EUSA Pharma buys rights to Janssen rare disease drug

UK-based EUSA Pharma has bought worldwide rights to Janssen’s rare diseases drug Sylvant (siltuximab) for $115 million.

EUSA already markets two oncology drugs and is seeking to build its presence in the rare disease market with Sylvant, which has been approved in the US since 2014 to treat multicentric Castleman’s disease, caused by an abnormal overgrowth of cells of the lymph system.

Although not classified as a cancer, the disease acts very much like lymphoma and Sylvant is the only approved treatment for the condition in more than 40 countries worldwide including Europe.

The disease affects around 1,900 patients in the US and a similar number in Europe, and due to the small numbers of patients the drug has market exclusivity under orphan drug regulations in both territories.

EUSA bought worldwide rights to the drug from Janssen Sciences Ireland and says it plans to expand its availability into other countries.

While the drug does not produce significant sales for the Johnson & Johnson unit, EUSA has plans to relaunch it and develop it in other indications.

Sylvant is a monoclonal antibody that blocks the action of interleukin-6 (IL-6), a multifunctional cytokine detected at elevated levels in iMCD patients.

EUSA said it plans to develop Sylvant in additional indications where IL-6 blockade may be effective – such as cytokine release syndrome associated with chimeric antigen receptor T-cell (CAR-T) therapy in cancer.

The company last month appointed Jeff Hackman, formerly acting CEO at rare disease company Novelion Therapeutics as president of its US operations.

EUSA’s team of 30 sales staff and medical science liaisons are undergoing training to relaunch the drug in the US this month.

EUSA will immediately relaunch through its European commercial and medical infrastructure, as well as expanding its operations into new territories, including the Republic of Korea, Canada and certain markets in South America and South East Asia.

Lee Morley, EUSA’s CEO (pictured above), said: “Sylvant is a perfect fit with EUSA’s oncology and rare disease focus, and provides the company with a major opportunity to continue its rapid growth. As the only approved treatment for the devastating disorder iMCD, we have ambitious plans to bring Sylvant to patients around the world.”

https://pharmaphorum.com/news/eusa-pharma-buys-rights-to-janssen-rare-disease-drug/

Fatal Drug ODs Soaring Among Middle-Aged Women: CDC

The rate at which middle-aged American women die from overdoses involving opioids and other drugs nearly quadrupled between 1999 and 2017, new government data shows.

In 1999, about seven out of every 100,000 deaths among U.S. women aged 30 to 64 was caused by a drug overdose, but by 2017 that rate had risen to about 24 women per 100,000 — a 260 percent increase, the U.S. Centers for Disease Control and Prevention said.

At the same time, rates of fatal ODs from opioids, specifically, rose nearly sixfold for middle-aged women.

The steepest increase was actually seen among older women — those aged 55 to 64 — noted a team led by Karin Mack, of the CDC’s National Center for Injury Prevention and Control.

In fact, the average age of death from overdose crept up by about three years over the course of the study period. In 1999, the average age of a fatal OD in middle-aged women was 43.5 years, but by 2017 it had risen to 46.3 years, Mack’s team reported.

The bottom line, the researchers said, is that “efforts are needed to reduce the number of deaths in this evolving epidemic among middle-aged women.”

One physician on the frontlines of the overdose crisis said multiple factors are contributing to these tragedies.

“We know that prescription opioids are still the main driver of the current opioid epidemic, but it’s important to understand the sharp rise of fentanyl-laced heroin responsible for increased numbers of deaths,” said Dr. Robert Glatter. He’s an emergency physician at Lenox Hill Hospital in New York City.

Fentanyl is an opioid that’s thought to be 50 times more potent than heroin and 100 times more potent than morphine.

“Cheap, illicitly manufactured fentanyl from China and Southeast Asia is making its way onto the streets in the U.S.,” Glatter explained.

He said that while men tend to have higher rates of drug abuse than women, women can be especially vulnerable.

“Women’s substance use tends to progress more rapidly from first-time use until addiction develops,” Glatter said. “Withdrawal can also be more intense for women, and they may also respond differently than men to specific medical treatments.”

The new CDC study relied on 1999-2017 data from the National Vital Statistics System.

The data revealed that for women aged 30 to 64, deaths linked to “synthetic opioids” — a class that includes fentanyl — rose about 17-fold during the study period. Steep increases were also seen for deaths involving heroin (a 10-fold rise), as well as those involving Valium, Xanax or other benzodiazepine drugs (a ninefold rise). Often, overdoses involved multiple drugs.

Why are women in middle age being hit especially hard by the opioid abuse crisis? Addiction specialist Dr. Harshal Kirane had some theories.

“Middle-aged women are often prevented from accessing care due to family responsibilities, child care considerations and financial disparities,” said Kirane, who directs addiction services at Staten Island University Hospital in New York City.

“Moreover, certain mental health issues — such as anxiety and depression — tend to occur at higher rates in women, which create profound obstacles to engagement in care,” he said.

Glatter agreed.

