyelinating
Polyneuropathy), and there is a
significant amount of off-label use.
Hospitals, physicians, and patients
would not switch, and historically have
not switched, from Ig products to nonIg products in response to a small but
significant and non-transitory increase
in price (‘‘SSNIP’’). Although Ig products
differ somewhat (e.g., based on sucrose
levels, immunoglobulin A content, or
concentration), ample evidence
demonstrates that the brands and
products are largely interchangeable.
Grifols and Talecris account for
approximately 8.4% and 22.8% of the
U.S. Ig market, respectively, and their
merger would leave three manufacturers
with nearly 100% of current U.S. Ig
sales.
ii. Albumin
Physicians use albumin to expand
blood volume, prime heart valves
during cardiac surgery, treat burn
victims, and replace proteins in treating
liver failure. In the United States, the
parties compete in the sale of two
different albumin concentrations: 5%
and 25% liquid. The 5% and 25%
concentrations have different clinical
uses, but if a 5% product is unavailable,
hospitals can dilute a 25% product to a
5% concentration if necessary. On the
manufacturing side, there are no
significant costs associated with shifting
production between 5% and 25%
albumin, and manufacturers can make
such changes in a matter of days.
Because competitive conditions—
including the number and identity of
suppliers—for 5% and 25% albumin
solutions are the same, it is appropriate
to analyze albumin as a single market
comprising both 5% and 25% products.
In most circumstances where it is
used, albumin has no viable substitutes.
While starches and salines can act as
volume expanders like 5% albumin,
those non-albumin products cannot
substitute for albumin in the great
majority of uses and do not
meaningfully constrain albumin prices
and, hence, are not included in the
relevant product market. Even for those
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few indications for which there might
be a potential alternative therapy,
hospitals generally prefer albumin and
would not switch from albumin to
another product in response to a SSNIP.
Grifols and Talecris have U.S. albumin
market shares of approximately 13%
each, and the Acquisition would leave
only four meaningful competitors in
that market.
iii. pdFVIII
Physicians use pdFVIII to treat
bleeding disorders, namely Hemophilia
A and von Willebrand Disease (‘‘VWD’’).
While both pdFVIII and its non-plasma
counterpart, recombinant Factor VIII
(‘‘rFVIII’’), can be used to treat
Hemophilia A, rFVIII and pdFVIII have
limited interchangeability and, hence,
limited ability to constrain each other’s
prices. For instance, although rFVIII is
the standard of care for previously
untreated patients with Hemophilia A
(due to the perception that pdFVIII
carries an increased risk of viral
transmission), evidence suggests that
patients using rFVIII are more likely to
develop inhibitors—antibodies that
impede the treatment’s effectiveness.
Thus, for some Hemophilia A patients,
pdFVIII is the only viable treatment.
Likewise, patients with severe VWD are
treated with pdFVIII products
containing von Willebrand Factor
(‘‘VWF’’). No recombinant products
contain VWF, so those patients also may
have no choice but to use pdFVIII.
Clinical considerations, not price,
determine whether a particular patient
is given pdFVIII or rFVIII, and hospitals
would not switch from pdFVIII to rFVIII
in response to an increase in the price
of pdFVIII. Grifols and Talecris account
for approximately 23% and 3.6% of the
U.S. pdFVIII market, respectively, and
their merger would leave only three
meaningful competitors in that market.
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IV. Industry Background and the
Acquisition’s Effects
A decade ago, there was robust
competition in the plasma-derived
products industry. After supply
increases in the early 2000s led to lower
prices, suppliers reduced production
and plasma collection capacity and
began to vertically integrate, placing
plasma collection almost entirely in the
control of the few remaining firms in the
market. Manufacturers also engaged in
horizontal consolidation, leading to an
industry dominated by three large firms,
including Talecris. In the years that
followed that consolidation, the Ig
market in particular experienced a
tightening of supply and dramatic yearover-year price increases.
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The relevant markets have
characteristics that allow manufacturers
to promote stability and rational,
coordinated behavior. First, the markets
are transparent, with firms monitoring
each other’s collections, output, pricing,
and future expansion plans. Second,
firms have engaged in signaling to limit
supply levels and maintain higher
prices. Third, if a firm were to ‘‘break
ranks’’ from a coordinated scheme, the
other manufacturers can detect any
‘‘cheating’’ over the course of the long
manufacturing period and inflict
punishment in other geographic
markets. Fourth, the relevant markets
are characterized by highly inelastic
demand, increasing the firms’ incentives
to coordinate because even a small
change in supply can have a large effect
on price.
