IP Library › Granted Patent US 10,711,038
Granted Patent B2
US 10,711,038 · App. 15/471,462 · Granted Jul 14, 2020

Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders

Inventors: Kunwar Shailubhai (Audubon, PA); Gary S. Jacob (New York, NY)
Assignee: Bausch Health Ireland Limited
C07K7/08A61K9/0031A61K9/02A61K9/08A61K31/192A61K31/519A61K38/10A61K38/12A61K45/06A61K47/02A61K47/60C07K7/64H05K999/99
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Quick Facts
Patent No.
US 10,711,038
App. No.
15/471,462
Granted
Jul 14, 2020
Kind
B2
Abstract

The invention provides novel guanylate cyclase-C agonist peptides and their use in the treatment of human diseases including gastrointestinal disorders, inflammation or cancer (e.g., a gastrointestinal cancer). The peptides can be administered either alone or in combination with an inhibitor of cGMP-dependent phosphodiesterase. The gastrointestinal disorder may be classified as either irritable bowel syndrome, constipation, or excessive acidity etc. The gastrointestinal disease may be classified as either inflammatory bowel disease or other GI condition, including Crohn's disease and ulcerative colitis, and cancer.

Claims (6)

1. A method for treating Irritable Bowel Syndrome (IBS) comprising:

administering daily orally to a patient an effective dosage of a guanylate cyclase receptor agonist having the amino acid sequence of SEQ ID NO:1, wherein said agonist is a [4,12;7,15] bicyclic peptide, and

administering to said patient an effective dose of a cGMP-dependent phosphodiesterase inhibitor comprising sulindac sulfone or zaprinast, either concurrently or sequentially with said agonist.

2. The method of claim 1 , wherein the IBS is associated with constipation.

3. The method of claim 1 , further comprising administering to said patient an effective dose of at least one anti-inflammatory agent.

4. The method of claim 3 , wherein said anti-inflammatory agent is a steroid or nonsteroid anti-inflammatory drug (NSAID).

Assignments (14)
U.S. PATENT SECURITY AGREEMENT Recorded Nov 25, 2025
From: BAUSCH HEALTH IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 073715/0375 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
Reel/Frame 073654/0300 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 9, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 063942/0001 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062078/0276 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061882/0708 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY INTEREST Recorded Jun 13, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 060346/0705 →
SECURITY INTEREST Recorded Oct 5, 2021
From: BAUSCH & LOMB IRELAND LIMITED; BAUSCH HEALTH COMPANIES INC.; DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH; TECHNOLAS PERFECT VISION GMBH
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 057821/0800 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2020
From: SHAILUBHAI, KUNWAR; JACOB, GARY S.
To: SYNERGY PHARMACEUTICALS, INC.
Reel/Frame 052827/0187 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2020
From: SYNERGY PHARMACEUTICALS, INC.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 052827/0294 →
RELEASE OF SECURITY INTEREST Recorded Mar 6, 2019
From: CRG SERVICING LLC
To: SYNERGY PHARMACEUTICALS INC.
Reel/Frame 048521/0005 →
SECURITY INTEREST Recorded Sep 5, 2017
From: SYNERGY PHARMACEUTICALS INC.
To: CRG SERVICING LLC, AS AGENT
Reel/Frame 043488/0741 →
Continuity (6)
Continuation 14964157 · Dec 9, 2015
Continuation 14228843 · Mar 28, 2014
Division 13010267 · Jan 20, 2011
Continuation 12133344 · Jun 4, 2008
Provisional Application 60933194 · Jun 4, 2007
Related Publication 20170209531A1 · Jul 27, 2017