South San Francisco-based Pliant Therapeutics announced it had inked a strategic collaboration and license deal with Novartis.
The agreement revolves around the development and commercialization of
Pliant’s preclinical candidate, PLN-1474, and up to three more integrin
targets for liver fibrosis associated with nonalcoholic steatohepatitis
(NASH).
NASH is similar to cirrhosis of the liver but occurs in patients who
drink little or no alcohol. It is a multifactorial disease, involving
fibrosis, inflammation and fatty liver. It is associated with high
cholesterol, obesity and type 2 diabetes.
At this time, there are no specific treatments for NASH except for
lifestyle changes and various medications for the associated diseases.
PLN-1474 was discovered by Pliant. It is a small molecule selective inhibitor of integrin αVβ1. In preclinical research, PLN-1474 selectively blocked the activation of TGF-beta, which is mediated by αVβ1. This decreased the growth of fibrotic tissue within the liver. Pliant is currently running IND-enabling studies on the drug.
Under the terms of the deal, Novartis is paying $80 million to Pliant
upfront as well as an undisclosed equity investment commitment. The
deal is for worldwide exclusive license to PLN-1474 and up to three more
candidates. Also, Novartis will fund Pliant’s research and development
activities related to the deal.
Pliant
will handle development of PLN-1474 through Phase I. Then Novartis will
take over all future development, manufacturing and commercialization
activities.
Pliant will be eligible for various milestone payments as well as
tiered royalties from the mid-single digits to low double digits.
“Our research continues to generate compelling preclinical evidence
that supports the advancement of PLN-1474 as a clinical candidate and
validates our approach of evaluating αVβ1 integrin
inhibition to treat advanced liver fibrosis associated with NASH,” said
Bernard Coulie, president and chief executive officer of Pliant.
“Pairing Pliant’s leading integrin biology and drug discovery
capabilities with Novartis, a world-leader with one of the broadest
pipelines investigating mono and combination therapies for liver
diseases including NASH, will support our goal of developing novel
therapies for fibrotic diseases and potentially bring meaningful
treatment options to patients.”
The NASH market is projected
to be worth about $35 billion, but so far it has eluded the biopharma
industry. Any number of companies, big and small, are tackling the
disease, including Viking Therapeutics, Madrigal Pharmaceuticals,
Intercept Pharmaceuticals, Genfit, Allergan, Gilead Sciences, Novo
Nordisk and others.
The company closest to a marketable product is Intercept, which filed
a New Drug Application with the U.S. Food and Drug Administration (FDA)
for obeticholic acid on September 27, 2019. It met the primary endpoint
of a Phase III trial in NASH patients and is the only FDA-designated
Breakthrough Therapy for NASH with fibrosis. The company requested a
Priority Review, which if granted would result in a six-month review
period, giving a target action date around the end of March 2020. The
company also indicated it planned to file a marketing authorization
application (MAA) with the European Medicines Agency (EMA) by the end of
the year.
Obeticholic acid has been approved to treat primary biliary
cholangitis (PBC) by the FDA under the brand name Ocaliva. PBC is a
chronic disease where bile ducts in the liver are gradually destroyed,
inhibiting the liver’s ability to clear toxins from the body and leading
to cirrhosis.
The next-closest is probably France-based Genfit and its elafibranor. It has received Fast Track Designation from the FDA for NASH and Breakthrough Therapy Designation for primary biliary cholangitis.
NASH is projected to become the leading cause of liver transplants in the U.S. as early as 2020.
https://www.biospace.com/article/pliant-partners-with-novartis-on-liver-fibrosis-and-nash/
Wednesday, October 23, 2019
After phase 3 bust, Lilly cans pancreatic cancer program for Armo buyout drug
Eli Lilly is canning the lead program for the crown jewel of its $1.6
billion Armo Biosciences buyout after the drug put up a poor showing in
pancreatic cancer. The Big Pharma said it was ending the phase 3 study of pegilodecakin in its third-quarter earnings presentation.
