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Bayer Roundup cancer trial postponed

Bayer (OTCPK:BAYRY -3.9%) says it has reached an agreement with plaintiffs’ lawyers to postpone a Missouri jury trial related to its Roundup weedkiller to allow more time for settlement talks.

“While Bayer is constructively engaged in the mediation process, there is no comprehensive agreement at this time,” the company says.

Bayer had been set to face a fourth U.S. jury trial over allegations that Roundup causes cancer, with four cancer patients in the hometown of its Monsanto subsidiary expected to begin making their case today.

Inovio, Moderna score CEPI funds for coronavirus vaccine

In a swift response to the spread of a new coronavirus from China, global outbreak preparedness group Coalition for Epidemic Preparedness Innovations (CEPI) unveiled funding for three early-stage vaccine programs.

Moderna this week disclosed that it’s working with federal researchers on a candidate, and now it’ll have financial backing from CEPI. Pennsylvania-based Inovio Pharmaceuticals scored $9 million in funding for its own program, and CEPI is further expanding a partnership with the University of Queensland.

For Moderna, CEPI’s funding will cover manufacturing for an mRNA vaccine candidate against the new coronavirus strain. The work will be further supported by federal researchers at the National Institute of Allergy and Infectious Diseases (NIAID) who will conduct preclinical tests and a phase 1 study.

Separately, the CEPI grant will cover Inovio’s development costs through phase 1 for the biotech’s candidate, dubbed INO-4800. The vaccine is based on Inovio’s DNA medicine platform that the company says enables rapid development of a vaccine against emerging threats.

Inovio and CEPI already have some history. In 2018, CEPI awarded Inovio up to $56 million over five years for its work on Middle East respiratory syndrome (MERS) and Lassa fever vaccine candidates.


Inovio was involved in the Zika outbreak response as well and reached human testing with its vaccine candidate in just seven months, CEO Joseph Kim said in a statement.

“We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging Chinese coronavirus 2019-nCoV,” he added.

The company has routinely jumped into emerging disease research, but has yet to take a product through to an approval. Moderna doesn’t have any approved drugs or vaccines, either.

The coronavirus out of Wuhan has already killed 26 people and infected at least 881 people, China state TV reported this week.


Aside from those vaccine efforts, Baylor College of Medicine has a program to develop new coronavirus vaccines for severe acute respiratory syndrome and MERS, Peter Hotez, dean for the National School of Tropical Medicine, told FiercePharma. In conjunction with NIAID, plus scientists in New York and Shanghai, the team is testing whether the vaccines could protect against the new coronavirus.

CEPI formed in 2017 as a partnership between governments, philanthropists, pharma companies and others to address a gap in vaccine development funding after Ebola and Zika caught the world off guard. The group set out to raise $1 billion to fund research against numerous threats, and, so far, it has granted $450 million.

Pfizer challenges Roche blockbusters with 3 discount biosim launches

Pfizer hit some unexpected roadblocks with its first U.S. biosimilar launch, but it’s not giving up in the budding field. Now, the drugmaker is launching biosims to three Roche cancer blockbusters at discounts ranging from 22% to 24%.

The company has already rolled out Zirabev and Ruxience, its biosimilars to Roche’s Avastin and Rituxan, respectively, at discounts of 23% and 24%. On February 15, it’s planning to launch Herceptin biosimilar Trazimera at a 22% discount, the company said Thursday.

All three Roche meds are already facing U.S. biosimilar competition and pulled in more than $10 billion combined at peak. For its part, Pfizer says it’ll be the first company to market three oncology monoclonal antibody biosimilars in the U.S.

The drugmaker has been active in the U.S. biosim market, starting with its Inflectra launch in October 2016. That copycat to Johnson & Johnson’s blockbuster immunology med Remicade hit the market at a 15% discount and couldn’t gain traction against the entrenched competition.

Pfizer later sued J&J for making “anticompetitive” deals with payers that blocked out biosimilar competition. Pfizer said J&J tied Remicade’s rebates to the stipulation that payers don’t use biosimilars, while J&J hit back that Pfizer hadn’t offered enough value to win business.

U.S. sales for Inflectra have picked up somewhat and reached $208 million in the first nine months of 2019. Still, that’s compared to a much bigger $2.32 billion haul for Remicade over the same span.

Since that rollout, Pfizer has also launched Retacrit, a biosim to J&J’s Procrit and Amgen’s Epogen. That copycat hit the market in November 2018 at a 33% discount. On an October conference call, Pfizer’s biopharma chief Angela Hwang said Retacrit had nabbed 16% of market share, the most of any biosim in the U.S.

