Drug Development and Manufacturing

Biopharmaceutical Manufacturer
Recently, Novartis announced an agreement with Takeda to acquire Xiidra (lifitegrast ophthalmic solution), Takeda’s new drug for dry eye disease. Xiidra is currently the only prescription medication approved to treat ocular damage caused by dry eye disease and alleviate its symptoms. This acquisition will enrich Novartis’s ophthalmology drug pipeline.
Dry eye disease is a common inflammatory condition that, if left untreated, can cause severe pain and lead to corneal damage and vision impairment. In the United States, approximately 34 million people are affected by this condition. Symptoms reported by patients include dry eyes, ocular discomfort, stinging, and intermittent blurred vision. Risk factors for dry eye disease include age and gender (it is more prevalent in women). Prolonged screen time, contact lens wear, and undergoing cataract and refractive surgeries may also increase the risk of developing dry eye disease.
Xiidra is a prescription eye drop whose active ingredient, lifitegrast, inhibits the binding of lymphocyte function-associated antigen 1 (LFA-1) to intercellular adhesion molecule 1 (ICAM-1), thereby reducing T-lymphocyte-mediated inflammation. It not only treats ocular surface damage caused by dry eye disease but also alleviates the associated discomfort symptoms. Phase 3 clinical trials have demonstrated that this new medication has a rapid onset of action and exhibits favorable safety and tolerability profiles.
The approval of this new drug was based on data obtained from four clinical trials involving approximately 1,000 patients. In three of these trials, Xiidra significantly reduced patients’ eye dryness scores (EDS) after 6 and 12 weeks of treatment. In two clinical trials, Xiidra demonstrated significant improvement in EDS as early as 2 weeks after initiation of treatment.
Under the agreement, Novartis will pay an upfront payment of $3.4 billion and potential subsequent payments of up to $1.9 billion based on milestones. Novartis will also acquire nearly 400 employees associated with this product.
“Xiidra has a unique dual mechanism of action, representing the kind of innovative therapy we aim to acquire through investment,” said Mr. Paul Hudson, CEO of Novartis Pharmaceuticals. “We look forward to bringing this new medication to more patients.”
References:
[1] Novartis to acquire Xiidra?, expanding front-of-eye portfolio and strengthening leadership in eye care. Retrieved May 9, 2019, from https://www.novartis.com/news/media-releases/novartis-acquire-xiidra-expanding-front-eye-portfolio-and-strengthening-leadership-eye-care
Source: WuXi AppTec