Euro Biotechnology

Biotech stocks are staging a rebound following the losses incurred in the week ended Oct. 12 amid catalysts that include the third-quarter earnings …

João Siffert has been appointed head of research and development and chief medical officer of Abeona Therapeutics (NASDAQ: ABEO). As a result of Siffert’s hire, former chief medical officer Juan Ruiz will become head of European medical affairs. Siffert’s experience includes executive roles at Nestle Health Science, Avanir Pharmaceuticals, Avera Pharmaceuticals. New York-based Abeona is developing cell and gene therapies to treat life-threatening rare genetic diseases. The company’s lead programs include treatments for the inherited skin disorder epidermolysis bullosa, and Sanfilippo syndrome type A, which is an inherited metabolic disorder.

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Kitty Yale has been appointed chief development officer of Akero Therapeutics. She joins Akero from Gilead Sciences, where she was vice president of clinical operations. Akero emerged earlier this year with $65 million in financing and an experimental drug for the liver disease nonalcoholic steatohepatisis (NASH) that was licensed from Amgen (NASDAQ: AMGN). The company, which splits its operations between Cambridge, MA, and San Francisco, plans to start Phase 2 studies testing the NASH drug by mid-2019.

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[Source: Research & Innovation] On 25 October 2018 a conference dedicated to bioenergy research, development and technologies will take place in Brussels. The event will provide insights into the impacts of R&D funded through the EU Framework Programmes for Research and Innovation; including providing access to the bioenergy R&D Impact Report and an opportunity to influence the recommendations to increase future R&D impacts. During the workshop key industry experts will share their insights on the future of bioenergy technologies and there will be opportunities for you to discuss and understand how to increase the impacts of your own research projects.
Venue: Sofitel Brussels Le Louise, Avenue de la Toison d’Or 40, 1050 Brussels, Belgium

A new report by the Office of Inspector General at the U.S. Department of Health and Human Services (HHS) reaffirms concerns with a regulatory decision that undermines the health and well-being of America’s seniors.

In an abrupt reversal of long-standing policy, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare Advantage health plans can impose “step therapy” requirements on patients who need drugs covered under Medicare Part B.

The new directive – which affects more than one-third of all Medicare beneficiaries – will force some patients to fail first on a medicine preferred by their insurance companies before they can receive the therapy prescribed by their doctors.

More than 230 patient and provider groups have warned the new policy “could put patients’ health at risk” and impose greater administrative burdens on physicians.

But what does this have to do with the HHS Inspector General? Well, in a new report, the independent watchdog reveals that patients are often wrongly denied care by health plans participating in the Medicare Advantage program. According to the report:

• The “central concern” is that health plans may put profits before patients. The report notes “potential incentives” that encourage health plans to “inappropriately deny access to services and payment in an attempt to increase their own profit.”
• Health plans routinely deny coverage, forcing patients to file appeals or forego the medical care they need. In fact, 75 percent of all coverage or payment denials issued by health plans were overturned at the first stage of the appeal process, which strongly suggests the insurance industry is taking a “deny first” approach to caring for America’s seniors.
• Seniors face a “confusing and overwhelming” appeals process, which may explain why only 1 percent of coverage denials are actually appealed.
• The often inaccurate denials of coverage by health plans are particularly worrisome for seniors who rely on Medicare Advantage and “may be especially burdensome for beneficiaries with urgent health conditions.”

These startling facts do not bode well for seniors, particularly as the Trump administration provides these same health plans new tools to restrict seniors’ access to prescription medicines.

And now UnitedHealth-the largest insurance carrier in the Medicare Advantage program-is rushing to impose the flawed fail first approach on millions of seniors starting next year. As the Society for Women’s Health Research cautioned in a recent letter, the current approach is flawed because it “lacks basic beneficiary protections and agency oversight that should be fundamental to any utilization management policy.”

The Trump administration should reverse course and withdraw this harmful policy. At the very least, it should not allow insurance companies to rush forward until basic safeguards are in place that ensure seniors aren’t wrongly denied the medicines they need.

As the stock market continued its volatile swings this week, investors at the BIO Investor Forum-which wrapped up today in San Francisco-seemed to take it all in stride and remain focused on the long-term promise of advancements and breakthroughs in the life sciences. 

Attendance was up over previous years and included attendees from 34 countries, giving the event a distinctly international flavor. Many were drawn to the conference’s expertly led panel sessions and the opportunity to seek and find collaborators and partners.

Some topics covered in the educational sessions were not on the horizon five years ago. One panel covered investments in microbiome-related companies which have accelerated over the past three years, demonstrating high investor expectations for a myriad of applications beyond gut and digestion-related therapies. Other sessions looked at the ever-increasing digital space, exploring the benefits from the collaboration of biopharma and digital therapy providers, new analytical techniques utilizing digital health care records and applying artificial intelligence to improve therapy development. 