When Lilly got its hands on pegilodecakin, a PEGylated form of the anti-inflammatory cytokine IL-10, Armo had moved it into the clinic for melanoma as well as pancreatic, lung and kidney cancers and other solid tumors.
The drug didn’t start out at Armo, though—Merck picked it up years before when it swallowed up Schering-Plough, but subsequently lost interest and shelved it. Two Merck Research Labs scientists who had worked on pegilodecakin still believed in it and reached out to biotech entrepreneur Peter Van Vlasselaer, who built Armo around it.
Lilly announced
on Wednesday last week that the drug missed its primary endpoint in the
phase 3 Sequoia trial, which combined pegilodecakin with a chemo
cocktail and tested it against the cocktail, known as FOLFOX, alone. The
combo failed to extend the lives of patients with metastatic pancreatic
cancer whose disease had worsened during or following treatment with
first-line Gemzar (gemcitabine).
Pancreatic cancer remains one of the deadliest and most difficult cancers to treat, with five-year survival rates in the single digits. But Lilly is hopeful about pegilodecakin’s utility in other cancer types.
“Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting. We are grateful to the patients, investigators and researchers who participated in the study,” said Maura Dickler, M.D., vice president of late-phase development at Lilly Oncology, last week.
“While we are disappointed by the outcome of the Sequoia study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy,” Dickler said.
The demise of the pancreatic cancer program comes amid an otherwise rosy quarter for Lilly—“Don’t Hold Your Nose ‘Cause LLY Smells Like A Rose This Morning,” wrote Cantor Fitzgerald analysts, citing an uptick in revenues that was driven by volume, or selling more drugs, rather than by raising prices.
https://www.fiercebiotech.com/biotech/after-phase-3-bust-lilly-bids-armo-buyout-drug-adieu
When Lilly got its hands on pegilodecakin, a PEGylated form of the anti-inflammatory cytokine IL-10, Armo had moved it into the clinic for melanoma as well as pancreatic, lung and kidney cancers and other solid tumors.
The drug didn’t start out at Armo, though—Merck picked it up years before when it swallowed up Schering-Plough, but subsequently lost interest and shelved it. Two Merck Research Labs scientists who had worked on pegilodecakin still believed in it and reached out to biotech entrepreneur Peter Van Vlasselaer, who built Armo around it.
Pancreatic cancer remains one of the deadliest and most difficult cancers to treat, with five-year survival rates in the single digits. But Lilly is hopeful about pegilodecakin’s utility in other cancer types.
“Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting. We are grateful to the patients, investigators and researchers who participated in the study,” said Maura Dickler, M.D., vice president of late-phase development at Lilly Oncology, last week.
“While we are disappointed by the outcome of the Sequoia study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy,” Dickler said.
The demise of the pancreatic cancer program comes amid an otherwise rosy quarter for Lilly—“Don’t Hold Your Nose ‘Cause LLY Smells Like A Rose This Morning,” wrote Cantor Fitzgerald analysts, citing an uptick in revenues that was driven by volume, or selling more drugs, rather than by raising prices.
https://www.fiercebiotech.com/biotech/after-phase-3-bust-lilly-bids-armo-buyout-drug-adieu
Million-dollar marketing juggernaut pushes 3D mammograms
When Dr. Worta McCaskill-Stevens made an appointment for a mammogram
last year, she expected a simple breast cancer screening―not a
heavy-handed sales pitch.
A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.
“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.
A short time later, a technician asked again: Was the patient sure she didn’t want 3D?
Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.
A Kaiser Health News investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle―and millions of dollars―behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.
“There’s a lot of money to be made,” said Dr. Steven Woloshin, director of the Center for Medicine and Media at The Dartmouth Institute for Health Policy and Clinical Practice, who published a study in January showing that the healthcare industry spends $30 billion a year on marketing.
