Employer Coalition Launches to Combat High Prescription Drug Costs

The Pacific Business Group on Health (PBGH), The ERISA Industry Committee (ERIC) and the National Alliance of Healthcare Purchasing Coalitions (National Alliance) have partnered to launch the Employers’ Prescription for Affordable Drugs (EmployersRx), a coalition uniting employers in advocacy for policies that will address our nation’s biggest health care challenge—the high cost of prescription drugs.

“As the largest collective purchaser of health care, businesses have a responsibility to employees and their families to tackle this important issue,” said Elizabeth Mitchell, president and CEO of PBGH. “Employers and patients are tired of bearing the brunt of high costs caused by a gamed system set up by drug manufacturers and pharmacy benefit managers. Employers are doing everything they can to contain costs, but this problem is too big to fix without action from the government.”
The coalition supports policies that would increase transparency by forcing middlemen, such as pharmacy benefit managers (PBMs), to make pricing data available to payers. Additionally, drug companies would be required to report and justify price increases for some drugs. Furthermore, the coalition supports changes that would strengthen competition by prohibiting practices that stifle the development and use of generic drugs and biosimilars, and increase value by ending secretive PBM schemes, like spread pricing.
Spending on prescription drugs in the United States has skyrocketed, growing from $236 billion in 2007 to $333 billion in 2017—a 41% increase. Employers spend 21 cents of every health care dollar on prescription drugs—more than twice the national spending rate on retail drugs. These increases contribute to rising overall insurance rates. Kaiser Family Foundation’s recently released data shows that employer premiums rose five percent from last year to average $20,576.
Funds that could be used by companies to increase employee wages or reinvest in the company are instead being used to underwrite massive profits for drug makers. The Kaiser Family Foundation also released survey results that reported one in four Americans find it difficult to afford medication, and four in five agree that prescription drug costs are unreasonable.
EmployersRx is committed to driving the passage of legislation that supports competition, transparency and value by empowering its members to be effective advocates through policy briefs, training and support. EmployersRx features insights and recommendations informed by case studies from employers, including Albertsons, Caterpillar and the University of Southern California.
https://www.biospace.com/article/releases/employer-coalition-launches-to-combat-high-prescription-drug-costs/

Galderma: Positive Phase 2 Results for Investigational Botulinum Toxin

Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, recently announced the Phase 2 clinical trial results for its novel ready-to-use investigational botulinum toxin, QM1114. The multicenter, randomized, double-blind, placebo-controlled study successfully demonstrated the safety and efficacy of Galderma’s liquid formulation of botulinum toxin type A for the treatment of glabellar lines (frown lines). The Phase 3 clinical trial program will begin soon to support regulatory submissions globally.¹

“As a physician, I need to be confident that innovation in aesthetic treatment is the result of scientific rigor. I am encouraged by the results of the Phase 2 QM1114 study, which demonstrated initial safety and efficacy at all doses with high patient satisfaction,” said Dr. Joel Cohen*, Director of AboutSkin Dermatology and DermSurgery in Colorado, and investigator in the Phase 2 clinical trial. “It is exciting to see the development of a new toxin formulation that can offer convenience and the potential to eliminate the need for reconstitution in my practice.”
Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and manufactured using an animal-origin free process, QM1114 has been designed and developed specifically for use in aesthetics. The QM1114 liquid formulation reduces preparation time needed in clinic and has the potential to increase accuracy, as it is ready-to-use, in contrast with current treatments that require reconstitution before administration. Market research suggests that on average, over 70 percent of injectors do not delegate the reconstitution process because they ‘do not feel comfortable with someone else doing it.’²
Additionally, Galderma recently received a manufacturing license from the Swedish Medical Products Agency (MPA) for a new state-of-the-art manufacturing facility at the Center of Excellence, located in Uppsala, Sweden.³ This new facility, built to the highest quality standards, is designed exclusively to meet the production and safety requirements of QM1114. It will also ensure that Galderma can meet increasing worldwide demand as the company’s innovative aesthetics pipeline grows.
https://www.biospace.com/article/releases/galderma-announces-positive-phase-2-results-for-its-proprietary-liquid-formulation-of-an-investigational-botulinum-toxin-and-approval-of-new-state-of-the-art-manufacturing-facility/

Large Amounts Of Insider Trading In Aprea Therapeutics Following IPO

Aprea Therapeutics Inc APRE 2.53% shares cooled a bit Tuesday after getting off to a hot start on the market following an Oct. 3 IPO. The oncology biotech company, which is conducting Phase III testing, saw its stock shoot as high as $21 last week from its $15 IPO price.

The Trades

On Monday, there were several large insider purchases of Aprea stock. Most of the purchases are options being exercised, resulting in trades executed well below market price. The following are some of the noteworthy insider trades reported Monday.

