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Makena (hydroxyprogesterone caproate) is a synthetic progestin. The drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. It has been withdrawn and cannot lawfully be distributed.
Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
Details:
FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
Lead Product(s): Ferumoxytol
Therapeutic Area: Hematology Product Name: Feraheme
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition November 16, 2020
Details:
With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not suitable or ineffective.
Lead Product(s): Ferumoxytol
Therapeutic Area: Hematology Product Name: Feraheme
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition October 01, 2020
Details:
Under the terms of the termination agreement, all of AMAG’s rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin.
Lead Product(s): Bremelanotide Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Vyleesi
Highest Development Status: ApprovedProduct Type: Peptide
Recipient: Palatin Technologies
Deal Size: $16.3 million Upfront Cash: $12.0 million
Deal Type: Divestment July 27, 2020
Details:
Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery or due to life-threatening or uncontrolled bleeding.
Lead Product(s): Ciraparantag
Therapeutic Area: Hematology Product Name: PER977
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Norgine
Deal Size: $290.0 million Upfront Cash: $30.0 million
Deal Type: Licensing Agreement July 23, 2020
Details:
Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT).
Lead Product(s): Ciraparantag
Therapeutic Area: Hematology Product Name: PER977
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2020
Details:
Transaction allows AMAG to advance its strategic focus on Feraheme, Makena and its pipeline, consistent with previously announced plans.
Lead Product(s): Prasterone
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Millicent Pharma Limited
Deal Size: $125.0 million Upfront Cash: $20.0 million
Deal Type: Divestment May 21, 2020
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