81 FR 9469 - Hikma Pharmaceuticals PLC and C.H. Boehringer Sohn AG & Co. KG; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 81, Issue 37 (February 25, 2016)

Page Range		9469-9472
FR Document		2016-04039

The consent agreement in this matter settles alleged violations of federal law prohibiting 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.

Federal Register, Volume 81 Issue 37 (Thursday, February 25, 2016)

[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9469-9472]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-04039]

-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 151-0044]

Hikma Pharmaceuticals PLC and C.H. Boehringer Sohn AG & Co. KG;
Analysis 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 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 March 22, 2016.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/hikmabenconsent online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write ``In the Matter of Hikma
Pharmaceuticals PLC and C.H. Boehringer Sohn AG & Co. KG,--Consent
Agreement; File No. 151-0044'' on your comment and file your comment
online at https://ftcpublic.commentworks.com/ftc/hikmabenconsent by
following the instructions on the web-based form. If you prefer to file
your comment on paper, write ``In the Matter of Hikma Pharmaceuticals
PLC and C.H. Boehringer Sohn AG & Co. KG,--Consent Agreement; File No.
151-0044'' on your comment and on the envelope, and mail your comment
to the following address: Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D),
Washington, DC 20580, or deliver your comment to the following address:
Federal Trade Commission, Office of the Secretary, Constitution Center,
400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC
20024.

FOR FURTHER INFORMATION CONTACT: Jordan Andrew (202-326-3678), Bureau
of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 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 February 19, 2016), on the World Wide Web,
at http://www.ftc.gov/os/actions.shtm.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before March 22, 2016.
Write ``In the Matter of Hikma Pharmaceuticals PLC and C.H. Boehringer
Sohn AG & Co. KG,--Consent Agreement; File No. 151-

[[Page 9470]]

0044'' 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 http://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 privileged or confidential,'' as discussed 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/hikmabenconsent by following the instructions on the web-based
form. If this Notice appears at http://www.regulations.gov/#!home, you
also may file a comment through that Web site.
If you file your comment on paper, write ``In the Matter of Hikma
Pharmaceuticals PLC and C.H. Boehringer Sohn AG & Co. KG,--Consent
Agreement; File No. 151-0044'' on your comment and on the envelope, and
mail your comment to the following address: Federal Trade Commission,
Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610
(Annex D), Washington, DC 20580, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024. If possible, submit your paper comment to the
Commission by courier or overnight service.
Visit the Commission Web site at http://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 appropriate. The
Commission will consider all timely and responsive public comments that
it receives on or before March 22, 2016. You can find more information,
including routine uses permitted by the Privacy Act, in the
Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

Analysis of Agreement Containing Consent Order To Aid Public Comment

The Federal Trade Commission (``Commission'') has accepted, subject
to final approval, an Agreement Containing Consent Order (``Consent
Agreement'') from Hikma Pharmaceuticals PLC (``Hikma'') and C.H.
Boehringer Sohn AG & Co. KG (``Boehringer'') that is designed to remedy
the anticompetitive effects that otherwise would have resulted from
Hikma's proposed acquisition of forty-nine Abbreviated New Drug
Applications (``ANDAs'') from Ben Venue Laboratories, Inc. (``Ben
Venue''), a subsidiary of Boehringer, in five generic injectable
pharmaceutical markets. Boehringer recently exited the markets related
to these ANDAs when it ceased its manufacturing and other operations
through Ben Venue. Under the terms of the proposed Consent Agreement,
Hikma is required to divest to Amphastar Pharmaceuticals, Inc.
(``Amphastar'') the Ben Venue ANDAs it will acquire from Boehringer
related to acyclovir sodium injection, diltiazem hydrochloride
injection, famotidine injection, prochlorperazine edisylate injection,
and valproate sodium injection.
The proposed Consent Agreement has been placed on the public record
for thirty days for receipt of comments from interested persons.
Comments received during this period will become part of the public
record. After thirty days, the Commission will again evaluate the
proposed Consent Agreement, along with the comments received, in order
to make a final decision as to whether it should withdraw from the
proposed Consent Agreement, or make final the Decision and Order
(``Order'').
Pursuant to a Sale and Purchase Agreement dated December 4, 2014
(``Proposed Acquisition''), Hikma proposes to acquire forty-nine ANDAs
from Boehringer for approximately $5 million. The Commission alleges in
its Complaint that the Proposed Acquisition, if consummated, would
violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and
Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C.
45, by lessening future competition in the markets for acyclovir sodium
injection, diltiazem hydrochloride injection, famotidine injection,
prochlorperazine edisylate injection, and valproate sodium injection in
the United States. The proposed Consent Agreement will remedy the
alleged violations by replacing the competition that would otherwise be
eliminated by the Proposed Acquisition.