KHN’s investigation shows that industry money has shaped policy, public opinion and patient care around 3D by:
Taxpayers write the check for many 3D screenings, which add about $50 to the cost of a typical mammogram. Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D, according to a KHN analysis of federal data.
Hologic’s Peter Valenti said the company’s marketing is educational. His company is a “for-profit organization, but our premise is to try to improve the healthcare for women globally,” said Valenti, president of Hologic’s breast and skeletal health solutions division.
The debate over 3D mammograms illustrates the tension in the medical community over how much research companies should do before commercializing new products. In a statement, officials at Hologic said it would be “irresponsible and unethical” to withhold technology that detects more breast cancers, given that definitive clinical trials can take many years.
On average, 3D screenings may slightly increase cancer detection rates, finding about one extra breast tumor for every 1,000 U.S. women screened, according to a 2018 analysis in the Journal of the National Cancer Institute. Most studies also show that 3D screenings cause fewer “false alarms,” in which women are called back for procedures they don’t need, said Dr. Susan Harvey, a Hologic vice president.
Yet newer tech isn’t necessarily better―and it can cause harm, said Dr. Otis Brawley, a professor at Johns Hopkins University. “It’s unethical to push a product before you know it helps people,” he said.
“Can we say that 3D is better?” asked McCaskill-Stevens. “We don’t know.”
The American Cancer Society, Susan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.
When the Food and Drug Administration (FDA) approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective (PDF) at finding breast cancer (PDF)―not at improving survival.
“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.
Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.
Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.
Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.
Yet some studies suggest that 3D mammograms are less accurate than 2D.
A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.
And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California Davis School of Medicine.
Valenti said the newest 3D systems provide about the same radiation dose as 2D.
Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them―or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.
A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the preventive services task force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.
Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.
“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.
Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.
Dr. Liane Philpotts, chief of breast imaging at Yale School of Medicine, championed a 2016 Connecticut bill to mandate insurance coverage for 3D screenings. “When I look at a 2D mammogram now, I don’t know how we read them with any degree of confidence,” Philpotts said in a letter of support (PDF). “They seem grossly inadequate.”
Philpotts’ letter did not mention she has worked as a consultant for Hologic, which paid her $13,500 from 2013 to 2018, mostly for research, according to Open Payments. In an interview, Philpotts said her work for Hologic has not influenced her medical advice. “[Tomosynthesis is] just so much better for patients,” she said. “I feel very passionately about it.”
Dr. Linda Greer, a community radiologist in Phoenix, has said she was “shocked” by how many more tumors were detected with 3D than 2D. In a 2013 interview, she told Everyday Health, “We got scared about what we were missing for so many years” with 2D mammograms. Greer has accepted more than $305,000 from makers of mammography machines, including $222,000 related to 3D products, according to the Open Payments database.
Greer noted she maintains her intellectual independence by writing her own presentations, even if Hologic pays for her travel. “I don’t think I could be bought,” she said.
In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a small, company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”
Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “
While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.
“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government
Valenti said Hologic wanted more women to have access to the technology. So Hologic launched a public campaign―with a website, paid celebrity tweets and billboards―to pressure private insurers to cover 3D.
Hospitals and radiology practices―who stand to benefit from an expanded pool of paying customers―are also fierce advocates for insurance coverage.
In 2017, a doctor at New York’s Memorial Sloan Kettering Cancer Center asked a local assemblywoman to introduce a bill mandating insurance coverage for 3D screenings.
In a statement, an official at Memorial Sloan Kettering said the hospital supported the bill to improve patient care. “Our patients deserved the most optimal screening available,” said Dr. Elizabeth Morris, chief of the hospital’s breast imaging service.
Supporters of 3D mammograms also rallied around an insurance mandate in Texas in 2017. Registered supporters included HCA Healthcare, a for-profit chain that manages 185 hospitals, and the Black Women’s Health Imperative. That group also testified before an FDA panel in 2010 to advocate approving Hologic’s device.