“People with untreated or undertreated depression or anxiety are at higher risk for substance abuse, with middle-aged women in this demographic at higher risk for opiate as well as benzodiazepine abuse,” Glatter said. “Women who are victims of domestic violence are also at higher risk of substance abuse.”

All of this means that more outreach must be done to help women who are vulnerable to addiction.

Kirane suggested that “we must expand the entire infrastructure for addiction care in our country, and address the comprehensive needs for women struggling with opioid-related issues.”

Crucial to these efforts are boosting women’s access to education about overdose, allowing them easy access to the overdose antidote naloxone, and widening the availability of medication-assisted treatments aimed at weaning people off addictive drugs, Kirane said.

The new report was published Jan. 11 in the CDC’s Morbidity and Mortality Weekly Report.

More information

The American Academy of Family Physicians has more on opioid addiction.

SOURCES: Robert Glatter, M.D., emergency physician, Lenox Hill Hospital, New York City; Harshal Kirane, M.D., director, addiction services, Staten Island University Hospital, New York City; Jan. 11, 2019, Morbidity and Mortality Weekly Report

https://consumer.healthday.com/general-health-information-16/drug-abuse-news-210/fatal-drug-ods-soaring-among-middle-aged-women-cdc-741409.html

FDA to study vaping addiction among young adults, NBC reports

The FDA is looking into the “epidemic of e-cigarette use” by teens and young adults, with a hearing expected to take place on January 18th, NBC News says. The report profiles a 15-year old from North Carolina, whose vaping habit has morphed into a $150/week addiction, plummeting academic performance, and culminated in a seizure, leading him to undergo a 40-day addiction rehab program

https://thefly.com/landingPageNews.php?id=2847283

Allscripts, Microsoft partner on cloud-driven clinical trials model

• Allscripts life sciences arm Veradigm is teaming up with Microsoft in an attempt to change the way clinical trials are conducted.
• The aim is to develop an integrated research model that allows trial data to be collected through point-of-care technology platforms in an attempt to speed time to market of new therapies while reducing research and development costs.
• The collaboration will initially focus on extending Allscripts cloud-based EHR platforms with features such as automated “matchmaking” between trial protocols and doctors and patients who qualify for the studies.

The partnership is Microsoft’s latest effort in healthcare using artificial intelligence and Azure, the tech giant’s cloud computing service. Microsoft recently announced the availability of FHIR Server for Azure, an open-source project on GitHub aimed at easing the exchange and management of healthcare data in the cloud.

Last summer, Microsoft joined Amazon, Google, IBM, Oracle and Salesforce in committing to remove barriers to the adoption of technologies for healthcare interoperability, especially when possible through the cloud and AI. More recently, the company upped its ante in the industry with the creation of a formal unit, Microsoft Healthcare.

In addition to building out cloud-based EHRs, the Allscripts-Microsoft project will likely include pilot programs to explore and develop processes, workflows and a compliance framework to support research done using the new trial model.

Veradigm officials likened the project’s potential to improve clinical research to the way rideshare apps disrupted traditional taxi services.

“By integrating research at the point of care, we have the potential to lower costs, increase efficiencies, and remove bottlenecks that inhibit research, all while improving the welfare of patients,” Veradigm CEO Tom Langan said in a statement.

Big Data is fueling a “new gold rush” of tech companies eager to cash in on its business opportunities, a Fortune analysis concluded last year. Personal information, health histories, medical claims, medications, clinical trials and academic research produce roughly 750 quadrillion bytes of data daily — nearly a third of data worldwide, according to the report.

In a research note, Leerink praised the Allscripts push into life sciences via Veradigm and the Microsoft partnership. However, the bank questioned Allscripts’ rosy three-year revenue CAGR forecast of 5.5% to 9% — 1.5% to 2.5% of which ties to Veradigm.

“We like how MDRX is pursuing new higher growth markets, but at the same time we believe that VEEV [Veeva Systems] and MDSO [Medidata Solutions] are extremely well penetrated in the clinical trials space and we have a tough time seeing how the market will be ‘transformed,’ the note reads. “In our view, the announcement and presentation seem to suggest a pivot of strategy focused on capitalizing on the robust growth of the life sciences industry.”

https://www.healthcaredive.com/news/allscripts-microsoft-partner-on-cloud-driven-clinical-trials-model/545488/

Medical records key to Apple health strategy

• As Apple makes inroads into the healthcare and wellness market, establishing itself as the platform for consumers’ personal health records will be central to the tech giant’s app, services and wearables strategies, according to a new report from research firm CB Insights.
• Apple is aiming to take advantage of the lack of an existing third party developer ecosystem for healthcare data by building the first open platform for the market, modeled after the attractive third-party developer ecosystem it has created in its app store, according to the report.
• Current market players in Apple’s line of fire include health IT and EHR companies and medical device makers that are building commodity consumer-facing devices, the report said.

Apple’s strategy has the potential to become a new paradigm for healthcare by empowering patients to make decisions and give data access to whomever they choose, the research firm suggests.

