JPM: Pfizer upped COVID-19 vax capacity with 'out of the box manufacturing'

 Earlier this week, Pfizer partner BioNTech upped the pair’s 2021 COVID-19 output projection to 2 billion doses for 2021, up from a previous estimate of 1.3 billion. But how will the companies get there?

By doing things “very differently and very out of the box in manufacturing,” CEO Albert Bourla explained Tuesday during a fireside chat at the J.P. Morgan Healthcare Conference.

There are “so many initiatives we have put in place,” Bourla said, including changing the the way it works with partners on raw materials, reimagining its operational flow to improve capacity, designing new equipment—and working with manufacturers to get that new equipment delivered quickly—and more.

And getting there was no easy feat. “I have to say that I have admiration for our manufacturing team as much as I have for our research team,” Bourla said. “It’s almost equally difficult to scale up manufacturing at that level so fast as it was to develop the vaccine, and both teams have risen to the occasion.”

So what will those additional doses mean for Pfizer’s bottom line? “Clearly, it’s complicated, and clearly there are a lot of dynamics that are happening right now,” Bourla said—but he did for the first time share a 2021 profit prediction of between $3.00 and $3.10 per share at the midpoint, safely above the $2.96 per share that analysts had been expecting.

Unlike major vaccine players AstraZeneca and Johnson and Johnson, Pfizer hasn’t pledged not to profit off its shot—though the “common element” among all the players’ pricing strategies is that “everybody has priced their vaccine well below the value” to society, Bourla said.

But he does see a potential scenario where, after the pandemic phase is done, Pfizer has “repeated business because there’s COVID around” that “we want to keep controlled or that because there are new strains”—and in that situation, the company might use “prices that reflect cutting-edge technology,” similar to those for other next-gen vaccines.

And speaking of next-gen vaccines, Pfizer expects to eventually wield more of them, including an mRNA-based flu vaccine it’s been working on for the last three years.

“I think it’s a must,” Bourla said of taking mRNA technology into other fields. “I don’t think after all this know-how … that we will not utilize it to be able to provide medical solutions for other devastating diseases.

“Within a year, we accumulated scientific knowledge and technology and know-how of years. We have developed infrastructure that normally would take years to be able to develop,” Bourla continued. "It’s time to use it for the better of humanity.”

https://www.fiercepharma.com/pharma/jpm-how-did-pfizer-up-its-covid-19-vaccine-capacity-out-box-manufacturing-ceo-says

Bayer plans 3 new drugs, banks on gene, cell therapy allogeneic cancer meds

 German pharma giant Bayer has plans to introduce three news drugs with annual sales potential of $1.22 billion (€1 billion) but these will not offset the fall in revenue the company anticipates from the loss of patents over its two best-sellers.

Stefan Oelrich, the company head, who joined in 2018 from rival Sanofi, acknowledged that the new drugs would not compensate for the effects of the forthcoming patent expiry on both its blood thinner Xarelto and eye medicine Eylea, which will start this year in stages globally. The two drugs generate more than €6bn ($6.2 billion) in annual sales, over a third of Bayer’s pharma revenue. “No company in the world . . . would be able to fill such a gap just at once,” said Oelrich at a media meet on Wednesday.

Bayer recently announced a partnership with German vaccine maker CureVac to accelerate the development of a Covid-19 vaccine.

Bayer is still struggling from its ill-fated acquisition of Monsanto in 2016 and the slew of lawsuits it inherited for Monsanto’s weed killer Roundup’s carcinogenic effects.

Its share price has dropped by over 50 percent in the last five years. After agrichemicals business pharma is its second-largest revenue puller with annual sales of over €18 billion. “The pipeline is light, especially in oncology, but has some more promising products,” said Sebastian Bray, an analyst at Berenberg.

Bayer has turned its focus to cell and gene therapy in the last two years and spent over €5 billion in acquiring companies specializing in the research and development of these sciences.

“We are aiming to launch at least three new clinical substances per year,” Oelrich revealed. The approval processes in these spaces are less tedious and time-consuming and even the R&D cycles are shorter.

But for these investments to pay-off, it will take at least another four to five years. He said the medium-term impact could be larger, with Bayer working on seven promising cell and gene therapy products in clinical development. Bray said Bayer’s move into this new field was right: “Cell and gene therapy are the higher growth markets in pharma,” he said.

Bayer recently invested $105 million in a funding round in closely held Senti Biosciences, a California-based company using synthetic biology to develop off-the-shelf cell therapies for cancer. It is the third cell therapy company to receive investment from Bayer.