Linda Goler Blount, the group’s president and CEO, said the organization was advocating for early detection long before its partnership with Hologic began in 2016.
“If you’re low-income, you’re much less likely to get 3D mammography than if you’re upper-income,” Blount said.
Blount noted that her group remains “independent and free to speak our mind.”
Rose, a radiologist, testified on behalf of the Texas insurance bill twice. The practice where Rose works, Solis Mammography, put out press releases in favor of the legislation. In 2010, Rose testified in favor of 3D screenings at an FDA advisory panel.
In the past six years, he has received $317,000 from companies that manufacture mammogram machines, including more than $50,000 related to specific 3D products, according to the Open Payments database. Twelve percent of Rose’s 3D-related payments were related to research.
Rose said industry money hasn’t influenced him. “I can tell you it had zero impact,” Rose said.
In 2014, Rose co-wrote an influential paper that described the benefits of 3D mammograms.
Collectively, Rose and 12 of his co-authors accepted more than $1 million from the four leading manufacturers of 3D equipment over the past six years, including $589,000 related to 3D products, according to a KHN analysis of Open Payments data. In addition, Hologic contributed $855,000 to research in which many of these authors took leading roles.
Valenti said Hologic doesn’t expect anything in return for the payments: “We let the product and the doctor speak for themselves.”
“There is no connection between the society’s educational grants and statement development,” said Sharon Grutman, a society spokeswoman.
Fran Visco, president of the National Breast Cancer Coalition, has advocated for women for decades. But she said she’s at a loss for a solution to curtail industry influence in medicine.
“It’s incredibly troubling,” said Visco, a breast cancer survivor. “Everyone has a different stake in all this, and it all seems to be tied to financial gain.”
https://www.fiercebiotech.com/medtech/a-million-dollar-marketing-juggernaut-pushes-3d-mammograms
A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.
“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.
Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.
A Kaiser Health News investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle―and millions of dollars―behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.
“There’s a lot of money to be made,” said Dr. Steven Woloshin, director of the Center for Medicine and Media at The Dartmouth Institute for Health Policy and Clinical Practice, who published a study in January showing that the healthcare industry spends $30 billion a year on marketing.
KHN’s investigation shows that industry money has shaped policy, public opinion and patient care around 3D by:
- Paying influential doctors. In the past six years, 3D equipment manufacturers―including Hologic, GE Healthcare, Siemens Medical Solutions USA and Fujifilm Medical Systems USA―have paid doctors and teaching hospitals more than $240 million, including more than $9.2 million related to 3D mammograms, according to a KHN analysis of the Medicare Open Payments database. Just over half of that money was related to research; other payments covered speaking fees, consulting, travel, meals or drinks. The database shows that influential journal articles―those cited hundreds of times by other researchers―were written by doctors with financial ties to the 3D industry.
- Marketing directly to consumers. Manufacturers have urged women to demand “the better mammogram,” using celebrity spokeswomen such as breast cancer survivor Sheryl Crow. Manufacturers spent $14 million to market 3D screening over the past four years, not including spending on social media, according to Kantar Media, which tracks the advertising industry.
- Lobbying state lawmakers. Private insurers in 16 states are now legally required to cover 3D screenings, along with Medicaid programs in 36 states and Washington, D.C. Officials at Hologic, the leading manufacturer, told KHN that about 95% of insured women have coverage for tomosynthesis.
- Funding experts and advocates. Hologic has given educational grants (PDF) to the American Society of Breast Surgeons, a medical association that recently recommended (PDF) 3D mammograms as its preferred screening method, according to the group’s website. Hologic declined to reveal amounts. Hologic also has funded patient advocates such as the Black Women’s Health Imperative, which lobbies for access to 3D mammograms.
Taxpayers write the check for many 3D screenings, which add about $50 to the cost of a typical mammogram. Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D, according to a KHN analysis of federal data.
