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Pharmaceutical Trends for 2017: Biosimilars

November 3, 2016 By

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Genome Editing – Progressing Trend

October 31, 2016 By

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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2017 – Year of Equilibrium for Medical Costs  

October 20, 2016 By

Medical Costs

Frank Magliochetti Report

PwC calls 2017 the “year of equilibrium for medical costs” in its recent publication, Medical Cost Trend: Behind the Numbers 2017. Authors of the PwC report expect growth rate for 2017 to remain unchanged at apricewaterhousecoopers_frankmagliochettireport 6.5 percent.

There are two main components of healthcare costs:

  • Unit price of services
  • Utilization, which is the volume and intensity of use of those services

Identifying trends in both unit price and utilization elucidates changes in overall spending. In other words, trends in unit prices and utilization provide a clear picture of whether costs are rising or falling, or if consumers are using more or fewer specific services and products.

Price, rather than utilization, had historically been the primary force behind medical cost trends. In the early 2000s, utilization grew to become on par with price as a major contributor to healthcare trend growth. Retail clinics and urgent care centers have made it more convenient for consumers to receive healthcare, and this convenience led to higher utilization. Greater utilization often results in reduced spending later down the road, especially if consumers use these clinics for preventive screening and for treatment of minor conditions before they become serious problems, but these savings may not reduce the short-term costs of higher utilization.

Recently, however, the price trend grew while the utilization trend declined. This decline in utilization shifts the focus back on the price trend, and does it in a frankmagliochettireport-health_costs-trends-2017way that may affect utilization.

Trends in 2017

PwC predicts mainstream attention and regulatory recognition will cause behavioral health, once largely ignored as a necessary health treatment, to become a crucial part of employer health benefits. The organization also expects slower cost growth among specialty drugs for the first time in several years.

PwC expects employers to consider new benefit strategies, especially those that focus on leveraging high-performing networks with lower costs and higher quality.

At 30 percent from hospital inpatient and 19 percent from hospital outpatient, about half of employer health costs currently come from hospital spending, but costs for prescription drug care will probably see modest cost increases in 2017. Political pressure will likely suppress some of the largest drug cost increases. Furthermore, PwC predicts pharmacy benefit managers will adopt new and more aggressive strategies, which will likely contribute to deflation in the medical cost trend.

What the Trends Mean for Businesses

Always looking for new ways to reduce costs, employers will likely focus less on cost sharing and more on sharing new provider networks. They may realign cost sharing for ambulatory services, for example, evaluate current arrangements made by pharmacy benefit managers, or explore high-performance networkmedicalcoststrends_frankmagliochettireport arrangements.

Faced with competition from new sites of care, healthcare providers who want to grow their market share may consider consolidations or affiliations with other health systems. They may create new partnerships with insurers, provide a more convenient healthcare experience to consumers, or collaborate with pharmacy benefits managers.

Insurers may find it challenging to keep premiums low and control costs in 2017. Transforming business models and encouraging patients to visit lower-cost, high quality providers may help.

In all PwC predicts medical costs will continue to rise in 2017 at the same rate as they did in 2016. The authors of the study predict larger increases in the future.

Source

http://www.pwc.com/us/en/health-industries/health-research-institute/behind-the-numbers.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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C -Diff Rates Highest in the Northeast  

September 30, 2016 By

Highest C-Diff Rates in US are in the Northeast

Frank Magliochetti Report

Clostridium difficile (C. difficile or C. diff) is a deadly superbug that causes severe illness, diarrhea and sometimes death in thousands of people in the United States each year. Now a study shows that infection rates of these antibiotic-resistant bacteria are highest in the Northeastern section of the nation.

northeast_frankmagliochettidifficileinfection causes inflammation of the colon and diarrhea severe enough to be life threatening. The Centers for Disease Control and Prevention (CDC) saysC. difficile is now the most common microbial cause of hospital-acquired infections in U.S. hospitals, and that these infections cost up to $4.8 billion annually in excess healthcare costs – and that number reflects the costs for just for acute care facilities, not for nursing homes or other healthcare institutions.

diffcaused nearly half a million infections in 2011, and 29,000 patients died within 30 days of receiving their initial diagnosis ofC. difficileinfection that year. C. difficile infections are usually a regional problem, as patients transfer from hospitals to nursing homes and back into the community, which allows the disease to spread.

