News

Biogen's Spinraza is still churning—even after Novartis' rival Zolgensma launch

biogen
Biogen beat sales and earnings estimates in the third quarter, it announced Tuesday. (Biogen)

        Biogens Spinraza has faced its first full quarter of competition from Novartis gene therapy Zolgensma and early figures show the meds might be able to grow sales alongside one another. 

        The Boston biotech on Tuesday reported that Spinraza continues to roll even with Zolgensma on the scene after Novartis’ May launch. During the third quarter, Spinraza sales grew 17% to $547 million, besting consensus analyst expectations by $30 million.

        But Spinraza generated a good chunk of those revenues—$310 million—outside the U.S., where its not yet facing Zolgensma competition. Right now, the two drugs are only squaring off in the States in SMA patients under age 2.

De-Risking the Solid Form Landscape of an API

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

        RELATED: Novartis’ Zolgensma beats data woe, as Mayzent hits reimbursement hurdles

        For its part, Novartis on Tuesday reported that Zolgensma generated $160 million in the third quarter after its May FDA approval, beating expectations. The drug has weathered a data manipulation scandal, payer resistance and more, but uptake has so far been strong, CEO Vas Narasimhan said. Novartis also said Tuesday itll face Zolgensma delays in Europe and Japan over manufacturing problems. 

        Both meds carry sky-high price tags and treat a rare, muscle-wasting disease. A one-time treatment, Zolgensma is the worlds most expensive med at $2.1 million. Biogen launched Spinraza in early 2017 at $750,000 for the first year and $375,000 for subsequent years.

        Overall, Biogen on Tuesday reported third-quarter revenues of $3.6 billion and non-GAAP earnings per share of $9.17, beating analyst expectations of $3.5 billion and $8.21, respectively.

        Multiple sclerosis revenues grew 2% to $2.35 billion versus the same period last year, while biosimilar sales grew 36% to $184 million after the company launched its Humira copy in Europe last October. Royalties from Roches sales of multiple sclerosis Ocrevus also chipped in $188 million, a 37% jump from last years third quarter.

        RELATED: Biogen resurrects aducanumab, arguing expanded data set supports FDA filing in Alzheimers  

        Even with the solid financial performance, the news at Biogen on Tuesday centered on aducanumab, an Alzheimers candidate the drugmaker plans to submit to the FDA in early 2020 based on a new data analysis and after discussions with the FDA. Previously, Biogen discontinued development after a futility analysis determined the med wouldnt benefit patients. 

        On Tuesday’s conference call, Biogen CEO Michel Vounatsos said that earlier analysis was “incorrect” because it “didn’t effectively evaluate all of the variables” in two phase 3 trials assessing the med. Some analysts have their doubts, as one trial showed a clinical benefit and another didnt. Still, Biogens shares were up about 26% Tuesday.



Excerpt from URL:https://www.fiercepharma.com/pharma/biogen-stuns-biopharma-aducanumab-filing-news-but-it-also-beat-financial-expectations-q3



  ▲ Last article:   Roche sponsors iHeart country music concert for vets ---Oct 22, 2019
  ▼ Next article:   Novartis' Zolgensma faces stepped-up manufacturing scrutiny ---Oct 22, 2019
                    More ……      

 



News FullText Search