Bayer’s heart failure pill hinders kidney disease, heart disease in phase 3

Five years after kicking off a massive phase 3 program, Bayer has good news for its heart failure pill finerenone. The drug beat placebo at staving off progression of kidney disease and lowered the risk of heart attacks and strokes in patients with chronic kidney disease (CKD) and Type 2 diabetes.

The study, known as FIDELIO-DKD, is part of a program pitting finerenone against placebo in 13,000 patients with varying severities of kidney disease from early to advanced. Patients received a 10-mg or 20-mg dose of finerenone or placebo on top of the standard of care for CKD. Treatments can include ACE inhibitors and angiotensin II receptor blockers to slow down kidney disease as well as drugs to lower blood sugar levels.

Finerenone beat placebo at staving off kidney failure—when patients need dialysis or a transplant to survive—death from kidney disease or slowing decline in estimated glomerular filtration rate, namely the rate at which the kidneys could filter blood.

It also hit a key secondary endpoint, prolonging time to death from heart disease, or time to nonfatal cardiovascular events such as stroke, heart attack or hospitalization because of heart failure. Bayer will present full data at an upcoming medical meeting. A second phase 3 study, FIGARO-DKD, is slated to read out next year.

Bayer is also testing the drug in a 5,500-patient study to see whether it can beat placebo at keeping patients alive and reducing hospitalizations or urgent visits for heart failure.

Finerenone is a next-generation mineralocorticoid receptor antagonist, or MRA, designed to block the production of steroids in the body that degrade heart function and lead to kidney problems. Older MRAs are already used to control high blood pressure and tamp down on inflammation and scarring that come with diabetic kidney disease, but their use is limited.

“Safety concerns mean that existing MRAs are only used as a last resort—Pfizer’s Inspra or the older spironolactone are examples—and Bayer is hoping to show that finerenone is an entirely different proposition,” Evaluate wrote earlier this year. Bayer believes its non-steroidal nature and better selectivity should lead to fewer side effects, including very high potassium levels.

Evaluate called the phase 3 program a “bold bet” but one with a potentially dwindling likelihood of paying off. Though cross-trial comparisons are always tricky, the finerenone data will be held up against the record of Invokana, Johnson & Johnson’s SGLT2 inhibitor.

The FDA slapped the diabetes med with a black box warning for amputation risks in 2017 but went ahead and OK’d it for diabetic kidney disease last September, making it the first drug of its class for this indication. In a pivotal trial, Invokana reduced the risk of end-stage kidney disease by 32% and tamped down on cardiovascular events by 20% to 30%. Evaluate expects SGLT2 drugs from AstraZeneca and Eli Lilly to turn up similar results.

https://www.fiercebiotech.com/biotech/bayer-s-heart-failure-pill-hinders-kidney-disease-heart-disease-phase-3

Lilly to not share early-stage data on COVID-19 antibody – Morgan Stanley

In a note, Morgan Stanley’s David Risinger says Eli Lilly (LLY -1.9%) is not planning to publish results from a Phase 1 clinical trial evaluating antibody LY-CoV555 in hospitalized COVID-19 patients according to the company’s investor relations.

Lilly’s decision appears to dash expectations of early release of data from an ongoing 400-subject Phase 2 trial, BLAZE-1, assessing the candidate in patients with mild-to-moderate COVID-19. The study’s estimated completion date is next month.

The antibody was identified from a blood sample taken from one of the first U.S. patients to recover from the infection and was developed by Lilly scientists in only three months after being identified by collaborators AbCellera and the Vaccine Research Center at NIAID.

https://seekingalpha.com/news/3589906-lilly-to-not-share-early-stage-data-on-covidminus-19-antibody-morgan-stanley

AstraZeneca, Lilly, Sanofi and others raise prices to start July

A pandemic hasn’t stopped some pharma companies from implementing their traditional mid-year price hikes.

