Senate Overwhelmingly Passes Bill to Address Prescription Opioids

The U.S. Senate overwhelmingly supported a new bill aimed at opioid abuse and other addictive drugs.

In a 99 to 1 vote, the Senate passed the bill that looks to cut down on the flow of illegal narcotics entering the United States through the mail, as well as taking aim at the abuse of prescription opioid medication – a problem that has grown to an epidemic in the United States. Among the measures the Senate bill does is provides a simpler approach for companies and organizations to research non-addictive pain treatments, according to the Associated Press.Additionally, the U.S. Food and Drug Administration (FDA) would be allowed to “require drugmakers to package smaller quantities of drugs like opioids,” the AP reported. Smaller quantities, which could be sold in three- and seven-day treatment packets, would hopefully cut down on the number of prescription drugs in circulation and reduce the chances of abuse.

Additionally, the bill provides funding through federal grants for treatment centers and for the training of emergency workers who would respond to potential overdose issues.

The AP noted that the U.S. House of Representatives passed its own legislation earlier this year that also attempts to address some of these same issues. The two chambers of Congress will now have to hash out the differences between the bills before voting on the combined package.

Opioid abuse has become a significant problem across the United States. Statistics provided by the U.S. Department of Health and Human Services indicate that approximately 116 Americans die daily from opioid overdoses. That same data showed that 11.5 million people in 2016 misused prescription opioids. Those statistics were based on 2016 numbers, the most recent data that department has compiled. Earlier this year the U.S. Centers for Disease Control and Prevention (CDC) released a report earlier this year that shows opioid-related emergency room visits spiked 30 percent across the states between July 2016 and September 2017. Midwestern states were particularly hard hit with spikes of 70 percent, the CDC report said.

The issues with opioid abuse have become so significant that the White House has weighed in on the matter several times. Last month, during a meeting with his Cabinet, President Donald Trump called on U.S. Attorney General Jeff Sessions to file lawsuits against certain drug manufacturers whose drugs have contributed to the opioid crisis. During that meeting, Trump highlighted some of the lawsuits states and municipalities have brought against a number of opioid drugmakers, including Purdue Pharma, Teva Pharmaceutical, Johnson & Johnson, Endo International, and Allergan. Certain distributors, like Wal-Mart, Walgreens and CVS have also been named in the lawsuits.

The U.S. Department of Justice has already gotten involved in the legal matters between state and local governments and opioid manufacturers. In April the Department of Justice filed a motion to participate in settlement discussions as a “friend of the court.” The friend of the court filing comes about a month after the DOJ formed a task force to target opioid manufacturers and distributors for the roles they have allegedly played in the increase of addiction across the country.

In May the FDA approved the first non-opioid treatment to manage withdrawal symptoms from opioid addiction. Kentucky-based US WorldMeds snagged the greenlight for Lucemyra (lofexidine hydrochloride) for the mitigation of opioid withdrawal symptoms in adults. Approval for the treatment was based on positive trial data that showed the medication significantly reduced the severity of withdrawal symptoms in comparison to placebo.

https://www.biospace.com/article/jc1n-senate-overwhelmingly-passes-bill-to-address-prescription-opioids/

Allergan and Sosei Halt Alzheimer’s Trial Over Safety Concerns

Allergan and its development partner Sosei Group have voluntarily suspended clinical trials of HTL0018318 in Alzheimer’s and other types of dementia because of safety problems.

HTL0018318 is a selective small molecule muscarinic M1 receptor agonist. It is being developed for cognitive issues in patients with Alzheimer’s disease and other dementias, including dementia with Lewy bodies.

The drug was in Phase I clinical trials in the United States, sponsored by Allergan, and in a Phase II clinical trials in Japan sponsored by Sosei. The trial in Japan was for patients with Lewy body dementia. An additional Phase Ib clinical trial in Alzheimer’s disease has finished in Europe and is currently being analyzed. That trial is sponsored by Sosei’s subsidiary Heptares Therapeutics.

