19932 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices 

and Asia. Abrika is a Sunrise, Florida 

based specialty generic pharmaceutical 

company engaged in the formulation 

and commercialization of both 

controlled release and immediate 

release products. 

Generic Isradipine Capsules 

Isradipine belongs to a group of drugs 

known as calcium channel blockers. 

Calcium is involved in blood vessel 

contraction, and by blocking calcium, 

isradipine relaxes and widens the blood 

vessels, thereby lowering blood 

pressure, preventing spasms of the 

blood vessels of the heart and reducing 

the oxygen needs of the heart muscle. 

Isradipine is typically prescribed to 

patients as a blood pressure lowering 

medication, and is also used to treat 

hypertension, ischemia and depression. 

Generic isradipine was first introduced 

in the United States in 2006. Sales in 

that year totaled approximately 

$3 million. 

Actavis and Abrika are the only two 

companies selling generic isradipine 

capsules in the United States. The 

number of generic suppliers has a direct 

and substantial effect on generic pricing, 

as each additional generic supplier can 

have a competitive impact on the 

market. Because there are multiple 

generic equivalents for isradipine 

capsules, the branded version no longer 

significantly constrains the generic’s 

pricing. 

Entry into the market for the 

manufacture and sale of generic 

isradipine capsules would not be 

timely, likely, or sufficient in its 

magnitude, character, and scope to deter 

or counteract the anticompetitive effects 

of the acquisition. Entry would not take 

place in a timely manner because the 

combination of generic drug 

development times and FDA drug 

approval requirements takes at least two 

years. Entry would not be likely because 

the relevant market is relatively small 

and in decline, limiting sales 

opportunities for any new entrant. 

The proposed acquisition would 

cause significant anticompetitive harm 

to consumers in the U.S. market for the 

manufacture and sale of generic 

isradipine capsules. The acquisition 

would eliminate Abrika as a competitor 

and create a monopoly in the market for 

the manufacture and sale of generic 

isradipine capsules. The evidence 

indicates that the presence of more than 

one competitor allows customers to 

negotiate lower prices and that the 

reduction in the number of competitors 

in this market would allow the merged 

entity to unilaterally exercise market 

power with a resulting increase in 

prices. 

The Consent Agreement 

The proposed Consent Agreement 

effectively remedies the proposed 

acquisition’s anticompetitive effects in 

the relevant product market. Pursuant to 

the Consent Agreement, Actavis and 

Abrika are required to divest certain 

rights and assets related to the generic 

isradipine capsules to a Commissionapproved acquirer no later than ten (10) 

days after the acquisition. Specifically, 

the proposed Consent Agreement 

requires that Abrika divest its rights and 

assets relating to generic isradipine 

capsules to Cobalt. 

The acquirer of the divested assets 

must receive the prior approval of the 

Commission. The Commission’s goal in 

evaluating a possible purchaser of 

divested assets is to maintain the 

competitive environment that existed 

prior to the acquisition. A proposed 

acquirer of divested assets must not 

itself present competitive problems. 

Cobalt, which specializes in the sale 

and marketing of generic 

pharmaceuticals, is the United States 

arm of the Arrow Group, a private 

multinational that employs over 700 

individuals. The Arrow Group has 

experience in the development, 

manufacturing, and sale of 

pharmaceuticals and has production 

facilities in Canada, Malta, Australia 

and Brazil. Cobalt is an acceptable 

acquirer of generic isradipine because it 

has experience in distributing and 

marketing generic pharmaceutical 

products in the United States. Currently, 

the company has received FDA approval 

for the sale of nine generic products. 

The acquisition by Cobalt does not 

present a competitive problem in the 

generic isradipine market because 

Cobalt currently does not participate in 

the market and has no independent 

plans to enter. With its resources, sales 

and marketing capabilities, and 

experience with generic products, 

Cobalt should be successful in restoring 

the competition that would be lost if the 

proposed Actavis/Abrika transaction 

were to proceed unremedied. 

If the Commission determines that 

Cobalt is not an acceptable acquirer of 

the assets to be divested, or that the 

manner of the divestitures to Cobalt is 

not acceptable, the parties must unwind 

the sale and divest the assets within six 

(6) months of the date the Order 

becomes final to another Commissionapproved acquirer. If the parties fail to 

divest within six (6) months, the 

Commission may appoint a trustee to 

divest the generic isradipine capsule 

assets. 

The proposed remedy contains 

provisions to ensure that the 

divestitures are successful. Abrika’s 

isradipine product is manufactured for 

Abrika by a third-party manufacturer. 

As part of the divestiture, Abrika will 

transfer its supply arrangement to 

Cobalt. Actavis and Abrika will transfer 

all confidential business information 

related to Abrika’s isradipine product to 

Cobalt. Finally, Actavis and Abrika will 

provide technical assistance to Cobalt to 

allow it to manufacture isradipine in 

substantially the same manner and 

quality employed or achieved by 

Abrika. 