 

C. Diff Rates Have Been Highest in the Northeast – for a Decade

Rates of this deadly superbug were highest in the Northeast over the last decade, according to a study published in the American Journal of Infection Control.

Researchers from the University of Texas analyzed 2.3 million cases of C. difficile infection that occurred between 2001 and 2010. They found the highest incidence of the infection in the Northeast, where about eight patients developed a C. difficileinfection for every 1,000 patients discharged from a hospital. The Midwest had the second highest C. diff infections at 6.4 infections per 1,000 discharges, followed by the South at five per 1,000 and the West at 4.8 infections per 1,000 discharges.

Deaths from C. difficile infections were highest in the Midwest at 7.3 percent and among older adults at 9 percent.

The scientists also discovered that C. difficile is a seasonal disease. Most cases occurred in the spring, infecting 6.2 people for every 1,000 discharges. Infection rates were second highest in the winter at 5.9 per 1,000, followed by summer and fall.

The rates of C. diff infections for adults and older adults followed the overall trends, with most adults developing a C. diffinfection (CDI) during spring. CDIs among children were highest in the winter.

“The peak incidence in the spring could be attributed to increased utilization of antibiotics in winter months,” explain the authors of the study. “Prior studies have found a 1 to 2 month lag time between antibiotic exposure and the development of CDI.”

Controlling the Risk of C. Difficile Infections in all 50 States

Over-prescribing and inappropriate prescribing of antibiotics raises the patient risk of CDI. About half of all patients receive an antibiotic at some time during hospitalization, according to CDC statistics, but 30 to 50 percent of antibiotics prescribed in hospitals are incorrect or unnecessary. Using proper infection control procedures and careful prescribing of antibiotics can prevent CDIs.c-difficile-frankmagliochetti

CDIs are usually associated with medical care; patients who take antibiotics and receive medical care are at the highest risk for aC. difficile infection.

Doctors often prescribe broad-spectrum antibiotics that kill a wide variety of dangerous bacteria. Unfortunately, these antibiotics can also kill off beneficial bacteria living in the human gut. These beneficial bacteria help digest food and boost the immune system to help protect the body against infection. Taking antibiotics can suppress these beneficial bacteria for several weeks or even months, which leaves the body vulnerable to pathogens – such as C. difficile – when the individual comes into contact with a contaminated surface or with another person with the disease. Unnecessary use of antibiotics and poor infection control increases the speed at which C. difficile spreads within a facility or between facilities when a patient transfers.

“C. difficile infections cause immense suffering and death for thousands of Americans each year,” said Tom Frieden, M.D., M.P.H, and Director of the CDC. “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

Source

https://www.ncbi.nlm.nih.gov/pubmed/25952045

http://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html

https://www.cdc.gov/hai/organisms/cdiff/Cdiff_clinicians.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Handheld Medicine

September 27, 2016 By

Handheld Medicine: Doctors Connecting with Patients using Smartphones

Frank Magliochetti Report

Doctors are connecting with patients in an entirely new way – through smartphones.Mobile payments, apps, and digital advertising changed the way retailers work by providing new opportunities to attract new customers, build loyalty and improve sales. Now these same technologies that altered retail are revolutionizing the world of medicine. The use of smartphones and apps helps drive down costs, increases access to information, and fulfills the public’s desire for “anytime, anywhere” diagnosis, treatment and monitoring.

frankmagliochetti_doctormobilevideocallUntil now, the healthcare industry has underutilized smartphones, apps and even connected medical accessories. This is changing, as connectivity allows consumers to take control of their own care. The adoption of mobile health apps has doubled in only two years. The percentage of consumers with at least one medical, health or fitness app increased from 16 percent in 2013 to 32 percent in 2015, according to PWC.

Primary care practitioners and chronic disease managers are leading the way towards a new generation of telemedicine, and patients are eager to follow. Doctors in India set up patients with smart home monitoring kits that connect wireless to the company’s online platform. From there, patients can connect with a wide range of specialists, including dermatologists, cardiologists and fertility doctors who can conduct virtual examinations and prescribe medicine from remote locations.

