Sanofi to Form New Company With Focus on Active Pharmaceutical Ingredients

 Sanofi SA said Tuesday that it is creating a new company that will focus on active pharmaceutical ingredients and go by the name of Euroapi.

The French pharmaceutical giant said the new company--which will focus on the molecules that give a drug its therapeutic effect--is poised to be the largest European player in the sector. It is expected to generate 1 billion euros ($1.22 billion) in sales by 2022, Sanofi said.

An initial public offering for the company on Euronext Paris will be evaluated for 2022, Sanofi said.

Euroapi's chief executive officer will be Karl Rotthier, effective as of Jan. 18. The company will employ 3,200 skilled employees and will have its headquarters in France, according to Sanofi.

Sanofi's stake in Euroapi will be 30%, said Philippe Luscan, executive vice president of global industrial affairs at the pharmaceutical giant.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-to-Form-New-Company-With-Focus-on-Active-Pharmaceutical-Ingredients-32178105/

Novartis, once wary of Chinese M&A, dives into BeiGene's I-O

 

Swiss drugmaker Novartis paid $650 million to snag an immuno-oncology drug from BeiGene Ltd, the latest Western drugmaker turning to China for must-have assets to fill holes in their cancer portfolios.

Novartis Chief Executive Vas Narasimhan's move, which could bring $1.55 billion in milestone payments and royalties for BeiGene, is also an about-face from comments two years ago when he raised data quality and innovation worries as barriers to Big Pharma's Chinese M&A dreams.

Novartis will co-develop BeiGene's tislelizumab, an anti-PD-1 antibody similar to Keytruda from Merck and Opdivo from Bristol-Myers Squibb which help the immune system attack cancer and which have reaped billions of dollars in sales.

Pfizer's $200 million investment in China's CStone Pharmaceuticals in September, also targeting an immuno-oncology asset, is another such a deal.

Like Pfizer, Novartis has been tardy in developing cancer immunotherapy assets, with home-grown spartalizumab failing in a trial against skin cancer last year. That boosted urgency to scoop up BeiGene's asset that Novartis hopes to pair with other medicines.

Susanne Schaffert, Novartis's cancer area head, pledged to use tislelizumab "to develop transformative combination therapies for patients", she said.

BeiGene's drug has long been coveted by Western drugmakers: Celgene bought tislelizumab rights in 2017 for $263 million, but returned them when the U.S. company was bought by Bristol-Myers Squibb for $74 billion in 2019.

"DATA QUALITY"

In May 2019, Novartis's Narasimhan struck a dour tone about Chinese M&A targets, telling investors "you don't see real fundamental new target discovery leading to novel drugs" and that "data quality needs to go up".

With gaps to fill, however, Narasimhan is now adding BeiGen's tislelizumab, also because the drug may have properties that could overcome problems that compromise other immuno-oncology drugs' anti-tumour activity.

Novartis will promote tislelizumab in North America, the European Union and Japan.

Tislelizumab is approved in China for lymphoma and bladder cancer.

https://www.marketscreener.com/quote/stock/CSTONE-PHARMACEUTICALS-57946082/news/Novartis-once-wary-of-Chinese-M-A-dives-into-BeiGene-s-cancer-immunotherapy-32179341/

Pfizer forecasts 2021 earnings of $3 to $3.10 per share

 Pfizer Inc expects 2021 earnings of between $3 and $3.10 per share, Chief Executive Officer Albert Bourla said at a J.P. Morgan healthcare conference on Tuesday.

Wall Street analysts on average expect Pfizer to earn $3.07 per share, according to IBES data from Refinitiv.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/REFILE-Pfizer-forecasts-2021-earnings-of-3-to-3-10-per-share-32179037/

Alexion Highlights Commercial, Clinical and Financial Progress at JPM

 - Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020 -

- Expects to exceed the high end of 2020 revenue guidance, given at Q3 2020 results, of $5.9-$5.95 billion -

- Recently announced acquisition agreement will enhance AstraZeneca’s presence in immunology and provides opportunity to expand on Alexion's innovative complement-technology platforms -

https://www.businesswire.com/news/home/20210112005200/en/%C2%A0Alexion-Highlights-Commercial-Clinical-and-Financial-Progress-at-the-39th-Annual-J.P.-Morgan-Healthcare-Conference

Glaxo, Vir to test antibody for COVID-19 treatment

 Britain’s GSK and U.S.-based Vir Biotechnology will evaluate one of their monoclonal antibodies in patients with mild to moderate COVID-19 in an early- to mid-stage trial, the companies said on Tuesday.