I. The Relevant Products and Structure of the Markets

The relevant products are all generic versions of injectable
pharmaceutical products. Generic versions of these products are usually
launched after a branded product's patents expire, or a generic
supplier successfully challenges such patents in court or reaches a
legal settlement with the branded manufacturer. Once multiple generic
suppliers enter a market, the branded drug manufacturer usually ceases
to provide any competitive constraint on the prices for generic
versions of the drug. Rather, the generic suppliers compete only
against each other. Sometimes, however, a branded injectable drug
manufacturer may choose to lower its price and compete against generic
versions of the drug, in which case it would be a participant in the
generic drug market.
The relevant products at issue and the structure of each of the
relevant markets is as follows:
Acyclovir sodium injection is an antiviral drug used to
treat chicken pox, herpes, and other related infections. Three firms,
Boehringer, Fresenius Kabi

[[Page 9471]]

AG (``Fresenius''), and AuroMedics Pharma LLC (``AuroMedics''),
currently have ANDAs for this drug that have been approved by the U.S.
Food and Drug Administration (``FDA''). Only Fresenius and AuroMedics
currently supply acyclovir sodium injection to the market. Hikma and
one other firm are likely to enter the market in the near future. The
Proposed Acquisition would therefore reduce the number of likely future
suppliers of acyclovir sodium injection from five to four.
Diltiazem hydrochloride injection is a calcium channel
blocker and antihypertensive used to treat hypertension, angina, and
arrhythmias. There are four firms that currently have FDA-approved
ANDAs for diltiazem hydrochloride injection, Hikma, Boehringer,
Hospira, Inc. (``Hospira''), and Akorn, Inc. (``Akorn''), but only
Hikma, Hospira, and Akorn currently supply the market. No other firms
are likely to enter the market in the near future. Thus, the Proposed
Acquisition would reduce the number of likely future suppliers of
diltiazem hydrochloride injection from four to three.
Famotidine injection treats ulcers and gastroesophageal
reflux disease. Three firms currently sell the vial presentation of
famotidine injection, Hikma, Fresenius, and Mylan N.V. Boehringer has
an FDA-approved ANDA for famotidine injection vials, but had no sales
of the drug in 2014. No other companies appear to be poised to enter
the market in the near future. The Proposed Acquisition would therefore
reduce the number of likely future suppliers of famotidine injection
from four to three.
Prochlorperazine edisylate injection is an antipsychotic
used to treat schizophrenia and nausea. Boehringer owned virtually the
entire market for prochlorperazine edisylate injection in 2013, but it
exited the market in mid-2014. Since that time, Heritage
Pharmaceuticals Inc. has assumed all sales of prochlorperazine
edisylate injection. Hikma is the only other company that has an FDA-
approved ANDA for prochlorperazine edisylate injection, but it is not
currently supplying the market. Another firm has prochlorperazine
edisylate injection in its development pipeline and anticipates
achieving FDA approval of its ANDA in the near future. Thus, the
Proposed Acquisition would reduce the number of likely future suppliers
of prochlorperazine edisylate injection from four to three.
Valproate sodium injection is used to treat epilepsy,
seizures, bipolar disorder, anxiety, and migraine headaches. There are
two firms that currently supply valproate sodium injection in the
market, Hikma and Fresenius. Boehringer has an FDA-approved ANDA for
valproate sodium injection but exited the market in July 2014. Another
firm has valproate sodium injection in its development pipeline and
anticipates achieving FDA approval of its ANDA in the near future.
Thus, the Proposed Acquisition would reduce the number of likely future
suppliers of valproate sodium injection from four to three.

