Gilead Presents Proof of Concept Data for GS-6207, 1st-in-Class HIV Capsid Inhibitor

Phase 1b Study Demonstrates Potent Antiviral Efficacy Following a Single Subcutaneous Injection of GS-6207, No Discontinuations Due to Adverse Events –

Gilead Sciences, Inc. (NASDAQ: GILD) today presented the first clinical data in people living with HIV on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV capsid function. The Phase 1b data demonstrate the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo. In addition, Gilead presented preclinical data demonstrating that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV. These data were presented at the 10^th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.

GS-6207 is an investigational long-acting antiretroviral agent that can be delivered subcutaneously. GS-6207 recently received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) as a potential therapy for heavily treatment-experienced people living with multi-drug resistant HIV. GS-6207 acts in a novel way compared with currently available antiretroviral agents by interrupting the activity of HIV capsid, a protein that surrounds and protects the virus’ genetic material and essential enzymes. GS-6207 may interrupt multiple distinct stages of the viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells.

“The data presented at IAS underscore our commitment to scientific discovery, building on Gilead’s legacy of transformative advances in HIV therapies,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “GS-6207’s multi-stage mechanism of action profile is distinguishable from currently approved classes of antiretroviral agents and may provide a new avenue for the development of long-acting treatment regimens for people living with HIV.”

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Presents-Proof-of-Concept-Data-for-GS-6207-a-First-in-Class-Capsid-Inhibitor-in-28940260/

Takeda: Subcutaneous Vedolizumab Meets Primary Endpoint in Crohn’s

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) (‘Takeda’) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD) who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.1

In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50.1 Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.

‘Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab, whether that is intravenously or subcutaneously. These data, alongside the pivotal VISIBLE 1 results in ulcerative colitis, provide a more comprehensive picture of the new investigational subcutaneous formulation of vedolizumab as maintenance therapy for both ulcerative colitis and Crohn’s disease,’ said Asit Parikh, MD PhD, Head of Takeda’s Gastroenterology Therapeutic Area Unit.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/Takeda-Pharmaceutical-Investigational-Subcutaneous-Formulation-of-Vedolizumab-Meets-Primary-Endpoi-28939980/

Philips sales spurred by rising Chinese healthcare spend

Rising healthcare spending by the Chinese government helped Dutch health technology company Philips post better-than-expected sales growth for the second quarter, putting its shares among the top performers in Europe on Monday.

Philips, which sells products ranging from toothbrushes to medical imaging systems, said comparable sales had improved 6% in the second quarter. Analysts had on average only pencilled in a 4.5% improvement.

Philips shares rose 4% in the first hours of trading in Amsterdam, making them one of the top performers in the Stoxx600.

Growth was helped by a “double digit” sales increase in China, Philips said, as the Chinese government ramps up healthcare spending, expanding hospitals and investing in more advanced technologies.

“Healthcare in China is still not sufficient to meet the demands of an ageing society,” Chief Executive Frans van Houten told Reuters in a phone interview.

“The government has said it would expand capacity, and that is exactly what is happening. This trend for us is more important than fluctuations in GDP (gross domestic product) growth, and we expect it to continue in the coming years.”

Demand and orders for hospital equipment, medical systems and personal care devices also increased in the United States and Europe, keeping Philips optimistic about the months to come.

“We saw growth in all our segments in the second quarter and we expect that to continue”, Van Houten told reporters.

“We had strong traction in emerging markets and that is set to continue. Also, we expect mature markets to come in stronger in the second half of the year.”

TARIFF CLOUDS

Although sales in the U.S. and China remained strong, Philips said the trade disputes between the two countries remained its main worry, as both its end products and components are hit by new tariffs.

“The main cloud hanging over us is the possible fourth batch of tariffs,” Van Houten said. “If that would happen, it would increase the amount by which our earnings are hit by 20 million euros this year, but nobody knows whether it will happen.”

Philips currently expects tariffs to shave 45 million euros (£41 million) off its 2019 core earnings.

Once a sprawling conglomerate, Philips is now purely focused on healthcare after spinning off its lighting and consumer electronics divisions in recent years.

The company reaffirmed its target for total comparable sales growth of 4% to 6% per year until 2020, and said its profit margin would move up from 13.1 to around 14% this year.

Adjusted earnings before interest, taxes and amortisation (EBITA) jumped 14% to 549 million euros in the second quarter, while the margin climbed 60 basis points to 11.8%, roughly meeting expectations.

https://www.marketscreener.com/ROYAL-PHILIPS-6289/news/Royal-Philips-Philips-sales-spurred-by-rising-Chinese-healthcare-spending-28937680/

Bayer sells Dr. Scholl’s footcare brand to Yellow Wood Partners

Bayer signed a deal on Monday to sell its Dr. Scholl’s footcare brand to U.S. private investment firm Yellow Wood Partners for $585 million (£469.31 million), the second of two consumer care products it had put on the block.

Bayer, whose stock has slumped amid lawsuits over an alleged cancer-causing effect of its Roundup weed killer, struck a deal in May to sell U.S. sun care brand Coppertone to Nivea maker Beiersdorf for $550 million.

The divestments are part of a wider overhaul unveiled in November by Bayer Chief Executive Werner Baumann, who is under pressure to boost the share price.

Bayer’s Dr. Scholl’s, which generated $234 million in sales last year, is primarily a North American brand. Rival Reckitt Benckiser owns the Scholl footcare business outside North America.

Bayer acquired weed killer Roundup as part of the $63 billion takeover of U.S. seeds and pesticides maker Monsanto last year. The German company has said Roundup is safe to use.

