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Boston Scientific Announces Results For Second Quarter 2020

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MARLBOROUGH, Mass., July 29, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) generated sales of $2.003 billion during the second quarter of 2020. This represents a decline of (23.9) percent on a reported basis, (23.1) percent on an operational1 basis and (28.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP loss of $147 million or $(0.11) per share (EPS), compared to GAAP earnings of $154 million or $0.11 per share a year ago, and achieved adjusted earnings per share of $0.08 for the period, compared to $0.39 a year ago.

“We remain focused on the safety of our team, our customers and the patients they serve, and were pleased to see the business recovering over the course of the quarter,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific. “With a strong pipeline of differentiated products and an agile global team, we’ll continue to execute on our strategy and make prudent decisions to position us for success as deferred procedures resume.”

Second quarter financial results and recent developments:

  • Reported a GAAP loss of $(0.11) per share. Achieved adjusted earnings per share of $0.08. The company did not provide second quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
  • Second quarter sales declined in each of our reportable segments4, compared to the prior year period:
    • MedSurg: (29.6) percent reported, (29.1) percent operational and (28.4) percent organic
    • Rhythm and Neuro: (33.2) percent reported, (32.7) percent operational and (33.4) percent organic
    • Cardiovascular: (18.7) percent reported, (17.6) percent operational and (25.3) percent organic
  • Second quarter regional5 sales declined, compared to the prior year period:
    • U.S.: (28.4) percent reported and operational
    • EMEA (Europe, Middle East and Africa): (27.2) percent reported and (25.6) percent operational
    • APAC (Asia-Pacific): (14.8) percent reported and (14.0) percent operational
    • Emerging Markets3: (19.7) percent reported and (14.6) percent operational
  • Received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device which is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation. This next-generation implant is the first LAAC device that can be fully recaptured, repositioned and redeployed in the left atrial appendage, with additional design features to enhance safety and performance while treating a wider range of patient anatomies than the previous WATCHMAN LAAC device.
  • Received FDA approval for the SYNERGY™ XD Bioabsorbable Polymer (BP) Drug-Eluting Stent (DES) System, the next-generation SYNERGY BP-DES platform with the only 48 mm length DES available in the U.S. and enhanced deliverability features to enable improved arterial navigation in percutaneous coronary intervention (PCI) cases. The system was recently launched in Japan following approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
  • Received FDA 510(k) clearance and began limited market release for the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope. The LUX-Dx ICM System can be programmed remotely and have settings adjusted without requiring patients to visit their physician’s office and is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians.
  • Received approval for the Eluvia™ Drug-Eluting Vascular Stent System from China’s Center for Medical Device Evaluation and will begin a limited market release by the end of the year. Also announced results of a sub-study of patients from the IMPERIAL trial who were treated with the Eluvia stent during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trials Livestream event. Data demonstrated the Eluvia stent offers durable and consistent results in complex and long lesions, with an average lesion length of 162.8 mm and that patients treated with the Eluvia stent had a 77.2% Kaplan-Meier primary patency rate, a 13.6% clinically-driven target lesion revascularization rate and no stent thrombosis, despite long, heavily calcified lesions.
  • Received CE Mark and began limited European release for the INTELLANAV STABLEPOINT™ Ablation Catheter enabled with DIRECTSENSE™ Technology. This first-of-its-kind catheter combines measures of mechanical contact, or contact force, with local impedance to provide insight into the cardiac tissue’s response to ablation.
  • Received Centers for Medicare & Medicaid Services (CMS) approval for a new transitional pass-through (TPT) payment category to describe single-use endoscopes, including the EXALT™ Model D Single-Use Duodenoscope, to facilitate Medicare beneficiary access to the advantages of new and innovative devices by allowing for adequate payment while cost data is collected, starting July 1, 2020. The EXALT™ duodenoscope is the world’s first and only single-use, flexible duodenoscope cleared by the U.S. Food and Drug Administration (FDA), which eliminates the risk of infection from inadequate scope reprocessing between procedures.
  • Presented positive findings from the largest reported clinical experience to date with the LOTUS Edge™ Aortic Valve System at TVT Connect. Data from a pre-specified interim analysis of the first 50 patients enrolled in the European RESPOND EDGE post-market registry demonstrated no reports of mortality, no repeat procedures for valve-related dysfunction or re-hospitalization for valve-related symptoms and excellent valve hemodynamics, the lowest PVL rates in this valve category and a reduced permanent pacemaker implantation rate in line with competitive valves in real-world experience.
  • Commenced enrollment of the FROZEN-AF investigational device exemption (IDE) clinical trial which will evaluate the safety and effectiveness of the POLARx™ Cryoablation System for the treatment of paroxysmal atrial fibrillation (AF), an intermittent form of AF which causes an irregular and often abnormally fast heart rate.
  • Announced at HRS 2020 Science final results from the UNTOUCHED study of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System, the only FDA-approved implantable defibrillator without wires touching the heart, demonstrating high efficacy and safety of the device and a lower rate of inappropriate shock than many similar devices. Also presented as a late-breaking clinical trial at the virtual meeting were results from the investigator-sponsored PRAETORIAN trial confirming that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing.
  • Published a meta-analysis of 1,011 prostate cancer patients in The Journal of the American Medicine Association (JAMA) Network Open which found that placing SpaceOAR Hydrogel® before radiation is an effective preventative strategy to reduce treatment-induced rectal complications. Each year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 men will undergo prostate radiotherapy. Recently, SpaceOAR surpassed 100,000 patients treated worldwide.
  • Announced The Lancet Neurology publication of the INTREPID study—a double-blind, randomized study evaluating the Vercise™ Deep Brain Stimulation (DBS) system for Parkinson’s disease. One-year results demonstrated a significant 51% improvement in motor symptoms (UDPRS III scores) compared to pre-surgery screening and six additional hours of ON time – or daily symptom control – over medication.
  • Launched a multi-year program to combat racism, inequity and injustice, including $3.5 million in philanthropic commitments, focused on five pillars: community, economic empowerment, education, healthcare disparities and government/legislative change.
  • Increased financial flexibility by completing a public offering of $1.7 billion aggregate principal amount of Senior Notes, as well as completing an approximately $2.0 billion public offering of common stock and mandatory convertible preferred stock, and using a portion of the proceeds of both offerings to repay borrowings under our revolving credit facility and a significant portion of our pre-payable bank debt.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, as well as the Q2 divestiture of our intrauterine health franchise.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition.

5. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

Net sales for the second quarter by business and region:

         

Change

   

Three Months Ended
June 30,

 

Reported
Basis

 

Less: Impact
of Foreign
Currency
Fluctuations

 

Operational
Basis

 

Less:
Impact of
Recent
Acquisitions /
Divestitures

 

Organic
Basis

(in millions)

2020

2019

         
                           
 

Endoscopy

$

348

$

470

 

(26.0)%

 

(0.5)%

 

(25.5)%

 

—%

 

(25.5)%

 

Urology and Pelvic Health

228

348

 

(34.5)%

 

(0.4)%

 

(34.1)%

 

(1.7)%

 

(32.4)%

 

MedSurg

576

818

 

(29.6)%

 

(0.5)%

 

(29.1)%

 

(0.7)%

 

(28.4)%

 

Cardiac Rhythm Management

351

498

 

(29.4)%

 

(0.6)%

 

(28.8)%

 

—%

 

(28.8)%

 

Electrophysiology

51

84

 

(39.2)%

 

(0.3)%

 

(38.9)%

 

—%

 

(38.9)%

 

Neuromodulation

122

204

 

(40.0)%

 

(0.3)%

 

(39.7)%

 

2.9%

 

(42.6)%

 

Rhythm and Neuro

525

786

 

(33.2)%

 

(0.5)%

 

(32.7)%

 

0.7%

 

(33.4)%

 

Interventional Cardiology

495

706

 

(29.9)%

 

(1.1)%

 

(28.8)%

 

—%

 

(28.8)%

 

Peripheral Interventions

340

320

 

6.0%

 

(1.0)%

 

7.0%

 

24.4%

 

(17.4)%

 

Cardiovascular

834

1,026

 

(18.7)%

 

(1.1)%

 

(17.6)%

 

7.7%

 

(25.3)%

 

Medical Devices4

1,935

2,631

 

(26.5)%

 

(0.8)%

 

(25.7)%

 

3.0%

 

(28.7)%

 

Specialty Pharmaceuticals5

68

n/a

 

n/a

 

n/a

 

n/a

 

n/a

 

n/a

Net Sales

$

2,003

$

2,631

 

(23.9)%

 

(0.8)%

 

(23.1)%

 

5.6%

 

(28.7)%

                                           
         

Change

   

Three Months Ended
June 30,

 

Reported
Basis

 

Less: Impact
of Foreign
Currency
Fluctuations

 

Operational
Basis

(in millions)

2020

2019

     
                   
 

U.S.