II. Competitive Effects

The transaction will reduce competition by decreasing the number of
future suppliers in in each of these markets; in generic pharmaceutical
products, prices generally decrease as the number of competing generic
suppliers increases. In addition, the injectable pharmaceutical
industry generally, and the generic products at issue in this
investigation in particular, are highly susceptible to supply
disruptions caused by the inherent difficulties of producing sterile
liquid drugs. Recent manufacturing problems have made it difficult for
customers to obtain sufficient quantities of, and contributed to price
increases of, several of the generic injectable products impacted by
this transaction. By reducing the number of likely future competitors
in these markets, the Proposed Acquisition will likely create a direct
and substantial anticompetitive effect on prices for each of the
relevant products, absent the remedies required by the proposed Consent
Agreement.
In each of the relevant markets, either Hikma or Boehringer, or
both, currently do not supply an existing generic product. For markets
in which Hikma is not a current competitor, it is likely to become one
in the near future. Boehringer has recently exited each of these
markets, but, absent the Proposed Acquisition, it would have had the
incentive to sell these ANDAs to a third-party supplier who would
likely bring these products to market. Hikma, which already has an
approved ANDA or is likely to soon achieve FDA approval for an ANDA in
each of the five relevant markets at issue, lacks that incentive, and
thus, customers would be deprived of the price decreases that likely
would have accompanied third-party entry into each of these
concentrated markets.

III. Entry

Entry into each of these generic injectable product markets will
not be timely, likely, or sufficient in magnitude, character, and scope
to deter or counteract the likely anticompetitive effects of the
Proposed Acquisition. The combination of drug development times and
regulatory requirements, including FDA approval, takes well in excess
of two years.

IV. The Consent Agreement

The Consent Agreement effectively remedies the Proposed
Acquisition's anticompetitive effects in each relevant market. Under
the Consent Agreement, Hikma is required to divest the Ben Venue ANDAs
it will acquire from Boehringer related to acyclovir sodium injection,
diltiazem hydrochloride injection, famotidine injection,
prochlorperazine edisylate injection, and valproate sodium injection to
Amphastar. Hikma must accomplish these divestitures and relinquish its
rights no later than ten days after the acquisition.
Amphastar is a global pharmaceutical company based in Rancho
Cucamonga, California and has over 1,200 employees worldwide. The
company owns five pharmaceutical manufacturing facilities and produces
a variety of branded and generic pharmaceutical products. Amphastar
manufactures and sells sixteen injectable drug products in the United
States, as well as a broad range of other pharmaceutical dosage
formulations, including emulsions, suspensions, jellies, and
lyophilized products. The company sells most of its products through
long-standing relationships with major group purchasing organizations,
drug wholesalers, and retailers in the United States. With its
experience in generic markets, and in injectable products in
particular, Amphastar is expected to replicate fully the competition
that would otherwise have been lost as a result of the Proposed
Acquisition.
The Commission's goal in evaluating possible acquirers of divested
assets is to maintain the competitive environment that existed prior to
the acquisition. If the Commission determines that Amphastar is not an
acceptable acquirer, or that the manner of the divestitures or releases
is not acceptable, the parties must unwind the sale or release of
rights to Amphastar and divest the products to a Commission-approved
acquirer within six months of the date the Order becomes final. In that
circumstance, the Commission may appoint a trustee to divest the
products if the parties fail to divest the products as required.
The proposed Consent Agreement contains several provisions to help
ensure that the divestitures are successful. The Order requires
Boehringer to maintain the economic viability, marketability, and

