AbbVie Inflated Prices For Two Major Drugs, Engaged In Anticompetitive Practices: House Panel

 

• AbbVie Inc (NYSE: ABBV) significantly inflated prices over the past two decades for patients in the U.S. who take the drugs Humira and Imbruvica, a report released by the House Oversight and Reform Committee found.

• The committee concluded that the price increases led to billions of dollars in corporate revenue and hefty bonuses for company executives.

• “AbbVie pursued a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anticompetitive pricing practices,” the report states.

• The report comes after the panel reviewed more than 170,000 internal data, documents, and communications related to the medications over the last 18 years.

• Chairwoman Carolyn Maloney, D-N.Y., issued a subpoena for the documents last year because the company refused to cooperate with a previous request for the materials.

• A representative for AbbVie did not respond to a request for comment.

• Humira, a rheumatoid arthritis treatment, was released in 2003 when the company was Abbott Laboratories. AbbVie has since raised the cost frequently, and by more than 470%, with an annual supply now costing about $77,000, the report said.

• In 2020 alone, AbbVie reported billion in U.S. net revenue for Humira.

• AbbVie faces no current competition in the U.S. from biosimilar versions of Humira, even though six biosimilars have received FDA approval.

• Meanwhile, AbbVie, in conjunction with Janssen Biotech, has increased the price of Imbruvica, a drug used to treat mantle cell lymphoma and other cancers, by 82% since it launched in 2013.

• In 2013, the drug was priced at $99,776 annually. Today, it’s priced at $181,529.

• Experts estimate that by 2026, Imbruvica will be the fourth best-selling drug in the U.S.

• Today’s full committee hybrid hearing with AbbVie CEO Richard Gonzalez and experts on pricing practices for Humira and Imbruvica has begun at 10:00 a.m. ET.

• Price Action: ABBV shares closed up 0.27% at $117.21 on Tuesday.

https://finance.yahoo.com/news/abbvie-inflated-prices-two-major-214721687.html

Why Agenus Soared

 Shares of Agenus (NASDAQ:AGEN) skyrocketed 20.6% on Tuesday. The big gain came after the company announced a deal to license bispecific antibody program AGEN1777 to Bristol Myers Squibb (NYSE:BMY). 

What really lit a fire under the biotech stock from today's news was just how much Bristol Myers Squibb was willing to fork over for rights to AGEN1777. The big drugmaker is paying Agenus $200 million upfront. Agenus also stands to receive up to $1.36 billion in milestones as well as tiered double-digit royalties on potential sales for the product.

AGEN1777 hasn't advanced into clinical testing yet. However, the experimental therapy has demonstrated promise in preclinical studies in treating tumors where anti-PD-1 or anti-TIGIT antibodies aren't effective by themselves. 

Agenus plans to file an Investigational New Drug (IND) application by June 30, 2021, to begin an early stage clinical study of AGEN1777. Bristol Myers Squibb expects to explore the use of the experimental therapy in treating non-small cell lung cancer as well as other high-priority indications.

https://www.fool.com/investing/2021/05/18/why-agenus-stock-skyrocketed-today/

Magenta Therapeutics started at Buy by B. Riley

 Target $21

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India's Biological E. to produce J&J COVID-19 vaccine

 India's Biological E. will produce the Johnson & Johnson COVID-19 vaccine alongside its own candidate, its managing director told Reuters on Tuesday, which could boost the country's overall supplies amid a shortage.

"The infrastructure and plants are completely separate for both the products and we will be producing both independent of each other," Mahima Datla said in a text message, declining to give any timeline or other details.

She told Reuters in February that Biological E. was looking to contract-manufacture about 600 million doses of the J&J vaccine annually. India's government, however, did not factor in any production of J&J this year in the country in a list of likely vaccine output released last week.

J&J confirmed to Reuters it was working with Biological E. on manufacturing its vaccine.

"We believe Biological E. will be an important part of our global COVID-19 vaccine supply network, where multiple manufacturing sites are involved in the production of our vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed," a J&J India spokesperson said in an email.

