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AMGN On Watch, GALE Reports Positive Data, EBS Secures BARDA Contract


Amgen Inc. (AMGN) on Friday reported positive results from its Repatha cardiovascular outcomes study, dubbed FOURIER. The company's cholesterol drug Repatha received FDA approval on August 27, 2015.

The FOURIER study evaluated whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduced cardiovascular events.

The company noted that the FOURIER study has established for the first time that Repatha decreases LDL-C (low-density lipoprotein cholesterol ) to unprecedented low levels and reduces risk of cardiovascular events with no new safety issues.

According to the study results, Repatha significantly reduced risk of hard major adverse cardiovascular events by 20% while risks of heart attack, stroke and coronary revascularization were nominally reduced by 27%, 21% and 22%, respectively.

But despite the encouraging results, the stock fell more than 6% on Friday as investors are not sure if the results are that impressive to reduce the reimbursement barriers that exist for Repatha, which costs over $14,000 a year. However, Amgen thinks otherwise.

Terming the results as a game changer, Sean Harper, executive vice president of Research and Development at Amgen, said, "Even though high-risk patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event. It's remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years".

Originally touted as a blockbuster, sales of Repatha have been anemic since its launch. The global sales of the drug have been just $141 million in 2016.

AMGN closed Friday's trading at $168.61, down 6.38%.

Atara Biotherapeutics Inc. (ATRA) expects initial data from its phase I trial of autologous version of ATA188 in patients with primary and secondary progressive multiple sclerosis to be presented by its collaborating investigators at a medical conference in late April.

The company plans to initiate a phase I trial of ATA188 in multiple sclerosis in the second half of 2017.

ATRA closed Friday's trading at $20.05, up 7.51%.

The detailed results presented from a phase III study of Amgen Inc's (AMGN) Repatha on cardiovascular outcomes seems to have had a domino effect on the share price of other cholesterol drug makers on Friday.

Shares of The Medicines Company (MDCO) fell as much as 26% in intraday trading on Friday before recovering most of its losses despite reporting positive final results from its phase II study of Inclisiran for the treatment of hypercholesterolemia, dubbed ORION-1.

The company first reported positive top-line results from the interim analysis with Day 90 follow-up for all 501 patients enrolled in the ORION-1 study last October. The trial results demonstrated robust and durable knockdown of LDL-C, as well as impressive safety and tolerability.

The following month, i.e., in November of 2016, the company presented positive results from the analysis of Day 90 data for 497 patients, as well as analysis of preliminary Day 180 data for 189 patients, enrolled in the ORION -1 study.

The study results reported last November demonstrated that a single injection of Inclisiran (300 mg) lowered "bad cholesterol" (LDL-C) by an average of 51% at Day 60, which were durable to Day 90 (mean 45% and up to 76%) while two injections of Inclisiran (300 mg) lowered LDL-C by an average of 57% at Day 120, which was durable to Day 180 (mean 52% and up to 81%).

According to the final ORION-1 study results reported on Friday, the optimal starting dose regimen (300 mg injection administered on Day-1 and Day-90) lowered LDL-C by an average of 52.6% and up to 81% at Day-180.

Inclisiran is licensed by Medicines Co from Alnylam Pharmaceuticals Inc. (ALNY).

MDCO hit an intraday low of $38.85 on Friday before closing the day's trading at $48.38, down 7.99%.

Galena Biopharma Inc. (GALE) on Friday reported positive final results from its investigator-sponsored phase 1/2a clinical trial of GALE-301 for the prevention of cancer recurrence in ovarian and endometrial cancer patients in the adjuvant setting.

The final data from the early stage clinical trial demonstrates that GALE-301 is well tolerated and is able to obtain statistically significant disease free survival in a small number of patients treated with the optimal dose, noted the company.

Enrollment has been completed in the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in ovarian and endometrial cancer.

GALE closed Friday's trading at $0.62, up 0.85%.

Emergent BioSolutions Inc. (EBS) has signed a $100 million, two-year contract with the Biomedical Advanced Research and Development Authority for the delivery of BioThrax to the Strategic National Stockpile.

BioThrax is the only FDA-licensed vaccine available for pre-exposure protection against anthrax infection.

Last December, the company signed a follow-on contract with CDC valued at up to $911 million to supply to the Strategic National Stockpile approximately 29.4 million doses of BioThrax through September 2021.

BioThrax pricing under this BARDA procurement contract is the same as BioThrax pricing under the CDC follow-on contract.

EBS closed Friday's trading at $30.47, down 1.36%.

by RTTNews Staff Writer

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