April 22, 2018 – By Eugene Smith. Apr 22 is a negative day so far for iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) as the ETF is active during the day after losing 0.88% to hit $104.96 per share. The exchange traded fund has 9.03B net assets and 2.58% volatility this month. Over the course of the …

The Hospitals Biotechnology Market report explores and analyses the essential factors of market depending on present industry situations, market needs, business strategies and the growth condition.This report isolates the Hospitals Biotechnology market capacity, production, market share, price, …

Two-hundred biotech allies from more than 40 different states visited Washington D.C. this week. These advocates met with policymakers on Capitol Hill and in the administration to share BIO’s vision and policy priorities for a strong biotech industry.

When it came to the topic of prescription drug costs, part of our message to both Republican and Democratic lawmakers was that facts matter. And the facts are that we are on the cusp of amazing biopharmaceutical breakthroughs and the trend on prescription drug costs is heading in the right direction. Both are wins for patients and society more broadly.

A new report released by the IQVIA Institute – a health care data analytics firm – helps reaffirm these and other facts that are often ignored. The report is IQVIA’s annual review of medicine use and spending on prescription drugs, and their most recent report takes a close look at what happened in 2017. Here are four key takeaways:

Prescription drug costs are remarkably stable. IQVIA reports that national spending on prescription drugs increased less than 1% last year. Looking at retail and mail-order pharmacies only, where the vast majority of patients purchase medicines, spending actually declined 2.1%. Furthermore, this slow trend is expected to continue in the coming years, with growth projected to be in the 2-5% range annually for the next five years, well in-line with expected overall healthcare spending trends. Brand-name drug prices are remarkably steady too. The average net price for patented brand name drugs grew less than 2% in 2017, which is below the rate of inflation.

Competition in the marketplace is working. An estimated 90% of all drugs dispensed in the U.S. are lower-cost generics, up from 72% a decade ago. Additionally, generics were dispensed 97% of the time “it was possible to do so.” Looking at the next five years, competition from generics and biosimilars is expected to decrease the sales of brand-name drugs by $105 billion. This is further proof that our drug discovery ecosystem strikes the right balance between the need for both continued innovation and affordable access.

Drugmakers continue to provide substantial discounts and rebates to lower overall costs. While many news stories and industry critics focus on headline-grabbing list prices for new medicines, the reality is that manufacturers continue to provide substantial discounts, rebates, and other price concessions that substantially lower the cost burden. Last year, that amounted to nearly $130 billion in total savings. Unfortunately, for far too many patients, their out-of-pocket costs for drugs do not take these rebates into account. It’s time for all insurers to pass these savings along to patients.

Innovation is happening at a rapid pace. The IQVIA report highlights the amazing advances taking place aimed at helping patients with cancer and rare diseases. IQVIA notes that new drug launches “rebounded in 2017,” with 21 new drugs tackling rare diseases and 14 new cancer therapies. This innovation is occurring thanks to the hard work and dedication of the biopharmaceutical community, but also because of “significant shifts in the regulatory process.”

The House Agriculture Committee approved on Wednesday, April 18, amendments to the panel’s Farm Bill addressing some key BIO policy priorities:

• Trade: An amendment by Rep. Neal Dunn (R-Fla.) would create a Biotechnology and Agricultural Trade Program. This amendment is reflective of BIO-supported R. 5379, the Growing American Food Exports Act, introduced by Reps. Dunn (R-FL) and Panetta (D-CA) on March 22.The amendment reaffirms Foreign Agriculture Service (FAS) has the authority to advocate to our trade partners on all new agricultural production techniques in addition to biotechnology.
  

  “Trade is critical to the American agricultural economy, as 20 percent of U.S. grown goods are bound for foreign markets,” explains BIO.  “It is essential that USDA is properly equipped to advocate for the fair treatment of the American farmer and U.S. grown goods around the world, which this legislation will ensure.” 

