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Wednesday, September 15, 2021

Sage Gets Fast-Track Designation for Huntington's Disease Treatment

 Sage Therapeutics Inc. said it has gotten a fast-track designation from the Food and Drug Administration for its Sage-718 drug candidate to be developed as potential treatment for Huntington's disease.

The fast track is a process for facilitating the development and review of new treatments for severe conditions.

Sage said it expects to start a Phase 2 trial with the drug candidate in early to moderate Huntington's disease in late 2021.

Huntington's disease is a rare, inherited neurodegenerative disease, Sage said. As many as 30,000 adults are diagnosed with the disease in the U.S. each year, the company said.

https://www.marketscreener.com/quote/stock/SAGE-THERAPEUTICS-INC-16917559/news/Sage-Therapeutics-Gets-Fast-Track-Designation-for-Huntington-s-Disease-Treatment-36430211/

Biogen Plans Phase 3b Trial of Spinal Muscular Atrophy Drug

 Biogen Inc. will launch a Phase 3b trial of nusinersen for people with late-onset spinal muscular atrophy, testing a higher dose level of the drug.

The study will focus on patients who have previously been treated with Evrysdi, a Genentech Inc. drug. It aims to include children, teenagers and adults, with enrollment set to begin this year. In the two-and-a-half year study, patients will get two 50 mg loading doses of nusinersen two weeks apart, following by a 28 mg maintenance dose every four months, the company said.

Spinal muscular atrophy causes an insufficiency of survival motor neuron protein, which helps maintain motor neurons that enable sitting, standing and movement. People with the disease lose the ability to do simple everyday tasks, Biogen said.

Nusinersen may help supplement treatment after Evrysdi because Evrysdi shows a reduced drug concentration as patients' weight and age increase. Motor neuron exposure to nusinersen remains similar as patients age and grow, Biogen said.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-Plans-Phase-3b-Trial-of-Spinal-Muscular-Atrophy-Drug-36430902/

Hookipa Working With Merck in Advanced Head and Neck Cancers

 Hookipa Pharma Inc. said it is in a clinical collaboration and supply agreement with Merck & Co. to evaluate HB-200 and Keytruda for patients with advanced head and neck squamous cell carcinoma.

Shares of Hookipa rose 5.6% to $6.57 in premarket trading.

Hookipa said the collaboration was initiated based on promising data from the continuing HB-200 Phase 1/2 clinical trial in advanced human papillomavirus 16-positive cancers.

With an HB-200 program data read-out anticipated by the fourth quarter of 2021, Hookipa said it anticipates initiating a Phase 2 trial with HB-200 in combination with Keytruda in 2022. The company said it is planning additional Phase 2 expansion cohorts to start in the first quarter of 2022.

https://www.marketscreener.com/quote/stock/HOOKIPA-PHARMA-INC-57291650/news/Hookipa-Working-With-Merck-in-Advanced-Head-and-Neck-Cancers-36431091/

U.S. buys additional doses of Eli Lilly, Regeneron COVID-19 therapy

 Eli Lilly and Company said on Wednesday the U.S. government bought 388,000 additional doses of its COVID-19 antibody therapy, as infections surge due to the fast-spreading Delta variant.

The news comes after Regeneron Pharmaceuticals Inc said late on Tuesday the U.S. government was buying 1.4 million additional doses of its COVID-19 antibody cocktail, REGEN-COV.

Lilly said its deal with the U.S government is expected to generate approximately $330 million in revenue in the second half of 2021, with about 200,000 doses expected to be shipped in the third quarter this year and the remaining in fourth.

"The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates," Lilly's chief scientific and medical officer Daniel Skovronsky said.

The drugmaker will supply additional doses of etesevimab to be paired with doses of its other COVID-19 antibody therapy, bamlanivimab, previously purchased by the U.S. government.

Bamlanivimab and etesevimab are authorized for use in people 12 years and above with mild-to-moderate infection and at high risk for progression to severe COVID-19.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-U-S-buys-additional-doses-of-Eli-Lilly-Regeneron-COVID-19-therapy-36430592/

Exact Sciences in Talks With Pfizer Amid Cologuard Sales-Force Changes

 Exact Sciences Corp. on Wednesday said it is in talks that could result in major changes to its Cologuard promotion agreement with Pfizer Inc. after the drugmaker scaled back promotional activity for the at-home colon-cancer screening test.

Exact said Pfizer recently cut the number of sales positions supporting its internal-medicine therapeutic area, and that it has hired about 400 of the sales representatives who were displaced by Pfizer, nearly doubling the size of its primary care field sales team to more than 850 representatives.

Exact, a Madison, Wis., molecular-diagnostics company, inked a Cologuard co-promotion agreement with New York-based Pfizer in late 2018, and the companies last year said they had extended the deal through 2022.

However, Exact on Wednesday said Pfizer is currently promoting Cologuard with a smaller team, and that its partner isn't making in-person sales calls in 41 states due to recent Covid-19 internal policies. Exact, meanwhile, said its newly expanded sales team is in the field and interacting with healthcare providers in person, focused solely on Cologuard initially.

https://www.marketscreener.com/quote/stock/EXACT-SCIENCES-CORPORATIO-9232/news/Exact-Sciences-in-Talks-With-Pfizer-Amid-Cologuard-Sales-Force-Changes-36433999/

Calliditas Therapeutics Shares Drop After PDUFA Date Pushed Back

 Calliditas Therapeutics AB shares were down 10% to $22.16 after the company said the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act goal date for its New Drug Application seeking accelerated approval for Nefecon to Dec. 15.

