AbbVie ($ABBV) stayed strong on its view that autoimmune giant Humira--the biggest-selling drug in the world right now--will weather challenges at home and abroad.
On the April 28 first quarter earnings call, CFO Bill Chase said that international sales for Humira (adalimumab) rose 4.6% to nearly $1.4 billion on a currency adjusted basis.
He was joined by chairman and CEO Rick Gonzalez in re-asserting that biosimilar challenges to the franchise will be vigorously contested.
The company has been steadfast that a series of patents covering Humira will extend its status 6 more years beyond the end of 2016 in the U.S. against a biosimilar. Its exclusivity is set to expire in the European Union in April 2018.
Chase said on the call said that as far as 2016 is concerned internationally, continued growth in the second half of 2016 remains on the cards. "We are forecasting 3% operational growth for international Humira in the second quarter," Chase said.
"Excluding Venezuela, this growth would've exceeded 5%. We currently expect a negative 4% currency impact on international Humira in the second quarter, resulting in a modest decline year-over-year on a reported basis. However, we remain on track with our previously communicated full-year guidance for Humira outside the U.S., including the mid-single-digit operational growth expected internationally."
The company took further action to write down losses in Venezuela as the country struggles with continued weak global oil prices that have sapped it of foreign currency and severely weakened the bolivar exchange rate.
"During the quarter, as a result of the economic conditions in Venezuela and the lack of availability of U.S. dollars at the government's official exchange rate, we changed the exchange rate we use in Venezuela to the floating DICOM [a Venezuela central bank set exchange rate on certain goods] rate," Chase said.
"This resulted in a charge of $298 million, related to a devaluation of our net monetary assets in Venezuela. This will also impact revenue booked for products sold in Venezuela."
But neither executive specifically named Incheon-based Samsung Bioepis, which in March launched a U.K. lawsuit challenging Humira patents.
Samsung Bioepis, a venture between majority partner South Korea's Samsung Group and Biogen ($BIIB), alleged that AbbVie has been trying to extend exclusivity for Humira through a form of evergreening.
"Samsung Bioepis is taking this action to ensure that our affordable, high-quality biosimilars will reach the patients who need them most," Samsung Bioepis spokesman Mingi Hyun said in an email to FiercePharmaAsia.
"We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication. We believe competition should take place in the market, and not through such misuse of the patent system."
As well, the Sandoz generics and biosimilars unit of Novartis ($NVS) is on track to begin a Phase III trial on a biosimilar in mid-December.
- here's the release from AbbVie