Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Notices 39409

increase because of their minimal

market presence, lack of scale

economies and lack of consumer brand

loyalty. The proposed merger is likely to

lead to unilateral anticompetitive effects

in the OTC pediculicide market by

eliminating the actual, direct, and

substantial competition between Pfizer

and Warner and allowing the combined

firm to raise prices.

The proposed Consent Order

remedies the merger’s anticompetitive

effects by requiring that Pfizer divest its

entire RID brand of pediculicide and all

assets associated with this product line

to Bayer.

Drugs for the Treatment of Alzheimer’s

Disease

Pfizer and Warner market the only

two products sold in the United States

for the treatment of Alzheimer’s disease,

Aricept and Cognex, respectively.

Aricept dominates the market with more

than 98 percent market share, while

Cognex accounts for the remainder of

the market. While the FDA has recently

approved one new product, Novartis

AG’s Exelon, for the treatment of

Alzheimer’s disease, Novartis has yet to

market its product. Even taking into

account Novartis’s entry into the

market, the market will still be highly

concentrated. There are significant

barriers to entry into this market. New

entry into the manufacture and sale of

drugs for the treatment of Alzheimer’s

disease is difficult, expensive and timeconsuming because of the lengthy

development periods, the need for FDA

approval, and the substantial sunk costs

required to research, develop,

manufacture and sell these drugs. As a

result, entry likely to deter or counteract

the likely anticompetitive effects of the

proposed merger is unlikely.

The merger would result in Pfizer’s

having a monopoly in the market for

drugs for the treatment of Alzheimer’s

disease, with that monopoly position

lessening only slightly when Exelon is

launched in the United States.

Accordingly, the merger would increase

Pfizer’s dominant position in the

market, allowing it to increase prices

and potentially eliminate Cognex, the

smaller competitor, from the market.

The proposed Consent Order remedies

the merger’s anticompetitive effects by

requiring Warner to divest Cognex to

First Horizon Pharmaceutical

Corporation.

EGFr-tk Inhibitors for the Treatment of

Cancer

Pfizer and Warner are developing

Epidermal Growth Factor receptor

tyrosine kinase (‘‘EGFr-tk’’) inhibitors

for the treatment of solid cancerous

tumors. Solid tumor cancer targets

include head and neck, non-small-cell

lung, breast, ovarian, pancreatic and

colorectal cancers. Currently, over 1.2

million Americans are diagnosed with

solid tumor cancers each year. It is

anticipated that EGFr-tk inhibitors will

be used in conjunction with surgery,

radiation and chemotherapy to treat

cancer patients.

EGFr-tk inhibitors target the EGFr

oncogene that regulates cancer cell

growth. The EGFr has been identified as

being over-expressed (too prevalent) in

as many as 700,000 of the 1.2 million

Americans diagnosed with a solid tumor

cancer each year. Patients with an overexpression of EGFr are believed to have

a worse prognosis than other cancer

patients. Accordingly, scientists have

developed drugs that attemp to inhibit

the EGFr activity of cell division signal

transduction that results in cancer cell

proliferation.

The most advanced EGFr-tk inhibitors

include those being developed by Pfizer

and Warner. Pfizer and Warner are two

of only a few companies in clinical

development of EGFr-tk inhibitors for

solid tumor cancers. There are

significant barriers to entry into the

market. In order to enter the market, a

firm must incur substantial sunk costs

to research, develop, manufacture and

sell EGFr-tk inhibitors.

The proposed merger is likely to

create anticompetitive effects in the

EGFr-tk inhibitor market by potentially

eliminating one of the few research and

development efforts in this area. As a

result of the merger, the combined

entity could unilaterally delay,

terminate or otherwise fail to develop

one of the two competing EGFr-tk drugs,

resulting in less product innovation,

fewer choices, and higher prices for

consumers.

To resolve these concerns, the

proposed Consent order requires Pfizer

to return its EGFr-tk inhibitor, CP–

358,774, to its development partner,

OSI. OSI holds a contractual right to

obtain CP–358,774 should Pfizer

terminate development efforts. Thus,

while other companies have expressed

interest in acquiring the rights to CP–

358,774, none may do so without the

prior approval of OSI.

The proposed Consent Order

maintains competition in the research

and development of EGFr-tk inhibitors

for the treatment of cancer by requiring

that Pfizer fulfill its obligations under

the May 23, 2000 agreement between

Pfizer and OSI to (1) transfer and

surrender its rights to CP–358,774 to

OSI; (2) grant OSI a royalty-free,

irrevocable worldwide license,

including the right to sublicense, to all

of its rights in, and to, the patents

currently owned jointly by OSI and

Pfizer relating to EGFr-tk ihibitors; (3)

complete, a Pfizer’s cost, ongoing

clinical trials of CP–358,774; (4) provide

OSI with a manufacturing and supply

agreement for the continued supply of

CP–358,774, pending transfer of

manufacturing technology to a new

manufacturer; (5) assume liability for all

completed clinical trials; and (6)

transfer all know-how and technology

relating to CP–358,774 to OSI. The

Consent Order also provides for an

Interim Trustee to be appointed to

oversee Pfizer’s obligations under the

Order and to ensure the continued

development and viability of CP–

358,774.