$

1,058

$

1,478

 

(28.4)%

 

—%

 

(28.4)%

 

EMEA

416

571

 

(27.2)%

 

(1.6)%

 

(25.6)%

 

APAC

410

481

 

(14.8)%

 

(0.8)%

 

(14.0)%

 

Latin America and Canada

51

101

 

(49.4)%

 

(6.3)%

 

(43.1)%

 

Medical Devices4

1,935

2,631

 

(26.5)%

 

(0.8)%

 

(25.7)%

 

Specialty Pharmaceuticals5

68

n/a

 

n/a

 

n/a

 

n/a

 

Net Sales

$

2,003

$

2,631

 

(23.9)%

 

(0.8)%

 

(23.1)%

                   
 

Emerging Markets3

$

255

 

$

318

 

(19.7)%

 

(5.1)%

 

(14.6)%

                   
 

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

   
 

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

                         

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance, and the impact of the COVID-19 outbreak on the company’s results of operations. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in dollars.

Use of Non-GAAP Financial Information

A reconciliation of the company’s non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company’s use of these non-GAAP financial measures, is included in the exhibits attached to this press release.

CONTACT:

       

Media:

Kate Haranis

 

Investors:

Susie Lisa, CFA

 

508-683-6585 (office)

   

508-683-5565 (office)

 

Media Relations

   

Investor Relations

 

Boston Scientific Corporation

   

Boston Scientific Corporation

 

kate.haranis@bsci.com

   

BSXInvestorRelations@bsci.com

Use of Non-GAAP Financial Measures

To supplement our unaudited condensed consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss) and adjusted net income (loss) per share (EPS) that exclude certain amounts, operational net sales, which exclude the impact of foreign currency fluctuations and organic net sales, which exclude the impact of foreign currency fluctuations and the impact of recent aforementioned acquisitions and divestitures. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.

To calculate adjusted net income (loss) and adjusted net income (loss) per share we exclude certain charges (credits) from GAAP net income available to common stockholders. Amounts are presented after-tax at the company’s effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with FASB Accounting Standards Codification section 740-270-30, “General Methodology and Use of Estimated Annual Effective Tax Rate.” Please refer to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K filed with the Securities and Exchange Commission or any Quarterly Report on Form 10-Q that we file thereafter for an explanation of each of these adjustments and the reasons for excluding each item.

The GAAP financial measures most directly comparable to adjusted net income (loss) and adjusted net income (loss) per share are GAAP net income (loss) and GAAP net income (loss) per share available to common stockholders.

To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior period. To calculate organic net sales growth rates, we remove the impact of recent aforementioned acquisitions with no prior period related net sales from operational net sales. In addition, to calculate organic net sales growth rates, we remove from prior year, sales from product lines that we divested. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales on a GAAP basis.

Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the accompanying schedules.

Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments’ measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance.

We believe that presenting adjusted net income (loss) and adjusted net income (loss) per share, operational net sales and organic net sales, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/boston-scientific-announces-results-for-second-quarter-2020-301101773.html

SOURCE Boston Scientific Corporation

Company Codes: NYSE:BSX

Source: https://www.biospace.com/article/releases/boston-scientific-announces-results-for-second-quarter-2020/?s=75

Biotechnology

Perceptive debuts LianBio with cancer and heart disease programs from BridgeBio, MyoKardia

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After working in stealth since October, Perceptive Advisors is unveiling its latest biotech: LianBio, which serves the dual mission of bringing much-needed new drugs to China and helping U.S. biotech companies expand their operations into Asia.

LianBio launches with a trio of assets licensed from MyoKardia and BridgeBio Pharma companies Navire Pharma and QED Therapeutics. LianBio is handing over more than $60 million upfront in exchange for development and commercialization rights to the programs in China and “selected Asian markets.” BridgeBio and MyoKardia will pick up equity in the LianBio, too.

