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SVRA Disappoints, SNY/REGN's Praluent Price To Be Cut, OBSV On Watch

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Today's Daily Dose brings you news about Abbott's HeartMate 3 LVAD pivotal trial; ObsEva's upcoming catalysts for the year; Sanofi and Regeneron's ODYSSEY OUTCOMES study results; Savara's failed INDIE trial and Varian's new business deal.

Read on…

The long-term data for Abbott's (ABT) pivotal MOMENTUM 3 trial has demonstrated an overall survival of 83 percent at 2-years and marked improvement in clinical outcomes for patients suffering with advanced heart failure.

The MOMENTUM 3 is a pivotal prospective, randomized, controlled trial to evaluate the safety and effectiveness of HeartMate 3 LVAD compared to the HeartMate 2 LVAD for the treatment of advanced, refractory, left ventricular heart failure.

The long-term cohort of HeartMate 3 LVAD met its primary endpoint with 77.9 percent event free survival (survival free from disabling stroke and device removal due to malfunction), showing superiority over the HeartMate II LVAD at 56.4 percent.

The HeartMate 3 LVAD is CE Mark approved and FDA approved for short-term (bridge-to-transplant) use in the United States. The HeartMate 3 LVAD is limited by federal law to investigational use in the United States for long-term (destination therapy) support.

ABT closed Friday's trading at $63.60, up 2.80%.

MiMedx Group Inc.'s (MDXG) investigational micronized amniotic tissue, AmnioFix Injectable, has been granted the Regenerative Medicine Advanced Therapy designation for use in the treatment of Osteoarthritis of the knee by the FDA.

The Regenerative Medicine Advanced Therapy, or RMAT, designation helps to expedite the development and review of marketing application of a regenerative medicine therapy, including increased meeting opportunities with the FDA, early interactions to discuss any potential surrogate or intermediate endpoints and the potential to support accelerated approval.

The Company has plans to initiate a phase 2B clinical study of AmnioFix Injectable for osteoarthritis of the knee this year.

A phase III study of AmnioFix Injectable in the treatment of Achilles Tendonitis, and a phase III study of AmnioFix Injectable in the treatment of Plantar Fasciitis, initiated in January of this year, are underway.

Early this month, the Company was notified by the NASDAQ of non-compliance with the NASDAQ Listing Rules for not having filed its Form 10-K for the year ended December 31, 2017. The NASDAQ's notice has no immediate effect on the listing of the Company's common stock.

MDXG closed Friday's trading at $7.42, down 6.31%.

ObsEva SA (OBSV) has a couple of events to watch out for in the coming months.

The Company expects 12 week results from its phase 2b clinical trial of OBE2109 for the treatment of endometriosis, dubbed EDELWEISS, in mid-2018.

Results of live birth rates and 28-day neonatal safety from the phase III clinical trial of Nolasiban in IVF, dubbed IMPLANT2, are anticipated in the fourth quarter of 2018.

Initial efficacy results from a phase 2a clinical trial of OBE022 in pre-term labor, known as PROLONG, are anticipated in late 2018.

OBSV closed Friday's trading at $14.00, unchanged from the previous day's close.

The much awaited results of ODYSSEY Outcomes trial, conducted by Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN) are out.

The ODYSSEY OUTCOMES study was designed to determine whether the addition of cholesterol-lowering drug Praluent to intensive statin therapy reduced major adverse cardiac events among patients who had previously experienced an acute coronary syndrome, such as a heart attack or unstable angina.

Praluent, developed by Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN), was approved by the FDA on July 24, 2015, for the treatment of patients with heterozygous familial hypercholesterolemia or atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

The ODYSSEY OUTCOMES trial involved 18,924 patients who had an acute coronary syndrome (ACS) within the previous 12 months, residual LDL cholesterol levels of 70 mg/dL or higher, non-high-density lipoprotein cholesterol of 100 mg/dL or higher, or apolipoprotein B of 80 mg/dL or more after two to 16 weeks of intensive or maximally tolerated statin therapy. The median duration of follow-up in this trial was 2.8 years.

According to the study results, reported on Mar.10, 2018, Praluent reduced the overall risk of major adverse cardiac events (MACE) by 15%, a significant difference compared to placebo. The MACE, which is the primary efficacy endpoint of the study, included hospitalization for unstable angina, heart attack, stroke or cardiovascular death.

Although there was no significant difference between Praluent group and placebo group for coronary heart disease death and cardiovascular death, the rate of all-cause death was significantly lower by 15 percent with Praluent compared to placebo. The LDL-C levels after a median follow-up of 2.8 years were 53.3 mg/dL in the Praluent arm compared with 101.4 mg/dL in the placebo group.

Praluent had a more pronounced effect in patients with baseline LDL-C levels at or above 100 mg/dL. In this patient population, Praluent reduced MACE by 24%, coronary heart disease death was reduced by 28%, cardiovascular death by 31% and all-cause death by 29% compared with placebo.

The U.S. Wholesale Acquisition Cost (WAC) price of Praluent, excluding discounts, is $14,600 per year. The global net sales of Praluent were $194 million in the full year 2017, up from $116 million in 2016.

Based on the ODYSSEY OUTCOMES study results, the Institute for Clinical and Economic Review has calculated the value-based price benchmarks for Praluent to be $2,300-$3,400 per year if used to treat all patients who meet trial eligibility criteria, and $4,500-$8,000 per year if used to treat higher-risk patients with LDL cholesterol at 100 mg/dL or more despite intensive statin therapy. Value-based pricing is the cost of the drug that would align with its benefits to patients.

Sanofi and Regeneron will be meeting with U.S. payers to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients.

REGN closed Friday's trading at $341.70, up 0.27%.

Savara Inc. (SVRA) has pulled the plug on its investigational product Aironite following the failure of its INDIE study to meet the primary endpoint.

The INDIE study was a phase II study which evaluated the efficacy of Aironite on maximum exercise capacity (peakVO2), activity levels, and quality of life after four weeks of dosing in patients with heart failure with preserved ejection fraction.

The study did not meet its primary endpoint of improvement in peak exercise capacity assessed by cardiopulmonary exercise testing (CPET), or its secondary endpoints, according to the Company.

Savara does not plan to support any new development of Aironite.

SVRA closed Friday's trading at $10.98, down 2.49%.

Varian Medical Systems Inc. (VAR) has been selected by the Instituto Mexicano del Seguro Social to install seven treatment centers across Mexico with modern radiotherapy treatment systems, including the country's first Edge system for image-guided stereotactic radiosurgery.

Each of the seven treatment centers will be equipped with Edge system and six VitalBeam systems, plus a full suite of Varian's treatment planning and oncology information software to manage cancer patient workflow. All installations will be completed by December 2018.

EYMSA is Varian's long-standing distributor in Mexico.

VAR closed Friday's trading at $126.55, up 2.46%.

VolitionRx Limited (VNRX) has offered to sell 3.5 million shares of common stock at a public offering price of $2.40 each.

The gross proceeds to Volition from this offering are expected to be approximately $8.4 million.

The underwriters have a 30-day option to purchase up to 525,000 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about March 13, 2018, subject to the satisfaction of customary closing conditions.

VNRX closed Friday's trading at $2.29, down 22.11%.

by RTTNews Staff Writer

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