SIGA Technologies in $629m contract with BARDA for smallpox drug stockpiling

Siga signed a multiyear contract with BARDA for the delivery of oral and IV formulations of TPOXX to the Strategic National Stockpile.

Biomedical Advanced Research and Development Authority (BARDA) and Siga Techsigned a contract valued at roughly $629m (535m).

TPOXX is Sigas antiviral, approved by the US Food and Drug Administration (FDA) in July of 2018, for the treatment of smallpox to mitigate the impact of a potential outbreak.

Per the contract, Siga will develop intravenous (IV) formulation of the drug and make post-marketing advances of the oral treatment. The agreement states that Siga will deliver 1.7m courses of treatment to the stockpile after development, with 212,000 courses of IV treatment and the rest of the order made up of oral treatments.

The contract consists of a five-year base pay and a total contract period of up to ten years. Base period activities of the contract are valued at roughly $52m but, if all options of the contract are exercised, the deal could be worth a total $629m.

BARDA is a division of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.

The contract is to supply TPOXX, tecovirimat, in different formulations for the Strategic National Stockpile, which holds pharmaceuticals and supplies in case of a public health emergency, should local supplies run out.

Phil Gomez, CEO of Siga, told us that one of the objectives of the contract is to sustain the stockpile that currently holds 1.7m courses after the courses currently held expire.

Siga is still in late-stage development of an IV formulation of TPOXX, which will provide a treatment option for patients who may be too sick to take an oral formulation of the drug, according to the company.

https://www.marketscreener.com/SIGA-TECHNOLOGIES-INC-10830/news/SIGA-Technologies-signs-629m-contract-with-BARDA-for-smallpox-drug-stockpiling-27301937/

Pot company CEO expects American market to open up

The head of a big publicly traded pot company said he’s preparing for potential changes that will make his products available in America.

Cannabis is still illegal in the United States under federal law, even though a number of states have legalized marijuana. But Bruce Linton, the co-founder and CEO of Canopy Growth (CGC), told CNN’s Julia Chatterley on the First Move show Friday that he thinks some of the laws prohibiting marijuana could soon be relaxed.

“Republicans have had a strong history of supporting state rights,” Linton told Chatterley.

Linton said he believes federal regulators could decide it’s okay for pot to be legal in states like California and Massachusetts that have already approved the sale and possession of small amounts of marijuana. They could leave in place a broader federal ban.

“If they did that, it would be good for me,” Linton said.

Content by University at Buffalo

Superbug Sleuths

UB researchers are on the trail of a deadly pathogen.

Pot’s illegality hasn’t stopped American companies from getting involved in the business.

Shares of Canopy Growth have soared since Corona owner Constellation Brands said last month it was spending $4 billion to boost its stake in the company.

Constellation (STZ) first invested in Canopy Growth last year, when it bought a 10% stake The company upped its holding in Canopy last month to 38%, and it has the option to purchase a majority controlling share of more than 50%. The two companies plan on developing cannabis-based beverages for countries where that is legal.

Canopy is one of several pot stocks that have been on a tear in the past few months. Tilray(TLRY) and Cronos (CRON) have both surged because investors are betting on a big boost in sales as Canada’s legalization of recreational marijuana draws closer.

Shares of tiny New Age Beverages (NBEV), a maker of trendy Kombucha drinks, has soared more than 300% in the past five days — including an 80% pop Thursday — after the company said last month it would debut CBD infused drinks. CBD is cannabidiol, a non-psychoactive component of cannabis.

Even DavidsTea (DTEA) — a Montreal-based company — has gotten caught up in the pot frenzy. Shares surged 12% Thursday on speculation that it could make a play for the marijuana market.

But New Age Beverages, DavidsTea and Tilray plunged Friday as some investors fear that the pot stock craze could be a bubble. Canopy and Cronos also took a hit Friday.

Still, more big beverage companies — and even drug makers — may invest in cannabis as a result of the Constellation-Canopy deal. That could make the pot stocks a better long-term bet.

Tilray’s CEO suggested on CNBC that cannabis made sense as a hedge for beverage makers and pharmaceutical firms. Another Canadian pot company, Aurora Cannabis (ACBFF), has surged this week on speculation it could do a deal with Coca-Cola (KO).

