Maintains Buy
Tuesday, December 31, 2019
Neovasc files U.S. application for Reducer
Thinly traded nano cap Neovasc (NASDAQ:NVCN) is up 66% premarket in reaction to the filing of a U.S. marketing application for its Neovasc Reducer for the treatment of refractory angina. The submission includes a request for an advisory committee meeting.
The device was CE Mark’d in November 2011.
‘Abuse of the system’: Health economist on the rising costs of combination drugs
Drugmakers for years have developed combination drugs, medications that combine two or more drugs into a single pill, in an effort to improve convenience for patients. However, the prices of these combination drugs usually cost more than the sum of their generic active ingredients, according to NBC News.
One example is the generic acid reflux drug Zegerid, manufactured by Dr. Reddy’s Laboratory. Zegerid’s list price is $14,213 for a 90-day supply, significantly higher than the sum of the prices of its main active ingredients: omeprazole and sodium bicarbonate. With a coupon, the two main ingredients would cost just $34 for a 3-month period.
“We’re not talking about transformative new therapies,” Chana Sacks, MD, an internist and medical researcher at Boston-based Massachusetts General Hospital, told NBC when asked about combination drugs. “We’re talking about very small tweaks to medicines that we have been using for these very reasons for years.”
Dr. Sacks authored a study on combination drugs in 2018 in which she found that brand-name combination drugs cost Medicare $925 million more in 2016 than their generic components.
In addition, drugmakers have continued to increase the prices on these reformulated combination treatments.
Vimovo, a combination painkiller manufactured by Horizon, has increased by more than 1,600 percent since 2013, according to NBC News.
Horizon purchased Vimovo from AstraZeneca in 2013. Its list price was $114 for a two-month supply. Within weeks, the list price was raised to $799, and nine price hikes later, the painkiller costs $2,482 for a two-month supply.
The price hikes have largely gone unnoticed by patients because drugmakers offer financial assistance programs to them, or patients only pay attention to their copay amounts, according to the report.
“It’s an abuse of the system,” Devon Herrick, a health economist who examined drugmakers who reformulate over-the-counter drugs into expensive combination drugs. “Their business model essentially involves gouging insurers and health plans, which ultimately costs consumers,” he wrote in an analysis.
Mr. Herrick sees the financial assistance programs as a way to work around pharmacies that might suggest less expensive options to patients.
“If a drug company has to go around the local pharmacy and sign up independent pharmacies, it’s a case of gaming the healthcare system,” Mr. Herrick told NBC. “They try to circumvent the local pharmacy from saying ‘that’s over the counter.'”
Horizon told NBC News that it works to offer patients low copays for its drugs through various programs, including HorizonCares. It works with specific pharmacies to dispense combination drugs and reduce patients’ out-of-pocket costs to as little as $10.
“Part of our commercial strategy to increase adoption and access to our medicines in the face of these incentives to use generic alternatives is to offer physicians the opportunity to have patients fill prescriptions through independent pharmacies participating in our HorizonCares patient access program, including shipment of prescriptions to patients,” a 2019 quarterly filing from Horizon reads.
Americans Need to Tackle Youth Obesity: U.S. Task Force
Childhood obesity is such a crisis in America that officials have been updating recommendations for how early intervention should begin.
Obesity now affects as many as 20% of the nation’s children.
The U.S. Preventive Services Task Force reviewed the literature on kids between 2 and 18 years of age and now recommends that kids over 6 be screened using a measure of body fat based on height and weight called Body Mass Index (BMI). The Task Force also recommends intensive behavioral therapy for those kids who are obese. Behavioral therapy was shown to reduce blood pressure, although it did not show any reduction in cholesterol.
While the Task Force saw no benefit to performing obesity screenings on kids younger than 6, this isn’t to say it’s not a problem. Children between the ages of 2 and 5 as a group showed a sharp increase in obesity rates over just the last few years, according to a report from the American Academy of Pediatrics (AAP).
The AAP’s 2018 report also found an upward trend for all definitions of overweight and obesity among 2- to 19-year-olds, most pronounced among adolescents. And some ethnic groups are at greater risk than others. White and Asian American children have significantly lower rates of obesity than black and Hispanic kids. The report added that, contrary to the notion that obesity in youth has remained stable or decreased in recent years, it found no evidence of a decline at any age.
Because of the lifelong negative health consequences of obesity, it’s important to talk to your child’s doctor about steps to take to stop weight gain as early as possible.
More information
The AAP has more on childhood obesity and how to prevent it.
Big Advances Made Against Diabetes in 2019
A new artificial pancreas system, drugs that help control blood sugar and protect the heart and the kidneys, a new medication that delays type 1 diabetes, and a new way to track blood sugar throughout the day — 2019 was a pretty big year in diabetes care.
