Amgen has posted a strong set of results for the second quarter and announced that GlaxoSmithKline will be its licensing partner for the much-touted investigational osteoporosis drug denosumab.

First to the figures and net profit leapt 40% to $1.27 billion, though much of the rise was due to Amgen receiving a $115 million income tax benefit. Product sales were down 2% to $3.63 billion, as revenues from Aranesp (darbepoetin alfa) fell 16% to $693 million. The decline was principally due to reimbursement problems and label changes the company has faced, although sales of its older erythropoiesis stimulating agent, Epogen (epoetin alfa) were up 3% at $638 million, helped by a price increase.

Combined turnover of Amgen’s white blood cell stimulators Neulasta (pegfilgrastim) and Neupogen (filgrastim) slipped 4% to $1.16 billion, while sales of the anti-inflammatory Enbrel (etanercept), partnered with Wyeth, were up 7% to $899 million. Sensipar (cinacalcet), for the treatment of secondary hyperparathyroidism in dialysis patients, were up 11% to $167 million, while sales of the colorectal cancer drug Vectibix (panitumumab) were up 75% at $56 million.

Amgen said that full-year 2009 earnings, excluding items, should be in the region of $4.80-$4.95 per share, up from its previous $4.55-$4.75 estimate. Revenues should be towards the upper end of its $14.80-$15.20 billion guidance.

Chief executive Kevin Sharer said that “we are optimistic about our financial performance in 2009 and are focused on making denosumab a success”. A step in that direction has been made with the agreement signed with GSK which will see the UK drugs major market the monoclonal antibody for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico on approval.

GSK will register and commercialise denosumab for all indications in countries where Amgen does not currently have a presence, including China, Brazil, India and South Korea, but the collaboration gives the biotechnology firm the option of selling the drug in Europe and certain emerging markets in the future. Amgen is keeping all the rights for PMO and oncology in North America and for all cancer indications in Europe and specified markets. Daiichi Sankyo was signed up as Amgen’s denosumab partner in Japan in July 2007.

$120 million initial payment from GSK
In cash terms, Amgen is picking up an initial payment and near-term commercial milestones totalling $120 million. In Europe, the firms will share profits and in the emerging markets, GSK will purchase denosumab from Amgen to meet demand.

Mr Sharer said the deal will help Amgen get denosumab to patients in Europe and other parts of the world “more effectively than if we commercialised the drug globally on our own". He added that the two firms together “are uniquely positioned to help medical providers and patients understand the clinical promise and economic value of denosumab”.

His counterpart at GSK, Andrew Witty, added that 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”.