Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Notices 26355 

Authority: Government in the 

Sunshine Act, 5 U.S.C. 552b. 

Laura E. Sinram, 

Acting Secretary and Clerk of the 

Commission. 

[FR Doc. 2022–09667 Filed 5–2–22; 4:15 pm] 

BILLING CODE 6715–01–P 

FEDERAL TRADE COMMISSION 

[File No. 221 0002] 

Hikma Pharmaceuticals PLC/ 

Custopharm, Inc.; Analysis of 

Agreement Containing Consent Orders 

To Aid Public Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed consent agreement; 

request for comment. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

federal law prohibiting unfair methods 

of competition. The attached Analysis of 

Proposed Consent Orders to Aid Public 

Comment describes both the allegations 

in the complaint and the terms of the 

consent orders—embodied in the 

consent agreement—that would settle 

these allegations. 

DATES: Comments must be received on 

or before June 3, 2022. 

ADDRESSES: Interested parties may file 

comments online or on paper, by 

following the instructions in the 

Request for Comment part of the 

SUPPLEMENTARY INFORMATION section 

below. Please write: ‘‘Hikma/ 

Custopharm; File No. 221 0002’’ on your 

comment and file your comment online 

at https://www.regulations.gov by 

following the instructions on the webbased form. If you prefer to file your 

comment on paper, please 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. 

FOR FURTHER INFORMATION CONTACT: 

Steven Wilensky (202–326–2650), 

Bureau of Competition, Federal Trade 

Commission, 400 7th Street SW, 

Washington, DC 20024. 

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 of Agreement Containing 

Consent Orders 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 

website at this web address: https://

www.ftc.gov/news-events/commissionactions. 

You can file a comment online or on 

paper. For the Commission to consider 

your comment, we must receive it on or 

before June 3, 2022. Write ‘‘Hikma/ 

Custopharm; File No. 221 0002’’ 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 https://

www.regulations.gov website. 

Due to protective actions in response 

to the COVID–19 pandemic and the 

agency’s heightened security screening, 

postal mail addressed to the 

Commission will be delayed. We 

strongly encourage you to submit your 

comments online through the https://

www.regulations.gov website. 

If you prefer to file your comment on 

paper, write ‘‘Hikma/Custopharm; File 

No. 221 0002’’ 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. 

Because your comment will be placed 

on the publicly accessible website at 

https://www.regulations.gov, you are 

solely responsible for making sure your 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include sensitive personal information, 

such as your or anyone else’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 your 

comment does not include sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by 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)— 

including competitively sensitive 

information such as costs, sales 

statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

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). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on https://

www.regulations.gov—as legally 

required by FTC Rule 4.9(b)—we cannot 

redact or remove your comment from 

that website, unless you submit a 

confidentiality request that meets the 

requirements for such treatment under 

FTC Rule 4.9(c), and the General 

Counsel grants that request. 

Visit the FTC website at https://

www.ftc.gov to read this Notice and the 

news release describing this matter. The 

FTC Act and other laws 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 it 

receives on or before June 3, 2022. For 

information on the Commission’s 

privacy policy, including routine uses 

permitted by the Privacy Act, see 

https://www.ftc.gov/site-information/ 

privacy-policy. 

Analysis of Agreement Containing 

Consent Orders 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’’), 

Custopharm, Inc. (‘‘Custopharm’’), 

Water Street Healthcare Partners, LLC 

(‘‘Water Street’’), Water Street 

Healthcare Partners III, L.P. (‘‘Fund III’’), 

Water Street Healthcare Partners IV 

(‘‘Fund IV’’), L.P., and Long Grove 

Pharmaceuticals, LLC (‘‘Long Grove’’) 

(collectively, ‘‘Respondents’’). The 

purpose of the Consent Agreement is to 

remedy the anticompetitive effects that 

would likely result from Hikma’s 

acquisition of Custopharm (‘‘the 

Proposed Acquisition’’). Pursuant to an 

agreement dated September 27, 2021, 

Hikma proposes to acquire Custopharm 

in a transaction valued at approximately 

$375 million. As part of the Proposed 

Acquisition, Custopharm agreed to 

carve out one of its pipeline products, 

injectable triamcinolone acetonide 


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26356 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Notices 

(‘‘TCA’’), and transferred its TCA assets 

to Long Grove. 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 U.S. market 

for injectable TCA. The Consent 

Agreement will remedy the alleged 

violations by preserving the competition 

that otherwise would be eliminated by 

the Proposed Acquisition. 

