While most patients with commercial insurance pay around $30 monthly with manufacturer discount cards, those without coverage face the drug’s full list price.

By Aaron Sull, Jewish Breaking News

Millions of Americans struggling with obesity finally have access to an affordable weight-loss drug after Teva Pharmaceuticals won FDA approval for the first generic version of a highly effective medication.

The Israeli drugmaker announced it has received FDA clearance to sell generic liraglutide injection, a copy of Novo Nordisk’s expensive obesity drug Saxenda that currently costs patients over $1,300 per month.

“With this approval, and by launching a generic for Saxenda, we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,” said Ernie Richardsen, Teva’s senior vice president and head of U.S. commercial generics.

Saxenda generated $165 million in sales through June, representing a substantial market opportunity for Teva’s generic alternative.

While most patients with commercial insurance pay around $30 monthly with manufacturer discount cards, those without coverage face the drug’s full list price.

Liraglutide works by mimicking a hormone called glucagon-like peptide-1 that the body naturally produces in the small intestine when you eat.

This hormone performs several critical functions: it signals the brain when you’re full, slows down digestion so food stays in your stomach longer, and helps regulate blood sugar by triggering insulin release.

However, the body’s natural version only works for minutes after eating. Liraglutide stays active for 24 hours, requiring just one daily injection to maintain its appetite-suppressing effects.

Patients start with a small 0.6 mg dose that increases weekly until reaching the full 3 mg maintenance dose.

The medication slows digestion and reduces appetite, causing people to eat less and lose weight over time. Users must also follow reduced-calorie diets and increase physical activity.

Clinical trials involving 3,731 patients over 56 weeks showed impressive results. Three out of five people lost at least 5% of their body weight, while one in three achieved weight loss exceeding 10%.

FDA approval covers adults with obesity and those who are overweight with related health problems like diabetes or high blood pressure. Adolescents aged 12-17 who weigh more than 132 pounds and have obesity can also receive the medication.

Breaking into the GLP-1 market represents a significant achievement for Teva.

Manufacturing complex generic drugs like liraglutide requires sophisticated production capabilities that many competitors lack, giving the Israeli pharmaceutical giant an advantage in this lucrative space.

“This is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva’s diverse complex generics portfolio, demonstrating once again our proven ability to sustain a world-class Generics Powerhouse,” says Richardsen.

More than one-third of American adults suffer from obesity, creating enormous demand for effective treatments. Medical research shows losing just 5-10% of body weight significantly improves health outcomes and reduces risks of heart disease and diabetes.

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Teva’s stock fluctuation is not the result of wrongdoing regarding the U.S. opioid abuse epidemic, but rather something born of the creativity of lawyers, says company CEO.

By Sophie Shulman, Calcalist

Last year was a good one for Teva Pharmaceutical Industries Ltd., according to CEO Kåre Schultz. The company achieved its forecasts and followed its plan very closely, he said, speaking at the company’s annual press conference in Tel Aviv.

Teva published its fourth quarter and annual earnings report for 2019 last week, reporting $16.9 billion in sales and free cash flow of $2.1 billion. In the past, Schultz has repeatedly forecasted that 2019 will be the year Teva hit rock bottom; the company forecasts sales of $17 billion in 2020 and free cash flow of between $1.8 billion and $2.2 billion. While not a dramatic improvement, the forecasts break the trend of plummeting revenues, which is the best Teva can do at the moment, he said.

Teva recently completed its two-year reorganization plan, which saw 13,000 people laid off globally. The announcement, made shortly after Schultz stepped in as CEO in December 2017, shocked the Israeli public, he said Wednesday. Most of those laid off, however, had already found new jobs as they were highly educated, he said.

Schultz also referred to Teva’s stock performance. While it climbed sharply on NYSE since the publication of the reports, a long-term viewpoint reveals the company is orbiting a market capitalization of $14 billion. According to Schultz, the stock is not affected by Teva’s business performance but rather by the current legal troubles the company faces in the U.S. as a result of the cross-state opioid abuse damages lawsuits.

Teva is not being sued because it did something wrong, Schultz said, but rather because of a creative idea generated by some U.S. lawyers who specialize in suing companies because certain patients died. A lawsuit cannot be filed against Mexico’s drug cartel, nor can most addicts be sued due to their problematic history, he added.