The Acquisition would substantially
lessen competition in the relevant
markets. It would eliminate actual,
direct, and substantial competition
between Grifols and Talecris. Moreover,
given that each of the relevant markets
already is highly concentrated, the
Acquisition would facilitate successful
coordinated interaction among the few
remaining meaningful competitors,
leading to reduced supply and higher
prices for consumers. In addition, the
Acquisition increases the likelihood that
consumers would experience lower
levels of innovation and service in the
markets for the Relevant Products.
V. Entry Conditions
Neither new entry nor expansion
sufficient to deter or counteract the
Acquisition’s anticompetitive effects is
likely to occur within two years. The
barriers to entering the plasma
fractionation industry are extraordinary,
with costs reaching hundreds of
millions of dollars. Indeed, the barriers
are so immense that de novo entry is
unrealistic in less than five years. For
example, an entrant must develop a
product and secure all necessary
regulatory approvals, with the required
clinical trials alone taking up to three
years. Additionally, the time and capital
investment required to build and obtain
regulatory clearance for a fractionation
facility are significant, taking four to
eight years and costing $100 million or
more. Finally, entrants must navigate a
substantial body of intellectual property
in the field, including trade secrets
relating to purification and safety, and
must incur substantial product research
and development costs before bringing a
product to market. Accordingly, new
entry by a domestic or foreign firm
would not be timely, likely, or sufficient
to counteract the Acquisition’s
anticompetitive effects.
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VI. The Consent Agreement
The proposed Consent Agreement
requires Grifols to divest certain assets
to Kedrion and take other actions to
alleviate the Acquisition’s effects. In
particular, the Consent Agreement
expedites the entry of an additional
competitor into each of the relevant
markets, making a potential industrywide coordinated scheme more difficult,
and limiting the combined firm’s ability
to raise prices.
Kedrion possesses the resources and
ability to be an effective competitor and
meaningful constraint on any potential
coordination in the industry. Created in
2001, Kedrion is the seventh largest
fractionator in the world. Specializing
in the development, production, and
distribution of plasma-derived products,
Kedrion actively sells plasma-derived
products in more than 30 countries.
Kedrion currently sells IVIG in a
number of European and other markets
and has started the process for FDA
approval of its own IVIG product for
sale in the United States. Kedrion also
expects final FDA approval to sell a new
albumin product in the United States in
2011. It currently operates two plants in
Italy and is nearing completion of an
expansion to its manufacturing facility
in Godollo, Hungary.
Under the Consent Agreement, Grifols
will enter into a sale-and-leaseback
agreement with Kedrion for Talecris’
Melville fractionation facility.
Specifically, Kedrion will acquire the
Melville facility and lease it back to
Grifols for three to four years to ensure
continuity of operations; at the end of
the lease term, Kedrion can assume
Melville operations and fractionate its
own plasma. Additionally, Grifols will
divest to Kedrion plasma collection
centers and sell Kedrion an initial
supply of raw plasma, ensuring that
Kedrion will have an independent and
reliable source of raw plasma.
In addition, Grifols will manufacture
and supply Kedrion with FDA-approved
and established IVIG, albumin, and
pdFVIII products. Kedrion will market
and sell private-label versions of
Talecris’ Gamunex IVIG and Plasbumin
albumin for a period of seven years.
And Grifols will transfer to Kedrion all
commercial agreements and rights to
sell Koate pdFVIII in the U.S. market,
making Kedrion the sole provider of
Koate in the United States. Kedrion will
also have the option to purchase the
rights to manufacture Koate for sale in
the United States.
Through the Consent Agreement,
Kedrion will have immediate market
access and the ability to supply
customers with established products in
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all three product markets. Kedrion’s
presence in the U.S. market will add
incremental supply of these life-saving
products while still allowing the
combined firm to take full advantage of
the Acquisition’s expected efficiencies.
In addition, Kedrion will also have the
opportunity to hire Grifols and Talecris
employees to facilitate its entry and
ensure continuity in the manufacture
and sale of its products. By eliminating
many of the industry’s immense barriers
to entry, the Consent Agreement will
facilitate Kedrion’s current and future
entry with its own IVIG and albumin
products and position Kedrion to
replace the competition lost as a result
of the Acquisition.
To ensure that the Commission
remains informed about the status of the
proposed divestitures, the Consent
Agreement also requires the parties to
file periodic reports with the
Commission until the divestitures are
accomplished. Furthermore, the OMA
requires that the parties maintain all
assets scheduled to transfer to Kedrion
and authorizes the Commission to
appoint a monitor to oversee the various
agreements between Kedrion and
Grifols. Under the OMA, Grifols and
Talecris must maintain the full
economic viability, marketability, and
competitiveness of the proposed
divested business and assets. This
includes, among other things, retaining
all rights, title, and interest in the
divested assets, maintaining operations
in their regular course, and not
interfering in Kedrion’s hiring of
designated Grifols and Talecris
employees. If Grifols does not comply
with the OMA or any of the Consent
Agreement’s other terms, the
Commission may appoint a divestiture
trustee to divest the assets and enter
into a product manufacturing agreement
with a Commission-approved acquirer.
