Bristol-Myers Squibb Announces Specialty Pharmacy Patient Management Programs For Sprycel® (dasatinib) Patients

Bristol-Myers Squibb Announces Specialty Pharmacy Patient Management Programs For ® (dasatinib) Patients

Amy Merves, 609-252-6934orJohn Elicker, 609-252-4611orDavid Caruba, 609-524-6798

(NYSE: BMY) and today announced the launch of patient management programs for (dasatinib) patients with a select group of specialty pharmacy providers. The specialty pharmacies include Accredo, CuraScript, Diplomat, Biologics and Avella (formerly The Apothecary Shops). The distribution of will remain open to other specialty and retail pharmacies.

These patient management programs are consistent with Bristol-Myers Squibb’s customer-centric strategy and will mark an important initiative within Bristol-Myers Squibb.

“Bristol-Myers Squibb is committed to supporting patients and empowering them to take an active role in managing their health,” said John Tsai, vice president, U.S. Medical, Bristol-Myers Squibb. “We are excited to introduce these additional patient-centric programs that help support appropriate medication management.”

Specialty pharmacies are uniquely positioned to provide support services to patients for oral oncology medications. They also play an important role in the management of oncology patients through trained clinical staff who provide education and outreach that may help patients stay adherent to prescribed therapies. Bristol-Myers Squibb and Otsuka believe these services are critically important in oncology.

“Bristol-Myers Squibb is committed to providing support to cancer patients to help ensure they have access to the medications they need,” said Murdo Gordon, senior vice president, U.S. Oncology Division, Bristol-Myers Squibb. “Collaborative patient management programs with organizations such as specialty pharmacies are an extension of that commitment.”

Bristol-Myers Squibb’s agreements with specialty pharmacy providers are an important addition to its existing suite of patient support services such as My Sprycel (dasatinib) Support, which offers patients a variety of tools designed to keep patients informed about their treatment with and motivated to stay involved in their care, in close collaboration with their healthcare provider. To learn more about this program, please visit or call 1-877-526-7334.

is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of is based on cytogenic and major molecular response rates. The trial is ongoing and further data will be required to determine long-term outcome.

is associated with the following warnings and precautions: myelosuppression; bleeding-related events; fluid retention; QT prolongation; congestive heart failure, left ventricular dysfunction, and myocardial infarction; pulmonary arterial hypertension (PAH); and use in pregnancy. Please read the Important Safety Information section below.

was first approved for the treatment of adults with CML who are resistant or intolerant to prior therapy including imatinib in 2006 by the United States (US) Food and Drug Administration (FDA). At that time, was also approved for adults with Ph+ ALL who are resistant or intolerant to prior therapy. is now approved and marketed worldwide for these indications in over 60 countries including the European Union (EU), Japan and Canada.

is also an FDA-approved treatment for adults with newly diagnosed chronic phase CML (since October 2010). received accelerated FDA approval for this indication. The effectiveness of is based on cytogenetic response and major molecular response rates. The first-line trial (known as DASISION) is ongoing and further data will be required to determine long-term outcome. Additional country approvals for this indication total over 50.

CML is a slow-growing type of leukemia in which the body produces an uncontrolled number of abnormal white blood cells. According to the most recent statistics, about 26,300 people are living with the disease in the United States. It is estimated that 5,430 new cases will be diagnosed in 2012. CML occurs when pieces of two different chromosomes break off and attach to each other.The new chromosome is called the Philadelphia chromosome, which contains an abnormal gene called bcr-abl gene. This gene produces the BCR-ABL protein, that signals cells to make too many white blood cells. There is no known cause for the genetic change that causes CML.

is indicated for the treatment of adults with:

Cardiac adverse reactions were reported in 5.8% of 258 patients taking SPRYCEL, including 1.6% of patients with cardiomyopathy, heart failure congestive, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction. Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

SPRYCEL may increase the risk of developing PAH, which may occur anytime after initiation, including after more than one year of treatment. Manifestations include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be reversible on discontinuation of SPRYCEL. Evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiating SPRYCEL and during treatment. If PAH is confirmed SPRYCEL should be permanently discontinued.

SPRYCEL may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant when taking SPRYCEL.

It is unknown whether SPRYCEL is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue SPRYCEL.

SPRYCEL is a CYP3A4 substrate and a weak time-dependent inhibitor of CYP3A4

The safety data reflect exposure to SPRYCEL in 258 patients with newly diagnosed chronic phase CML in a clinical study (median duration of therapy was 18 months) and in 2182 patients with imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow-up).

The majority of SPRYCEL -treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. In the newly diagnosed chronic phase CML study, SPRYCEL was discontinued for adverse reactions in 6% of patients. In patients resistant or intolerant to prior imatinib therapy, SPRYCEL was discontinued for adverse reactions in 15% patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

is a registered trademark of Bristol-Myers Squibb Company.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the commercialization of (dasatinib) in the United States, Japan, and major European countries. was discovered and developed by Bristol-Myers Squibb.

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Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka – people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 24 countries and regions around the world, with consolidated sales of ¥1,154.6 billion for fiscal year 2011. For more information, visit .

, and are registered trademarks of Bristol-Myers Squibb. All other brands listed are the trademarks of their respective owners.