Connect with us

Government

FT is Reporting that Moderna is planning on Pricing Its Vaccine 25%-50% Higher than Pfizer/BioNTech Vaccine

Texas Deaths Climb As Cases Slide; Moderna Reportedly Prices COVID-19 Vaccine At $60 Per Course: Live Updates

Published

on

This article was originally published by ZeroHedge.

Texas Deaths Climb As Cases Slide; Moderna Reportedly Prices COVID-19 Vaccine At $60 Per Course: Live Updates Tyler Durden Tue, 07/28/2020 - 17:55
Summary:
  • Texas 7-day death average hits new record high
  • Modern to price vaccine at $50-$60 per dose
  • California sees fewest new cases in 3 weeks
  • Illinois reports best numbers in a week
  • Rhode Island sees concerning uptick in new cases
  • Goldman points out decline in doctor's cases
  • Washington DC, Illinois, Minnesota, Kentucky and Puerto Rico added to quarantine list
  • Arizona reported another 2,107 cases
  • New York reports latest batch of cases
  • 4 more Marlins players test positive
  • Africa nears 1 million COVID-19 cases
  • Florida reports new record single-day deaths
  • Belarus president says he had virus
  • Fla. suffers biggest one-day jump in hospitalizations
  • Oldham faces tightened COVID-19 restrictions in bid to prevent lockdown
  • BoJo defends travel restrictions on Spain
  • Bill Gates sits for interview on CNBC
  • Sun Belt states see promising pull back
  • China reports 1st case in Beijing in 3 weeks
  • Head of China's CDC takes experimental vaccine
  • WHO warns COVID-19 isn't going to be "seasonal" like the flu
  • Germany joins list of European countries warning on travel to Spain
  • Tokyo suffers another 270 cases
  • Vietnam makes mask-wearing mandatory again
  • Madrid tightens virus restrictions amid resurgence fears
* * * Update (1740ET): The Texas numbers are in, and in keeping with the trend of falling numbers in the Sun Belt, the state reported 8,342 new cases over the last 24 hours, bringing the 7-day average to 7,803 cases per day, the lowest since July 9. Here's a rundown of the day's data courtesy of KXAN News. On the other hand, the number of deaths in the state increased by 164, with a 7-day average of 156 deaths. The Department of Health and Human Services has again reported incomplete hospitalization data "due to a transition in reporting to comply with new federal requirements." Only 91% of hospitals reported complete data to DSHS, reflecting 9,593 Texans currently hospitalized due to COVID-19. In other news, the FT reports that Moderna, the biotech darling that has received roughly $1 billion in government money to expedite its vaccine trial, is pitching its coronavirus vaccine at about $50 to $60 per course, higher than other vaccine makers have agreed to charge governments, according to inside sources cited by the paper. This premium price would apply to the US and other high-income countries. * * * Update (1610ET): New infections slowed in two of the worst hit US states grappling with outbreaks, California and Arizona, even as deaths hit  new single-day record in Florida. With Texas numbers still in the post, BBG's initial tally showed the US increasing cases by 1reported a record number of deaths. The American Federation of Teachers authorized its members to strike if schools reopen without proper safety measures. Coronavirus cases in the US increased 1% as compared with the same time Monday to 4.31 million, according to data collected by Johns Hopkins University and Bloomberg News. The increase was below the average 1.7% daily gain over the past week. Deaths rose 0.7% to 148,298. * * * Update (1440ET): Despite new records for deaths and hospitalizations out of Florida, Arizona saw cases slow again on Tuesday, as did California, which reported 6,000 new virus cases, fewer than the 14-day average of 9,159 and the lowest daily tally since July 5. The state had 73 additional deaths, lower than the 14-day average of 99. Hospitalizations from COVID-19, which reached a record last week, decreased 0.6% to 6,896 people, while the number of intensive-care patients fell 1.8%. Meanwhile, the average rate of positive tests over the past two weeks was stable for the fifth straight day at 7.5%. * * * Update (1345ET): As the tri-state area adds Illinois and a handful of other states to its travel advisory list, the state, which was home to one of the earliest known outbreaks in the US, just reported its lowest daily case numbers in a week. Illinois has reported 1,076 new COVID-19 cases and 30 additional deaths Tuesday. This brought the state's total to 173,731 cases, including 7,446 deaths. The state's 7-day positivity rate now stands at 3.8%. As of Monday night, officials said 1,383 people were hospitalized with COVID-19, with 329 patients in the ICU and 128 patients on ventilators. * * * Update (1245ET): As the tri-state area makes some new additions to its quarantine list, Rhode Island is seeing a concerning uptick in new cases, pushing the positivity rate above 3% for the first time in six weeks. As investors dig through reams of data searching for signals about the direction of the US epidemic, a team of analysts at Goldman Sachs said that while the number of new cases is still well above the levels from two weeks ago, a dip in doctor's appointments related to COVID-19 over the past few days portends a coming decline, they said. The decline has been seen across nearly all states.