Canopy’s Linton agreed the major drug companies and beverage producers must have a cannabis strategy. He argued these industries can’t ignore pot, and Constellation is ahead of the curve.

But he warned that the United States is “still a no fly zone” for marijuana sales as long as it remains federally illegal.

https://money.cnn.com/2018/09/21/news/companies/canopy-growth-ceo-cannabis-marijuana/index.html

S&P’s Big Sector Shakeup, Explained

Standard & Poor’s and Morgan Stanley Capital International are reclassifying the companies that constitute the S&P 500 Index for the first time since 1999. What makes the change more interesting is that it shifts the balance of the index.

The new communication services sector will come into being Friday after the market close, replacing the telecom services sector.

The MSCI plans to enact the changeover Dec. 3.

For the uninitiated, S&P’s Global Industry Classification Standard currently classifies S&P 500 companies into 11 industry groups, with tech, financials, health care, consumer discretionary and industrial sectors among the heavily weighted. The weightings of these sectors are roughly 25.8 percent, 14.7 percent, 13.7 percent, 12.9 percent and 9.9 percent, respectively.

The telecom services sector accounted for only 1.8 percent of the index.

Company Moves

The new communication services sector will draw about half of the companies from the tech sector, while the remaining half will comprise media and telecom companies such as Netflix, Inc. NFLX 1.14%, Comcast Corporation CMCSA 0.24%, CBS Corporation CBS 0.04%and AT&T Inc. T 1.38%.

Tech stalwarts such as Alphabet Inc GOOGL 1.63% GOOG 1.75% and Facebook, Inc. FB 1.86% will defect to communication services.

Consumer discretionary will now be an Amazon.com, Inc. AMZN 1.51%-dominant group. The online retail behemoth is likely to account for 35 percent of the group’s weighting as opposed to its current 28 percent.

Apple Inc. AAPL 1.08% is likely to dominate the tech sector, accounting for roughly one-fifth of the sector’s weighting, as Facebook and Google parent Alphabet switch allegiance to S&P’s new class. The sector will be dominated by chipmakers, hardware and software companies.

New Kid In Town

The communication services group will have a market capitalization of $2.8 trillion, according to market cap data compiled by Barron’s as of Aug. 29. The weightings of major additions to the new group are as follows:

• Alphabet: 31.5 percent
• Facebook: 18.3 percent
• AT&T: 8.4 percent
• Verizon Communications Inc. VZ 0.91%: 8.1 percent
• Comcast: 6.1 percent
• Disney: 6 percent
• Netflix: 5.8 percent

The FANG group sans Amazon will account for about 55 percent of the new group’s weighting, making it top-heavy.

What It Means For Investors

The communication services sector will now be the fourth-biggest sectoral class after IT, health care and financials.

Investors may soon have to adjust their portfolios to account for the sector changeover, and funds that track the S&P 500 sectors are expected to undergo the most shifts.

In March, Vanguard said it is creating custom benchmarks for three sector funds — the Vanguard Consumer Discretionary Index Fund, the Vanguard Information Technology Index Fund and the Vanguard Telecommunication Services Index Fund — and their corresponding ETF shares in response to the GICS changes.

https://www.benzinga.com/news/18/09/12389592/from-facebook-to-netflix-the-s-ps-big-sector-shakeup-explained

Loblaw unit gets medical marijuana license from Health Canada

Loblaw Cos Ltd’s drugstore chain on Friday received approval from Health Canada to be a licensed producer of cannabis for medical purposes.

“As trusted medication experts, we believe pharmacists have an important role to play in the safe and informed use of medical cannabis, and this is the first step in our journey to provide medical cannabis to our patients,” Loblaw said in an emailed statement.

Shoppers Drug Mart can now label and test associated products under the health regulator’s Access to Cannabis for Medical Purposes Regulations.

After the production license, companies require a cannabis sales license to dispense medical marijuana.