The trial, under the UK-based AGILE initiative, is expected to begin in the first quarter of 2021 at multiple sites across the UK, the companies said in a joint statement.

https://www.reuters.com/article/healthcoronavirus-glaxosmithkline/gsk-vir-to-test-antibody-for-covid-19-treatment-idUSL4N2JN1XM

Novavax taps Baxter for commercial production as COVID-19 vaccine nears finish line

 With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

The Bloomington, Indiana-based CMO will tackle fill-finish work on Novavax’s recombinant nanoparticle adjuvanted vaccine, a Novavax spokeswoman said via email. The company’s candidate, NVX-CoC2373, is still in phase 3, though it's eyeing a phase 3 data readout sometime during the first quarter.

Back in August, Novavax was already setting lofty production goals. On a conference call, Chief Medical Officer Filip Dubovsky, M.D., said the company expected to be able to make “well over a couple billion units” each year, beginning in 2021. That’s more than enough for the Gaithersburg, Maryland-based biotech to single-handedly meet U.S. demand, which Dubovsky pegged at around 500 million to 600 million doses annually.

As of January, Novavax has built out a worldwide manufacturing network with production firepower to churn out 2 billion vaccine doses per year, CEO Stan Erck said Monday at the annual J.P. Morgan healthcare conference. The company plans to deliver 110 million doses to the U.S. in the second quarter of the year, he added.

Novavax in May bought Praha Vaccines and its vaccine plant in the Czech Republic, which boasts annual capacity of 1 billion doses, Erck told investors in August. It also brought Fujifilm into the fold to produce clinical supplies and signed AGC Biologics and PolyPeptide to help produce its Matrix-M adjuvant.

In September, the company added two more manufacturing partners, tapping vaccine powerhouse the Serum Institute of India and generics player Endo.

Meanwhile, the company in November revealed two new real estate transactions meant to bolster its manufacturing and commercial presence in its home state of Maryland. The first, a 15-year lease for some 122,000 square feet of space, will house offices, manufacturing and R&D activities and is expected to come online early this year. At the same time, a Novavax affiliate snapped up 9.7 acres on Firstfield Road in Gaithersburg for future development.

Novavax may not have been the first to the finish line in the vaccine race, but plenty of countries are still hoping the biotech’s shot can help see their immunization efforts through. The U.K. has secured 60 million doses, while the U.S. is set to receive a little over 100 million doses initially. Plus, Novavax isn’t stopping there. The company late last week locked in a purchase agreement with Australia for 51 million doses.

https://www.fiercepharma.com/manufacturing/novavax-taps-baxter-for-commercial-production-as-covid-19-vaccine-nears-finish-line

Boston Scientific sinks after downbeat sales outlook

 Shares of Boston Scientific Corp. BSX, -4.53% sank 4.2% in premarket trading Tuesday, after the medical technology company provided a fourth-quarter sales outlook that was below Wall Street forecasts. The company expects to report sales for the quarter to Dec. 31 of $2.71 billion, down 6.8% from a year ago and below the FactSet consensus of $2.86 billion. Among the company's business segments, MedSurg revenue is projected to increase 1.5%, Rhythm and Neuro sales are expected to decline 6.1% and Cardiovascular sales are seen falling 12.0%. The FactSet consensus implied a Cardiovascular sales decline of just 3.4%. The stock has dropped 13.2% over the past three months through Monday, while the SPDR Health Care Select Sector ETF XLV, -0.73% has advanced 8.1% and the S&P 500 SPX, +0.16% has tacked on 7.5%.

https://www.marketwatch.com/story/boston-scientifics-stock-sinks-after-downbeat-sales-outlook-2021-01-12