Alexion's New Formulation of Ultomiris Gets CHMP Backing

Alexion Pharmaceuticals, Inc. ALXN announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris (ravulizumab)in the European Union.The company noted that the European Commission typically reaches a decision on approval in approximately two months of the CHMP recommendation. Hence, a decision on the same is expected in November 2020.

Ultomiris is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

PNH is a serious ultra-rare blood disorder and aHUS is an ultra-rare disease that can cause progressive injury to vital organs.

Shares of the company have gained 3.4% compared with the industry’s growth of 0.6%.

The CHMP positive opinion is based on a comprehensive chemistry, manufacturing and control (CMC) submission and a supplementary clinical data. Ultomiris 100 mg/mL would constitute an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment.

Alexion plans to submit regulatory filings in the United States and the EU in the third quarter of 2021 for an Ultomiris subcutaneous formulation and device combinations for PNH and aHUS that can be self-administered at home, after completion of the ongoing phase III study and collection of 12-month safety data.

Zacks Rank &Stocks to Consider

Alexion currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Bio Techne Corp TECH and Alimera Sciences Inc. ALIM. While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne and Alimera carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 85.3% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 8.3% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 26.9% year to date.


Alexion Pharmaceuticals, Inc. Price

Alexion Pharmaceuticals, Inc. Price

Alexion Pharmaceuticals, Inc. price | Alexion Pharmaceuticals, Inc. Quote

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