Amgen talks up blockbuster prospects
pharmafile | November 12, 2008 | News story | Research and Development, Sales and Marketing | Amgen
Amgen says two of its pipeline products are potential blockbusters in three indications.
The company is keen to reaffirm its pipeline potential in the face of a declining blockbuster anaemia portfolio.
Sales of Aranesp and Epogen have been hit by new restrictions on their use in the US and Europe, and Amgen is now looking to new drugs to replace their once rapid growth.
The company's chief executive Kevin Sharer said: "In 2001, Amgen had two blockbuster products and today we have five blockbusters on the market.
"Over the next five years we could have three more drugs achieve blockbuster status: Sensipar (cinacalcet), denosumab for osteoporosis and denosumab for cancer-related indications."
The US biotech giant has high hopes for potential first-in-class monoclonal antibody denosumab, which helps the regeneration of bones and could achieve blockbuster status in two separate indications, an analyst meeting was told.
Currently in late-stage clinical development, denosumab is the first fully human monoclonal antibody that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Amgen expects to file the drug for its first indication, post-menopausal osteoporosis, by the end of 2008 or early 2009.
Amgen is considering looking for a marketing partner to maximise denosumab's value, but Sharer stressed the company would not rush into striking a deal.
The treatment is being studied in a range of other bone loss conditions, including rheumatoid arthritis and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients). Its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer is also being investigated.
The company has completed enrolment in most of denosumab's oncology studies and expects to be able to review data from the first skeletal-related events (SRE) studies in the first half of 2009.
Also on course for sales of over $1 billion is Sensipar, which was launched in 2004 to treat hyperparathyroidism, which causes high levels of calcium in the blood and can lead to kidney stones and bone pains.
Key data in 2009
Amgen is anticipating 17 key phase II and III clinical study results in 2009 and 2010, including those for denosumab (oncology), AMG 386 and AMG 655 for various cancer indications, and its Sensipar/Mimpara EVOLVE trial, an outcomes study in dialysis patients.
Amgen has more than 50 molecules in its pipeline, which has more than doubled in size since 2001.
The company has endured a difficult two years, with sales growth minimal for the first three month of 2008. But an extensive programme of cost reduction recently saw strong third quarter profit growth.
Net income rose to $1.2 billion, up from $201 million in the same period last year, after 12 months in which the company cancelled plans for a new manufacturing plant in Ireland and decided to cut 2,600 jobs.
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