Shire plc SHPG announced that the European Commission has granted marketing authorization to Onivyde, in combination with fluorouracil (5-FU) and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following treatment with Eli Lilly and Company’s LLY Gemzar-based therapy.
The approval did not come as a surprise given that Onivyde had been granted a positive opinion from the Committee for Medicinal Products for Human Use in July.
With the approval, Shire is authorized to market Onivyde, also known as nal-IRI or MM-398, in the EU, Iceland, Liechtenstein and Norway. Note that Onivyde is already approved in the U.S. for this indication.
The marketing approval was based on positive data from the NAPOLI-1 study.
The study met the primary and secondary endpoints as Onivyde, in combination with 5-Fu/Lv, significantly improved overall survival, progression-free survival and objective response compared to 5-FU/LV alone in patients with metastatic pancreatic cancer.
However there were some adverse reactions (incidence ≥20 percent) associated with treatment of Onivde in combination with 5-Fu/Lv. These included diarrhea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anemia, stomatitis, and pyrexia.
We note that Shire has a licensing agreement with Merrimack Pharmaceuticals, Inc. MACK, under which the former is responsible for the development and commercialization of Onivyde outside the U.S. and Taiwan. In Taiwan, PharmaEngine holds the commercialization rights to Onivyde, after the product license was granted in Mar 2016. Meanwhile in the U.S., Merrimack markets the drug.
According to the company’s press release, pancreatic cancer is the fourth leading cause of cancer-related death and there are limited treatment options available. Therefore, the approval of Onivyde is in line with Shire's focus of developing and commercializing treatments for the most promising markets of oncology.
Zacks Rank & a Stock to Consider
Shire carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Exelixis, Inc EXEL, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’s loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to a gain of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
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