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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 It has been withdrawn and cannot lawfully be distributed.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:
Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA).
Lead Product(s): Aclidinium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Duaklir
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
Makena, also referred to as 17 α-hydroxyprogesterone caproate, 17-OHPC, 17-HPC, or 17P, is the only FDA-approved treatment to reduce the risk of 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 June 14, 2022
Details:
Under the terms of the Acquisition agreement, Covis Pharma has completed the acquisition of Eklira® (aclidinium bromide), known as Tudorza® in US and marketed as Bretaris® in some countries, and Duaklir® (aclidinium bromide/formoterol), marketed as Brimica®, from AstraZeneca.
Lead Product(s): Aclidinium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Eklira
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: AstraZeneca
Deal Size: $270.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 05, 2022
Details:
Covis has entered into an Exclusive Promotion and Distribution Agreement with Novartis Pharmaceuticals Canada, whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri® Breezhaler® and PrUltibro® Breezhaler® in Canada.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Seebri Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 05, 2022
Details:
Covis Pharma acquired the rights of Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol), inhaled respiratory medicines used for the maintenance treatment of COPD from AstraZeneca.
Lead Product(s): Aclidinium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Eklira
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: AstraZeneca
Deal Size: $270.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 01, 2021
Details:
Ciraparantag is a novel small, water-soluble molecule being investigated for reversal of anticoagulation induced by direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH).
Lead Product(s): Ciraparantag
Therapeutic Area: Hematology Product Name: PER977
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Norgine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The publication presents the results of a meta-analysis of individual participant data from five trials examining injectable 17-alpha hydroxyprogesterone (17-OHPC), also referred to as MakenaÒ or generic alternatives.
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 March 26, 2021
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 published preclinical data demonstrate that ciraparantag has several key attributes including its ability to reverse the anticoagulant effect of apixaban, rivaroxaban, edoxaban, dabigatran, and LMWH.
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 November 19, 2020
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