Hikma says "low likelihood" of US approval this year for Advair generic

Hikma Pharmaceuticals announced Thursday that the FDA issued a complete response letter regarding the company's filing seeking approval of a generic version of GlaxoSmithKline's asthma and chronic obstructive pulmonary disease therapy Advair Diskus (fluticasone/salmeterol). Shares in Hikma fell as much as 9 percent on the news, with partner Vectura down up to 10 percent.

According to Hikma, the agency classed the letter as "major," adding that "given the nature of the feedback…there is a low likelihood of approval this year" for the therapy, called VR315. The drugmaker said that based on an initial assessment of the FDA's letter, no material issues were raised regarding the substitutability of the proposed device, which uses Vectura's dry powder inhaler and formulation technology.

Hikma indicated that it is in the process of reviewing the letter and will provide an update on its application once it has completed its assessment and discussed this with the FDA. The company added that it "will work collaboratively with the FDA to address their outstanding questions."

In March, Mylan received a complete response letter from the FDA regarding its regulatory filing for a generic version of Advair, with the US company recently saying that it disagreed with the agency's assessment of the standards that must be met by its proposed product. Last month, Teva launched AirDuo RespiClick (fluticasone/salmeterol), along with its authorised generic version, in the US, with the fixed-dose combination products containing the same active ingredients as Advair. However, GlaxoSmithKline spokeswoman Sarah Alspach noted at the time that "neither branded AirDuo, nor its authorised generic are therapeutically equivalent or substitutable for Advair."

GlaxoSmithKline recently reaffirmed that it expects 2017 earnings-per-share growth in the range of 5 percent to 7 percent if generic versions of Advair are not launched in the US this year. However, if a substitutable generic competitor to Advair is introduced in the US market mid-year, GlaxoSmithKline expects full-year Advair sales in the country of around 1 billion pounds ($1.3 billion), with "flat to a slight decline" in earnings per share.