Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA.
The U.S. Food and Drug Administration (FDA) issued Hikma Pharmaceuticals a Complete Response Letter (CRL) in May 2017 for its abbreviated New Drug Application (ANDA) for its generic version, VR315, of GlaxoSmithKline’s Advair Diskus. Hikma and its development partner, Vectura Group plc, addressed all of the issues in the CRL except one, which it appealed through the FDA’s dispute resolution process. But the FDA upheld its original finding.
The FDA requested another clinical endpoint study. As a result, Hikma and Vectura have already finalized the plans for a new clinical trial and expects to begin patient enrollment soon. It hopes to submit a new response to the FDA with the new data as early as 2019. If everything goes well, Vectura and Hikma think they could launch the generic version in 2020.
Reuters notes, “Hikma already faced a delay in U.S. approval for its Advair generic in 2017, as did rival generics company Mylan, and last month a third Advair copy from Novartis’s Sandoz division also got knocked back by the FDA.”
Although GSK might be able to gain some breathing room by this delay, it’s not much. Mylan’s generic version could be approved by the FDA this year. Reuters says, “The timing of the arrival of generic Advair in the United States is critical to GSK’s near-term earnings outlook. The drugmaker expects its 2018 earnings, at constant exchange rates, to be flat to down 3 percent if generic Advair launches in the U.S. market by mid-year. Without generics, earnings would be up 4 to 7 percent.”
Vectura chief executive officer James Ward-Lilley said in a statement, “Whilst the outcome of the dispute resolution process is disappointing, we now have a clear pathway forwards, and we and our partner Hikma remain confident in, and committed to the approval of VR315. Assuming the successful execution of the new study and a standard regulatory review, we now expect a potential approval and launch during 2020. Importantly, we are one of the few first movers into this complex area and in this process, we have cleared up a significant number of issues which we believe has strengthened our insight and likelihood of success. These learnings support our confidence that we have the capabilities to achieve U.S. regulatory approval for our extensive inhaled generic pipeline, which includes versions of the three current largest U.S. inhaled brands.”
Hikma recently had a change at the top of the company. On February 20, the board of directors appointed Sigurdur (Siggi) Olafsson as chief executive officer and executive director of the board. The company’s current chairman and chief executive officer, Said Darwazah, will take on the position of executive chairman.
Olafsson, who will start his duties in the U.S. before moving to the UK, is most recently president and chief executive officer of the Global Generic Medicines Group of Teva Pharmaceuticals, Inc.. Prior to that position he was president of Actavis from 2012 to 2014, where he worked since 2003. From 1998 to 2003 he held several positions with Pfizer Inc.’s Global R&D business in the UK and U.S.