The safety concerns arose in a single animal toxicology study in non-human primates. That study was evaluating different dosing levels of the drug over a nine-month period. A rare tumor was observed at doses and durations higher than those used clinically in humans to date. So far, the drug has been investigated in 310 humans in the U.S. and Europe, including health patients and patients with mild to moderate Alzheimer’s disease. In humans, the drug has been well-tolerated with no serious side effects at the tested doses for up to 28 days.

The companies have reported the safety issues to the U.S. Food and Drug Administration (FDA) and the Japan Pharmaceutical & Medical Devices Agency (PMDA). At this point, the companies’ scientists are reviewing all data accumulated so far.

As a result of these findings and the suspension of the trials, the start of a planned Phase II trial in Alzheimer’s and Lewy body dementia will be delayed by at least six months. Sosei notes that because of the delay, its revenue will be impacted next year because it doesn’t believe it will receive a major milestone payment from Allergan in 2019 related to the progress of the program.

The two companies entered the global research-and-development and commercialization partnership in April 2016 under a deal where Allergan licensed exclusive global rights to a portfolio of novel subtype-selective muscarinic receptor agonists. The deal was potentially worth $3.35 billion. Allergan paid $125 million up front and Heptares was eligible for milestone payments of up to $665 million linked to successful Phase I, II and III clinical development, as well as launch of the first three licensing compounds for multiple indications. There was an additional $2.5 billion tied to certain annual sales milestones for several years after launch. Heptares is also eligible for up to double-digit tiered royalties on net sales. Allergan also committed up to $50 million to R&D.

“We were very surprised to see these results given the safety profile HTL0018318 has exhibited across all previous animal and clinical studies,” said Tim Tasker, Sosei’s chief medical officer, in a statement. “We have taken these steps in the best interests of patient safety which is our number one priority. We are committed to working with clinical investigators, R&D teams and our regulatory authorities to understand better the reason for the findings from this animal toxicology study and so enable the human clinical development program with HTL0018318 to continue as soon as possible. We remain confident that this compound has the potential to deliver important benefits to patients with AD and DLB.”

https://www.biospace.com/article/-cp8r-allergan-and-sosei-halt-alzheimer-s-trial-over-safety-concerns/

Ligand rises after Viking’s study of VK2809 hits primary goal

Shares of Ligand Pharmaceuticals (LGND) are higher in early trading after Viking Therapeutics (VKTX) announced top-line results from a Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated low-density lipoprotein cholesterol, or LDL-C. The study successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo, Viking said. In May of 2014, the companies announced that Ligand licensed the rights to five programs to Viking. The drug candidates and programs covered by the license agreement included VK0612, VK5211, VK0214, a portfolio of orally available small molecule EPOR agonists for the potential treatment of anemia and a portfolio of orally available small molecule inhibitors of the enzyme DGAT-1 for the potential treatment of lipid disorders such as obesity and dyslipidemia. Also as part of that transaction, Ligand agreed to extend a $2.5M convertible loan facility to Viking that can be used to pay Viking’s operating and financing-related expenses. In early trading, shares of Viking Therapeutics have more than doubled to $21.57. Meanwhile, Ligand is up 6% to $268.62 per share.

https://thefly.com/landingPageNews.php?id=2792066

Citron Research calls Tilray news ‘promotional and misleading’

Citron Research just tweeted, “$tlry has now crossed to promotional and misleading They announce that they are supplying cannabis to an already arranged study that does not involve them tinyurl.com/y79y62pp. No collaboration Low float a promo is a dirty combo for.” Shares of Tilray are up 12%, or $14.74, to $134.93 in early trading. The company’s CEO is appearing tonight on Jim Cramer’s Mad Money show.
https://thefly.com/landingPageNews.php?id=2792089