Volume for the stock was $156,000 shares at 12:40 p.m. ET, compared to its 65-day average volume of 27,000 shares. The stock hit its 52-week low of $20.50 on Aug. 20.

In March, Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of its trial.

In its review of the NDA, the FDA has requested further analyses of the trial data which the company has provided to the FDA. The FDA has classified these analyses as a major amendment to the NDA, extending the PDUFA goal date to December.

https://www.marketscreener.com/quote/stock/CALLIDITAS-THERAPEUTICS-A-44458575/news/Calliditas-Therapeutics-Shares-Drop-10-After-PDUFA-Date-Pushed-Back-36435692/

U.S. hopes COVID vaccine boosters will decrease not just deaths, but virus spread

 U.S. officials preparing to roll out COVID-19 booster shots in the face of waning vaccine protection and surging hospitalizations and deaths caused by the highly contagious Delta variant are hoping boosters might prevent mild cases as well.

In theory, that could reduce virus transmission - a goal officials have been less explicit about - and hasten America's recovery.

“It is not the primary reason (for boosters), but it could actually be a very positive offshoot," Dr. Anthony Fauci, one of the Biden Administration's COVID-19 advisers and the nation’s top infectious disease doctor told Reuters.

The main reason for boosters, Fauci said in a telephone interview, is to reverse the trend of rising "breakthrough" infections among people who are fully vaccinated, a point that many experts dispute.

Available data has shown that most severe breakthrough cases have occurred in people over 65 or among those who are immunocompromised. That latter group is already recommended for a third dose.

Dr. Larry Corey, a virologist at Seattle's Fred Hutchinson Cancer Center who is overseeing the U.S.-government backed COVID-19 vaccine trials, is a proponent of using booster doses to bolster antibody levels enough to prevent infection.

"If you don't get infected, you're not going to transmit it to others, and we will more effectively abort the epidemic, and that has economic benefits," Corey said.

The problem there, many experts point out, is that there is scant scientific evidence showing that boosters will in fact prevent infections and transmission.

Some government studies have shown that when infected with the Delta variant, fully vaccinated people can transmit the virus, mostly to unvaccinated people.

"If you take a look at the evidence from the United States, it is very clear that protection against infection and mildly to moderately symptomatic disease is diminishing," Fauci said.

It is happening among many of the U.S. study populations – including a recent study https://www.reuters.com/business/healthcare-pharmaceuticals/covid-19-vaccines-hold-strong-against-delta-protection-waning-older-adults-2021-09-10 of 600,000 COVID-19 cases in 13 states and large cities. “Not dramatically, but enough," he said.

'WHAT'S THE GOAL?'

While some 63% of eligible people in the United States are fully vaccinated, the Delta variant has caused a surge in the deadly disease among the unvaccinated.

The two most widely used vaccines in the United States – those based on messenger RNA (mRNA) technology made by Pfizer Inc with BioNTech SE and Moderna Inc – are highly effective but less so against Delta. Cases are rising among the vaccinated - including some that result in hospitalization and death.

The U.S. Food and Drug Administration will release data on a possible booster shot on Wednesday morning ahead of a Friday meeting of its vaccine advisory panel. It will include a briefing on the impact of boosters in Israel https://www.reuters.com/world/middle-east/israel-present-covid-19-booster-shot-data-fda-experts-2021-09-05, where the government has closely tracked recipients of the Pfizer/BioNTech shot.

During weekly White House COVID-19 briefings, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, White House COVID-19 Response Coordinator Jeffrey Zients and Fauci have expressed concern that waning immunity against mild, symptomatic COVID-19 could lead to reduced protection against severe disease, hospitalization and death, pointing to data from Israel.

Other countries that have started or are planning booster programs, including Israel - and in the U.K. for people over 50 - have been more frank about the goal to reduce transmission.

Debate over booster doses in the United States has become a sore point for virologists, who largely remain unconvinced that the vaccines are losing their ability to prevent severe disease and hospitalization.

This week, an article in the journal Lancet by two departing FDA vaccine experts and senior scientists at the World Health Organization, challenged the rationale for booster doses https://www.reuters.com/world/us/covid-19-vaccine-boosters-not-widely-needed-top-fda-who-scientists-say-2021-09-13, saying more evidence is needed to justify their widespread use and that most cases of COVID-19 are spread by the unvaccinated.

Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the FDA' vaccine advisory panel, is unconvinced by arguments that boosters are needed just yet.

“The question is, what's the goal? If the goal of the third dose is to enhance protection against serious illness, there's no evidence that that's a problem," Offit said. If the goal is to increase levels of neutralizing antibodies with the aim of decreasing asymptomatic or mild cases, “then we should see those data.”

Corey said the bar for proving a vaccine prevents disease transmission is high.

"Is there proof today? No, but there is every reason to believe that this is possible, and may be beneficial," he said.

Fauci, however, said Israeli data shows that since the booster campaign started, the country has started seeing a decline in the virus’ reproduction number, which represents how many other people a person will COVID-19 is likely to infect. The more immunity in a population, the lower the reproduction number.

Fauci said he is confounded by arguments from vaccine experts that boosters are only needed when vaccines stop preventing severe disease, hospitalization and death.

“What is the magic, mystical issue about hospitalization? I don’t understand that," he said. "What we’re really saying is we don’t care about anything except keeping people out of the hospital. Really? You’re kidding.”

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-U-S-hopes-COVID-vaccine-boosters-will-decrease-not-just-deaths-but-virus-spread-36429567/