With former Shire cancer unit, French pharma Servier expands in Boston

Servier, the French pharma giant that just acquired Shire’s oncology unit for $2.4 billion, is putting a US innovation outpost in Kendall Square. The new unit will be called Servier BioInnovation, and it’s just recruited two executives to head it up — likely hunters for partnerships and tech that will advance Servier’s pipeline.

This marks the second French pharma giant to announce a Kendall Square outpost in the past 24 hours. Just yesterday, Ipsen announced it was moving its US headquarters from New Jersey to Boston.

The two directors of Servier BioInnovation are ex-Biogen exec Christian Schubert and University of Massachusetts’ director of tech commercialization Rekha Paleyanda. They’ll be in charge of heading up Servier’s US R&D and external innovation, and business development and licensing activities.

Today, Servier already has a bit of a US presence with some academic collaborations with Harvard and MIT in Boston. It’s also partnered with biotechs and pharma throughout the US, and supports the LabCentral incubator. And after the April news that Servier was buying up Shire’s oncology unit, the French company will have a much bigger footprint on this side of the Atlantic. In a statement, Servier said the acquisition allows Servier to establish an “immediate and direct commercial presence in the US.”

“Servier BioInnovation represents Servier’s commitment to expanding its growing presence in the U.S. for the long-term through R&D and business development and licensing activities,” said Christophe Thurieau, director of research centers and the Servier International Research Network (SIRN) at Servier’s R&D headquarters. “Christian Schubert and Rekha Paleyanda are established leaders in external innovation, business development and licensing in the biotechnology sector with deep experience in both academic research and commercial business development. The Boston area provides an amazing concentration of innovation, especially in the field of oncology, for partnerships that will advance science and build on Servier’s history as a leading global pharmaceutical innovator.”

The US outpost is just the start, Servier said. It has plans to broaden the SIRN presence worldwide, opening up offices in Beijing, China next.

https://bit.ly/2xZK236

More biotech IPOs in the wings: Kezar, Eidos

Biotechs are coming out of the woodwork this morning to set terms for their IPOs. So far, we’ve tracked five companies raising roughly $486 million combined, including an IPO from ex-con Sam Waksal’s Kadmon spinoff MeiraGTx $MGTX.

MeriaGTx — $75 million

The company’s founder, Waksal, is a biotech exec once sentenced to prison for his insider trading conviction involving Martha Stewart. He was also the founder of Kadmon, a company he had to bail from before it could file its own IPO back in 2016. And now his brainchild — under the direction of former Kadmon commercial chief Alexandria Forbes — has filed to raise $75 million.

The gene therapy company said it’s priced its IPO at $15 per share, intending to use the new cash to push five of its product candidates into Phase I/II trials. The company has been building out gene therapy manufacturing operations to support its work, which is initially focused on ophthalmology, or eye diseases, where the first generation of developers found some early successes. MeiraGTx said much of the new IPO money will go toward four ophthalmology programs and one salivary gland program.

Magenta Therapeutics — $100M
Joining MeiraGTx in pricing this morning is Magenta Therapeutics $MGTA, which plans to sell at $14 to $16 per share. We covered Magenta’s IPO plans late last month, when the company had penciled in a $100 million public offering. At the range Magenta announced today, the company should raise right around that mark.

According to a statement filed with the SEC, the cash will be used to push forward Magenta’s most advanced clinical program: a cell therapy called MGTA-456. The drug, currently in Phase II trials, is being tested in patients with inherited metabolic disorders. Magenta says new IPO money would advance the treatment through a pivotal trial, pay for some commercialization activities, and also fund research into additional indications for the therapy, such as sickle cell disease and blood cancers. Beyond that, Magenta might use the new funds to back MGTA-145, a novel stem cell mobilization product candidate.

Kezar Life Scienes — $86M
Next up is Kezar Life Sciences, which expects to sell between $14 and $16 per share. This one also isn’t brand new to us, as we covered their initial S-1 filing in late May.  The company’s amended S-1 notes the max capital raised could be $85.9 million.

Kezar $KZR has plans to use the IPO money to push forward its pipeline of autoimmune drugs. Spun out of Amgen with small molecules from the plate of the former Onyx Pharmaceuticals, Kezar’s lead product is KZR-616. The drug is a selective immunoproteasome inhibitor that’s about to be tested in a Phase Ib/II trial in lupus and lupus nephritis. The IPO might also fuel KZR-616 for the treatment of idiopathic inflammatory myopathies and up to three additional autoimmune indications into Phase Ib or Phase II clinical trials.

Autolus Therapeutics — $125M
Then there’s London-based Autolus Therapeutics, which is developing cancer therapies based on CAR-T cell technology. The company plans to raise $125 million by offering 7.8 million shares between $15 and $17 per share.

The company, founded in 2014, will use a big chunk of the proceeds to get proof-of-concept in Phase I/II clinical trials of AUTO2 in multiple myeloma, AUTO3 in pediatric ALL and DLBCL, and AUTO4 in peripheral T-cell lymphoma. It hopes to advance three product candidates through later phases of clinical development and, potentially, registration, according to its F-1.

Eidos Therapeutics — $100M

Last up is San Francisco-based Eidos Therapeutics, BridgeBio’s startup focused on TTR amyloidosis. The biotech is out of the IPO chute looking at $100 million by offering 6.3 million shares at $15 to $17 per share. Insiders are buying up half.