Clinicians in the United States can now use their smartphones as digital otoscopes. A growing number of clinicians now send patients with chronic conditions home with connected pacemakers, glucose trackers, ECG monitors and other types of remote monitoring devices. Patients can turn their phones into precision digital scales for weighing out food or connect their bathroom scales to mobile app on their phones to track their weight. Symptom checkers, activity trackers, and on-demand e-visits are now available directly to consumers.

The Future of Smartphone Medicine

Moving towards mobile care will cause a dramatic shift in the needs of the healthcare community. Organizations will need assistance managing utilization, connecting healthcare providers working in remote locations, and overseeing the massive amount of data transferred and stored. There will be an increasing need to evaluate the security, privacy and risk associated with using these new tools.frankmagliochetti-report

Connected tools will create fresh links between healthcare and industries with which it rarely interacts, such as retail, hospitality and financial services. Connectivity will also generate more opportunities for healthcare providers and patients to plug in.

Healthcare providers can look forward to engaging in virtual medicine as more facilities build that technology into their long-term strategic plans. Virtual medicine allows health systems to move away from centralized brick-and-mortar locations towards decentralized partnerships and joint ventures to create “bedless” hospitals. Even with the limited smartphone medicine in use today, a growing share of clinicians can already deliver care remotely.

Patients are Eager to Participate

About 68 percent of adults in the United States have smartphones, according to Pew Research Center, which is up from just 35 percent in 2011. Tablet ownership is up to 45 percent.

aha_frankmagliochettiConsumer interest in telemedicine is growing as quickly as interest in smartphones. According to survey results provided by the American Hospital Association, 74 percent of U.S. consumers would be willing to use telehealth services and 30 percent already use computers or mobile devices to check for medical information. Seventy percent are comfortable communicating with their doctors via email, text or video rather than seeing them in person. More than three out of four patients believe that access to care is more important than human interaction with their healthcare providers.

Advanced hardware technology, the introduction of new apps and wireless links facilitates the move towards handheld medicine.

Sources:

http://www.pwc.com/us/en/health-industries/top-health-industry-issues/care-in-palm-of-hand.html

https://www.doctorkepaas.com/

http://www.medicalpracticeinsider.com/news/oto-converting-iphone-digital-otoscope

https://play.google.com/store/apps/details?id=rascsoft.precisionbalance&hl=en

http://weightgurus.com/http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/

http://www.aha.org/research/reports/tw/15jan-tw-telehealth.pdf

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Combating Antibiotic Resistant Bacteria:

September 24, 2016 By

How the Fight is Progressing in 2016  

Frank Magliochetti Report

Bacteria that are resistant to common antibiotics have been around for some time. Unfortunately, they have frankmagliochetti_antibodiesbecome more widespread and more deadly than they were in times past. Following are some new major developments that may result in mankind either succumbing to antibiotic resistant bacteria or overcoming it altogether.

 

A New Danger

The civil war in Syria has nearly completely destroyed vital medical infrastructure. Thousands of doctors, nurses, medics, paramedics and other medical professionals have either been killed or have fled the country. Medical equipment is in short supply and operations are commonly conducted in caves or poorly lit basements. However, the war has brought about so many cases of antibiotic resistant bacteria that Newsweek has openly questioned whether or not the war may in fact spell the end of antibiotics altogether.

The root cause for this high level of antibiotic resistant bacteria are common the world over. Syrians, like many people around the world, used antibiotics far too freely in the past. However, the ongoing war has resulted in serious bacterial infections not seen outside of war zones. What is more, as Syrians travel in search of safety and shelter, the infections could potentially spread to others. Jordan, aware of the serious dangers that these infections may pose, has wisely implemented tight new controls on the use of Colistin to ensure that it is seldom used and thus remains effective against bacterial infections.

Another altogether different danger comes from the fact that a growing number of diseases are now becomingfrankmagliochettireport_worldhealthorganization more resistant to antibiotics than ever before. As the World Health Organization recently reported, cases of antibiotic resistant chlamydia, gonorrhea and syphilis are on the rise around the world. This has led the WHO to issue new guidelines specifying which antibiotics should and should not be used to combat these diseases. Serious fungal infections are also becoming resistant to antibiotics, a new trend that could have serious consequences for people with compromised immune systems.

