GlaxoSmithKline PLC (NYSE:GSK) has come up with a plan that will enable it to file for approval of its triple-combo drug for COPD patients sooner than earlier anticipated. The company reached the decision to accelerate filing of its new drug application (NDA) for its ICS/LAMA/LABA combo after it met with FDA officials.
In the new plan, GlaxoSmithKline will file the NDA for the drug combination by the end of 2016. The company previously planned to seek regulatory clearance of the multiple drug combo treatment in 2018.
Fisher Asset Management is currently the hedge fund with the largest position in GSK at 11.66 million shares, or just below $500 million.
The accelerated NDA filing for ICS/LAMA/LABA should help GSK unlock a new revenue stream at a time when competitive threat is growing against its drugs in the respiratory treatment market. Several generics manufacturers are preparing to enter the market with copycats of GSK’s drugs, posing serious top-line risks.
Despite the already difficult pricing environment, many generics companies believe there is still room to push prices of branded medicines even lower. Therefore, if GSK secures approval for its COPD triple combo drug next year, it would have an opportunity to protect its revenues from competitive threat in the COPD market.
However, outside of generics, GlaxoSmithKline is also keeping an eye on the efforts of rival branded drug developers. These include Novartis AG (NYSE:NVS), AstraZeneca PLC (NYSE:AZN) and Boehringer Ingelheim, which are also active in the branded and combo treatment markets for respiratory and cancer drugs. Nevertheless, the triple combo territory appears to be an area that not many branded drug developers are planning to go into and that might provide GSK some relief.
GlaxoSmithKline is wading into the triple combo market at a time when cancer researchers recently disclosed that multiple drug combinations could offer much hope in battling cancer. With that in mind, several drug companies are in the process of testing multi-drug combinations for combating cancer. One of the potential areas of challenge is pricing given the growing outcry over expensive drugs with politicians and regulators taking the cue.