Amgen reacquires all product rights to Prolia® (denosumab), XGEVA® (denosumab) and Vectibix® (panitumumab) from GSK in 48 countries

AmgenAmgen (NASDAQ:AMGN) today announced that it has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia® (denosumab), XGEVA® (denosumab) and Vectibix® (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions throughout the world. The agreement involves key expansion markets for Amgen including Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand.

GSK has held select regional rights to Prolia and XGEVA since 2009 and to Vectibix since 2010 under license from Amgen. In 2014, GSK generated approximately $111 million in combined sales from these licenses. Amgen will make undisclosed milestone payments to GSK on signing and on the successful transition of the products back to Amgen. Amgen will book all product sales following this transition.

"This unique agreement with GSK allows Amgen to regain rights to three important growth products, and to directly serve more patients in key expansion markets," said Robert A. Bradway, chairman and chief executive officer of Amgen. "The agreement also allows Amgen to build additional commercial infrastructure in oncology and bone health, two strategically important therapeutic areas for Amgen with emerging late-stage pipeline assets."

Amgen will work closely with GSK to enable a seamless transition for customers and patients. GSK will continue to hold the license and sell and distribute the products for an interim transition period that will vary by country. The majority of markets are planned to be transitioned back to Amgen within a 12-month period.

Amgen anticipates this transaction to be accretive to adjusted earnings in 2017.

About Prolia® (denosumab)
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts).

Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is also approved for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

Prolia is administered as a single subcutaneous injection of 60 mg once every six months.

About XGEVA® (denosumab)
XGEVA was approved by the FDA in 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors (XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma).

In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to zoledronic acid (the previous standard of care) in preventing SREs, which were defined as radiation to bone, pathologic fracture, surgery to the bone, and spinal cord compression. XGEVA is administered as a single subcutaneous injection of 120 mg once every 4 weeks.

In 2013, XGEVA was approved by the FDA as the first-and-only treatment for adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. XGEVA is administered as a single subcutaneous injection of 120 mg once every 4 weeks with additional 120 mg doses administered on days 8 and 15 of the first month of therapy.

In 2014, XGEVA was approved by the FDA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA is administered as a single subcutaneous injection of 120 mg once every 4 weeks with additional 120 mg doses administered on days 8 and 15 of the first month of therapy.

About Vectibix® (panitumumab)
Vectibix is the first fully human anti-EGFR antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC). Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Most Popular Now

Study finds lack of racial diversity in cancer dru…

New research published in JAMA Oncology has found a lack of racial and ethnic diversity in clinical trials for cancer drugs. The study - conducted by researchers from UBC...

Preventing tumor metastasis

Researchers at the Paul Scherrer Institute, together with colleagues from the pharmaceutical company F. Hoffmann-La Roche AG, have taken an important step towards the dev...

A new drug could revolutionize the treatment of ne…

The international team of scientists from Gero Discovery LLC, the Institute of Biomedical Research of Salamanca, and Nanosyn, Inc. has found a potential drug that may pre...

Interactions discovered in cells insulating nerve …

Schwann cells form a protective sheath around nerve fibres and ensure that nerve impulses are transmitted rapidly. If these cells are missing or damaged, severe neurologi...

Anniversary of the pivotal RE-LY® trial marks a de…

Boehringer Ingelheim today announces the ten-year anniversary of the RE-LY® trial publication(1-3) recognising the contribution made in the decade since by patients, heal...

AstraZeneca agrees to buy US FDA Priority Review V…

AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsid...

Breast cancer can form 'sleeper cells' after drug …

Breast cancer medicines may force some cancer cells into 'sleeper mode', allowing them to potentially come back to life years after initial treatment. These are the early...

Pfizer invests half billion dollars to advance sta…

Pfizer announced an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina...

The Pfizer Foundation invests in 20 organizations …

The Pfizer Foundation announced 20 grants* to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to...

FDA grants Fast Track designation for Farxiga in c…

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the ...

Amgen and Allergan announce positive top-line resu…

Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798...

Experimental validation confirms the ability of ar…

Insilico Medicine, a global leader in artificial intelligence for drug discovery, announced the publication of a paper titled, "Deep learning enables rapid identification...