Canadian cannabis producers in the past few months have been signing up deals with distributors as the country legalizes recreational marijuana in October.

https://www.marketscreener.com/LOBLAW-COMPANIES-LTD-1410613/news/Loblaw-unit-gets-medical-marijuana-license-from-Health-Canada-27299010/

After AbbVie Suit, Feds Probe Industry-Provided Drug Educational Support

A federal investigation is underway into whether or not the nursing and other medical services provided by some pharmaceutical companies to doctor’s offices actually violate the law due to serving an illegal commercial service.

This morning the Wall Street Journal raised the question as several companies are under investigation over the notion of the services being part of a kickback scheme. This week California’s Insurance Commissioner filed a lawsuit against Illinois-based AbbVie over allegations of a kickback scheme to support sales of blockbuster rheumatoid arthritis treatment Humira in the state. Part of the charges leveled by the insurance commissioner argues that the nurses employed by AbbVie to new Humira patients are not there to benefit the patients or doctors, but to benefit AbbVie. The commissioner said that AbbVie will only provide the nurses if the doctors continue to prescribe Humira to patients.

The Journal reported that other companies such as Amgen, Biogen, Bayer, Eli Lilly, Gilead Sciences and Sanofi, all offer these kinds of services and more. The companies say the assistance they field benefits patients be helping defray copay costs and by providing disease education. However, in its report, the Journal said critics and federal prosecutors are concerned that the employees being fielded by drug companies are there to encourage the use of drugs prescribed by the companies that pay for the assistance, rather than alternative treatments. The Journal added that critics also argue the use of these extension-employees actually contributes to the high costs of healthcare because they are “pushing higher-priced drugs on people.”

There are laws on the books against this. A federal anti-kickback law “prohibits payments to induce drug prescriptions or other medical care that is reimbursed by government health programs.” The Journal reported.

AbbVie said it has complied with all state and federal laws regarding its Ambassador program. However, other programs run by different pharma companies have shut down, the Journal said. Following a probe by the U.S. Attorney’s office in New York, Sanofi shut down its certified diabetes educator program. The certified nurses in that program assisted patients with questions related to diabetes, as well as trained them on how to use Sanofi’s diabetes treatments. The Journal reported that Sanofi is cooperating with the latest investigation.

Gilead Sciences has been probed over assistance it provided to patients who were prescribed with hepatitis C drugs Sovaldi and Harvoni. Federal authorities have probed Biogen for “educational assistance” it provided for multiple sclerosis patients, the Journal added.

The nursing and medical assistance programs aren’t the only types of issues some investigators have had with the industry. Companies have also been investigated over charitable donations to 501(c)(3) organizations that provide financial assistance to Medicare patients. Pharma companies are allowed to provide philanthropic support to charities that provide patient assistance. However, companies are not allowed to use their financial influence to urge the charitable organizations to give preference to their own medications. The companies are further prohibited from providing financial assistance to people who receive their medications through government assistance programs such as Medicaid or Medicare.

Despite those rules, some companies have come under investigation for supporting those organizations. In 2016 BioSpace highlighted allegations made in court that Celgene had donated millions of dollars to charities to help patients afford high-priced cancer drugs the company manufactures and markets. The government said it was a scheme to turn a profit of billions of dollars. In August 2017 Celgene agreed to pay $280 million to settle the allegations of fraud.

https://www.biospace.com/article/jc1n-following-abbvie-lawsuit-government-scrutinizes-industry-provided-drug-educational-support-services/

Should Pharma Companies Have to Pay for Medicare? House Can’t Decide

As federal lawmakers continue to wrangle over legislation to help curb the opioid crisis in the United States, the House of Representatives is showing some division over the costs that some pharmaceutical companies may have to pay for Medicare coverage.

The issue relates to a budget bill passed earlier this year that pushes the timeline up from 2020 to 2019 for pharmaceutical companies to cover larger portions of costs for their medicines that are covered through Medicare Part D. The costs have typically been considered out of pocket expenses for individuals.

As the House addresses a number of bills aimed at curbing the opioid crisis, PhRMA, the lobbying arm of the pharmaceutical industry, is urging House members to include a provision in the opioid bill to roll back that Medicare coverage plan to its 2020 date, The Hill reported this morning. It is certainly a move that has many people up in arms and PhRMA and Republican lawmakers, who are in the House majority, are the target of their ire.

