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Wednesday, July 10, 2019

NuVasive launches Pulse platform

NuVasive (NASDAQ:NUVA) commences the commercial launch of its Pulse integrated technology platform designed to help surgeons adopt more efficient less disruptive surgical techniques across all spine procedures.
The company says it engineered Pulse to improve workflow, reduce procedure variability and increase procedure reproducibility.

Mylan hit on continued EpiPen shortage

Mylan N.V. (MYL -5.2%) slips on below-average volume on the heels of a Bloomberg report that patients and pharmacists are still scrambling to obtain emergency allergic reaction treatment EPiPen (epinephrine injection), in short supply for over a year now.
Consumers are also having difficulties procuring alternatives (i.e., Sandoz’s Symjepi, licensed from Adamis Pharmaceuticals (ADMP +0.3%)) due to uneven distribution, apparent lack of familiarity with new products and the reluctance of insurers to pay for similar treatments.
Teva Pharmaceutical Industries (TEVA -3.9%) is supposed to launch its generic version in the U.S. by year-end.

Teladoc: CVS MinuteClinic Launches Virtual Visit Offering in 8 More States

CVS Health (NYSE: CVS) today announced that MinuteClinic, the company’s retail medical clinic, has rolled out its virtual visit offering in eight additional states. People with minor illnesses and injuries, skin conditions and other wellness needs can now seek care through MinuteClinic Video Visits, a telehealth offering, in the states of ArkansasConnecticutHawaiiIndianaMinnesotaMissouriOklahoma and Texas. MinuteClinic Video Visits provide patients with access to care 24 hours a day, seven days a week from their mobile device or computer.
A CVS Health study found that 95 percent of patients who opted to receive a telehealth visit during the pilot phase of the program, were highly satisfied with the quality of care they received.1 In the same study, 95 percent of patients were also satisfied with the convenience of using the telehealth service and the overall telehealth experience. Since MinuteClinic Video Visits launched in August 2018, thousands of Video Visits have been conducted in 18 states and Washington, DC, with more than half taking place outside of traditional clinic hours.
Working collaboratively with Teladoc (NYSE: TDOC), the global leader in virtual care, and leveraging Teladoc’s technology platform, patients can receive care via a MinuteClinic Video Visit, initiated through their computer or mobile device, including through the CVS Pharmacy app.  Patients who opt to seek care through a fully customized MinuteClinic Video Visit experience the same high-quality, evidence-based care they receive at traditional MinuteClinic locations inside select CVS Pharmacy and Target stores.
Video visits can be used to provide care for patients ages two years and older who are seeking treatment for a minor illness, minor injury, or a skin condition. Each patient will complete a health questionnaire and be matched to a board-certified health care provider licensed in their state, who will review the completed questionnaire with the patient’s medical history, and proceed with the video-enabled visit.

Ligand: Positive Top Line Results from Phase 1 Captisol-enabled Iohexol Trial

Study achieved primary endpoint demonstrating pharmacokinetic bioequivalence between Captisol-enabled Iohexol and OMNIPAQUE™
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced positive top line results from a Phase 1 clinical trial of its internal Captisol-enabled (CE) Iohexol program. The CE-Iohexol program was established in January 2018 to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity. Based on top line data, the trial achieved the primary endpoint demonstrating pharmacokinetic bioequivalence between CE-Iohexol injection and a reference Iohexol injection (OMNIPAQUE™) after intravenous (IV) administration in healthy adults. CE-Iohexol injection was safe and well tolerated, and adverse events were in line with the known safety profile of OMNIPAQUE. Details and data from the Phase 1 trial have been submitted for presentation at future scientific conferences.
“Our team did an excellent job executing this trial ahead of schedule, and we are very encouraged by the top line results of this Phase 1 trial,” said John Higgins, Chief Executive Officer of Ligand. “We have confidence in the continued development of CE-Iohexol with the goal to advance it to additional studies to support a registration filing. After the full data is published later this year, we look forward to exploring potential commercial partnerships for this program.”
“This trial represents a promising milestone in the pursuit of a safer agent for patients who receive intravenous contrast for their radiology and cardiology tests and procedures,” said Peter A. McCullough, MD, MPH, Vice Chief of Medicine, Baylor University Medical Center, Dallas TX, and President, Cardiorenal Society of America. “Top line results showed that this unique product incorporating a patented formulation ingredient had the expected pharmacokinetic profile compared to the reference standard agent, yet it potentially offers less kidney injury when given in patients with baseline kidney disease, diabetes, and multiple associated risk factors.”