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement. It is not intended to
constitute an official interpretation of
the proposed Decision and Order or to
modify its terms in any way.
By direction of the Commission,
Commissioner Kovacic recused and
Commissioner Brill issuing a separate
concurring statement.
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Donald S. Clark,
Secretary.
Concurring Statement of Commissioner
Julie Brill
I concur in the Commission’s decision
to issue a complaint against Grifols
challenging its acquisition of Talecris. I
write separately to express my view that
whether to resolve this matter through
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33301
the proposed consent order is a close
call, though I ultimately concur in that
decision as well.
The vitally important plasma protein
industry has seen considerable
consolidation in recent years. Today,
only four significant active competitors
remain as to immune globulin (‘‘Ig’’), the
largest product by sales at issue in this
merger: Grifols, Talecris, CSL and
Baxter.1 In the meantime, prices have
increased substantially. Just two years
ago, when CSL tried to buy Talecris, the
Commission alleged that these ‘‘price
increases have been caused by the
consolidation of competitors and the
resulting increases in concentration.’’ 2
The industry has operated as a tight
oligopoly in the words of a 2007
Department of Health and Human
Services report, carefully controlling
supply, avoiding robust price
competition, and engaging in signaling
of future competitive moves.3
One outgrowth of the supply
limitations and coordinated behavior
described in the Commission’s CSL
complaint has been the difficulty safetynet providers have had in obtaining Ig
under the 340B Drug Pricing Program.
This Congressionally mandated program
is designed to provide pharmaceuticals
at reduced prices to health care
providers serving indigent and other atrisk patients. All too often, however,
plasma-derivative manufacturers have
not made their products available at
statutorily-mandated prices.4 This
subverts Congress’s goal of ensuring
access to life-saving pharmaceuticals
and increases costs to the health care
system overall.
Against this backdrop, almost any
merger in this industry would merit the
significant scrutiny this one has
received at the FTC. Although Grifols is
today one of the smaller firms in the
U.S. market, with a roughly 9% share of
Ig sales, it recently launched a new 10%
concentration intravenous Ig product
that could threaten the industry-leading
products offered by Talecris, Baxter and
CSL. In addition, as alleged in the
Commission’s current complaint, the Ig
market is highly concentrated and the
change in market concentration effected
by this merger easily raises a
presumption of enhanced market power
under the antitrust agencies’ 2010
Merger Guidelines.5 Finally, as also
alleged in the complaint, the risk of
post-merger coordinated behavior is
very real, given the history of
coordination in this industry and the
fact that the immediate post-merger U.S.
Ig market will consist of three firms of
roughly equal size. Given these and
other significant facts, I strongly support
issuance of the Commission’s
complaint.
Whether the consent order does
enough to remedy competition concerns
is a much closer call. On the one hand,
the consent allows for the near-term
introduction of product into the market
from a new competitor, Kedrion. The
consent should also facilitate Kedrion’s
entry into the U.S. market with its own
Ig product in several years. On the other
hand, Grifols will keep 67 of Talecris’s
69 plasma collection centers, as well as
its own 80 centers, while divesting two
to Kedrion. In addition, the Melville,
NY, manufacturing plant that Grifols is
divesting to Kedrion is a smaller facility
that is not currently outfitted to purify
fractionated plasma into finished
product. While Grifols will fractionate
and purify a ‘‘Designated Amount of
[finished] Product’’ for Kedrion for
several years under the consent order,
Kedrion may need to build or purchase
a new facility in order to effectively
compete over the longer term.6
In the end, given the particular facts
and circumstances of this matter, I
support the consent because it provides
some degree of immediate, sure relief to
consumers. I expect, though, that the
Commission, other Federal and State
agencies, and affected purchasers will
closely monitor these markets, both as
to future proposed consolidations and
potential coordinated behavior,
including behavior that may adversely
impact indigent and other at-risk
patients through the critical 340B
program.
1 A fifth competitor, Octapharma, withdrew its Ig
product from the market in September 2010 due to
safety concerns. As the Commission alleges in its
complaint, ‘‘its future competitive significance is
uncertain.’’
2 Compl. ¶ 33, FTC v. CSL Ltd., No. 09–1000
(D.D.C., filed May 28, 2009), available at https://
www.ftc.gov/os/caselist/0810255/091110cslcerberusunsealedcmplt.pdf.
3 Id. ¶¶ 37–44.
4 See, e.g., Public Hospital Pharmacy Coalition,
‘‘Access to IVIG by Safety Net Hospitals
Participating in the 340B Drug Discount Program’’
(Sept. 2006), available at https://www.phpcrx.org/
public/documents/pdfs/IVIG_report.pdf.