This suggests virus spread could be at the start of a national decline. The prevalence of CLI symptoms is a leading indicator of virus spread. Today, four states with elevated levels of new cases over 100 per million per day now have new cases on a sustained downward trajectory. Three of those — Texas, South Carolina, and Utah — saw CLI symptom prevalence peak about 12 days before the peak in confirmed cases. In Arizona, the decline in reported cases was roughly coincident with the decline in symptom prevalence.
Here's more on that via this chart: And here's Goldman's latest daily heat map. * * * Update (1125ET): Arizona reported 2,107 (+1.3%) new cases, bringing the statewide total to 165,934, along with 104 deaths, bringing the death toll in Arizona to 3,408. Some 12.7% of cases were positive, while ICU capacity in the state declined to 84%. Meanwhile, the latest New York numbers are in, and they suggest no change to the trend... Cuomo also announced that Washington DC, Illinois, Minnesota and Kentucky and Puerto Rico have been added to the tri-state area quarantine list. They will join 31 other states on the travel quarantine list. * * * Update (1035ET): Florida reported its biggest daily jump in COVID-19 deaths on Tuesday as its death toll blew past 6,000. Florida reported 191 fatalities in the last 24 hours, according to the state health department. Florida also reported 9,230 new cases, pushing the total to over 440,000, the second highest tally in the country behind California. Florida's total death toll rose to 6,240, the ninth highest in the country. Hospitalizations statewide increased by a record 585 new patients, bring the total to 24,917 to date, and 9,023 currently hospitalized as of 1030ET. Statewide, the positivity rate hit 11.69%. Meanwhile, the WHO's latest Africa update showed that the number of confirmed cases on the continent is nearing 1 million. In other news, Belarus President Alexander Lukashenko, the last of Europe's Soviet-era Strongmen still in power, has told the press that he had the virus. If accurate, Lukashenko would join Brazilian President Jair Bolsonaro as a leader who has played down the virus, but also been infected himself. * * * Update (1030ET): Is this it for the 2020 MLB season? Another scheduled game - Tuesday's bout between the Phillies and the Yankees - has been postponed after 4 more Marlins players tested positive for the virus. Here's more from Sports Illustrated:
After the latest round of coronavirus testing, the Miami Marlins had four additional players test positive, according to Ken Rosenthal of The Athletic. This means that 17 players have reportedly tested positive over the past five days. On Monday, there were 11 players and two coaches as the total confirmed cases on Miami's roster. The team remains in Philadelphia after Monday night's home opener against the Baltimore Orioles was canceled. According to Rosenthal, one of the team members who tested positive had a subsequent test that came back negative. In order for a player to be eligible to rejoin the team, they would need two negative tests recorded 24 hours apart. As a result of the Marlins outbreak, the Philadelphia Phillies postponed Monday's game against the New York Yankees at Citizens Bank Park. The Phillies hosted the Marlins over the weekend but have had no players test positive in the early round of results, according to the New York Post's Joel Sherman. Tuesday night's Phillies game against the Yankees was also postponed. MLB Commissioner Rob Manfred appeared on MLB Network and said that the Miami outbreak was not a "nightmare" scenario for the league and trusted the protocols in place.
Nearly 20 players on the team have tested positive over the last 5 days. More signs that the players are having second thoughts about agreeing to the season are being seen across social media, as players like and share posts critical of the league. The NY Post reported yesterday that Rob Manfred has "no plans" to cancel play following a conference call with all 30 team owners. Instead, they will "redouble" their health efforts. * * * Update (0925ET): After Germany on Tuesday urged its citizens to avoid traveling to Catalonia, the Spanish government in Madrid started pushing for countries imposing travel restrictions or warnings to focus on the specific regions of Spain (ie Catalonia, specifically the area in and around Barcelona) instead of the entire country. But in an interview filmed Tuesday morning, British PM Boris Johnson warned that the signs of a "second wave" of coronavirus are beginning to emerge across Europe, as he defended changing travel advice on Spain. BoJo backed the decision, announced on Sunday, to advise travelers returning from Spain to the UK to quarantine for 14 days due to the recent resurgence in the country. Additionally, the UK, which is only just exiting its own lockdown, is already seeing problems in the Greater Manchester area, where tougher restrictions have been introduced in Oldham, Greater Manchester in a bid to prevent a local lockdown, Sky News reports. The PM added: "What we have to do is take swift and decisive action where we think that the risks are starting to bubble up again," BoJo said during a Tuesday visit to Nottingham. * * * Bill Gates on Tuesday morning sat for an interview with the Squawk Box team where he assured all viewers that skepticism about the safety of the coronavirus vaccine candidates had been greatly exaggerated. Once the FDA has slapped its imprimatur on a candidate, Americans and others shouldn't hesitate to accept the final product. Gates's interview follows