Non-US big biopharma stocks led the way in Q3

… suggesting that those looking for investment gains would do best to search further afield.

It was a tale of two continents when it came to the performance of some of the industry’s biggest companies and stock indices over the past nine months. Those eschewing the conventional wisdom of betting on biopharma’s largest single market did much better, with European investments outperforming.
The strong showing so far this year from indices tracking large European drug makers contrasts with a lacklustre performance from the likes of the Nasdaq biotech index and the flat returns from the S&P Pharmaceuticals. The noise around drug pricing as the US heads towards the 2020 elections is only likely to increase, which could spell a rocky end to the year for the sector.

Stock index	9-mth change
Nasdaq Biotechnology (US)	3%
S&P Pharmaceuticals (US)	0%
Dow Jones Pharma and Biotech (US)	0%
S&P 500 (US)	19%
DJIA (US)	15%
Dow Jones Stoxx 600 Healthcare (EU)	20%
Thomson Reuters Europe Healthcare (EU)	14%
Euro Stoxx 50 (EU)	20%
FTSE-100 (UK)	10%
Topix Pharmaceutical Index (Japan)	3%

Some of the US stagnation has to do with the wider global economy, with the country’s trade war with China affecting US stocks across the board. US biopharma might also have been a victim of its own success; last year the sector ticked up strongly towards the end of the year, as investors tried to find safe havens in a volatile market, and this has made for harder comparisons.
Europe almighty
The political and economic volatility in the US cleared the way for non-US based companies to shine. Roche investors appear to have stopped fretting about biosimilar competition for some of the company’s biggest drugs, and the continued strong performance of new products like Ocrevus and Hemlibra, plus clinical wins for Tecentriq, prompted an 18% lift in the Swiss company’s shares.
Hemlibra’s originator, Chugai, has also benefited from the drug’s sales, with its shares rising 32% over the year.
Some wins from Astrazeneca’s oncology pipeline helped this group become one of the best big cap performers over the past nine months, as Tagrisso and Lynparza notched up strong sales and Imfinzi impressed in clinical trials. Elsewhere, Emma Walmsley’s overhaul and refocus of Glaxosmithkline resulted in a 17% share price lift.

Big pharma: top risers and fallers in first 9 months of 2019
	Share price	Market capitalisation ($bn)
	9-mth change (local currency)	30 Sep 2019	9-mth change
Top 3 risers
Roche	19%	253.3	42.7
Astrazeneca	17%	116.9	20.7
Glaxosmithkline	17%	108.4	12.2
Top 3 fallers
Abbvie	(18%)	112.0	(26.7)
Pfizer	(18%)	198.7	(53.6)
Eli Lilly	(3%)	108.0	(11.3)*
Note: *Lilly’s share count decreased by 70 million.

The gains made by European companies at the top of the table were juxtaposed with the big falls experienced by US companies at the bottom. Between them Abbvie, Pfizer and Lilly lost a combined $92bn of value, some of the heaviest losses recorded by big pharma stocks over the past five years.
Abbvie continued to flounder on investor disquiet over its decision to acquire Allergan and ongoing concerns that the company cannot find a way out of its dependence on Humira. Corporate activity was also behind Pfizer’s fall as investors took a dim view on its plans to merge its generics division with Mylan.
Pfizer’s announcement that it was lowering full-year earnings guidance and disappointing forecasts for its remaining products also contributed to one of the biggest share price slides for the company in a decade. Lilly has also failed to recover after it lowered full-year revenue expectations in the first quarter.
Race to the bottom
Among the world’s other big drug makers, with the exception of Celgene, the top performers were all Asian stocks. Jiangsu Hengrui Medicine continued to consolidate its position as one to watch in terms of China’s growing strength in oncology.
Celgene’s presence at the top of the big caps was purely due to the increasingly stringent FTC making Bristol Myers Squibb jump through competition hoops, including the disposal of Otezla, to get its acquisition done. This deal is now expected to close at the end of the year or in early 2020.