New Answers

Thankfully, there are new answers on the horizon. German researchers at the University of Tubingen have recently been examining the human body to look for ways to combat infection. After analyzing bacteria found in the nose, they discovered a single gene that had the potential to help them create a completely new antibiotic. This antibiotic, currently known as lugdunin, has been tested on mice and the results show that it could effectively be used to treat both MRSA and Enterococcus infections.

Scientists at the University of Melbourne have taken a different route albeit one that is no less effective. Their new genetically engineered peptide polymers (or SNAPPs as they are more commonly known) can tear down cell walls and kill bacteria rather than simply halt the growth of infection. The SNAPPs are not toxic and pose no risk to infected people but further research is needed to determine how well the treatment works and what worldeconomicforum_frankmagliochettidangers it could pose.

It is also encouraging to see that world leaders are taking the threat seriously. On September 21, the United Nations General Assembly will host an all day, high level meeting on the topic of drug-resistant bacteria. Earlier this year, the World Economic Forum called for more research into antibiotic resistant infections while the G7 noted that tackling such infections should be a priority. The G20 recently made a united commitment to working together to reduce such infections. While only time will tell if these and other efforts will be successful, there is hope that one day antibiotic resistant bacteria will no longer result in serious infections, amputations and deaths.

Source

http://www.newsweek.com/2016/09/23/bashar-al-assads-war-syria-could-spell-end-antibiotics-498035.html

http://www.who.int/mediacentre/news/releases/2016/antibiotics-sexual-infections/en/

http://www.smithsonianmag.com/smart-news/fungal-infections-are-getting-worse-they-become-drug-resistant-180960283/?no-ist

www.bbc.com/news/health-36910766

http://news.nationalgeographic.com/2016/09/in-first–united-nations-will-consider-antibiotic-resistance/

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Mechanical Thrombectomy

September 19, 2016 By

Re-Emerging Technique for Removing Blood Clots

Frank Magliochetti Report

A brain stroke occurs when certain lymph, veins or arteries form a blood clot in the brain, which if not treated on time can cause brain damage, long term disability or death. CDC says that stroke is considered as one of the top five diseases and the cause of the most deaths in America. The intensity of the stroke depends on the age but Ischemic stroke usually occurs in adults. Every year, over 795,000 Americans have strokes resulting in around 130,000 deaths.   Since 2012, the standard procedure for treating a stroke has been tPA. There were trials conducted in the same year to create a more productive technique that would allow doctors to remove the blood clot completely. The FDA finally approved frankmagliochetti-report-_stent_retrieverthe “Neurovascular Stent Retriever” technique in late 2012. However, the technique did not come into fame until the year 2016. Now, this technique is used by many hospitals in the US to treat Ischemic strokes.

The technique is a mix of the stent retriever and tPA. To better understand the retriever process, one needs to understand how exactly tPA helped with removing the blood clot.

tPA, also known as Tissue Plasminogen Activator is a protein which is administered to the brain where the blood clot is. The protein converts the Plasminogen to plasmin, which breaks down the clot. This process proved successful in only one third of the patients. In the failed cases, the blood clot did reduce but did not disappear.

In order to take this process a step further, the FDA approved the neurovascular stent retriever process which removes the blood clot directly from the site.

tPA , neurovascular stent retriever process to remove blood clots has and will continue to save many lives. This re-emergence and enhancement to existing solutions can be considered a wake up call to how  existing technology can be revitalized with new breakthroughs to deliver an even more powerful solution.

-Frank Magliochetti 

First, tPA is registered so that the clot reduces in size and detaches itself from the blood vessels. Next, a stent retriever goes into the brain to remove the blood clot. The stent retriever is either made of metal or polymer and the usage of it depends on the patient’s age and the blood clot size. This neurovascular stent retriever procedure is called “Thrombectomy”

In 2012 this procedure had been used on various patients who had speedy recoveries, experts are trying to make a more flexible and thin catheter which can easily go through the femoral artery to extract the clot.

massachusettsgeneralhospital_frankmagliochetti

Massachusetts General Hospital in Boston is a 205 years old hospital that has two departments for treating strokes. The hospital has a neurology and neurosurgeon department that deals with patients with brain diseases.

According to WHO (World Health Organization), there are around 15 million people in the world who are the victims of strokes and diabetes.