• Biotech Education: Another provision offered by Rep. Dunn would set up a national science-based education campaign to increase public awareness of the kinds of technology used in food and agricultural production.This amendment establishes that USDA, in consultation with FDA, the Department of Education, and stakeholders, should establish a biotechnology education campaign aimed at providing consumers accurate, reliable information on the rigorous, science-based regulatory system that products of biotechnology undergo.
  

  “Congress invests tens of millions of dollars annually in USDA, FDA, and EPA to carefully scrutinize products of biotechnology and ensure they are safe for both the environment and human and animal health. Yet many consumers do not even know these products are reviewed by federal scientists and regulators, as regulators have not historically shared their story or defended their work,” says BIO.  “Congress and the Administration have a strong interest in the public knowing that these products are carefully regulated using robust, sound science.”

• Gene Edited Plants: An amendment offered by Rep. Ted Yoho (R-Fla.) directs USDA, in consultation with FDA and EPA, to issue a report to Congress within 180 days of enactment with plans on how to improve the federal government’s policies and procedures with respect to gene edited plants.The report requirement directs the agencies to minimize the regulatory burdens, ensuring a positive environment for research and development, clarify that certain gene edited products do not warrant pre-market review, among other criteria.

• Gene Edited Animals: Yoho also offered an amendment (discussed and then withdrawn) that would have directed USDA, in consultation with FDA, to within 180 days of enactment to issue a report on existing authorities within USDA to regulate products of animal biotechnology.Rep. Yoho gave very concerned remarks accompanying his amendment about how innovation in animal biotechnology has been stifled, and he is eager to help alleviate the regulatory challenges facing the animal biotechnology industry.

• Biostimulant Definition: A BIO-supported amendment defining “biostimulants” was included in the base language. Such as a definition will help create a clearer regulatory path for these valuable products.

The House legislation cleared the Committee by a 26-20 party-line vote.

“As the bill heads to the floor, I hope the House recognizes the long-term certainty it provides for America’s farmers, just as it preserves nutrition programs for people who need help feeding themselves and their families,” said U.S. Secretary of Agriculture Sonny Perdue. “USDA stands ready to provide technical assistance as the bill progresses in the House, and we look forward to working with our friends in the Senate as well.”

“As Republicans and Democrats have farm interests in their own districts and states, we are hopeful that the 2018 Farm Bill can move forward in a bipartisan manner,” Perdue added.

As BIO CEO, everywhere I go – including Tokyo and Hong Kong last month – I talk about what sets America apart as the country responsible for innovating more new medicines than the rest of the world combined. Other countries have great scientists, but no other country can match U.S. innovation policy, our world-leading biotech ecosystem or the diverse financing opportunities we provide for biotech companies at every stage of growth.

On Tuesday, BIO honored the Member of Congress who has arguably done more than any other to create this competitive advantage and stand up the U.S. biotechnology sector over the last four decades – U.S. Senator Orrin Hatch (R-Utah).

When the story of the BIO century and the new golden age of cures is written, the leadership of Utah’s senior senator will be on page one. He has driven almost every piece of groundbreaking legislation that has ensured our industry will thrive. He is the architect of the modern biotech ecosystem. If his name is not actually on the legislation, he has pushed it through Congress as the Chairman of the Senate HELP, Finance and Judiciary Committees.

Hatch – the Senate President pro tempore and third in line to the presidency – is retiring at the end of his term next January after 42 years in the upper body. In a time of extreme partisanship, it is difficult to lose a Senator who has made it his mission to have strong relationships across the aisle and ensure that pro-science legislation incorporates many voices and ideas.

Nowhere is this more evident than the groundbreaking law known as the Hatch-Waxman Act – the single most important piece of legislation ever crafted to commercialize biotech products and broaden patient access to life-saving treatments. This legislation created a true balance by allowing patients to get timely access to cheaper generic drugs, while ensuring that strong market incentives exist to continue the innovation cycle and bring new therapies to market.