A record number of meetings scheduled through BIO One-on-One Partnering-over 3,000! -reflected the enthusiasm for the great science that is fueling investment in biotech start-ups. Partnering increased nine percent over last year.   

The event attracted the most investors in 10 years. Over 320 qualified private equity and public investors from around the world, particularly Asia, attended the conference this year. Interest from the investment community is on the rise for rapidly evolving areas of scientific and medical discoveries like gene therapy, cell therapy, genome editing and other innovative technologies.

But don’t take our word for it. These attendees shared their #BIF18 experience with us during the last two days.

BIO’s buzz center hosted interviews with thought-leaders focused on breakthrough technologies and the investment climate for biotechnology.

A gallery of photos highlights the networking that may lead to the next advancements in life-saving treatments.

The Conference program offered provocative and thought-provoking sessions on attracting Chinese investors, new CFIUS review regulations, investment strategies, new research on Alzheimer’s treatments and more. 

A Virtual Attendee Package including panels, therapeutic sessions and fireside chats from the 2018 Investor Forum is available for purchase .

• BIO sponsors meetings and conferences throughout the year that support industry-wide success. The full list of events is on the BIO website.

  The Most registered investors in 10 years.

Exact Sciences has gone from being a customer of Biomatrica, a San Diego-based vendor of equipment for storing and preserving blood and saliva samples, to now being the company’s owner.

Madison, WI-based Exact (NASDAQ: EXAS), which is developing diagnostic tests for several types of cancer, said Thursday that it has acquired Biomatrica for an undisclosed sum.

Biomatrica manufactures and sells tools for preserving biological samples. These include circulating tumor DNA, cells, and other biomarkers in blood, saliva, and tissue samples stored-and shipped from-laboratories across the globe, the company said.

Exact’s sole product on the market is Cologuard, a non-invasive,… Read more »

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[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: ERC-2019-PoCPillar: Excellent ScienceOpening Date: Deadline: Thu, 25 Apr 2019 17:00:00 (Brussels local time)Modification Date: Thu, 18 Oct 2018Latest information: The submission session is now available for: ERC-2019-POC(ERC-POC)

Despite some recent market volatility, the industry is well positioned for long-term growth and success.

That was the underlying theme of the opening Plenary Luncheon and Fireside Chat at the 2018 BIO Investor Forum (BIF).

The fireside chat featured an informative and wide-ranging conversation with industry investing veteran Ed Hurwitz, managing director at MPM Capital. The discussion was moderated by Susanne Mulligan, managing director, life sciences banking, at BMO Capital Markets.

BIO President & CEO Jim Greenwood kicked off the lunch by discussing how the fundamentals of the industry are strong and how our understanding of human biology continues to advance at a breathtaking pace. Greenwood highlighted how this increased understanding of the science gives investors more confidence to provide key financing for companies throughout their growth cycle.

Hurwitz echoed this point during the fireside chat, noting that our improved  understanding of science has changed the trends in investing.

Because of advances in science, more companies today can attract the capital they need to motor through tough times and bad markets.

In his remarks, Greenwood noted how this trend is playing out by highlighting some key data points: 

• Initial public offerings in 2018 are much stronger than in years’ past:  39 so far this year – compared to 24 for all of last year and just 22 in 2016. 
• U.S. companies have pulled in $3.8 billion in IPOs and are on track for the second highest amount raised in a decade.
• More preclinical-stage companies are going public than any other year in a decade.
• There have been more than 800 secondary offerings since 2013. These offering have raised more than $100 billion for biotech companies.
• 2018 could be a record year for VC investment in this sector, beating last year’s record of $7.6 billion for U.S. companies.
• Globally, data from Evaluate Pharma shows a record $13.2 billion into biopharma in 2018. That’s ahead of last year’s record $12.2 billion.
• We can expect more than 40 novel drug approvals this year. 

“As an industry, we’ve gone from talking about our potential to realizing it,” said Greenwood.

MPM Capital has played an important role in making this success possible. As Mulligan noted in her comments, MPM Capital has about $1.5 billion under management; launched 22 start-ups since 2010; 35 of their portfolio companies have gone public since 2005; and there have been 46 drug approvals from companies that the firm has invested in. The firm continues to be a leader in the oncology space and has one of the most experienced leadership teams in the business.

During the fire side chat, Hurwitz talked about the MPM entrepreneurial engine, its deep bench of expertise and the role it plays in helping turn great ideas into well-capitalized, well-run companies. 

Access business panels, therapeutic sessions, and fireside chats from the 2018 Investor Forum by purchasing a Virtual Attendee Package .

Merck (NYSE: MRK) has appointed Jim Scholefield to serve as its chief information and digital officer. He starts his new job at the Kenilworth, NJ, pharmaceutical giant on Oct. 29. Scholefield is currently chief information officer at Nike (NYSE:NKE). His experience also includes executive roles at Coca Cola (NYSE: KO), Northern Trust (NYSE: NTRS), and Ford Motor Company (NYSE: F).

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