Roche hemophilia blockbuster drug Hemlibra lawsuit wins, doesn't infringe on Shire patent

Roche recently ushered in a good news, and the company's development of a new drug for hemophilia Hemlibra(emicizumab).

Hemlibra is the first regular prophylactic treatment approved for adults and children with hemophilia A who have produced coagulation factor VIII inhibitors in the body in more than 20 years. It is a bispecific monoclonal antibody that can activate the natural coagulation cascade. Coagulation factors IXa and X, the two proteins necessary to restore the natural coagulation process, bring together to restore the coagulation process in patients with hemophilia A. In clinical studies, Hemlibra has been shown to significantly reduce bleeding events and improve body function. Dr. Sandra Horning, Chief Medical Officer, Roche Pharmaceuticals, said: "Hemlibra is the first drug with better efficacy than factor VIII prophylaxis, which is the standard of care for patients with hemophilia A who do not produce inhibitors. We look forward to working closely with the drug review agency to use Hemlibra for the treatment of patients with hemophilia A as soon as possible. At the same time, as we spend World Hemophilia Day together, we are very happy to share this news with the community."

Hemlibra received its first breakthrough therapy designation in September 2015 and was approved by the US FDA in November 2017 for the reduction or prevention of bleeding frequency in children and adults with haemophilia A who produced VIII inhibitors. Hemlibra has also recently been approved by regulators in other countries around the world, including the European Commission in February 2018 for the regular prevention of bleeding episodes in patients with haemophilia A who have developed VIII inhibitors.

Hemlibra, developed by Chugai Pharmaceutical, a subsidiary of Roche, is a bispecific monoclonal antibody targeting coagulation factors IXa and X. The drug is designed to bring factor IXa and factor x together, thereby activating the natural coagulation cascade and restoring the coagulation process in hemophiliacs. Hemlibra is a type of prophylactic treatment in which the ready-to-use solution is administered by subcutaneous injection once a week to prevent or reduce bleeding episodes. So far, the Hemlibra has been approved by the United States, the European Union and Japan.

In a Hemlibra-related patent infringement case, the Tokyo District Court ruled in favor of its company, Chugai Pharma, according to Roche's statement. The court ruled that the Hemlibra did not infringe on the patent 4313531 held by Baxalta GmbH, a wholly owned subsidiary of Shire. Although the ruling is not directly related to other patent challenges outside Japan, Roche said it was very encouraged by the results.

In fact, when Hemlibra was approved by the US FDA, Shire filed a lawsuit in the Delaware District Court for patent infringement by Roche products. The protracted patent battle is expected to be decided later this year, according to information released by Shire. In that case, Shire filed a preliminary injunction in December, claiming that Roche and Sino-Foreign Pharmaceutical Products Hemlibra violated its U.S. patent 7033590. At the time, Shire claimed that it did not require a one-size-fits-all ban on the sale of Hemlibra, but rather a "carve-out" that would allow those with the greatest need to continue accessing Hemlibra treatment. (Note: carve-out refers to the direct exclusion of certain objects in a treaty or agreement, that is, what the parties have agreed to exclude before the dispute arises).

Since last year, Roche, with its Hemlibra in hand, has been trying to break into the seven global pharmaceutical markets (the United States, five European countries and Japan) with hemophilia A drugs worth about $7 billion. Currently, the hemophilia A inhibitor segment is dominated by Shire and Novo Nordisk's two bypass agents (BPAs): Feiba(FVIII inhibitor bypass active agent) and NovoSeven (recombinant human coagulation factor VIIa for injection, rFVIIa). The listing of Roche's Hemlibra is expected to significantly erode Shire and Novo Nordisk's share in this segment. According to data released by Pmlive, Feiba had sales of $0.45 billion in 2017.

The industry is very optimistic about the business prospects of Hemlibra. Recently, Corey Weian (Clarivate Analytics) released the "2018 most noteworthy drug forecast". The report predicts 12 new drugs (blockbuster drugs) that will be on the market in 2018 and whose sales are expected to exceed $1 billion in 2022, with Hemlibra topping the list with $4.002 billion.

References:http://med.sina.com/article_detail_103_2_43514.html