The German group, which is scheduled to release second-quarter results on July 30, is also looking for a new owner of its animal health business, the world’s largest maker of flea and tick control products for pets, which analysts have said could fetch 6 billion to 7 billion euros.

Reuters this month quoted sources familiar with the matter as saying Bayer had approached U.S. drug firm Elanco Animal Health about a possible tie-up.

Bayer’s consumer healthcare business, bolstered by the 2014 acquisition of a Merck & Co division for $14 billion, will focus on remaining brands that require more medical expertise.

The business has faced falling revenues as U.S. consumers switched from established drugstores to online shops.

Boston-based Yellow Wood will create a standalone company for the Dr. Scholl’s consumer brand and it plans to invest in the business to drive growth and profitability, Bayer added.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-Bayer-sells-Dr-Scholl-s-footcare-brand-to-Yellow-Wood-Partners-28939754/

Bayer may benefit from home advantage in St. Louis Roundup cancer trial

 Bayer AG, facing an upcoming trial in St. Louis over allegations that its Roundup weed killer causes cancer, has recruited Missouri-based expert witnesses to make its case in a place where it has century-old roots but where juries often hit companies with huge damages.

Four expert witnesses Bayer is seeking to admit hail from Missouri universities, and some legal experts said the company is trying to clinch its first favorable Roundup verdict by emphasizing its reputation as a major local employer.

Bayer on Tuesday announced it would create an additional 500 “high-paying” jobs in the St. Louis area. The Bayer unit that makes the glyphosate-based herbicide, the former Monsanto Co, was founded in St. Louis in 1901. Monsanto employed 5,400 full-time employees in the St. Louis area as of May 2018, according to company statements.

The trial in St. Louis County Circuit Court, expected to begin on Aug. 19, was brought by Illinois resident Sharlean Gordon, who says she was diagnosed with non-Hodgkin’s lymphoma after using Roundup for around 14 years at her home. It is the fourth trial over Roundup and the first one outside of California, where three juries hit Bayer with verdicts as large as $2 billion. Bayer is appealing those verdicts.

Bayer denies glyphosate or Roundup cause cancer, saying decades of studies have shown glyphosate to be safe. The company said it looked forward to presenting the scientific evidence to juries. It said the experts in the upcoming St. Louis trial are at the top of their field and were selected for their expertise, not their Missouri ties.

The Germany-based company has lost nearly 40 billion euros ($33.75 billion) in market valuation since the first Roundup jury verdict in August 2018. Bayer last month announced it had set up a committee to help resolve the litigation, saying it would “constructively engage” in court-mandated mediation talks.

NEW WITNESSES

Bayer has said in court papers and hearings that juries in California’s traditionally liberal Bay Area, where the first three trials took place, were unfairly influenced by news coverage of the trials and harbored negative attitudes toward Monsanto in part because of its development of genetically modified seeds.

The company’s experts in those cases came mostly from states other than California. In the St. Louis trial, Bayer is so far seeking to admit a total of 14 scientific expert witnesses. None previously testified in the Roundup litigation.

Of the more than 13,400 Roundup claims nationwide that have yet to go to trial, about 75% have been filed in St. Louis city or county courts, according to plaintiffs’ lawyers. Those courts have a history of issuing large punitive damages against companies and have often been criticized by business groups for issuing favorable plaintiffs rulings.

By suing in the county where Bayer’s crop science business is headquartered, plaintiffs can also take advantage of procedural rules allowing them to compel live testimony from executives who work locally. In the California trials, jurors only saw video depositions of Monsanto executives.

David Noll, a professor at Rutgers Law School, said Bayer appeared to be hiring local experts to appeal to St. Louis jurors. “(They) are not seen as hired guns, flying in from afar, but … can explain the case in a way local jurors understand,” Noll said.

But Alexandra Lahav, a law professor at the University of Connecticut, said Bayer could simply be using new experts that the company thinks would have a better rapport with the jury and “not necessarily because the experts are local.”

Counting on a more favorable jury pool in a company’s backyard is not a new tactic.

New Jersey-based Merck & Co, which in the early 2000s faced thousands of lawsuits by patients over its Vioxx painkiller, won several trials in New Jersey, which plaintiffs lawyers at the time attributed to the company’s strong ties to the state.

Merck in 2013 settled some 27,000 Vioxx claims for $4.85 billion.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Bayer-could-benefit-from-home-advantage-in-St-Louis-Roundup-cancer-trial-experts-28938464/?countview=0

Bayer Drug Iberogast Under Investigation

Bayer AG’s (BAYN.XE) digestive medication Iberogast is at the center of an investigation by the Cologne public prosecutor’s office for a possible connection with the death of a person who took the medication, German business magazine Handelsblatt reports.

–According to the publication, the conglomerate refused to add warnings about possible liver damage and failure to the drug’s package leaflet for years.

–The company only added them last year, when it became known that a woman in Germany died of liver failure and interior bleeding who previously took the medication, Handelsblatt reports.

–Bayer wasn’t immediately available for comment.

Full story (in German): https://bit.ly/2Y9Sncd

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-Drug-Iberogast-Under-Investigation-Handelsblatt-28938150/?countview=0

FDA OKs including new survival data in labeling of AstraZeneca’s Imfinzi

AstraZeneca (NYSE:AZN) perks up 1% premarket on light volume following its announcement that the FDA has signed off on including overall survival (OS) data from the Phase 3 PACIFIC study in the package insert of IMFINZI (durvalumab) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent platinum-based chemo and radiation therapy.

The data showed an OS benefit compared to placebo with a 32% reduction in the risk of death.

https://seekingalpha.com/news/3479613-fda-oks-inclusion-new-survival-data-labeling-astrazenecas-imfinzi-shares-1-percent-premarket