Wednesday, September 26, 2018
Regulus provides pipeline updates
Regulus provided an update on advancements to its pipeline programs. In Hepatitis B virus programs, the company has identified several microRNA targets that serve as host factors for the virus. The company believes that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. The company currently expects to file an IND for the HBV program in 2H19, with the potential of achieving human proof-of-concept in a Phase 1 study. In the Glioblastoma multiforme program, its lead anti-miR candidate targeting microRNA-10b demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolamide in an orthotopic GBM animal model. In combination with TMZ, the addition of a single dose of anti-mir-10b led to a more than two-fold improvement in survival compared to TMZ alone. The company expects to nominate a clinical candidate by year-end and plans to seek a partner to further advance its development. In its Non-Alcoholic Steatohepatitis program, its lead candidate has demonstrated improvement in key endpoints with significant improvement of liver fibrosis and hyperglycemia compared to control-treated animals. The company plans to seek a partner to further advance its development. In its Autosomal Dominant Polycystic Kidney Disease program, and in consultation with the FDA, the company has initiated a new 27-week chronic mouse toxicity study with several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. Data from the new study are anticipated in 1Q19.
https://thefly.com/landingPageNews.php?id=2796065
LeMaitre Vascular Buys Clot Management Business from Applied Medical
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it has acquired the vascular clot management business of Applied Medical Resources Corporation for $14.2 million, of which $11.0 million was paid at closing and $3.2 million will be paid in two post-closing installments. As part of the transaction, the parties also signed a transition services agreement under which Applied Medical will continue to manufacture the product line for LeMaitre Vascular for one year.
Applied Medical's clot management product line, including Syntel® embolectomy and thrombectomy catheters, Python® over-the-wire embolectomy catheters, Latis® graft cleaning catheters and irrigation catheters, is now available through LeMaitre Vascular. Sales of the business during the latest 12-month period were $3.4mm.
Dave Roberts, LeMaitre Vascular's President, commented, "We are pleased to expand our clot management product offering through this acquisition, which adds a latex-free over-the-wire embolectomy catheter to our sales bag."
Gary Johnson, Applied Medical's Group President, added, "We are confident that our vascular customers will continue to receive the highest level of service and support from LeMaitre."
Business Outlook
In Q4 2018, LeMaitre Vascular expects the acquired business to add $0.5 million to $0.6 million in sales, and have no impact on operating income due to short-term business transition related costs.
About LeMaitre Vascular
LeMaitre Vascular is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. The Company's diversified product portfolio consists of brand name devices used in arteries and veins outside of the heart. Additional information can be found at www.lemaitre.com.
About Applied Medical
Applied Medical is dedicated to providing innovative solutions that enhance patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, Applied is proud to have a significant and sustainable impact on healthcare by delivering breakthrough technologies that enhance clinical care and satisfy the pressing economic needs of its customers.
Headquartered in Southern California, Applied Medical provides its products and unique business model to more than 75 countries. To learn more about Applied Medical, visit appliedmedical.com.
https://www.nasdaq.com/press-release/lemaitre-vascular-acquires-clot-management-business-from-applied-medical-20180926-01074
Applied Medical's clot management product line, including Syntel® embolectomy and thrombectomy catheters, Python® over-the-wire embolectomy catheters, Latis® graft cleaning catheters and irrigation catheters, is now available through LeMaitre Vascular. Sales of the business during the latest 12-month period were $3.4mm.
Dave Roberts, LeMaitre Vascular's President, commented, "We are pleased to expand our clot management product offering through this acquisition, which adds a latex-free over-the-wire embolectomy catheter to our sales bag."
Gary Johnson, Applied Medical's Group President, added, "We are confident that our vascular customers will continue to receive the highest level of service and support from LeMaitre."
Business Outlook
In Q4 2018, LeMaitre Vascular expects the acquired business to add $0.5 million to $0.6 million in sales, and have no impact on operating income due to short-term business transition related costs.
About LeMaitre Vascular
LeMaitre Vascular is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. The Company's diversified product portfolio consists of brand name devices used in arteries and veins outside of the heart. Additional information can be found at www.lemaitre.com.
About Applied Medical
Applied Medical is dedicated to providing innovative solutions that enhance patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, Applied is proud to have a significant and sustainable impact on healthcare by delivering breakthrough technologies that enhance clinical care and satisfy the pressing economic needs of its customers.
Headquartered in Southern California, Applied Medical provides its products and unique business model to more than 75 countries. To learn more about Applied Medical, visit appliedmedical.com.
https://www.nasdaq.com/press-release/lemaitre-vascular-acquires-clot-management-business-from-applied-medical-20180926-01074
Hologic to Acquire Focal Therapeutics for $125 Million, Boosting Breast Surgery
Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that it has signed a definitive agreement to acquire Focal Therapeutics, a privately-held company, for $125 million in cash. In conjunction with Hologic’s recent acquisition of Faxitron Bioptics, Focal strengthens the Company’s position in the rapidly growing market for breast conserving surgery.
The transaction adds Focal’s innovative BioZorb marker to the Company’s Breast Health product portfolio. BioZorb is an implantable three-dimensional marker that helps clinicians overcome challenges in breast conserving surgery, or lumpectomy. The marker, placed by the surgeon, is used to mark the tumor excision site for monitoring and future treatments, and its unique open design allows for tissue in-growth during the healing process.
“Focal Therapeutics has commercialized an innovative marker that improves the standard of care for breast cancer patients by creating a permanent, three-dimensional indicator of the surgical site,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “Coupled with our recent acquisition of Faxitron, BioZorb further expands our ability to help women diagnosed with breast cancer from screening through surgery.”
