Shire Gets Positive CHMP Opinion for Hemophilia A Drug

Shire plc SHPG announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval  of Adynovi [Antihemophilic Factor (Recombinant), PEGylated].

Adynovi is an extended half-life recombinant Factor VIII (rFVIII) treatment for adults and adolescents aged 12 and older living with hemophilia A for on-demand and prophylactic use. The drug was first approved as Adynovate by the FDA in the United States for hemophilia A, in pediatric patients under 12 years of age.

Adynovate was also approved by the FDA for use in surgical settings for both adult and pediatric patients. It then received approval in Japan, Canada, Colombia and Switzerland.

We note that the CHMP submission was based on outcomes from three phase III studies of patients with hemophilia A, a designated orphan disease by the European Commission. It is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII (FVIII) in the blood.

The CHMP opinion will be reviewed by the European Commission, which will grant marketing authorization in the EU. If approved, the adults and adolescent patients having hemophilia A in Europe will get a new treatment option with a twice-weekly prophylaxis dosing schedule. This will help the patients to manage their hemophilia A care with their physicians in the way that works best for them.

Meanwhile, Shire is also evaluating another candidate, SHP654, for the treatment of patients with hemophilia A. In October 2017, the FDA granted orphan drug designation to the same.

Some other companies are also evaluating candidates for hemophilia A. In August 2017, another company Roche Holding AG RHHBY declared that the FDA has accepted its Biologics License Application (“BLA”) and granted Priority Review for its hemophilia A candidate, emicizumab. The priority review was granted as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors.

Zacks Rank & Stocks to Consider

Shire carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space include Ligand Pharmaceuticals Incorporated LGND and Corcept Therapeutics Incorporated CORT. Both the companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 40.5% year to date.

Corcept’searnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in twol of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 144.5% year to date.

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