The Hill noted that Ben Wakana, executive director of Patients for Affordable Drugs, tweeted out his opposition. On his Twitter account, Wakana said “Big Pharma” is “trying to use the opioids bill as a vehicle to give themselves $4 billion windfall.” He said many of these companies are the ones that contributed to the opioid crisis in the first place, The Hill said.

Opioid addiction has become a scourge across the United States. According to the U.S.Department of Health and Human Services, 116 Americans die daily from opioid overdoses. 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.

Whatever the House does, it will have to be approved by the Senate. Earlier this week the U.S. Senate overwhelmingly passed a package of 70 bills aimed at the opioid crisis that included provisions to require carrier companies like FedEx or UPS to more carefully screen packages coming into the country for illegal opioids. The Senate plan also addresses regulatory changes that would help opioid-addicted individuals have better access to treatments. The legislation would also allow federal agencies to award grant money to state and local organizations battling the opioid crisis, The Hill reported.

The two chambers will have to hash out any differences in the legislation before passing a cohesive bill.

Taking on the opioid crisis is something that the White House has been advocating. Earlier this year 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. 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.” A friend of the court provides information and expertise in order to assist a judge in rendering a verdict. 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. The DOJ said it intended to use criminal and civil penalties to hold people accountable if they are convicted of adding to the crisis.

https://www.biospace.com/article/jc1n-should-pharmaceutical-companies-have-to-pay-for-medicare-the-house-can-t-decide/

Boston Scientific Details Stent for peripheral arterial disease

Today, Boston Scientific (NYSE: BSX) announced positive 12-month data from the IMPERIAL trial, the first head-to-head drug-eluting stent trial in the superficial femoral artery (SFA). Results were presented during a late-breaking clinical trial session at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Diego, and at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Lisbon, Portugal. The clinical findings will be published in The Lancet.

The IMPERIAL trial evaluated the Eluvia^™ Drug-Eluting Vascular Stent System versus the Zilver^® PTX^® Drug-Eluting Peripheral Stent in patients with symptomatic peripheral artery disease (PAD). PAD occurs when fatty or calcified atherosclerotic material, called plaque, builds up on the walls of the arteries of the legs, restricting blood flow and causing pain, swelling, ulceration and in some cases, the need for amputation of the affected limb. Stents are commonly used to restore and maintain blood flow, reducing symptoms and improving quality of life.

In the IMPERIAL trial, the Eluvia stent, which utilizes a drug-polymer combination to offer sustained release of the drug paclitaxel, exhibited superior rates of primary patency, a measure of the target vessel remaining unobstructed at 12 months, and thus able to provide sufficient blood flow to the lower limbs.¹ Patients in the Eluvia arm of the study also experienced higher rates of freedom from target lesion revascularization (TLR), thus reducing their need for repeat procedures at one year, when compared to those treated with the drug-coated Zilver PTX. Key findings from the IMPERIAL trial include:

• Patients treated with the Eluvia stent had a statistically significant difference in the primary patency rate of 88.5 percent, compared to 79.5 percent in patients treated with the Zilver PTX (p=0.0119);²
• Data demonstrated that the Eluvia stent had half the TLR rate at 4.5 percent, in contrast to 9.0 percent observed within the Zilver PTX cohort;
• Over 95 percent of patients who received the Eluvia stent were free of major adverse events at one year, compared to 91.0 percent of patients who received the Zilver PTX.

“These impressive clinical outcomes suggest that sustained elution of paclitaxel, delivered by the Eluvia stent, better matched the timing of restenosis in the SFA that can occur months later, thereby reducing the need for repeat interventions,” said William Gray, M.D., system chief, Division of Cardiovascular Disease at Main Line Health, president, Lankenau Heart Institute in Wynnewood, Pennsylvania, and co-principal investigator of the IMPERIAL trial. “Based on these findings, we believe that the Eluvia stent can be a preferred therapy option when treating patients with arterial blockages in the superficial femoral or proximal popliteal arteries.”

https://www.marketscreener.com/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-Eluvia-Drug-Eluting-Stent-Demonstrates-Superior-Results-In-IMPERIAL-Trial-27302487/