[[Page 9472]]

competitiveness of the assets to be divested until they are transferred
to Hikma, and requires Hikma to do the same until such time as they are
transferred to a Commission-approved acquirer. The Order also requires
that the parties transfer all confidential business information,
regulatory, formulation, and manufacturing reports, as well as provide
access to employees who possess or are able to identify such
information. Because the products related to the Boehringer (Ben Venue)
ANDA assets have already exited the market, the Order does not require
a transitional supply agreement.
The purpose of this analysis is to facilitate public comment on the
proposed Consent Agreement, and it is not intended to constitute an
official interpretation of the proposed Order or to modify its terms in
any way.

By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2016-04039 Filed 2-24-16; 8:45 am]
BILLING CODE 6750-01-P

Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices 9469

doxycycline monohydrate capsules as that Lupin supply G&W with generic embodied in the consent agreement—
commodity products. As the number of doxycycline monohydrate capsules for that would settle these allegations.
suppliers offering a therapeutically two years while Lupin transfers the DATES: Comments must be received on
equivalent drug increases, the price for manufacturing technology to G&W’s or before March 22, 2016.
that drug generally decreases due to the facility. To ensure the success of the ADDRESSES: Interested parties may file a
direct competition between the existing generic doxycycline monohydrate comment at https://
suppliers and each additional supplier. capsules divestiture, the proposed D&O ftcpublic.commentworks.com/ftc/
The Proposed Acquisitions would requires Lupin to provide transitional hikmabenconsent online or on paper, by
combine two of only four companies services to assist G&W in establishing its following the instructions in the
offering the 50 mg and 75 mg strengths manufacturing capabilities and securing Request for Comment part of the
of generic doxycycline monohydrate all of the necessary FDA approvals. SUPPLEMENTARY INFORMATION section
capsules, likely leading consumers to These transitional services include below. Write ‘‘In the Matter of Hikma
pay higher prices. technical assistance to manufacture the Pharmaceuticals PLC and C.H.
In addition, the Proposed product in substantially the same Boehringer Sohn AG & Co. KG,—
Acquisitions likely would cause manner and quality employed or Consent Agreement; File No. 151–0044’’
significant anticompetitive harm to achieved by Gavis, and advice and on your comment and file your
consumers by eliminating future generic training from knowledgeable employees comment online at https://
competition that would otherwise have of the parties. ftcpublic.commentworks.com/ftc/
occurred in the mesalamine ER capsule To assist G&W with completing the hikmabenconsent by following the
market if Lupin and Gavis remained regulatory work and setting up and instructions on the web-based form. If
independent. The evidence shows that validating the manufacturing for the you prefer to file your comment on
anticompetitive effects are likely to generic mesalamine ER product, G&W paper, write ‘‘In the Matter of Hikma
result from the Proposed Acquisitions will enter into a consulting agreement Pharmaceuticals PLC and C.H.
due to the elimination of an additional with Gavis’s current CEO, Dr. Boehringer Sohn AG & Co. KG,—
independent entrant in the market for Veerappan Subramanian, who will not Consent Agreement; File No. 151–0044’’