J&J said last month it had sought permission to conduct a local clinical trial in India for its single-dose vaccine.

Biological E., based in the southern Indian city of Hyderabad, also plans to produce 75 million to 80 million doses of its own vaccine a month from August. The drug has been developed with Baylor College of Medicine in Houston and Dynavax Technologies Corp.

The United States said in March it would finance Biological E.'s efforts to produce at least 1 billion doses of COVID-19 vaccines by the end of 2022.

Reuters reported on Tuesday that India was unlikely to resume major exports of COVID-19 vaccines until at least October as it diverts shots for domestic use, a longer-than-expected delay set to worsen supply shortages from the global COVAX initiative.

https://finance.yahoo.com/news/1-indias-biological-e-produce-155805987.html

Pfizer, Moderna vaccines can block variant hitting Asia: lab study

 Gold-standard experiments on two COVID-19 vaccines suggest that they confer immunity against a subtype of the SARS-CoV-2 variant tearing through India. But the research also hints that this subtype is more resistant to antibodies than are other forms of the virus.

“These vaccines are working,” says Mehul Suthar, an immunologist at Emory University in Atlanta, Georgia, who led the research1. Still, the results underscore the need to continue monitoring vaccine response to SARS-CoV-2 mutations, which often affect the all-important spike protein that the virus uses to infect cells. “Because of the spectrum of mutations that have accumulated within the spike protein, the antibodies just don’t work as well,” says Suthar.

First detected in India last October, the variant B.1.617 was this year linked to a rapid rise in cases in a handful of Indian states and has now been found in more than 40 countries. The subtypes B.1.617.1 and B.1.617.2 have both been detected with increasing frequency in India in the past few months; both carry two mutations linked to increased transmissibility. Because of their quick spread, scientists are keen to find out whether the various forms of B.1.617 undermine COVID-19 vaccines.

Other research has analysed how well the vaccine made by Pfizer in New York City and BioNTech in Mainz, Germany, fares against B.1.617. But that work did not use actual SARS-CoV-2; instead, it used other viruses engineered to have key mutations found in B.1.6172,3.

For their experiments, Suthar and his team used B.1.617.1 itself, making their assay a ‘gold standard’ test for vaccine efficacy. The researchers combined the virus with antibody-laden blood serum from people who had received either the Pfizer vaccine or that made by Moderna of Cambridge, Massachusetts, both based on mRNA. This allowed the team to study how well antibodies induced by vaccination could ‘neutralize’ the virus, or block it from infecting cells.

The team’s data show that antibodies generated by vaccination are seven times less effective at blocking B.1.617.1 than at neutralizing the coronavirus strain that circulated early in the pandemic. But antibodies from all 25 vaccinated people were able to neutralize B.1.617.1 to some extent.

“It’s pretty important work,” says Scott Weaver, a virologist at the University of Texas Medical Branch at Galveston. But he noted that the results offer one snapshot of immunity, which can change over time. For a full picture, Weaver says, “we need to test sera from people who have been vaccinated at various points in time in the past”.

The findings underscore the need to increase vaccination rates, Suthar says. “So long as there is a naive population out there, the virus is going to infect, replicate and mutate.”

The findings have not yet been peer reviewed.

doi: https://doi.org/10.1038/d41586-021-01329-9

https://www.nature.com/articles/d41586-021-01329-9\\\

Kinnate Bio: FDA OKs application; to begin Phase 1

 KIN-2787 is the company’s RAF inhibitor candidate for patients with mutant BRAF-driven solid tumors

Planned initiation of Phase 1 clinical trial for KIN-2787 in mid-2021

Ended the quarter with cash and cash equivalents and investments of $383.1 million

Closed $35 million Series A financing of Chinese joint venture in May 2021

https://finance.yahoo.com/news/kinnate-biopharma-inc-reports-first-200500578.html

Redhill Bio started at Buy by Wainwright

 Target $23

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