Theravance Inc (NASDAQ:THRX) Under Pressure Post Japanese And EU Approval


Dallas, Texas 10/21/2013 (Financialstrend) – Close watchers of $3.3 billion biotech firm Theravance Inc (NASDAQ:THRX) would have been left bemused by the constant flips its fortunes faced at the hands of various national drug approval agencies in September. In spite of relative good news emanating about approvals from agencies, the stock of this share has been under pressure. As of close of % business on October 18, the stock had shed close to 17% of its market value in comparison to September 18. In fact in the past week it has seen its market value plummet by 5.7%. The stock is trading at $34.17 per share as of close of business as of October 18, as against a consensus analyst price target of $42.

A quick recap of how the drug makers target drug has fared with regulators is warranted here. On September 20, FDA’s Japanese counterpart ruled on a new drug application that Teheravance had filed in collaboration with GlaxoSmithKline (GSK). The approval was received for an inhaled drug “Relvar” for treating the lung ailment Asthma. But the Japanese regulator decided against granting a go ahead for using the same for treating patients suffering from “chronic obstructive pulmonary disease”.

This decision will seem to confuses lay people since in U.S. FDA had approved the use of the same drug to treat “chronic obstructive pulmonary disease” while not approving it for Asthma treatment. To make it more confusing, the European Drug Agency has approved the drug for treating both “chronic obstructive pulmonary disease” and “asthma” on September 19.

Post the go ahead from Japanese drug approval agency, Theravance Inc (NASDAQ:THRX) has to pay $10 million to Glaxo. Over the past 12 months, the drug maker has managed to up its sales to $9.9 million and has accumulated net loss from operations of close to $139 million.