Cannabis stocks in focus after Tilray gets DEA approval to import cannabis drug

Shares of cannabis stocks are in focus after Canadian marijuana producer Tilray (TLRY) announced approval by the U.S. Drug Enforcement Administration to import a cannabinoid study drug into the U.S. from Canada. DEA APPROVAL: On Tuesday, Tilray announced that the U.S. DEA has granted approval to import a cannabinoid study drug into the U.S. for a clinical trial at the University of California San Diego Center for Medicinal Cannabis Research examining its safety, tolerability and efficacy for Essential Tremor. Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol and tetrahydrocannabinol. The study is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation. Essential Tremor is a neurological movement disorder characterized by involuntary and rhythmic shaking. ‘PROMOTIONAL AND MISLEADING’: Following the announcement, short-seller Citron Research tweeted, “$tlry has now crossed to promotional and misleading They announce that they are supplying cannabis to an already arranged study that does not involve them. No collaboration Low float a promo is a dirty combo for.” The tweet comes after Citron announced a short position in Tilray on September 4 via Twitter, saying, “Citron LOVED $TLRY at $26 but now we are SHORTING stock. Cowen lowered est and still raised tgt $62 only shows “RETAIL INVESTORS GONE MAD” and forgot $TLRY went public at $17 – 6 weeks ago. We would expect an equity raise at these levels. By far most expensive in space.” Citron also issued a report on September 12, which said, “Since August 15, US marijuana stocks Tilray and Cronos (CRON) have significantly outpaced the performance of their Canadian traded peers. Due to federal regulation, US listed stocks cannot have any operations in the US without losing their listings, whereas Canadian listed stocks can have US operations. The US will be the largest cannabis market in the world. Today, the California market is over 5x larger than all of Canada. Despite obvious logic, we’ve seen US retail investors pile into the US listed marijuana stocks…Lastly, over the past week Citron has received hundreds of emails from investors ranging from anti-Semitic to threats on family, but NOT one of them could justify the price increases with any analysis whatsoever. We have been publishing for 17 years and this is generally a sign of a retail bubble.” WHAT’S NOTABLE: On Monday, Bloomberg reported that Coca-Cola (KO) is monitoring the nascent cannabis drinks industry and is in talks with Canadian marijuana producer Aurora Cannabis (ACBFF) to develop the drinks. Aurora Cannabis announced Tuesday it responded to a request from the Investment Industry Regulatory Organization of Canada regarding reports on potential partnerships with beverage companies. “The company’s policy is not to comment on speculative media reports. The company does confirm that it engages in exploratory discussions with industry participants from time to time. At this time the company confirms there is no agreement, understanding or arrangement with respect to any partnership with a beverage company,” the company said. CANNABIS STOCKS: Publicly-traded companies in the space include Cronos Group, Canopy Growth (CGC), Tilray, Cannabis Science (CBIS), Innovative Industrial Properties (IIPR) and Aurora Cannabis. PRICE ACTION: Tilray surged roughly 20% to $144.55 in morning trading.

https://thefly.com/landingPageNews.php?id=2792114

Teva Has Early Results of Debt Tender Offer; Elects Early Settlement

Teva Pharmaceutical Industries Limited (NYSE: TEVA) announced today the early tender results in connection with its previously announced tender offers (the “Offers”) to purchase for cash for a combined aggregate purchase price (exclusive of accrued and unpaid interest) of up to $400 million (the “Maximum Amount”) a portion of the following series of notes issued by finance subsidiaries of Teva and guaranteed by Teva:

• 1.700% Senior Notes due 2019, CUSIP 88167A AB7 / ISIN US88167AAB70, issued by Teva Pharmaceutical Finance Netherlands III B.V. (the “Priority 1 Notes”);
• 0.375% Senior Notes due 2020, ISIN XS1439749109, issued by Teva Pharmaceutical Finance Netherlands II B.V. (the “Priority 2 Notes”), and
• 2.250% Senior Notes due 2020, CUSIP 88166H AD9 / ISIN US88166HAD98, issued by Teva Pharmaceutical Finance IV, LLC (the “Priority 3 Notes” and together with the Priority 1 Notes and Priority 2 Notes, the “Notes”).