a slew of vaccine-related news. Taken together, the intended message is clear: With the bilateral relationship unraveling and US economic fundamentals continuing to deteriorate, vaccine-related headlines are the market's last hope for survival. It follows news from yesterday about Moderna's vaccine candidate, which is entering its Phase 3 trial. During his interview on Tuesday, Gates praised the "low-cost" vaccines from AstraZeneca and Moderna...and seemingly dismissed concerns about safety and side-effects out of hand. Yesterday, the worst-hit Sun Belt states showed promising signs that infections are slowing. Meanwhile, in China, the number of new cases confirmed daily has continued to creep higher as more cases were confirmed on Tuesday. Beijing on Tuesday reported one new coronavirus case, its first in 21 days. The new case was confirmed just days after Beijing started reopening more public transit and lifting other restrictions inspired by the outbreak. The case was just 1 of 68 reported Tuesday across the mainland. With anxieties on the rise, the head of China's Center for Disease Control and Prevention surprised his audience by revealing that he had been injected with an experimental coronavirus vaccine. The talk, according to the AP, was intended to show the Chinese people that there's nothing wrong with taking such a vaccine. "I’m going to reveal something undercover: I am injected with one of the vaccines,” Gao Fu said in a webinar Sunday hosted by Alibaba Health, an arm of the Chinese e-commerce giant, and Cell Press, an American publisher of scientific journals. “I hope it will work." Suffering its own "third wave" outbreak, Hong Kong is considering postponing its upcoming legislative elections, according to local press reports, as a resurgence of new cases over the last 2 weeks has rattled Hong Kong society. Authorities reported 98 local infections on Tuesday, a slight ebb after the city found more than 100 local cases for six consecutive days. The city's contact tracers have had trouble tracing the origins of new infections. As the outbreak worsens, HK is imposing its most restrictive social distancing measures yet. Elsewhere in Asia, Vietnam and its provinces are imposing mandatory mask-wearing orders after an unexpected surge in community infections stemming from an outbreak in Danang (reported 11 new cases yesterday). The province has put about 7,000 people in quarantine for 14 days. Over the past three days, the region has reported 15 new cases. Vietnam had all but claimed victory over the virus, having gone almost 100 days without even a single new local patient. In Tokyo, officials confirmed about 270 new cases of the virus on Tuesday, Nikkei reported, citing an unidentified person. That’s more than twice the 131 cases the Japanese capital found Monday. The city has reported more than 100 new daily cases for weeks as it faces a renewed resurgence. Finally, moving over to the Asia-Pacific region, Victoria reported another 384 cases and six deaths over the past 24 hours, and said that it will suspend all but the most urgent elective surgeries. As the outbreak in its second-most populous state intensifies, Australia is sending a medical team to help Papua New Guinea confront an alarming surge in cases, according to Canberra's Acting Foreign Affairs Minister Simon Birmingham. The small Pacific island state had 62 cases as of Tuesday, up from just eight 11 days ago. All the while, worries about a second wave have intensified across Europe. Spanish Prime Minister Pedro Sanchez responded angrily to the UK after Britain ratcheted up its travel restrictions to include a popular set of Spanish islands, and mandated quarantines for all travelers visiting the UK from Spain.
"The decision is unbalanced,” Sanchez said about these new restrictions. The Balearic and Canary Islands “have a lower incidence of the virus than is being registered right now” in Britain, Sanchez said.
Speaking to the BBC, Local Government Minister Simon Clarke said "we respectfully disagree with the Spanish government...You do have to make decisions on a country-wide basis. There is going to be internal transfer within Spain." Globally, cases have reached 16,409,902, according to data from Johns Hopkins University. Source: Worldometer This comes just after the worldwide death toll topped 650k to 652,531. Source: Worldometer The WHO has warned against complacency over coronavirus transmissions in the northern hemisphere, saying that the virus does not behave like influenza, which typically follows a set "flu season". Adding to the growing number of European countries that have advised their citizens to avoid travel to Spain, Germany on Tuesday urged travelers to avoid Catalonia and Barcelona over fears they might contract the virus. As was widely expected, the biggest COVID-19 vaccine trial in the world got under way on Monday with the first of 30,000 volunteers for Moderna's major 'Stage 3' trial which is being run in cooperation with the US government. While Spain denounced the new travel restrictions that will put the final nail in the coffin of the 2020 peak tourism season, the regional government in Madrid has just made the wearing of face masks mandatory in all public areas, while limiting the number of people allowed to gather in a given space to ten. Finally, Iran has reported 235 new deaths from the novel coronavirus, a record single-day toll for the Islamic Republic, which has the highest death toll in the Middle East.

