510 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 

REYATAZ is a protease inhibitor 

indicated for use in combination with 

other antiretroviral agents for the 

treatment of human immunodeficiency 

virus (HIV–1) infection in patients 3 

months and older weighing at least 10 

kilograms. 

In a letter dated August 19, 2014, 

Bristol-Myers Squibb notified FDA that 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, had been discontinued. The 

REYATAZ 150-, 200-, and 300-mg 

capsule strengths continue to be 

marketed by Bristol-Myers Squibb. The 

100-mg dosage strength of this drug 

product is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated July 

7, 2014 (Docket No. FDA–2014–P– 

0980), under 21 CFR 10.30, requesting 

that the Agency determine whether 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, were withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REYATAZ (atazanavir 

sulfate) capsules, 100 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that REYATAZ (atazanavir 

sulfate) capsules, 100 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that the product was not 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REYATAZ (atazanavir 

sulfate) capsules, 100 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to REYATAZ (atazanavir sulfate) 

capsules, 100 mg, may be approved by 

the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: December 30, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30909 Filed 1–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Her2 Monoclonal Antibodies, 

Antibody Drug Conjugates, and Site 

Specific Antibody Conjugate Methods 

for the Treatment of Cancer 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR part 404, 

that the National Institutes of Health, 

Department of Health and Human 

Services, is contemplating the grant of 

an exclusive patent license to HUIYU 

Pharmaceuticals Co, Ltd located in 

Neijiang City, CHINA to practice the 

inventions embodied in U.S. Provisional 

Patent Application 61/833,732, filed 

June 11, 2013 entitled ‘‘Her2-Specific 

Monoclonal Antibodies and Conjugates 

Thereof’’ [HHS Ref. No.: E–351–2013/0– 

US–01], and International Application 

PCT/US2014/041492, filed June 9, 2014 

entitled ‘‘Her2-Specific Monoclonal 

Antibodies and Conjugates Thereof’’ 

[HHS Ref. No.: E–351–2013/0–PCT–02], 

any PCT, US or foreign applications 

claiming the benefit of. The patent 

rights in these inventions have been 

assigned to the Government of the 

United States of America. 

The prospective exclusive license 

territory may be limited to China, and 

the field of use may be limited to: 

The use of the m860 monoclonal 

antibodies as mono-specific antibodies; or 

targeting moieties for immunoconjugates, 

wherein the antibodies are conjugated to 

auristatin F and analogues thereof, for the 

treatment of HER2 positive cancers. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before 

February 5, 2015 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Eggerton Campbell, Ph.D. 

Licensing and Patenting Manager, 

Cancer Branch, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–5282; Facsimile: (301) 435– 

4013; Email: 

Eggerton.Campbell@nih.gov. 

SUPPLEMENTARY INFORMATION: These 

inventions concern Antibody Drug 

Conjugates (ADCs). ADCs can 

demonstrate high efficacy as cancer 

therapeutics, however, much more can 

be done to improve their efficacy and 

safety profile. Site-specific antibody 

drug conjugation is a promising way to 

do this. 

The scientists at the NIH have 

identified a fully human monoclonal 

antibody, m860, that binds to cell 

surface-associated Her2 with affinity 

comparable to that of Trastuzumab 

(Herceptin) but to a different epitope. In 

addition, the scientist developed a sitespecific glycan engineering method to 

conjugate the antibody to the small 

molecule drug auristatin F. The ADC 

prepared though this site-specific 

approach shows very good stability, cell 

surface binding activity and also potent 

specific cell killing activity against Her2 

positive cancer cells, including 

Trastuzumab resistant breast cancer 

cells. This ADC has the potential to be 

developed as a targeted therapeutic for 

Her2-overexpressing cancers. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR part 404. The 

prospective exclusive license may be 

granted unless the NIH receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404 

within thirty (30) days from the date of 

this published notice. 

Applications for a license in the field 

of use that are filed in response to this 

notice will be treated as objections to 

the grant of the contemplated exclusive 

license. Comments and objections 

submitted to this notice will not be 

made available for public inspection 

and, to the extent permitted by law, will 

not be released under the Freedom of 

Information Act, 5 U.S.C. 552. 

Dated: December 30, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–30878 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 


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