“Acquiring Focal Therapeutics strengthens our position in an attractive, adjacent breast health market, and is consistent with our capital deployment goals,” said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer. “The transaction is accretive to our revenue growth rate and gross margin, broadens our recurring revenue base, and provides attractive return on invested capital.”
Focal generated approximately $16 million of revenue in the last 12 months. The acquisition, which is expected to close in early October, is estimated to be neutral to Hologic’s non-GAAP earnings per share in fiscal 2019, and accretive thereafter.
“We are very excited to become part of Hologic,” said Dr. Gail Lebovic, Focal’s co-founder and Chief Medical Officer. “Hologic’s long-standing commitment to early cancer detection is key for success in breast conserving surgery. Hologic is the perfect fit for our company.”
Anthem returning to ObamaCare exchange in Ohio in 2019
Anthem will be once again selling individual health insurance plans next year in Ohio after its dramatic exit from the Obamacare exchanges during 2018.
The insurance company will sell plans in 25 counties in the state including Warren and Butler counties, according to filings with the Ohio Department of Insurance, which regulates the exchanges.
Open enrollment for coverage next year begins Nov. 1. and runs through Dec. 15.
Most counties in the region will have more options to choose from next year, signaling the market is starting to stabilize.
In 2018, eight companies sold health insurance products on the exchange in Ohio and 42 counties had just one insurer with an additional 20 counties having only two.
But for next year, 10 companies have filed rates and forms for the department to review and all 88 counties will have at least one insurer. Preliminary filings show 16 counties with just one insurer and 33 counties with two.
Miami County will have two insurance carriers next year selling individual plans instead of one. This year the only individual plan in the county — sold by CareSource — is not in-network with Upper Valley Medical Center, the only hospital in the county.
Molina and Medical Mutual are entering new counties and health insurance startup Oscar Health is expanding into the Columbus metro.
“I think what it tells me on the surface is that carriers are slightly more optimistic about what the exchange could offer,” said Scott McGohan, CEO of insurance benefits brokerage firm McGohan Brabender.
Costs of individual plans are still rising, though subsidies offset those spikes for some people.
The average premium in Ohio for individual plans will increase 8.2 percent, according to early cost estimates submitted to Ohio Department of Insurance.
In 2018, the weighted average premium for an individual plan was $5,798.83. For 2019, companies are proposing to sell products an an average $6,274.08 premium, up 8.2 percent.
While the increase still outpaces employer-sponsored insurance, the rates are rising at a slower pace than last year when premiums rose an average of 34 percent.
About 11 percent of the increase was because the Ohio Department of Insurance required insurance companies to assume they would lose federal subsidies that help lower costs.
UnitedHealth: Optum backs startup that uses AI to aid in medical diagnosis
A venture fund at Minnetonka-based UnitedHealth Group is part of a $33 million fundraising round for an Iowa startup that’s developing an autonomous diagnosistic system featuring artificial intelligence (AI).
Called IDx, the company this year received clearance from the Food and Drug Administration to market the first medical device using AI to detect greater than a mild level of the eye disease diabetic retinopathy in adults with diabetes.
The startup on Wednesday announced fundraising that’s intended to accelerate market adoption of the technology and development of related products. It includes money from Optum Ventures, which UnitedHealth Group launched last year.
“We expect this investment to accelerate the adoption of IDx-DR, a unique and much-needed solution for the 30 million people with diabetes in the U.S. alone who need to be tested for diabetic retinopathy each year,” said Stefan Abrams, vice chairman at IDx, in a news release.
Optum is the UnitedHealth Group division for health care services including information technology, direct patient care and pharmaceutical benefits management. Last year, the company launched Optum Ventures, a series of domestic and international funds meant to invest in digital care, consumer care and health analytics with artificial intelligence, big data and machine learning.
Company officials said in April that Optum Ventures has $600 million to invest. Last year, UnitedHealth listed among the venture fund’s first four investments a startup called Mindstrong Health, which uses machine learning and artificial intelligence to analyze a patient’s smartphone interactions. The goal is “to help diagnose and treat neuropsychiatric and neurodegenerative disorders such as depression, schizophrenia and post-traumatic stress disorder,” UnitedHealth Group said in a news release.
The financing announced Wednesday was led by venture capital firm 8VC, where founding partner Drew Oetting said in a statement that IDx leveraged expertise at University of Iowa Health Care “to develop a clinically-inspired AI — not a black box.”
Sarah London, senior principal at Optum Ventures, said in the news release: “The health care industry needs to accelerate its adoption of AI to reduce costs and drive efficiencies. We are confident that IDx will transform health care by increasing patient access to early disease detection.”
Epizyme: FDA Lifts Partial Clinical Hold on Tazemetostat Clinical Program
Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration(FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.
Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.
Epizyme’s formal response to the FDA included a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat, which took into account both published literature and the company’s clinical experience to date. This followed a report of a single case of T-LBL in its tazemetostat pediatric study. Epizyme provided a thorough assessment of efficacy and safety data across all of its trials in hematological malignancies and solid tumors, in both adults and children, and convened a panel of external scientific and medical experts who reviewed and validated the findings.
‘The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL,’ said Robert Bazemore, president and chief executive officer of Epizyme. ‘We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program. We remain steadfast in our commitment to bringing this potential therapeutic option to cancer patients in need of safe and effective new treatments.’
Epizyme will now engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries. The company is also working closely with its study partners to reach a similar resolution for their respective trials in which tazemetostat is being studied in combination with other therapies.
Entasis Therapeutics opens at $13.45, IPO priced at $15.00 per share
Entasis Therapeutics (ETTX) priced 5M shares at $15.00. The deal size was increased to 5M shares from 4.1M shares and priced below the $16.00-$18.00 range. Credit Suisse and BMO Capital acted as joint book running managers for the offering.
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