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Pfizer to Acquire GBT for $5.4B, Adding Sickle Cell Disease Drug and Pipeline

Pfizer said the deal will complement and further enhance its 30-plus year heritage in rare hematology and reinforce its commitment to treating sickle cell…

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Global Blood Therapeutics (GBT) President and CEO Ted W. Love, MD

Pfizer has agreed to acquire Global Blood Therapeutics (GBT) for $5.4 billion cash, the companies said Monday, in a deal that continues the pharma giant’s spate of acquisitions made possible by the billions of dollars generated by its COVID-19 vaccine and antiviral drug.

Pfizer said the deal will complement and further enhance its 30-plus year heritage in rare hematology and reinforce its commitment to treating sickle cell disease (SCD), for which GBT has a marketed drug Oxbryta® (voxelotor) approved by the FDA in 2019.

That year, Pfizer acknowledged that a synthetic glycomimetic it licensed from GlycoMimetics, rivipansel, had failed a Phase III trial in patients with SCD who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous opioids. Soon after, Pfizer ended an up-to-$340 million ($15 million upfront) collaboration with GlycoMimetics launched in 2011.

Rivipansel wasn’t Pfizer’s only SCD candidate in recent years. In 2020, Pfizer quietly ended a Phase I trial of PF-04447943, only a year after publication of a preclinical study that the phosphodiesterase 9A inhibitor “demonstrated PK/PD effects suggestive of inhibiting pathways that may contribute to vaso-occlusion.” PF-04447943 has since been dropped from Pfizer’s pipeline.

Pfizer said GBT’s expertise, portfolio, and pipeline, holds potential to address the full spectrum of critical needs for the SCD community, which Pfizer has committed to engaging through the deal.

“We are excited to welcome GBT colleagues into Pfizer and to work together to transform the lives of patients, as we have long sought to address the needs of this underserved community,” Albert Bourla, Pfizer’s Chairman and CEO, said in a statement. “The deep market knowledge and scientific and clinical capabilities we have built over three decades in rare hematology will enable us to accelerate innovation for the sickle cell disease community and bring these treatments to patients as quickly as possible.”

The Wall Street Journal first reported Pfizer’s advanced talks to acquire GBT on Friday, about two weeks after a Bloomberg News report identified GBT as a potential takeover target, touching off a 41% jump on the company’s share price August 4, from $33.93 to $47.99.

Shares of GBT rose 4% to $66.64 in midday trading as of 12:54 p.m. ET.  Pfizer shares dipper 0.43% to $49.06 from $49.27.

51% Sales gain

Citing the acquisition announcement, GBT postponed its scheduled quarterly conference call with analysts, but did release second quarter results showing product sales of $71.55 million for Oxbryta, up nearly 51% from $47.555 million in Q2 2021.

The Q2 sales result fell in line with the forecast of analyst John Newman, PhD, CFA of Canaccord Genuity, who early Monday before the deal was announced raised his quarterly sales forecast for Oxbryta from $64 million to $71 million, citing strong pediatric uptake of the drug.

Global Blood Therapeutics President and CEO Ted W. Love, MD, said a crucial factor behind the successful development of Oxbryta was shifting the R&D focus from relieving pain, the traditional concern of sickle cell disease (SCD) drug developers, to improving the health of red blood cells. [Global Blood Therapeutics]
“We expect faster Oxbryta uptake in pediatric sickle cell disease patients vs adolescents or adults, as we believe parents and physicians see greater urgency to treat the disease in young children,” Newman wrote in a research note. “We also expect better compliance and adherence for younger patients overall.”

So far this year, Oxbryta has generated $126.71 million in product sales, up 46% from $86.598 million in the first half of 2021. Oxbryta racked up $194.749 million in product sales in 2021, up 57% from $123.803 million in 2020.

Pfizer said it plans to build on those sales by leveraging its global platform to accelerate distribution of Oxbryta to parts of the world most impacted by SCD. In addition to the U.S., Oxbryta is approved in the European Union, United Arab Emirates, Oman and Great Britain.

Speaking on GEN’s “Close to the Edge” video interview series last year, GBT President and CEO Ted W. Love, MD, complimented Pfizer as well as Moderna for their rapid development of COVID-19 vaccines [Pfizer partnered with BioNTech to develop COMIRNATY®] based on messenger RNA (mRNA).

“The application of that technology positioned Moderna and Pfizer to really do something that I think people would have thought unfathomable a few years ago. So I think the rate of acceleration of us being able to use novel technology, novel science, it’s accelerating.  And I think that’s going to continue, which is why I’m so excited and, quite frankly, proud of our industry,” Love said.