Teva to Present New Data on AJOVY at American Headache Society

Three late breakers, one oral presentation and 27 posters showcase AJOVY as a preventive treatment for migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present 31 scientific abstracts for AJOVY® (fremanezumab-vfrm) injection at the 61st Annual Scientific Meeting of the American Headache Society, taking place in Philadelphia from July 11-14, 2019. AJOVY is indicated for the preventive treatment of migraine in adults.
“Migraine continues to be a difficult to treat disease and as the migraine treatment landscape evolves, we remain committed to improving the lives of patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “We are pleased to be presenting 31 posters and presentations at AHS this year, and our presence underscores Teva’s ongoing focus on addressing the treatment challenges that migraine patients face.”
The data to be presented include findings from the FOCUS study, a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy and safety of quarterly and monthly treatment with AJOVY, compared to placebo. The FOCUS study is the largest study to date in patients who inadequately responded to 2-4 classes of preventive migraine treatments, and is the first study of its type to be conducted in chronic as well as episodic migraine patients. Of note, this year’s AHS meeting is the first time that FOCUS data will be presented at a U.S. meeting.

PhRMA-backed Study Shows Hospitals Significantly Hike Drug Prices

A study commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA) revealed that hospitals across the United States typically charge five times more for medications than their costs. This results in an increase in cost-sharing and premiums for patients, the study found. The latest study follows one conducted two years ago with similar results.
The pricing analysis was conducted by the Moran Company and builds on a previous study conducted in 2017. Both studies analyzed the cost of 20 medications administered in hospitals found that the amount hospitals receive after negotiations with commercial payers is, on average, almost twice what they paid to acquire the medicine.

The study comes hard on the heels of a White House proposal executive order directing the government to set up regulations and guidances that will require insurers, doctors, hospitals and others in the industry to provide information about the negotiated and often discounted cost of care. The rule would compel hospitals and other medical practices to publicly disclose the negotiated amounts they charge insurance companies. The goal of the executive order is to arm patients with pricing data in order to provide them with a greater control over their health care costs, particularly as some life-saving drugs, such as insulin, have seen their prices doublebetween 2012 and 2016.
The pharmaceutical industry has borne the brunt of blame over the high costs of medications, however, PhRMA and other industry associations have pointed to other players as the real culprits of escalating costs of prescription drugs. The data from the two Moran studies implies that the criticisms raised by pharma trade groups are correct in that assessment, at least regarding pricing established through hospitals. A study released last month also showed that the murky rebate system also drives up the costs of prescription medicines.
In addition to examining the 20 drugs, the 2019 study also estimated what the price increases mean for hospitals that acquire medicines through the 340B drug discount program, which was designed to provide medications for uninsured patients. While the 340B program aims to keep drug costs lower for those patients, the study found the opposite happened. According to the study, data from the hospitals “show they are providing less and less care to needy patients.”

In order to determine how much money the hospitals were making off of the markups on the drugs covered by the 340B program, Moran said it “applied a conservative 340B discount to the medicines” in the sample. The discount was “25% off a public Medicare Part B drug price known as “Average Sales Price,” which reflects an average discount given to all U.S. purchasers (except certain sales) to hospital markups at 340B hospitals.” Moran said it is a conservative estimate of manufacturer discounts as the average 340B discount can range from 25% to 50% off a medicine’s list price. As an example of its estimate, Moran said a medicine with an average sale price of $2,500 can be purchased from the pharma companies for an estimated $1,875. Then, the hospitals can mark up the price in order to receive payment of $6,000 from an insurer for the cost of the medicine. According to Moran, the hospitals are making $4,125 off that discounted drug.
“This study shines a light on a growing problem in our health care system,” Moran said in its announcement.

Amneal Pharma to restructure, expects cost reduction by $50M

Amneal Pharmaceuticals (NYSE:AMRX) has designed a restructuring plan to reduce cost base, further right size its organization and optimize manufacturing infrastructure.
The plan is expected to reduce total annual cost base by ~$50M, with majority of the restructuring milestones anticipated to be achieved during 2020.
Key elements of the plan include operating budget reductions, more efficient organizational structures; re-prioritization of R&D projects; and realignment of manufacturing and R&D infrastructure.
Additional details regarding the restructuring plan and charges will be provided later.
The Company expects adjusted EBITDA for 2019 in the range of $425M to $475M from $600M – 650M.
Update: Shares are down 20% premarket on modest volume.