BESPONSA (inotuzumab ozogamicin) Approved for Treatment of Adult Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia, available for order at Biologics, Inc.

August 22, 2017

CARY, N.C. (August 22, 2017) Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected by Pfizer, Inc. to be a specialty pharmacy provider for BESPONSA® (inotuzumab ozogamicin), a promising new IV therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Approved by the U.S. Food and Drug Administration (FDA) on August 17, 2017, BESPONSA is an anti-CD22 antibody-drug conjugated to calicheamicin, a potent cytotoxic antibiotic. It targets the marker CD22, which is expressed in more than 90% of patients with B-cell ALL.1 By binding to B cell-specific CD22 receptors, BESPONSA is internalized, triggering the release of the cytotoxic agent that causes double-strand DNA breaks and apoptosis. 2

Last year, the FDA put BESPONSA on the fast track to approval, granting priority review as a Breakthrough Therapy designation based on results from the phase III INO-VATE trial. Final results from the trial found the drug generated significantly more complete remissions than standard treatment, while also providing a better bridge to transplant.3   Compared to intensive chemotherapy, BESPONSA produced a bone marrow complete response nearly three times greater than conventional therapy. Additionally, nearly twice as many patients were able to progress to allogeneic transplant. Progression risk was also significantly reduced by 55%, and 2-year survival was more than double the control group at 23% vs. 10%.4

“Clinical trial results for BESPONSA are very impressive, demonstrating significant clinical benefits,” said Brandon Tom, vice president, Biopharma Services, McKesson Specialty Health. “We look forward to being a specialty pharmacy provider for this exciting new therapy that could potentially play a role in changing the treatment landscape for ALL.”

BESPONSA is a welcome addition to the limited treatment options oncologists now have for relapsed or refractory ALL. Adults diagnosed with this rapidly progressing and deadly disease currently have a challenging outlook, with only about 20 to 30 percent achieving a complete remission.5 BESPONSA offers patients new options for improved outcomes while also providing many of them the opportunity to undergo stem cell transplant, a potentially curative treatment.

Biologics’ oncology specialty pharmacy is committed to providing patient-centric care throughout the patient’s cancer journey. The company is recognized across the industry for its high-touch patient care model that supports patients with a multidisciplinary care team. Each team includes a pharmacist with in-depth knowledge of oncology pharmaceuticals, an experienced oncology nurse, and a financial counselor who is familiar with various financial assistance programs and organizations available to help cancer patients. The care team works together to develop individualized care plans that address the unique clinical, financial and emotional needs of each patient and that streamline communication back to the treating provider, empowering high-quality care and optimal outcomes.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

About Biologics

Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payers and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk.

Biologics is part of McKesson Specialty Health, a division of McKesson Corporation empowering the community patient care delivery system by helping community practices advance the science, technology and quality of care. Through innovative clinical research, business and operational solutions, facilitated by integrated technology systems, we focus on improving the financial health of our customers so they may provide the best care to their patients. Our combined organization will help better support patients and expedite access to oncology therapies. For more information, visit www.McKessonspecialtyhealth.com and www.biologicsinc.com.

1. http://www.ascopost.com/issues/august-25-2016/inotuzumab-ozogamicin-improves-outcomes-vs-standard-therapy-in-relapsedrefractory-acute-lymphoblastic-leukemia/
2. http://www.onclive.com/web-exclusives/fda-grants-inotuzumab-ozogamicin-priority-review-for-all
3. http://www.ascopost.com/issues/august-25-2016/inotuzumab-ozogamicin-shows-clear-benefit-in-acute-lymphoblastic-leukemia/
4. Ibid.
5. http://www.hematology.org/Thehematologist/Years-Best/7005.aspx

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