generic mesalamine ER. Customers and be employed by Lupin post-transaction. on your comment and on the envelope,
competitors expect that the price of this Dr. Subramanian is the founder of Gavis and mail your comment to the following
pharmaceutical product will decrease and has previously served as the chief address: Federal Trade Commission,
with new entry by Lupin and Gavis. scientist for the company. He has been Office of the Secretary, 600
Thus, absent a remedy, the Proposed involved with the development and Pennsylvania Avenue NW., Suite CC–
Acquisitions will likely cause U.S. manufacturing of the generic 5610 (Annex D), Washington, DC 20580,
consumers to pay significantly higher mesalamine ER product since the or deliver your comment to the
prices for generic mesalamine ER. company started the formulation. G&W following address: Federal Trade
IV. The Consent Agreement will also inherit Gavis’s ongoing patent Commission, Office of the Secretary,
The proposed Consent Agreement litigation related to mesalamine ER. Constitution Center, 400 7th Street SW.,
effectively remedies the competitive G&W intends to retain Gavis’s current 5th Floor, Suite 5610 (Annex D),
concerns raised by the acquisitions in counsel to continue the litigation. Washington, DC 20024.
the markets at issue by requiring Gavis The purpose of this analysis is to FOR FURTHER INFORMATION CONTACT:
to divest all its rights and assets relating facilitate public comment on the Jordan Andrew (202–326–3678), Bureau
to doxycycline monohydrate capsules proposed Consent Agreement, and it is of Competition, 600 Pennsylvania
and mesalamine ER to G&W. Founded not intended to constitute an official Avenue NW., Washington, DC 20580.
in 1919, G&W is a privately held, interpretation of the proposed Order or SUPPLEMENTARY INFORMATION: Pursuant
family-owned, generic pharmaceutical to modify its terms in any way. to Section 6(f) of the Federal Trade
company. G&W develops, manufactures, By direction of the Commission. Commission Act, 15 U.S.C. 46(f), and
sells, and distributes generic Donald S. Clark, FTC Rule 2.34, 16 CFR 2.34, notice is
pharmaceuticals and over-the-counter Secretary. hereby given that the above-captioned
products within the United States. [FR Doc. 2016–04040 Filed 2–24–16; 8:45 am]
consent agreement containing a consent
The Commission’s goal in evaluating order to cease and desist, having been
BILLING CODE 6750–01–P
possible purchasers of divested assets is filed with and accepted, subject to final
to maintain the competitive approval, by the Commission, has been
environment that existed prior to the FEDERAL TRADE COMMISSION placed on the public record for a period
Proposed Acquisitions. If the of thirty (30) days. The following
Commission determines that G&W is not Analysis to Aid Public Comment
[File No. 151–0044]
an acceptable acquirer, or that the describes the terms of the consent
manner of the divestitures is not Hikma Pharmaceuticals PLC and C.H. agreement, and the allegations in the
acceptable, the proposed Order requires Boehringer Sohn AG & Co. KG; complaint. An electronic copy of the
the parties to unwind the sale of rights Analysis To Aid Public Comment full text of the consent agreement
to G&W and then divest the products to package can be obtained from the FTC
a Commission-approved acquirer within AGENCY: Federal Trade Commission. Home Page (for February 19, 2016), on
six months of the date the Order ACTION: Proposed Consent Agreement. the World Wide Web, at http://
mstockstill on DSK4VPTVN1PROD with NOTICES

