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Thursday, August 6, 2020

AstraZeneca in first COVID-19 vaccine deal with Chinese company

Shenzhen Kangtai Biological Products (300601.SZ) will produce AstraZeneca Plc’s (AZN.L) potential COVID-19 vaccine in mainland China, the British drugmaker said on Thursday, its first deal to supply one of the world’s most populous countries.
The deal underscores Astra’s frontrunner position in a global race to deliver an effective vaccine, given that Chinese ventures are leading at least eight of the 26 global vaccine development projects currently testing on humans.
Under the agreement Shenzhen Kangtai, one of China’s top vaccine makers, will ensure it has annual production capacity of at least 100 million doses of the experimental shot AZD1222, which AstraZeneca co-developed with researchers at Oxford University, by the end of this year, AstraZeneca said.
The Shenzhen-based company must have capacity to produce at least 200 million doses by the end of next year as part of the exclusive framework agreement, its statement on the Chinese social media site WeChat said.
The two companies will also explore the possibility of cooperation on the vaccine candidate in other markets, AstraZeneca said.
They did not respond to requests for further comment.
There are no approved vaccines for COVID-19, the highly contagious respiratory illness caused by the coronavirus.
AstraZeneca has signed manufacturing deals globally including the United States, Britain, South Korea and Brazil, resulting in a target to make more than 2 billion doses of the vaccine.
For China, this marks another major deal to secure access to a COVID-19 vaccine developed by a foreign company as the country’s other potential shots under development enter late stage of human trials.
Other collaborations between Chinese and Western players include a tie-up between Germany’s BioNTech (BNTX.O) and Fosun (600196.SS) (2196.HK), as well as one between Inovio Pharma (INO.O) and Beijing Advaccine Biotechnology.
The scramble for treatments and vaccines to curb the pandemic has boosted global pharmaceutical companies’ shares, particularly those in China.
Shenzhen Kangtai’s market value has surged almost 90% to about $20 billion over the past month, with shares hitting all-time highs on Tuesday. The Shenzhen-listed stock was down 10% on Thursday.
In 2019, the company, whose main products are vaccines for Hepatitis B, flu and measles and rubella, reported net profits of 574.5 million yuan ($82.68 million) on revenue of 1.94 billion.

FDA OKs Glaxo antibody-drug conjugate for last-line multiple myeloma

The FDA approves GlaxoSmithKline’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) for the treatment of adults with relapsed/refractory multiple myeloma (MM) who have received at least four prior lines of therapies (“last-line” use).
It is the first anti-B-cell maturation antigen (BCMA) therapy approved anywhere in the world. BCMA is a protein found on the surface of MM cells that plays a key role in the survival of plasma cells.
The nod triggers a $20M milestone payment to antibody-drug conjugate technology licensor Seattle Genetics (NASDAQ:SGEN) who will also receive royalties on net sales.
Glaxo’s marketing application in Europe should be OK’d next month. The EMA’s advisory group CHMP adopted a positive opinion in late July backing approval.

Becton, Dickinson FQ3 top-line down 11%; guidance trails EPS consensus

Becton, Dickinson (BDX) fiscal Q3 results:
Revenues: $3,855M (-11.4%); BD Medical: $2,122M (-8.2%); BD Life Sciences: $951M (-10.1%); BD Interventional: $782M (-20.3%).
Net Income: $277M (-32.9%); EPS: $0.97 (-35.8%); non-GAAP EPS: $2.20 (-28.6%).
CF Ops: $2,058M (+5.1%).
FY 2020 Guidance: Revenues: decrease 2.5% – 3.0% percent on reported; non-GAAP EPS: $9.80 – 10.00. The average analyst estimate is $10.38.
For comparison purposes, original outlook provided during FQ1 was revenue growth of 1.5% – 2.5%; non-GAAP EPS: $11.90 – 12.10. Subsequent guidance, until today, was withdrawn due to pandemic disruptions.

Cardinal Health EPS beats by $1.34, misses on revenue

Cardinal Health (NYSE:CAH): Q4 Non-GAAP EPS of $2.23 beats by $1.34.
Revenue of $36.69B (-1.8% Y/Y) misses by $130M.
Adjusted operating income decreased 13% to $442M vs. consensus of $400.5M.

MediciNova rallies on positive ibudilast data in alcohol use disorder

MediciNova (NASDAQ:MNOV) announces positive results from a Phase 2 clinical trial evaluating MN-166 (ibudilast) for the treatment of alcohol use disorder (AUD). The results were presented virtually at the American Psychological Association Annual Meeting.
Ibudilast significantly reduced the number of heavy drinking days compared to placebo (p=0.03).
There was a significant effect of ibudilast on alcoholic beverage images (ALC) versus non-alcoholic beverage images (BEV) percent signal change in the bilateral ventral striatum (VS) evaluated by fMRI (p=0.02).
Predicting Drinking by Medication: Significant interaction between ibudilast and activation in the VS on subsequent drinking (p=0.02). Patients treated with ibudilast and had attenuated VS activation drank the least in the week after the scan.
Ibudilast significantly reduced binge drinking after 14 days of treatment.


Relief Therapeutics on go to test inhaled version on lead drug in COVID-19

August 6, 2020

The FDA has signed off on a Phase 2/3 clinical trial, AVICOVID-2, evaluating an inhaled formulation of Relief Therapeutics’ (OTCPK:RLFTF) lead candidate RLF-100 (aviptadil) in moderately to severely ill COVID-19 patients to prevent progression to respiratory failure.
The study, led by collaboration partner NeuroRx, will enroll ~288 subjects. The primary endpoint is the proportion of patients progressing to acute respiratory distress syndrome (ARDS) compared to placebo (both on top of standard-of-care treatment). The estimated primary completion date is October.
Aviptadil, a synthetic form of human vasoactive intestinal peptide (VIP), works by binding to receptors on alveolar cells in the lungs, the same cells that SARS-CoV-2 binds to. The company says VIP protects these cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cell death and upregulating the production of surfactant, the loss of which is believed to play a role in COVID-19 respiratory failure.

Bausch Health to spin off eye care business

Bausch Health Companies (NYSE:BHC) jumps 35% premarket on light volume in reaction to a report that it plans to spin of Bausch + Lomb which accounted have its revenue last year.
It acquired the eye care business for $8.7B in 2013 under then-CEO Michael Pearson.