Hologic’s Peter Valenti said the company’s marketing is educational. His company is a “for-profit organization, but our premise is to try to improve the healthcare for women globally,” said Valenti, president of Hologic’s breast and skeletal health solutions division.
The debate over 3D mammograms illustrates the tension in the medical community over how much research companies should do before commercializing new products. In a statement, officials at Hologic said it would be “irresponsible and unethical” to withhold technology that detects more breast cancers, given that definitive clinical trials can take many years.
On average, 3D screenings may slightly increase cancer detection rates, finding about one extra breast tumor for every 1,000 U.S. women screened, according to a 2018 analysis in the Journal of the National Cancer Institute. Most studies also show that 3D screenings cause fewer “false alarms,” in which women are called back for procedures they don’t need, said Dr. Susan Harvey, a Hologic vice president.
Yet newer tech isn’t necessarily better―and it can cause harm, said Dr. Otis Brawley, a professor at Johns Hopkins University. “It’s unethical to push a product before you know it helps people,” he said.
A fuzzy picture
As a senior researcher at the National Cancer Institute, McCaskill-Stevens didn’t need a glossy brochure to learn about 3D mammograms. She helped design a $100 million federally funded study of 165,000 women, which will measure whether women are helped or hurt by 3D testing. The study, now recruiting patients, will follow the women for five years.“Can we say that 3D is better?” asked McCaskill-Stevens. “We don’t know.”
The American Cancer Society, Susan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.
When the Food and Drug Administration (FDA) approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective (PDF) at finding breast cancer (PDF)―not at improving survival.
“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.
Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.
Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.
Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.
Yet some studies suggest that 3D mammograms are less accurate than 2D.
A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.
And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California Davis School of Medicine.
Valenti said the newest 3D systems provide about the same radiation dose as 2D.
Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them―or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.
A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the preventive services task force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.
Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.
“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.
Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.
Dr. Liane Philpotts, chief of breast imaging at Yale School of Medicine, championed a 2016 Connecticut bill to mandate insurance coverage for 3D screenings. “When I look at a 2D mammogram now, I don’t know how we read them with any degree of confidence,” Philpotts said in a letter of support (PDF). “They seem grossly inadequate.”
Philpotts’ letter did not mention she has worked as a consultant for Hologic, which paid her $13,500 from 2013 to 2018, mostly for research, according to Open Payments. In an interview, Philpotts said her work for Hologic has not influenced her medical advice. “[Tomosynthesis is] just so much better for patients,” she said. “I feel very passionately about it.”
Dr. Linda Greer, a community radiologist in Phoenix, has said she was “shocked” by how many more tumors were detected with 3D than 2D. In a 2013 interview, she told Everyday Health, “We got scared about what we were missing for so many years” with 2D mammograms. Greer has accepted more than $305,000 from makers of mammography machines, including $222,000 related to 3D products, according to the Open Payments database.
Greer noted she maintains her intellectual independence by writing her own presentations, even if Hologic pays for her travel. “I don’t think I could be bought,” she said.
Building a brand
The first question many women have about 3D mammograms is: Are they less painful?In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a small, company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”
Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “
While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.
“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government
Changing the law
For years, women who wanted a 3D screening had to pay an extra $50 to $100 out-of-pocket.Valenti said Hologic wanted more women to have access to the technology. So Hologic launched a public campaign―with a website, paid celebrity tweets and billboards―to pressure private insurers to cover 3D.
Hospitals and radiology practices―who stand to benefit from an expanded pool of paying customers―are also fierce advocates for insurance coverage.
In 2017, a doctor at New York’s Memorial Sloan Kettering Cancer Center asked a local assemblywoman to introduce a bill mandating insurance coverage for 3D screenings.
In a statement, an official at Memorial Sloan Kettering said the hospital supported the bill to improve patient care. “Our patients deserved the most optimal screening available,” said Dr. Elizabeth Morris, chief of the hospital’s breast imaging service.