Other big drugmakers ($25bn+): top risers and fallers in first 9 months of 2019
	Share price	Market capitalisation ($bn)
	9-mth change (local currency)	30 Sep 2019	9-mth change
Top 3 risers
Jiangsu Hengrui	84%	70.4	25.6
Celgene	55%	51.9	23.8
Chugai	32%	43.4	11.8
Top 3 fallers
Celltrion	(26%)	17.9	(6.8)
Regeneron	(26%)	30.0	(9.8)
Biogen	(23%)	42.9	(17.7)

In the meantime, little changed for the biggest fallers this quarter except for their respective positions. Celltrion’s production problems at its main factory, which started earlier in the year, coupled with increasing competition for its biosimilar versions of Rituxan and Herceptin, saw it overtake Regeneron and Biogen to claim the quarter’s wooden spoon.
Regeneron continues to struggle with replacing sales of its biggest product, Eylea, which are predicted to peak this year. Meanwhile Biogen has never really recovered from the implosion of aducanumab in March. A series of other clinical setbacks including last month’s decision to ditch elenbecestat, the last Bace inhibitor in development, and the canning of BG00011 in idiopathic pulmonary fibrosis following safety concerns, have not helped assuage investors’ fears about Biogen’s ageing and lacklustre pipeline.
The recent departure of the group’s head of research, Michael Ehlers, is another blow and could add further pressure on the company to indulge in M&A. However, going down this route would come with considerable risk and, if executed poorly, could see Biogen remain among the sector’s worst performers.
https://www.evaluate.com/vantage/articles/data-insights/quarterly-shareprice-performance/europe-and-asia-provide-safe-haven

Trump to sign executive order giving MA more flexibility, improving Medicare

President Donald Trump will sign an executive order to give Medicare Advantage (MA) plans more flexibility and reduce regulations for certain medical professionals.
Trump will deliver a speech Thursday at The Villages retirement community in Florida to outline the order, which directs the Department of Health and Human Services (HHS) to develop regulations that would give MA beneficiaries more diverse options in their plans.
The executive order is part of an effort by the Trump administration to contrast Medicare with single-payer proposals such as “Medicare for All.”

“Today’s executive order reflects importance on protecting what works on our system and fixing what is broken,” HHS Secretary Alex Azar said on a call with reporters previewing the order.
Azar said part of the order calls for HHS to propose reforms to Medicare that enable providers to practice “at the top of their licensure.”
He said there are “artificial restraints” that prevent nurse practitioners and physician assistants from providing care they are licensed for and that the agency will pursue regulations to loosen such restraints.
The order will also call for a payment model that adjusts supplemental MA benefits to give beneficiaries capped or monetary rebates for seeking high-value care.
It also seeks to ensure that the fee-for-service part of Medicare, where a majority of beneficiaries get care, is not disadvantaged compared to MA plans.
“The executive order commissions us to look at all regulations, guidance and steering fee for service,” Azar said. “How does the enrollment process work when people come in?”
He added that the order will also deal with improving access through network adequacy in MA plans.
“Part of that will now include being able to factor in the availability of telehealth services or other innovative technology as part of providing access through MA plans,” Azar said.
MA plans will be able to provide telehealth as a supplemental benefit starting in 2020.
The executive order comes as the Trump administration has touted lower premiums on MA. Premiums for 2020 MA plans are expected to decline in 2020 by 14% compared with 2019.
The average premium is likely to be the lowest since 2007, the Centers for Medicare & Medicaid Services has said.
https://www.fiercehealthcare.com/payer/trump-to-sign-executive-order-giving-ma-more-flexibility-improve-medicare

Obalon Shares Inflate As Weight Loss Balloon Maker Delivers Positive News

Shares of Obalon Therapeutics Inc OBLN 9.5%, a developer of novel technologies for weight loss, were advancing strongly Thursday morning.

What Happened

San Diego, California-based Obalon said it has retired the remaining $5 million of its long-term debt facility with Pacific Western Bank.
The company also said in an 8-K filing with the SEC that it believes it has regained compliance with the Nasdaq Listing Rule regarding shareholder equity, by increasing it above the minimum required for continued listing.

Why It’s Important

Obalon said the retirement of debt has served to remove the risks and restrictions of carrying long-term debt.
Additionally, the debt payoff removes an interest burden to the tune of $350,000 annually, the company said.
“We are pleased to continue to transform the company’s financial position and believe that with no long-term debt and our current cash position, we are well-positioned to drive our strategy to bring the Obalon Balloon System to patients in need of a proven weight loss solution,” CFO William Plovanic said in a statement.
“We remain focused on converting consumer interest in our novel FDA-approved balloon system into patient treatments and successful weight loss experiences, and we are looking forward to the first patient treatments at our company-owned and managed Obalon Center for Weight Loss.”
https://www.benzinga.com/news/19/10/14538817/obalon-shares-inflate-as-weight-loss-balloon-maker-delivers-positive-news

Behind PDS Biotech’s Rally

Shares of the thinly traded, nano-cap biotech PDS Biotechnology Corp PDSB 24.33% were rallying strongly Thursday on above-average volume.

