Orexo wins opioid drug appeal against Teva

A U.S. appeals court on Monday revived Swedish pharmaceutical company Orexo AB’s lawsuit accusing a unit of Israel’s Teva Pharmaceutical Industries Ltd of infringing a patent for its opioid addiction drug Zubsolv.

Shares of Orexo closed 30.9 percent higher in Stockholm after the decision by the U.S. Federal Circuit Court of Appeals in Washington, D.C., which handles intellectual property cases. Teva is one of the world’s largest makers of generic drugs.

Lawyers for Orexo and Teva’s Actavis Elizabeth unit did not immediately respond to requests for comment.

Opioids, including prescription painkillers and heroin, played a role in 42,249 U.S. deaths in 2016 according to the U.S. Centers for Disease Control and Prevention.

Health officials and politicians often characterize opioid abuse as a serious public health problem or epidemic.

Orexo sued after the Teva unit applied with the U.S. Food and Drug Administration to market a generic version of Zubsolv.

While both sides agreed that the product covered by Orexo’s patent made it easier to treat opioid abuse, a lower court judge found the patent unenforceable because the ingredients were generally known or easily determined.

But the appeals court said the Teva unit failed to establish by “clear and convincing evidence” that Orexo’s patent claims were “obvious” and should therefore be voided.

Circuit Judge Pauline Newman said Orexo’s patent provided a “significant improvement” for treating opioid addiction, and that its “novel formulation” allowed patients to reduce dosages and lower dependency.

“Although the need to reduce this abuse was known, recognizing a need does not render the solution obvious,” Newman wrote.

The appeals court returned Orexo’s case to U.S. District Judge Sue Robinson in Delaware for further proceedings.

The case is Orexo AB et al v Actavis Elizabeth LLC, U.S. Federal Circuit Court of Appeals, No. 2017-1333.

https://www.reuters.com/article/us-teva-orexo-zubsolv/orexo-soars-after-winning-opioid-drug-appeal-against-teva-idUSKCN1LQ290

Infectious Theory of Alzheimer’s Disease Gets Some Attention with $1 Million Prize

The predominant theory behind the causes of Alzheimer’s disease is related to the accumulation of a type of protein in the brain of patients called beta-amyloid. This theory has come under criticism lately, largely due to the lack of success of a number of drugs that prevent or clear beta-amyloid in late-stage clinical trials. Later in the disease, another tangle of a different type of protein, tau, shows up in the disease.

Over the last 20 years or so, a theory circles around that the instigating factor in Alzheimer’s disease might be an infectious agent. And it’s back. A recent article on National Public Radiolooks at this theory and profiles a man who is offering $1 million of his own money to researchers who can provide good data proving it.

Leslie Norins is a medical publisher and editor who received his medical degree from Duke University Medical School and his PhD from the University of Melbourne in Australia, where he focused on immunology. He spent seven years running a laboratory at the U.S. Centers for Disease Control and Prevention (CDC) before going into medical publishing.
He is the founder and president of Alzheimer’s Germ Quest, Inc., a public benefit corporation formed in 2017 to “accelerate research on possible infectious causes of Alzheimer’s disease.”

In 2014, Norins became interested in the possible link between infectious diseases and Alzheimer’s and made a two-year review of the scientific literature on the subject. He thought he found a pattern. He told NPR, “It appeared that many of the reported characteristics of Alzheimer’s disease were compatible with an infectious process. I thought for sure this must have already been investigated, because millions and millions of dollars have been spent on Alzheimer’s research.”

There has been research, but it has not been a large focus. In a 2018 article in the Journal of Alzheimer’s Disease by Aristo Vojdani, chief executive officer of Immunosciences Lab in Los Angeles and a faculty member at Loma Linda University, with his colleagues, wrote, “As early as the 1980s, molecular virologist, Ruth Itzhaki began to investigate if there was a causal connection between infections and neurodegenerative disorder. Although the theory has yet to be universally embraced, in 2017 Itzhaki and 33 other scientists from all over the world published a review article in this very journal presenting evidence for the causal role of pathogens in Alzheimer’s disease (AD).”

After his review of the literature, Norins is convinced that a single infectious agent, which hasn’t been specified or possibly even discovered, causes Alzheimer’s disease, which for his purposes he’s dubbed the “Alzheimer’s Germ.”

One example of supporting work is a study published in Neuron in June suggesting that viral infection influences Alzheimer’s disease progression. Researchers from the Icahn School of Medicine at Mount Sinai evaluated data on the brains of 622 people who had indications of Alzheimer’s and 322 people who did not. They found levels of herpes virus in the Alzheimer’s patients that were up to twice as high as the non-disease group.