Pfizer’s successful development of COMIRNATY generated billions of dollars for the company—$36.781 billion in 2021 and $22.075 billion in the first six months of this year alone.

The company has since spent some of that money on an acquisition spree. Since the vaccine was emergency-authorized in 2020, Pfizer last year bolstered its oncology drug portfolio by acquiring Trillium Therapeutics for $2.26 billion.

In April, Pfizer shelled out up to $525 million for ReViral, a developer of antiviral therapeutics targeting respiratory syncytial virus (RSV). A month later, Pfizer bought Biohaven Pharmaceuticals for $11.6 billion cash, expanding its portfolio and pipeline with therapies for migraine led by the FDA-approved rimegepant (Nurtec® ODT).

“We’ve been very clear that our goal is to add $25 billion of risk adjusted revenue by 2030 and I think we are making very good progress against that,” Aamir Malik, Chief Business Innovation Officer, told analysts July 28 on the company’s quarterly earnings call. “This year you saw our transaction with ReViral and subsequently with Biohaven, which respectively we believe have the potential to add $1.5 billion and $6 billion in peak sales to our business, and this was on the back of a very active 2021

Looking beyond pain

On GEN’s “Close to the Edge,” Love said a crucial factor behind the successful development of Oxbryta was shifting the R&D focus from relieving pain, the traditional concern of SCD drug developers, to improving the health of red blood cells.

“We really needed to kind of flip how people were thinking from not just pain but, what is really going on in sickle cell disease? And we’ve been now trying to get people to understand that a disease that occurs on one protein that’s trapped inside your red cell is really killing the red cells first. It’s killing the red cell first,” Love said on “Close to the Edge.”

“I was very strident early on. We are not going to develop a drug focused on pain. We are going to focus on the fundamental basis of this disease, which is the hemoglobin polymerization that’s killing the red cell. And what we ultimately agreed to with the Food and Drug Administration is that the primary endpoint for our drug’s approval would be stopping the polymerization from killing the red cell,” Love added.

Oxbryta won accelerated FDA approval in November 2019 as a treatment for SCD in patients 12 years old and older. The FDA based its approval on positive clinical data Oxbryta generated in the Phase III HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) trial (NCT03036813). Of 274 patients evaluated, more than 50% treated with Oxbryta achieved greater than 1 g/dL increase in hemoglobin, compared with 6.5% receiving placebo.

Oxbryta is indicated as an SCD treatment in patients ages 4 and up. The drug is also under clinical review in:

  • SCD patients 2-15 years of age, the focus of the Phase III HOPE-KIDS 2 trial (NCT04218084), a confirmatory study designed to measure the mean change in transcranial doppler (TCD) flow velocity, seeking to demonstrate a decrease in stroke risk. HOPE-KIDS 2 was initiated in December 2019 as a condition of the accelerated approval.
  • SCD pediatric patients up to 17 years of age, the focus of the Phase IIa HOPE-KIDS 1 trial (GBT440-007; NCT02850406), an open-label, single- and multiple-dose trial evaluating the safety, tolerability, pharmacokinetics and exploratory treatment effect of Oxbryta in pediatric patients as young as 6 months of age..
  • SCD patients 12 years of age and older, the focus of a planned Phase IV study set to evaluate daily physical activity in those patients.

Love has also defended Oxbryta’s $125,000/year list price, which GBT had pledged not to raise through this year, citing the drug’s efficacy against SCD and savings to SCD patients of over $700,000 in otherwise lost lifetime income due to the disease.

“If you go into a disease area where there’s nothing available, looking at the alternative price value of the alternative is a silly discussion. The alternative is to continue to let these patients suffer and die,” Love told investors attending the Biotechnology Innovation Organization (BIO) CEO & Investor Conference in New York in February 2020.

$3 Billion franchise

Also in GBT’s pipeline is inclacumab, a fully human monoclonal antibody targeting P-selectin which is under study in two Phase III trials as a potential quarterly treatment to reduce the frequency of painful vaso-occlusive crises (VOCs) and reduce hospital readmission rates due to VOCs.

GBT has an exclusive worldwide up-to-$127 million-plus licensing agreement with Roche for inclacumab inked in 2018 –$2 million paid upfront to Roche, up to $125 million tied to achieving development and commercialization milestones, plus tiered royalties. Inclacumab has established pharmacokinetic data, safety and tolerability in more than 500 patients.