What Happened

PDS, which engages in the development of multifunctional immunotherapic products, announced a modified clinical trial collaboration agreement with Merck & Co., Inc. MRK 1.07%.
PDS’ lead Versamune-based immunotherapy PDS0101 will be evaluated in a Phase 2 trial in combination with the latter’s anti-PD-1 therapy Keytruda as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16, or HPV16, infection.
The modification follows the recent FDA approval for Merck’s Keytruda as a monotherapy in patients whose tumors express PD-L1, or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.
PDS0101 is PDS’ proprietary clinical-stage immunotherapeutic administered by subcutaneous injection to treat HPV-associated cancers.

Why It’s Important

“We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients,” said Dr. Lauren Wood, chief medical officer at PDS, said in a statement.
Recently released Phase 1 data that evaluated the PDS0101 monotherapy demonstrated unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses in a majority of evaluable patients, according to PDS.
A lack of dose-limiting toxicities at all tested doses was observed, the company said.
The companies did not disclose the details of the collaboration.

What’s Next

PDS is the portfolio company of London-listed Netscientific Plc. On the collaboration news, Netscientific shares were rallying over 75% on the London Stock Exchange.
https://www.benzinga.com/general/biotech/19/10/14539754/whats-behind-pds-biotechs-rally

Preventing heart failure by altering the circadian clock

When people suffer heart attacks, the resulting scarring of the heart tissue often leads to chronic heart failure. Researchers at the University of Guelph in Canada have discovered a drug that they believe can prevent that scarring and the progression to chronic heart failure.
The drug, SR9009, works by capitalizing on the circadian clock inside the heart—the genes that turn on and off at specific times to regulate heart rate, blood pressure and other functions. In mouse models, administering SR9009 shortly after a heart attack reduced inflammation and scarring, allowing the heart to better repair itself. The researchers reported the results in Nature Communications Biology.
SR9009 works by disrupting genes that would normally activate immune responses after a heart attack. In mice, it tamped down the production of the NLRP3 inflammasome, a protein complex that promotes scarring. When they combined the drug with conventional therapies used to promote blood flow after heart attacks, the animals’ hearts healed to the point where it almost looked as if no cardiac event had happened at all, the researchers reported.

“No scar, no heart damage, no heart failure,” said Tami Martino, Ph.D., professor and director of the Centre for Cardiovascular Investigations at the University of Guelph, in a statement. “We were amazed to see how quickly it worked,” she added.

Several companies are targeting the NLRP3 inflammasome to treat a variety of diseases. Late last year, U.K. and Ireland-based startup Inflazome raised €40 million ($46 million) to develop its pipeline of NLRP3-targeted drugs to treat diseases marked by excessive inflammation such as Alzheimer’s disease and inflammatory bowel disease. Another U.K. startup, Nodthera, raised £28 million ($40 million) to develop an NLRP3 inflammasome inhibitor for conditions such as nonalcoholic steatohepatitis.
What makes the University of Guelph approach distinctive is its focus on the circadian clock. SR9009 specifically targets REV-ERB, a family of nuclear receptors that regulate the circadian clock. The researchers showed that activating REV-ERB with SR9009 in mice lowered the production of NLRP3, when they administered the drug after conventional heart attack treatments.
Because REV-ERB is most active during sleep, they gave the drug to some of the mice at bedtime. Those animals showed better heart healing than did mice who were given SR9009 at wake time, the researchers reported. They suggested that in people, the first dose could be given during the initial treatment after a heart attack with a follow-up dose at sleep time, they said.
The University of Guelph scientists believe the research could inspire new approaches to treating patients immediately following heart attacks. “We hope our experimental study will stimulate the initiation of translational research targeting REV-ERB, and indeed explore an emerging class of drugs that target the circadian mechanism, to benefit treatment of patients clinically,” they wrote in the study.
https://www.fiercebiotech.com/research/preventing-heart-failure-by-altering-circadian-clock

U.S. seeks e-cigarette companies’ data on advertising, sales

The U.S. Federal Trade Commission has ordered a half-dozen e-cigarette companies to turn over sales and advertising data, the federal regulator said on Thursday, in the first sign of a likely probe into marketing practices by the companies.