WHO has encouraged all the underdeveloped countries to adopt this neurovascular stent retriever procedure. As compared to other medical innovations of 2016, this procedure has a low cost. FDA believes that by the end of 2016, Mechanical Thrombectomy will cure around 60,000 patients who will live a healthy life.who_frankmagliochettireport

 

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FDA approves Concentric Medical’s Trevo clot retrievers

http://www.massdevice.com/fda-approves-concentric-medicals-trevo-clot-retrievers/

September2, 2016

The FDA granted expanded approval to 2 of Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.

The indications expand previous clearances for the devices, won in 2012, which cleared the stryker-frankmagliochettiretrievers for removing blood clots and restoring blood flow in stroke patients who can’t be treated with tissue plasminogen activator or for patients who didn’t respond to t-PA therapy.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone. Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability,” FDA Center for Devices and Radiological Health neurological and physical  medicine devices division director Carlos Peña said in a press release.

“This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients,” Dr. Amrou Sarraj, of Houston’s University of Texas Health Science Center, said in prepared remarks. “These patients now have a significantly better chance for an independent life without disability.

“So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long term disability,” Sarraj said. “The FDA clearance of the Trevo retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway – from EMS to emergency room physicians to neurologists to interventionalists – continue to come together to deliver fast and efficient treatment of stroke.”

Trevo is a transcatheter clot removal device designed to retrieve blood clots by gripping at the clot and pulling it back through the blood vessel along with the device, according to the FDA.

Approval came based on data from a clinical trial of the device along with t-PA and medical management of blood pressure and disability symptoms which found that 29% of patients treated with the Trevo device were functionally independent at 3 months, 10% higher than those not treated with the device.

Stryker picked up Concentric Medical in 2011 for $135 million.

 

Thrombectomy System Market: Overview

http://www.openpr.com/news/356824/Forecast-On-Thrombectomy-System-Market-Global-Industry-Analysis-and-Trends-till-2025.html
With rapid technological advancement, increase in the number of aging population and increase in demand for minimally invasive surgery, the thrombectomy system global market is expected to have healthy growth rate in the forecast period (2012-2025).

Thrombectomy System Market:
Depending on geographic region, global thrombectomy system market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa.
North America holds the largest share of the global thrombectomy system market, due to high aging population and wide technological advancement.

Wall St. darling Penumbra launches latest thrombectomy device in the U.S.

http://www.fiercebiotech.com/medical-devices/wall-st-darling-penumbra-launches-latest-thrombectomy-device-u-s

Penumbra ($PEN), one of the top devicemaker IPOs last year, unveiled its latest thrombectomy product to the U.S. market.

Dubbed the ACE 68 Reperfusion Catheter, the vascular device uses the latest tracking technology to extract blood clots in acute ischemic stroke patients more quickly and safely, the company said. The device, which is part of the company’s Penumbra System, was penumbra-frankmagliochettireportdesigned with a new tracking platform from hub to tip, and features a unique coil winding geometry along 16 transitions to deliver an optimal tracking profile.

The announcement, along with supporting data, was made Monday at the Society of NeuroInterventional Surgery’s 13th Annual Meeting in Boston.

The Alameda, CA-based company markets medical devices that include several neurovascular access products, the ACE system, neurovascular embolization products, a neurosurgical tool as well as peripheral embolization and thrombectomy devices.

Penumbra, which raised about $125 million when it went public last September, has seen its stock price trade in a 52-week range of $35.31 to $61.87. Canaccord Genuity, which recently set a price target of $67 per share for Penumbra, has raised its rating of the company to a buy. Canaccord pegged Penumbra’s market cap at $1.83 billion with a price-to-earnings ratio of 959.19.

In May, Penumbra reported total revenue grew to $57.9 million in Q1 versus $39 million for the same period a year ago. Analysts had set a consensus estimate of $53.1 million. Revenue for neuro products grew to $41.3 million for the period, and sales of peripheral vascular products increased to $16.6 million.

Trevo Clot Retrievers Approved for Use

Direct Thrombectomy Safe, Effective in Stroke Patients

FDA Approves Trevo Device for Stroke

http://www.medscape.com/viewarticle/868389

Two devices for mechanically removing blood clots now can be used in conjunction with clot-dissolving tissue plasminogen activator (tPA) as an initial therapy for acute ischemic strokes, the US Food and Drug Administration (FDA) announced today.

