Published: Tuesday, March 22, 2022 · 10:44 PM | Updated: Tuesday, March 22, 2022 · 10:44 PM
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🗝️ Key Points
- A small AstraZeneca (AZN, Financial) spinoff that was struggling has been revived thanks to what it thinks could become a billion-dollar drug.The turnaround for Boston-based.
- (ALBO, Financial) came last summer when the biotech earned approval of Bylvay, a drug that treats liver disease, in both the U.S.
- “We have an approved product and the opportunity to take Bylvay into other indications.”Results of a phase 3 study of Bylvay in another pediatric liver disease, Alagille.
A small AstraZeneca (
AZN, Financial) spinoff that was struggling has been revived thanks to what it thinks could become a billion-dollar drug.
The turnaround for Boston-based Albireo Pharma Inc. (
ALBO, Financial) came last summer when the biotech earned approval of Bylvay, a drug that treats liver disease, in both the U.S. and Europe. The company thinks the treatment could achieve blockbuster status, although FiercePharma Reported pharma consulting firm Evaluate believes $300 million is more realistic.
“For a small company that’s been an R&D company for a long time, to transition to a commercial company is no small feat,” Albiero CEO Ron Cooper said. “We have an approved product and the opportunity to take Bylvay into other indications.”
Results of a phase 3 study of Bylvay in another pediatric liver disease, Alagille syndrome, are expected sometime this year. If the company can score approval for that condition, the potential market for Bylvay could Double. Albireo estimates there are 25,000 people around the world with Alagille syndrome and another 25,000 with progressive familial intrahepatic cholestasis.
Albireo also is enrolling patients in a phase 3 study of Bylvay against another pediatric liver disorder, biliary atresia. If all goes according to plan, that trial would read out in 2024. There are approximately 50,000 people in the world with the condition.
“The really strong results of Bylvay and PFIC translate really well to other diseases like Alagille and biliary atresia,” Cooper said. “We believe Bylvay could be a blockbuster product—over a billion dollars in the second half of the decade. We get there by making Bylvay, not into a PFIC drug, but a pediatric cholestatic liver disease drug.”
At just under $31, the company’s shares are up about $10 since early last December. Wall Street seems to think the stock has plenty of room to grow, with analysts rating it a strong buy with an average 12-month target price of $75.20 and a high of $84, according to Yahoo Finance.
Sales of Bylvay were $7 million last year, twice what the company thought it would be. Albiero is responsible for commercializing the drug in the U.S. and Europe. In other territories, it’s working with third-party marketers.
The company is confident of a smooth rollout since Bylvay is the only drug prescribed for PFIC, the diagnosis of the condition is simple and the web of specialists who treat children with cholestatic liver disease is a tight-knit group in Europe and the U.S.
Competition for Bylvay is looming, however. Last September, the Food and Drug Administration greenlighted Mirium Pharmaceuticals Inc.’s (
MIRM, Financial) Livmarli as the first treatment for Alagille syndrome. Mirum also is testing the drug in PFIC and biliary atresia.
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