The company bought personal health record startup Gliimpse in 2016. A step tracker and calendar give consumers a reason to engage regularly with the app, which also tracks wellness metrics such as physical activity, mindfulness, nutrition and sleep. In 2018, Apple said it would integrate EHR data into the iPhone’s health record and would open the API to third parties through a software development tool called HealthKit.

Apple is part of a group pushing for a technology called Fast Healthcare Interoperability Resources (FHIR) to become the standard for increasing the exchange of data between hospitals, physicians and other relevant parties, the report notes.

More than 120 healthcare organizations are part of Apple’s health record beta, including Adventist Health System, Mount Sinai, Cleveland Clinic, Intermountain Healthcare and LabCorp, CB Insights said.

An edge for Apple is its own strong brand. “Various existing healthcare players have notoriously terrible brand and customer experience, which has been Apple’s focus as a company. As healthcare moves to a more proactive model, which requires reaching out to patients, having a strong brand is a major component,” the report states.

Apple could also reshape the medical research industry, CB Insights said. In 2015, the company launched ResearchKit to let medical researchers conduct studies using the iPhone. The kit simplifies the process of signing up for a study and can identify eligible candidates through their health records. It also enables remote monitoring of patients. Based on the success of ResearchKit, Apple in 2016 launched CareKit, which allows physicians and hospitals to monitor patients.

The company took a major step forward in the medical device arena when it received FDA clearance in September for an Apple Watch Series 4 application to provide a single lead electrocardiogram for heart monitoring. Apple has struck key partnerships to develop other health capabilities as well, addressing areas such as mindfulness and physical activity, therapy for stroke patients, psychiatric care support, ADHD, migraine prevention and binge eating, CB Insights said.

https://www.healthcaredive.com/news/medical-records-key-to-apple-health-strategy-analysis-finds/545638/

Grassley to home in on drug pricing, insurance mergers as Senate panel chair

• Senate Finance Committee Chairman Chuck Grassley previewed Wednesday his health policy priorities for the new Congress, pledging to scrutinize mergers such as the CVS-Aetna deal, pursue bipartisan legislation to bring down drug costs and work to allow cheaper drug imports from Canada.
• But the Republican from Iowa warned that allowing Medicare Part D to directly negotiate with drug companies is a proposal he has no interest in pursuing, saying that intervening in the private sector is a step too far.
• Grassley also was a co-sponsor of a bill to kill the 2.3% excise tax on medical devices, part of the Affordable Care Act the industry has lobbied against for years.

Grassley, who has been critical of the pharmaceutical industry, pointed to three bills he would like to move forward: the Creating Equal Access to Equivalent Samples Act, which aims to prevent brand drugmakers from blocking generic manufacturer competition; pay-for-delay legislation targeting anti-competitive patent settlements payments from brands to generic makers to not compete; and the Safe and Affordable Drugs from Canada Act of 2019, which would allow importation of prescription drugs from Canada.

The drug importation bill, which Grassley introduced Wednesday with Democratic Senator Amy Klobuchar for the new Congress, would permit importation of branded drugs from approved pharmacies in Canada.

“Our legislation would allow for the safe importation of less expensive drugs from Canada, increasing competition, bringing down drug costs, and saving American families money,” Klobuchar said in a statement.

President Donald Trump has backed the import idea, and taking on drugmakers for high prices is seen as a rare potential area for bipartisan cooperation in the new Congress. Last July HHS directed FDA to establish a working group on drug importation, but the effort has seen little movement since.

Grassley also told reporters that he discussed healthcare antitrust concerns with Department of Justice Attorney General nominee William Barr Wednesday morning, but said he was unsure if he would lead specific investigations into individual mergers.

“This is a major issue of mine,” Grassley said. “I want to make sure that the antitrust laws are enforced, I intend to pursue with the Justice Department to make sure they are doing thorough reviews. When you have less competition, you have higher prices.”

He also pegged waste, fraud and abuse in Medicare and Medicaid as a priority, and said he would wait until comments are submitted on HHS’ International Pricing Index model before having a conversation with HHS Secretary Alex Azar about the proposal.

“I don’t want foreign countries setting our drug prices,” Grassley said.

https://www.healthcaredive.com/news/grassley-to-zoom-in-on-drug-pricing-insurance-mergers-as-senate-panel-chai/545756/

J&J hikes U.S. prices an about two dozen medicines, Reuters reports

Johnson & Johnson hiked U.S. prices on roughly two dozen prescription medications on Thursday, including psoriasis treatment Stelara, prostate cancer drug Zytiga, and blood thinner Xarelto, Reuters reports. The company joined many other peers that boosted U.S. prices on hundreds of prescription drugs earlier this month, the report says. Most of the J&J price hikes were between 6%-7%, the report says, citing data from Rx Savings Solutions. The increases came as Congressional Democrats introduced a bill aimed at cutting the cost of prescription medicines for American consumers, the report says

https://thefly.com/landingPageNews.php?id=2847281