GBT’s pipeline also includes GBT601 (formerly GBT021601), an oral, once-daily, next-generation sickle hemoglobin (HbS) polymerization inhibitor under study in Phase I and Phase II/III trials. The Phase I trial (NCT04983264) was completed in late 2021, then restarted in the second quarter of 2022 to evaluate a higher daily dose of GBT601 than previously studied, based on patient demand. In June, GBT announced the initiation of the Phase II portion of the Phase II/III trial (NCT05431088), with the primary outcome measure of the Phase II portion being the number of patients with a change from baseline in hemoglobin, or Hb, levels through Week 12.

GBT has presented positive Phase I proof-of-concept data for GBT601 at the American Society of Hematology’s ASH 2021 conference, held December 11-14 in Atlanta. GBT said the data has shown GBT601’s potential to improve clinical outcomes in people living with SCD, while reducing pill burden.

Both GBT601 and inclacumab have received FDA Orphan Drug and Rare Pediatric Disease designations.

GBT’s pipeline includes preclinical programs designed to treat SCD through HbF inducers (which could also potentially treat beta thalassemia), through a collaboration with Syros Pharmaceuticals; anti-sickling drugs; and inflammation and oxidative stress reduction.

If approved, GBT’s pipeline and Oxbryta could underpin an SCD franchise that according to the company could achieve combined worldwide peak sales of more than $3 billion.

Pfizer said it will acquire all outstanding shares of GBT for $68.50 per share in cash, a 7% premium to GBT’s closing share price of $63.84 on Friday. The deal’s total enterprise value of approximately $5.4 billion includes debt and is net of cash acquired.

Pfizer said it will buy GBT using cash on hand. The company reported $2.47 billion in cash and cash equivalents as of April 3; Pfizer has yet to disclose its second quarter balance sheets.

The boards of both companies have unanimously approved the transaction, which is subject to customary closing conditions, including receipt of regulatory approvals and approval by GBT’s stockholders.

“Pfizer will broaden and amplify our impact for patients and further propel much-needed innovation and resources for the care of people with sickle cell disease and other rare diseases, including populations in limited-resource countries,” Love said Monday in a statement. “We look forward to working together with Pfizer to serve our communities and advance our shared goal of improving health equity and expanding access to life-changing treatments to create a healthier future for all.”

The post Pfizer to Acquire GBT for $5.4B, Adding Sickle Cell Disease Drug and Pipeline appeared first on GEN - Genetic Engineering and Biotechnology News.

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Global Wages Take A Hit As Inflation Eats Into Paychecks

Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook…

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Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook clouded by uncertainties have led to a decline in real wages around the world, a new report published by the International Labour Organization (ILO) has found.

As Statista's Felix Richter reports, according to the 2022-23 Global Wage Report, global real monthly wages fell 0.9 percent this year on average, marking the first decline in real earnings at a global scale in the 21st century.

You will find more infographics at Statista

The multiple global crises we are facing have led to a decline in real wages.

"It has placed tens of millions of workers in a dire situation as they face increasing uncertainties,” ILO Director-General Gilbert F. Houngbo said in a statement, adding that “income inequality and poverty will rise if the purchasing power of the lowest paid is not maintained.”

While inflation rose faster in high-income countries, leading to above-average real wage declines in North America (minus 3.2 percent) and the European Union (minus 2.4 percent), the ILO finds that low-income earners are disproportionately affected by rising inflation. As lower-wage earners spend a larger share of their disposable income on essential goods and services, which generally see greater price increases than non-essential items, those who can least afford it suffer the biggest cost-of-living impact of rising prices.

“We must place particular attention to workers at the middle and lower end of the pay scale,” Rosalia Vazquez-Alvarez, one of the report’s authors said.

“Fighting against the deterioration of real wages can help maintain economic growth, which in turn can help to recover the employment levels observed before the pandemic. This can be an effective way to lessen the probability or depth of recessions in all countries and regions,” she said.

Tyler Durden Mon, 12/05/2022 - 20:00

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Unprecedented Liquidations Lead To Historic Collapse In Investors’ Oil Exposure

Unprecedented Liquidations Lead To Historic Collapse In Investors’ Oil Exposure

By John Kemp, senior market analyst

Portfolio investors sold…

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Unprecedented Liquidations Lead To Historic Collapse In Investors' Oil Exposure

By John Kemp, senior market analyst

Portfolio investors sold petroleum heavily for the third week running as fears about disruption to crude oil flows from the price cap on Russia’s exports receded.

