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CANbridge Pharmaceuticals and Puma Biotechnology Agree to Terminate NERLYNX® License Agreement and Settle Arbitration

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CANbridge Pharmaceuticals Returns Nerlynx Rights to Puma in Greater China

CANbridge Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing drug candidates in China and North Asia, and Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, have agreed to terminate their 2018 license agreement, in which Puma granted CANbridge exclusive rights to develop and commercialize NERLYNX® (neratinib) in Greater China, and to settle their arbitration related to the license agreement.

Simultaneous to the termination of the 2018 license agreement between CANbridge and Puma, Puma has agreed with Pierre Fabre, a global pharmaceutical and healthcare products company, to amend the terms of their 2019 license agreement, which grants Pierre Fabre exclusive rights to develop and commercialize NERLYNX® within Europe, Turkey, Middle East and Africa, to also include Greater China, which includes mainland China, Taiwan, Hong Kong and Macau. CANbridge and Pierre Fabre have also simultaneously entered into agreements pursuant to which CANbridge will provide Pierre Fabre certain transition services in Greater China and distribute and market NERLYNX® for Pierre Fabre in Hong Kong, Macau, and Taiwan until year end 2022, with an option to renew.

Under the terms of the various agreements implementing this transaction among the three companies, Puma will receive an upfront payment of $50 million from Pierre Fabre in consideration for the amendment to their 2019 license agreement, and CANbridge will receive a one-time $20 million termination fee from Puma to return all rights to neratinib in Greater China back to Puma. Finally, Puma has agreed to dismiss the arbitration demand it filed on July 28, 2020 against CANbridge related to the parties' 2018 license agreement, and as part of the settlement, CANbridge has agreed to dismiss its counterclaims against Puma.

James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc., said, "We are pleased to have reached a mutually beneficial agreement that also serves patients, as CANbridge shifts its focus to rare disease and rare oncology. We look forward to working closely with Pierre Fabre to continue to bring this important medicine to patients in Hong Kong, Taiwan and Macau."

Neratinib is approved in the United States for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and HER2-positive metastatic breast cancer and is marketed in the United States as NERLYNX® (neratinib) tablets.

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers to address unmet medical needs.

CANbridge has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In greater China, where it is a recognized leader in orphan diseases, CANbridge has an exclusive licensing agreement to commercialize Hunterase®, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than 11 countries worldwide. CANbridge also has a collaborative agreement with the Horae Gene Therapy Center at UMass Medical School for the research and development of gene therapies to treat rare genetic diseases.

For more on CANbridge Pharmaceuticals Inc., please go to: www.canbridgepharma.com.

IMPORTANT SAFETY INFORMATION, U.S. INDICATIONS

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) 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 H2-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.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

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