The order was sent to JUUL Labs Inc, RJ Reynolds Vapor Company, Fontem US Inc, Logic Technology Development LLC, Nu Mark LLC and NJOY LLC, the FTC said in a statement.
The FTC is seeking annual sales data and information on giveaways, data on product placement and flavors, as well as information on the companies’ use of celebrities as internet influencers and marketing on college campuses to sell the electronic smoking devices.
Part of the FTC mission is to enforce truth-in-advertising laws.
“The goal is to assist the Commission, policy makers, and the public to better understand the rapidly growing e-cigarette market,” the FTC said.
The FTC request comes amid a mysterious outbreak of serious vaping-related lung illnesses whose cause has yet to be determined.
The U.S. Centers for Disease Control and Prevention has said that there have been 805 confirmed and probable cases of lung illness in 46 states, as well as 12 deaths associated with vaping in the United States. Four other U.S. deaths have since been reported by states. The CDC is expected to update its numbers later on Thursday.
Meanwhile, the agency has urged people to stop using e-cigarette or vaping products, including those containing THC, the psychoactive ingredient in marijuana.
The Trump administration has announced plans to remove all flavored e-cigarette products from the market in the United States amid concerns that flavors like mint and mango attract children to the products.

https://www.marketscreener.com/news/U-S-seeks-e-cigarette-companies-data-on-advertising-sales–29332821/

EssilorLuxottica: $14B investment to eliminate poor vision by 2050

Launched on the sidelines of the 74th session of the United Nations General Assembly on September 24th, the report defines the scale of uncorrected poor vision globally and outlines solutions to eliminate the world’s largest unaddressed disability within one generation. This is in line with EssilorLuxottica’s mission to help people see more, be more and live life to its fullest.
Speaking on the report, Jayanth Bhuvaraghan, Head of Mission at EssilorLuxottica said: ‘This is a once in a lifetime opportunity to end a public health crisis. With the launch of this new report, we are elevating our efforts by providing a roadmap outlining key priorities, actions and investment required to eliminate poor vision in a generation. The time is now, but we cannot do it alone. The eye health sector must seek the support and engagement of many partners whose resources can accelerate progress’.
The world’s largest unaddressed disability
Uncorrected poor vision is the world’s most widespread disability: it affects one in three people across the globe, 90 percent of whom live at the economic base of the pyramid, and costs the global economy $272 billion in lost productivity each year. By 2050, uncorrected poor vision is predicted to reach epidemic proportions with over 50 percent of the world’s population expected to suffer from myopia, many with serious vision-threatening side effects and drastic long-term implications.
Efforts to bring good vision to everyone, everywhere are being led by both the public and private sector and supported by multilateral organizations and donors. And while great strides have been made in the areas of accessibility, affordability, addressing funding gaps and using innovation to produce cost-effective products and services, there remains a need to do more.
Poor vision can be eliminated by 2050
To gather more evidence-based insight into the scale of this vision care crisis, identify possible solutions and mobilize both public and private stakeholders, we initiated the report using analytical support provided by McKinsey. Findings indicate uncorrected poor vision can be eliminated by 2050 through an investment of $14 billion over the next 30 years, dedicated to creating sustainable access points for eye health services, innovating for affordable solutions, funding subsidized and free services as well as raising awareness.
Using the key findings of the report as a starting point, we hosted a panel discussion, in partnership with the social enterprise and media platform Devex, (repeated in para 1)at the United Nations General Assembly. The discussion examined how we can overcome obstacles to meeting the 2050 target of universal vision, the need for specific funding, partnerships and raising awareness, as well as how we can jointly tackle the issue through economies of scale and cross-sector collaboration.
The panel included Jayanth Bhuvaraghan, Head of Mission at EssilorLuxottica; Nick Martin, Deputy CEO, The Fred Hollows Foundation; Allyala Nandakumar, Chief Economist at the Office of the Global AIDS Coordinator, USA and Former Chief Economist for Global Health, USAID; Dr. Serge Resnikoff, International Expert on Eye Health and Former Senior Policy Advisor and Coordinator, World Health Organization as well as Elizabeth Smith, Co-founder and Chief Executive, EYElliance.
Download the report here and watch a recording of the panel discussion here.

https://www.marketscreener.com/ESSILORLUXOTTICA-4641/news/EssilorLuxottica-14B-investment-to-eliminate-poor-vision-by-2050-29333058/