“This has been a good year for patients who have diabetes. There have been a lot of changes and there are more options. These changes will have far-reaching benefits,” explained Dr. Akankasha Goyal, an endocrinologist at NYU Langone Health in New York City.
In case you missed some of the latest diabetes developments, here’s a look at some of what happened in 2019:
Delaying type 1 diabetes
An immunotherapy treatment called teplizumab delayed the onset of type 1 diabetes in people who were at high risk of developing the disease. The drug is also now being tested in a phase 3 trial in people who were recently diagnosed with type 1 diabetes.
Another drug — anti-thymocyte globulin (ATG) — was given to people with newly diagnosed type 1 diabetes. Two-year study results were released this year. The drug helped preserve the function of insulin-producing beta cells and lowered blood sugar levels.
“These were amazing results in a new-onset type 1 diabetes population,” said Sanjoy Dutta, vice president of research at JDRF (formerly the Juvenile Diabetes Research Foundation). In addition to teplizumab and ATG, there have been a number of other promising drug studies this year, Dutta said.
The buzz on diabetes technology
In mid-December, the U.S. Food and Drug Administration approved the Tandem Control-IQ, an algorithm that can be used with the Tandem t:slim X2 insulin pump and the Dexcom G6 continuous glucose monitoring system. The algorithm itself could potentially be used with other devices as well. The algorithm isn’t yet designed to be free of user input. People have to enter the amount of carbohydrates they eat into the machine so it can calculate the proper insulin dose.
Another system — the iLet by Beta Bionics — was given “Breakthrough Device” status by the FDA in December. That means the device can move through the approval process faster. This artificial pancreas system is designed to be fully automatic. The only input users need to provide is their weight.
A different type of advancement in technology came for people using continuous glucose monitors (CGM). In June, the FDA approved the Eversense CGM by Senseonics. Instead of a sensor worn outside of the body with a thin wire inserted under the skin, the Eversense sensor is implanted under the skin and is worn for 90 days. Other CGM sensors are typically worn for a week or two. Information from the sensor is sent to an app on the user’s phone via a transmitter worn on the body.
“We have patients who have an implantable sensor and they absolutely love it,” said Goyal. She said it’s been a challenge getting some insurance companies to pay for it, but she’s hoping that will improve in 2020 when Medicare starts paying for the implantable sensors.
Managing heart and kidney complications
Several new classes of medications have been introduced during the last decade, including drugs known as SGLT2s (Farxiga, Jardiance, Invokana) and GLP1s (Trulicity, Victoza, Ozempic, Bydureon, Byetta, Adlyxin). Researchers are learning the drugs not only help lower blood sugar levels, they also help protect the heart and kidneys.
A study published earlier in the year found that both SGLT2s and GLP1s reduced the risk of heart and blood vessel disease in people with a history of those problems. The research also found that SGLT2s could significantly lower the risk of heart failure for people with type 2 diabetes. Both classes of drugs also showed positive effects on kidney health, but SGLT2s appeared to offer more kidney protection.
“These new classes of drugs lower blood glucose levels and help reduce the risk of complications. We don’t see that with other medications,” Goyal said.
A GLP1 medication — liraglutide (Victoza) — was approved by the FDA in June 2019 to treat type 2 diabetes in children aged 10 and older. It’s the first drug besides metformin and insulin that’s been approved for treating pediatric type 2 diabetes.
Treating severe low blood sugar
Dutta also noted that two new versions of glucagon — a hormone used to treat severe low blood sugar episodes — were approved by the FDA. One is called Baqsimi, administered through the nose via a special device. It’s the first non-injectable type of glucagon. The second version approved is an auto-injector called GVOKE, designed to be easier for caregivers to use. Until this year, glucagon was only available in a kit that required users to mix a dry powder with sterile water, and then draw it up into a syringe before injecting.
More information
Read more about treating your diabetes from the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
SOURCES: Akankasha Goyal, M.D., endocrinologist, NYU Langone Health, New York City; Sanjoy Dutta, Ph.D., vice president, research, JDRF (formerly the Juvenile Diabetes Research Foundation)
10 Biotech M&A Targets Under The Scanner For 2020
Biopharma M&A activity scaled record highs in 2019, with a few mega mergers announced involving names such as Bristol-Myers Squibb Co BMY, Roche Holdings AG Basel ADR RHHBY and AbbVie Inc ABBV.
It’s feared that the frenetic pace of M&A in the sector could slow down in the coming year.
Yet there are fundamental reasons to think otherwise: there could at least be many more bolt-on acquisitions as companies, especially cash-rich big pharma companies with an ageing pipeline, strive to reinvigorate slowing growth.
The upcoming year is likely to see many hostile deals, Evaluate Pharma reported, citing Steven Slaughter, managing director of Manulife Investment Management.
