After robust earnings performance by pharma bigwigs in the past couple of weeks, it was a relatively quiet period for the sector. Novo Nordisk (NVO – Free Report) beat estimates for both earnings and sales in the second quarter. J&J (JNJ – Free Report) filed regulatory applications to get the label of its multiple myeloma drug, Darzalex updated to include a split dosing regimen. Allergan (AGN – Free Report) exercised its option to buy development/commercialization rights to Editas Medicine, Inc.’s (EDIT – Free Report) lead CRISPR genome-editing ocular therapy, EDIT-101.
Recap of the Week’s Most Important Stories
Novo Nordisk Q2 Earnings & Sales Beat: Novo Nordisk beat estimates for both earnings and sales in the second quarter. Earnings per American depositary receipt of 68 cents were higher than 59 cents earned in the year-ago period. Total revenues of $4.38 billion rose 2% in local currency. While sales in the Diabetes and Obesity Care segment rose 4% in local currency, the same in Biopharmaceuticals segment declined 4%.
Novo Nordisk maintained its sales growth and operating profit growth guidance in the range of 3-5% and 2-5%, respectively, both measured in local currencies
J&J Seeks Approval for Split Dosing Regimen of Darzalex: J&J filed regulatory applications in both the United States and EU for label expansion of its multiple myeloma drug, Darzalex. J&J is looking to get the label of Darzalex updated to allow prescribing the medicine by splitting the first infusion of Darzalex over two consecutive days. Approval for this split dosing option is likely to improve the administration profile of the medicine.
Darzalex is a key contributor to J&J’s sales growth. The drug recorded sales of $432 million in the second quarter, rising 69.4% year over year. Darzalex is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings. Darzalex was approved in the first line setting in May 2018.
Allergan Buys Ocular Candidate from Editas: Allergan exercised its option for the discovery and development of genome editing company Editas’ lead CRISPR genome-editing ocular therapy, EDIT-101. It is being developed for Leber congenital amaurosis (LCA10), a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness. For exercising the option, Allergan paid Editas a fee of $15 million per their deal in March last year. Allergan is now responsible for development and commercialization of EDIT-101.
Allergan had teamed up with Editas last year for the discovery and development of up to five of the latter’s genome-editing ocular programs including EDIT-101. The alliance will see Allergan shelling out $90 million upfront as well as milestone payments and royalties. If the investigational new drug (IND) application for EDIT-101 is accepted by the FDA, Allergan will be entitled to pay another $25 million to Editas. CRISPR technology has the potential to create drugs with durable efficacy
AstraZeneca/Merck’s Selumetinib Granted Orphan Designation in Europe: AstraZeneca (AZN – Free Report) and partner Merck (MRK – Free Report) announced that their MEK 1/2 inhibitor, selumetinib has been granted orphan designation by the European Medicines Agency (EMA) for the treatment of neurofibromatosis type 1 (NF1), an incurable genetic condition that affects newborns. This designation is assigned to drugs, which are intended to treat rare disease.
Selumetinib is being evaluated in a phase I/II SPRINT study pediatric patients with inoperable NF1-related plexiform neurofibroma’s (PN’s), which are benign tumors
The NYSE ARCA Pharmaceutical Index rose 0.4% in the last five trading sessions.
All the stocks were in the green except J&J, which declined 0.6%. AstraZeneca recorded the highest gain of 2.4%.
(See the last pharma stock roundup here: Pharma Stock Roundup: PFE Dominates Headlines, BMY Drug Gets EU Approval)
What’s Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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