Novartis Inks $8.7 Billion Gene Therapy Deal to Buy AveXis
Novartis NVS announced that it has inked a deal to acquire the U.S. based clinical stage gene therapy company, AveXis, Inc AVXS.
AveXis is focused on developing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases.
Pursuant to the agreement, Novartis will execute the acquisition through its subsidiary for a cash-tender offer of $218 per share ($8.7 billion) of AveXis’ common stock, representing a premium of 88.1%. The culmination of this transaction is subject to customary closing conditions. Novartis anticipates completion of this buyout in the second half of 2018. Boards of both companies have approved the acquisition deal.
Shares of Novartis, a Swiss drug maker, inched up 1.58% in pre-market trading on Apr 9, following the news release. The AveXis stock also soared 83.8% in pre-market trading session. The Novartis stock has outperformed the industry year to date, having lost 3.7% comapred with the industry’s decline of 4.8%.
The impending buyout will add AveXis’ lead candidate, AVXS-101, to the acquirer’s portfolio, strengthening the latter’s presence in gene therapy and neuroscience space. AVXS-101 is being developed or the treatment of spinal muscular atrophy (SMA), a neurodegenerative disease, accounting for the highest genetic cause of death in infants.
Notably, both the FDA and the European Medicines Agency (EMA) have granted AVXS-101 an orphan drug designation for the treatment of SMA and the FDA has granted AVXS-101, a fast track status for the treatment of SMA Type 1. The regulatory agency has also granted a breakthrough therapy designation to AVXS-101 for addressing SMA Type 1 in pediatric patients.
A regulatory filing in the United States is expected in the second half of this year with a launch anticipated in 2019. The company also secured PRIME and Sakigake designations for the candidate in Europe and Japan, respectively.
Significantly, an approved product for the cure of SMA in the United States is Biogen’s BIIB, Spinraza (nusinersen), the first and the only treatment to get an FDA nod in the country for the indication.
However, if approved, AVXS-101 would be the first-ever one-time gene replacement therapy for SMA in the United States.
Apart from AVXS-101, the deal will also expand Novartis pipeline into other genetic disorders including Rett Syndrome and amyotrophic lateral sclerosis.
Initially, though the acquisition is anticipated to negatively impact Novartis’ operating income due to increased research & development expenses, it is later on expected to substantially contribute to the company’s bottom line from 2020 onward.
We remind investors that in January 2018, Novartis entered into a licensing agreement with Spark Therapeutics to develop and commercialize the latter’s gene therapy, Luxturna (voretigene neparvovec), in the markets outside the United States.
We note that Luxturna was approved in the United States last December as a one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 (retinal pigment epithelial 65 kDa protein) gene.
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Zacks Rank & Key Pick
Novartis carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Ligand Pharmaceuticals Incorporated LGND, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved north from $3.78 to $4.20 for 2018 and from $4.75 to $5.32 for 2019 in the last 60 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has surged 49.6% over a year.
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