Teva is engaging in the Offers to reduce its total debt and decrease its overall interest expense. Teva expects to fund the Offers with available cash on hand.

Subject to the terms and conditions of the Offers, Teva expects that it will accept for purchase Notes validly tendered and not validly withdrawn at or prior to the Early Tender Time for a combined aggregate purchase price (exclusive of accrued and unpaid interest) equal to the Maximum Amount. The settlement for the Notes accepted by Teva in connection with the Early Tender Time is expected to take place on Thursday, September 20, 2018 (the “Settlement Date”). The amount of each series of Notes that is to be purchased on the Settlement Date will be determined in accordance with the acceptance priority levels and the proration procedures described in the Offer to Purchase, dated September 4, 2018 (the “Offer to Purchase”), subject in each case to the Maximum Amount and the applicable Tender Cap. It is expected that Priority 1 Notes will be subject to a proration factor of approximately 50% and Priority 2 Notes will be subject to a proration factor of approximately 21%. The Company will purchase approximately $300 million aggregate principal amount of the Priority 1 Notes and approximately €89.8 million aggregate principal amount of the Priority 2 Notes. No Priority 3 Notes will be purchased pursuant to the Offers. Payments for Notes purchased will include accrued and unpaid interest from and including the last interest payment date applicable to the relevant series of Notes up to, but not including, the Settlement Date.

The Withdrawal Deadline has passed and has not been extended. Notes tendered pursuant to the Offers may no longer be withdrawn, except as required by law.

The Offers will expire at 11:59 p.m., New York City time, on October 1, 2018, unless extended or earlier terminated (as it may be extended or earlier terminated, the “Expiration Time”). However, as Teva intends, subject to the terms and conditions of the Offers, to accept for purchase the Maximum Amount on the Settlement Date, further tenders of Notes prior to the Expiration Time will not be accepted for purchase.

https://www.biospace.com/article/releases/teva-announces-early-results-of-debt-tender-offer-and-election-of-early-settlement/

Thermo Fisher Scientific Expands Genome Editing IP Portfolio

Thermo Fisher Scientific, Inc., the world leader in serving science, has licensed CRISPR technologies from the Broad Institute and ERS Genomics (foundational University of California IP) to bolster its genome editing intellectual property (IP) portfolio. Under the terms of the licenses, Thermo Fisher is granted global non-exclusive rights to products, tools and services for research.

“As one of the most enabling technology platforms in the life sciences today, genome editing holds the promise to further unravel the function of DNA elements and genes and to set in motion the development of new drugs and therapies, including cell therapies,” said Helge Bastian, vice president and general manager of synthetic biology at Thermo Fisher. “These licenses expand our industry-leading genome editing capabilities and demonstrate our continued commitment to enabling our customers to unleash the technology’s full potential in their research programs.”

When combined with previous licenses from ToolGen, Inc., Thermo Fisher now holds one of the most complete CRISPR IP portfolios. This supports an industry-leading CRISPR product line that includes Invitrogen TrueCut Cas9 Protein v2.0, Invitrogen TrueGuide Synthetic gRNAs and Invitrogen LentiArray CRISPR Libraries.

In addition to its CRISPR IP portfolio, Thermo Fisher also holds exclusive rights to the Tal Effector Nuclease (TALEN) IP portfolio. The powerful TALEN genome editing technology complements CRISPR, enabling Thermo Fisher to provide a wide selection of product and service solutions to help customers advance their research programs.

“The combination of CRISPR and TALEN technologies provides a complete genome editing toolbox that moves researchers closer to the promise of delivering on the potential of synthetic biology,” said Jon Chesnut, Thermo Fisher’s senior director of R&D for synthetic biology.

For more information on Thermo Fisher’s Genome Editing products and services please visit: www.thermofisher.com/genomeediting

https://www.biospace.com/article/releases/thermo-fisher-scientific-expands-genome-editing-ip-portfolio/