Amgen reacquires all rights to Prolia® (denosumab) in Australia

Amgen and GSK to Work Together to Ensure a Smooth Transition for
Prolia® Patients and Their Physicians

SYDNEY (December 15, 2015) – Today Amgen Inc. (Amgen) entered into an agreement with Glaxo Group Limited (GSK) to reacquire all rights to Prolia®  (denosumab) in Australia. This agreement terminates a collaboration originally signed in 2009 relating to the commercialisation of Prolia for osteoporosis indications in Australia. All Australian commercial activities assigned to GSK under the collaboration agreement will be transitioned back to Amgen by the end of the first quarter of 2016 and Amgen will assume sole responsibility for promoting Prolia in Australia.

The decision, mutually agreed by Amgen and GSK, to end the collaboration with Prolia in Australia enables Amgen to focus on continuing to build commercial infrastructure for this important growth product, as well as for future pipeline products. Amgen will work closely with GSK to ensure a seamless transition for Prolia customers, beginning immediately.

“GSK Australia is proud of its contribution in establishing Prolia as an important medicine in the treatment of osteoporosis.  Over the last five years, many Australians with osteoporosis have benefited  from  treatment  with  Prolia  due  to  our  collaboration  with  Amgen. We  will  work seamlessly together to ensure the transition is smooth for our customers with no impact on patient care,”  said Geoff McDonald, General Manager, GSK Australia.

“GSK has been an exceptional partner to Amgen in Australia and we are extremely grateful for how strongly they have established Prolia in the primary care setting,” said James Priour, General  Manager,  Amgen  Australia.  “Amgen  is  committed  to  building  on  this  established presence so that more and more Australian osteoporosis patients can benefit from this therapy, which was discovered and developed by Amgen and first approved in Australia in 2010.”

Amgen originally entered into the collaboration with GSK in 2009 to co-promote Prolia in Australia, New Zealand, the European Union, Switzerland, Norway, Russia and Mexico. In April of 2014, Amgen and GSK terminated the agreement in all markets excluding Australia.

About Prolia® (denosumab)

PROLIA is indicated for the treatment of osteoporosis in postmenopausal women to reduce the

risk of vertebral, non-vertebral and hip fractures and to increase bone mass in men with osteoporosis at increased risk of fracture.1   PROLIA is reimbursed for women and men aged 70 or over with a Bone Mineral Density (BMD) T-score of -2.5 or less.2

PROLIA has a mechanism of action unlike other osteoporosis treatments. Administered every six months as a subcutaneous injection, PROLIA is the only therapy that targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Through highly specific inhibition of RANK ligand, PROLIA decreases bone resorption, and improves bone density at all measured skeletal sites.1

PROLIA is a twice-yearly injection under the skin, usually administered by a general practitioner or practice nurse, and works by targeting the cells that break down bone (osteoclasts) thereby making bone less susceptible to osteoporosis-related fractures.1

Safety Information

As with any medicine, there is a risk of side effects. The most commonly reported side effects reported in a study of men with low bone mass, occurring in at least 5 per cent of PROLIA- treated men were: back pain, joint pain and upper respiratory tract infection.1

Low calcium levels must be corrected prior to starting PROLIA. Skin infections with swelling and redness have been reported with PROLIA. A dental condition called jaw osteonecrosis has been rarely reported in patients treated with PROLIA. Patients are encouraged to maintain good oral hygiene practices during treatment with PROLIA.1

PROLIA is not appropriate for patients who have: low calcium levels; hypersensitivity to denosumab, Chinese hamster ovary (CHO) –derived proteins or to any component of the medicine.1

Daily calcium and vitamin D supplements are recommended during treatment with PROLIA. Patients are encouraged to discuss any concerns about their treatment with their healthcare professional.

PBS Information: Authority required (STREAMLINED) Refer to PBS Schedule for full information.

MINIMUM PRODUCT INFORMATION

INDICATION: Treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral, non-vertebral and hip fractures. Treatment to increase bone mass in men with        

osteoporosis at increased risk of fracture. CONTRAINDICATIONS: Hypocalcaemia. Hypersensitivity to denosumab, CHO-derived proteins or any component. Pregnancy and in women trying to get pregnant.  PRECAUTIONS: Correct hypocalcaemia prior to initiating therapy. Monitor calcium in patients predisposed to hypocalcaemia. Adequate intake of calcium and Vitamin D is important. ADVERSE EFFECTS: Hypocalcaemia, skin infections (predominantly cellulitis), pancreatitis, rarely jaw osteonecrosis, very rarely atypical femoral fractures. DOSAGE AND ADMINISTRATION: Single subcutaneous injection of 60 mg, once every 6 months. Ensure adequate intake of calcium and Vitamin D. No dose adjustment required in the elderly or in renal impairment. PRESENTATION: Pre-filled syringe with automatic needle guard. Product Information is available by contacting Amgen Australia on 1800 646 998 or via http://www.amgen.com.au/Prolia.PI.

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.

For more information, visit  www.amgen.com and follow us on  www.twitter.com/amgen.

 

MEDIA CONTACTS:

Amgen Australia

Rachel Gibb, +612 98701349

Claire Russell, +612 98701390

 

GSK Australia

Bernadette Murdoch

+614 4995 0745

 

1.    Prolia® (denosumab) approved Product Information. 26 March 2015. http://www.amgen.com.au/Prolia.PI

2.    Pharmaceutical Benefits Scheme accessed at http://www.pbs.gov.au/medicine/item/5457Fon 28th September 2015