Hedge funds and other money managers sold the equivalent of 42 million barrels in the six most important oil-related futures and options contracts over the seven days ending on Nov. 29.

Sales over the three most recent weeks totalled 190 million barrels, more than reversing the 169 million barrels purchased over the previous six weeks in October and early November. As Bloomberg adds, money managers have trimmed positioning in Nymex crude for three weeks in a row. A breakdown of the data show the drop in positions is mostly from money managers cutting long exposure, rather than an abrupt short-covering.

In the latest week, sales were again concentrated in crude (-40 million barrels), especially Brent (-39 million), with only insignificant changes in other contracts.

Brent is the contract with the most direct exposure to the crude exports from Russia subject to the price cap announced by the United States, the European Union and their allies on Dec. 2.

Fund managers cut their net position in Brent to just 99 million barrels (6th percentile for all weeks since 2013) last week from 238 million barrels (50th percentile) on Nov. 8.

Bullish long positions outnumbered bearish short ones in Brent by a ratio of just 2.17:1 (11th percentile), down from 6.74:1 in late October (76th percentile).

The long-short ratio is the lowest for two years since November 2020, before the first successful coronavirus vaccines were announced a few weeks later.

Fears the price cap would reduce global crude supplies appear to have prompted a wave of buying in both physical and paper markets throughout late September and early October.

Precautionary buying drove front-month Brent futures up to a high of almost $99 per barrel on Nov. 4 from just $84 on Sept. 26. It also helped keep the futures market in a steep six-month backwardation.

But as it became clear the cap would be set at a relatively high level, with a relaxed approach to enforcement, this buying has reversed, causing prices and spreads to fall sharply.

With the risk from the price cap removed, for now investors’ attention has returned to the weak outlook for the economy and oil consumption in 2023.

Tyler Durden Mon, 12/05/2022 - 14:21

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The Gall Of Lockdowners Who Support China’s Anti-Lockdown Protests

The Gall Of Lockdowners Who Support China’s Anti-Lockdown Protests

Authored by Michael Senger via ‘The New Normal’ Substack,

If the intent…

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The Gall Of Lockdowners Who Support China's Anti-Lockdown Protests

Authored by Michael Senger via 'The New Normal' Substack,

If the intent was to get western elites to simultaneously support totalitarianism in their own countries while pretending to oppose it in China, then Xi Jinping has certainly made his point...

Across the political spectrum, voices have risen up in support of the Chinese people who’ve launched protests of unprecedented scale against the Chinese Communist Party’s indefinite Covid lockdown measures.

As well they should. Even by Chinese standards, the lockdowns that Xi Jinping pioneered with the onset of Covid are horrific in terms of their scale, their duration, their depravity, and the new totalitarian surveillance measures to which they’ve led. Anyone who participates in a protest in China runs a risk of being subject to cruel and arbitrary punishment. For ordinary Chinese people to brave that risk in defiance of this new form of inhuman medical tyranny is an act of courage worthy of admiration.

There are notable exceptions to the otherwise widespread support the protesters have received. Apple has been silent about the protests, and had the gall to limit the protesters’ use of a communication service called AirDrop in compliance with the CCP’s demands, even as it threatens to remove Twitter from its app store over Elon Musk’s free speech policy. This comes even after Apple has long ignored requests by FCC officials to remove the Chinese-owned app TikTok from its app store over unprecedented national security concerns. So Apple complies with requests by the Chinese government, but not the United States government. Let that sink in…

Apple is, unfortunately, far from alone in its CCP apologism. Anthony Fauci told CNN that China’s totalitarian lockdowns would be fully justified so long as the purpose was to “get all the people vaccinated.”

This kind of apologism for the CCP’s grisly bastardization of “public health” is horrific, especially coming from the man most widely seen as the leader of America’s response to Covid.

But what may be even more galling than this apologism is the widespread support China’s anti-lockdown protesters have received even among those who demonized anti-lockdown protesters in their home countries and wished their lockdowns were more like China’s.

In 2020, the New York Times denounced anti-lockdown protesters as “Anti-Vaxxers, Anticapitalists, Neo-Nazis” and urged the United States to be more like China.

But in 2022, the New York Times admired the bravery of China’s anti-lockdown protesters fighting Xi Jinping’s “unbending approach to the pandemic” that has “hurt businesses and strangled growth.”

In 2020, CNN published an open letter from “over 1,000 health professionals” denouncing anti-lockdown protests as “rooted in white nationalism” while admiring “China’s Covid success compared to Europe.”

