Acentrus Specialty Partners with Puma Biotechnology to Bring Nerlynx® (neratinib) to Health Systems and Hospitals in the Acentrus Network

IRVING, Texas–(BUSINESS WIRE)–Acentrus Specialty™, a national network of health systems and hospitals committed to providing specialty pharmacy care for their patients, has finalized an agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) to provide qualified Acentrus clients access to NERLYNX® (neratinib).

“We are pleased to provide our network hospitals and their patients access to an important breast cancer treatment,” said Acentrus Specialty Vice President George Zula. “Limited distribution drugs like NERLYNX® are highly sought after but can be difficult to obtain. Acentrus works with drug companies to open the door to these medications for specialty pharmacies operated by our network hospitals. This means that patients can begin potentially life-saving treatments sooner and with the significant advantage of integrated care from pharmacy professionals they know and trust.”

Participation in Acentrus is open to hospital organizations of all sizes, types and affiliations. Clients, which range from academic medical centers to community-based hospitals, share one goal: to provide their patients with high-quality care in a setting where clinical and pharmacy services are integrated.

There is no cost for an organization to join the Acentrus network, which provides more than 100 health systems and hospitals with the following benefits:

• Access to difficult-to-obtain specialty medications
• Data management
• Collaboration with health system peers dedicated to sharing best practices
• Portfolio of other services to help hospital-based specialty pharmacies meet the needs of their patients, including backup and contract pharmacy as well as expertise in licensing and accreditation

Specialty medications represent the fastest growth sector in pharmacy, with 1-2% of all claims accounting for 50-60% of all expenses. Specialty pharmaceuticals are typically limited distribution drugs (LDDs) available only to certain providers through exclusive networks established by manufacturers.

About Acentrus Specialty

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Acentrus Specialty is the integrated care network and health system solution for specialty pharmacy, addressing the largest and fastest growing area of health care expenditures by empowering members to deliver exceptional, cost-effective, locally integrated care. This is accomplished through a portfolio of services and specialty pharmacy products, as well as member sharing of clinical and operational best practices. The network of health systems consists mainly of academic medical centers and integrated delivery networks, serving more than 4.6 million inpatient admissions annually, treated by nearly 200,000 physicians. Follow Acentrus on LinkedIn or on the web at acentrusrx.com.

IMPORTANT SAFETY INFORMATION

NERLYNX^® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

• As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

• In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

• Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

• Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

• Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS:

The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

• NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

• NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

• Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H₂-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H_2-receptor antagonists.
• Strong CYP3A4 inhibitors: Avoid concomitant use.
• Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.
• Strong or moderate CYP3A4 inducers: Avoid concomitant use.
• P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

• Lactation: Advise women not to breastfeed.

Please see Full Prescribing Information for additional safety information.

Contacts

For Acentrus Specialty
Steve Campanini

469-299-7250

[email protected]