[FR Doc. 2011–14082 Filed 6–7–11; 8:45 am]
PO 00000
Frm 00111
Fmt 4703
Sfmt 9990
BILLING CODE 6750–01–P
5 The Ig market share and HHI figures in the
Commission’s complaint date from 2009 and are
thus conservative, as they count Octapharma as a
market participant, which it currently is not.
6 Compare In re Polypore Int’l, Inc., 2010–2 Trade
Cas. ¶ 77,267, 2010 FTC LEXIS 97, at *108–110
(F.T.C. 2010) (requiring divestiture of second
manufacturing plant to ensure that divestiture
assets constituted viable ongoing business).
E:\FR\FM\08JNN1.SGM
08JNN1
Agencies
[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33298-33301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14082]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 101 0153]
Grifols, S.A. and Talecris Biotherapeutics Holdings Corp.;
Analysis of Agreement Containing Consent Orders to Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed Consent Agreement.
-----------------------------------------------------------------------
SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair or deceptive acts or
practices or unfair methods of competition. The attached Analysis to
Aid Public Comment describes both the allegations in the draft
complaint and the terms of the consent order--embodied in the consent
agreement--that would settle these allegations.
DATES: Comments must be received on or before July 1, 2011.
ADDRESSES: Interested parties may file a comment online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write ``Grisfols-Talecris,
File No. 101 0153'' on your comment, and file your comment online at
https://ftcpublic.commentworks.com/ftc/grifols-talecris, by following
the instructions on the web-based form. If you prefer to file your
comment on paper, mail or deliver your comment to the following
address: Federal Trade Commission, Office of the Secretary, Room H-113
(Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580.
FOR FURTHER INFORMATION CONTACT: Jeffrey Perry (202-326-2331), FTC,
Bureau of Competition, 600 Pennsylvania Avenue, NW., Washington, DC
20580.
SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec. 2.34 the
Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that
the above-captioned consent agreement containing a consent order to
cease and desist, having been filed with and accepted, subject to final
approval, by the Commission, has been placed on the public record for a
period of thirty (30) days. The following Analysis to Aid Public
Comment describes the terms of the consent agreement, and the
allegations in the complaint. An electronic copy of the full text of
the consent agreement package can be obtained from the FTC Home Page
(for June 1, 2011), on the World Wide Web, at https://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington,
DC 20580, either in person or by calling (202) 326-2222.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before June 10, 2011.
Write ``Grifols-Talecris, File No. 101 0153'' on your comment. Your
comment--including your name and your state--will be placed on the
public record of this proceeding, including, to the extent practicable,
on the public Commission Web site, at https://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to
remove individuals' home contact information from comments before
placing them on the Commission Web site.
Because your comment will be made public, you are solely
responsible for making sure that your comment does not include any
sensitive personal information, like anyone's Social Security number,
date of birth, driver's license number or other state identification
number or foreign country equivalent, passport number, financial
account number, or credit or debit card number. You are also solely
responsible for making sure that your comment does not include any
sensitive health information, like medical records or other
individually identifiable health information. In addition, do not
include any ``[t]rade secret or any commercial or financial information
which is obtained from any person and which is privileged or
confidential,'' as provided in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do
not include competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.
If you want the Commission to give your comment confidential
treatment, you must file it in paper form, with a request for
confidential treatment, and you have to follow the procedure explained
in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept
confidential only if the FTC General Counsel, in his or her sole
discretion, grants your request in accordance with the law and the
public interest.
---------------------------------------------------------------------------
\1\ In particular, the written request for confidential
treatment that accompanies the comment must include the factual and
legal basis for the request, and must identify the specific portions
of the comment to be withheld from the public record. See FTC Rule
4.9(c), 16 CFR 4.9(c).
---------------------------------------------------------------------------
Postal mail addressed to the Commission is subject to delay due to
heightened security screening. As a result, we encourage you to submit
your comments online. To make sure that the Commission considers your
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/grifols-talecris by following the instructions on the web-based
form. If this Notice appears at https://www.regulations.gov/#!home, you
also may file a comment through that Web site.
If you file your comment on paper, write ``Grifols-Talecris, File
No. 101 0151'' on your comment and on the envelope, and mail or deliver
it to the following address: Federal Trade Commission, Office of the
Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, NW.,
Washington, DC 20580. If possible, submit your paper comment to the
Commission by courier or overnight service.
Visit the Commission Web site at https://www.ftc.gov to read this
Notice and the news release describing it. The FTC Act and other laws
that the Commission administers permit the collection of public
comments to consider and use in this proceeding as
[[Page 33299]]
appropriate. The Commission will consider all timely and responsive
public comments that it receives on or before July 1, 2011. You can
find more information, including routine uses permitted by the Privacy
Act, in the Commission's privacy policy, at https://www.ftc.gov/ftc/privacy.htm.