Supporters of 3D mammograms also rallied around an insurance mandate in Texas in 2017. Registered supporters included HCA Healthcare, a for-profit chain that manages 185 hospitals, and the Black Women’s Health Imperative. That group also testified before an FDA panel in 2010 to advocate approving Hologic’s device.
Linda Goler Blount, the group’s president and CEO, said the organization was advocating for early detection long before its partnership with Hologic began in 2016.
“If you’re low-income, you’re much less likely to get 3D mammography than if you’re upper-income,” Blount said.
Blount noted that her group remains “independent and free to speak our mind.”
Paying doctors
Dr. Stephen Rose has been an especially active advocate for 3D screenings.Rose, a radiologist, testified on behalf of the Texas insurance bill twice. The practice where Rose works, Solis Mammography, put out press releases in favor of the legislation. In 2010, Rose testified in favor of 3D screenings at an FDA advisory panel.
In the past six years, he has received $317,000 from companies that manufacture mammogram machines, including more than $50,000 related to specific 3D products, according to the Open Payments database. Twelve percent of Rose’s 3D-related payments were related to research.
Rose said industry money hasn’t influenced him. “I can tell you it had zero impact,” Rose said.
In 2014, Rose co-wrote an influential paper that described the benefits of 3D mammograms.
Collectively, Rose and 12 of his co-authors accepted more than $1 million from the four leading manufacturers of 3D equipment over the past six years, including $589,000 related to 3D products, according to a KHN analysis of Open Payments data. In addition, Hologic contributed $855,000 to research in which many of these authors took leading roles.
Valenti said Hologic doesn’t expect anything in return for the payments: “We let the product and the doctor speak for themselves.”
A web of relationships
The American Society of Breast Surgeons, lists Hologic as a corporate partner. In May, the society recommended 3D mammograms as its preferred screening method.“There is no connection between the society’s educational grants and statement development,” said Sharon Grutman, a society spokeswoman.
Fran Visco, president of the National Breast Cancer Coalition, has advocated for women for decades. But she said she’s at a loss for a solution to curtail industry influence in medicine.
“It’s incredibly troubling,” said Visco, a breast cancer survivor. “Everyone has a different stake in all this, and it all seems to be tied to financial gain.”
https://www.fiercebiotech.com/medtech/a-million-dollar-marketing-juggernaut-pushes-3d-mammograms
Bluebird Bio readies Zynteglo launch as EU approves ‘refined’ manufacturing
A manufacturing hiccup that Bluebird Bio’s believed might
delay its gene therapy launch until 2020 has not only been overcome, the
company now says it expects to enroll its first patients there yet this
year.
The Cambridge, Massachusetts-based company Tuesday said
the European Medicines Agency has approved the “refined commercial drug
product manufacturing specifications for Zynteglo.” Bluebird has yet to
seek FDA approval for the treatment.Bluebird Bio in June said the launch of the one-time treatment for patients 12 and over with transfusion-dependent beta-thalassemia might be delayed in the EU until 2020. Even though it was approved, regulators wanted Bluebird to “tighten up” its manufacturing before treating its first commercial patient. It said at the time that as it tweaked its manufacturing it also would use the time to qualify and train the staff and facilities that will handle the treatments.
Tuesday, Bluebird Bio Chief Commercial Officer Alison Finger said its goal is now to enroll “our first commercial patient in 2019.”
She said it was the first step in a country-by-country launch, to serve “TDT patients with Zynteglo and providing a treatment option that offers the possibility of a transfusion-free future.”
Bluebird Bio has priced Zynteglo in Europe at €1.575 million ($1.77 million), a cost that is amortized over five years and only if it works on patients treated for transfusion-dependent beta-thalassemia. Bluebird has yet to seek approval of the gene therapy in the U.S. but has told investors to expect it will file with the FDA by the end of this year.
