GSK to co-market Amgen’s osteoporosis drug in Europe
pharmafile | July 28, 2009 | News story | Sales and Marketing |Â Â Amgen, Deals, GSKÂ
GlaxoSmithKline has signed a major deal with Amgen to co-market its new osteoporosis treatment denosumab in Europe, Australia, New Zealand and Mexico and other markets.
Denosumab is awaiting approval in the US and Europe for use in osteoporosis and a range of cancer-related bone diseases, and analysts believe it could earn $2-3 billion in peak sales.
The drug's osteoporosis sales are expected to represent around a third of this total, and the deal is likely to boost its commercial chances in a crowded and competitive market.
The link-up makes good sense for both parties, as Amgen only has specialist salesforces in the US and Europe, while GSK still retains a large primary care salesforce across the globe. GSK also has an existing presence in osteoporosis with Boniva/Bonviva, a treatment co-marketed with Roche.
"This pioneering treatment that Amgen has developed will be a strong addition to our biopharmaceuticals portfolio," commented Andrew Witty, chief executive of GlaxoSmithKline.
"The data for denosumab is very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions. Together with Amgen we are committed to increasing worldwide access to this medicine."
Amgen will retain global rights to market the drug in its cancer related indications, but is calling on GSK's global marketing scale and expertise in osteoporosis to help it boost sales.
Amgen does not currently have a commercial presence in China, Brazil, India or South Korea, so GlaxoSmithKline will register and market denosumab for all indications in these countries as well. The deal does, however, allow Amgen the option to take an expanded role in marketing the drug in both Europe and some emerging markets in the future.
Japan stands outside the new agreement as Amgen agreed a marketing deal with Daiichi Sankyo in July 2007 giving it rights to market the drug there in all indications.
"Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialised the drug globally on our own," said Amgen chief executive Kevin Sharer.
"Amgen and GlaxoSmithKline together are uniquely positioned to help medical providers and patients understand the clinical promise and economic value of denosumab."
The osteoporosis market has been dominated by bisphosphonate drugs, most notably Merck's market leading Fosamax. But when this lost its US patent last year, a flood of generic products entered the market, and the total value of the therapy area fell 22%.
Lilly has two drugs in the area, Evista and Forteo, and this franchise looks set to dominate the market in the coming years.
Novartis is another major player in the market, with its once-yearly version of Zometa (zoledronic acid) called Reclast/Aclasta.
Once approved, denosumab will be given to patients as an injection every six months by primary care doctors. This will make it the first non-vaccine biological product that primary care doctors will administer to patients. This groundbreaking setting would have represented a major challenge to Amgen in marketing terms, hence why GSK's primary care and vaccine heritage will help introduce the drug to the market.
Cancer indications
Amgen has chosen to retain marketing rights for its numerous proposed indications in cancer. These are: bone metastases and their consequences, cancer treatment-induced bone loss due to hormone ablative therapy, multiple myeloma and bone erosions in rheumatoid arthritis. This is in keeping with its own heritage in products for cancer-related complications, namely blood-boosting erythropoeitins such as Aranesp (darbepoeitin alfa).
Denosumab is a fully human monoclonal antibody and works by specifically inhibiting RANK Ligand, an essential mediator of the cells that break down bone.
The drug was recently boosted when a head-to-head trial with Novartis' Zometa (zoledronic acid) showed denosumab to be superior in treating breast cancer patients with bone metastases.
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