The devices in question are the Trevo ProVue and Trevo XP ProVue Retrievers, both from Concentric fda-frank-magliochetti-reportMedical. The FDA first approved this clot-removal technology in 2012 to restore blood flow in patients experiencing strokes who can’t receive tissue plasminogen activator (tPA) and patients who don’t respond to the drug.

In broadening the indication, the agency said that the Trevo clot retrievers should be used within 6 hours of symptom onset and only after tPA is administered.

“This is the first time FDA has allowed the use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of tPA alone,” said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, in a news release. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”

The Trevo clot retrievers are inserted into the occluded blood vessel via catheter. An expandable wire mesh at the distal end grips the clot, which a physician can pull back through the blood vessel along with the device for extraction through a catheter or sheath.

The FDA approved the expanded indication for the Trevo clot retrieval technology on the basis of a clinical trial comparing 96 randomly selected patients treated with the device as well as tPA and medical management of blood pressure and disability symptoms; 249 patients received only tPA and medical management. Of patients undergoing thrombectomy with a Trevo device, 29% were functionally independent 3 months after their stroke. This was the case for only 19% of those forgoing thrombectomy.

The Trevo devices come with the risk of failure to retrieve the clot, malfunctions such as breakage, and navigation problems that can lead to perforated blood vessels.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Filed Under: Featured, Frank Magliochetti Report, Healthcare Industry, News Tagged With: , , ,

Drug Breakthrough for HSDD

September 16, 2016 By

Sprout Pharmaceuticals

Frank Magliochetti Report

Sex, specifically women’s sexuality, is often considered a topic that the public and the media tip toe around. For some time now, there has been demand for a addyi-frank-magliochetti-reportmedication that will serve a similar function as Viagra but for the female population that requires a libido boost. Since there are pharmaceutical drugs created that aid men having trouble with sexual activity which are widely advertised and accepted as a legitimate prescription, advocates for female sexual health have been discussing this inequality in healthcare and the possible solutions. Male sexual health medicines have been around for a significant amount of time, however, the female alternative is still in the beginning stages.

Given the current political and societal atmosphere women’s sexual health is a frequently debated topic. There have been numerous doctors frankmagliochettireport_addyand advocates for the past several years that have spoken out on behalf of the need for a drug that can aid the female population that suffers from various medical issues that make participating in sexual activity difficult or altogether impossible. With the rising demand for such a product pharmaceutical companies have been working on creating the solution. In August of 2015, the FDA finally approved a pill that was developed for such a purpose. This drug called Flibanserin is made by Sprout Pharmaceuticals and is sold under the brand name Addyi; given the pink coloration of the pills they have come to be known as the “little pink pill.”

Sprout Pharmaceuticals has made a great breakthrough with Addyi; not enough attention has been given to finding potential solutions for those suffering with HSDD.

Frank Magliochetti

Addyi is intended for use in premenopausal women suffering from a disorder known as Hypoactive Sexual Desire Disorder (HSDD), this disorder decreases women’s libido for no known reason and negatively impacts the lives of women suffering from HSDD. HSDD can negatively impact the affected women’s relationships and generate unneeded difficulty and stress, Addyi is intended to alleviate these issues by boosting the libido in women suffering from HSDD. Addyi, unlike the potential alternatives that are in the research stages. manages to aid women in the increasing of their libido without the use of hormones. Flibanserin is designed to balance the neurotransmitters in women’s brains in order to increase their libido. The neurotransmitters that are impacted frankmagliochettireport-addyi-sproutpharmaby this drug are dopamine, serotonin, and norepinephrine.  Addyi has been available for prescription since October of 2016. According to Sprout Pharmaceuticals it should be available through insurance companies and will cost anywhere from $30 to $75 whether the patient has insurance or does not have insurance. Addyi has shown that it has a few side effects such as sleepiness, faintness (loss of consciousness) and, low blood pressure.

