HHS License-Based Vaccines & Therapeutics

 

Active Licenses - Vaccines and Therapeutics Developed with Technologies Licensed from HHS Intramural Research Programs

Comirnaty®
Comirnaty (COVID-19 vaccine, mRNA) is a messenger RNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Licensee: BioNTech/Pfizer
FDA Approval: August 23, 2021
First Commercial U.S. Sale: 2020 (EUA)
Agency: NIH
U.S. Patents: 10,960,070
 
Abecma®
Abecma (idecabtagene viceocel) is a chimeric antigen receptor (CAR) T-cell therapy treatment for multiple myeloma. It is used for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. 
Licensee: Bluebird Bio
FDA Approval: March 26, 2021
First Commercial U.S. Sale: 2021
Agency: NIH
U.S. Patents: 9,765,342; 10,767,184;          10,815,487; 10,738,312; 10,738,313, 10,844,387; 10,829,767; 10,900,042; 10,876,123; 10,815,488; 10,829,768; 10,837,019; 10,829,769
 

Ebanga®

Ebanga (ansuvimab-zykl) is a human monoclonal antibody for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.

Licensee:

Ridgeback Biotherapeutics

FDA Approval:

December 21, 2020

First Commercial U.S. Sale:

2021

Agency:

NIH

U.S. Patents:

10,160,795; 10,273,288
 

Zokinvy®

Zokinsky (lonafarnib) is a farnesyltransferase inhibitor that helps prevent the buildup of defective progerin or progerin-like protein of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). Hutchinson-Gilford and progeroid laminopathies are two distinct fatal diseases marked by premature aging.

Licensee:

Progeria Research Foundation/Elger Biopharmaceuticals 

FDA Approval:

November 20, 2020

First Commercial U.S. Sale:

2021

Agency:

NIH

U.S. Patents:

7,838,531; 8,257,915; 8,691,501; 8,828,356
 

Tecartus®
Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy for the treatment of mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (ALL).

Licensee:

Kite Pharma
FDA Approval: July 24, 2020
First Commercial U.S. Sale: 2020
Agency: NIH
U.S. Patents: 9,855,298; 10,322,146

Spravato®

Spravato (esketamine) is a nasal spray used in conjunction with an oral antidepressant for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

Licensee:

Janssen Therapeutics

FDA Approval:

March 6, 2019

First Commercial U.S. Sale:

2019

Agency:

NIH

U.S. Patents:

8,785,500; 9,539,220; 9,592,207   

Lumoxiti™

Lumoxiti is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Licensee:

AstraZeneca

FDA Approval:

September 13, 2018

First Commercial U.S. Sale:

2019

Agency:

NIH

U.S. Patents:

 4,892,827; 5,747,654; 5,980,895; 6,074,644; 6,147,203; 6,558,672; 7,355,012; 7,541,034; 7,777,019; 7,982,011; 8,809,502; 9,592,304
 

Luxturna®

Luxturna (voretigene neparvovec-rzyl) is a new gene therapy to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

Licensee:

Spark Therapeutics

FDA Approval:

 December 18, 2017

First Commercial U.S. Sale:

2018

Agency:

NIH

U.S. Patents:

7,419,817
 

Yescarta®

A chimeric antigen receptor (CAR) genetically modified autologous T cell immunotherapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Licensee:

Kite Pharma

FDA Approval:

October 18, 2017

First Commercial U.S. Sale:

2018

Agency:

NIH

U.S. Patents:

 7,575,742; 8,298,525; 8,636,997
 

Ella®

A progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

Licensee:

Laboratoire HRA Pharma

FDA Approval:

March 10, 2015

First Commercial U.S. Sale:

2016

Agency:

NIH

U.S. Patents:

 9,283,233; 9,616,073; 10,159,681
 

Kepivance®

Kepivance® (palifermin) is a human keratinocyte growth factor protein produced using recombinant DNA technology. It is used to decrease the incidence and duration of severe mouth sores in patients with hematologic cancers who receive myelotoxic therapy. In such a therapy, the patients' myeloid cells are first destroyed by chemotherapy alone or in combination with radiation, and then reconstituted with a bone marrow transplant. Kepivance® is the first and only therapy to treat the severe mouth sores that afflict these patients as a painful and unavoidable side effect of the treatment.

Licensee:

Amgen Inc.

FDA Approval:

December 15, 2004

First Commercial U.S. Sale:

2005

Agency:

NIH

U.S. Patents:

 5,654,405; 5,665,870; 5,707,805;
5,731,170; 5,741,642; 6,420,531;
6,709,842; 6,833,132; 7,026,291
 

Myalept®

Myaylept (metreleptin) is an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Lipodystrophy is a rare disorder characterized by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and is associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Licensee:

Aegerion Pharmaceuticals, Inc.

FDA Approval:

February 25, 2014

First Commercial U.S. Sale:

2014

Agency:

NIH

U.S. Patent:

7,183,254; 8,318,666
 

Velcade®

A treatment for multiple myeloma that works by specifically inhibiting an enzyme complex known as the proteosome. Under an accelerated approval program, the FDA has allowed the use of Velcade® in patients who have failed two prior therapies. The selectivity and manageable side-effect profile of this boronic dipeptide compound makes it an exciting new cancer drug. NIH researchers made a critical contribution by developing stable, pharmaceutically acceptable compositions of these important compounds. Indeed, as the first proteosome inhibitor to be approved by the FDA, Velcade® opens the door for a new class of useful drugs.

Licensee:

Millennium Pharmaceuticals

FDA Approval:

May 13, 2003

First Commercial U.S. Sale:

2003

Agency:

NIH

U.S. Patents:

 6,699,835; 6,713,446; 6,958,319;
7,109,323
 

Archive of Products Previously Developed Using HHS Technologies