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US Bioservices Selected by Verastem Oncology™ to Dispense COPIKTRA™ (duvelisib) Capsules

September 27, 2018

FRISCO, Texas--(BUSINESS WIRE)--Sep 27, 2018--US Bioservices, a specialty pharmacy that is a part of AmerisourceBergen, today announced that it has been selected by Verastem Oncology TM to dispense COPIKTRA™ (duvelisib) capsules. The U.S. Food and Drug Administration (FDA) has approved COPIKTRA™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.

COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Lymphoma is the most common blood cancer, and CLL/SLL and FL are common types of indolent non-Hodgkin lymphomas (iNHL). There are an estimated 681,000 people living with non-Hodgkin lymphoma in the US alone, including nearly 350,000 cases of CLL/SLL or FL. Many of these patients will eventually relapse or develop refractory disease.

“Specialty pharmacies like US Bioservices have an important role in supporting and coordinating care between providers, patients and the manufacturers that create innovative treatments,” said Randy Maloziec, Vice President BioPharma Relations, US Bioservices. “As cancer care becomes more advanced, it’s important that we continue to innovate our services to increase collaboration among stakeholders, improving access and the quality of patient care.”

US Bioservices’ Oncology Center of Excellence includes specialty-trained pharmacists and nurses who offer patients caring support and specialized education to help them achieve the greatest benefit from their therapy. In addition to the education materials that will be provided with each dispense, US Bioservices’ clinicians will proactively reach out to patients to provide additional information and personalized support.

Through the breadth of resources available at AmerisourceBergen, US Bioservices develops solutions to ensure all patients on therapy receive uncompromising support to navigate their treatment, clinically, economically and socially. AmerisourceBergen companies supporting the launch of this therapy include ASD Healthcare and Oncology Supply for specialty distribution, ICS for specialty logistics and ION Solutions for community oncology practice contracting.

Use of COPIKTRA is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

Please see www.COPIKTRAHCP.com/prescribinginformation for full Prescribing Information including BOXED WARNING and Medication Guide.

This therapy is a limited distribution medication that is only available from select specialty pharmacies. Physicians may submit prescriptions to US Bioservices via phone (877) 757-0667, fax (888) 899-0067, ePrescribe or the MyPathpoint Prescriber Portal.

About COPIKTRA™ (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. 1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies. 5 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013; 20:1-11. 2 Reif K et al. Cutting Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240. 3 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.

About AmerisourceBergen

AmerisourceBergen provides pharmaceutical products, value-driving services and business solutions that improve access to care. Tens of thousands of healthcare providers, veterinary practices and livestock producers trust us as their partner in the pharmaceutical supply chain. Global manufacturers depend on us for services that drive commercial success for their products. Through our daily work—and powered by our 21,000 associates—we are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #12 on the Fortune 500, with more than $150 billion in annual revenue. The company is headquartered in Valley Forge, Pa. and has a presence in 50+ countries. Learn more at amerisourcebergen.com.

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CONTACT: AmerisourceBergen

Francesca Gunning

610-727-7433 – Office

215-603-9264 – Mobile

fgunning@AmerisourceBergen.com

or

Tierney Communications

Courtney Dysart

215-790-4349 – Office

215-237-7431 – Mobile

cdysart@tierneyagency.com

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY HOSPITALS ONCOLOGY PHARMACEUTICAL FDA NURSING MANAGED CARE

SOURCE: AmerisourceBergen

Copyright Business Wire 2018.

PUB: 09/27/2018 08:45 AM/DISC: 09/27/2018 08:45 AM

http://www.businesswire.com/news/home/20180927005411/en

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