Joel Dudley, co-author of the study, said in a statement in June, “I don’t think we can answer whether herpes viruses are a primary cause of Alzheimer’s disease. But what’s clear is that they’re perturbing networks and participating in networks that directly accelerate the brain towards the Alzheimer’s topology.”

Dudley told CNN, “The title of the talk that I usually give is, ‘I Went Looking for Drug Targets, and All I Found Were These Lousy Viruses.’”

He suspects the study results could assist in identifying virus biomarkers that might help diagnose Alzheimer’s and assess an individual’s risk for the disease.

“This is the most compelling evidence ever presented that points to a viral contribution to the cause or progression of Alzheimer’s,” said co-author Sam Gandy, professor of neurology and psychiatry and director of the Center for Cognitive Health at Mount Sinai in New York, reports CNN.

In response to Dudley’s article, Keith Fargo, director of scientific programs and outreach for the Alzheimer’s Association, noted that much more work would need to be done to prove a connection between herpes viruses and Alzheimer’s. “However, if viruses or other infections are confirmed to have roles in Alzheimer’s, it may enable researchers to find new antiviral or immune therapies to treat or prevent the disease. The Alzheimer’s Association welcomes new ideas in the Alzheimer’s field and new avenues to pursue for potential treatments and prevention strategies.”

And although Norins $1 million award is eye-opening, it’s a drop in the bucket compared to the $2 billion the National Institutes of Health (NIH) spends on amyloid and tau research.

James Burke, professor of medicine and psychiatry at Duke University’s Alzheimer’s Disease Research Center, told NPR he wasn’t willing to abandon the amyloid theory completely, but said, “There may be many roads to developing Alzheimer’s disease and it would be shortsighted to focus just on amyloid and tau. A million-dollar prize is attention-getting but the reward for identifying a treatable target to delay or prevent Alzheimer’s disease is invaluable.”

https://www.biospace.com/article/infectious-theory-of-alzheimer-s-disease-receives-some-attention-with-1-million-prize/

New FDA Guidelines Could Limit the Reach of Bulk Compounded Drugs

When Martin Shkreli raised the price of toxoplasmosis drug Daraprim by 5,000 percent, a San Diego-based Imprimis Pharmaceuticals began to offer a compound of pyrimethamine and leucovorin as a low-cost alternative – about $1 per pill compared to the new price of $750 per pill.

Imprimis has a history of offering low-cost options to high-priced drugs through its compounded formulas. In addition to its Daraprim option, Imprimis has developed tiopronin delayed release compounded formulations as a lower-cost alternative to the orphan drug Thiola, used for the treatment of cystinuria. Imprimis has also offered a compounded alternative to Allergan’s Restasis eye drop.

Other companies have also offered compounded versions of high-priced drugs. Buffalo, N.Y.-based Athenex began to offer a compounded version of the blood pressure treatment, Vasostrict.

The Wall Street Journal reported that Athenex intended to sell the treatment for 35 percent less than the branded treatment. UK Healthcare, which is the University of Kentucky’s associated hospitals and clinics, struck a deal with Athenex for the compounded blood-pressure treatment in order to save about $350,000 per year, the Journal said.

Colorado-based Osh’s Affordable Pharmaceuticals is offering a compounded version of Syprine, a treatment for Wilson disease, the Journal reported. The Osh’s version will be significantly cheaper than the branded treatment, which is sold for about $21,000 per month. A generic marketed by Teva is sold for $18,000 per month, the Journal said. The Osh’s version will have a cost of about $120, the Journal said.

Other companies are also taking a look at providing compounded versions of drugs, the Journalsaid. However, last week, new guidelines put forth by the U.S. Food and Drug Administration (FDA) would hinder the notion of compounded drugs being sold due to price increases. The new guidelines will address the limits of compounded drugs that can be shipped across state lines.

In its announcement, the FDA said it is addressing concerns over compounded medications that are of “poor quality” and could cause harm to patients. While the FDA pointed to some concerns over safety, the new guidelines will undercut some of the actions of the compounding companies that are related to pricing. The new guidelines will allow for the compounding of drugs when there is a shortage of medication or if there is a special need, but, as the Journalreported, providing alternatives due to the cost of branded drugs is not a valid reason.

The new FDA guidelines regarding compounders are looking at those companies that provide large amounts of compounded medications to health agencies. The FDA said it will address its guidelines because compounded drugs “can pose unique risks.”

