On April 4, 2014 Amgen reported top-line results from the primary overall survival (OS) analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF) (Press release Amgen, APR 4, 2014, View Source;p=RssLanding&cat=news&id=1915897 [SID:1234500366]). Results showed that, while the primary end point of durable response rate was met (as previously reported), the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec (p=0.051). The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and to initiate an immune response to target cancer that has metastasized, or spread to other areas of the body.
The global, randomized, open-label Phase 3 trial enrolled patients with unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec every two weeks through direct tumor injection or GM-CSF subcutaneously for the first 14 days of each 28-day cycle, for up to 18 months.
The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.

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On April 3, 2014 Amgen reported that it would end an agreement with GlaxoSmithKline Plc for the marketing of its osteoporosis drug in some regions outside the United States (Press release, Amgen, APR 3, 2014, View Source [SID:1234502170]).

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Amgen said it would take over the marketing of the drug, sold under the brand name Prolia, in most areas under the agreement, including the European Union, Switzerland, Norway, Russia and Mexico, by Dec. 31.

GSK will continue to market the drug in Australia, Amgen said in a regulatory filing.

"GSK and Amgen have reached a mutual agreement to end their existing agreement…," a GSK spokesman said in an emailed statement, adding, "This new arrangement will allow GSK to increase focus on executing important new product launches over the next few years."

Amgen said it would pay GSK $275 million over the rest of the year and reimburse the British drugmaker $15 million for costs incurred during the transition period.

Prolia generated worldwide sales of $744 million in 2013, a 58 percent increase from a year earlier. (link.reuters.com/mux28v)

According to the agreement signed in July 2009, Amgen retained the rights to market the drug in the United States and Canada as a treatment for osteoporosis and other conditions and as a treatment for cancer in Europe, Australia, New Zealand and Mexico.

Amgen also said on Thursday that GSK would continue to market the drug as a treatment for conditions other than osteoporosis in countries such as China, Brazil, India and South Korea.

GSK holds the marketing rights in these regions until 2024, according to Amgen’s annual report.

Amgen is developing the drug in late-stage studies as a treatment for other forms of osteoporosis, including glucocorticoid-induced osteoporosis and male osteoporosis.

The company is also testing the drug, denosumab, as a treatment for cancer-related bone damage.

Denosumab is sold under the brand name Prolia as a treatment for three conditions, including postmenopausal osteoporosis in women at high risk of fracture.

The drug is approved in the United States as a treatment for giant cell tumor of the bone and is sold under the brand name Xgeva. (Reporting by Vrinda Manocha in Bangalore; Editing by Simon Jennings)

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of complex generic products developed since 1984 (CV Richard Dicicco, APR 2, 2014, View Source [SID:1234501869]). Harvest Moon Pharma develops, manufactures sells and/or licenses-out to the trade, worldwide, these complex generic drug products and biosimilars. After seeking scientific advice from the EMA, Harvest Moon Pharma has biosimilars of adalimumab, rituximab and trastuzumab entering phase I clinical trials in Europe. These mAbs were developed in Europe with comparability studies to both the European and USA reference listed biological, are produced in the USA, and comply with the EMA mAb adopted and revised guidelines. They will be filed in Europe and the USA in 2016. Harvest Moon Pharma offers etanercept, infliximab and bevacizumab which will be filed in Europe and the USA in 2017. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics, biosimilars and the emerging markets of MENA, APAC and BRICKTM.

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