Lialda for ulcerative colitis
In fiscal 2015, Lialda added $684.4 million to Shire’s (SHPG) top line, reflecting an 8% annual increase in sales. This was supported by a 10% rise in prescription volume. Despite the price increase, sales growth was moderated by sales deductions and destocking.
Lialda received FDA (U.S. Food and Drug Administration) approval in 2007 for “the induction of remission in patients with active, mild to moderate ulcerative colitis.”
Wall Street analysts expect Lialda to generate $716.7 million and $730.6 million in fiscal 2016 and 2017, respectively.
The ulcerative colitis market is dominated by Johnson & Johnson’s (JNJ) Remicade and Simponi, Takeda Pharmaceutical’s (TKPYY) Entyvio, and AbbVie’s (ABBV) Humira. With patent expiration for biologics such as Remicade and Humira and a potential biosimilar launch in the United States, the ulcerative colitis market would face cutthroat competition.
Shire wins Lialda patent infringement case against Watson
On March 29, 2016, Shire won its patent infringement case for Lialda against Watson, which is now Actavis. Watson had filed an ANDA (Abbreviated New Drug Application) with the FDA to launch a generic version of Lialda. The United States District Court for the Southern District of Florida ruled that Actavis’s proposed ANDA infringed on the patent for Lialda, which doesn’t expire until June 8, 2020.
With changing market dynamics, there are fluctuations in the share prices of pharmaceutical and biotechnology companies. As a result, it’s often risky to invest directly in these companies. To be on the safer side and still get exposure to the equities, investors can invest in the ProShares Ultra Nasdaq Biotechnology (BIB). The fund holds 1.3% of its total holdings in Shire stock.