But in 2022, CNN admired China’s anti-lockdown protesters as “young people” who “cry for freedom”

In 2020, the Washington Post denounced anti-lockdown protesters as “angry” populists who “deeply distrust elites,” and wished the United States was more like China.

But in 2022, the Washington Post celebrated global “demonstrations of solidarity” with China’s anti-lockdown protests.

In 2020, the New Yorker denounced anti-lockdown protesters as “militias against masks” while marveling at how “China controlled the coronavirus.”

But in 2022, the New Yorker admired the protesters standing up to Xi Jinping.

Earlier this year, Amnesty International issued a statement of concern about Canada’s anti-lockdown Freedom Convoy protests being affiliated with “overtly racist, white supremacist groups,” even as Justin Trudeau invoked the Emergencies Act to crush the protests.

But now, Amnesty International has issued a statement urging the Chinese government not to detain peaceful protesters.

These headlines are, of course, in addition to the hundreds of other commentators, influencers, and health officials, such as NYT journalist Zeynep Tufekci, who used their platforms in 2020 to urge for lockdowns that were even stricter than those their governments imposed, but now join in support for those in China protesting the same policies they were urging their own countries to emulate.

Etymologically, Zeynep’s latter comment makes no sense. Lockdowns had no history in western public health policy and weren’t part of any democratic country’s pandemic plan prior to Xi Jinping’s lockdown of Wuhan in 2020. Though some countries, such as Italy, imposed lockdowns shortly before the United States, their officials too had simply taken the policy from China. Thus, because no other precedent existed, any call for a “real lockdown” or a “full lockdown” in spring 2020 was inherently a call for a Chinese-style lockdown.

Though by “full lockdown” Zeynep may have intended somewhere in between the strictness of lockdowns in the United States and China, there was no way for any reader to know what that medium was; it existed only in her own head. Thus, the reader is left only with a call for a “full lockdown,” and the only example of a “successful” “full lockdown” that then existed was a full Chinese lockdown.

Zeynep’s latter comment further illustrates the efficacy of what was arguably some of the CCP’s most effective lockdown propaganda in early 2020: The ridiculous viral videos of CCP cadres “welding doors shut” so poor Wuhan residents couldn’t escape.

CCP apologists have argued that these videos prove the CCP was not trying to influence the international response to Covid, because they make the CCP look so bad. But on the contrary, the over-the-top inhumanity of the idea of welding residents’ doors shut was precisely the purpose of this propaganda campaign. The idea had to be so absurd that no decent government would ever actually try it. It thus gave the CCP and its apologists an infinite excuse for why lockdowns “worked” in China and nowhere else—because only China had ever had a “real lockdown” in which residents were welded into their homes.

When those with a decent knowledge of geopolitics or a bit of common sense see a graph like this, which looks nothing like that of any other country in the world, from a regime with a long history of faking its data on virtually every topic, the conclusion is obvious: China’s results are fraudulent. But to simple minds, a weld is a strong, durable bond capable of incredible feats, from supporting skyscrapers to spaceships. Surely, if a weld can do all that, then it must be able to stop a ubiquitous respiratory virus?

The entire concept is, of course, utterly asinine. You cannot stop a respiratory virus by indefinitely suspending everyone’s rights. But this idea that lockdowns had worked in China because the CCP had gone so far as to weld people into their homes was invoked over and over again during Covid, creating a limitless “No-True-Scotsman” out for lockdown apologists as to why lockdowns weren’t “working” anywhere except China. Whether COVID-19 cases went up, down, or sideways, the solution would always be the same: “Be more like China.”

The use of this darkly humorous propaganda campaign of welding residents into their homes speaks to two key points as to how Xi Jinping and CCP hawks like him view China’s relationship with the west. The first is that westerners will never respect the CCP; thus, you can make westerners believe anything so long as it confirms westerners’ prior belief that the CCP is barbaric.

Second, Xi Jinping sees the concepts of democracy and human rights as mere propaganda that western elites use to further their own self-interest. So long as they approve of a policy, then it’s not a human rights violation, but if they oppose it, then it is. It remains to be seen whether the response to Covid will, in the long run, ultimately advance Xi’s goal of making the world China. But insofar as the intent was to get western elites to simultaneously support totalitarianism in their own countries while pretending to oppose it in China, then he’s certainly made his point.

*  *  *

Michael P Senger is an attorney and author of Snake Oil: How Xi Jinping Shut Down the World. Want to support my work? Get the book

Tyler Durden Mon, 12/05/2022 - 15:53

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