The drug is being manufactured in Europe by Apceth Biopharma, whose CEO Christine Guenther said the CDMO was “in the final stages of preparing to manufacture a cell-based gene therapy for commercial use.”
https://www.fiercepharma.com/manufacturing/bluebird-bio-readies-zynteglo-launch-as-eu-approves-refined-manufacturing
Medicare Funding Weighs on Eli Lilly’s Revenue
Eli Lilly & Co. posted a lower-than-expected revenue for the
latest quarter as the company provided more funding for seniors through a
Medicare plan under a change in federal law that took effect this year.
The pharmaceutical company posted third-quarter revenue of $5.48 billion, up 3.2% from the same quarter last year but below the $5.5 billion analysts polled by FactSet had expected. Lilly said an 8% volume increase drove revenue up.
Shares of Lilly fell about 2.2% in midday trading. Lilly’s stock was down about 7.2% this year.
The Indianapolis company’s U.S. sales stayed about flat at $3.06 billion as higher sales for its key products, such as diabetes treatment Trulicity, psoriasis drug Taltz and migraine medication Emgality offset lower volume of erectile-dysfunction pill Cialis.
Cialis saw sales drop 61% from a year earlier, with the company attributing the decline to its loss of patent exclusivity.
Overseas sales rose 8% to $2.42 billion, Lilly said.
Trulicity sales, which rose 24% for the quarter compared with a year earlier, still missed expectations due to Lilly’s increased share of funding for seniors in the Medicare Part D drug benefit, Chief Executive David Ricks told The Wall Street Journal.
Under the change to Part D, companies like Lilly must now pay 70% of prescription costs when members reach a certain level of spending for the year, up from 50% last year.
More than one-third of Trulicity’s U.S. sales are through Part D, and many seniors hit a gap in coverage known as the doughnut hole from May through August. Lilly’s funding for seniors during the coverage gap reduced net pricing for Trulicity. Strong prescription volume growth for Trulicity, however, paints a “healthy picture,” Mr. Ricks said.
Also contributing to the sales miss was the company’s withdrawal of its Lartruvo cancer drug after a study showed that it failed to prolong overall survival in a clinical trial.
Lilly posted net income of $1.37 a share, up 22% from the comparable quarter last year. Adjusted earnings were $1.48 a share, up 10% from the prior year and beating the $1.40 a share analysts had expected.
For the full year, Lilly said it sees adjusted earnings to be between $5.75 a share and $5.85 a share, up from its previous guidance of between $5.67 a share and $5.77 a share. Analysts are expecting $5.72 a share for the full year.
The company said it is sponsoring a clinical study with the University of Southern California’s Alzheimer Institute to test whether Lilly’s drug solanezumab can slow the progression of memory problems in older people who don’t yet show symptoms of Alzheimer’s disease but are at risk of decline. The “A4” study for the drug, which failed to help patients already diagnosed with Alzheimer’s in past trials, is likely to yield results in 2022, Chief Scientific Officer Daniel Skovronsky said on a call with investors.
“We just have to wait patiently for those results to see if someone can have efficacy in this very early population,” Mr. Skovronsky said.
Biogen Inc. on Tuesday said it plans to seek regulatory approval early next year for an Alzheimer’s drug that had been considered a lost cause after the company pulled the plug on late-stage studies due to disappointing results.
https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Medicare-Funding-Weighs-on-Eli-Lilly-s-Revenue-Update-29442770/
The pharmaceutical company posted third-quarter revenue of $5.48 billion, up 3.2% from the same quarter last year but below the $5.5 billion analysts polled by FactSet had expected. Lilly said an 8% volume increase drove revenue up.
Shares of Lilly fell about 2.2% in midday trading. Lilly’s stock was down about 7.2% this year.
The Indianapolis company’s U.S. sales stayed about flat at $3.06 billion as higher sales for its key products, such as diabetes treatment Trulicity, psoriasis drug Taltz and migraine medication Emgality offset lower volume of erectile-dysfunction pill Cialis.