becomes final. The proposed Order www.ftc.gov/os/actions.shtm.
further allows the Commission to SUMMARY: The consent agreement in this You can file a comment online or on
appoint a trustee in the event the parties matter settles alleged violations of paper. For the Commission to consider
fail to divest the products as required. federal law prohibiting unfair methods your comment, we must receive it on or
The proposed Consent Agreement and of competition. The attached Analysis to before March 22, 2016. Write ‘‘In the
Order contain several provisions to help Aid Public Comment describes both the Matter of Hikma Pharmaceuticals PLC
ensure that the divestitures are allegations in the draft complaint and and C.H. Boehringer Sohn AG & Co.
successful. The proposed D&O requires the terms of the consent order— KG,—Consent Agreement; File No. 151–

VerDate Sep<11>2014 18:07 Feb 24, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices 9471

AG (‘‘Fresenius’’), and AuroMedics headaches. There are two firms that effects of the Proposed Acquisition. The
Pharma LLC (‘‘AuroMedics’’), currently currently supply valproate sodium combination of drug development times
have ANDAs for this drug that have injection in the market, Hikma and and regulatory requirements, including
been approved by the U.S. Food and Fresenius. Boehringer has an FDA- FDA approval, takes well in excess of
Drug Administration (‘‘FDA’’). Only approved ANDA for valproate sodium two years.
Fresenius and AuroMedics currently injection but exited the market in July
IV. The Consent Agreement
supply acyclovir sodium injection to the 2014. Another firm has valproate
market. Hikma and one other firm are sodium injection in its development The Consent Agreement effectively
likely to enter the market in the near pipeline and anticipates achieving FDA remedies the Proposed Acquisition’s
future. The Proposed Acquisition would approval of its ANDA in the near future. anticompetitive effects in each relevant
therefore reduce the number of likely Thus, the Proposed Acquisition would market. Under the Consent Agreement,
future suppliers of acyclovir sodium reduce the number of likely future Hikma is required to divest the Ben
injection from five to four. suppliers of valproate sodium injection Venue ANDAs it will acquire from
• Diltiazem hydrochloride injection is from four to three. Boehringer related to acyclovir sodium
a calcium channel blocker and injection, diltiazem hydrochloride
antihypertensive used to treat II. Competitive Effects injection, famotidine injection,
hypertension, angina, and arrhythmias. The transaction will reduce prochlorperazine edisylate injection,
There are four firms that currently have competition by decreasing the number and valproate sodium injection to
FDA-approved ANDAs for diltiazem of future suppliers in in each of these Amphastar. Hikma must accomplish
hydrochloride injection, Hikma, markets; in generic pharmaceutical these divestitures and relinquish its
Boehringer, Hospira, Inc. (‘‘Hospira’’), products, prices generally decrease as rights no later than ten days after the
and Akorn, Inc. (‘‘Akorn’’), but only the number of competing generic acquisition.
Hikma, Hospira, and Akorn currently suppliers increases. In addition, the Amphastar is a global pharmaceutical
supply the market. No other firms are injectable pharmaceutical industry company based in Rancho Cucamonga,
likely to enter the market in the near generally, and the generic products at California and has over 1,200 employees
future. Thus, the Proposed Acquisition issue in this investigation in particular, worldwide. The company owns five
would reduce the number of likely are highly susceptible to supply pharmaceutical manufacturing facilities
future suppliers of diltiazem disruptions caused by the inherent and produces a variety of branded and
hydrochloride injection from four to difficulties of producing sterile liquid generic pharmaceutical products.
three. drugs. Recent manufacturing problems Amphastar manufactures and sells
• Famotidine injection treats ulcers have made it difficult for customers to sixteen injectable drug products in the
and gastroesophageal reflux disease. obtain sufficient quantities of, and United States, as well as a broad range
Three firms currently sell the vial contributed to price increases of, several of other pharmaceutical dosage
presentation of famotidine injection, of the generic injectable products formulations, including emulsions,
Hikma, Fresenius, and Mylan N.V. impacted by this transaction. By suspensions, jellies, and lyophilized
Boehringer has an FDA-approved ANDA reducing the number of likely future products. The company sells most of its
for famotidine injection vials, but had competitors in these markets, the products through long-standing
no sales of the drug in 2014. No other Proposed Acquisition will likely create relationships with major group
companies appear to be poised to enter a direct and substantial anticompetitive purchasing organizations, drug
the market in the near future. The effect on prices for each of the relevant wholesalers, and retailers in the United
Proposed Acquisition would therefore products, absent the remedies required States. With its experience in generic
reduce the number of likely future by the proposed Consent Agreement. markets, and in injectable products in
suppliers of famotidine injection from In each of the relevant markets, either particular, Amphastar is expected to
four to three. Hikma or Boehringer, or both, currently replicate fully the competition that
• Prochlorperazine edisylate injection do not supply an existing generic would otherwise have been lost as a
is an antipsychotic used to treat product. For markets in which Hikma is result of the Proposed Acquisition.
schizophrenia and nausea. Boehringer not a current competitor, it is likely to The Commission’s goal in evaluating
owned virtually the entire market for become one in the near future. possible acquirers of divested assets is
prochlorperazine edisylate injection in Boehringer has recently exited each of to maintain the competitive
2013, but it exited the market in mid- these markets, but, absent the Proposed environment that existed prior to the
2014. Since that time, Heritage Acquisition, it would have had the acquisition. If the Commission
Pharmaceuticals Inc. has assumed all incentive to sell these ANDAs to a third- determines that Amphastar is not an
sales of prochlorperazine edisylate party supplier who would likely bring acceptable acquirer, or that the manner
injection. Hikma is the only other these products to market. Hikma, which of the divestitures or releases is not
company that has an FDA-approved already has an approved ANDA or is acceptable, the parties must unwind the
ANDA for prochlorperazine edisylate likely to soon achieve FDA approval for sale or release of rights to Amphastar
injection, but it is not currently an ANDA in each of the five relevant and divest the products to a
supplying the market. Another firm has markets at issue, lacks that incentive, Commission-approved acquirer within
prochlorperazine edisylate injection in and thus, customers would be deprived six months of the date the Order
its development pipeline and of the price decreases that likely would becomes final. In that circumstance, the
anticipates achieving FDA approval of have accompanied third-party entry into Commission may appoint a trustee to
mstockstill on DSK4VPTVN1PROD with NOTICES