• Seizinger Bernd R. (Director) Exercised 527,940 @ Avg Price: 4 cents.
• Magni Guido (Director) Buys 6,500 @ Avg Price: $15.
• HENNEMAN JOHN B III (Director) Buys 23,407 @ Avg Price: $3.20.
• Korbel Gregory Alan (VP of Business Dev’t) Buys 64,822 @ Avg Price: 12 cents.
• Attar Eyal C. (SVP, Chief Medical Officer) Buys 78,030 @ Avg Price: 8 cents.
• Coiante Scott M (SVP, Chief Financial Officer) Buys 153,324 @ Avg Price: 24 cents.
• SCHADE CHRISTIAN S (Director, President & CEO) Buys 317,085 @ Avg Price: 52 cents.

Why It’s Important

Company insiders often have the best sense of where a company and a stock are headed.
While many Americans associate the term “insider trading” with illegal activity, company insiders are free to buy and sell shares of their own company’s stock, provided they follow disclosure laws.
Illicit insider trading occurs when a company insider trades after gaining meaningful non-public information about the company, or if an insider buys or sells shares of stock without disclosing the trades via Securities and Exchange Commission filings.
Company insiders whose compensation includes shares of stock can’t be faulted for selling those shares and raising cash periodically.
Insider buying is typically considered particularly noteworthy, and traders watch closely for changes in patterns or unusual insider trading activity.

Benzinga’s Take

As if small cap biotech stocks weren’t typically volatile enough on their own, the first few months of trading for a biotech IPO can be especially volatile and unpredictable.
Aprea traders should expect plenty of noise and volatility surrounding the initial wave of Wall Street analyst coverage, the company’s first quarterly earnings report and the expiration of its lockup period.
It’s always good to see insiders buying shares of stock, but all of the buys reported on Monday happened at steep discounts to market price. Traders will get their first sense of how company insiders feel about Aprea when the lockup period expires and insider trades start happening at market price.
https://www.benzinga.com/general/biotech/19/10/14563195/large-amounts-of-insider-trading-in-aprea-therapeutics-following-ipo

Vir Biotech IPO: What You Need To Know

A clinical-stage immunology company targeting infectious diseases is planning a public listing this week.

The IPO Terms

San Francisco, California-based Vir Biotechnology, Inc. is seeking to offer 7.143 million shares in an IPO, with the shares expected to be priced between $20 and $22 apiece, the S-1/A filing revealed.
At the midpoint of the estimated price range, the offering is expected to raise about $150 million.
The company has applied for listing its shares on the Nasdaq under the ticker symbol “VIR.”
Goldman Sachs, JP Morgan, Cowen and Barclays are the underwriters for the offering.

The Company

Vir, founded in 2016, is a clinical-stage immunology company, which used a combination of immunologic insights and cutting-edge technology to treat and prevent serious infectious diseases.
Infectious diseases cause hundreds of billions of dollars of economic burden each year, according to the company.
Vir has four technology platforms, focused on antibodies, T cells, innate immunity and small interfering ribonucleic acid or siRNA.
Its product pipeline consists of candidates targeting hepatitis B virus, influenza A, HIV, and tuberculosis.

Source: S-1 filing
Vir expects to use the net proceeds from the offering to fund R&D of its product candidates, including VIR-2218, VIR-3434, VIR-2482.

The Finances

Vir reported revenues of $10.67 million, comprising grant and contract revenues, for fiscal year 2018 compared to $2.71 million a year ago. The net loss, however, widened from $69.85 million in 2017 to $115.88 million in 2018.
For the six months ended June 30, revenues were $5.71 million compared to $4.66 million in the same period last year. The loss for the half-year period widened $56.04 million to $62.60 million.
https://www.benzinga.com/general/biotech/19/10/14562402/vir-biotech-ipo-what-you-need-to-know

Global Blood Therapeutics target upped to $104 from $96 by Wells Fargo

Maintains Outperform
https://www.benzinga.com/stock/GBT/ratings

Viela Bio in deal with Mitsubishi Tanabe Pharma to develop inebilizumab in Asia

Viela Bio (NASDAQ:VIE) collaborates with Mitsubishi Tanabe Pharma (OTCPK:MTZPY) to develop and commercialize inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody in nine Asia regions for neuromyelitis optica spectrum disorder, as well as other potential future indications.

Under the terms of collaboration, Viela will receive an up-front licensing fee of $30M as well as additional milestone payments and payments based, in part, on sales revenue.

MTPC will be responsible for development and commercialization of inebilizumab in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore, and Taiwan.

https://seekingalpha.com/news/3504650-viela-bio-inks-deal-mitsubishi-tanabe-pharma-develop-inebilizumab-asia

Ionis earns $10M milestone from Bayer on advancement of clotting disorder med

Ionis Pharmaceuticals (NASDAQ:IONS) announces that collaboration partner Bayer (OTCPK:BAYRY) has decided to advance antisense candidate IONIS-FXI-Lrx for the potential treatment of clotting disorders.

Under their May 2015 agreement, Bayer has exclusive rights to develop Ionis’ Factor XI-targeting programs for clotting disorders. Its decision to proceed with this candidate triggers a $10M milestone payment to Ionis, who is eligible for additional milestones and tiered royalties in the low-to-high 20% range on gross margins.

https://seekingalpha.com/news/3504651-ionis-earns-10m-milestone-bayer-advancement-clotting-disorder-candidate