“They’re not FDA approved. Nor do compounded drugs undergo premarket review for safety, effectiveness or quality. Moreover, if a compounder distributes drugs to multiple states, it can be very difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem,” the FDA said in a statement.

The regulatory agency pointed to a 2012 outbreak of fungal meningitis that was related to a compounded drug. The FDA said the outbreak led to 64 deaths and about 750 cases of fungal meningitis. The FDA said the compounded drug used was not sterile. It had become contaminated before distribution to patients and providers, the FDA said.

https://www.biospace.com/article/new-fda-guidelines-could-limit-the-reach-of-bulk-compounded-drugs/

In phishing attack on prospective IPO company, another worry for biotech

Hackers obtained personal information for some 1,100 people through an email account of an employee of a growing Peninsula biotech company.

The phishing incident in July was revealed Thursday by Guardant Health Inc. in its filing for a $100 million initial public offering, and it showcases the vulnerability of health care companies, including biotech companies, hospitals and others that hold personal and precious health and financial data on millions of people.

In the attack on Redwood City-based Guardant, which builds so-called “liquid biopsy” tests that can detect cancer from a simple blood draw, hackers over a five-day period in July got access to data, including “protected health information,” for about 1,100 people. The stolen information included patients’ names, contact information, birth dates, medical diagnosis codes and — in “a very limited number of cases,” the company said in its IPO filing — Social Security numbers.

A company spokesman said in an email Monday morning to the San Francisco Business Times that the incident remains under investigation and “we can’t comment further at this time.”

Guardant plans to provide “timely notices” of the attack to the U.S. Department of Health and Human Services, certain state regulators and patients. But the company did not say in its filing when it will tell cancer patients that their personal information was compromised.

Guardant said it hired an unidentified cybersecurity firm to conduct an investigation.

“We continue to analyze the information that was accessed and intend to take additional steps to prevent future unauthorized access to our system and the data we maintain,” the company said in its IPO filing, “but we cannot guarantee that additional incidents will be avoided.”

Phishing typically occurs when an electronic communication tries to get someone to open an infected file or link that uploads malware that opens a door to the employer’s computer system.

Guardant’s breach could have financial implications at a critical time when various companies are staking out space in the liquid biopsy field. Those companies are developing tests to identify cancer so doctors can adjust the treatment regimen of current cancer patients and working on tests that, eventually, could detect cancer even before symptoms appear.

Besides Guardant, those companies include Roche-owned Foundation Medicine Inc., Menlo Park-based Grail Inc., San Carlos’ Natera Inc. (NASDAQ: NTRA) and giant Illumina Inc. (NASDAQ: ILMN).

Investors have pumped billions of dollars into a liquid biopsy quest that faces all the same risks of drug and medical device development: cash, scientific, clinical trial, regulatory and data security.

To be sure, Guardant isn’t alone when it comes to phishing attacks. Cybersecurity experts and others in the biotech industry say that virtually all health care providers, including those that compile clinical trial data, face such attacks.

The breadth and depth of the information those companies collect makes them targets. Guardant, for example, collects health data as well as credit card and other financial information. It stores it in a combination of on-site systems and cloud-based data centers.

The company, led by CEO Helmy Eltoukhy and President AmirAli Talasaz, uses external security and infrastructure vendors to manage parts of its data centers, the company said in its SEC filing.

A report earlier this year by Verizon found 750 data breaches, including 536 where data disclosure was confirmed. Most of those breaches were internal and the result of miscellaneous errors, crimewave and misuse of privileged access to data, the study found, with financial gain as the largest motive. In 79 percent of cases, medical data was compromised, personal data in 37 percent and payment data in 4 percent.

The broad attacks, however, don’t make them any less costly.

Violations of the federal Health Insurance Portability and Accountability Act, or HIPAA, for example, can lead to civil fines of up to $55,910 per violation, not exceeding $1.68 million per calendar year, and criminal penalties of up to $250,000 per violation and/or imprisonment.

California’s patient privacy laws outline penalties for violations of up to $250,000 and could open the company to individual lawsuits.

Guardant, which has raised $550 million in its six years and has nearly 350 employees, has introduced two liquid biopsy tests for advanced stage cancer. Its four-year-old Guardant360 test, with a list price of $7,800, has been ordered 70,000 times and used by more than 5,000 oncologists, sold to more than 40 biopharmaceutical companies and all 27 National Comprehensive Cancer Network centers.

https://www.bizjournals.com/sanfrancisco/news/2018/09/10/phishing-biotech-guardant-health-ipo-liquid-biopsy.html

Chinese pharma heavy Hansoh joins fledgling biotechs in Hong Kong IPO line

More than four months after first opening its doors to a big crowd of R&D focused biotechs, the Hong Kong Stock Exchange has seen a special guest walk in: A storied company running a profitable innovative and generic drug business in China.

