Glaxo sees lower profit this year, split plans on track

 Britain’s GSK forecast a dip in earnings this year as it grapples with COVID-19 disruptions and invests in its pipeline of new drugs, and said its plans to split into two businesses were on track.

The world’s biggest vaccine maker by sales said on Wednesday it expected adjusted earnings to fall by a mid- to high-single digit percentage at constant exchange rates.

Turnover for the fourth-quarter of 2020 fell 2% to 8.74 billion pounds ($11.9 billion) and adjusted earnings came in at 23.3 pence per share, both slightly higher than analysts’ average forecast.

While the COVID-19 pandemic has boosted demand for GSK’s over-the-counter painkillers, it has disrupted other parts of its business as patients have made fewer trips to doctors.

Earlier on Wednesday, GSK said it was teaming up with German biotech firm CureVac to develop a COVID-19 vaccine to target several variants of the virus with one shot.

Rather than developing its own COVID-19 shot, GSK has so far focused on supplying its vaccine booster, or adjuvant, to other drugmakers. But it has had two big setbacks, as a project with Sanofi was delayed, while China’s Clover ended its deal with GSK on Monday.

Meanwhile, companies using new technologies that don’t require adjuvants, including Pfizer/BioNTech and Moderna, are already rolling out COVID-19 vaccines.

GSK last year launched a two-year programme to split in two after the merger of its over-the-counter products business into a venture with Pfizer that created a market leader with brands from Sensodyne toothpaste to Panadol painkillers. That will be split from its drug making business.

https://www.reuters.com/article/us-gsk-results/gsk-says-split-plans-on-track-forecasts-dip-in-profit-this-year-idUSKBN2A31OT

Jazz Pharmaceuticals to Acquire GW Pharma

 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and GW Pharmaceuticals plc (Nasdaq: GWPH) today announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company's lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

The two companies will host a conference call today at 8:30 AM ET to discuss this transaction. The live webcast may be accessed from the Investors section of the companies' websites at www.jazzpharmaceuticals.com and www.gwpharm.com. Please connect prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing (855) 353-7924 in the U.S., or (503) 343-6056 outside the U.S., and entering passcode 5591214.

A replay of the conference call will be available through February 10, 2021, by dialing (855) 859-2056 in the U.S., or (404) 537-3406 outside the U.S., and entering passcode 5591214. An archived version of the webcast will be available for at least one week in the Investors section of the companies' websites at www.jazzpharmaceuticals.com or www.gwpharm.com.

https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-acquire-gw-pharmaceuticals-plc-creating

AbbVie Earnings Top Estimates, Guidance Strong

 Early Wednesday, AbbVie stock rose after the pharmaceutical company reported adjusted profit of $2.92 per share on $13.86 billion in sales for its fourth quarter.

On average, analysts polled by FactSet expected AbbVie (ABBV) to earn $2.85 per share, on an adjusted basis, and to report nearly $13.7 billion in sales.

In the year-earlier period, AbbVie earnings were $2.21 a share on $8.7 billion in sales.

For the year ending in 2021, AbbVie guided to EPS of $12.32-$12.52. The Street expected AbbVie earnings of $12.20 per share and $54 billion in sales.

https://www.investors.com/news/technology/abbvie-stock-abbvie-earnings-q4-2020/

Biden dithers on vaccination while COVID’s new strains rage

 Two straight weeks of good news: COVID-19 cases are declining, hospitalizations are likewise down and the daily pace of vaccinations is on the rise nationwide. What’s not to celebrate? Plenty, sadly.

The nation’s leading infectious-disease experts are warning that the situation is dire, because new, more dangerous strains of the novel coronavirus threaten the success of the US vaccination ­effort. They caution that we’re in a race to vaccinate the American population before the virus becomes vaccine-resistant.

Message to the Biden administration: The public doesn’t want to see any more presidential news conferences announcing climate day, racial-equity day, immigration-reform day or any other boutique-left themes. Every day needs to be vaccination day. Urgency needs to be translated into action.

A variant dubbed B.1.1.7 ­appeared in Britain in September. It’s at least 50 percent more contagious than original strain, and it forced much of the UK into fresh lockdowns. The US Centers for Disease Control and Prevention predict it will be the dominant strain here by March.

A new strain from South Africa blasts right through the antibody drugs used to treat former President Donald Trump and may also resist some vaccines. An especially lethal Brazilian strain is producing carnage in the Amazon ­region, even causing serious illness in young people.

The threat from these new strains “changes everything,” warns Peter Hotez, of Baylor College of Medicine, including the vaccine timetable.

Biden’s goal for finishing vaccination is the end of summer, but that’s too late, says Hotez: “We’re going to have to figure out a way to vaccinate the American people by late spring. That’s a tall order.”

Hotez admits that “to get there, we need a rate of immunization two or three times higher” than Biden’s plan. Most experts agree. Jennifer Nuzzo of Johns Hopkins says “we are in a race against time.” Ashish Jha from Brown University insists “there is zero justification for not vaccinating around the clock. We are in a race against the variants.”

Biden claims his administration is waging “war” against the virus. Don’t believe it. He’s making open borders a higher priority. That’s deadly. Mexico is overwhelmed by COVID-19.

Mexican farm workers cross the border, decline to be tested and spread the infection along the border towns, The New York Times reports. Yuma County, Ariz., where migrants harvest lettuce, has the highest infection rate in the United States.

Biden has put tight restrictions on international air travel, while halting the Remain in Mexico program and border-wall construction. Air travelers must test negative before embarking, quarantine on arrival and test negative again. But what’s the point, if people from dozens of countries walk through Mexico and enter with none of those restrictions?