Teva decided to settle in Oklahoma because it was a small court with one judge and no jury, and thus a loss was guaranteed, Schultz said. Johnson & Johnson did not settle and lost, and they will probably lose the appeal as well, and only when they reach the supreme court will someone show the same allegations can be levied against alcohol makers, he added.

Schultz said he does not know when the matter will be finished. The trial was the initiative of local municipalities, not of states, he said, which is why all 50 states need to agree on one solution. The opioid abuse damages lawsuits are political, he added, and if a settlement is not reached the case could drag in court for a decade, which is no use to the public.

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Teva announced a settlement with two Ohio counties on Monday, averting a trial scheduled for later that day. 

By Lilach Baumer, CTech

Teva Pharmaceutical Industries Ltd. announced on Monday that it had reached an agreement in principle with attorneys general from North Carolina, Pennsylvania, Tennessee, and Texas, and with certain private plaintiffs, for a global settlement framework of the opioid abuse-related lawsuits against it.

According to the framework, Teva will donate buprenorphine-naloxone, a medication used to treat opioid use disorder, in quantities valued at around $23 billion in wholesale acquisition costs. The amount Teva will donate covers the majority of what U.S. patients are estimated to need over the next decade, the company said. Teva will also pay $250 million over the next 10 years.

Teva also announced on Monday a settlement agreement with both Cuyahoga and Summit counties of Ohio, whose lawsuits were set to be discussed in a Cleveland federal court the same day. The agreement removes Teva from the Track 1 opioid litigation. Under it, Teva will provide both counties with buprenorphine-naloxone valued collectively at $25 million over the next three years, as well as a cash payment of $25 million paid over the same period of time.

The settlement framework will put an end to most claims against Teva. Earlier this month, Wells Fargo analyst David Maris estimated that the fine the company faces could be as high as $5 billion.

Following the announcement, Teva closed 8.67% up on NYSE Monday.

Teva is just one of many opioid manufacturers and distributors who have been forced to shoulder the blame for the American opioid abuse epidemic. Around 2,500 lawsuits were set to be discussed in Monday’s trial, filed by states, counties, cities, and others, and Teva was not the only company scrambling to reach a settlement out of court in the weeks before.

McKesson Corp., AmerisourceBergen Corp., and Cardinal Health Inc., which between them distribute around 90% of all U.S. drugs, also reached a settlement with the two Ohio counties on Monday, agreeing to pay $215 million between them.

Talks in which they had been involved to reach a more global settlement failed Friday. As the distributors and Teva were the main defendants in the track 1 litigation — Johnson & Johnson having reached a $20.4 million settlement with the two counties earlier this month, as did Allergan and Purdue Pharma — Monday’s trial was averted.

One defendant, Walgreens Boots Alliance, has not yet reached a settlement and will be rescheduled for trial at a later date.

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After a several-year delay, Teva received U.S. approval for its EpiPen in August 2018.

By JNS.org

Teva Pharmaceutical Industries has projected that its generic version of the Mylan EpiPen will capture about one-quarter of the U.S. market by the end of 2019, announced CEO Kare Schultz on Tuesday.

“When the device’s approval was announced last year, analysts suggested it could add $250 million to Teva’s annual revenue and 4-6 cents per share in earnings, providing a welcome lift for a company that has fired thousands of employees and worked to reduce its debt load to $27 billion from $35 billion,” reported Reuters.

The EpiPen, short for epinephrine auto-injector, is a medical device that injects doses of adrenaline for those who have severe allergies.

Mylan, which was subjected to backlash for drastically increasing the price of its EpiPen a few years ago, also manufactures a generic version of the device that, like Teva’s, costs around $300.

The U.S. EpiPen market is valued at around $750 million annually.

After a several-year delay, Teva received U.S. approval for its EpiPen in August, but Schultz said more “validations” were mandated by the U.S. Food and Drug Administration, which it has completed.

Schultz added that although any pharmacy can acquire Teva’s products, the firm does not have a large enough supply for pharmacies and retailers.

“We will be filling up the supply chain more and more over the coming months,” said Schultz, who estimated that Teva’s product could capture 50 percent of market share by the end of next year.