The pink pill was previously submitted to the FDA sixty times for approval and the continued to require additional testing to be positive that the drug was safe, effective, and could not be misused to sexually assault someone. however, the FDA now believes that by the end of the year the pink pill will be as prominent as Viagra. The strides this development is making for women’s health are phenomenal. Addyi becoming even half as popular as Viagra will demonstrate the significant changes that have been made in the way that society views women’s sexual health and will change the entire conversation  in regards to sex. Women’s pleasure is no longer a nonexistent aspect of the equation in mainstream conversations about sexual health, this development has the potential to be as groundbreaking as when the birth control pill was first developed in the 1960s.

Related Stories:

Snapshot of Sprout Pharmaceuticals

http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=182739307

Addyi general information

http://www.addyi.com/

What is HSDD?

http://www.everydayhealth.com/sexual-health/hypoactive-sexual-desire-disorder.aspx

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Filed Under: Featured, Frank Magliochetti Report, Healthcare Industry News, Healthcare Innovations, News Tagged With: , , , ,

Prescription Drugs – The Price Game

September 13, 2016 By

Prescription Drugs in The US 

Frank Magliochetti Report

fda-frank-magliochetti-report

If we look back ten years ago, the price of prescription drugs were fairly low and it was easy for patients to buy their medication from the pharmacy.   2016 has not only brought new innovative medical drugs and vaccines, it has brought drug prices that are much higher than before.

We might put the blame on the companies who research and manufacturer the drugs, however, the truth is  this huge influx in pricing is simply that drug companies have the right to monopolize and set  pricing how it sees fit; many wonder if the government should get involved in the pricing of a private industry produced product.

Though the products are approved by the FDA, naturally, the company/manufacturer claims they are simply working to get back their initial investment back.  Add to that private insurers and third party pharmacies, which all benefit when from the companies producing the drugs and want the market to turn towards them. It’s a loop that goes round and round from the manufacturer to the pharmacy.

frank-magliochetti-report-drug-pricingThe influx in price does not end here. With so many rare drugs created this year to fight specific diseases, there are specific companies that are the sole manufacturer of the approved drugs. The US government allows the companies to lay claim to their drug for at least twenty years after it is released. With a price rate at 100%, many people are unable to buy these drugs and hence may have to wait years for the generics to arrive in the market. These generics are priced 45% less than the original drugs.

Many place some portion of blame on the FDA due to the lengthy process and expense it takes for a drug to be accepted by the committee and then approving a virtual monopoly for the company first to the finish line.  With years of testing and billions of dollars invested in making the drug, the company is required to make further changes if the FDA does not approve the drug.

Manufacturer’s reason that the drugs are sold at high prices because they have to recoup on the research and trail funding (among other expenses) needed to bring the product to market.

The prices for drugs to fight Hepatitis or the recent EpiPen increase are two recent examples of companies exercising their right to price the drugs however they want.frank-magliochetti-report-drug-pricing

What can be done to help curb the escalating cost of new medications entering the market?  Is it a more economical FDA approval process which will help lessen the initial trial investment or more government involvement in the research and development of these much needed drugs and their pricing matrix.

A 2016 study published in the journal of the American Medical Association cites the following five reasons for the rise in prices.

Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world.

Go to the official post by clicking the link below:

http://time.com/money/4462919/prescription-drug-prices-too-high/

Countries with national health programs have government entities that either negotiate drug prices or decide not to cover drugs whose prices they deem excessive. No similar negotiating happens in the U.S.

When a Republican-majority Congress created the Medicare drug benefit in 2003, they barred the program that now covers 40 million Americans from negotiating drug prices. Medicaid, on the other hand, must cover all drugs approved by the Food and Drug Administration, regardless of whether a cheaper, equally or more effective drug is available. And private insurers rarely negotiate prices because the third party pharmacy benefits managers that administer prescription drugs, such as Express Scripts and CVS Health, often receive payments from drug companies to shift market share in their favor, according to the study.

We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices.

In an effort to promote innovation, the U.S. has a patent system that allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years or more. The FDA also gives drug manufacturers exclusivity for certain products, including those that treat people with rare diseases.

But sometimes, drug companies deploy questionable strategies to maintain their monopolies, the study says. The tactics vary, but they include slightly tweaking the nontherapeutic parts of drugs, such as pill coatings, to game the patent system and paying large “pay for delay” settlements to generics manufacturers who sue them over these patents.