The Commission has appointed 

Denise F. Smart of Smart Consulting 

Group, LLC as the Interim Monitor to 

oversee the asset transfer and to ensure 

Actavis and Abrika’s compliance with 

all of the provisions of the proposed 

Consent Agreement. Ms. Smart has over 

twenty years of experience in the 

pharmaceutical industry. Her 

experience includes providing 

consulting services in healthcare 

business development and regulatory 

compliance to major pharmaceutical 

companies, biotechnology companies 

and medical device companies. In order 

to ensure that the Commission remains 

informed about the status of the 

proposed divestitures and the transfers 

of assets, the proposed Consent 

Agreement requires Actavis and Abrika 

to file reports with the Commission 

periodically until the divestitures and 

transfers are accomplished. 

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. E7–7478 Filed 4–19–07; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Health 

Promotion and Disease Prevention 

Research Centers, Special Interest 

Project Competitive Supplements 

(Panels 5–6), Request for Applications 

(RFA) DP07–002 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices 19933 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 1 p.m.–4 p.m., June 11, 

2007 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Health Promotion and Disease 

Prevention Research Centers, Special Interest 

Project Competitive Supplements (Panels 5–

6),’’ RFA DP07–002. 

Contact Person for More Information: 

Susan Goodman, D.D.S., Scientific Review 

Administrator, Office of the Chief Science 

Officer, CDC, 1600 Clifton Road NE., 

Mailstop D74, Atlanta, GA 30333, Telephone 

404–639–4940. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 13, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–7500 Filed 4–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Health 

Promotion and Disease Prevention 

Research Centers: Special Interest 

Project Competitive Supplements 

(Panels 1–4), Request for Applications 

(RFA) DP07–002 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces a meeting of the 

aforementioned Special Emphasis 

Panel. 

Time and Date: 8:30 a.m.–5 p.m., June 19, 

2007 (Closed). 

Place: Doubletree Buckhead, 3342 

Peachtree Road, NE., Atlanta, Georgia 30326. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Health Promotion and Disease 

Prevention Research Centers, Special Interest 

Project Competitive Supplements (Panels 1–

4),’’ RFA DP07–002. 

Contact Person for More Information: 

Juliana Cyril, M.P.H., PhD., Associate 

Director for Policy and Peer Review, Office 

of the Chief Science Officer, CDC, 1600 

Clifton Road NE., Mailstop D74, Atlanta, GA 

30333, Telephone 404–639–4939. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 13, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–7502 Filed 4–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): The Sexual 

Networks of African American STI 

Repeaters, an Elaboration of Risk, 

Potential Extramural Project (PEP) 

2007–R–01 and Dynamic Mathematical 

Modeling of Sexual Transmission of C. 

Trachomatis Transmission in the 

United States, Evaluating Impact on 

Prevention Strategies on Chlamydial 

Incidence, Prevalence and Sequelae, 

PEP 2007–R–02 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 12 p.m.–2 p.m., May 15, 

2007 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘The Sexual Networks of 

African American STI Repeaters, an 

Elaboration of Risk,’’ PEP 2007–R–01, and 

‘‘Dynamic Mathematical Modeling of Sexual 

Transmission of C. Trachomatis 

Transmission in the United States, 

Evaluating Impact on Prevention Strategies 

on Chlamydial Incidence, Prevalence and 

Sequelae,’’ PEP 2007–R–02. 

Contact Person for More Information: 

Susan Goodman, D.D.S., Scientific Review 

Administrator, Office of the Chief Science 

Officer, CDC, 1600 Clifton Road NE., 

Mailstop D74, Atlanta, GA 30333, Telephone 

404–639–4940. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 13, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–7503 Filed 4–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Health 

Promotion and Disease Prevention 

Research Centers, Special Interest 

Project Competitive Supplements 

(Panels 9–11), Request for 

Applications (RFA) DP07–002 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 8:30 a.m.–5 p.m., June 18, 

2007 (Closed). 

Place: Doubletree Buckhead, 3342 

Peachtree Road NE, Atlanta, GA 30326, 

telephone 404–321–1234. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Pub. L. 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Health Promotion and Disease 

Prevention Research Centers, Special Interest 

Project Competitive Supplements (Panels 9–

11),’’ RFA DP07–002. 

Contact Person for More Information: 

Juliana Cyril, M.P.H., PhD, Scientific Review 

Administrator, Office of the Chief Science 

Officer, CDC, 1600 Clifton Road NE., 

Mailstop D74, Atlanta, GA 30333, Telephone 

404–639–4639. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 


sroberts on PROD1PC70 with NOTICES