Analysis of Agreement Containing Consent Order to Aid Public Comment
I. Introduction
The Federal Trade Commission (``Commission'') has accepted from
Grifols, S.A. (``Grifols'') and Talecris Biotherapeutics Holdings Corp.
(``Talecris''), subject to final approval, an Agreement Containing
Consent Orders (``Consent Agreement'') and Decision and Order, and has
issued a Complaint and the Order to Maintain Assets (``OMA'') contained
in the Consent Agreement. The Consent Agreement is designed to remedy
the anticompetitive effects resulting from Grifols' proposed
acquisition of Talecris (the ``Acquisition''). Under the Consent
Agreement, Grifols will: (i) Divest the fractionation facility
currently owned by Talecris in Melville, New York, to Kedrion S.p.A.
(``Kedrion''); (ii) divest plasma collection centers to Kedrion; (iii)
divest to Kedrion Talecris' Koate DVI plasma-derived Factor VIII
(``pdFVIII'') business, including the Koate brand name, in the United
States; and (iv) for a seven-year period, manufacture immune globulin
(``Ig''), albumin, and Koate for Kedrion to sell in the United States.
The proposed Consent Agreement has been placed on the public record
for 30 days to solicit comments from interested persons. Comments
received during this period will become part of the public record.
After 30 days, the Commission will again review the proposed Consent
Agreement and will decide whether it should withdraw from the proposed
Consent Agreement, modify it, or make it final.
On June 6, 2010, Grifols entered into an agreement to acquire
Talecris for approximately $3.4 billion in cash and stock. The
Commission's Complaint alleges that the Acquisition violates Section 5
of the FTC Act, as amended, 15 U.S.C. 45, and if consummated, would
violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and
Section 5 of the FTC Act by lessening competition in the U.S. markets
for Ig, albumin, and pdFVIII (the ``Relevant Products'').
II. The Parties
Grifols is a public company, headquartered in Barcelona, Spain. Its
bioscience division develops and manufactures human blood plasma-
derived products with manufacturing facilities in Barcelona and Los
Angeles, California. Grifols entered the U.S. market in 2002, when it
acquired the assets of a U.S. manufacturer, Alpha Therapeutics
Corporation, and 42 plasma collection centers from SeraCare. Since
then, Grifols has acquired additional plasma centers and is now
vertically integrated, making it the second largest plasma collector in
the world. Grifols employs approximately 6,000 people worldwide and had
global 2009 revenues of $1.3 billion.
Talecris is also a public company--owned in part by the private
investment firm Cerberus Capital Management, L.P. (``Cerberus'')--that
specializes in the development, manufacture, and worldwide sale of
human blood plasma-derived products. Talecris began its U.S. operations
in 2005, when Cerberus acquired Bayer AG's global plasma business and
Precision Pharma in the same year. Talecris is headquartered in
Research Triangle Park, North Carolina, with additional regional
headquarters in Canada and Germany. Like Grifols, Talecris is a
vertically integrated company, owning numerous plasma collection
centers, as well as manufacturing facilities in Clayton, North
Carolina, and Melville, New York. It employs approximately 5,000 people
worldwide and had global 2009 revenues of approximately $1.5 billion.
III. Market Structure and Relevant Products
A. Relevant Geographic Market
The relevant geographic market in which to analyze the
Acquisition's effects is the United States. Plasma-derived products
must be FDA-approved for sale in the United States, which requires that
these products be made solely from plasma collected in the United
States in FDA-approved collection centers and manufactured in FDA-
approved plants. Thus, plasma products not approved for sale in the
United States do not provide viable competitive alternatives for U.S.
consumers in the face of an increase in price for U.S. products.
B. Relevant Product Markets
i. Ig
Ig is a plasma protein replacement therapy largely used to treat
immune deficient patients. The relevant product market for Ig includes
all brands, concentrations (i.e., 5% and 10%), formulations (i.e.,
liquid and lyophilized/powder), and means of administration (i.e.,
intravenous and subcutaneous). Because intravenous Ig (``IVIG'')
accounts for the overwhelming majority of Ig sales in the United
States, industry participants often refer to the Ig market as the IVIG
market. Although IVIG is available in two concentrations (5% and 10%),
they are therapeutically equivalent. The main difference is one of
convenience: A 10% IVIG requires less volume, meaning treatment
typically takes less time. Ig has numerous FDA-approved indications
(e.g., primary immunodeficiencies and Chronic Inflammatory
Demyelinating Polyneuropathy), and there is a significant amount of
off-label use.
