- Teva Pharmaceutical Industries Ltd. this week brought the latest copycat version of Shire plc's Lialda to the U.S. market, adding to the Irish pharma's list of competition woes.
- Lialda gained the Food and Drug Administration's approval in 2007 to treat mild to moderate ulcerative colitis. Not long after, it became Shire's top-selling internal medicine and by 2016 was raking in nearly $800 million annually.
- Despite holding a patent set to expire in 2020, Shire saw the first generic version of its drug hit the U.S. last summer. That entry pushed Lialda sales down 28% in 2017.
Shire is facing threats to multiple franchises. Roche AG's recently greenlighted Hemlibra (emicizumab-kxwh), for instance, could erode up to 30% of sales for Shire's recombinant antihemophilic factor therapies Advate and Adynovate by 2022. Hemlibra, along with other new hemophilia treatments, also put at risk half of the sales for the smaller pharma's Feiba (anti-inhibitor coagulant complex), a treatment for patients who have developed inhibitors.
Additionally, manufacturing issues suppressed uptake of Shire's hereditary angioedema (HAE) drug Cinryze (C1 esterase inhibitor [human]) — inconveniently right at the time when rival company CSL Behring LLC was launching its own HAE offering, Haegarda (C1 esterase inhibitor [human]).
Amid that growing competition, Shire earlier this year lowered its 2020 revenue guidance from $20 billion to between $17 billion and $18 billion. Earlier-than-expected Lialda (mesalamine) generics were likely responsible for at least part of that revision.
The drug makes up the largest chunk of sales for Shire's internal medicine unit, which — while far from its most important — is still responsible for a little more than 10% of the company's total pharmaceutical revenue. As such, the introduction of Zydus Pharmaceuticals' copycat last year fueled a 5% hit to the unit.
Now, there's yet another generic to contend with — and the probable loss of even more revenue.
Shire maintains it has already braced itself for the launch of a second Lialda generic, accounting for it in the revised 2020 guidance.
"As demonstrated by the performance of Adderall XR, we have experience competing in markets with generic competition," the company said in an email.
"Fundamentally we don't expect this recent development to impact our commercial strategy for Lialda, which is to continue to optimize Shire's branded Lialda share in a competitive market, while at the same time competing in the generic portion of the Lialda market through our authorized generic distribution arrangement with Prasco."
Meanwhile, the U.S. launch of 1.2 gram, delayed release mesalamine is a sliver of positive news for Teva, which as of late has suffered from increasing competition to its best-selling multiple sclerosis treatment Copaxone (glatiramer acetate) — among other problems. With that franchise under siege, the Israeli drugmaker's generic business will have to shoulder some additional weight.
"The launch of mesalamine is a significant addition to Teva's generic portfolio," Brendan O'Grady, head of North America Commercial at Teva, said in a March 26 statement. "With more than a million people in the U.S. estimated to suffer from inflammatory bowel diseases, including ulcerative colitis, this is an important and more affordable generic treatment option for our customers."