Cialis saw sales drop 61% from a year earlier, with the company attributing the decline to its loss of patent exclusivity.
Overseas sales rose 8% to $2.42 billion, Lilly said.
Trulicity sales, which rose 24% for the quarter compared with a year earlier, still missed expectations due to Lilly’s increased share of funding for seniors in the Medicare Part D drug benefit, Chief Executive David Ricks told The Wall Street Journal.
Under the change to Part D, companies like Lilly must now pay 70% of prescription costs when members reach a certain level of spending for the year, up from 50% last year.
More than one-third of Trulicity’s U.S. sales are through Part D, and many seniors hit a gap in coverage known as the doughnut hole from May through August. Lilly’s funding for seniors during the coverage gap reduced net pricing for Trulicity. Strong prescription volume growth for Trulicity, however, paints a “healthy picture,” Mr. Ricks said.
Also contributing to the sales miss was the company’s withdrawal of its Lartruvo cancer drug after a study showed that it failed to prolong overall survival in a clinical trial.
Lilly posted net income of $1.37 a share, up 22% from the comparable quarter last year. Adjusted earnings were $1.48 a share, up 10% from the prior year and beating the $1.40 a share analysts had expected.
For the full year, Lilly said it sees adjusted earnings to be between $5.75 a share and $5.85 a share, up from its previous guidance of between $5.67 a share and $5.77 a share. Analysts are expecting $5.72 a share for the full year.
The company said it is sponsoring a clinical study with the University of Southern California’s Alzheimer Institute to test whether Lilly’s drug solanezumab can slow the progression of memory problems in older people who don’t yet show symptoms of Alzheimer’s disease but are at risk of decline. The “A4” study for the drug, which failed to help patients already diagnosed with Alzheimer’s in past trials, is likely to yield results in 2022, Chief Scientific Officer Daniel Skovronsky said on a call with investors.
“We just have to wait patiently for those results to see if someone can have efficacy in this very early population,” Mr. Skovronsky said.
Biogen Inc. on Tuesday said it plans to seek regulatory approval early next year for an Alzheimer’s drug that had been considered a lost cause after the company pulled the plug on late-stage studies due to disappointing results.
https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Medicare-Funding-Weighs-on-Eli-Lilly-s-Revenue-Update-29442770/
Arvinas up 13% on encouraging cancer candidate data
Thinly traded Arvinas (ARVN +13.2%) is up on double normal volume, albeit on turnover of only 386K shares, on the heels of preliminary data
from Phase 1 clinical trials evaluating the safety, tolerability and
pharmacokinetics of candidates ARV-110 (metastatic castration-resistant
prostate cancer) and ARV-471 (ER+/HER2- locally advanced/metastatic
breast cancer).
All doses have been well-tolerated with no
dose-limiting toxicities. Exposures for both have reached levels
associated with tumor growth inhibition observed in preclinical studies.
Dose-escalation data on ARV-110 will be released in H1 2020 followed by the same on ARV-471 in H2 2020.
Both candidates are protein degraders based on the company’s PROTAC platform.
https://seekingalpha.com/news/3508408-arvinas-13-percent-encouraging-cancer-candidate-dataXBiotech commences mid-stage study of bermekimab in painful skin disorder
Enrollment is underway in a Phase 2 clinical trial evaluating XBiotech’s (XBIT -0.3%)
bermekimab in patients with hidradenitis suppurativa, a condition
characterized by small painful lumps under the skin, typically in areas
where skin rubs together (e.g., armpits, groin, buttocks, breasts).
The primary endpoint of the 150-subject study is
the proportion of responders at week 12 versus placebo as measured by a
scale called HiSCR. The estimated primary completion date is July 2020.
Bermekimab (MABp1) is a monoclonal antibody that binds to (inhibits) the pro-inflammatory protein interleukin-1alpha (IL-1α).
https://seekingalpha.com/news/3508421-xbiotech-commences-mid-stage-study-bermekimab-painful-skin-disorder
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