FDA Withdraws Draft Guidance on Biosimilar Development

The U.S. Food and Drug Administration (FDA) withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.

The guidance “Statistical Approaches to Evaluate Analytical Similarity” was initially issued in September 2017. The FDA withdrew the draft guidance on June 21. The guidance was intended to provide advice for biosimilar developers regarding the “evaluation of analytical similarity between a proposed biosimilar product and a reference product,” the FDA said. The FDA withdrew its guidance following public input that expressed some concerns. One of the filers was Sarfaraz K. Niazi, an adjunct professor specializing in biosimilar development at the University of Illinois and the founder of Pharmaceutical Scientist, Inc., a consulting company. In his petition, Niazi said the FDA should waive bridging studies for qualified non-US comparators and encouraging payers to reimburse only for biosimilars when prescribed for new patients.

Additionally, Niazi raised concern over errors in the analytical similarity testing protocols. As a result, Niazi offered alternative approaches that limit the testing to non-release quality attributes to reduce the number of reference product batches required. Doing so would create a mechanism to make reference samples freely available and allow more ethical in vitro immunogenicity testing, according to a statement issued by Pharmaceutical Scientist.

The FDA said it will withdraw the guidance as it “give further consideration” to the scientific and regulatory issues that are involved. The comments raised concerns over cost and efficiency of biosimilar development, which included the number of reference product lots that the 2017 draft guidance recommended biosimilar developers sample in the “evaluation of high similarity and the statistical methods” for the evaluation, the FDA said. The regulatory agency added that by addressing the raised issues in the future, it can “advance principles that can promote a more efficient pathway for the development of biosimilar products.”

“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the FDA can do more to support the development of biosimilars, as well as promote the market acceptance of these products. As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,” FDA Commissioner Scott Gottlieb said in a statement.

Biosimilars are designed to have active properties that are similar to an approved drug, called a reference drug by the FDA. They are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. Biosimilars have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010. Since they were allowed in the United States, the FDA has approved 11 biosimilar treatments, with the most recent being Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). Fulphila was approved in June to reduce the duration of fever or other signs of infection with a low count of neutrophils, a type of white blood cells in chemotherapy patients.

Gottlieb added that one of the central aspects of biosimilar development is the analytical studies that used to demonstrate that the biosimilar product is “highly similar” to its reference product, meaning the medication it is similar to. Gottlieb said the agency will take a fresh look at its draft considerations and will continue to work with biosimilar developers as it moves forward with a new guidance draft.

“By supporting the more efficient development of biosimilars over the long term and helping reduce barriers to bringing these products to market, we can help ensure patients get access to affordable, safe and effective treatment options,” Gottlieb said.

https://bit.ly/2KBPZIB

Why Nevro Corp. Was Downgraded By Morgan Stanley

The bullish case for Nevro Corp NVRO 8.29% — a medical device company that focuses on the treatment of chronic pain — no longer applies for three reasons, according to Morgan Stanley.

The Analyst

Morgan Stanley’s David Lewis downgraded Nevro from Overweight to Equal-weight with a price target lowered from $94 to $88.

The Thesis

The bullish case for Nevro’s stock was based on the following expectations, Lewis said in a Monday downgrade note:

• Material market share gains.
• An expansion of the total addressable market through new initiatives.
• Clinical superiority for the Senza spinal cord stimulation system.

All three catalysts now hold risk, Lewis said.

Nevro’s commercial message of boasting clinically superior therapies isn’t resonating as much as expected, while competing platforms like Abbott Laboratories ABT 0.02% Burst and Medtronic PLC MDT 0.49%‘s Intellis have gained market traction, the analyst said.

Expectations for expansion into new markets not only hasn’t occurred, but Nevro is stuck in a “near-term catalyst void,” Lewis said, giving the example of the company’s diabetic neuropathy and non-surgical back pipelines. After timeline delays, the candidates are slated to begin enrollment in mid-2019, the analyst said.

The superiority of Nevro’s Senza could face challenges from Saluda’s Evoke system in January 2019 or beforehand, Lewis said. The Saluda platform can be programmed to automatically adjust stimulation levels to a patient’s preferred level and could be statistically superior to traditional SCS treatments, negatively affecting Nevro’s commercial message, he said.

https://bit.ly/2tZDfRF

School security is a rapidly growing business

They’re investing in video surveillance, entry control systems, lockdown training and armed police on site. And some are considering newer gadgets that claim to fill security gaps, including door barricades and bulletproof backpacks.

School security is a rapidly expanding business, according to research by Jim Dearing, senior security analyst at IHS Markit. The education sector of the security market grew to $2.7 billion last year, up from $2.5 billion in 2015. The proportion of schools using video surveillance grew to 70% in 2013, up from 20% in 1999.

The market for security equipment is flattening now that the vast majority of schools are stocked up, Dearing said.

Scrambling to find safety solutions

This year’s National Active School Shooter Conference has had to increase its exhibition hall size by three times, said Sean Burke, president of the School Safety Advocacy Council. The number of exhibitors at the conference, taking place in Orlando in July, has gone up 25% compared to last year.

“Security companies are adapting products for the school market,” he said. “Some aren’t proper for a school environment.”

Dearing agrees that some schools that already have “real security” are exploring another wing of the market, representing more niche, non-traditional devices.

Many schools are using these gadgets as quick fixes, to show the community they’re doing something, said Rick Kaufman, an emergency management consultant who led the crisis response team at Columbine High School. He now advises school districts on their security plans.

“Schools are scrambling,” he said. “They’re not looking at what might be the best solution.”

Some of these gadgets pose a number of safety problems of their own, he said. For example, door jams are a violation of many state egress codes, because wheelchair-bound students can’t exit.