Jiangsu Hansoh is filing for an IPO two years after rumors of a $3 billion public debut first surfaced. It was founded and still run by Huijuan Zhong, one half of a power couple towering over China’s pharma industry. Her husband, Piaoyang Sun, is the head of Jiangsu Hengrui Medicine, internationally known for a PD-1 drug Incyte paid millions to partner with.
Zhong currently holds a controlling stake in the company — 78% — through a vertical line of entities, while Cen Junda of Apex Medical claims 19%. Hillhouse Capital is in for 3% based on a 2016 investment.

In the 20-plus years since Zhong first created the company, she has built an integrated R&D and manufacturing operation with commercial drugs in six therapeutic areas — central nervous system, oncology, antibiotics, diabetes, gastrointestinal and cardiovascular. In 2017, Hansoh booked around $900 million (RMB $6185.5 million) in revenue.

Two key contributors to that figure are its generic olanzapine tablets — sold as a treatment of schizophrenia and bipolar disorder — and copycat version of chemotherapy drug pemetrexed.

While this kind of first-to-market generic will remain a core focus for Hansoh as a public company, it also has an ambitious plan for the novel compounds in its giant pipeline, which totals “nearly 100 drug candidates.”

In its application, Hansoh spotlighted four of these among the 30 assets it’s looking to launch between now and 2020: HS-10296, an EGFR tyrosine kinase inhibitor for non-small cell lung cancer; flumatinib mesylate, which attempts to treat chronic myelogenous leukemia by targeting the Bcr-Abl gene; hepatitis B drug HS-10234; and a long-acting GLP-1 therapy dubbed polyethylene glycol loxenatide.

https://endpts.com/chinese-pharma-powerhouse-hansoh-joins-fledgling-biotechs-in-the-hong-kong-ipo-line/

7 reasons why Big Tobacco is likely to move into the marijuana industry

The next catalyst for marijuana investors may come from an obvious place: Big Tobacco.

While alcoholic-beverage companies have been active in the marijuana industry, Big Tobacco curiously has not.

But new comments made by an Altria MO, -0.50% executive show that the company is evaluating opportunities in marijuana. Altria owns Phillip Morris USA, which makes Marlboro cigarettes. Before digging deeper into the logic of cigarette companies getting into marijuana, let’s review marijuana stocks with the help of a chart.

Chart

Please click here for an annotated chart of marijuana stock Canopy GrowthCGC, +2.17% Please note the following:

• The chart shows the sell signal given by The Arora Report in June right at the prior peak. Subsequently the stock lost more than one-third of its value.

• The chart shows The Arora Report signal to buy Canopy Growth. When The Arora Report gives a buy signal, it simultaneously gives a target zone and a stop zone.

• The chart shows when Constellation Brands STZ, +0.22% known for its Corona beer, invested about $4 billion in the company, paying a whopping premium of 51%.

• Just prior to the Constellation Brands investment news, Canopy Growth was well on its way to lose one-half of its value from the peak because it reported earnings below the consensus and significantly below the whisper numbers. Stocks move based on the difference between reported earnings and projections compared to the whisper numbers.

• The start of an “up” move in a stock on heavy volume is considered positive. The chart shows that there was heavy volume when the present up move started.

Ask Arora: Nigam Arora answers your questions about investing in stocks, ETFs, bonds, gold and silver, oil and currencies. Have a question? Send it to Nigam Arora.

• The chart shows when Canopy Growth stock reached the price that Constellation Brands paid. The chart shows a red candle at that time, indicating that sellers were coming in. This was perfectly reasonable behavior on the part of the sellers because, under normal circumstances, the stock would have likely pulled back.

• The chart shows that after the red candle, rumors of more deals in the marijuana industry started. Those rumors moved the entire marijuana sector, including marijuana ETF MJ, +3.07% Tilray TLRY, +14.35% Neptune TechnologiesNEPT, -4.15% Aurora Cannabis ACBFF, +1.46% Aphria APHQF, +5.80% and Cronos Group CRON, +1.25%

• Subsequently, rumors gained credibility on the news that Diageo DEO, +0.71%the maker of Smirnoff and Johnnie Walker, was in talks with at least three Canadian cannabis companies.

