AstraZeneca: Emergent to resume J&J COVID-19 vaccine production in Baltimore

 Emergent BioSolutions said on Wednesday it will resume production of Johnson & Johnson's COVID-19 vaccine at its troubled Baltimore facility, where operations were stopped in April after millions of doses were found to be contaminated.

The resumption comes after J&J last week slashed its 2021 production target of its single-dose vaccine to between 500 million and 600 million doses from its original goal to produce a billion shots.

The resumption follows additional reviews and collaboration with the FDA and manufacturing partners, Emergent Chief Executive Officer Robert Kramer said.

The FDA has so far approved five batches from the Emergent facility since production there was paused, and J&J is working to clear additional doses for use, the drugmaker said last week.

U.S. health regulators in April halted operations at the Baltimore plant following a discovery that ingredients from AstraZeneca's COVID-19 vaccine, also being produced there at that time, contaminated a batch of J&J's vaccines.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices.

J&J's vaccine, considered more convenient for use, storage and shipping to remote areas, has seen a relatively slow uptake in Europe and the United States due to safety concerns and the production issues.

Johnson & Johnson and the FDA did not immediately respond to Reuters requests for comment.

The Wall Street Journal, which first reported the news, cited a letter from the FDA saying the agency had no objections with the plant resuming manufacturing. (https://on.wsj.com/3iXSAfg)

The facility could make as many as 120 million doses a month at full capacity, but the finished doses might not be available until this fall, the Journal reported, citing a source.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Emergent-to-resume-J-J-COVID-19-vaccine-production-at-Baltimore-plant-35996548/

FDA accepts application for Roche's faricimab for macuolar degeneration, edema

  -- Across four phase III studies, approximately half of patients receiving

      faricimab could extend treatment time to every four months -- the first 
      time this level of durability has been achieved in phase III nAMD and DME 
      studies 
 
   -- If approved, faricimab would be the first and only medicine designed to 
      target two distinct pathways that drive retinal diseases that can cause 
      vision loss 
 
   -- The European Medicines Agency has also validated the faricimab Marketing 
      Authorisation Application submission in nAMD and DME 

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Press-Release-FDA-accepts-application-for-Roche-s-faricimab-for-the-treatment-of-neovascular-age-r-35996825/

Sanofi Lifts 2021 Guidance After 2Q Sales Grew

 Sanofi SA said Thursday that sales grew in the second quarter and raised its full-year guidance.

The French pharmaceutical major posted a declining net profit for the quarter compared with the same period in 2020, when the metric went up as a result of a share repurchase transaction completed with Regeneron Pharmaceuticals Inc.

Net profit came in at 1.21 billion euros ($1.43 billion) for the period, from EUR7.60 billion in the same period the year prior, on sales that grew to EUR8.74 billion from EUR8.21 billion in the same quarter of 2020.

Business net income --a key profit metric that excludes some items-- increased to EUR1.73 billion from EUR1.60 billion the year prior.

Business earnings per share were EUR1.38 in the quarter, up from EUR1.28 in 2020.

The company revised its outlook upwards, now guiding for 2021 business EPS growth of around 12% at constant exchange rates, barring unforeseen adverse events. Sanofi had previously guided for business EPS growth in the high-single digits at constant exchange rates.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-Lifts-2021-Guidance-After-2Q-Sales-Grew-35997328/

AstraZeneca 2Q Net Profit Dropped Despite Higher Revenue; Raises Guidance

AstraZeneca PLC said Thursday that net profit declined on-year in the second quarter, though total revenue increased, and raised its core earnings-per-share guidance for 2021.

The pharmaceutical major posted a profit of $550 million in the quarter, down from $756 million in the same period a year prior, on sales which grew to $8.22 billion from $6.28 billion, including revenue generated from the company's Covid-19 vaccine.

Core earnings per share were $0.90 in the quarter, down from $0.96 in the same quarter a year prior, as the metric continued to suffer from the impact of the company's Covid-19 vaccine, which AstraZeneca is developing at no profit.

AstraZeneca raised its guidance for core EPS growth in 2021 following the recently completed acquisition of Alexion Pharmaceuticals Inc. and the issuance of new shares. It said it expects total revenue to increase by a low-twenties percentage and core EPS to be in the range of $5.05 to $5.40. It had previously guided for the metric to be in a range of $4.75 and $5.

"The guidance does not incorporate any revenue or profit impact from sales of the pandemic Covid-19 vaccine," AstraZeneca said, adding that it recognizes uncertainties related to the effects of the pandemic, including the impact from potential new medicines for Covid-19 in clinical development.

