Replies to post #160992 on Biotech Values

[DewDiligence]

THRX, ELN ink $1B royalty deal:

http://finance.yahoo.com/news/theravance-elan-enter-1-0-060200789.html

Theravance and Elan Corporation today announced that they have entered into a royalty participation agreement wherein Elan will purchase a participation interest in potential future royalty payments related to four respiratory programs partnered with GlaxoSmithKline: RELVAR™ ELLIPTA™/BREO™ ELLIPTA™, ANORO™ ELLIPTA™, MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist) monotherapy (GSK961081, or MABA ‘081), and vilanterol (VI) monotherapy. Under the terms of the agreement, Elan will make a one-time cash payment of $1.0 billion to Theravance in exchange for a 21% participation interest in the potential future royalty payments from the four programs…

[jq1234]

THRX/GSK: ANORO (UMEC/VI) for COPD - FDA Briefing Doc:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM367411.pdf

[DewDiligence]

GSK/THRX “son of Advair” phase-3 succeeds in asthma:

http://finance.yahoo.com/news/gsk-theravance-announce-positive-results-130000596.html

The combination ICS/LABA drug, called Breo Ellipta in the US, was approved for COPD in May 2013 (#msg-87790274). In many other countries, where the brand name is Relvar Ellipta, this comabination is approved for COPD and asthma.

Breo Ellipta should not be confused with Anoro Ellipta, GSK/THRX’s LABA/LAMA combination drug, where FDA approval is pending (#msg-91874192).

[jq1234]

THRX/GSK: Submission to US Regulatory Authorities for Breo Ellipta (Fluticasone Furoate/Vilanterol) in Asthma

LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 06/30/14 -- GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo® Ellipta®.

The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.

Today's filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma. The clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.

http://investor.thrxinc.com/releasedetail.cfm?ReleaseID=857021

FF/VI 100/25mcg was approved by the US Food and Drug Administration under the brand name Breo Ellipta in May 2013 as a prescription medication for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.