Read More

Continue Reading

Government

Breaking the tape

The top performers among drugs launched in 2020 were each the first of their kind.

Published

on

Breaking the tape

The top performers among drugs launched in 2020 were each the first of their kind.

By Joshua Slatko • josh.slatko@medadnews.com

The leaders in pharma’s Class of 2020 were all firsts. Veklury, for COVID, and Tepezza, for thyroid eye disease, were each the first drug of any kind to be approved by FDA for their respective disease targets. And while other treatments for migraine exist, Ubrelvy was the first orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. The era of follow-ons in pharma may not entirely be over; but surely the industry’s researchers are still breaking barriers. 

Earning nearly $5.57 billion in sales during the product’s first full calendar year on the market, Veklury was the first drug approved by FDA for the treatment of COVID-19.

Veklury

The very first drug to be approved in the United States for the treatment of COVID-19, Gilead’s Veklury received emergency use authorization from FDA during May 2020, an expanded EUA three months later, and full approval for treating patients with COVID requiring hospitalization during October 2020. Veklury had originally been developed for the treatment of hepatitis C and had been studied in Ebola and Marburg virus, without success. 

FDA approval was based on three randomized controlled trials including final results of the National Institute of Allergy and Infectious Diseases’ double blind, placebo-controlled Phase III ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, Veklury became a standard of care for the treatment of COVID-19 in hospitalized patients.

In the randomized, double-blind, placebo-controlled ACTT-1 trial, Veklury significantly improved time to recovery as compared to placebo – by five days in the overall study population (10 versus 15 days) and seven days in patients who required oxygen support at baseline (11 versus 18 days). As a secondary endpoint, Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation or ECMO (13 percent versus 23 percent). In the overall patient population, there was a trend toward reduced mortality with Veklury compared with placebo at Day 29.

In June 2021, Gilead announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury. All three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different time frames over the course of the pandemic and across geographies. Two of the studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.

In January 2022, FDA granted expedited approval of a supplemental new drug application for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The expanded indication allowed for Veklury to be administered in qualified outpatient settings that can administer daily intravenous infusions over three consecutive days. FDA also expanded the pediatric EUA of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.

These actions by FDA came amidst a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant. In contrast, Veklury targets the highly conserved viral RNA polymerase, thereby retaining activity against existing SARS-CoV-2 variants of concern. In vitro laboratory testing has shown that Veklury retains activity against the Omicron variant. 

Quarterly sales, VekluryThe FDA sNDA approval, pediatric EUA expansion, and updated National Institutes of Health Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings were based on results from the PINETREE Phase III randomized, double-blind, placebo-controlled trial. The study evaluated the efficacy and safety of a three-day course of Veklury for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. An analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, demonstrated that treatment with Veklury resulted in a statistically significant 87 percent reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7 percent, 2/279) compared with placebo (5.3 percent, 15/283). In the study, no deaths were observed in either arm by Day 28.

In February, Gilead released data demonstrating the in vitro activity of Veklury against 10 SARS-CoV-2 variants, including Omicron. Results of Gilead’s studies were consistent with other in vitro studies independently conducted by researchers from institutions in other countries, including Belgium, the Czech Republic, Germany, Poland and the United States, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron.

The study analyzed in vitro antiviral activity by two methods to understand the susceptibility of 10 major SARS-CoV-2 variants to Veklury. The study results showed similar activity of Veklury against the variants and an early ancestral A lineage isolate detected in Seattle, Wash. (WA1 strain). Specifically, Delta and Omicron variants both remained fully susceptible to Veklury, and these laboratory results demonstrated that Veklury has remained active against all major variants isolated over the past two years.

In April, FDA approved a supplemental new drug application for Veklury for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval made Veklury the first and only approved treatment for pediatric COVID patients in the United States. Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a five-day treatment course is recommended. The approval was supported by results from the CARAVAN Phase II/III single arm, open-label study, which demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.

Tepezza

Tepezza

Tepezza was the first drug ever approved by FDA for the treatment of thyroid eye disease.

