ACT Buys AGN, NBS Needs A Close Watch, No Pain For TRVN, TKMR Does A Deal

(RTTNews) - Shares of Actavis plc (ACT) touched an all-time high on Monday after the company agreed to acquire Allergan Inc. (AGN) in a deal valued at $66 billion.

Brent Saunders, CEO and President of Actavis said, "The combination is expected to generate strong free cash flow of more than $8 billion in 2016 and substantial growth thereafter, which will enable the rapid repayment of debt. We expect that the combination will result in double-digit accretion to non-GAAP earnings within the first 12 months."

Actavis expects the transaction to generate at least $1.8 billion in annual synergies commencing in 2016, in addition to the $475 million of annual savings previously announced by Allergan in connection with Project Endurance. (Project Endurance is a program to identify opportunities to optimize the company's structure and processes, prioritize its highest value investments and deliver long-term growth and increased stockholder value).

ACT touched a high of $255.51 on Monday before closing at $247.94, up 1.71%.

Clovis Oncology Inc. (CLVS) has entered into oncology clinical trial collaboration with GlaxoSmithKline LLC. (GSK)

Accordingly, a phase 1/2 trial to evaluate the combination of Clovis' drug candidate Rociletinib (CO-1686) with GlaxoSmithKline's approved drug Trametinib in patients with advanced or metastatic mutant epidermal growth factor receptor non-small cell lung cancer is planned to start in the first half of 2015.

CLVS closed Monday's trading at $53.33, down 2.84%.

NeoStem Inc. (NBS) announced Monday that a phase II study of its lead product candidate AMR-001, dubbed PreSERVE AMI trial, has demonstrated statistically significant mortality benefit in patients with acute myocardial infarction, according to initial data.

AMR-001, also known NBS10, is an autologous bone marrow-derived, CD34 positive selected stem cell product being developed to treat damaged heart muscle following an acute myocardial infarction ("AMI" or heart attack).

Read on to find out why NeoStem shares slumped more than 27% in extended trading...

The primary endpoint of the PreSERVE AMI trial, i.e., improvement in cardiac perfusion (RTSS) measured by SPECT imaging at baseline and 6 months has shown no meaningful difference between the treatment and the control group.

Commenting on the primary endpoint result, the company noted that the data suggests cardiac perfusion may not be a future suitable tool to assess NBS10, which is consistent with FDA guidance that mortality and MACE are the appropriate approvable endpoints to determine efficacy of a cellular therapy for cardiac disease as opposed to imaging endpoints.

The secondary endpoints of the study include the occurrence of MACE (major adverse cardiac events) like premature death; recurrent heart attack; chronic heart failure; significant arrhythmias; and acute coronary syndrome.

There was also a statistically significant relationship between higher cell doses and improvement in ejection fraction and reduced incidence of serious adverse events and a dose-dependent numerical decrease in major adverse cardiac events in the PreSERVE AMI trial, noted the company.

NBS closed Monday's trading 9.89% higher at $6.78. In after-hours, the stock fell 27.29% to $4.93.

NeoStem has scheduled a conference call for Tuesday, November 18th at 8:00 AM EST.

Novavax Inc. (NVAX) has initiated a phase II clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle vaccine candidate. This trial is being conducted under the company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority.

NVAX closed Monday's trading at $4.90, down 7.20%. In after-hours, the stock was up 1.43% at $4.97.

Trevena Inc.'s (TRVN) phase 2a/b trial of its drug candidate TRV130 in moderate-to-severe postoperative acute pain has achieved the primary endpoint of statistically greater pain reduction than placebo over 48 hours.

The trial also proved that administration of TRV130 3 mg every 3 hours has statistically superior analgesic efficacy compared to morphine.

Commenting on the study results, Lynn Webster, past president of the American Academy of Pain Medicine, said "The data from this trial are impressive, suggesting that TRV130 may offer a superior product profile versus morphine, which frequently causes dose-limiting adverse events and often fails to fully manage post-surgical pain."

TRVN closed Monday's trading 1.80% higher at $5.66.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has licensed its proprietary lipid nanoparticle delivery technology for exclusive use in Dicerna Pharmaceuticals Inc.'s (DRNA) investigational product candidate for primary hyperoxaluria type 1 - DCR-PH1.

Primary hyperoxaluria type 1 (PH1) is a rare, inherited liver disorder that often results in kidney failure, and for which there are no approved therapies.

Under the agreement, Dicerna will pay Tekmira $2.5 million upfront and payments of $22 million in aggregate development milestones, plus a mid-single-digit royalty on future PH1 sales.

Dicerna expects to initiate phase I trials of DCR-PH1 in 2015.

TKMR closed Monday's trading at $17.24, up 5.06%. DRNA closed the day's trading 2.48% higher at $9.50.