There hasn’t been a dull moment for investors of Theravance Inc (NASDAQ:THRX) since the company submitted an NDA for COPD/asthma drug BREO before the Food and Drug Administration in 2012. In March 2013, ahead of the vote by the FDA’s advisory committee, there were speculations of a possible takeover by partner GlaxoSmithKline plc (ADR) (NYSE:GSK) on expectations of a positive outcome.
In April 2013 came the announcement that the company’s board had approved the separation of its two businesses into two publicly traded companies. The announcement served to prop up the share price despite unfavorable Q1 2013 results, largely weighed down by a positive one-time item last year.
Spinoff
A spinoff is usually a positive as separation of two disparate assets normally unlocks hidden value in the company. It happens with large companies as well as mid-cap entities. We saw this happen when Abbott Laboratories (NYSE:ABT) spun off its biotech wing into an independent company, AbbVie Inc (NYSE:ABBV). More recently, Elan Corporation, plc (ADR) (NYSE:ELN) spun off its drug discovery business in December 2012. It may not be entirely due to the spinoff but from separation to-date the stock of spun-out Prothena Corporation PLC (NASDAQ:PRTA) appreciated 180% while Elan, which was bought by Perrigo Company (NYSE:PRGO) is up, 54%.
LAMA candidate TD-4208
On Sept. 4, Theravance Inc (NASDAQ:THRX) announced that its long-acting muscarinic antagonist, or LAMA, candidate TD-4208 met primary and secondary endpoints in a phase 2 study, treating patients with moderate to severe COPD.
Asthma and COPD have similar symptoms as they both cause inflammation that limits airflow. The causes are different; asthma is a reversible temporary allergic reaction, and COPD is irreversible due to a combination of lung tissue breaking down. Children with severe cases of asthma are much more likely to develop COPD later in life.
In May, Theravance Inc (NASDAQ:THRX) and GlaxoSmithKline plc (ADR) (NYSE:GSK) entered the once-daily COPD market when the FDA approved Breo Ellipta.
LAMA/LABA: Potential and competition
The global market for COPD/asthma treatments was worth $25 billion in 2010 and is expected to grow to $27 billion by 2017.
Long-acting bronchodilators such as LAMA and LABA (long-acting β2-agonist) and combinations of the two have brought about a dramatic change in management of COPD and changed the way the medical industry looks at the disease. In July 2013, Ultibro Breezhaler from Novartis AG (ADR) (NYSE:NVS) became the first in class of fixed-dose, once-daily LAMA/LABA combination to be recommended for approval by the European regulator for sale in Europe.