AstraZeneca, for instance, raised prices on 21 medicines from 1.5% to 6% this month, GoodRx reports. But while the U.K.-based company increased stickers on far more medicines than its peers did in July, it wasn’t alone. Eli Lilly, Sanofi, GlaxoSmithKline and Biogen each slightly raised prices on one or two of their medicines.

Beyond Big Pharma, smaller companies United Therapeutics, Dynavax, Arbor Pharmaceuticals, Paratek, Rigel Pharmaceuticals and others raised certain drug prices. Overall, pharma companies have marked up 42 branded medicines by an average of 3.5%, according to the website. Those hikes follow 857 pushed through from January 1 to June 30.

The price hike for Sprout Pharmaceuticals’ controversial “female Viagra” medicine Addyi was among the largest in July. The company implemented a 9.3% price hike on the medicine, taking its 30-day list price to $478.

Some medicines on the list already saw price hikes earlier in the year, and the latest round took their cumulative 2020 increases beyond single-digit percentages. Addyi, for instance, is up 19.5% total so far this year, according to GoodRx. The price for Omeclamox-Pak from Cumberland Pharmaceuticals is up 13.4%.

Pharma companies have often raised prices twice per year—at the start of the year and in July—but amid scrutiny in recent years, many companies have moved to once-per-year price hikes in January. The latest moves show that while some companies are comfortable increasing prices in the current climate, others are staying away for one reason or another.

But even as list prices have continued to grow, pharma companies have also battled for better formulary positioning by offering bigger rebates and discounts. In the first quarter of 2020, net prices declined by an average of 2.6%, according to an analysis by SSR Health. That was despite average list price increases of 2.3%.

https://www.fiercepharma.com/pharma/astrazeneca-lilly-sanofi-and-other-companies-raise-prices-to-start-july-report

A Cheap, Simple Way to Control the Coronavirus

Simple at-home tests for the coronavirus, some that involve spitting into a small tube of solution, could be the key to expanding testing and impeding the spread of the pandemic. The US Food and Drug Administration should encourage their development and then fast track approval.

One variety, paper-strip tests, are inexpensive and easy enough to make that people could test themselves every day. You would simply spit into a tube of saline solution and insert a small piece of paper embedded with a strip of protein. If you are infected with enough of the virus, the strip will change colour within 15 minutes.

Your next step would be to self-quarantine, notify your doctor and confirm the result with a standard swab test — the polymerase chain reaction nasal swab. Confirmation would give public health officials key information on the virus’s spread and confirm that you should remain in quarantine until your daily test turned negative.

Once paper strips’ efficacy is definitively proved and they are cleared by the FDA, …we’ll have not only a true day-to-day sense of COVID-19’s path. We’ll also have a far better means to quickly contain and end this terrible plague.

–

E25Bio, Sherlock Biosciences, Mammoth Biosciences, and an increasing number of academic research laboratories are in the late stages of developing paper-strip and other simple, daily COVID-19 tests. Some of the daily tests are in trials and proving highly effective.

The strips could be mass produced in a matter of weeks and freely supplied by the government to everyone in the country. The price per person would be from $1 to $5 a day, a considerable sum for the entire population, but remarkably cost effective.

Screening the population for infection, however, is different from determining whether someone is infected.

The US Food and Drug Administration has recently approved group PCR testing to screen large numbers of people. (Group testing, which is used in other countries, assays multiple swab samples at once and if the virus is found, individuals are tested.) So there is reason to hope that the FDA will also approve paper-strip tests as a way to find out where the virus has spread.

Hope needs to be replaced with surety. Biotech companies are reluctant to take these tests to market for fear that the FDA will disparage them for being less sensitive than the nasal swab tests. The nasal swab test can detect extremely small quantities of viral particles.

But the problem with the nasal swab tests is their cost, which ranges from $50 to $150. They also require laboratory assessment, which can take days. That is why, the Centres for Disease Control and Prevention reports, nine of 10 infected Americans never get tested. It’s also why those who do get tested, generally are tested only once.

