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Global pharmaceutical company Pfizer Inc, together with partner Avillion LLP, produced a drug called Bosulif that beat Novartis’ Gleevec in a late-stage study of untreated leukemia patients. Pfizer will pursue global regulatory approvals for the expanded use of the medication.

Mace Rothenberg, MD, chief development officer of Oncology in the Pfizer Global Product Development stated that, “This is an important milestone for Pfizer’s emerging hematology portfolio as we work to develop new treatments for patients with acute and chronic hematologic malignancies.”

Shares for Pfizer inched up 0.3% at $31.60, coinciding with the gains among health stocks. However, a separate issue regarding US president-elect Donald Trump’s plan to incentivize American firms to expel their growth in overseas cash piles may possibly spur a new wave of deal making in the pharmaceutical industry seeking to buy its way into growth. This has caused the current stock for Pfizer to remain with little gains.

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Leukemia, Gleevec

Most individuals with chronic myeloid leukemia (CML) have a genetic mutation called the Philadelphia chromosome which makes the bone marrow to generate an enzyme that consequently activates the increase of abnormal and unhealthy white blood cells—Leukemia.

Bosulif is currently approved in the US and EU to treat patients with Ph+ CML resistant to, or intolerant of prior therapy, including Gleevec, which is hailed as the standard-of-care therapy for these patients.

Sun Pharmaceutical Industries Ltd, India's largest drug maker, had previously introduced its generic version of Gleevec in the US in February, pricing it about 30% lower than the original drug's yearly price of around $90,000.

Phase 3 Trial: Success

Positive results have been registered from a phase 3 comparison of bosutinib (Bosulif, Pfizer-Avillion) and imatinib (Gleevec) as first-line treatments in patients with CML in the Bosutinib Trial in First-Line ChrOnic Myelogenous Leukemia TREatment (BFORE).

Managed Care, a publication dealing with the latest developments in the healthcare industry, explained the Pfizer-Avillion medication. “Bosutinib is an oral, once-daily tyrosine kinase inhibitor (TKI) that inhibits the Bcr-Abl kinase, which promotes CML; it is also an inhibitor of Src-family kinases. Bosutinib was approved by the FDA in September 2012 for the treatment of adults with Ph+ CML who were resistant to or intolerant of prior therapy. The current approved dosage of bosutinib is 500 mg once daily with food.”

The study achieved its crucial endpoint of a superior major molecular response (MMR) at 12 months with bosutinib, compared with imatinib.

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BFORE was an open-label study intended to evaluate the efficiency and safety of bosutinib as treatment for adults with chronic phase Ph+ CML. The study involved 536 patients at sites coming from North America, Asia, and Europe.

The patients were randomly given bosutinib (400 mg) or imatinib, for the interval of the study. The main objective was to establish the advantage of bosutinib over imatinib at 12 months by comparing MMRs, or what we call the amount of patients in each treatment arm whose levels of Bcr-Abl1 kinase had fallen to below 0.1%.

Based on the results, Pfizer will work with the US Food and Drug Administration (FDA) and other regulatory authorities to potentially make bosulif available for Ph+ CML patients in the first-line setting.

Partnership

Pfizer and Avillion entered a collaborative development agreement in year 2014 to accomplish the BFORE trial.

“This successful partnership between Pfizer and Avillion is good news for CML patients because additional first-line treatment options allow physicians to tailor therapy based on individual patient considerations,” said Allison Jeynes-Ellis, MD, Chief Executive Officer of Avillion. “The outcome of this partnership reinforces our belief in the potential of our innovative business model for the co-development and partnership of late-stage clinical candidates.”

Avillion provided subsidy and performed the study to produce the clinical data that will be used to backing up regulatory filings for marketing authorization of bosutinib as a first-line treatment for patients with chronic-phase Ph+ CML, under the terms of the agreement.

Pfizer has reserved all rights to commercialize bosutinib globally.

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