And this is a serious problem, the study concludes, because drug prices decline to 55% of their original brand name cost once there are two generics on the market and to 33% of original cost with five generics.

The FDA takes a long time to approve generic drugs.

Application backlogs at the FDA have led to delays of three or four years before generic manufacturers can win approval to make drugs not protected by patents, the study says.

Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down.

Pharmacists in 26 states are required by law to get patient consent before switching to a generic drug, the authors wrote. This reportedly cost Medicaid $19.8 million dollars in 2006 for just one drug: a statin called simvastatin whose brand name is Zocor. Costs ran higher because pharmacists didn’t get patient consent and Medicaid had to pay for the costlier brand name drug even though a cheaper product was available.

Drug prices aren’t really justified by R&D.

Although drug manufacturers often cite research and development costs when defending high prescription prices, the connection isn’t exactly true. Most of the time, scientific research that leads to new drugs is funded by the National Institutes of Health via federal grants. If not, it’s often funded by venture capital. For example, sofosbuvir, a drug that treats hepatitis C, was acquired by Gilead after the original research occurred in academic labs.

This is an ongoing issue with little short term relief in place for patients in need of pricey medications to help them live a longer healthy life.

Related information:

Reasons for the Rise in Prices

Prescription drug prices are skyrocketing in the United States due in large part to government regulations, a new analysis finds.

These regulations allow drug manufacturers to charge monopolistic prices that aren’t opposed by competing market forces, the researchers believe.

The result? For each person in the United States, $858 was spent on prescription drugs, compared with an average of $400 per person across 19 other industrialized nations. Prescription medications now comprise an estimated 17 percent of overall health care expenses, the authors of the new report said.

Drug makers charge high prices for drugs thanks largely to “market exclusivity” regulations intended to allow them to recoup the research and development costs for new breakthrough medications

To read the entire article please click the link below to head to the official CBS site:

http://www.cbsnews.com/news/whats-behind-the-sharp-rise-in-prescription-drug-prices/

Help with the high cost of hepatitis C drugs

Information below is aggregated from a USA Today article

After legal battles and lobbying efforts, thousands of people with hepatitis C are gaining earlier access to expensive drugs that can cure this condition.

States that limited access to the medications out of concern over sky-high prices have begun to lift those restrictions – many, under the threat of legal action.   And commercial insurers such as Anthem Inc. and United HealthCare are doing the same.

Massachusetts is the latest state to decide that anyone with hepatitis C covered by its Medicaid program will qualify for the newest generation of anti-viral drugs. [https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-06-30-2.html] Previously, managed care plans serving Medicaid members often limited the drugs, with a list price of up to $1,000 a pill or more, to people with advanced liver disease only.

The expansion follows a threatened lawsuit against drugmakers by Massachusett’s attorney general, which induced companies to offer the state bigger rebates on the medications, making them more affordable.

Click the link below to head to the official USA Today site to read the entire article

http://www.usatoday.com/story/news/2016/07/02/kaiser-help-with-high-cost-of-hep-c-drugs/86636294/

Hepatitis C drug costs leave many without care

Hepatitis C treatment costs tens of thousands of dollars per patient. The illness progresses slowly over decades, so most states’ Medicaid programs control costs by treating the sickest first and requiring others to wait.  The conflict over hepatitis C drugs heralds a challenge likely to persist into the future, as new drugs for other illnesses thrill doctors and patients with their effectiveness — and scare health plans with their prices.

Hepatitis C is a big concern for government, because it disproportionately affects low-income people, who are more likely to be on Medicaid, and prisoners, whose care is also the state’s responsibility. An estimated 3 million to 5 million Americans, and 67,000 to 100,000 people in Massachusetts, are infected with hepatitis C, although only half know it.

Click the link to jump to the official Boston Globe website to read the entire article:

https://www.bostonglobe.com/metro/2016/04/09/for-hepatitis-patients-cure-for-high-drug-prices/j2X4aVi7BEpU5BSL0YV0vN/story.html

Mylan CEO Bresch: ‘No one’s more frustrated than me’ about EpiPen price furor

Watch the video below

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Filed Under: Featured, Frank Magliochetti Report, Healthcare Industry News, Healthcare Trends, Medical Drugs, News Tagged With: , , , ,