its ANDA in the near future. Thus, the each of these concentrated markets. divest the products if the parties fail to
Proposed Acquisition would reduce the divest the products as required.
number of likely future suppliers of III. Entry The proposed Consent Agreement
prochlorperazine edisylate injection Entry into each of these generic contains several provisions to help
from four to three. injectable product markets will not be ensure that the divestitures are
• Valproate sodium injection is used timely, likely, or sufficient in successful. The Order requires
to treat epilepsy, seizures, bipolar magnitude, character, and scope to deter Boehringer to maintain the economic
disorder, anxiety, and migraine or counteract the likely anticompetitive viability, marketability, and

VerDate Sep<11>2014 18:07 Feb 24, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

9472 Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices

competitiveness of the assets to be GENERAL SERVICES a Federal building. Public Law 114–48,
divested until they are transferred to ADMINISTRATION 129 STAT. 488, dated August 7, 2015,
Hikma, and requires Hikma to do the designated the Hollings Judicial Center
[Notice-PBS–2015–01; Docket 2015–0002;
same until such time as they are Sequence 30]
located at 83 Meeting Street in
transferred to a Commission-approved Charleston, South Carolina as the ‘‘J.
acquirer. The Order also requires that Federal Management Regulation; Waties Waring Judicial Center.’’
the parties transfer all confidential Redesignation of Federal Building Dated: February 17, 2016.
business information, regulatory,
AGENCY: Public Buildings Service (PBS), Denise Turner Roth,
formulation, and manufacturing reports,
as well as provide access to employees General Services Administration. Administrator of General Services.
who possess or are able to identify such ACTION: Notice of a bulletin. General Services Administration
information. Because the products
related to the Boehringer (Ben Venue) SUMMARY: The attached bulletin Redesignation of Federal Building
ANDA assets have already exited the announces the redesignation of a
PBS–2015–01
market, the Order does not require a Federal building.
DATES: This bulletin expires August 26,
TO: Heads of Federal Agencies
transitional supply agreement.
2016. The building redesignation SUBJECT: Redesignation of Federal
The purpose of this analysis is to Building
remains in effect until canceled or
facilitate public comment on the 1. What is the purpose of this bulletin?
superseded by another bulletin.
proposed Consent Agreement, and it is This bulletin announces the redesignation of
not intended to constitute an official FOR FURTHER INFORMATION CONTACT: a Federal building.
interpretation of the proposed Order or General Services Administration, Public 2. When does this bulletin expire? This
to modify its terms in any way. Buildings Service (PBS), Office of bulletin announcement expires August 26,
Portfolio Management, Attn: Chandra 2016. The building designation remains in
By direction of the Commission. Kelley, 77 Forsyth Street SW., Atlanta, effect until canceled or superseded by
Donald S. Clark, GA 30303, at 404–562–2763, or by email another bulletin.
Secretary. at chandra.kelley@gsa.gov. 3. Redesignation. The former and new
[FR Doc. 2016–04039 Filed 2–24–16; 8:45 am] SUPPLEMENTARY INFORMATION: This name of the redesignated building is as
BILLING CODE 6750–01–P bulletin announces the redesignation of follows:

