Businessweek

Amgen and Zhejiang Beta Pharma Co., Ltd. announced that the companies have signed an agreement to form a joint venture to commercialize Amgen's Vectibix(R) (panitumumab) in the Chinese market. Together, Amgen and Zhejiang Beta Pharma aim to quickly and efficiently deliver Vectibix to patients in China. The joint venture will benefit from Zhejiang Beta Pharma's strong expertise in the development and commercialization of molecularly targeted therapies as well as Zhejiang Beta Pharma's industry-leading oncology sales network in China. Zhejiang Beta Pharma's China capabilities are complementary to Amgen's global expertise in the development and manufacturing of human therapeutics. This joint venture brings one step closer to providing Chinese patients with Amgen's medicines and supports their strategy of expanding in key, fast-growing markets.

Amgen Inc. Presents at UBS Global Healthcare Conference, May-21-2013 10:00 AM. Venue: Sheraton New York Hotel, 811 Seventh Avenue, New York, New York, United States. Speakers: Joseph P. Miletich, MD, PhD, Senior Vice President ­ R&D.

Amgen announced that the phase 3 head-to-head ASPECCT ('763) trial evaluating Vectibix® (panitumumab) versus Erbitux® (cetuximab) as a single agent for the treatment of chemorefractory metastatic colorectal cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95% CI: 0.839, 1.113) favoring the Vectibix arm. Overall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia. Colorectal cancer is the third most common cancer found in both men and women in the U.S., and is the second leading cause of cancer deaths.1, 2 Approximately 1.2 million cases of colorectal cancer are expected to occur globally. Detailed safety and efficacy data will be submitted for presentation at an upcoming medical meeting later 2013. ASPECCT is a global, randomized, parallel assignment, open-label, Phase 3 non-inferiority trial designed to compare the effect of Vectibix versus Erbitux on overall survival for monotherapy treatment of chemorefractory mCRC in 1,010 patients with wild-type KRAS tumors (primary endpoint). Secondary endpoints included safety, patient reported outcomes, progression-free survival, time to response, time to treatment failure and duration of response. Patients were randomized in a 1:1 ratio to receive 6 mg/kg of intravenous Vectibix every 14 days or 400 mg/m2 of an initial dose of intravenous Erbitux followed by 250 mg/m2 of intravenous Erbitux every seven days.

Transgenomic Inc. announced that it has entered into a collaboration with Amgen Inc. to develop a CE-IVD test to screen patients with metastatic colorectal cancer (mCRC) for RAS mutations (KRAS and NRAS). These RAS mutations, identified using the CE-IVD CRC RAScan(TM) kits which use Surveyor(R) -Wave(R) technology, provide physicians with important information regarding tumor mutation status to inform clinical treatment decisions for their mCRC patients. Financial terms of the agreement were not disclosed. Transgenomic's CLIA-certified laboratory in the United States (U.S.) is available immediately to receive patient samples for testing. In Europe, CE-IVD registered test kits will be available for purchase shortly. Test kits will also soon be available for purchase in the U.S. (for research use only).

The Maryland Attorney General Douglas F. Gansler announced that Amgen Inc., has resolved allegations that it reported inflated pricing data for its prescription drugs Aranesp, Enbrel, Epogen, Neulasta, Neupogen, and Sensipar. The inflated pricing caused Maryland and the other settling states' Medicaid programs to overpay for those drugs. As a result of the agreement, Amgen will pay $10,945,425.00 of which Maryland will recover $295,630. A portion of that amount will be forwarded to the federal government, which funds a percentage of the Maryland Medicaid program. Maryland and 35 other states alleged that Amgen overstated drug pricing data and therefore inflated the 'Average Wholesale Price' (AWP) and the 'Wholesale Acquisition Cost' (WAC) benchmarks used by most states' Medicaid programs. The drug pricing data determines the cost - or, reimbursement rates - of the affected drugs that have been dispensed to Medicaid patients. The inflated AWP and WAC pricing data artificially expanded the 'spread' between the actual price of the named drug and the inflated price that state Medicaid programs paid to providers and pharmacies. The states further alleged that after creating the inflated spread, Amgen marketed that spread and the promise of more money it provided to Medicaid providers in order to boost Amgen's sales of the named drugs. The agreement was negotiated by a team from the National Association of Medicaid Fraud Control Units that included attorneys and analysts from New York, California, Illinois, Indiana, and North Carolina.