15 Fastest-Growing Private Life Science Companies in the U.S.

It has been noted repeatedly that during the Gold Rush, the most successful businesses were the ones that sold shovels, picks and sluices to the gold prospectors. In many ways, that’s true today in any number of industries, including biopharma.

Inc. magazine collates an annual list of the fastest-growing private companies in America. This year, 15 of the top 5,000 were related to healthcare, medical devices and biopharma. Many of them were clinical research organizations (CROs) or consultancies that help biopharma companies move through the development, regulatory and commercial processes. Here’s a look.

uBiome (#50). Headquartered in San Francisco, uBiome utilizes machine learning, artificial intelligence (AI), and advanced statistics to analyze the microbiome. The company was founded in 2012. It offers several sequencing-based clinical microbiome screening tests.

ViGene Biosciences (#81). Based in Rockville, Maryland, Vigene offers AAV, lentivirus and adenovirus-based products and custom services for use in life science research, gene therapy and cell therapy. In April, Vigene announced a partnership with Virovek to use Virovek’s AAV Production Technology, BAC-to-AAV, in AAV GMP productions.

Acuity Surgical (#201). Located in Dallas, Texas, Acuity Surgical offers tools and technology used in spinal surgeries. Products include natural bone void filler for spine surgery, AcuPac Allograft Tissue, and A-Link Z fusion systems.

MedSource (#1363). With corporate headquarters in Houston, Texas and locations in San Diego, Boston, Raleigh, NC, and Newcastle, UK, MedSource is a full-service clinical research organization (CRO) focused on complex diseases and study designs. It provides services in oncology, neurology/CNS, rare/orphan diseases, and endocrinology, infectious diseases, transplant, respiratory/pulmonary, urology/nephrology, pain management and others.

Novasyte (#1692). Headquartered in Carlsbad, California, Novasyte was founded by two former Medtronic executives and provides quick-to-market sales, clinical, field service and field correct teams for the healthcare industry in the U.S. and Canada. Its areas of expertise are medical device, diagnostic and pharmaceutical segments. This was the sixth year Novasyte made the 500 List of Fastest-Growing Private Companies in America, where it jumped from #2,428 in 2017 to its current position of #1692.

BioAgilytix (#1833). Located in Durham, NC, BioAgilytix offers large molecule bioanalysis with tailored services for biomarker, immunogenicity, pharmacokinetics, and cell-based assays. On July 11, BioAgilytix announced a strategic collaboration with biOasis Technologies to develop and validate bioanalytical methods to support Bioasis’ lead candidate to treat HER2+ brain cancer.

Steep Hill (#2387). With laboratories around the world, Steep Hill specializing in lab testing, research and development, licensing, genetics and remote testing for cannabis, to ensure recreational cannabis is compliant with public safety standards. It has labs in Alaska, California, Canada, France, Spain and other locations. In May, Steep Hill and Eybna Technologies launchedDelta, which produces custom terpene formulation for incorporation into cannabis-derived products.

Nuventra Pharma Sciences (#2819). Based in Durham, NC, Nuventra is a pharmaceutical consulting company. The company has more than 50 scientific consultants and focuses on clinical pharmacology and PK/PD, which can be used to inform drug development. In May, it announced it was opening a new office in Cambridge, Massachusetts.

The FDA Group (#2959). Located in Westborough, MA, The FDA Group offers quality assurance consulting and auditing services for GMP, GCP, GLP, and PV. The company has more than 500 specialists worldwide, with more than 75 who were previously employed by the U.S. Food and Drug Administration (FDA).

BioPoint (#3115). Headquartered in Wakefield, MA and Carlsbad, CA, BioPoint is a life sciences consulting company focused on accelerating all aspects of drug development, and ensuring compliance at a global level. Areas of expertise are pharmacovigilance, drug safety and risk management, regulatory affairs, market access, and clinical operations and biometrics.

Caldera Medical (#3209). Located in Agoura Hills, CA, Caldera Medical develops and markets differentiated surgical implants specifically to treat Stress Urinary Incontinence and Pelvic Organ Prolapse. In June, Caldera teamed with the Foundation for International Urogynecological Assistance (FIUGA) to support urogynecological education, research and care worldwide.

Atlantic Research Group (#3302). Based in Charlottesville, VA, Atlantic Research Group (ARG) is a rare disease-focused contract research organization (CRO). It provides a comprehensive clinical program development services that range from pre-launch consulting to commercialization. It was founded in 2004.

DSP Clinical Research (#3500). Headquartered in Fairfield, NJ, DSP Clinical Research is a CRO focused on clinical trial management. Those services include study startup, ongoing study management, multi-vendor management, site monitoring, study rescue and cleanup, site and monitor training and auditing, data management, statistics and medical writing, and FDA submissions.

ProPharma Group (#3733). With offices throughout the U.S., Europe, Asia and Australia, ProPharma Group partners with life science companies to provide expertise in pharmacovigilance, development lifecycle and other services. In July, ProPharma Group, which is a portfolio company of Linden Capital Partners, acquired Xendo Holding, a Netherlands-based provider of compliance consulting, engineering and technical support, regulatory affairs, and pharmacovigilance services.