Former name New name

Hollings Judicial Center, 83 Meeting Street Charleston, SC 29401– J. Waties Waring Judicial Center, 83 Meeting Street Charleston, SC
2256. 29401–2256.

4. Who should we contact for further (WTC) Health Program Scientific/ implementation and improvement of the
information regarding redesignation of this Technical Advisory Committee (STAC). WTC Health Program, as outlined in the
Federal building? U.S. General Services PHS Act, at the discretion of the WTC
Administration, Public Buildings Service,
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010, Program Administrator.
Office of Portfolio Management, Attn:
Public Law 111–347 (Jan. 2, 2011), In accordance with Section 3302(a)(2)
Chandra Kelley, 77 Forsyth Street SW.,
Atlanta, GA 30303, telephone number: 404– amended by Public Law 114–113 (Dec. of the PHS Act, the WTC Program
562–2763, or email at chandra.kelley@ 18, 2015), added Title XXXIII to the Administrator will appoint the members
gsa.gov. Public Health Service Act (PHS Act), of the committee, which must include at
establishing the WTC Health Program least:
Dated:
within HHS (42 U.S.C. 300mm to • 4 occupational physicians, at least
Denise Turner Roth, two of whom have experience treating
Administrator of General Services.
300mm–61). Section 3302(a) of the PHS
Act established the WTC Health WTC rescue and recovery workers;
[FR Doc. 2016–03963 Filed 2–24–16; 8:45 am]
Program STAC. The STAC is governed • 1 physician with expertise in
BILLING CODE 6820–Y1–P by the provisions of the Federal pulmonary medicine;
Advisory Committee Act, as amended • 2 environmental medicine or
(Pub. L. 92–463, 5 U.S.C. App.), which environmental health specialists;
• 2 representatives of WTC
sets forth standards for the formation
DEPARTMENT OF HEALTH AND responders;
and use of advisory committees in the
HUMAN SERVICES • 2 representatives of certified-
Executive Branch. PHS Act Section
eligible WTC survivors;
Centers for Disease Control and 3302(a)(1) establishes that the STAC • 1 industrial hygienist;
Prevention will review scientific and medical • 1 toxicologist;
evidence and make recommendations to • 1 epidemiologist; and
Request for Nominations of the WTC Program Administrator on • 1 mental health professional.
Candidates To Serve on the World additional WTC Health Program At this time the Administrator is
Trade Center Health Program eligibility criteria and on additional seeking nominations for members
mstockstill on DSK4VPTVN1PROD with NOTICES

Scientific/Technical Advisory WTC-related health conditions. Section fulfilling the following categories:
Committee (the STAC or the 3341(c) of the PHS Act requires the • Environmental medicine or
Committee), Centers for Disease WTC Program Administrator to also environmental health specialist
Control and Prevention, Department of consult with the STAC on research • Occupational physician;
Health and Human Services regarding certain health conditions • Pulmonary physician;
related to the September 11, 2001 • Representative of WTC responders;
The CDC is soliciting nominations for terrorist attacks. The STAC may also be • Representative of certified-eligible
membership on the World Trade Center consulted on other matters related to WTC survivors.

VerDate Sep<11>2014 18:07 Feb 24, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

Document Created: 2018-02-02 14:35:09
Document Modified: 2018-02-02 14:35:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Proposed Consent Agreement.
Dates		Comments must be received on or before March 22, 2016.
Contact		Jordan Andrew (202-326-3678), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
FR Citation		81 FR 9469