FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Approved Gastroenterology Drugs in Clinical Development

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            Lead Product(s): Bismuth Subsalicylate

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Arcadia Consumer Healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition March 20, 2020

            Details:

            Acquisition further strengthens Arcadia's consumer healthcare product portfolio.

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            Lead Product(s): Certolizumab Pegol

            Therapeutic Area: Gastroenterology Product Name: Cimzia

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: UCB Pharma S.A.

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 08, 2020

            Details:

            Ferring joins with UCB to promote CIMZIA prefilled syringe for Crohn’s disease in the United States. Co-promotion strengthens commitment to patients living with Crohn’s disease by reaching more gastroenterologists while also continuing patient support programs.

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            Lead Product(s): Vancomycin Hydrochloride

            Therapeutic Area: Gastroenterology Product Name: Vancocin

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: ANI Pharmaceuticals Inc

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 25, 2020

            Details:

            Edge Pharma has signed an agreement with ANI Pharmaceuticals to market the company's FDA approved Vancomycin Hydrochloride for Oral Solution USP, a generic equivalent to Vancocin®.

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            Lead Product(s): Dioctyl Sulfosuccinic Acid

            Therapeutic Area: Gastroenterology Product Name: Enemeez

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Quest Products, LLC

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition June 24, 2020

            Details:

            Quest will add the Enemeez and DocuSol brands of bowel care products, to its' portfolio of self-care products.

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            Lead Product(s): PALONOSETRON HCL

            Therapeutic Area: Gastroenterology Product Name: Aloxi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Aloxi® has demonstrated its efficacy in delayed nausea and vomiting where available agents have hitherto provided insufficient effects.

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            Lead Product(s): Elobixibat

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hercules Capital

            Deal Size: $105.0 million Upfront Cash: $10.0 million

            Deal Type: Financing June 09, 2020

            Details:

            These funding arrangements with new and existing partners provide the company additional flexibility and cash runway into the beginning of 2022, past the planned approval and commercial launch of odevixibat for the treatment of progressive familial intrahepatic cholestasis.

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            Lead Product(s): Scopolamine Butyl Bromide

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration April 22, 2020

            Details:

            Cara Care has teamed up with the Consumer Healthcare Business Unit of Sanofi Germany to provide Sanofi’s Buscomint® bei Reizdarm drug with Cara Care’s digital companion app for digestive conditions.

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            Lead Product(s): Ustekinumab

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 16, 2020

            Details:

            Scottish Medicines Consortium has accepted Janssen Pharmaceutical’s Stelara for use on the National Health Service Scotland to treat moderately to severely active ulcerative colitis (UC) in adults.

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            Lead Product(s): Naloxegol

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: RedHill Biopharma

            Deal Size: $67.5 million Upfront Cash: $52.5 million

            Deal Type: Divestment April 02, 2020

            Details:

            In 2015, AstraZeneca entered into a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik in the US, which has now been transferred to RedHill.

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            Lead Product(s): Eravacycline

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: AcelRx Pharmaceuticals

            Deal Size: $26.9 million Upfront Cash: Undisclosed

            Deal Type: Acquisition March 16, 2020

            Details:

            Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA™ for the treatment of complicated intra-abdominal infections and DSUVIA® for the treatment of acute pain.

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