When it earned approval in January 2020, Horizon Therapeutics’ Tepezza became the first and only FDA-approved medicine for thyroid eye disease, a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation, and facial disfigurement. Tepezza is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions.

The FDA approval of Tepezza was supported by a robust body of clinical evidence, including statistically significant, positive results from the Phase II clinical study, as well as the Phase III confirmatory clinical study OPTIC. The OPTIC study found that significantly more patients treated with Tepezza (82.9 percent) had a meaningful improvement in proptosis (≥ 2 mm) as compared with placebo patients (9.5 percent) without deterioration in the fellow eye at Week 24. Additional secondary endpoints were also met, including a change from baseline of at least one grade in diplopia (double vision) in 67.9 percent of patients receiving Tepezza compared to 28.6 percent of patients receiving placebo at Week 24. In a related analysis of the Phase II and Phase III clinical studies, there were more patients with complete resolution of diplopia among those treated with Tepezza (53 percent) compared with those treated with placebo (25 percent).

In October 2020, Horizon announced new long-term follow-up data from the Phase II clinical trial of Tepezza, which showed a sustained response up to one year following completion of treatment for thyroid eye disease. All patients with Week 72 data (37/37) reported some improvement in at least one of the study outcomes from baseline. 97 percent (36/37) of study participants had an improvement in clinical activity score (decrease of at least 1 point). 86 percent (31/36) had any decrease in proptosis. One patient chose elective TED surgery at Week 70 and did not have proptosis measurements at Week 72. Of patients with baseline diplopia, 70 percent (23/33) had an improvement of at least one grade. 70 percent (26/37) had disease inactivation (CAS of 0 or 1 point).

During December 2020, Horizon announced that the company expected a short-term disruption in Tepezza supply as a result of government-mandated COVID-19 vaccine production orders related to Operation Warp Speed that dramatically restricted capacity available for the production of Tepezza at its drug product contract manufacturer, Catalent. In March 2021, FDA cleared a prior approval supplement to the previously approved Biologics Licensing Application giving Horizon authorization to manufacture more Tepezza drug product resulting in an increased number of vials with each manufacturing slot. The company began to resupply the market in April, which ended the supply disruption.

Tepezza Quarterly SalesIn April 2021, new pooled data from the Tepezza Phase II and III trials was published in The Lancet Diabetes & Endocrinology. This data further reinforced that Tepezza significantly improves proptosis and diplopia for TED patients in different subgroups, with most maintaining a long-term response. There was no evidence for acute disease rebound (increase in percentage of patients no longer meeting proptosis, diplopia or ophthalmic composite outcome) seven weeks after the last dose of Tepezza. Proptosis (87 percent; 62/71), diplopia (66 percent; 38/58) and ophthalmic composite outcome (92 percent; 66/72) responses were observed seven weeks after the last dose of Tepezza. A post-hoc analysis of the composite ophthalmic outcome indicated that 81 percent (68/84) of Tepezza patients versus 44 percent (38/87) of placebo patients were responders at Week 24. Proptosis (67 percent; 38/57), diplopia (69 percent; 33/48) and composite outcome response (83 percent; 48/58) were observed 51 weeks after the last dose of Tepezza for those who had long-term off-treatment data available.

Additionally, in a post-hoc analysis, Tepezza-treated patients with more severe disease (those with ≥3 mm of proptosis and/or inconstant or constant diplopia) and those with less severe disease at baseline both experienced significant improvements in proptosis and diplopia. In patients with more severe disease, those treated with Tepezza had a proptosis response of 79 percent (50/63) compared to 17 percent (11/65) of those who received placebo, and a diplopia response of 68 percent (38/56) compared to 31 percent of those who received placebo (15/49). In patients with less severe disease, those treated with Tepezza had a proptosis response of 71 percent (15/21) compared to 9 percent in those who received placebo (2/22), and a diplopia response of 80 percent (8/10) compared to 30 percent in placebo (3/10).

In post-hoc analyses, patients who received Tepezza in both the lower baseline CAS subgroup (4 or 5) and the higher CAS subgroup (6 or 7) demonstrated statistically significant improvements compared with placebo in proptosis and diplopia. Overall response and CAS of 0 or 1 response also improved.

Post-hoc analysis from the Phase III study also demonstrated that in patients treated with Tepezza, those with higher (≥10 IU/L) or lower (<10 IU/L) serum thyrotropin-binding inhibitory immunoglobulin (TBII) baseline levels both had a proptosis response (mean reduction of -3.65 mm and -3.01 mm, respectively) with no treatment difference between the two groups. In patients with higher baseline TBII, 71 percent (10/14) of patients who received Tepezza experienced an improvement in diplopia compared to 23 percent (3/13) of patients who received placebo.