Hospitals, physicians, and patients would not switch, and
historically have not switched, from Ig products to non-Ig products in
response to a small but significant and non-transitory increase in
price (``SSNIP''). Although Ig products differ somewhat (e.g., based on
sucrose levels, immunoglobulin A content, or concentration), ample
evidence demonstrates that the brands and products are largely
interchangeable. Grifols and Talecris account for approximately 8.4%
and 22.8% of the U.S. Ig market, respectively, and their merger would
leave three manufacturers with nearly 100% of current U.S. Ig sales.
ii. Albumin
Physicians use albumin to expand blood volume, prime heart valves
during cardiac surgery, treat burn victims, and replace proteins in
treating liver failure. In the United States, the parties compete in
the sale of two different albumin concentrations: 5% and 25% liquid.
The 5% and 25% concentrations have different clinical uses, but if a 5%
product is unavailable, hospitals can dilute a 25% product to a 5%
concentration if necessary. On the manufacturing side, there are no
significant costs associated with shifting production between 5% and
25% albumin, and manufacturers can make such changes in a matter of
days. Because competitive conditions--including the number and identity
of suppliers--for 5% and 25% albumin solutions are the same, it is
appropriate to analyze albumin as a single market comprising both 5%
and 25% products.
In most circumstances where it is used, albumin has no viable
substitutes. While starches and salines can act as volume expanders
like 5% albumin, those non-albumin products cannot substitute for
albumin in the great majority of uses and do not meaningfully constrain
albumin prices and, hence, are not included in the relevant product
market. Even for those
[[Page 33300]]
few indications for which there might be a potential alternative
therapy, hospitals generally prefer albumin and would not switch from
albumin to another product in response to a SSNIP. Grifols and Talecris
have U.S. albumin market shares of approximately 13% each, and the
Acquisition would leave only four meaningful competitors in that
market.
iii. pdFVIII
Physicians use pdFVIII to treat bleeding disorders, namely
Hemophilia A and von Willebrand Disease (``VWD''). While both pdFVIII
and its non-plasma counterpart, recombinant Factor VIII (``rFVIII''),
can be used to treat Hemophilia A, rFVIII and pdFVIII have limited
interchangeability and, hence, limited ability to constrain each
other's prices. For instance, although rFVIII is the standard of care
for previously untreated patients with Hemophilia A (due to the
perception that pdFVIII carries an increased risk of viral
transmission), evidence suggests that patients using rFVIII are more
likely to develop inhibitors--antibodies that impede the treatment's
effectiveness. Thus, for some Hemophilia A patients, pdFVIII is the
only viable treatment. Likewise, patients with severe VWD are treated
with pdFVIII products containing von Willebrand Factor (``VWF''). No
recombinant products contain VWF, so those patients also may have no
choice but to use pdFVIII.
Clinical considerations, not price, determine whether a particular
patient is given pdFVIII or rFVIII, and hospitals would not switch from
pdFVIII to rFVIII in response to an increase in the price of pdFVIII.
Grifols and Talecris account for approximately 23% and 3.6% of the U.S.
pdFVIII market, respectively, and their merger would leave only three
meaningful competitors in that market.
IV. Industry Background and the Acquisition's Effects
A decade ago, there was robust competition in the plasma-derived
products industry. After supply increases in the early 2000s led to
lower prices, suppliers reduced production and plasma collection
capacity and began to vertically integrate, placing plasma collection
almost entirely in the control of the few remaining firms in the
market. Manufacturers also engaged in horizontal consolidation, leading
to an industry dominated by three large firms, including Talecris. In
the years that followed that consolidation, the Ig market in particular
experienced a tightening of supply and dramatic year-over-year price
increases.
The relevant markets have characteristics that allow manufacturers
to promote stability and rational, coordinated behavior. First, the
markets are transparent, with firms monitoring each other's
collections, output, pricing, and future expansion plans. Second, firms
have engaged in signaling to limit supply levels and maintain higher
prices. Third, if a firm were to ``break ranks'' from a coordinated
scheme, the other manufacturers can detect any ``cheating'' over the
course of the long manufacturing period and inflict punishment in other
geographic markets. Fourth, the relevant markets are characterized by
highly inelastic demand, increasing the firms' incentives to coordinate
because even a small change in supply can have a large effect on price.
The Acquisition would substantially lessen competition in the
relevant markets. It would eliminate actual, direct, and substantial
competition between Grifols and Talecris. Moreover, given that each of
the relevant markets already is highly concentrated, the Acquisition
would facilitate successful coordinated interaction among the few
remaining meaningful competitors, leading to reduced supply and higher
prices for consumers. In addition, the Acquisition increases the
likelihood that consumers would experience lower levels of innovation
and service in the markets for the Relevant Products.
V. Entry Conditions
Neither new entry nor expansion sufficient to deter or counteract
the Acquisition's anticompetitive effects is likely to occur within two
years. The barriers to entering the plasma fractionation industry are
extraordinary, with costs reaching hundreds of millions of dollars.