“Additional tools”

Shooter Detection Systems uses military technology to detect gunfire and trigger school video management systems. CROTEGA is an “interior suppression system” that sprays a non-toxic, vinegar-like irritant from ceiling fittings with the goal of disorienting a shooter.

BulletBlocker is a manufacturer of bulletproof backpacks and clothing. Founder Joe Curran said sales have shot up by 400% since Parkland. Though school districts don’t typically purchase his products, Curran said he’s now receiving many inquiries from concerned parents. Some have bought backpacks in bulk and donated them to their kids’ schools.

Many districts have purchased a door barricade called the Bolo Stick. It would keep classroom doors shut during a shooting in an effort to buy time for a police response.

“We’re getting calls left and right,” said founder Bill Barna. It was barely an industry before, he said, but it’s now surging. In the first quarter of 2018, the company’s made more sales than in all of 2017. Since 2014, it has grown five-fold.

“I’m not here to make a million dollars,” said Barna, the Bolo Stick founder. “I’m here to save a million lives.”

Unlocking funding

The historical holdback for schools in deciding which tools to implement has been the lack of funding.

But since Parkland and other recent mass shootings, districts have generally freed up funds, said Kaufman, allowing sales to rise.

Financing safety is a balancing act that relies on a combination of local and state tax dollars and grant money. Various private grant programs now award funding to schools that apply. A handful of states make use of modest state grants. And some states — like Minnesota, where Kaufman now works — allow districts to enact levies to raise additional revenue for security.

In California, funds are scarce, said Dale Marsden, superintendent of the San Bernadino Unified School District. He prefers to spend the little cash they receive on preventative measures and to promote a culture of safety.

“We don’t want to become emotionally reactive,” he said. “It’s about staying one step ahead of the bad guys.”

https://cnnmon.ie/2tMgv8M

Biotech Analyst Says Ignoring Wall Street Brings Bigger Payday

If you want to make money in biotech you are better off doing the opposite of what your sell side analyst tells you to do.

That’s the conclusion Cowen & Co. senior research analyst Phil Nadeau came to after looking at four years of data on Nasdaq Biotech companies and their investment ratings. While Cowen found an inverse relationship between analysts’ ratings and biotech performance since 2015, rating upgrades and downgrades were an even worse predictor of stock performance.

Whenever there was a change toward a strong buy rating on a company, the worse the prognosis for shares. Ratings trending toward a strong sell performed better. Equity analysts are also heavily weighted toward buy ratings and don’t tend to change their views much despite market volatility and shifting investor sentiment, says Nadeau. Nadeau himself rates 35 companies — with 27 of those buys, six holds and no sells — according to Bloomberg data.

Where does all this leave investors?

“Unfortunately (for our job security and sense of self-worth),” Nadeau advises clients in a note that “a non-consensus investment strategy that goes against the consensus sell-side opinion could generate superior returns.”

https://bloom.bg/2Kutsyc

Piper on the fence on volume growth of Supernus Trokendi XR

Supernus Pharmaceuticals (SUPN -4.7%) slips on below-average volume on the heels of a note from Piper Jaffray’s David Amsellem (Neutral/$47) stating that the results from an in-house survey of 25 neurologists suggested weakening volume growth for top seller Trokendi XR which accounted for 77% of the company’s 2017 product sales ($226.5M/294.1M).

Mr. Amsellem adds that the significance of the pressure on volume/sales growth is “unclear” but he believes Trokendi XR will not be a significant revenue growth drive in the coming years.

https://bit.ly/2KFPASa

Trump administration names new U.S. drug enforcement chief

The Trump administration on Monday named a top White House lawyer as the new head of the U.S. Drug Enforcement Administration after the agency’s prior acting administrator announced his retirement last month.

Uttam Dhillon, who most recently served as deputy White House counsel, was named as the DEA’s acting administrator at a time when the agency is devoting much of its attention to grappling with a national opioid epidemic.

According to the Centers for Disease Control and Prevention, 42,000 people died from opioid overdoses in 2016. U.S. President Donald Trump declared the crisis a public health emergency in October.

“The work of the Drug Enforcement Administration is critical to fighting this crisis, and President Trump and I are committed to continuing to give it the strong leadership it deserves,” Attorney General Jeff Sessions said in a statement.

Dhillon replaces Robert Patterson, a 30-year agency veteran who became the DEA’s acting head in October following the departure of Chuck Rosenberg, who himself had led the DEA in an acting, rather than Senate-confirmed, capacity since 2015.

Patterson in an email to employees on June 18 said he “realized that the administrator of the DEA needs to decide and address priorities for years into the future — something which has become increasingly challenging in an acting capacity.”

Dhillon earlier in his career served under President George W. Bust as director of the Department of Homeland Security’s Office of Counternarcotics Enforcement. Before that, he served as an associate deputy attorney general in the Justice Department.

https://reut.rs/2tOXcvu

Amedisys hikes borrowing capacity for ‘acquisition opportunities’

Amedisys, the publicly-traded home health company based in Baton Rouge, is nearly doubling its borrowing capacity by $250 million, to $550 million, in an effort to capitalize on new acquisition opportunities.

The new credit facility also has an expansion option to allow for further upsizing, Amedisys said in a news release. The firm will use the proceeds to pay of its existing senior term loan and revolving credit line balance. Additional proceeds will be used to “capitalize on a strong pipeline of acquisition opportunities.”

“The new facility will provide us with increased operational flexibility, reduced pricing and incremental capital for acquisition opportunities in our pipeline,” President and CEO Paul Kusserow said in a statement.

Amedisys, with a market cap of nearly $3 billion, is one of the largest home health companies in the U.S. The company has grown over the years through aggressive acquisitions of other home health and personal care companies.

https://bit.ly/2KH9NKL