As for getting vaccine shots into people’s arms, Biden has ­instructed the Federal Emergency Management Agency to help 11 states so far set up and operate vaccination sites. He needs to ­expand this effort.

Recently, Pfizer failed to deliver doses as promised, slowing the pace of vaccinations in many places, including New York City. A shortage of raw materials was partly to blame. That’s a lesson for the future. America needs a medical supply chain with active ingredients made in the homeland.

The US is also pitifully behind in identifying germ threats before they become widespread. Many countries routinely sample positive COVID tests for unusual ­mutations. The UK samples 10 percent of its tests. The US shockingly samples less than 1 percent, less than any other developed country.

The Trump administration called on the CDC to boost surveillance testing last spring, and the Biden administration should make it a priority. Now and for the future. Surveillance testing is vital to identify future germ threats or even a biological attack.

The experts warn that Biden has a half-year window to vaccinate and conquer the pandemic. Our return to normal life depends on it. Yet instead of focusing on this one urgent mission, as he promised before he was elected, Biden is rolling out the left’s wish list. Our lives be damned.

Betsy McCaughey is a former lieutenant governor of New York and author of “The Next Pandemic.”

https://nypost.com/2021/02/02/biden-dithers-on-vaccination-while-covids-new-strains-rage/

Mexico approves Russian Sputnik V vaccine, signs deal for supply

 Mexico has approved emergency use of Russia’s Sputnik V vaccine after signing a contract for millions of doses of the product, Deputy Health Minister Hugo Lopez-Gatell said on Tuesday.

In a morning news conference, Lopez-Gatell said Mexico’s contract provided for 7.4 million doses between February and April, with more due in May.

“This gives us an enormous opportunity to accelerate vaccination in Mexico,” said Lopez-Gatell, whose country began using the Pfizer vaccine in December.

Later, at an evening news conference, Lopez-Gatell said Mexican health regulator COFEPRIS had authorized Sputnik V for emergency use.

Mexico is trying to secure as much vaccine supply as possible for its 126 million people following delays of some products amid a global scramble for vaccines.

Latin American nations, including Argentina and Mexico, showed an early interest in locking down supplies of the Russian vaccine. In December, the makers of Sputnik V requested to carry out clinical trials in Mexico.

Global interest in Sputnik V was bolstered on Tuesday after peer-reviewed results from its late-stage clinical trial were published in The Lancet international medical journal.

Sputnik V was 91.6% effective in preventing people from developing COVID-19, according to those results.

Requiring two shots, Sputnik V has been approved for storage in normal fridges, rather than freezers, according to scientists at the Gamaleya Institute in Moscow that developed it.

This ease of transportation and distribution has appealed to Mexico, which has hard-to-reach rural areas and a struggling national healthcare system.

Mexican President Andres Manuel Lopez Obrador spoke with Russian President Vladimir Putin last week about buying 24 million doses of the vaccine.

Lopez-Gatell met Russian officials and gained access to technical files about the vaccine during a trip to Argentina in January. Argentina started rolling out Sputnik V to healthworkers in December.

https://www.reuters.com/article/us-health-coronavirus-mexico-russia/mexico-approves-russian-sputnik-v-vaccine-signs-deal-for-supply-idUSKBN2A21XN

Sinopharm's COVID-19 vax remained active against S.Africa variant, effect reduced

 Two COVID-19 vaccines from Chinese companies including Sinopharm triggered immunity against a highly transmissible coronavirus variant first found in South Africa, but their effect appeared weaker, a small-sample lab study released on Tuesday showed.

Variants of the virus have stirred concern that they might weaken effects of vaccines and treatments developed prior to their emergence.

Twelve serum samples each taken from recipients of two vaccines developed by a subsidiary of China National Pharmaceutical Group (Sinopharm) and a unit of Chongqing Zhifei Biological Products retained neutralising activity against the South African variant, their researchers said in a paper.

The paper was written by researchers from Sinopharm-affiliated Beijing Institute of Biological Products, the Institute of Microbiology of Chinese Academy of Sciences, which is co-developing a candidate with Zhifei unit, and two other Chinese agencies.

However, the samples' activity against the variant was weaker than against the original virus and another variant currently spreading globally, according to the paper published on website BioRxiv ahead its peer-review. bit.ly/3rfr2UZ

The activity reduction “should be taken into account for its impact for the clinical efficacy of these vaccines,” they said.

The Sinopharm vaccine is approved in China for general public use and is also used in several other countries including the United Arab Emirates. The Zhifei shot is in late-stage clinical trials in China and overseas.

Preliminary clinical trial data on vaccines from Novavax Inc and Johnson & Johnson also showed they were significantly less effective at preventing COVID-19 in trial participants in South Africa, where the potent new variant is widespread.

https://www.reuters.com/article/us-health-coronavirus-china-vaccine/sinopharms-covid-19-vaccine-remained-active-against-s-africa-variant-effect-reduced-lab-study-idUSKBN2A30DT

GSK, CureVac partnership eyes COVID-19 vaccine against multiple variants

 Britain’s GlaxoSmithKline and German biotech firm CureVac struck a 150 million euro ($180 million) deal to develop next-generation vaccines against COVID-19 that target several variants in one product.

In a joint statement on Wednesday, the partners said they were targeting a possible launch in 2022.

GSK, which holds a stake in CureVac, will also support the production of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate in 2021, they said.

For GSK, the world’s largest vaccine maker by sales, it marks a fresh attempt to play a relevant role in fighting the pandemic after a COVID-19 alliance with Sanofi was hobbled by development delays and after a similar collaboration with China’s Clover Biopharmaceuticals was ended.

https://www.reuters.com/article/us-health-coronavirus-gsk/gsk-curevac-partnership-eyes-covid-19-vaccine-against-multiple-variants-idUSKBN2A30U2