Indeed, the barriers are so immense that de novo entry is unrealistic
in less than five years. For example, an entrant must develop a product
and secure all necessary regulatory approvals, with the required
clinical trials alone taking up to three years. Additionally, the time
and capital investment required to build and obtain regulatory
clearance for a fractionation facility are significant, taking four to
eight years and costing $100 million or more. Finally, entrants must
navigate a substantial body of intellectual property in the field,
including trade secrets relating to purification and safety, and must
incur substantial product research and development costs before
bringing a product to market. Accordingly, new entry by a domestic or
foreign firm would not be timely, likely, or sufficient to counteract
the Acquisition's anticompetitive effects.
VI. The Consent Agreement
The proposed Consent Agreement requires Grifols to divest certain
assets to Kedrion and take other actions to alleviate the Acquisition's
effects. In particular, the Consent Agreement expedites the entry of an
additional competitor into each of the relevant markets, making a
potential industry-wide coordinated scheme more difficult, and limiting
the combined firm's ability to raise prices.
Kedrion possesses the resources and ability to be an effective
competitor and meaningful constraint on any potential coordination in
the industry. Created in 2001, Kedrion is the seventh largest
fractionator in the world. Specializing in the development, production,
and distribution of plasma-derived products, Kedrion actively sells
plasma-derived products in more than 30 countries. Kedrion currently
sells IVIG in a number of European and other markets and has started
the process for FDA approval of its own IVIG product for sale in the
United States. Kedrion also expects final FDA approval to sell a new
albumin product in the United States in 2011. It currently operates two
plants in Italy and is nearing completion of an expansion to its
manufacturing facility in Godollo, Hungary.
Under the Consent Agreement, Grifols will enter into a sale-and-
leaseback agreement with Kedrion for Talecris' Melville fractionation
facility. Specifically, Kedrion will acquire the Melville facility and
lease it back to Grifols for three to four years to ensure continuity
of operations; at the end of the lease term, Kedrion can assume
Melville operations and fractionate its own plasma. Additionally,
Grifols will divest to Kedrion plasma collection centers and sell
Kedrion an initial supply of raw plasma, ensuring that Kedrion will
have an independent and reliable source of raw plasma.
In addition, Grifols will manufacture and supply Kedrion with FDA-
approved and established IVIG, albumin, and pdFVIII products. Kedrion
will market and sell private-label versions of Talecris' Gamunex IVIG
and Plasbumin albumin for a period of seven years. And Grifols will
transfer to Kedrion all commercial agreements and rights to sell Koate
pdFVIII in the U.S. market, making Kedrion the sole provider of Koate
in the United States. Kedrion will also have the option to purchase the
rights to manufacture Koate for sale in the United States.
Through the Consent Agreement, Kedrion will have immediate market
access and the ability to supply customers with established products in
[[Page 33301]]
all three product markets. Kedrion's presence in the U.S. market will
add incremental supply of these life-saving products while still
allowing the combined firm to take full advantage of the Acquisition's
expected efficiencies. In addition, Kedrion will also have the
opportunity to hire Grifols and Talecris employees to facilitate its
entry and ensure continuity in the manufacture and sale of its
products. By eliminating many of the industry's immense barriers to
entry, the Consent Agreement will facilitate Kedrion's current and
future entry with its own IVIG and albumin products and position
Kedrion to replace the competition lost as a result of the Acquisition.
To ensure that the Commission remains informed about the status of
the proposed divestitures, the Consent Agreement also requires the
parties to file periodic reports with the Commission until the
divestitures are accomplished. Furthermore, the OMA requires that the
parties maintain all assets scheduled to transfer to Kedrion and
authorizes the Commission to appoint a monitor to oversee the various
agreements between Kedrion and Grifols. Under the OMA, Grifols and
Talecris must maintain the full economic viability, marketability, and
competitiveness of the proposed divested business and assets. This
includes, among other things, retaining all rights, title, and interest
in the divested assets, maintaining operations in their regular course,
and not interfering in Kedrion's hiring of designated Grifols and
Talecris employees. If Grifols does not comply with the OMA or any of
the Consent Agreement's other terms, the Commission may appoint a
divestiture trustee to divest the assets and enter into a product
manufacturing agreement with a Commission-approved acquirer.
The purpose of this analysis is to facilitate public comment on the
Consent Agreement. It is not intended to constitute an official
interpretation of the proposed Decision and Order or to modify its
terms in any way.
By direction of the Commission, Commissioner Kovacic recused and
Commissioner Brill issuing a separate concurring statement.
Donald S. Clark,
Secretary.
Concurring Statement of Commissioner Julie Brill
I concur in the Commission's decision to issue a complaint against
Grifols challenging its acquisition of Talecris. I write separately to
express my view that whether to resolve this matter through the
proposed consent order is a close call, though I ultimately concur in
that decision as well.
