Management holds a conference call to provide an overview of the Company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform and development strategy, as well as updates on key programs and anticipated milestones, on August 23 at 8:30 am. Weblink: https://edge.media-server.com/m6/p/sre5hjuj
Monday, August 20, 2018
Benefitfocus initiated at Guggenheim
Benefitfocus initiated with a Buy at Guggenheim. Guggenheim analyst initiated Benefitfocus with a Buy rating and a price target of $45.
Jazz hiring 100-plus sales reps to prep for new narcolepsy, leukemia launches
Jazz Pharmaceuticals is closing in on two new approvals, one on each side of the Atlantic, and it’s staffing up to hit the ground running on both launches.
CEO Dan Swisher said Jazz is adding 100 sales representatives in the U.S. for the expected approval of solriamfetol, a candidate to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. Although that figure won’t double the company’s sales force, it’s a “significant expansion” for the drugmaker, which is approaching $2 billion in sales this year. Jazz is also studying the use of solriamfetol in other conditions where excessive sleepiness is a problem, including Parkinson’s disease and multiple sclerosis.
Jazz has hired a full brand team for the rollout of solriamfetol, which it expects to become a significant addition to its portfolio with eventual sales of $500 million. Right now, it’s running a pre-launch disease awareness campaign targeted at healthcare professionals (HCPs) but expects to take marketing directly to consumers down the road.
“We’ve got this broad-based disease awareness campaign going to healthcare professionals. We look forward to having a more drug-specific awareness campaign coming later, and then obviously a lot of healthcare provider promotion, and then at the right point, activating consumers,” Swisher said.
Meanwhile, Jazz has bumped its European sales force to 80 from 50, with the expected European approval for Vyxeos as a first-line treatment for secondary acute myeloid leukemia next month. The drug was approved in the U.S. last August, and Swisher characterized the U.S. rollout as “going well” with a dedicated field force of 30 and anticipated sales of $120 million expected this year.
Jazz employs 1,200 people globally with corporate headquarters in Dublin and U.S. headquarters in Palo Alto, Calif. Swisher joined Jazz in January after 17 years at Sunesis Pharmaceuticals where he was president and CEO.
Jazz is, of course, still pushing on its bread-and-butter narcolepsy drug Xyrem, which has about 14,000 patients on treatment. Its target market is lots bigger: 60,000 patients already diagnosed and another estimated 60,000 who are undiagnosed, Swisher said. A recent narcolepsy awareness promotion with HCPs led to “near double-digit growth in new starts,” he said.
Jazz has its eyes on even broader use, too. Xyrem is up for a new approval in pediatric patients, and Jazz is hoping to roll out the drug for kids next year. It’s also pursuing a low-sodium version of Xyrem which currently has very high levels, a fact that’s noted by physicians as an issue in prescribing.
Jazz is pushing innovations and marketing around Xyrem as it faces a slew of upcoming generics, with eight tentatively approved by the FDA to date. With patent litigation now settled, the first Xyrem generic is expected to come to market in 2023.
UK regulator stands firm on ‘no’ for Roche med in postsurgery breast cancer
Back in June, England’s cost watchdog refused to recommend Roche’s Perjeta for postsurgery breast cancer patients. And it’s sticking by that decision.
In a new guidance document, the National Institute for Health and Care Excellence (NICE) once again declined to back the drug for routine NHS use, citing “uncertainty about how clinically effective” the drug is in the adjuvant setting.
“Overall survival is very likely to be overestimated,” it added, meaning that “cost-effectiveness estimates” from Roche are “implausible.”
That opinion isn’t the one the Swiss pharma giant was hoping for. It’s counting on Perjeta and other newer meds—such as multiple sclerosis-fighter Ocrevus and immuno-oncology product Tecentriq—to step up as biosimilars move in to challenge Roche’s older moneymakers, including Herceptin and Avastin.
And Roche has had success changing minds at NICE, too—including where Perjeta is concerned. In November 2016, after years of rejections, the gatekeeper finally gave Perjeta the OK in combination with Herceptin and chemo docetaxel as a treatment for early-stage breast cancer.
Roche still has time to turn things around in its newest indication, with a third appraisal committee meeting coming up in mid-October. But the company may need to sink Perjeta’s price if it wants to see an about-face.
Meanwhile, NICE isn’t the only agency that hasn’t been all that impressed by the drug’s postsurgery data. When the company unveiled results at last year’s American Society of Clinical Oncology meeting—and later when Perjeta grabbed an FDA approval—industry watchers and analysts dubbed the showing “weak.”
No-deal Brexit airlift? Sanofi may have to fly flu shots into U.K. for 2019-20 season
Several drugmakers are already stockpiling drugs in case of a no-deal Brexit. However, one crucial product simply cannot be reserved because it’s not possible to be made in advance: the seasonal flu vaccine.
As the possibility of Britain leaving the EU next March without a deal looms large, pharmas are worried their key drug deliveries will be held up at borders. For Sanofi, the world’s largest flu vaccine supplier, that means extreme measures may be needed to ensure the seasonal shot reaches the sales stand in time, Sanofi’s U.K. chief Hugo Fry recently told The Times.
Each year, scientists need to determine the circulating flu strains for the upcoming flu season months in advance. Vaccine makers then culture the viruses to make the shots, and after passing regulatory tests, millions of doses would start reaching markets in the Northern Hemisphere in August.
That would leave just a two-month window for early vaccination before October, when influenza activity usually begins to increase. A delay in the vaccines’ delivery could give people a shorter time to be vaccinated and protected.
“You often live hand to mouth in vaccine production because of the complexity of the manufacturing and the testing,” said Fry, as quoted by The Times. For the 2017-2018 season, Sanofi sold more than 5.7 million doses of its quadrivalent flu vaccine in the U.K., Louise Brant, a Sanofi spokeswoman, told FiercePharma.
The French pharma is now working on some contingency plans as it braces for the worst-case scenario in the 2019-2020 flu season.
Distribution of all of Sanofi’s vaccines is currently handled at Val de Reuil in Northwest France, and doses are transported to the U.K. via the English Channel, said Brant. The company is considering flying supplies to a predetermined spot in the U.K. where the government would release the delivery instantly, Fry told the British newspaper. Another option would be to mark trucks so that they can pass customs without the usual checks.
“We are considering all options and will work closely with Public Health England and NHS England to ensure we are prepared to mitigate any potential challenges, should they arise next year,” said Brant.
Earlier in August, Sanofi announced it is increasing its inventory of drugs for the U.K. from the usual 10 weeks to 14 instead, to ensure smooth supplies as it prepares for a no-deal Brexit. AstraZeneca has also said it is stockpiling drugs supplied by the U.K. and EU for each other. Merck & Co. is making its own plans, including reserving as much as six months’ worth of product in the face of a possible “temporary supply blackout” next March.
It is not yet clear whether the other two top flu vaccine makers—Seqirus and GlaxoSmithKline—are making their own flu-specific backup plans. A GSK spokesman told FiercePharma in general that it will work to ensure seamless supplies of medicines, vaccines and consumer healthcare products to patients after breakup. Measures it is implementing include expanding its ability in the region to conduct retesting and certification of medicines. Representative from Seqirus didn’t immediately reply to a request for comments.
About a month ago, the U.K.’s health secretary, Matthew Hancock, said he had met with pharma industry leaders to discuss growing NHS reserves of vaccines and medicines, according to The Independent. The plan includes options for industry stockpiling of vaccines, medical devices, clinical consumables and blood products.
Judge Issues Compensation Ruling for Long Battle Over Obamacare Mandate
A federal judge has issued a ruling ordering compensation of $718,000 to the Catholic Benefits Association (CBA) for legal fees and litigation costs. This ends a four and a half year court battle over the Obamacare Contraceptive, Abortifacient, Sterilization, and related Counseling Services Mandate (CASC). It follows CBA’s overwhelming federal court victory in March. The CASC mandate had attempted to force CBA members to violate Catholic moral teaching by covering contraceptives, abortifacients, and sterilization procedures in employee health plans. Failure to comply with these morally objectionable mandates carried crushing fines which, in the case of CBA’s membership, were estimated to be as much as 19 Billion dollars. CBA initiated lawsuits in 2013 and 2014 on behalf of its 1,000 plus Catholic employer members.
In March, 10th Circuit Judge David Russell’s final Declaratory Relief and Permanent Injunction validated all of CBA’s claims regarding the burden created on religious employers by the Obamacare Mandates. He granted permanent injunctive relief from these mandates and any similar future efforts from HHS to both current and future CBA members. He also directly noted the government’s violation of the Religious Freedom Restoration Act (RFRA).
Doug Wilson, CEO of the CBA said, “We are proud of a result which will benefit so many in coming years. In addition to our current and future members, Americans of all faiths will benefit from the legal precedents we have achieved and from the court’s affirmation of RFRA.”
Noting similar current regulations which attempt to coerce immoral actions by religious employers including federal mandates for the provision of transgender services and insurance coverage for clinical trials which include the use of embryonic stem cells, as well as the proliferation of state level healthcare mandates lacking in sufficient religious protections, Wilson said, “While it is gratifying to reach a successful conclusion to this (CASC) issue, there is so very much more to be addressed. Established as an Association of Catholic employers, we can engage wherever we have a member. That now includes almost every state and a growing membership. We are here for as long as it takes.”
The CBA was the largest plaintiff in the religious liberty battle over the contraceptive mandate, representing more religious employers than all of the 100 other similar lawsuits combined.
The Catholic Benefits Association is committed to ensuring the right of Catholic employers to provide life-affirming health coverage consistent with Catholic teaching. It includes hospitals, colleges, religious orders, privately owned Catholic businesses, 60 archdioceses and dioceses, and around 4,000 parishes. For more information, see www.catholicbenefitsassociation.org.
New Medical Specialty Needed for Growing Numbers of Diabetics?
The emerging field of diabetology–a sub-specialty of endocrinology focused on the treatment of people with diabetes–is intended to address an emerging crisis in health care: Nearly one-third of Americans has a type 2 diabetes diagnosis or has prediabetes.
Compounding this problem, numbers of endocrinologists, the physicians who specialize in treating diabetes, are dwindling as the older generation retires with fewer new physicians filling the ranks. This means the burden of care has fallen on primary care physicians, who treat 82 percent of diabetic patients.
Fourteen years after one-year fellowship programs were created to give primary care physicians the clinical skills to better manage diabetes and its complications, new research in the Journal of the American Osteopathic Association finds resistance among payers and other physicians may slow growth of the fledgling specialty.
In 2004, diabetology fellowship programs opened at Ohio University College of Osteopathic Medicine and East Carolina University Brody School of Medicine–both located in underserved communities. As of now there are four diabetes fellowship programs nationwide.
Unknown but not untested
According to researchers who surveyed all 39 physicians who graduated from the first two fellowship programs between 2005 and 2016, diabetologists are filling a much needed gap in patient care, however, acceptance and trust have been slow to come.
The survey tracked graduate physicians’ practice type and location, finding 41 percent in primary care, 20 percent working as hospitalists, 14 percent who are full-time diabetologists and 22 percent who went on to become endocrinologists. The survey also found all respondents were comfortable or very comfortable managing type 1 diabetes, type 2 diabetes, prediabetes, and metabolic syndrome.
However, when it came to perceptions from colleagues, responses were much more mixed. Only 28 percent reported that they agreed or strongly agreed that colleagues were receptive to their diabetes training. There was 19 percent who responded “neutral”, another 19 percent who disagreed or strongly disagreed that their colleagues were receptive to their training, and 33 percent who left this item blank.
“Some primary care physicians have been reluctant to refer diabetic patients to diabetologists because so many diabetologists are also primary care physicians. I think there’s a fear that patients will simply change physicians entirely,” says Amber Healy, DO, who graduated from Ohio University’s diabetology fellowship and co-authored the article in the JAOA. “Endocrinologists, on the other hand, believe that the diabetes fellowship constitutes a dangerous shortcut to becoming an endocrinologist, enabling a scope of practice overreach.”
Jay Shubrook, DO, who practices as a full-time diabetologist and served as a co-author on the JAOA article, believes these issues are improving and will continue to do so through education, advocacy and exposure.
“I think the biggest misconception is that diabetologists are trying to replace anyone. That’s just not true. The sheer number of patients with diabetes makes that impossible; there are way too many for any one group to handle,” says Dr. Shubrook. He adds that a one-to-one patient care model is far from the ideal care delivery model for diabetologists. Instead, he sees them being far more effective as a force multiplier for primary care.
At the federally qualified health center where he practices, Dr. Shubrook can treat patients directly but, more importantly, he can share his expertise with the other primary care physicians, raising their knowledge and proficiency.
Dr. Shubrook acknowledges that endocrinologists have a greater depth of knowledge in certain types of diabetes treatments but also notes they treat many other conditions–and some don’t even treat diabetes. “I realize ideally one option is endocrinologists could exclusively provide diabetes treatment. However, given the massive scope of the problem, that’s simply impossible. I think we are better off sacrificing some depth of knowledge in order to recruit and train physicians who are capable of making an impact.”
Getting recognition
Perhaps the biggest obstacle facing diabetologists is recognition from payers, who are reluctant to reimburse for a new specialty which is mostly unrecognized even by colleagues from its adjacent specialties. This creates a problem as healthcare is still paid for by volume. Primary care visits last between 10 and 15 minutes, because physicians need to see enough patients in a day in order to have a profitable practice. Unfortunately, that’s not nearly enough time to address the concerns of a patient with diabetes. Further, most diabetologists will actually get paid less as they end up seeing fewer patients in a system that rewards volume of care.
“No one with diabetes has just one health complaint,” says Dr. Shubrook. “The basic diabetes treatment and education could take twice as much time allotted for in a typical primary care visit–but most have multiple chronic conditions that also need attention.”
This creates a difficult position for physicians as they have to decide between giving a patient adequate time and attention within a single visit–which does not get reimbursed by their insurance–or asking the patient to come in for more frequent visits, which isn’t always possible for the patient’s schedule. However, if diabetologists were recognized as specialists, they could get reimbursed at higher rates, which would allow them to spend more time with patients.
“Board certification is the standard for payers to recognize a physician as a specialist,” says Dr. Shubrook. “Right now diabetology just doesn’t have that.”
Dr. Shubrook says diabetologists will likely have their own board and certification exams in the future. Until that happens, he says payers have started to acknowledge and accept board certification in advanced diabetes management, which comes from the National Association of Diabetes Educators. He recommends all new fellows get this recognition.
“Our graduates are doing such good work–and it’s meaningful work that’s having an impact,” says Dr. Shubrook. “Change comes slowly, especially in healthcare, but our patients are seeing a positive difference, so their insurers are too. I would encourage anyone who is passionate about providing care for diabetes and other chronic health conditions to take the leap and join this specialty.”
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