LabConnect (#3917). Headquartered in Seattle, WA, LabConnect provides global central laboratory services, including routine and esoteric laboratory testing, kit building, sample management, biorepository and scientific support services for biopharma, medical device and CROs.

https://bit.ly/2w2prYI

Myriad Genetics price target raised to $38 from $32 at Piper Jaffray

Piper Jaffray analyst William Quirk raised his price target for Myriad Genetics to $38 after the company reported Q4 above expectations. Management established guidance on a reported basis that appears well above consensus expectations, however when adjusting for the recent Counsyl transaction and other extraordinary items, both revenue and earnings are essentially in line, Quirk tells investors in a research note. He keeps a Neutral rating on the shares, but believes Myriad’s diversification story is in its “early stages, with significant upside potential driven by reimbursement wins.”

https://bit.ly/2N56QS7

Exact Sciences, Pfizer enter into promotion agreement for Cologuard

Exact Sciences (EXAS) and Pfizer (PFE) announced an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. Pfizer will join Exact Sciences’ sales representatives in reaching both physicians and health systems and will also actively participate in extending and deepening the Cologuard marketing campaign. Exact Sciences and Pfizer seek to increase colorectal cancer screening rates by accelerating adoption of Cologuard, a test that’s fully covered by Medicare and most major health insurance plans. Exact Sciences brings a sales force with expertise in colorectal cancer, the innovative science of Cologuard and a recognizable direct-to-consumer marketing campaign. Pfizer brings a large and experienced sales force and relationships integrating with the leading health systems, two areas where Cologuard is most often prescribed, along with deep marketing expertise. Under the terms of the agreement, Pfizer will co-promote Cologuard with Exact Sciences beginning in Q4. Exact Sciences will maintain responsibility for all aspects of manufacturing and laboratory operations of Cologuard. Pfizer will share gross profits and marketing expenses equally above an agreed upon baseline.

https://bit.ly/2OXv7tN

1M Said to Default On Their Student Loans Each Year

More than one million American student loan borrowers default on their debt each year, a new report says.

That means by 2023, approximately 40 percent of borrowers are expected to default.

That is according to a new report by the Urban Institute, a nonprofit research organization dedicated to developing evidence-based insights on critical socioeconomic issues. Researchers found about 250,000 student loan borrowers see their debts go into default every quarter, and an additional 20,000 to 30,000 borrowers default on their rehabilitated student loans.

“My results indicate that the likelihood of student loan default is positively correlated with holding other collections debt (e.g., medical, utilities, retail, or bank debt). About 59 percent of borrowers who defaulted on their student loans within four years had collections debt in the year before entering student loan repayment (compared with 24 percent among non-defaulters). Those who will default on their student loans are more likely to reside in neighborhoods that have more residents of color and fewer adults with a bachelor’s degree or higher, but a borrower’s personal credit profile is a stronger predictor of default than the neighborhood where she resides,” said Kristin Blagg, a research associate in the Education Policy Program at the Urban Institute.

The average defaulter is more likely to live in Hispanic and black neighborhoods, Blagg found. Her previous research has shown that minorities are more burdened by their education debt because their parents have a lower net wealth a well as higher rates of unemployment. These neighborhoods also have a median income of around $50,000, compared with $60,000 for non-defaulters.

The Urban Institute made a startling discovery: Those with the smallest loan balances had a higher probability of not paying off their debt. In fact, 1 in 3 people who had a student loan balance less than $5,000 defaulted within four years, compared with 15 percent of borrowers who owed more than $35,000.

This is because students who dropped out of college have less debt, but are easily burdened by debt since they do not have the benefit of a degree, said Mark Kantrowitz, a student loan expert, who spoke with CNBC.

Also, Kantrowitz said, “They often lack awareness of options for dealing with the debt, such as deferments, forbearances, income-driven repayment and loan forgiveness.”

The report then describes the relationship between a borrower’s credit profile and student loan default in a nationally representative sample of student loan borrowers, over the first four years of repayment. It found that by the time the student loan falls into the default, the borrower will see their credit score plunge by 60 points, to an average of around 550. Borrowers who stay current, usually have credit scores in the high 600s.

As we have mentioned, millennials are delaying marriage, home-buying and having kids (pretty much delaying the American dream), simply because of their gig-economy job(s) cannot cover debt servicing payments of their loans.

“Negative effects of student loan default can be wage garnishments, tax offsets, and other methods of loan collections,” said Elaine Griffin Rubin, senior contributor and communications specialist at Edvisors. “In addition, some states suspend or revoke state-issued professional licenses, and some states suspend a driver’s license because of a defaulted loan.”

To make the situation worse, defaulting on student loans increases the balance, likely due to collection fees and the accumulation of interest. Kantrowitz said a borrower could expect their balance to jump by over 10 percent after default.

These myriad consequences that come with a default can be hard to recover from, Kantrowitz said.

“At best, it delays participation in the American Dream,” he said. “At worst, they are shut out permanently.”