• The chart shows the Arora signal to take more partial profits and to raise stops to protect the remaining profits right at the peak of the rumors. Afterward, a shallow pullback occurred. In highly volatile stocks, it is common for unrealized profits to turn into losses. For this reason, the trade-management guidelines that are provided to The Arora Report subscribers call for taking partial profits, usually in small tranches at appropriate times and raising stops. In practice, there are more nuances and more complexities that investors need to learn to consistently make profits than the simple foregoing statement. The foregoing statement is kept simple for the sake of readability.

• A short squeeze occurs when short-sellers feel compelled to buy a stock to cover their shorts. A short squeeze temporarily causes an exaggerated move to the upside. Anticipating such a short squeeze, the chart shows the Arora buy signal to add for super-aggressive investors. The chart shows that a short squeeze did in fact occur.

• A technique that consistently adds to profits is to take advantage of a short squeeze to take partial profits. This is exactly what we did as shown on the chart.

• The chart shows falling volume after the rise. This is a slight negative, indicating that those motivated by FOMO (fear of missing out) may have already bought the stock.

• The chart shows that the relative strength index (RSI) has diverged. In plain English, it means that while the price of Canopy Growth stock continued to go higher, RSI was going lower. This is normally a sell signal for the short term. Such RSI signals work well in the short term when combined with segmented money flows. However, such signals often mislead investors into selling early when used alone or in strongly trending stocks that have not gone parabolic. Segmented money flows provide investors a significant edge. To learn more about segmented money flows, please see “11 marijuana stocks’ money flows show which are investor favorites.”

Mixing tobacco with marijuana

Here are the seven reasons why tobacco companies such as Altria, Phillip Morris International PM, -0.02% British American Tobacco BTI, -0.32% Turning Point Brands TPB, +5.72% Alliance One AOI, +0.58% Universal Corp. UVV, -0.67%Vector Group VGR, -0.16% and Imperial Brands ( IMBBY, +0.89% are likely to get into the marijuana business in a big way.

1. In many ways, the marijuana business is complementary to their existing tobacco business.

2. Cigarette companies are facing declining sales, and they are looking for growth levers. Marijuana is likely to see explosive growth over the coming years.

3. Even supposedly lower-risk tobacco products are beginning to increasingly come under attack for their health risks. In contrast, sentiment is building about the benefits of cannabis, and risks of cannabis are falling in the background.

4. Tobacco companies are rich, and they have the money to get into the cannabis industry.

5. Not too far in the distant future, branding will become a big part of the success in cannabis. Tobacco companies already know how to develop successful brands.

6. Tobacco companies already have huge distribution networks. They can easily add cannabis to those networks down the road. Right now, regulations are not likely to allow this, but tobacco companies are experts at lobbying.

7. Marijuana companies have to deal with a maze of regulations. Tobacco companies are already experts at handling regulations.

What to do now

Tobacco companies will likely provide a big step for marijuana investors to make multimillions. However, investors will need to be patient and be tuned to sources that can alert them early. Further, investors need to be careful with marijuana stocks because of their high valuations and high volatility. Investors will need expert guidance. Without expert guidance, it will likely be easier to lose money in marijuana stocks than make money.

Even with expert guidance, marijuana stocks are not a get-rich-quick proposition. This will not be a straight line up. There will be ups and downs even with expert guidance.

One technique that investors can consider is trade-around positions. In this technique, investors slowly build a core quantity when stock prices become attractive for the long term and then trade around the core position in shorter time frames. Proper diversification will also be important. Learning how to properly size positions will be essential.

In a nutshell, it will take knowledge, discipline and lots of patience on the part of investors to be successful in marijuana investing.

https://www.marketwatch.com/story/seven-reasons-why-big-tobacco-is-likely-to-make-a-move-on-the-marijuana-industry-2018-09-10?siteid=yhoof2&yptr=yahoo

Teva Canada announces launch of generic version of Abilify

Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries, announces that the complete line of Teva-Aripiprazole, a Health Canada approved, bioequivalent generic version of Abilify is now available in Canada. This once-daily extended release prescription medication is indicated for the treatment of schizophrenia in adolescents 15-17 years of age and adults 18 years of age or older. Aripiprazole tablets had annual sales of approximately $182M in Canada, based on IQVIA sales data as of July 2018. Teva-Aripiprazole is available immediately to pharmacies across Canada. This launch broadens Teva Canada’s portfolio of medicines that treat mental health conditions to 28, including seven in the same therapeutic class as Teva-Aripiprazole, all of which provide patients and payors with a full spectrum of affordable treatment options.
https://thefly.com/landingPageNews.php?id=2788101