President and CEO of BioUtah, Kelly Slone; U.S. Senator Orrin Hatch; President and CEO of BIO, Jim Greenwood

Hatch-Waxman passed in 1984, but Senator Hatch wasn’t through yet. In 2010, he honored his friend – the late Senator Ted Kennedy – by passing their bill to create a similar pathway for biosimilars that includes 12 years of data exclusivity for new biologic drugs. He once again applied the tenets of Hatch-Waxman, recognizing the important differences between biologics and small-molecule drugs. In so doing, Senator Hatch championed legislation that will drive the biotech industry forward for the next four decades.

Senator Hatch has been a champion for patients. He helped enact the Orphan Drug Act, which has led to more than 500 new treatments for rare diseases. On international deals, he worked tirelessly to secure foreign commitments to protect and respect our intellectual property, and he fought to ensure that changes to U.S. patent law were mindful of the importance of life sciences IP. He also helped double the medical research budget at the National Institutes of Health, providing critical new funding for university studies that biotech companies rely upon to commercialize new medicines and reduce suffering.

This year BIO is celebrating our 25^th anniversary with the theme “Make History.” That’s exactly what Orrin Hatch has done. The United States would not be the global leader in biotech – and we wouldn’t have the treatments and cures that exist today – without him. His work in Washington D.C. has helped transform modern medicine, and that’s why he’s such a worthy recipient of the BIO Lifetime Achievement Award.

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At the end of March, the U.S. Department of Agriculture, the government agency regulating genetically engineered plants, clarified that under its biotechnology regulations the agency “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques.” Essentially, this statement signals that the USDA does not, and has no intentions to, regulate gene edited plants, because using gene editing to make changes in plants is no different than selective breeding.

You could almost hear a collective sigh of relief on many farms throughout the nation, as this statement provides growers some certainty that researchers will not be forced to spend countless years and millions of dollars investing in their product through the regulatory process. The promise of gene-editing to solve some of the nation’s toughest agricultural challenges, suddenly became more promising.

In the wake of this new certainty, however, Wall Street Journal reporters Jacob Bunge and Amy Dockser Marcus dive into the question, “Will people eat it?”

And rightfully so. Even with the Federal Drug Administration and the World Health Organization determining that GMOs are safe, activists worked hard to sow fear and skepticism about the technology in the public. And it worked. Today, these same activists are looking to do the same by blurring the lines between GMOs and gene-editing. However, as Bunge and Marcus explain, these technologies are not the same:

“Those older techniques generally involve adding in genes from outside species, including bacteria, viruses and other plants. Inserting such genes enables crops to survive herbicide sprays or repel destructive bugs.

“The new gene-editing technologies enable scientists to achieve some of the same effects by altering the plants’ own DNA, without inserting new genes. With Crispr-Cas9, the most widely used system, scientists can program genetic guides to target a location along the plant’s DNA, where the Cas9 protein cuts the DNA. The cells change the DNA sequence as the cut is repaired. Scientists are using Crispr to make drought-resistant corn, reduced-gluten wheat and tomatoes with easy-to-remove stems.”

And just like the USDA alludes to in its statement, growers understand that gene-editing should instead be considered an advancement in selective breeding:

“[The agricultural industry] describes the editing technologies as an extension of plant breeding, the centuries-old practice of crossing plant strains to create improved offspring. Gene editing, the industry says, can yield the same results as crossbreeding, only faster.”

Bunge and Marcus note that the distinction between GMOs and gene-editing is “critical” for an industry that looks to develop plants that carry beneficial traits, such as disease-resistance and drought-intolerance, without breaking the bank or wasting precious time. According to the agriculture consulting firm Phillips McDougall, Ltd., it takes an average of 13 years and $136 million to develop and launch a traditional biotech crop (i.e. GMOs) through the current regulatory framework.