Student debt is a crisis that many Americans will not be able to recover from. The College Board, a non-profit organization, says the average cost of a U.S. degree is $34,740 a year at a private college, minus living costs.

Graduates of the Class of 2016 owe a staggering $37,000 each in student loans. Total Student Loans Owned and Securitized, Outstanding (SLOAS) has surpassed the $1.5 trillion mark in Q2 2018, which is second only to home mortgages among categories of consumer debt and the main reason Americans’ household debt has swelled to a record high.

Credit bubbles are all the same. It just happens that the life cycle of the student debt bubble is nearing a deleveraging period. According to both Keynesian and monetarist theory, when the student debt bubble cracks, the state should intervene directly, and bailout the millennials who made terrible life decisions in accumulating massive amounts of debt for a worthless liberal arts degree, simply because the myth of going to college would usher in a high paying job. As it has become increasingly evident, that is not the case in today’s gig-economy. The failing education system has duped millennials, they have now realized that the greatest con of all time is college.

https://bit.ly/2ORQtZE

Verizon throttled firefighters’ data plan during California wildfire

A Northern California fire chief said efforts to battle the largest wildfire in the state’s history were hampered by Verizon Communications Inc., which throttled the fire department’s mobile-data plan to the point that it made communications impossible.

“County Fire has experienced throttling by its ISP, Verizon,” Santa Clara County Fire Chief Anthony Bowden wrote in a court filing first reported by Ars Technica on Tuesday. “This throttling has had a significant impact on our ability to provide emergency services. Verizon imposed these limitations despite being informed that throttling was actively impeding County Fire’s ability to provide crisis-response and essential emergency services.”

The court document was filed as an addendum to a lawsuit filed by 22 state attorneys general seeking to reinstate federal net neutrality rules.

According to the filing, the fire department’s mobile-data plan was severely throttled after it surpassed its monthly data allowance while fighting the massive Mendocino Complex fire north of San Francisco. “Data rates had been reduced to 1/200, or less, than the previous speeds,” Bowden wrote. That impeded their efforts to communicate so much that firefighters were forced to use other departments’ ISPs, or their own personal mobile devices, he said.

When the department complained, “Verizon representatives confirmed the throttling, but rather than restoring us to an essential data transfer speed, they indicated that County Fire would have to switch to a new data plan at more than twice the cost, and they would only remove throttling after we contacted the department that handles billing and switched to the new data plan,” Bowden wrote.

The department eventually did upgrade to a new, more expensive plan.

Bowden said Verizon has throttled data during previous fires, and wrote: “It is likely that Verizon will continue to use the exigent nature of public safety emergencies and catastrophic events to coerce public agencies into higher-cost plans, ultimately paying significantly more for mission-critical service — even if that means risking harm to public safety during negotiations.”

In a statement to Ars Technica, Verizon VZ, +0.48%   admitted that the fire department’s data throttling should have been lifted because of the emergency situation, and blamed it on “a customer service mistake.” The company pledged to fix such issues going forward.

While the data throttling was not a direct cause of the net-neutrality repeal, customers now have fewer means of recourse to reverse such actions, and more limited ways to complain.

Verizon shares are up 3.7% this year, compared to the 4.5% gain by the Dow Jones Industrial Average DJIA, +0.25%  , of which it is a component.

More than 3,500 firefighters are still battling the Mendocino Complex fire, which has grown to more than 400,000 acres — about half the size of Rhode Island. One firefighter has been killed.

https://on.mktw.net/2nW5yht

Israel joins Europeans in banning Juul e-cigarettes citing ‘grave’ public health risk

Israel on Tuesday outlawed the import and sale of e-cigarettes made by Silicon Valley startup Juul Labs, citing public health concerns given their nicotine content.

A statement by Israel’s Health Ministry said the Juul device was banned because it contains nicotine at a concentration higher than 20 milligrams per millilitre and poses “a grave risk to public health.”

Since launching in 2015, the flash drive-sized vaping device has transformed the market in the United States, where it now accounts for nearly 70 percent of tracked e-cigarette sales. The company is valued at $15 billion based on its most recent funding round, according to venture capital database Pitchbook Inc.

In a statement Tuesday, Juul Labs Inc said it was “incredibly disappointed” with what it called a “misguided” decision by the Israeli government. The San Francisco company said it planned to appeal the ban, adding that its devices provide smokers “a true alternative to combustible cigarettes.”

The Israeli move was consistent with similar restrictions in Europe, the ministry’s statement said.

The ban, which goes into effect in 15 days, was signed by Prime Minister Benjamin Netanyahu, who also holds the health portfolio.

Israel’s Haaretz newspaper reported in May that Juul e-cigarettes were already available for purchase at 30 locations around the country.

Juul says it targets adult smokers, but it has faced scrutiny over the popularity of its products with teenagers.

In April the U.S. Food and Drug Administration launched a crackdown on the sale of e-cigarettes and tobacco products to minors, particularly those developed by Juul Labs.

https://reut.rs/2OSecsO

FDA PDUFA Date for Mallinckrodt Stannsoporfin is August 22, 2018

https://bit.ly/2N5m49P