In November 2021, Horizon announced findings of a real-world adherence analysis of Tepezza for the treatment of TED. The analysis found that more than 90 percent (n=995) of people who were prescribed Tepezza for TED went on to complete all eight infusions, indicating a high level of adherence to the medicine in clinical practice. The study evaluated 1,101 people living with TED (71 percent female, mean age 58 years) who started treatment with Tepezza prior to July 2020. Non-compliance was low at approximately 1 percent (n=15). Only 8 percent (n=84) reported that they discontinued because of adverse events.

In June 2022, Horizon announced results of a new analysis examining rates of hyperglycemia among patients treated with Tepezza for TED compared to placebo in the Phase II and OPTIC Phase III clinical trials. The analysis found a total of nine adverse event reports of hyperglycemia in eight patients (8/84, 10 percent) who received Tepezza, and one patient (1/86; 1.2 percent) who received placebo. The majority (5/8, 63 percent) of patients who experienced hyperglycemia while taking Tepezza had pre-existing diabetes. Of the hyperglycemic AEs reported in the Tepezza-treated patients, all were controlled with medicine. All reported AEs were grade 1 (>ULN-160mg/dl) or grade 2 (161 – 250mg/dl), and none led to study discontinuation. HbA1c levels increased by 0.22 percent in those treated with Tepezza compared to 0.04 percent among placebo patients.

Ubrelvy

Ubrelvy

Ubrelvy was the first orally administered calcitonin gene-related peptide receptor antagonist (gepant) to be approved by FDA for the treatment of migraine attacks once they start.

Approved by FDA in late December of 2019, Ubrelvy was the first orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. Ubrelvy works by blocking CGRP, a protein that is released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments were known to do. FDA’s approval was based on four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04, and 3110-105-002), which demonstrated efficacy, safety, and tolerability of orally administered Ubrelvy in the acute treatment of migraine. Both 50 mg and100 mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, compared with placebo. Ubrelvy joined AbbVie’s portfolio when that company completed its acquisition of Allergan in May 2020. 

In August 2020, AbbVie announced Serena Williams as the spokesperson for Ubrelvy to raise awareness of an effective acute treatment option for people living with migraine. The multichannel marketing campaign featuring Williams highlighted how Ubrelvy works for people with different lifestyles by helping individuals treat their migraine attacks anytime, anywhere. As spokesperson, she was featured in a video, available on social media, talking with neurologist and paid AbbVie consultant Dr. Jennifer McVige about her experience with migraine and Ubrelvy. Williams was also included in print and digital advertising and other marketing initiatives.

In September 2021, FDA approved Abb­Vie’s Qulipta, another drug from the gepant family, for the preventive treatment of episodic migraine in adults. Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist specifically developed for the preventive treatment of migraine. The approval was supported by data from a robust clinical program evaluating the efficacy, safety, and tolerability of Qulipta in nearly 2,000 patients who experienced 4 to 14 migraine days per month, including the pivotal Phase III ADVANCE study, the pivotal Phase IIb/III trial, and the Phase III long-term safety study.

Ubrevly quarterly salesIn the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, the primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All Qulipta dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from baseline of 7.8. A key secondary endpoint in the ADVANCE trial measured the proportion of patients that achieved a ≥50 percent reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that 56 percent/59 percent/61 percent of patients in the 10 mg/30 mg/60 mg Qulipta arms, respectively, achieved a 50-100 percent reduction, compared to 29 percent of patients in the placebo arm.

During June, AbbVie submitted a supplemental NDA to FDA for Qulipta to support the preventive treatment of chronic migraine in adults. If approved, Qulipta would be the first gepant cleared for the broad indication of the preventive treatment of migraine, including episodic and chronic. The supplemental NDA submission includes data from the pivotal Phase III PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. People living with chronic migraine experience headaches for 15 or more days per month, which, on at least eight of those days per month, have the features of migraine.

The Phase III PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period in adults with chronic migraine. The trial also demonstrated that treatment with Qulipta 60 mg once daily (QD) and 30 mg daily (BID) resulted in statistically significant improvements in all six secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period. 

Josh Slatko, Med Ad News Josh Slatko is contributing editor of Med Ad News and PharmaLive.com.

Read More

Continue Reading

Government

Over the top

The biopharma industry’s response to the global pandemic has propelled some COVID-19 vaccines into the leading ranks of the world’s best-selling products,…

Published

on

Over the top

The biopharma industry’s response to the global pandemic has propelled some COVID-19 vaccines into the leading ranks of the world’s best-selling products, with Pfizer/BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot.