“There are enough interesting targets where management teams don’t want to sell, but in the large-cap world balance sheets are becoming so large they just have to deploy some capital,” Slaughter was quoted as saying at the Jefferies Healthcare Conference.
Increased scrutiny by regulators could serve as a dampener. In 2019, the FTC made several second requests, requiring additional information for vetting M&A transactions.
10 Biotech M&A Targets For 2020
The following are potential targets that could find themselves in the M&A mix in the coming year.
- Gene editing company Crispr Therapeutics AG CRSP is speculated to be a potential target for Vertex Pharmaceuticals Incorporated VRTX, given the licensing agreement in place between the companies. Incidentally, Vertex itself is considered an M&A target.
- Alnylam Pharmaceuticals, Inc. ALNY, which has the first-ever FDA-approved RNAi therapeutic in Onpattro, is also a potential M&A target. Analysts single out Sanofi SA SNY as the likely pursuer, given the stake it has in Alnylam. It should be noted here that Sanofi recently agreed to buy Synthorx Inc THOR for $2.5 billion.
- Amarin Corporation’s AMRN attraction as an M&A target has increased following the FDA nod for an expanded indication for its fish oil pill Vascepa.
- Incyte Corporation INCY, which has a blockbuster commercial product in Jakafi.
- Global Blood Therapeutics Inc GBT, which recently received the FDA nod for its sickle cell disease treatment Oxbryta
Several gene therapy companies are discussed as M&A prospects. Notable among them are:
California pharmacies rarely take back unused opioids
Only 1 in 10 California pharmacies have programs to take back unused prescription opioids and just one in five give consumers accurate disposal information, according to a study that suggests drugstores could do more to help combat substance abuse.
For the “secret shopper”-style study, researchers called 898 pharmacies in California to inquire about the availability of take-back programs for leftover opioids and antibiotics, and find out how to safely dispose of these medicines at home.
“The danger of unused and unwanted prescription medication is substantial – from accidental childhood poisoning to pollution to intentional misuse,” said senior study author Dr. Hillary Copp of the University of California, San Francisco.
“The FDA recommends dropping off medications at a take-back site as the best option for disposal,” Copp said by email. “However, there are specific recommendations for medication disposal at home if the consumer does not have access to a take-back site.”
Just 19% of pharmacies correctly told callers they should bring unused opioids back to a drugstore or flush unused opioids down the toilet, the study found. Only 11% of pharmacies offered to take back unused opioids at their location.
With antibiotics, 47% of pharmacies correctly advised callers to return leftovers to a drugstore or to mix unused medicines with unpalatable substances like coffee grounds or kitty litter and place in a sealed container before tossing the drugs in the trash. Only 19% of pharmacies offered to take back unused antibiotics.
Tossing leftover antibiotics in the trash helps prevent people from taking them in the future for illnesses they can’t cure, which contributes to the rise of antibiotic-resistant superbugs that can’t be treated with available medicines, Copp said. Flushing antibiotics might get them into the water supply, also contributing to antibiotic resistance.
Flushing opioids, however, prevents them falling into the wrong hands and contributing to substance misuse, addiction and overdoses. Addicts might still take opioids they find in the trash, even mixed with dirt or kitty litter or other substances, Copp said.
All of the secret shoppers in the study posed as parents of children who recently had surgery. Callers asked pharmacies what to do with two leftover medications: the antibiotic Bactrim (sulfamethoxazole-trimethoprim), and liquid Hycet (hydrocodone-acetaminophen), a pain reliever containing an opioid compound.
Pharmacies gave callers the correct information about disposal of antibiotics and opioids far more often on weekdays than on weekends.
One limitation of the study is that results from California, where about 10% of the nation’s pharmacies are located, might not reflect what would happen elsewhere, the study team notes in the Annals of Internal Medicine.
Still, “the lack of consistent and clear information for patients is disturbing, particularly given risks for improper use of medications that are left in the home,” said Stacie Dusetzina, a researcher at Vanderbilt University School of Medicine in Nashville, Tennessee, who wasn’t involved in the study.
“Given the different strategies for disposal for different medicines, it seems that offering patients more opportunities to bring drugs back to pharmacies for proper disposal would help,” Dusetzina said by email.
The study results suggest that many pharmacies may be falling short as educators and as places for safe disposal, said Dr. Chana Sacks of Massachusetts General Hospital and Harvard Medical School in Boston.
“Patients may have other sources of information for questions about medication disposal – they might look it up on the internet before calling their pharmacy, for example,” Sacks, who wasn’t involved in the study, said by email. “But ideally pharmacies would be a place patients can count on to receive accurate information about all aspects of medications, including safe disposal.”
SOURCE: bit.ly/39mW6u9 Annals of Internal Medicine, online December 30, 2019.
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