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The decision, accompanied by the termination of operations in the pharmaceutical giant’s Netanya R&D center, marks one of the first major moves adopted by newly appointed CEO Kare Schultz.

By: Jack Ben-David

The Israeli pharmaceutical giant Teva is gearing up to cut half of its domestic workforce, leaving some 3,300 people out of work in a bid to remedy dire financial losses that have plagued the company in recent years.

In May, Teva reported huge losses of more than 18% in its second-quarter earnings, generating a dip in its share prices by 34.5% in less than a week.

The mass redundancy decision came after Teva’s board recently met to discuss plans that were already announced last May to pack up shop in 45 countries and sell multiple plants in 2017 and 2018.

The move is the first major decision taken by Kare Schultz who recently took over the reins at Teva as CEO to make the cuts required to keep the company on its feet.

The most drastic cuts by Schultz are expected to take place in the company’s headquarters in Petah Tikva, with 45% of workers––1,500 employees––to be laid off.

With the mas redundancies, the company––a hallmark of Israeli innovation––hopes to save approximately 50% of costs spent on administrative work.

In addition, operations in the firm’s R&D hub situated in Netanya will cease entirely, resulting in the eventual termination of all 350 employee contracts at the site.

Saddled with poor cash flow and low revenue caused by the loss of Copaxone patents, a drug used for treating multiple sclerosis, Schultz, with thirty years of experience in the industry, was brought in from Denmark’s Lundbeck to extricate the company from its financial straits to the tune of $2 million per year, plus bonuses.

Schultz appeared on Teva’s radar as an ideal candidate to steer its sinking ship and salvage its diminishing profits by ruthlessly cutting jobs and other overheads after he sacked almost 17% of Lundbeck employees.

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ISRAEL’S MEDICAL ACHIEVEMENTS

By Michael Ordman

Jerusalem displays Jewish-developed cholera vaccine

Dr. Waldemar Haffkine (sitting, center) worked mainly in India and developed vaccines against cholera and bubonic plague. (Credit: Haffkine Institute)

Dr. Waldemar Haffkine, a Russian-Jewish microbiologist, developed the cholera vaccine in 1892. Jerusalem’s Tower of David Museum is now exhibiting one of the original ampoules of vaccine. Dr. Haffkine also developed a vaccine for plague and was knighted by Queen Victoria in 1897. Sir Waldemar donated his extensive personal archive to the National Library of Israel.
https://www.timesofisrael.com/original-cholera-vaccine-turns-up-in-jerusalem/

ALS treatment trial shows success

Israel’s Brainstorm has announced positive final results from its phase 2a clinical trial of NurOwn cells in amyotrophic lateral sclerosis (ALS) patients used on 14 subjects at Hadassah Medical Center in Jerusalem. Nearly all subjects experienced clinical benefit.
https://www.brainstorm-cell.com/index.php/news-events/331-january-5-2015

Good results for Fabry Disease treatment

Israel’s Protalix Biotherepeutics reported good results in its trials of its PRX-102 treatment for the genetic disease Fabry’s. Even a low dosage had an average 78.8% decrease in the effect of pain on the patients’ functioning.
https://www.globes.co.il/en/article-protalix-jumps-on-positive-fabry-disease-trial-results-1000999518

Teva launches a generic painkiller

Israel’s Teva has launched the first FDA-approved generic equivalent to Celebrex (Celecoxib) Capsules in the US. Celebrex is used to treat arthritis, pain, menstrual cramps, and colonic polyps.
https://www.tevapharm.com/Media/News/Pages/2014/1996478.aspx

The fruitful way to conceive

Israel’s Fruitful Way Ltd. has pioneered a new, natural fertility and conception toolkit for couples who are trying to get pregnant. It includes a unique, science-backed dietary supplement, scientifically mated with a sophisticated fertility app.
https://www.fruitful4u.com/706

Israeli science saves 5-year-old girl

A 35-year-old study by Israel’s Professor Raphael Mechoulam convinced Denver-based physician Dr. Alan Shackelford to use synthesized cannabidiol or CBD to save 5-year-old Charlotte Figi who suffered 300 epileptic fits a week. Dr Shackelford immigrated to Israel in 2012.
https://www.greenprophet.com/2015/01/dr-cannabis-alan-shackelford-puts-medicine-into-cannabis-in-israel/

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