“We believe that synthetic biology will become an important pillar in next-generation cell and gene therapy, and that Senti Bio’s leadership in designing and optimizing biological circuits fits precisely with our ambition to prevent and cure cancer and to regenerate lost tissue function,” Juergen Eckhardt, head of Bayer’s venture arm, called Leaps by Bayer, said in a statement.

Bayer also initially took a minority stake in BlueRock Therapeutics before buying out the company in a $1 billion transaction. Leaps by Bayer also took part in a$215 funding round for Century Therapeutics.

The company is also banking on three new drugs with an annual sales potential of over €1bn. The drugs are—a cancer medicine named Nubeqa; a drug called Finerenone to treat diabetic kidney disease; and a drug to treat menopausal symptoms. The cancer drug has already been launched successfully, the kidney disease drug will be launched this year, and the third medicine is in the last stage of clinical trials and will be released in 2024, most likely.

https://www.industryleadersmagazine.com/bayer-plans-3-new-drugs-banks-on-gene-and-cell-therapy-allogeneic-cancer-medicines/

Organogenesis Reports Prelim Q4, 2020 Financial Results

 Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported preliminary financial results for the three months and twelve months ended December 31, 2020.

Fourth Quarter 2020 Preliminary Financial Results Summary:

• Net revenue of between $104.6 million and $106.0 million for the three months ended December 31, 2020, up 40% to 42% compared to net revenue of $74.6 million for the three months ended December 31, 2019.
  Net revenue is based upon:
  ○  Net revenue from Advanced Wound Care products of between $92.0 million and $93.2 million, up 45% to 47% year-over-year.
  ○  Net revenue from Surgical & Sports Medicine products of between $12.6 million and $12.8 million, up 12% to 14% year-over-year.
• Net revenue from the sale of PuraPly products of between $43.8 million and $44.6 million for the three months ended December 31, 2020, up 10% to 12% year-over-year.
• The Company expects to report positive GAAP net income and positive Adjusted EBITDA for the three months ended December 31, 2020.
  

Fiscal Year 2020 Preliminary Financial Results Summary:

• Net revenue of between $336.1 million and $337.5 million for the twelve months ended December 31, 2020, up approximately 29% compared to net revenue of $261 million for the twelve months ended December 31, 2019.
  Net revenue is based upon:
  ○  Net revenue from Advanced Wound Care products of between $293.0 million and $294.2 million, up approximately 33% year-over-year.
  ○  Net revenue from Surgical & Sports Medicine products of between $43.1 million and $43.3 million, up 7% to 8% year-over-year.
• Net revenue from the sale of PuraPly products of between $145.8 million and $146.6 million for the twelve months ended December 31, 2020, up 15% to 16% year-over-year.
• The Company expects to report positive GAAP net income and positive Adjusted EBITDA for the full fiscal year 2020 period.

https://www.globenewswire.com/news-release/2021/01/13/2158251/0/en/Organogenesis-Holdings-Inc-Reports-Preliminary-Financial-Results-for-Fourth-Quarter-and-Fiscal-Year-2020.html

Alexion Updates on Phase 3 Study of ULTOMIRIS in Severe Covid

 – Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis –

– Company will conduct further analysis of trial data to determine next steps –

– No new safety findings were observed for ULTOMIRIS use in COVID-19 –

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when ULTOMIRIS was added to best supportive care, compared to best supportive care alone. There were no new safety findings observed. The study will continue for patients already enrolled, including completion of all study visits and planned ULTOMIRIS dosing according to the study protocol.

“We would like to thank the patients and their families, as well as investigators and healthcare professionals, who were essential to this study. We greatly value their contributions to help investigate potential ways to address this devastating pandemic,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “While initial anecdotal reports from compassionate use cases were promising, these results demonstrate the importance of conducting controlled clinical trials to fully evaluate the potential of new treatment approaches and generate the necessary evidence to make informed decisions. We are disappointed in this initial outcome, but plan to further analyze the data to identify potential subgroups who may benefit and to determine next steps. In addition, we remain fully committed to our efforts to serve the rare disease community and to continuing to provide ULTOMIRIS to the patients who currently rely on it.”

The IDMC’s recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period. No secondary endpoints were analyzed as part of the interim analysis.

