Today's Daily Dose brings you news about takeover rumors surrounding Alexion Pharma; positive results of Amgen/Allergan's JASMINE study; and an update on Clearside Biomedical's New Drug Application for XIPERE.
Read on…
Alexion Pharmaceuticals Inc. (ALXN) is not new to takeover rumors. This developer of rare disease drug Soliris has been in acquisition crosshairs since 2016 - with Roche, Pfizer, Novartis and Amgen been reported as the potential buyers.
The rumors swirl again as Intereconomia.com on Thursday said that "the acquisition of Alexion by Amgen could take place in the next few days, and that the price per share would be around $200", citing people familiar with the matter.
In the second quarter ended June 30, 2019, Alexion reported revenue of $1.20 billion compared to $1.04 billion in the year-ago quarter. Soliris contributed $980.8 million to the recent second-quarter revenue compared to $898.2 million in the second quarter of 2018. On a non-GAAP basis, the EPS for the second quarter of 2019 was $2.64 compared to $2.07 in the second quarter of 2018.
ALXN closed Thursday's trading at $123.49, up 7.53%. In after-hours, the stock gained another 4.87% to $129.50.
Amgen (AMGN) and Allergan plc.'s (AGN) phase III study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituximab, compared to Rituximab in patients with CD20-positive B-cell non-Hodgkin's lymphoma has yielded positive results.
In the study, dubbed JASMINE, the overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituximab, showing clinical equivalence. The safety and immunogenicity profile of ABP 798 was comparable to Rituximab.
Roche and Biogen's Rituximab, sold under the name Rituxan, in the U.S., lost its patent protection in the United States in 2016. In Europe, the drug is sold under the name MabThera. The European patents covering the drug expired in 2013.
Rituximab is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Celltrion's Truxima and Sandoz's Rixathon are the two Rituximab biosimilars currently marketed in the EU. The first Rituximab biosimilar to be approved in the U.S. is Celltrion and Teva's Truxima, approved last November. Pfizer's Ruxience, the second biosimilar to Roche's Rituximab, was approved as recently as July 2019.
AMGN closed Thursday's trading at $203.42, down 0.25%.
Shares of Clearside Biomedical Inc. (CLSD) took a hit on Thursday, following an update on the Company's New Drug Application for XIPERE, which is under FDA review.
XIPERE, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis.
The FDA is slated to announce its decision related to XIPERE approval only on October 19, 2019. However, now the FDA's Office of Pharmaceutical Quality has asked Clearside to provide stability data for the triamcinolone acetonide suspension produced utilizing an enhanced manufacturing process implemented by the Company.
Against this backdrop, Clearside expects XIPERE to be denied approval by the FDA. The Company plans to re-submit the XIPERE NDA in the first quarter of 2020 with the requested stability data.
CLSD closed Thursday's trading at $0.77, down 38.21%.
Shares of Retrophin Inc. (RTRX) slumped more than 20% on Thursday, following disappointing results from its phase III study of Fosmetpantotenate in patients with pantothenate kinase-associated neurodegeneration.
The study, dubbed FORT, did not achieve its primary or secondary endpoints.
Pantothenate kinase-associated neurodegeneration, or PKAN, is a rare, genetic and life-threatening neurological disorder. People suffering from PKAN may experience movement disorders such as dystonia (sustained muscle contraction leading to abnormal posture), rigidity, dysphagia (problems swallowing), and twisting and writhing, as well as visual impairment. PKAN is estimated to affect up to 5,000 people worldwide.
Another clinical program of the Company to watch out for is Sparsentan, which is under two pivotal phase III studies - one in patients with focal segmental glomerulosclerosis, dubbed DUPLEX, and the other in patients with IgA nephropathy, dubbed PROTECT.
Top-line efficacy data from the DUPLEX study is expected in the first half of 2021, and that from the PROTECT study is anticipated in the first half of 2022.
RTRX closed Thursday's trading at $13.56, down 22.07%. In after-hours, the stock was up 1.77% at $13.80.
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