BridgeBio chief Neil Kumar has been bullish about this particular subsidiary in the group, even though it’s up against some heavyweight players in drug development, including Alnylam, Ionis and even Pfizer.

Their drug was initially advanced by Isabella Graef at Stanford and Mamoun Alhamadsheh, the company scientific co-founders, who nailed down preclinical evidence that the drug can stabilize TTR and prevent the cascade of events that causes the disease — a disease modifying approach that will now head to the clinic.

Eidos says most of the proceeds will fund the clinical development of AG10 for the treatment of ATTR-CM and ATTR-PN, including its ongoing Phase II ATTR-CM and planned Phase III ATTR-PN clinical trials.

https://bit.ly/2JGbbNa

White House officials call for accountable care organization rule changes

Accountable care organizations are failing to meet their promise to save Medicare money, and regulations governing the model need to change, according to senior White House officials.

“There are a lot of broken promises and failed estimates in the Affordable Care Act, and the hope and promise of this complicated value design is one of them,” Joseph Grogan, associate director of health programs at the White House’s Office of Management and Budget, said Wednesday at the National ACO, Bundled Payment and MACRA Summit.

Grogan based his comments on recent findings from Avalere that Medicare Shared Savings Program ACOs cost the agency $384 million from 2013 to 2016, despite a 2010 Congressional Budget Office prediction that the models would save $4.9 billion through 2019.

Policy changes are coming to Medicare Shared Savings Program ACOs via a proposed rule posted on OMB’s website. The rule will aim to facilitate ACOs’ transition to downside risk, according to a HHS summary of the rule.

Clinicians working within ACOs have heard the rule will slash how long they can stay in the Medicare Shared Savings Program without taking on downside risk. Grogan did not provide details about the rule on Wednesday. HHS submitted it for review on May 1 and OMB has up to 90 days to review the regulation.

Under Obama-era regulations, ACOs have the option to stay in Track 1, which only involves upside risk, for up to six years or two contract periods. Sources in the provider community said the agency will cut that period to three years or one contract period.

There are 561 Medicare ACOs this year, 82% of which are in Track 1.

Grogan did not confirm the report in his remarks. However, he said that one of the barriers to ACOs’ success is their resistance to face penalties if they miss savings goals.

“ACOs need to accept risk sooner rather than later,” Grogan said.

ACOs have pushed back against taking on risk because the CMS doesn’t provide enough information ahead of time on the patients they’ll be judged on, or goals they must meet to avoid financial penalties.

Grogan agreed that the CMS must be more transparent in its ACO evaluations before they can take on more risk. It’s unclear if the proposed rule will offer these assurances.

https://bit.ly/2sCqqx8

Link Between Screen Time and Eye Symptoms in Kids

My name is Priyanka Kumar. I am an attending ophthalmologist at the Children’s Hospital of Philadelphia and an assistant professor of ophthalmology at the Perelman School of Medicine at University of Pennsylvania. I am here today to talk to you about screen time and the recommendations for screen time in children.

The guidelines from the American Academy of Pediatrics and the American Academy of Ophthalmology are based on consensus statements.^[1,2,3] We recommend that children under 18 months of age avoid all digital screen time, with the exception of video chatting with apps such as FaceTime, Skype, WhatsApp, and similar types of programs. This is to make sure that we are stimulating them with natural visual stimuli in order to support visual development.

For children aged 18-24 months of age, it is recommended that parents and families slowly introduce digital screen time to their children. Parents should be actively involved with what is being watched, monitoring what is being seen, and educating their children about the program and the content.

For children who are 2-5 years of age, we recommend limiting screen time to about an hour a day. It is important to remember that this includes TV, computer, iPad, tablets, iPhones, and other types of electronic programming, with the exception of video chatting. It is really important to try to make sure that parents are showing their children high-quality programming and are still actively involved in terms of what is being watched and teaching their children about what is being seen.

For kids age 6 years and over, the limits are a little less clear. We understand that it can be very difficult to limit screen time based on the amount of homework that is being prescribed and the time that children need to spend on the computer to successfully accomplish their schoolwork. With that being said, it is important to really encourage children to do other things with their time. We still recommend limiting screen time in general to 1-2 hours a day, if possible.

This is important because we know that adults develop symptoms associated with a computer vision syndrome when they spend excess time on the computer or screens of any kind.^[4] These symptoms include headaches, fatigue, and asthenopia [eye strain]. We would assume that children are at risk of developing these same symptoms. That is why these limits are in place.

Interestingly enough, these [recommended] limits and [expectation of types of symptoms that may occur] are not based on any hard and fast science. However, more and more research is being done that tells us there is probably a correlation between these symptoms and screen time. A paper published in 2017^[5] found that children with more than 3 hours a day of total screen time are at a higher risk of developing asthenopia, headaches, motor tics, and potentially even refractive error.

This study was retrospective and observational, with a small cohort, and thus highlights the fact that we need more research in this area. We would really like to understand this a little better.

The flip side is that more work is being done examining the role of video games and dichoptic computer games to treat amblyopia which, for decades, has been treated with patching, eye drops, and glasses. I think this is an interesting area of research because children would much prefer to play a video game to having to wear a patch on their eye.

The research is showing us that all of these modalities used together potentially could treat amblyopia equally as effectively and improve compliance. Look out for the results from the next papers about these types of studies. Hopefully, we will have more information about this topic in general.

https://wb.md/2y0uf4g

Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs

Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs

Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs