“We continue to make good progress executing on our strategic initiatives,” said Tim Crew, CEO of Lannett. “During the quarter, we acquired five products from UCB and entered into three new agreements with our strategic alliance partners, which I am delighted to report have progressed and already created new revenue streams. To further build out our product offering, earlier today we announced the acquisition of a portfolio of primarily oral solution medications, comprised of 23 approved Abbreviated New Drug Applications and one pending ANDA. Moreover, we have re-aligned and added depth and expertise to the management team, resulting in improved manufacturing output and a re-invigorated marketing plan to launch our products. With regard to our third quarter financial results, profitability on an adjusted basis exceeded our expectations. Our financial performance reflected the discipline of lower adjusted operating expenses and a mix of positive and negative sales variances to a few of our key products. Looking ahead, our plan is to launch over the next several weeks, and into fiscal 2019, a number of our previously approved and recently acquired or in-licensed products. While these launches will have a marginal financial benefit to our fiscal fourth quarter performance, we expect a more substantive impact on fiscal 2019 financial results. Also, we continue to be engaged in numerous discussions with existing and new potential partners to add even more products to our portfolio that will further diversify our revenues, provide affordable alternatives for our customers, and enhance our efficiencies and bottom line.”
Monday, May 7, 2018
Diabetes Risk Elevated in Breast Cancer Survivors Treated with Hormone Therapy
Breast cancer survivors who were treated with either tamoxifen or an aromatase inhibitor (AI) for hormone receptor-positive breast cancer were significantly more likely to develop diabetes during a median follow-up of 5.9 years compared with women who did not have hormonal therapy, a case-control study found.
In a study of 2,246 female breast cancer patients with no history of diabetes before their diagnosis or in the first year thereafter, Israeli investigators found that hormone therapy increased the risk of diabetes by almost 2.5 times on multivariable-adjusted analysis compared with those who did not have hormone therapy, according to Rola Hamood, MD, of the University of Haifa, and colleagues.
The study, online in the Journal of Clinical Oncology,showed a Hazard Ratio (HR) of 2.40 (95% CI, 1.26 to 4.55; P=0.008). Some 48% of the diabetes that did occur in the entire diabetes cohort during follow-up could also have been prevented had patients not received hormonal therapy, the investigators reported. The risk of diabetes also persisted during the entire time women received hormone therapy.
The team emphasized that “breast cancer survivors should not be denied this treatment, because the survival benefits outweigh the risks.” Still, the “dramatic increase” in prevalence within a relatively brief time, and the establishment of hormone therapy as a risk factor that accounts for >45% of diabetes incidence in breast cancer survivors means that survivors who receive hormone therapy should be closely monitored.
The study included women diagnosed with primary nonmetastatic invasive breast cancer between 2002 and 2012. The primary outcome was diabetes-free survival, which was defined as the time from study entry (1 year after breast cancer diagnosis) to a first diagnosis of diabetes.
Of the total cohort of women analyzed, 324 developed diabetes over the follow-up interval. Analyzed by the type of hormonal therapy taken, the risk for diabetes was over twice as high among women who had tamoxifen compared with those who did not — HR of 2.25 (95% CI, 1.19 to 4.26; P=0.013).
The risk of developing diabetes among women who took an AI was considerably higher — HR of 4.27 (95% CI, 1.42 to 12.84; P=0.010) — compared with women not exposed to an AI during their treatment for breast cancer. Furthermore, after 13 years of observation, “the crude cumulative incidence rate of diabetes in the presence of death as a competing risk was 20.9% (95% CI, 18.3% to 23.7%),” the authors reported.
The study’s senior author, Hatem Hamood, MD, of Leumit Health Services in Karmiel, Israel, noted via email that if patients died before developing diabetes, they were not included in the analysis, since they were no longer at risk of diabetes. However, by doing this, “the cumulative incidence of diabetes will be overestimated, as it will be applied on survivors only. Thus, assessment of the cumulative incidence without taking into account the completing risk of death will likely lead to upward estimates, and thus the necessary adjustment was made to arrive at unbiased results.”
The prevalence rates of diabetes in the population of breast cancer survivors analyzed in the study increased from 6% in 2002 to 28% in 2015.
The researchers also analyzed a subcohort of 570 participants that included women with diabetes who were alive at the time the study was carried out; the mean time that had elapsed since breast cancer diagnosis was 6.4 years. Looking specifically at those who developed diabetes over time, the investigators found that participants who eventually developed diabetes made more frequent outpatient visits, were exposed to more drugs known to promote diabetes, and had received hormone therapy for longer periods of time than women who did not develop diabetes over the course of follow-up.
Following the diagnosis of diabetes, the same group of women were more likely to be obese, to consume an unhealthy diet, and to be physically inactive — all risk factors for diabetes. “Our findings demonstrate that diabetes management in our cohort was clearly suboptimal, as diabetes cases led an unhealthy lifestyle, characterized by obesity, lack of exercise, and poor nutrition,” Hamood said.
“Therefore, we believe that strategies should be targeted to the prevention of diabetes, which maximizes survival and minimizes the net health and economic burden of diabetes. A first step to realization of this goal is lifestyle modification targeting both dietary and physical activity behavior and by screening for diabetes.”
Asked for her perspective, Maryam Shafaee, MD, of the Dan L. Duncan Comprehensive Cancer Center of Baylor College of Medicine in Houston, pointed out that obesity in and of itself is a risk factor for breast cancer.
Because women in the current analysis who developed diabetes were significantly more likely to be obese than those who did not (P<0.001), they may have already been predisposed to develop diabetes independent of any effect that hormonal therapy might have had on their diabetes risk, Shafaee explained. Women who developed diabetes in the study were also significantly less likely to engage in any physical activity than women who did not (P<0.001), and being active appears to be protective against the development of both breast cancer and diabetes in general. Nevertheless, “I think the findings were noteworthy.
“We see a lot of breast cancer survivors in our clinics, and these are the kinds of issues they often struggle with. First, because treatment with an AI often causes joint pain, making exercise difficult, and second, because treatment with tamoxifen often causes hot flushes, making it unpleasant to exercise. Life after diagnosis and treatment of breast cancer is not the same as the way it was before, so a lot of things change in these patients’ lives — in their work as well as what they are able or willing to do after the diagnosis.
“But given that not only obesity but diabetes are huge risk factors for morbidity in breast cancer survivors, these issues need to be better addressed, and lifestyle modification and education are something our society as a whole needs to be more aware of and implement.”
The study was supported in part upported in part by grants from the Council for Higher Education in collaboration with the Graduate Studies Authority at the University of Haifa.
The researchers, as well as Shafaee, reported having no conflicts of interest.
Big shifts in pediatric care trends
Patterns of pediatric medical care in the U.S. are changing, researchers said here.
A study of commercially insured children found that they’re seeing caregivers less often, while a separate analysis found that pediatric visits to the clinic are becoming more complicated. Both studies were presented at Pediatric Academic Societies (PAS) annual meeting.
“The take-home message is that trends in pediatric care are changing a lot,” commented PAS session co-moderator Christopher Stille, MD, of the University of Colorado in Aurora.
But exactly what is driving the changes remains up in the air. “I don’t think we know that yet,” he told MedPage Today.
Over an 8-year period, children in a large commercial insurance program used less and less healthcare in almost all diagnostic groupings, with the decline driven by a marked drop in acute care visits, according to Kristin Ray, MD, of the University of Pittsburgh, and colleagues.
She said that in recent years, there have been changes in access to care. For instance, fewer children are uninsured, according to the National Health Interview Survey, and more are getting preventive care visits. On the other hand, out-of-pocket costs for the parents of insured children have been rising and after-hours access has been falling, according to the Agency for Healthcare Research and Quality.
To examine the issue, Ray’s group looked at claims data from a large national insurer from 2008 through 2016. The cohort had 3,457,180 person years of data in 2008, which fell to 3,048,568 person years in 2016.
Per 100 person years, they found, the number of visits to a primary care provider (a pediatrician, an internist, or a family practitioner) fell by 14% over the 8 years — the result of a 23% fall in acute care visits and a 9% increase in preventive care visits.
The decline in visits was seen across almost all diagnostic groupings, with the largest declines (>30%) for respiratory diseases, skin and soft tissue issues, urinary tract illness, and ear, dental, and mouth diseases. The only diagnostic grouping for which visits rose was psychiatric, behavioral, and substance abuse problems.
The investigators also found that patients weren’t simply going elsewhere — visits to specialists remained steady, emergency department calls fell by 4%, and while urgent care visits rose by 106%, the absolute numbers remained small.
Age also didn’t appear to play a role, Ray said.
One possible explanation is that the preventive visits are doing their jobs and there is simply less need for acute care, she told MedPage Today, adding that parents might have a better understanding of how to care for the child at home.
More worrisome, she said, is the possibility that “perhaps kids are missing out on care they need.”
The interactions between doctors and children have been perceived as becoming increasingly complex but there has been little study of the issue, according to Suk-fong Tang, PhD, of the American Academy of Pediatrics in Elk Grove Village, Illinois.
Her group turned to data from the National Ambulatory Medical Care Survey (NAMCS) for 1997 through 2015 and looked at changes in the proportion of Medicaid/CHIP-paid visits, trends in patient age, the well (versus problem-focused) visit mix, diagnosis of mental health conditions, referral rates, and prescription rates.
To enable comparisons, they broke the data into four cohorts: 1997-2001, 2002-2006, 2007-2011, and 2012-2015. From cohort one to cohort four, they found:
- Medicaid/CHIP-paid visits rose 91%
- Visits by patients, ages 13-21 years, rose 53%
- The proportion of well-child visits rose 28%
- Visits coded for mental health issues rose 127% (although the proportion of all visits remained low)
- Referral rates rose 37%
- Visits requiring a prescription rose 19%
Tang cautioned that the study was visit-based and doesn’t give population estimates. As well, there’s no community health center data and only office-based visits were included.
She said the evidence suggests that the perception of increasing complexity is correct, but the study doesn’t offer any clues as to why the changes are taking place.
Primary Source
Pediatric Academic Societies
Secondary Source
Pediatric Academic Societies
Fred’s to Sell EntrustRx to CVS
ACQUIRER: CVS Health, $62.79 billion market cap
SELLER: Fred’s, $62 million market cap
TARGET: EntrustRx, Fred’s specialty-pharmacy unit
PRICE: $40 million, plus an amount equal to inventory value
STATUS: Under agreement
RATIONALE: Fred’s has been working to sell noncore assets and Interim Chief Executive Joe Anto said in prepared remarks that proceeds will allow the company to “pay down a significant portion of our debt and also be used for general corporate purposes.”
CLOSING: Expected to close by the end of May.
STOCK: Shares in Fred’s rose 14% to $1.90 in after-hours trading.
Northland Securities Sticks to Its Hold Rating for Intersect ENT
Northland Securities analyst Suraj Kalia maintained a Holdrating on Intersect ENT (NASDAQ: XENT) today and set a price target of $32. The company’s shares opened today at $41.10, close to its 52-week high of $42.25.
Kalia wrote:
“We are raising our FY18 and FY19 numbers, in part due to elevated expectations on SINUVA. In our view, this story of marginal beats and “managing Street expectations” is not enough to elevate the stock from its current 10x sales multiple.”
Amag supply interruptions for Makena could be problematic, says Piper
Piper Jaffray analyst Christopher Raymond noted that Amag Pharmaceuticals’ 10-Q that was released after the close on Friday included what he believes to be new risk language around supply for Makena’s 1mL, single use vial. While similar language was in place in the 10-K, Raymond said the situation appears to have worsened and he thinks this could be “problematic” for the franchise if not resolved soon. He maintains a Neutral rating on Amag shares.
Delayed calorie disclosure rule takes effect for U.S. food sellers
Many restaurants, supermarkets, convenience stores and movie theaters across the United States are required starting on Monday to clearly display food calorie counts as part of a push to trim expanding American waistlines and control healthcare costs.
Almost 37 percent of U.S. adults are obese, according to the U.S. Centers for Disease Control and Prevention. Obesity raises the risk of preventable, life-threatening illnesses – including heart disease, stroke, type 2 diabetes and certain types of cancer – and is responsible for billions of dollars in annual healthcare costs.
Americans consume one-third of their calories away from home and proponents of the rule, more than 15 years in the making, say it gives people information to make healthier dietary choices.
“Menu labeling allows people an easy way to cut hundreds of calories or more with simple, split-second decisions,” said Margo Wootan, vice president for nutrition at the nonprofit Center for Science in the Public Interest, or CSPI, a leading proponent of calorie disclosure.
A recent review of nearly 30 studies from the Cochrane Collaboration nonprofit public interest group found that menu labeling helped people reduce calories by about 50 calories per meal, on average, according to CSPI. Menu labeling also has been shown to spur restaurants to reduce the calories in their foods, the group said.
The rule – part of the Affordable Care Act of 2010, popularly known as Obamacare – affects restaurants, grocery stores and other food sellers with 20 or more locations that sell ready-to-eat foods.
The rule also requires calorie labeling on more than 99 percent of the nation’s 5 million to 6 million vending machines.
The U.S. Food and Drug Administration last year extended the date for national compliance by a year.
Chains like Panera Bread Co, McDonald’s Corp and Starbucks Corp have been displaying such information for years in compliance with rules set by New York City, the state of California and other jurisdictions.
Opponents to the rule included companies like Domino’s Pizza Inc and industry groups such as the Food Marketing Institute, or FMI, which represents food retailers and wholesalers.
“We are trying to make lemonade out of the lemons FDA presented,” Jennifer Hatcher, the FMI’s chief public policy officer, said in a statement. FMI and other opponents argued that the rule piled additional costs and liability risks on businesses.
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