Therefore, USDA’s guidance on gene-editing is a step in the right direction, especially for researchers and farmers looking to harness the technology without heavy burden; however, as this Wall Street Journal piece outlines, for the public to embrace the technology they’ll need to understand that it is a continuum of selective breeding, not GMO 2.0.

Last year Jerry Feitelson was accepted into BIO’s Start-up Stadium at the annual BIO International Convention. Armed with his six-minute pitch, the CEO and Co-founder of Agribody Technologies, Inc. (ATI) stood before the assembled judges and explained how his technology might one day help to save the planet. ATI was one of a select group of companies approved to participate in the program which was started in 2015 to provide early stage companies the opportunity to engage key members of the investment community, venture philanthropy groups and BIO attendees. The 40 finalists were chosen based on potential for commercial viability and the technology they were developing.

Dr. Jerry Feitelson, CEO and Co-founder, Agribody Technologies

Feitelson’s ATI was an impressive applicant. Becoming fully operational in July 2016, the company has a patented “gene switch” genome editing technology with wide application for agriculture including higher yielding crops with tolerance to drought, low nutrients and disease, as well as extended shelf life of perishable produce. As Feitelson notes:

“One of the fundamental problems farmers need to confront is feeding the increasing population. Conventional breeding in many crops is flattening out; even transgenic applications are reaching their limit in many crops. Some crops have not had yield improvement for 20 or 30 years. We are focusing on yield but also the problem of lost crops after and during harvest due to disease and stress. It is only going to get worse with global climate change.”

ATI alfalfa field trials showed 20-45% higher yield than the non-transgenic controls with no loss of quality

The company claims that the gene switch technology can increase yields by up to 20% and enhance crop tolerance to stress. With food-sourcing problems caused by an ever-growing population, decreased farmland availability and climate change issues, ATI’s focus on mitigating these challenges was a big draw to the Start-up Stadium.

One of the judges listening to Feitelson’ pitch was John Lilly of Lateral Capital, LLC, an early stage investment fund which looks for compelling new companies like Agribody Technology. According to Lilly:

“Early Stage companies can be a very risky asset class-unless you can find great entrepreneurs like Jerry. And everybody in the economy knows that innovation comes from the bottom up. The Start-Up Stadium gives these new companies a chance to be heard in front of experienced investors who have capital to invest in their terrific new ideas.”

The Lateral Capital strategy is to find early stage companies with a finished product, their first customer, strong patents to protect them while they grow “and the ability to save the world…just a little bit.” Lilly saw in ATI’s technology, the potential for a world with less waste due to food spoilage and better returns for farmers. With significant partnerships already in place, ATI’s commercial viability was a reasonable expectation.

After ATI’s presentation at the Start-up Stadium, Lilly provided some immediate feedback to Feitelson. Over the next nine months, he regularly stayed in touch with ATI, making frequent introductions to other stakeholders and offering advice.

John Lilly, Managing Member, Lateral Capital, LLC

In March of this year Lateral Capital invested in ATI!

The journey from idea to breakthrough innovation is long and expensive, requiring infusions of money along the way. Yet early stage biotechs often don’t have the right access to investors and other stakeholders. That’s where BIO’s “Start-Up Stadium” comes in, connecting early stage companies with investors and state and regional affiliates.

Through this competition, BIO is looking to provide resources that boost the biotechnology industry as well as provide a clear, successful example to stakeholders that early-stage innovation is well represented at the world’s largest biotechnology event.

Each finalist presents a five to seven-minute pitch, followed up with written and oral feedback from the judges. Who knows what’s in store for these presenters? Maybe they will make lasting partnerships like ATI and Lateral Capital.

Find out more about the Start-up stadium here.

In the world of biotechnology investment, notorious for share price volatility and it “high-risk return” nature, investing in exchange traded funds (ETFs) or mutual funds might be the sensible route for retail investors. The minefield of sometimes-undecipherable medical and technical terms and acronyms, …