That experience has “given us the opportunity to learn about what it will take to launch oncology biosimilars as well as what we can expect in this particular space,” she said on the call.

Pfizer will be entering a competitive market with its newest biosims. Roche’s Rituxan already faces competition from the Teva-Celltrion team, while Avastin is facing off against a copycat from Amgen and Allergan. Herceptin faces competition from that same Amgen-Allergan duo, plus another in Mylan-Biocon.

Novo Nordisk delivers promised insulin price cuts, plus free option for emergency

Novo Nordisk recently rolled out its promised insulin price cuts, along with a new free emergency supply option. The diabetes drug maker delivered on two earlier announced plans—generic options and a $99-per-month, with-or-without insurance plan—along with an “Immediate Supply” program.

Novo’s new free, one-time emergency supply would give three vials or two packs of pens, or about a one-month supply, to people with prescriptions who may be at risk of rationing. The My$99Insulin program offers a similar three vials or two packs of pens on any Novo Nordisk insulins at a cost of $99 per month, while the generic or follow-on insulin is priced between $145 and $279 depending on the brand.

Novo Nordisk and competitors Sanofi and Eli Lilly announced last year that they would lower insulin prices amid increased criticism and political pressure.


While Novo already had patient assistance programs to help with insulin costs, “Over the last several years, the healthcare system and benefit design have changed, which has led to more people facing affordability challenges like those in high deductible healthcare plans or because they’re uninsured,” the company told FiercePharma in a statement.

Novo came up with the plans after talking to stakeholders, including critics, about insulin needs and gaps for some people with diabetes, adding the new options because “it’s clear that no one solution that will work for everyone and people need options.”

Patients and physicians can access the new programs through Novo said it plans to promote the programs on its social media platforms and corporate websites and through online advertising to patients. It’ll also use its sales force to talk to physicians, it said.


While insulin pricing has long been under fire, the Trump administration pressure—as well as a bipartisan Senate hearing in the spring along, with continued media and consumer criticism—led to the three largest diabetes drugmakers’ price cuts. Lilly first unveiled a generic Humalog insulin at half price in May, followed by Sanofi, which then expanded its savings program to add a $99-per-month subscription plan. Novo announced its price cut plans in September.

Judge OKs ad blitz for opioid epidemic claimants

The judge presiding over Purdue Pharma’s bankruptcy has approved a nationwide noticing program for potential monetary award claimants that would reach ~95% of U.S. adults.

The $23M campaign will include mailings, television and internet advertisements (including Facebook and Spotify).

The deadline for filing claims is June 30.

Opioid crisis-related tickers: McKesson (MCK -3.3%), AmerisourceBergen (ABC -5.2%), Cardinal Health (CAH -3.6%), Mallinckrodt (MNK -7.1%), Teva Pharmaceutical Industries (TEVA -4%), Johnson & Johnson (JNJ +0.1%), Endo International (ENDP -9%)

Drug ‘chaperone’ fends off Alzheimer’s in mice, preventing toxic protein clumping

Alzheimer’s disease has long been associated with the harmful proteins amyloid beta and tau. They clump up in the brain, disrupting neurons and causing memory loss and other symptoms. Researchers at Temple University’s Lewis Katz School of Medicine say they’ve found a new way to prevent amyloid beta and tau from building up in the brain.

The Temple team invented a drug that helps brain cells recognize defective proteins so they can stabilize or remove them altogether before they form toxic clumps. In mouse models of Alzheimer’s, animals who received the drug prior to developing symptoms experienced decreases in tau tangles and amyloid plaques, the researchers reported in the journal Molecular Neurodegeneration.

The researchers refer to their drug as a “chaperone,” because it’s designed to boost levels of a molecule that’s key to cells’ ability to sort and move proteins. That molecule, VPS35, separates dysfunctional proteins and moves them out of cellular compartments called endosomes so they can be discarded.

Previous research from Temple revealed that levels of VPS35 fall in Alzheimer’s disease. They linked that decline with the formation of tau tangles inside of neurons and amyloid plaques outside of them.

The drug chaperone, dubbed TPT-172, replenished levels of VPS35 in the mouse models. That restored the functioning of synapses, which are the places neurons connect and share information. The mice treated with the drug showed improvements in memory and behavior as compared to animals that were also destined to develop Alzheimer’s but were given no treatment. The researchers reported that the Alzheimer’s models that received TPT-172 behaved like normal, wild mice.