AstraZeneca's Covid-19 vaccine generated revenue of $894 million in the quarter, the company said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-2Q-Net-Profit-Dropped-Despite-Higher-Revenue-Raises-Guidance-35998204/

AstraZeneca exploring options for COVID-19 vaccine business

 

AstraZeneca is exploring options for the future of its COVID-19 vaccine business and expects greater clarity on the matter by the end of 2021, a senior executive told Reuters on Thursday.

The comments are the first time the drugmaker has publicly confirmed that it is reviewing the future of the business after a series of setbacks in its race to develop a shot for the world.

AstraZeneca agreed to work with the University of Oxford on its COVID-19 shot last year despite having no prior vaccine experience, taking on the project with a pledge not to make a profit during the coronavirus pandemic.

"We are exploring different options," AstraZeneca Executive Vice President and President of the BioPharmaceuticals Business Unit Ruud Dobber said, referring to the vaccines business.

"Before year-end, we will have more clarity... if you ask me, is the vaccine business a sustainable business for AstraZeneca for the next five or 10 years, that big strategic question is under discussion."

Dobber said that AstraZeneca was committed to delivering a massive rollout of hundreds of millions of doses that were covered by current contracts.

But he added that a "small group of people reporting into Mene (Pangalos, research chief) and myself are thinking about (whether this is) a sustainable business."

"We need to have that discussion with our senior executive team, and then with the board of AstraZeneca," he said.

"We are exploring different options, but it is far too early at this stage to conclude that (process)."

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Exclusive-AstraZeneca-exploring-options-for-COVID-19-vaccine-business-exec-says-36000545/

Merck Q2 earnings highlights

 

• Second-Quarter 2021 Worldwide Sales from Continuing Operations (Excluding Organon) Were $11.4 Billion, 22% Above Second-Quarter 2020; Excluding the Impact from Foreign Exchange, Sales Grew 19% Reflecting Ongoing Recovery from the COVID-19 Pandemic and Strong Underlying Demand Across the Company’s Portfolio of Innovative Products:

  • KEYTRUDA Sales Grew 23% to $4.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 20%

  • GARDASIL/GARDASIL 9 Sales Grew 88% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 78%

  • Animal Health Sales Grew 34% to $1.5 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 27%

• Second-Quarter 2021 GAAP EPS from Continuing Operations Was $0.48; Second-Quarter 2021 Non-GAAP EPS from Continuing Operations Was $1.31

• Progressed Pipeline and Secured Multiple Regulatory Approvals, Including FDA Approval of VAXNEUVANCE, Merck’s 15-Valent Pneumococcal Conjugate Vaccine, for Adults; FDA Approvals for Neoadjuvant/Adjuvant KEYTRUDA in Combination With Chemotherapy for High-Risk Early-Stage Triple-Negative Breast Cancer (KEYNOTE-522) and KEYTRUDA in Combination with Lenvima for the Treatment of Certain Patients With Advanced Endometrial Carcinoma (KEYNOTE-775/Study 309)

• Completed the Spinoff of Organon on June 2; Received Cash Distribution of Approximately $9 Billion

• 2021 Continuing Operations Financial Outlook:

• Expects Full-Year 2021 Sales Growth of 12% to 14%; Narrows and Raises Estimated Full-Year 2021 Revenue Range to be Between $46.4 Billion and $47.4 Billion, Including a Positive Impact from Foreign Exchange of Less Than 2%

• Expects Full-Year 2021 GAAP EPS to be Between $4.24 and $4.34; Expects Full-Year 2021 Non-GAAP EPS to be Between $5.47 and $5.57, Including a Positive Impact from Foreign Exchange of Approximately 2%

• https://finance.yahoo.com/news/merck-announces-second-quarter-2021-103000556.html

Arrowhead Gets Breakthrough Tag for Treatment of Alpha-1 Antitrypsin Deficiency Associated Liver Diseas

 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it was granted Breakthrough Therapy designation (BTD) by the U.S. Food and Drug Administration (FDA) for ARO-AAT, also known as TAK-999, the company’s second-generation investigational RNA interference (RNAi) therapeutic being co-developed with Takeda Pharmaceutical Company Limited ("Takeda”) as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD). Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission.

https://www.businesswire.com/news/home/20210729005199/en/Arrowhead-Pharmaceuticals-Receives-Breakthrough-Therapy-Designation-from-U.S.-FDA-for-ARO-AAT-for-the-Treatment-of-Alpha-1-Antitrypsin-Deficiency-Associated-Liver-Disease