Alexion (ALXN) Up 10 % YTD on Soliris & Ultomiris Strength
The going has been good for this biotech, which primarily focuses on developing and commercializing drugs for the treatment of patients with ultra-rare disorders.
Alexion recently came out with strong results for the third quarter of 2019, wherein it beat earnings and sales estimates, and raised its annual guidance.
Lead drug Soliris (for the treatment of paroxysmal nocturnal hemoglobinuria [PNH] and atypical hemolytic uremic syndrome [aHUS]) maintains momentum on the back of strong volume growth. The drug is also approved for the treatment of refractory gMG in patients. Additionally, the FDA approved the drug to treat neuromyelitis optica spectrum disorder (NMOSD).
Moreover, to combat generic competition for Soliris, once it loses patent protection, Alexion developed a long-acting C5 complement inhibitor, Ultomiris, for the treatment of adults with PNH, which consolidated its PNH franchise. The initial uptake of the drug has been strong and it recorded sales of $168.7 million in the first nine months of 2019. Meanwhile, Alexion is also working to expand Ultomiris’ label. The drug was recently approved in the United States for the treatment of aHUS in adults and children one month and older. The label expansion of the drug into additional indications will boost sales further.
Concurrently, Alexion is looking to strengthen its pipeline with acquisitions and collaborations. Last month, it entered a definitive agreement to acquire a clinical-stage biopharmaceutical company, Achillion Pharmaceuticals, Inc. ACHN, for $930 million to strengthen its PNH franchise. Achillion primarily focuses on the development of oral small molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, such as PNH and C3 glomerulopathy (C3G). The acquisition will add two clinical-stage candidates to Alexion’s pipeline — lead candidate, danicopan (ACH-4471), in phase II and ACH-5228 in phase I. A potential approval of danicopan will make the company a market leader in the PNH space.
The company also announced a collaboration agreement with Stealth BioTherapeutics Corp MITO for a late-stage therapy for mitochondrial diseases. Both companies announced an agreement to co-develop and commercialize elamipretide, a novel, potential first-in-class therapy that targets mitochondrial dysfunction. The candidate is currently being evaluated in a phase III study in patients with primary mitochondrial myopathy (PMM).
The development of other drugs will also reduce the company’s dependence on Soliris. Notably, Amgen AMGN is developing a biosimilar of Soliris.
Nevertheless, with a strong portfolio of rare disease drugs and a solid pipeline, we expect the company to continue on its growth trajectory.
Alexion currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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