By Andrew Humphreys • andrew.humphreys@medadnews.com

The ripple effects of the worldwide COVID-19 pandemic continue to be felt throughout the biopharmaceutical realm, from allocation of business resources to the revenue impact of new vaccines and treatments for the industry’s main players. No biopharma company has thrived more during the pandemic’s reign than Pfizer, which experienced the largest increase in market capitalization during 2021 at $127 billion, rising to $331 billion. 

Comirnaty became the first COVID-19 vaccine to gain full approval.

Pfizer has collaborated with BioNTech to jointly develop the mRNA-based coronavirus vaccine Comirnaty/BNT162b2 to help prevent COVID-19. Comirnaty/BNT162b2 accounted for 45 percent of Pfizer’s total revenue during 2021, coming in at $36.78 billion. For the first six months of 2022, Pfizer reported Comirnaty direct sales and alliance revenue of $22.08 billion. As of July 28, Pfizer forecasted $32 billion in revenue for Comirnaty for full-year 2022, with gross profit to be split evenly with BioNTech, which includes doses expected to be delivered throughout the fiscal year. 

Comirnaty is based on Bi­oN­Tech’s proprietary messenger RNA technology. As the first-ever approved mRNA therapy, Comirnaty additionally represents BioNTech’s first commercial product. Through the vaccine, BioNTech’s revenue grew from €482.3 million ($571 million) in 2020 to €18.98 billion ($22.45 billion) for 2021. In reporting first-quarter 2022 results, BioNTech reiterated the company’s prior full-year 2022 financial year outlook of €13 billion ($15.4 billion) to €17 billion ($20.11 billion).

Pfizer-BioNTech’s COVID-19 vaccine is authorized by the U.S. Food and Drug Administration under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Comirnaty (approved under a Biologics License Application)/BNT162b2 (authorized under EUA) in July 2022 became the first COVID-19 vaccine to be granted FDA approval for adolescents 12 years and older, following U.S. emergency use authorization in May 2021. Comirnaty became the first FDA-approved COVID-19 vaccine for individuals 16 years and older during August 2021. 

The impact of the worldwide pandemic led to the unseating of Humira (adalimumab) as the world’s top-selling pharmaceutical product in 2021, which was the medicine’s best-performing year ever. Humira has annually been the best seller among prescription medicines dating back to 2012. The drug’s combined revenue for 2021 between AbbVie and Japan’s Eisai topped $21.18 billion. AbbVie reported $20.69 billion of that total, the first time Humira broke the $20 billion barrier in one year for the North Chicago-based company. For first-half 2022, AbbVie reported Humira worldwide revenue of $10.1 billion.Humira

Humira is administered as a subcutaneous injection. The biologic therapy is approved for treating various autoimmune diseases in North America and in the European Union: rheumatoid arthritis (moderate to severe), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease (moderate to severe), plaque psoriasis (moderate to severe chronic), juvenile idiopathic arthritis (moderate to severe polyarticular), ulcerative colitis (moderate to severe), axial spondyloarthropathy, pediatric Crohn’s disease (moderate to severe), hidradenitis suppurativa (moderate to severe), pediatric enthesitis-related arthritis, non-infectious intermediate, posterior and panuveitis, pediatric ulcerative colitis (moderate to severe), and pediatric uveitis. Humira is approved in Japan for treating intestinal Behçet’s disease and pyoderma gangrenosum.

Humira is sold in other markets around the globe, including Japan, China, Brazil, and Australia. The medication accounted for 37 percent of AbbVie’s total net revenue during 2021 and nearly 36 percent during the first six months of 2022.

Moderna’s COVID-19 vaccine Spikevax (mRNA-1273) has been authorized for use or approved in more than 70 countries. The FDA fully approved the BLA for Spikevax for individuals 18 years of age and older in January 2022. Moderna’s COVID-19 vaccine was made available under EUA in the United States on Dec. 18, 2020. The full licensure of Spikevax in the United States joined that in Canada, Japan, the European Union, the UK, Israel, and other countries where the adolescent indication is additionally approved. 

During June 2022, Moderna gained EUA from the FDA for the company’s COVID-19 vaccine mRNA-1273 in young children ages 6 months through 5 years of age at a dose level of 25 µg. Moderna has additionally received emergency use authorization for a 50 µg two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 µg two-dose regimen for adolescents aged 12 through 17 years old. 

Spikevax marks Moderna’s first commercial product. Sales amounted to nearly $17.68 billion during full-year 2021. For the first six months of 2022, Moderna reported product sales of about $10.46 billion.