And that’s not all—LianBio has a “strategic relationship” with BridgeBio that gives it first dibs on the 20 programs already in the latter’s pipeline, as well as any assets it may bring under its umbrella in the next four years, said Konstantin Poukalov, a managing director at Perceptive Advisors and executive chairman of LianBio. The company will be on the hook for up to $505 million in milestone payments to BridgeBio and $147.5 million to MyoKardia.

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LianBio’s pipeline includes mavacamten—a treatment for hypertrophic cardiomyopathy (HCM), an inherited disorder that causes the muscle walls of the heart to thicken, potentially to the point where they can obscure blood flow. MyoKardia plans to submit the drug for FDA approval for obstructive HCM in early 2021 and continue to develop it for patients with the non-obstructive form of HCM and those with a specific kind of heart failure, in which the left ventricle can’t properly fill with blood and pumps less blood to the body than normal.

RELATED: GlaxoSmithKline veteran Zhi Hong launches Brii Biosciences with $260M

LianBio has also licensed infigratinib, QED Therapeutics’ EGFR inhibitor that’s in a phase 3 study for bile duct cancer, and a SHP2 inhibitor that Navire Pharma is developing for drug-resistant tumors and other hard-to-treat cancers. LianBio hands over $26.5 million upfront

The company views these as more than just licensing deals, Debra Yu, LianBio’s chief business officer said. It plans to pitch in and run clinical trials in China and other parts of Asia where appropriate.

“It isn’t just like we get mavacamten and we go wherever we want with it and pay them the royalties,” Yu said.

“In the case of mavacamten, MyoKardia already got it all the way through for the obstructive HCM indication and we’ll take it into China,” she added. “But for the other indications, in nonobstructive HCM and (heart failure with preserved ejection fraction), we will work side by side with them.”

As for infigratinib, that could mean testing the drug in cancers that QED is not yet looking at, but that are prevalent in China, such as gastric cancer, she added.

It’s part of Perceptive and LianBio’s bid to bring cutting-edge medicines to China and address what CEO Bing Li calls the gap between global innovation and the China market.

“China has predominantly been a generics market for most of its time,” Yu said. “Even today, there is still a very limited number of innovative drugs and certainly not those we would call ‘paradigm-shifting.”

As it advances its pipeline, LianBio aims to double its team by the end of the year. It will be on the hunt for more assets that it might want to pursue in China, both through its deal with BridgeBio and other potential partners.

When asked if LianBio would ever dive into in-house discovery and development, Poukalov said “nothing is ever off the table,” but that the core focus of the company’s model is “high-quality assets that are highly significantly derisked.”

“But once our therapeutic areas of focus are established, we are certainly willing to move to earlier stages of development,” Poukalov added. That could include putting together novel cancer-fighting combinations based on Navire’s SHP2 inhibitor.

“In the near-term, I don’t think we are going to be doing true benchwork—there are plenty of people who are good at doing that—but we will be utilizing what we know and the access we have to be creative and do early-stage development work,” he said.

Editor’s note: This story has been updated to remove the dollar amount of LianBio’s funding as it was incorrect.

Source: https://www.fiercebiotech.com/biotech/perceptive-debuts-lianbio-cancer-and-heart-disease-programs-from-bridgebio-myokardia

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Biotechnology

SMART research enhances dengue vaccination in mice

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Researchers from the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have found a practical way to induce a strong and broad immunity to the dengue virus based on proof-of-concept studies in mice. Dengue is a mosquito-borne viral disease with an estimated 100 million symptomatic infections every year. It is endemic in over 100 countries in the world, from the United States to Africa and wide swathes of Asia. In Singapore, over 1,700 dengue new cases were reported recently. 

The study is reported in a paper titled “Sequential immunization induces strong and broad immunity against all four dengue virus serotypes,” published in NPJ Vaccines. It is jointly published by SMART researchers Jue Hou, Shubham Shrivastava, Hooi Linn Loo, Lan Hiong Wong, Eng Eong Ooi, and Jianzhu Chen from SMART’s Infectious Diseases and Antimicrobial Resistance (AMR) interdisciplinary research groups (IRGs). 

The dengue virus (DENV) consists of four antigenically distinct serotypes and there is no lasting immunity following infection with any of the DENV serotypes, meaning someone can be infected again by any of the remaining three variants of DENVs.