Under the terms of the proposed 

Decision and Order (‘‘Order’’), 

Respondent Hikma shall not acquire any 

rights or interests in TCA products or 

assets, or any rights or interests in the 

therapeutical equivalent or biosimilar of 

TCA products without the prior 

approval of the Commission. The Order 

requires Respondents Long Grove and 

Water Street to operate and maintain in 

the normal course of business the TCA 

assets previously operated by 

Custopharm for a period lasting until 

four years after the Order date. 

The 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 

Consent Agreement, along with the 

comments received, to make a final 

decision as to whether it should 

withdraw from the consent agreement, 

modify it, or make final the proposed 

Order. 

I. The Respondents 

Respondent Hikma is a multinational 

pharmaceutical company with 

headquarters in London, England, and 

U.S. headquarters in Berkeley Heights, 

New Jersey. Hikma manufactures both 

branded and generic pharmaceutical 

products, including generic injectables. 

Respondent Custopharm is 

incorporated in the State of Texas with 

its principal place of business located in 

Carlsbad, California. Water Street owns 

a majority of Custopharm. Custopharm 

develops generic pharmaceutical 

products but does not have any of its 

own manufacturing capabilities and 

manufacturers its products exclusively 

through contract manufacturers. Those 

products are then sold through 

Custopharm’s commrcial arm, Leucadia 

Pharmaceuticals. 

Respondent Water Street Healthcare 

Partners, LLC is a private equity firm 

headquartered in Chicago, Illinois. 

Water Street is the General Partner of 

Respondents Fund III and Fund IV. 

Respondent Fund III is a private equity 

fund managed by Water Street located 

in Chicago, Illinois. Fund III’s portfolio 

includes Custopharm. Respondent Fund 

IV is a private equity fund managed by 

Water Street located in Chicago, Illinois. 

Fund IV’s portfolio includes Long 

Grove. Respondent Long Grove is a 

pharmaceutical company launched in 

2019 and headquartered in Rosemont, 

Illinois. Long Grove is owned by Fund 

IV. 

II. The Relevant Market 

In human pharmaceutical markets, 

prices generally decrease as the number 

of generic competitors increases. Prices 

continue to decrease incrementally with 

the entry of the second, third, fourth, 

and further pharmaceutical competitors. 

Accordingly, a reduction in the number 

of suppliers within each relevant market 

has a direct and substantial effect on 

pricing. 

The Proposed Acquisition would 

reduce future competition in the market 

for injectable TCA. Injectable TCA is a 

corticosteroid used for severe skin 

conditions and inflammation. Only 

three competitors currently market 

injectable TCA: Bristol-Meyers Squibb, 

Amneal Biosciences, and Teva 

Pharmaceutical Industries. Hikma and 

Custopharm are two of a limited number 

of suppliers capable of entering the TCA 

market in the near future. 

III. Entry 

Entry into the market at issue would 

not be timely, likely, or sufficient in 

magnitude, character, and scope to deter 

or counteract the anticompetitive effects 

of the Proposed Acquisition. The 

combination of drug development times 

and regulatory requirements, including 

approval by the FDA, is costly and 

lengthy. 

IV. Competitive Effects 

The effect of the Proposed 

Acquisition, if consummated, is likely 

to substantially lessen competition by 

eliminating future competition between 

Hikma and Custopharm in the market 

for injectable TCA. The evidence shows 

that the Proposed Acquisition, absent a 

remedy, would eliminate an additional 

independent entrant in the currently 

concentrated market for injectable TCA, 

which would have enabled customers to 

negotiate lower prices. Customers and 

competitors have observed—and the 

pricing data confirms—that the price of 

pharmaceutical products decreases with 

new entry even after several other 

suppliers have entered the market. 

Thus, absent a remedy, the Proposed 

Acquisition likely would cause U.S. 

consumers to pay significantly higher 

prices for injectable TCA in the future. 

V. The Proposed Order 

The proposed Order effectively 

remedies the competitive concerns 

raised by the Proposed Acquisition for 

the pharmaceutical product at issue. 

The proposed Order requires that Hikma 

not acquire any rights or interests in 

TCA products or assets, or rights or 

interests in the therapeutical equivalent 

or biosimilar of TCA products without 

the prior approval of the Commission. 

The proposed Order also requires Water 

Street and Long Grove to operate and 

maintain in the normal course of 

business the TCA assets for a period 

lasting until four years after the date the 

Order is issued. The proposed Order 

also allows the Commission to appoint 

an individual to serve as Monitor to 

observe and report on Respondents’ 

compliance with their obligations set 

forth in the Order. 

* * * * * 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement and proposed Order 

to aid the Commission in determining 

whether it should make the proposed 

Order final. This analysis is not an 

official interpretation of the proposed 

Order and does not modify its terms in 

any way. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

[FR Doc. 2022–09532 Filed 5–3–22; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 


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