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How Is Bioverativ’s Alprolix Positioned Now?

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Alprolix’s revenue trends

In 3Q17, Bioverativ’s (BIVV) drug Alprolix generated revenue of $88.5 million, which reflected a rise of ~4% on a year-over-year (or YoY) basis. In 3Q17, Alprolix contributed ~32.2% of Bioverativ’s net product sales.

Alprolix reported revenue of $264.2 million in the first nine months of 2017 (which ended in September 2017) compared to its revenue of $240.5 million in the first nine months of 2016.

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Recent clinical trial outcomes

In December 2017, Bioverativ and Swedish Orphan Biovitrum announced the results of their new post-hoc longitudinal analysis, which showed that individualized dosing of Alprolix with extended half-life therapy every 14 or more days might be an option for the treatment of individuals with severe hemophilia B.

The analysis of the clinical trial demonstrated that candidates who had received pre-study prevention therapy were well protected and had extended dosing intervals of 14 days or more with an ABR (annualized bleed rate) of 1.8 compared to 2.0 pre-study.

In the clinical trial, patients on pre-study episodic treatments demonstrated a reduction in their median ABR from 25 to 1.4. Candidates treated with more than 14-day dosing intervals were well controlled and had a median spontaneous ABR of 0.7 over three years.

In December 2017, Bioverativ also presented the results from its novel imaging study evaluating the extravascular distribution of factor IX therapies such as Alprolix. In the clinical trial, radiolabeled Alprolix and glycoPEGylated factor IX analog were administered in a preclinical model of hemophilia B and imaged at over five points in time.

In the trial, in-vivo SPECT imaging showed that Alprolix had demonstrated significantly higher distribution to extravascular areas such as the knee and shoulder joints over all points in time compared to the conventional factor IX therapy and the glycoPEGylated factor IX analog. Alprolix’s superior data in the clinical trials are expected to strengthen the drug’s marketing profile. The drug’s success in the clinical trial may also aid in its label expansion.

In the marketplace, Alprolix competes with Pfizer’s (PFE) BeneFix, Shire’s (SHPG) Bebulin, Baxter’s (BAX) Proplex T, and Aptevo Therapeutics’ (APVO) Ixinity. In 3Q17, Pfizer’s Benefix reported revenue of $151 million.

Alprolix’s revenue growth could boost the share price of the SPDR S&P Biotech ETF (XBI). Bioverativ makes up ~1.7% of XBI’s total portfolio holdings.

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