Today, Dengvaxia is the only vaccine available to combat dengue. It consists of four variant dengue antigens, one for each of the four serotypes of dengue, expressed from attenuated yellow-fever virus. The current three doses of immunization with the tetravalent vaccine induce only suboptimal protection against DENV1 and DENV2. Furthermore, in people who have not been infected by dengue, the vaccine induces a more severe dengue infection in the future. Therefore, in most of the world, the vaccination is only given to those who have been previously infected. 

To help overcome these issues, SMART researchers tested on mice whether sequential immunization (or one serotype per dose) induces stronger and broader immunity against four DENV serotypes than tetravalent-formulated immunization — and found that sequential immunization induced significantly higher levels of virus-specific T cell responses than tetravalent immunization. Moreover, sequential immunization induced higher levels of neutralizing antibodies to all four DENV serotypes than tetravalent vaccination.

“The principle of sequential immunization generally aligns with the reality for individuals living in dengue-endemic areas, whose immune responses may become protective after multiple heterotypic exposures,” says Professor Eng Eong Ooi, SMART AMR principal investigator and senior author of the study. “We were able to find a similar effect based on the use of sequential immunization, which will pave the way for a safe and effective use of the vaccine and to combat the virus.”

Upon these promising results, the investigators will aim to test the sequential immunization in humans in the near future.

The work was supported by the National Research Foundation (NRF) Singapore through the SMART Infectious Disease Research Program and AMR IRG. SMART was established by MIT in partnership with the NRF Singapore in 2007. SMART is the first entity in the Campus for Research Excellence and Technological Enterprise (CREATE) developed by NRF.  SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, performing cutting-edge research of interest to both Singapore and MIT. SMART currently comprises an Innovation Centre and five IRGs: AMR, Critical Analytics for Manufacturing Personalized-Medicine, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems. SMART research is funded by the NRF Singapore under the CREATE program.  

The AMR IRG is a translational research and entrepreneurship program that tackles the growing threat of antimicrobial resistance. By leveraging talent and convergent technologies across Singapore and MIT, they aim to tackle AMR head-on by developing multiple innovative and disruptive approaches to identify, respond to, and treat drug-resistant microbial infections. Through strong scientific and clinical collaborations, they provide transformative, holistic solutions for Singapore and the world.


Source: http://news.mit.edu/2020/smart-researchers-enhance-dengue-vaccination-mice-0811

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Biotechnology

Medtronic snaps up smart insulin pen maker Companion Medical in a ‘bold move’

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Medtronic is buying up leading smart insulin pen and phone app maker Companion Medical as it looks to shore up its growing weakness in the pump market.

The med tech major gets access to Companion’s InPen, a so-called smart insulin pen that not only delivers insulin, but also tracks insulin on board, provides an meal bolus calculator and shares information with connected systems.

The InPen last for around a year and works with short-acting insulins, although work is being done on long-acting insulins. The company made around $11 million in 2019 sales and was looking to triple that this year, after launching in late 2017, though its market penetration is pretty low.

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“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI),” said Sean Salmon, EVP and president of the Diabetes Group at Medtronic.

“We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual. This smart CGM system can help people think less about diabetes and be able to live life with more freedom, on their own terms.

”Our goal is to become a trusted partner that offers consistent support whether an individual wants to stay on MDI, transition to automated insulin delivery or take a break from their pump.”

Analysts at Jefferies said the buyout was a “bold move” and a “source of growth” for Medtronic, and could add $200 million in incremental revenue.  

It points out that Medtronic has “been floundering in diabetes,” losing around a point of share a month in the pump market. The Companion deal will help offset this, and allows Medtronic to serve not only the current and future pump market, but also those that chose to stay on pens, Jefferies said in a note the clients.

The plan now is to combine its diabetes tools (from its Nutriono and Klue buyouts) with InPen and integrate its own continuous glucose monitoring (CGM) system.

Jefferies notes however that the future of insulin delivery “remains a debate.” They firm muses whether smart pens “provide enough of a clinical leap for patients such that pumps prove too much of a relative burden for their benefits.”

Financial details of the deal were not made public. Medtronic’s shares were up nearly 2% Tuesday.

Source: https://www.fiercebiotech.com/medtech/medtronic-snaps-up-smart-insulin-pen-maker-companion-medical-a-bold-move

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