In the UK, the TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which includes an ULTOMIRIS cohort, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. This independent study remains ongoing.

https://www.streetinsider.com/Business+Wire/Alexion+Provides+Update+on+Phase+3+Study+of+ULTOMIRIS%C2%AE+%28ravulizumab-cwvz%29+in+Hospitalized+Patients+with+Severe+COVID-19/17820004.html

DOD, HHS Procure More Regeneron COVID-19 Antibody In Potential $2.6B Deal

 Regeneron Pharmaceuticals (Nasdaq: REGN) will supply an additional 1.25M treatment courses of an antibody cocktail composed of casirivimab and imdevimab to the U.S. government under a potential $2.63B agreement with the departments of Defense and Health and Human Services.

DOD said Tuesday the biotechnology company is scheduled to deliver the medicines during the first half of this year to be used as treatment for high-risk and non-hospitalized COVID-19 patients as part of Operation Warp Speed, the federal government's vaccination initiative with the private sector.

The Food and Drug Administration granted emergency use authorization to Regeneron's antibody combination drug in November 2020.

The agreement with the company will bring the total number of casirivimab-imdevimab treatment course orders from both DOD and HHS to more than 1.5M, according to the Pentagon.

DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense partnered with HHS' Biomedical Advanced Research and Development Authority and the U.S. Army for the contracting process.

HHS awarded $2.05B in contracts to Novavax and Regeneron in July to expedite COVID-19 drug production work. The latter company is working to deliver an initial 300K doses to health departments at the state and territorial levels.

https://www.govconwire.com/2021/01/dod-hhs-to-procure-more-doses-of-regenerons-covid-19-antibody-under-potential-2-6b-deal/

Baxter Germany to start production of BioNTech/Pfizer vaccine by early March

 Baxter plans to start production of the COVID-19 vaccine by BioNTech and Pfizer in Germany in late February or early March, Juergen Fleischer, personnel chief at Baxter Germany, said.

“We are still in the process of converting the production facility for the demands of BioNTech’s deep-frozen product,” he said.

The company will also make vaccines for Novavax at the site, Baxter had announced on Monday.

https://www.reuters.com/article/us-health-coronavirus-vaccines-baxter-in/baxter-germany-to-start-production-of-biontech-pfizer-vaccine-by-early-march-idUSKBN29I18Y

India wants Pfizer to do local study before covid vax approval

 Any vaccine maker, including Pfizer Inc that has sought emergency-use authorisation for its COVID-19 shot in India, must conduct an additional local study to be considered for the country’s immunisation programme, a senior government official told Reuters.

Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, did a months long local study on more than 1,500 people before seeking and receiving emergency approval on Jan. 3.

India, which has reached 10.5 million coronavirus infections - the second highest in the world after the United States - has also approved a homegrown vaccine made by Bharat Biotech ahead of its inoculation campaign which starts on Saturday.

Local media have reported that Pfizer had sought to import and distribute its vaccine in India without doing local trials. In early December, it was the first company to seek emergency-use approval in the world's second-most populous country but has not attended subsequent meetings called by India's Central Drugs Standard Control Organization, according to minutes here of the deliberations released on the drugs regulator's website.

“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.

The government has already distributed 16.5 million doses of the two approved vaccines to states, with a plan to deliver 600 million jabs to the most vulnerable people in the next six to eight months. Serum Institute has stockpiled 50 million doses of the AstraZeneca vaccine and says it will raise its monthly output to much more than that now the approval has come.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations. There are, however, provisions here under India's New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.

A Pfizer spokeswomen had no immediate comment.

The Pfizer vaccine, developed in partnership with Germany’s BioNTech SE, is already being administered to people in countries such as the United States and Britain. It was not immediately clear if any other countries had asked for similar smaller local trials before approving vaccines developed and tested abroad.

Paul said Indian officials have had discussions with Pfizer and Moderna Inc - both U.S. companies have reported more than 90% efficacy for their vaccines - to make the shots in India given its large pharmaceutical capacity. India is the world’s biggest vaccine maker.

Paul, a paediatrician who had taught at the state-run All India Institute of Medical Sciences, also said Russia’s Sputnik V, which is now undergoing last-stage trials in India after completing a Phase 2 study there, will soon apply for emergency-use approval in the country.

No vaccine maker will be given indemnity by the government should something go wrong, Paul said. Serum Institute had written to the government seeking indemnity. AstraZeneca has said it has received such indemnity in many other countries.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine-excl/exclusive-india-wants-pfizer-to-do-local-study-before-approval-official-idUSKBN29I1R9