The purpose of this analysis is to

facilitate public comment on the

proposed Consent Order, and it is not

intended to constitute an official

interpretation of the proposed Consent

Order or to modify its terms in any way.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 00–16041 Filed 6–23–00; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Request for Nominations of

Candidates To Serve on the National

Vaccine Advisory Committee,

Department of Health and Human

Services

The Public Health Service (PHS) is

soliciting nominations for possible

membership on the National Vaccine

Advisory Committee (NVAC). This

committee studies and recommends

ways to encourage the availability of an

adequate supply of safe and effective

vaccination products in the States;

recommends research priorities and

other measures the Director of the

National Vaccine Program should take

to enhance the safety and efficacy of

vaccines; advises the Director of the

Program in the implementation of

sections 2102, 2103, and 2104, of the

PHS Act; and identifies annually for the

Director of the Program the most

important areas of government and nongovernment cooperation that should be

considered in implementing sections

2102, 2103, and 2104, of the PHS Act.

Nominations are being sought for

individuals engaged in vaccine research

or the manufacture of vaccines or who

are physicians, members of parent

organizations concerned with

immunizations, or representatives of

39410 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Notices

State or local health agencies, or public

health organizations. Federal employees

will not be considered for membership.

Members may be invited to serve a fouryear term.

Close attention will be given to

minority and female representation;

therefore nominations from these groups

are encouraged.

The following information is

requested: name, affiliation, address,

telephone number, and a current

curriculum vitae. Nominations should

be sent, in writing, and postmarked by

August 30, 2000, to: Gloria Sagar,

Committee Management Specialist,

NVAC, National Vaccine Program

Office, Centers for Disease Control and

Prevention, 1600 Clifton Road, NE, m/

s D–66, Atlanta, Georgia 30333.

Telephone and facsimile submission

cannot be accepted.

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 the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: June 19, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–16031 Filed 6–23–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00065]

American Indian/Alaska Native Support

Centers for Tobacco Programs; Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of funds for fiscal year 2000

for cooperative agreements with

American Indian/Alaska Native (AI/AN)

tribes, tribal organizations, including

urban, and eligible inter-tribal consortia.

The purpose of the funds is to develop

or improve tobacco-related resource

networks and outreach to AI/AN tribes.

This will enable tribal communities to

address and impact the high rates of

tobacco use in this population.

Assistance to tribes may consist of

training and technical assistance,

networking and partnership building,

and promoting collaboration with other

tribes, national organizations (e.g.,

American Cancer Society, American

Lung Association), States and the

Federal government.

CDC is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2010, a national activity to reduce

morbidity and mortality and improve

quality of life. This announcement is

related to the focus area of Tobacco Use.

For the conference copy of ‘‘Healthy

People 2010’’ visit the internet site:

<http://www.health.gov/

healthypeople>.

B. Eligible Applicants

Eligible applicants are AI/AN tribes,

tribal organizations, including urban

and eligible inter-tribal consortia. An

individual AI/AN tribe or urban center

is eligible to apply if its tribal

population is at least 60,000 or if it

represents other regional AI/AN tribes

or urban populations with a combined

population of at least 60,000. Tribal

organizations and inter-tribal consortia

are eligible if they represent tribes

within a region with a combined

population of at least 60,000 and if they

are incorporated for the primary

purpose of improving AI/AN health and

represent such interests for the tribes or

urban Indian communities located in its

region. AI/AN tribes or urban

communities represented may be

located in one state or in multiple states.

An urban organization is defined as a

non-profit corporate body situated in an

urban center eligible for services under

Title V of the Indian Health Care

Improvement Act, PL 94–437, as

amended. Applicants should submit

with application an executive summary

of not more than one page and a

completed and signed Eligibility

Certification Form (see addendum 3 in

the application package). The Eligibility

Certification Form is a checklist, which

will define your eligibility.

Competition is limited to those

identified under ‘‘Eligible Applicants’’

because of the problems posed by

tobacco use as evidenced by high

prevalence, tobacco-related morbidity

and mortality and the unique challenges

faced by this population for tobacco

control and prevention (see addendum

2 in the application package).

Pre-Application Telephone Conference

Applicants are invited by CDC to

participate in a pre-application

technical assistance telephone

conference June 30, 2000 promptly at

2:00 p.m.(Eastern time) to discuss:

programmatic issues regarding this

program; how to apply; and questions

regarding the content of the program

announcement. This telephone

conference is expected to last one hour.

The conference name is Tobacco RFA.

The telephone bridge number for

Federal participants is 404–639–3277

for non-Federal participants call 1–800–

311–3437. Participants will need to

enter the following conference code

when prompted to be connected

#345150. All questions and comments

will be recorded and published on the

Internet at http://www.cdc.gov/funding

as an attachment to this program

announcement.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan or any other form.

C. Availability of Funds

Approximately $1,000,000 is available

in FY 2000 to fund five to six awards.

It is expected that the average annual

award will be $170,000, ranging from

$125,000 to $200,000. This award

amount includes expenses for indirect

costs. It is expected that the awards will

begin September 30, 2000 and will be

made for a 12-month budget period

within a project period of up to five

years.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Funding Preference

Funding preference will be given to

the geographical areas defined by the

Indian Health Service which

demonstrate need based on high

prevalence, high tobacco-related

morbidity and mortality; which lack

tobacco control initiatives and

culturally appropriate resources; and

which show early initiation of

commercial tobacco use among young

people. CDC will fund up to six awards,

only one award will be made within a

geographical area.

D. Program Requirements

In conducting activities to achieve the

goals and objectives of this program, the

recipient will be responsible for the

activities under 1 (Recipient Activities),

and CDC will be responsible for the

activities listed under 2 (CDC

Activities).

1. Recipient Activities

(a) Establish a technical support

center and assist tribes with tobacco

control needs such as data collection,