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Monday, January 30, 2023

Paxlovid sales forecasts may change with Pfizer view on China

 Clarity from Pfizer Inc this week on whether China's relaxation of its Zero-COVID policy and the surge in infections there will lead to a spike in demand for its antiviral Paxlovid could spur analysts to alter their 2023 sales forecasts for the treatment.

China was an insignificant market for Paxlovid before the strict infection-control policy was lifted, but Pfizer Chief Executive Albert Bourla said the company has since distributed millions of Paxlovid treatment courses there through a deal with China's Meheco.

Still, the status of deliveries later this year remains unclear. Talks between Pfizer and China's government health insurer bogged down over price, and the drug is only covered by China's broad healthcare insurance plan until late March.

Analysts say they have based their 2023 Paxlovid sales estimates primarily on public details of announced deals, with a token amount of estimated China sales from before the country dropped the Zero-COVID policy.

Their current estimates for over $10 billion in 2023 Paxlovid sales is less than half the $22 billion Pfizer is expected to report for 2022, according to Refinitiv data. Growth in China could help offset expected declines elsewhere as many governments have built inventories of the two-drug treatment.

Pfizer will report fourth-quarter and full-year 2022 results on Tuesday.

BMO Capital Markets analyst Evan Seigerman has forecast about $8.7 billion in global sales for Paxlovid in 2023, including $1.9 billion from the developed world outside of the United States, Europe and emerging markets, he said in an email, adding that he is hoping for more information.

"Given the opacity around access and broader availability in China, it is very difficult to model or forecast potential revenues from this product in the country," he said.

Billions of dollars in Paxlovid sales could be at stake for Pfizer.

Using treatment rates in other developed countries as a guide, UK data firm Airfinity forecast that total demand for outpatient COVID-19 treatments in China will reach 49 million courses over the next five months. The firm said around 23.5 million courses of Paxlovid would need to be administered over that period to keep the country's intensive care units from becoming overwhelmed.

scPharma: Commercial launch planned for February 20, 2023

  scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize therapies, advance patient care, and reduce healthcare costs, today announced that the company is targeting February 20, 2023 as the date for commercial availability of FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for outpatient treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. 

https://www.biospace.com/article/releases/scpharmaceuticals-provides-furoscix-furosemide-injection-commercial-updatecommercial-launch-planned-for-february-20-2023/

Kite, Arcellx to Co-develop and Co-commercialize CART-ddBCMA in Multiple Myeloma

  Kite Pharma, a Gilead Company (NASDAQ: GILD), and Arcellx Inc.,  (NASDAQ: ACLX), today announced the closing of the companies’ previously announced global strategic collaboration to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma. Multiple myeloma is an incurable disease for most patients and the need remains for effective, safe and broadly accessible therapies.

Currently being investigated in a Phase 2 pivotal trial, CART-ddBCMA is Arcellx’s T-cell therapy utilizing the company’s novel synthetic binder, the D-Domain. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the U.S., and Kite will commercialize the product outside the U.S.

https://www.biospace.com/article/releases/kite-and-arcellx-close-agreement-to-co-develop-and-co-commercialize-late-stage-clinical-cart-ddbcma-in-multiple-myeloma/

NLS Completes Open Label Extension Study in Narcolepsy

 

  • Six-month Open Label Extension (OLE) study for patients that completed the POLARIS Phase 2 randomized, double-blind study has achieved its final patient visit

  • 87% of patients who completed the POLARIS Phase 2 study requested to continue monotherapy treatment with Mazindol ER in the six-month OLE, rather than transition to other therapies

Ascendiant Capital Starts Heart Test at Buy

 

Price Target of $3.30

https://www.benzinga.com/news/23/01/30620761/ascendiant-capital-initiates-coverage-on-heart-test-laboratories-with-buy-rating-announces-price-tar

Alterity ATH434 Prevents Loss of Brain Cells in Parkinson’s Disease Animal Model

 Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that a study recently published in the journal Neurotherapeutics demonstrated that its lead clinical asset, ATH434, was neuroprotective in a genetic model of Parkinson’s disease (PD). Parkinson’s is a progressive neurodegenerative disorder that causes slow or abnormal movements of the body and non-motor features that contribute significantly to morbidity and reduced quality of life.

The publication, entitled “ATH434 Rescues Pre‑motor Hyposmia in a Mouse Model of Parkinsonism” assessed the impact of ATH434 on motor and non-motor deficits in mice with genetically induced Parkinson’s disease1. Hyposmia, defined as reduced sensitivity to odor, is an early and common non-motor symptom of PD that precedes the typical motor symptoms by several years, occurring in approximately 90% of early-stage cases of PD2.

The study found that ATH434 prevented a loss of smell in the younger mice and rescued it in older mice. More importantly, the authors also demonstrated that ATH434 prevented the development of motor impairment in older animals, which was associated with a reduction in iron levels and preservation of neurons in the substantia nigra, the brain region affected in Parkinson’s. These data support other studies indicating that ATH434 has a beneficial effect on the motor and non-motor symptoms in animal models of PD.

https://finance.yahoo.com/news/alterity-ath434-prevents-loss-brain-122500918.html

Regeneron upped to Outperform from Market Perform by Cowen

 Target to $875 from $775 

https://finviz.com/quote.ashx?t=REGN&ty=c&ta=1&p=d