Embedded Files
Hemlibira is now approved as a self-injectable subcutaneous treatment for most of hemophilia patients with dosage interval of once a week, once every two weeks and even once every four weeks.
Hemlibira is now approved as a self-injectable subcutaneous treatment for most of hemophilia patients with dosage interval of once a week, once every two weeks and even once every four weeks.
October 4, 2018
Genentech, a member of Roche Group, applied to the U.S. Food and Drug Administration (FDA) for approval of the hemophilia treatment Hemlibra to be used for non-inhibitor type patients. The drug a "breakthrough therapy designation" by FDA in April, and in June its New Drug Application was designated for priority review.
Hemlibra is superior to current conventional treatments in terms of both effectiveness and treatment applications. There are analysts who forecast that sales could grow to $5 billion (roughly 550 billion yen) (BioSpace report of September 18, 2018). The FDA was quick to designate it for priority review, and it is now approved as of October 4.
Hemlibra has now clear advantage against Shire's most important products that require intravenous injection in hospitals for three-to-four times a week.
Hemlibra has now clear advantage against Shire's most important products that require intravenous injection in hospitals for three-to-four times a week.
Once sales of Hemlibra to non-inhibitor patients begin in the U.S., Shire is likely to be forced to change its business model. Shire has been seeking to dominate market for specific rare diseases by means of aggressive M&A, but when Roche and other mega-pharmaceutical companies embark on developments in such areas, there is a strong chance that the business model will no longer render it viable.
May 2, 2018
Shire is the world's largest maker of treatments for hemophilia, with a 40% share of the market.
Shire is the world's largest maker of treatments for hemophilia, with a 40% share of the market.
Recently, however, it faces challenges from promising new competitors. With the emergence of these new competitors, investors need to examine and evaluate the drugs Shire has in its development pipeline for hemophilia.
Here we are not just talking about Hemlibra from Chugai (Roche). Pfizer and Spark are also working jointly on a new gene treatment called SPK-9001, and there are others.
The overall market for hemophilia drugs is pretty stagnant. Sales of major products in 2017 were $8.5 billion, up just 0.4% from the year before.
Shire has the biggest market share with its products, Advate and Feiba. The combined sales of the two products account for 45% of the market. This leaves room for concern that a new market entrant could be very disruptive.
Shire has the biggest market share with its products, Advate and Feiba. The combined sales of the two products account for 45% of the market. This leaves room for concern that a new market entrant could be very disruptive.
Click the table below for more information on hemophilia market
Report abuse