Drugs targeting amyloid in Alzheimer’s have so far proven disappointing, but combating toxic brain plaques is still an approach several biotechs are pursuing. Among them is T3D Therapeutics, which raised $15 million in a series B round late last year to develop a drug that addresses protein misfolding in the brain by correcting improper glucose and fat metabolism.

In December, Biogen paid $45 million to license an antisense treatment from Ionis that’s designed to reduce the production of tau protein. That drug is currently in phase 1 testing. And Biogen hasn’t given up on its amyloid-targeted drug aducanumab, even though an initial analysis of the phase 3 program questioned whether it would ultimately succeed.

Unlike other investigational therapies that are designed to block proteins, TPT-172 targets a cellular mechanism, which could help limit the potential side effects, argued Domenico Praticò, M.D., professor and director of Temple’s Alzheimer’s Center, in a statement. That adds “to the appeal of pursuing pharmacological chaperone drugs as novel Alzheimer’s treatments,” he said.

The next step for Praticò’s team is to test TPT-17 in older mice. “Because our most recent investigation was a preventative study, we want to know now whether this therapy could also work as a treatment for patients already diagnosed with Alzheimer’s disease,” he said.

2nd virus patient IDed; extent, duration of airport screening to be ‘re-evaluated’

The two U.S. residents who have been diagnosed with the new coronavirus had both traveled to Wuhan City, China, and arrived in the United States this month with no symptoms.

The Centers for Disease Control and Prevention said Friday that it has investigated at least 63 U.S. residents in 22 states for the virus. Eleven of those individuals tested negative. One man in Washington state and a woman in her 60s in Chicago have both been diagnosed with the respiratory virus. Officials said the woman, who returned from Wuhan on Jan. 13, is in stable condition but remains hospitalized, primarily for infection control.

Health officials in Chicago said the woman had not used public transportation or attended major events once back in the city. Her “close contacts” are being monitored.

As of Jan. 24, officials have screened more than 2,000 people from about 200 flights in the active entry screening program under way at five U.S. airports. No cases were identified as part of the program.

“We first began entry screening with a very clear focus on the epidemic center, that we would continue to evaluate and balance the utility of a border entry screening based on the totality of the circumstances,” a CDC official said. “Circumstances have clearly changed…The concentration of resources and efforts needs to be focused on the tremendous work that our state and local partners are doing to rapidly identify cases and contacts.”

They also said they are “re-evaluating” the extent and duration of airport screening.

China has halted flights out of Wuhan, quarantined the city, and canceled major Lunar New Year celebrations. Travel history and symptoms, including fever and coughing, are the primary reasons why individuals should contact a health care provider if they are concerned about an infection.

Here’s what we know about the virus: Health officials said Friday that the incubation period for the new coronavirus is about 14 days. The incubation periods for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), both coronaviruses, are 2 to 7 days and about 5 days, respectively, according to the CDC. There are at least 881 confirmed cases and 26 deaths of the new virus, according to China Central Television, as cited by The Wall Street Journal.

Raymond James’ Chris Meekins wrote in a research note that it is likely that there are 10 times the number of cases and deaths that have been publicly reported by China. “We doubt it will become a major issue in the U.S.,” he wrote. “We suspect more cases will show up in the U.S. and a death is possible, though unlikely.” The World Health Organization has not called the outbreak a public health emergency of international concern although it met twice this week to discuss whether to do so.

Here’s how the CDC is testing for the virus: If a potential patient is identified, respiratory samples and sometimes blood are sent to the CDC in Atlanta. Once the sample is prepared, the test takes four to six hours. “Part of the delay is the sample getting to CDC,” Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, said during a call with reporters.

Here’s how medical stocks are responding: A handful of vaccine developers and diagnostics firms have seen their shares soar, and some have used the rallies to raise money. It’s common for stocks of biotechnology firms and diagnostics makers to jump during disease outbreaks, Meekins said.

Co-Diagnostics Inc. CODX, -20.94%  on Friday said it had sold 3,448,278 shares of its common stock the day after it announced it is working on a screening test for the coronavirus. Its stock was down 18% in trading on Friday. Also, this week, Inovio Pharmaceuticals Inc. INO, +15.63%  and Moderna Inc. MRNA, -0.75%  separately said they had received grants from the Coalition for Epidemic Preparedness Innovations to develop a vaccine. Earlier this week, J.P. Morgan analysts wrote that “a positive bias is appropriate on pharma stocks broadly and makers of diagnostic kits and protective equipment (like gloves).”

The S&P 500 SPX, -0.67%  has gained 10% over the last three months, while the Health Care Select Sector SPDR Fund XLV, -1.42%  is up about 12%.