Keytruda ranks as the world’s top-selling cancer therapeutic. Global sales for Merck’s checkpoint inhibitor grew from $11.08 billion during 2019 to $14.38 billion for 2020 and $17.19 billion in 2021. For first-half 2022, Merck reported Keytruda global sales of $10.06 billion. The anti-PD-1 (programmed death receptor-1) therapy contains the active chemical pembrolizumab.

Keytruda

Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The humanized monoclonal antibody blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.

Outside the COVID-19 vaccine domain, Keytruda is expected to overtake Humira as the top-selling prescription medicine in 2023 when the latter’s U.S. market exclusivity is set to expire. AbbVie has entered into settlement and license deals with several adalimumab biosimilar manufacturers. The licenses in the United States will start during 2023 and the licenses in Europe began in 2018. “The inevitable arrival of Humira biosimilars in the U.S. next year means that AbbVie is hurtling towards biopharma’s biggest-ever patent cliff,” according to Evaluate Pharma analysis.

Meanwhile, Keytruda is anticipated to continue thriving as the product’s compound patent is protected from expiration in all majors markets until at least 2028 (the United States and China) and into the following decade in the EU and Japan. 

According to analysts from Evaluate Pharma, come 2028, Keytruda will remain the top-selling non-Covid treatment with estimated sales of $30.9 billion. By that year, the top-selling pharmaceutical of all-time, Humira, will no longer be a member of the top 10 sellers (see graphic on this page). 

Per Evaluate Pharma, the No. 2 seller in 2028 is projected to be Bristol Myers Squibb and Ono Pharmaceutical’s Opdivo (nivolumab), predicted to trail Keytruda by nearly half in revenue at $15.7 billion. A fully human monoclonal antibody that binds to the PD-1 on T and NKT cells, the biological product Opdivo has received approvals for various anti-cancer indications including bladder, blood, colon, head and neck, kidney, liver, lung, melanoma, mesothelioma and stomach.

Biggest Selling Drugs, Evaluate Pharma

Download the listing of the top 200 medicines based on global sales during 2021

Andrew Humphreys is contributing editor of Med Ad News and PharmaLive.com.

Read More

Continue Reading

Economics

Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition

Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and…

Published

on

Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and in today’s interview, The Dales Report’s Nicole Hodges talks with CEOs Dr. Roger McIntyre and Warren Gumpel of Braxia Scientific and KetaMD respectively.

For some background information, KetaMD is a U.S. based, privately-held, innovative telemedicine company, with a mission to address mental health challenges via access to technology-facilitated ketamine-based treatments. Braxia Scientific is Canada’s first clinic specializing in ketamine treatments for mood disorders. They recorded revenue of $1.49m for 2022 fiscal year, ended March 31. On a year-over-year basis, revenue increased 47.5%.

Here’s some highlights from the interview.

KetaMD gives Braxia a presence in the US

Dr. McIntyre says that KetaMD gives Braxia what they’ve had as their vision from the beginning: a US presence. KetaMD is a living program. It’s already running, has infrastructure, and patients. McIntyre believes that a program like KetaMD is something Braxia’s needed to scale and obtain commercial success.

With telemedicine, Braxia has a potential to serve a gap in access. The zeitgeist of “patient going to medicine” has flipped, McIntyre says. “Now it’s medicine goes to the patient, and that is long overdue.”

COVID speeding a trend that was already happening

In 2020, 80% of physicians indicated they had virtual visits. That’s a number up from 22% the year before. But this is something that many doctors, McIntyre included, believe always should have happened. The pandemic only was the catalyst for innovation and making the option viable.

While some treatments will always need a clinic or a hospital, McIntyre believes some treatments can be done safely at home. And they are, for many chronic diseases. He feels implementing ketamine and psychedelics would be among these treatments where service could be expanded into the home. It would require careful SOPs in place, best practices, and surveillance. But he believes Braxia Scientific could deliver this with KetaMD.

Gumpel to stay as CEO of KetaMD

Gumpel says that KetaMD benefits in this acquisition from being part of the world’s most prominent researchers in depression, psychedelics, and ketamine. In the acquisition, he’ll stay on as CEO. He admits that Dr. McIntyre has been a huge part of collecting the data on the safety of ketamine treatment, and has a strong motivation to “see this thing through until most of society can access that – or at least the people that need it and want it.”

Gumpel admits he has a personal connection to ketamine treatment. As a person who has experienced bouts of depression for years, it saved his life, he says. He is grateful he was living within walking distance of ketamine treatment in Manhattan. It made him extremely aware of the accessibility gap, which in part inspired KetaMD.

Be sure to tune in for the full interview regarding Braxia and KetaMD, right here on The Dales Report!

The post Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition appeared first on The Dales Report.

Read More

Continue Reading

Trending