The vitally important plasma protein industry has seen considerable
consolidation in recent years. Today, only four significant active
competitors remain as to immune globulin (``Ig''), the largest product
by sales at issue in this merger: Grifols, Talecris, CSL and Baxter.\1\
In the meantime, prices have increased substantially. Just two years
ago, when CSL tried to buy Talecris, the Commission alleged that these
``price increases have been caused by the consolidation of competitors
and the resulting increases in concentration.'' \2\ The industry has
operated as a tight oligopoly in the words of a 2007 Department of
Health and Human Services report, carefully controlling supply,
avoiding robust price competition, and engaging in signaling of future
competitive moves.\3\
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\1\ A fifth competitor, Octapharma, withdrew its Ig product from
the market in September 2010 due to safety concerns. As the
Commission alleges in its complaint, ``its future competitive
significance is uncertain.''
\2\ Compl. ] 33, FTC v. CSL Ltd., No. 09-1000 (D.D.C., filed May
28, 2009), available at https://www.ftc.gov/os/caselist/0810255/091110csl-cerberusunsealedcmplt.pdf.
\3\ Id. ]] 37-44.
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One outgrowth of the supply limitations and coordinated behavior
described in the Commission's CSL complaint has been the difficulty
safety-net providers have had in obtaining Ig under the 340B Drug
Pricing Program. This Congressionally mandated program is designed to
provide pharmaceuticals at reduced prices to health care providers
serving indigent and other at-risk patients. All too often, however,
plasma-derivative manufacturers have not made their products available
at statutorily-mandated prices.\4\ This subverts Congress's goal of
ensuring access to life-saving pharmaceuticals and increases costs to
the health care system overall.
---------------------------------------------------------------------------
\4\ See, e.g., Public Hospital Pharmacy Coalition, ``Access to
IVIG by Safety Net Hospitals Participating in the 340B Drug Discount
Program'' (Sept. 2006), available at https://www.phpcrx.org/public/documents/pdfs/IVIG_report.pdf.
---------------------------------------------------------------------------
Against this backdrop, almost any merger in this industry would
merit the significant scrutiny this one has received at the FTC.
Although Grifols is today one of the smaller firms in the U.S. market,
with a roughly 9% share of Ig sales, it recently launched a new 10%
concentration intravenous Ig product that could threaten the industry-
leading products offered by Talecris, Baxter and CSL. In addition, as
alleged in the Commission's current complaint, the Ig market is highly
concentrated and the change in market concentration effected by this
merger easily raises a presumption of enhanced market power under the
antitrust agencies' 2010 Merger Guidelines.\5\ Finally, as also alleged
in the complaint, the risk of post-merger coordinated behavior is very
real, given the history of coordination in this industry and the fact
that the immediate post-merger U.S. Ig market will consist of three
firms of roughly equal size. Given these and other significant facts, I
strongly support issuance of the Commission's complaint.
---------------------------------------------------------------------------
\5\ The Ig market share and HHI figures in the Commission's
complaint date from 2009 and are thus conservative, as they count
Octapharma as a market participant, which it currently is not.
---------------------------------------------------------------------------
Whether the consent order does enough to remedy competition
concerns is a much closer call. On the one hand, the consent allows for
the near-term introduction of product into the market from a new
competitor, Kedrion. The consent should also facilitate Kedrion's entry
into the U.S. market with its own Ig product in several years. On the
other hand, Grifols will keep 67 of Talecris's 69 plasma collection
centers, as well as its own 80 centers, while divesting two to Kedrion.
In addition, the Melville, NY, manufacturing plant that Grifols is
divesting to Kedrion is a smaller facility that is not currently
outfitted to purify fractionated plasma into finished product. While
Grifols will fractionate and purify a ``Designated Amount of [finished]
Product'' for Kedrion for several years under the consent order,
Kedrion may need to build or purchase a new facility in order to
effectively compete over the longer term.\6\
---------------------------------------------------------------------------
\6\ Compare In re Polypore Int'l, Inc., 2010-2 Trade Cas. ]
77,267, 2010 FTC LEXIS 97, at *108-110 (F.T.C. 2010) (requiring
divestiture of second manufacturing plant to ensure that divestiture
assets constituted viable ongoing business).
---------------------------------------------------------------------------
In the end, given the particular facts and circumstances of this
matter, I support the consent because it provides some degree of
immediate, sure relief to consumers. I expect, though, that the
Commission, other Federal and State agencies, and affected purchasers
will closely monitor these markets, both as to future proposed
consolidations and potential coordinated behavior, including behavior
that may adversely impact indigent and other at-risk patients through
the critical 340B program.
[FR Doc. 2011-14082 Filed 6-7-11; 8:45 am]
BILLING CODE 6750-01-P