The benefits of group testing

Clearly, if you’re infected and never tested, you can unwittingly spread the virus. And if you are tested, but just once, and the test comes back negative, you may still later become infectious. Finally, if your polymerase chain reaction swab is positive, but it takes five days to learn the result, you may spend those days transmitting the disease.

Group testing can dramatically lower nasal-swab-testing costs for universities and large companies. But absent federal coordination, it can’t be used routinely to test all Americans.

We need the best means of detecting and containing the virus, not a perfect test that no one can use. That is where paper-strip testing would have the advantage. Their ability to be used more frequently would trump the nasal swab test’s higher sensitivity. Paper-strip testing would also sharply improve diagnosis as those with a positive paper-strip test would still be given a nasal swab test.

Would everyone take a paper-strip test every day? Here market incentives will surely help. Once they are provided to all, employers would likely require their workers to take time-dated pictures of their negative test results before coming to work. Colleges would require students to do the same before coming to class. Restaurants could accept reservations only if accompanied by negative-test pictures. In short, everyone will have an incentive to test themselves daily to participate fully in the economy and return to normal life.

Once paper strips’ efficacy is definitively proved and they are cleared by the FDA, Congress can quickly authorise the production and distribution, for free, of a year’s supply. Then we’ll have not only a true day-to-day sense of COVID-19’s path. We’ll also have a far better means to quickly contain and end this terrible plague.

— Laurence Kotlikoff is a professor of economics at Boston University, and Michael Mina is an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health.

https://www.msn.com/en-ae/news/other/covid-19-a-cheap-simple-way-to-control-the-coronavirus/ar-BB16kh2K

Medtronic inks cross license deal with Tandem Diabetes Care

Aimed at avoid future legal spats over diabetes technology-related intellectual property, Medtronic (NYSE:MDT) and Tandem Diabetes Care (NASDAQ:TNDM) had executed a five-year cross-license agreement covering their respective patent portfolios in diabetes. The contract includes a provision not to clone each other’s products.

No payment were exchanged in the matter. Further terms remain confidential.

https://seekingalpha.com/news/3589856-medtronic-inks-cross-license-deal-tandem-diabetes-care

Relay Therapeutics sets IPO terms, to be valued at up to $1.5B

Relay Therapeutics Inc. RLAY, disclosed Thursday terms for its initial public offering, as the Massachusetts-based cancer treatment company looks to raise up to $264.6 million, and be valued at as much as $1.47 billion. Relay is offering 14.7 million shares in the IPO, which is expected to price between $16 and $18 a share. There will be 81.58 million shares outstanding after the IPO. The stock is expected to list on the Nasdaq under the ticker symbol “RLAY.” J.P. Morgan, Goldman Sachs, Cowen and Guggenheim Securities are the joint bookrunning managers. The company recorded a net loss of $24.9 million with no revenue and operating expenses of $26.5 million during the three months ended March 31, after a loss of $14.2 million on no revenue and expenses of $16.4 million in the same period a year ago. Regarding the company’s lead candidates in precision oncology, it has initiated a Phase 1 trial of RLY-1971 and has completed investigational new drug enabling activities for RLY-4008. The company is looking to go public at a time that the Renaissance IPO ETF IPO, 0.57% has run up 61.7% over the past three months while the S&P 500 SPX, -0.05% has gained 13.6%.

https://www.marketwatch.com/story/relay-therapeutics-sets-ipo-terms-to-be-valued-at-up-to-15-billion-2020-07-09

FDA clears Baxter next-gen bone graft substitute

July 9, 2020

The FDA has issued 510(k) clearance for Baxter International’s (NYSE:BAX) Altapore Shape Bioactive Bone Graft, its next-generation bone graft substitute product line.

The company says Altapore Shape is designed to enhance bone growth and help achieve fusion, leading to reduced pain and improved patient outcomes.

https://seekingalpha.com/news/3589847-fda-clears-baxter-next-gen-bone-graft-substitute