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AstraZeneca PLC

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AstraZeneca COPD Drug Finally Gets OK From FDA, inching closer to GSK leader

Lead Product(s): Budensonide,Glycopyrrolate,Formoterol

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere

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 July 24, 2020

Details:

The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.

GlaxoSmithKline

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Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Healthcare Products

Lead Product(s): Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dimetapp

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Foundation Consumer Healthcare

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 16, 2020

Details:

This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, Primatene Tablets® and FiberCon®.

AstraZeneca PLC

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Breztri Aerosphere Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial

Lead Product(s): Budensonide,Glycopyrrolate,Formoterol

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere

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 24, 2020

Details:

Results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere demonstrated a statistically significant reduction in moderate or severe exacerbations compared with 2 dual-combination therapies in moderate to very severe COPD.

AstraZeneca PLC

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AstraZeneca’s Bevespi Aerosphere approved in China for patients with COPD

Lead Product(s): Formoterol,Glycopyrronium Bromide

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

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 May 18, 2020

Details:

Approval by the NMPA was based on positive results from the Phase III PINNACLE 4 trial1 in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as compared to its monotherapy components and placebo.

AstraZeneca PLC

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Circassia To Terminate AstraZeneca Deal And Transfer Assets

Lead Product(s): Aclidinium Bromide

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Circassia Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination April 09, 2020

Details:

On completion of the Transaction, AstraZeneca will acquire the U.S. commercial rights to Tudorza® and Duaklir® together with certain ancillary rights and assets, from Circassia.

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Companies

AstraZeneca PLC

AstraZeneca COPD Drug Finally Gets OK From FDA, inching closer to GSK leader

GlaxoSmithKline

Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Healthcare Products

AstraZeneca PLC

Breztri Aerosphere Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial

AstraZeneca PLC

AstraZeneca’s Bevespi Aerosphere approved in China for patients with COPD

AstraZeneca PLC

Circassia To Terminate AstraZeneca Deal And Transfer Assets