Replies to post #165404 on Biotech Values

[DewDiligence]

CHMP approves GSK/THRX’s ICS/LABA combo for asthma and COPD:

http://finance.yahoo.com/news/relvar-tm-ellipta-tm-receives-173101087.html

In the EU, the brand name will be Relvar Ellipta (rather than Breo Ellipta in the US). Two fixed-dose combinations are available for asthma and one for COPD.

Revlar Ellipta should be not be confused with Anoro Ellipta, a LAMA/LABA combination using the same device that recently received an endorsement from an FDA advisory panel for COPD (#msg-91874192).

[DewDiligence]

NVS’ Onbrez Breezhaler (f/k/a QVA149) non-inferior to GSK’s Advair (Seretide) in phase-4 study:

http://in.reuters.com/article/2014/04/25/us-novartis-lung-idINBREA3O0D920140425

Given the mega-deal between NVS and GSK announced this week, it’s a little strange that NVS and GSK are still competitors in the respiratory arena. One would think the companies discussed having NVS include its respiratory portfolio in the asset swap with GSK, who is the clear leader in this arena.

[DewDiligence]

AZN’s LABA/LAMA combination for COPD succeeds in phase-3 trials:

http://in.reuters.com/article/2015/03/18/us-astrazeneca-copd-idINKBN0ME0LT20150318

The drug, which AstraZeneca acquired after buying Pearl Therapeutics two years ago [#msg-88847837], combines a long-acting beta-2 agonist (LABA) and a long-acting muscarine antagonist (LAMA). AstraZeneca plans to file PT003 for approval commencing in 2015.

Rival firms also have LAMA/LABA drugs that are more advanced than PT003, but AstraZeneca's drug is administered with a pressurized metered-dose inhaler instead of a dry-powder inhaler, which may suit elderly patients in particular.

[DewDiligence]

GSK/THRX—Relvar/Breo* Ellipta fails to show statsig survival benefit in COPD phase-4 study:

http://finance.yahoo.com/news/gsk-theravance-announce-results-summit-184000004.html

For the primary endpoint of the study, the risk of dying on FF/VI 100/25mcg [i.e. Relvar/Breo combination] was 12.2% lower than on placebo over the study period, which was not statistically significant (p=0.137).

THRX is down 22% on this news.

*Relvar and Breo are two brand names for the same ICS/LABA combination product. Ellipta is the brand name for the inhalation device.

[DewDiligence]

GSK submits NDA/MAA for triple-MoA* COPD regimen:

http://www.pmlive.com/pharma_news/gsk_files_first_application_for_triple_copd_therapy_1177783

Each component of this three-drug regimen is already on the market as monotherapy or as a component of a dual-MoA combination.

*LABA/LAMA/ICS.

[DewDiligence]

GSK/INVA—FDA approves Trelegy Ellipta—first triple-MoA product for COPD:

http://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-appropriate-patients-with-copd-in-the-us/

Trelegy Ellipta contains an ICS, a LAMA, and a LABA.

INVA is the former THRX (#msg-119698593).