The most important last barrier to cross or dismantle for drug developers is the approval of novel products that amplify the improvement of previous drugs. The approvals of drugs in the U.S. and Europe open the door for the same drugs to be approved and marketed in the rest of the world. For the revenue-generating firms, each and every approval helps grow their revenues. With regard to the small development-stage firms the approval of their first drug could change their lives forever.
One of the significant recent approvals granted to a development-stage firm was the FDA approval of Portola’s (PTLA) Factor Xa inhibitor anticoagulant drug Bevyxxa (betrixaban). As described in the firm’s prescribing information, the drug is the first and only oral anticoagulant indicated for prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Portola’s Next Moves and Its Upcoming Great News
Portola’s Next Moves
The next step for Portola now is launching the drug, which is expected in August 2017. We also expect a continued advancement in the firm’s pipeline products. There are two other products moving forward in clinical trials, but the focus of the firm is now on Cerdulatinib, which is an oral, dual-spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor for hematologic cancers that have relapsed or have not responded to prior therapies. The drug uniquely inhibits 2 key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies: The B-cell receptor pathway via Syk and key cytokine receptors via JAK. That’s why Portola is currently developing it for non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and other hematologic cancers, with a focus on patients with certain treatment-resistant mutations.
So, while Portola is celebrating the approval of its first drug Bevyxxa, it is working diligently on advancing its cancer product cerdulatinib; enrolling patients in the Phase 2a study, which is evaluating the drug’s safety and efficacy for the treatment of relapsed/refractory B-cell malignancies who have failed multiple therapies.
Portola’s Upcoming Great News
Portola’s good news has not ended with the approval of Bevyxxa. We are expecting another approval for the same product to come from Europe at the hands of the European Medicines Agency’s Committee for Human Medicinal Products (CHMP). This approval will be followed by many other approvals of the Bevixxa around the world, which are expected to be granted quicker than usual. The reason is that the hospitals around the world try to improve their emergency room capabilities through using the latest approved products and procedures. This is especially true when the products are life-savior.
Another Approval in August
We expect an upcoming approval in August of an extremely important product – Andexxa. This product is extremely needed because it is the first antidote for factor Xa inhibitors anticoagulants. Some of these new anticoagulants are already approved but have no antidotes that can stop the bleeding events when they occur. Many doctors refrain from prescribing these anticoagulants in spite of their numerous advantages over warfarin — the currently most used product, but with the advantage of having vitamin K as its antidote. Firms that have factor Xa inhibitor anticoagulants on the market, or in clinical trials are anxiously waiting for Portola’s product Andexxa approval for the sake of the patients’ safety and for expected tremendous increase in their anticoagulant sales.
Prohost Last Words
Bevyxxa is a very important hospital drug and many believe that its sales will be in the billions. The same can be said for the firm’s antidote drug Andexxa. Both these drugs and the firm’s extremely strong scientific fundamentals, technical capability, and other pipeline products made us believe that it is a candidate for acquisition by one of the large pharmaceutical companies.
We remain loyal to Portola.
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