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Incheon, South Korea-based Celltrion’s chairman Jung Jin Seo announced at last week’s JP Morgan Healthcare Conference the company’s strategy for the next decade. In particular, he indicated plans to launch a biosimilar every year until 2030.

Biosimilars are generic versions of biologic drugs. Unlike traditional generic drugs, they are not exact copies, but are similar to their branded counterparts. As such, they undergo an approval process similar to a new drug.

Biosimilars are often encouraged by payers because the increased competition leads to lower-priced drugs. In July, the U.S. Food and Administration (FDA) rolled out its Biosimilars Action Plan. Then-FDA Commissioner Scott Gottlieb noted that less than 2% of Americans use biologics, but they account for 40% of total spending on prescription drugs. They also represented 70% of the growth in drug spending from 2010 to 2015. They are projected to be the fastest-growing segment of drug spending.

As a result, the FDA and U.S. payers, he noted, should make it a priority to reduce the costs of biologics. In a speech at the Brookings Institution at the time, Gottlieb said the Action Plan was designed to help “make the process for developing biosimilars more efficient.”

Although biosimilars have been well-accepted in Europe, their adoption in the U.S. has been much slower. Some of this is related to pharma legal efforts and lawsuits to delay the biosimilar competitors from entering the U.S. market.

The Biosimilars Action Plan involved 11 key actions. They included:

1. Develop and implement new FDA review tools.
2. Create information resources and development tools for sponsors.
3. Enhance the Purple Book to include more data about approved biological products.
4. Explore the possibility of data sharing agreements with foreign regulators.
5. Establish a new Office of Therapeutic Biologics and Biosimilars (OTBB).
6. Expand on the agency’s Biosimilar Education and Outreach Campaign.
7. Publish final or revised draft guidance on biosimilar product labeling.
8. Provide more or extra clarity for developers on demonstrating interchangeability.
9. Provide additional clarity and flexibility on analytical approaches to evaluating product structure and function.
10. Give more support over product quality and manufacturing processes.
11. Engage in a public dialogue through a Part 15 hearing and opening a docket to request additional information from the public.

Other players in the biosimilar market include South Korea’s Samsung Bioepis, as well as Amgen, Pfizer and Teva Pharmaceutical.

Celltrion entered the biosimilar market in 2013 with a biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab), marketed as Remsima. There were apparently doubts at the time as to whether it would be approved at all, but since then the drug has proven to be very successful in Europe. An IQVIA report indicated Remsima had taken over 59% of Remicade’s market share.

Other competing biosimilar products from Celltrion include Truxima, a biosimilar to Roche’s rituximab for cancer and Herzuma, a biosimilar to Roche’s Herceptin for breast cancer. Part of Celltrion’s strategy is to offer “value-added,” versions of its biosimilars, such as a subcutaneously formulation of Remsima, compared to the infused version of the original drug.

Ho Ung Kim, head of Celltrion Healthcare’s medical and marketing division, said, “As a ‘first mover,’ Celltrion Healthcare has gained extensive experience in the biopharmaceutical field and is now ready to initiate a direct sales model.”

He added, “Celltrion Healthcare has set up its own sales network and overseas offices in 14 countries throughout Europe to secure price competitiveness, and strives to lead the global tumor necrosis factor alpha (TNF-alpha) inhibitors market with its innovative infliximab Remsima SC, which is projected to be worth approximately $50 billion.”

As the annual JP Morgan Healthcare Conference draws to a close, let’s celebrate the remarkable innovation that drives the biopharma industry. Here’s a look at the top 10 companies noted in the BioSpace Ideal Employer 2019 survey for being the most innovative and what they’ve been up to recently.

Regeneron Pharmaceuticals. Ranked as the top innovator in the survey, Regeneron has long had a reputation for innovation, and is often cited as Sanofi’s “innovation engine” because of its numerous collaborations with the French-based company. Regeneron has seven marketed products, including Arcalyst for rare autoinflammatory disease, Eylea for a common cause of blindness, Praluent for high cholesterol, and Dupixent for atopic dermatitis. It also has REGN-EB3, a three-antibody therapy used to treat Ebola.

On January 9, Regeneron announced results from LUMINA-1, a Phase II trial of garetosmab in patients with fibrodysplasia ossificans progressive (FOP), an ultra-rare genetic disorder that leads to abnormal bone formation. After 28 weeks, the drug decreased total lesion activity compared to placebo by 25%.

Verily Life Sciences. Formerly known as Google Life Sciences, Verily is Alphabet’s life science research company. It was originally a division of Google X. At this point, the company doesn’t have any marketed products and it’s not completely clear on the company’s overall focus. It has numerous partnerships, such as one with Sanofi to develop products for managing diabetes, a disease-detecting nanoparticle platform called project Tricorder, and a partnership with Johnson & Johnson on surgical robotics. It also has partnerships with Alon, 3M, Allergan, Biogen, Dexcon, GlaxoSmithKline, Mayo Clinic, Brigham and Women’s Hospital and many others.

On December 23, 2019, Verily partnered with Emory Healthcare to “deploy new solutions to help improve cost-effectiveness, operational efficiency and quality.” This deal with utilize Emory’s academic medical center and partner with Verily’s expertise in data science, analytics, user experience and product development. The initial focus is a deep analysis of existing drugs and lab-ordering patterns at Emory.

Illumina. Illumina develops, manufactures, and markets laboratory devices, with particular emphasis on DNA sequencing, genotyping, gene expression and proteomics. On January 4, 2020, Illumina announced a 15-year, non-exclusive deal with Roche. Not only will that increase the availability of next-generation sequencing-based in vitro diagnostic (IVD) tests on Illumina’s systems, but the two companies will collaborate to complement Illumina’s pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims.

That deal came only a short time after Illumina canceled a $1.2 billion merger with another next-generation sequencing company, Pacific Biosciences (PacBio). Illumina decided the deal was not likely to be approved by antitrust regulators in the U.S. and UK. Illumina holds about 80% of the global DNA sequencing market.

bluebird bio. Bluebird bio focuses on the nascent field of gene therapy. Currently its sole approved product is Zynteglo. It was approved by the European Commission (EC) on June 14, 2019 for patients 12 years or older with transfusion-dependent beta-thalassemia who did not have a β⁰/β⁰ genotype and for patients where hematopoietic stem cell (HSC) transplantation wasn’t appropriate, but a human leukocyte antigen (HLA-matched related HSC donor isn’t available. It’s a little difficult to mention bluebird without mentioning the price of Zynteglo, which is $1.8 million in Europe. In addition to its scientific innovation, bluebird bio is innovative in terms of pricing structure. Zynteglo’s price is spread out over five years, with an initial upfront price of 315,000 euros with the four additional yearly payments due only if the treatment continues to work.

The product launched in Germany on Jan. 13, 2020. Bluebird initiated the rolling Biologics Licensing Application for Zynteglo in the U.S. and is currently in discussions with the U.S. Food and Drug Administration (FDA) on the timing and various components of the submission. They hope to complete the BLA submission in the first half of this year.

Biogen. Biogen specializes in therapies for central nervous system disorders. Some of its most well-known products are Alprolix for hemophilia B, Avonex, Fampyra, Tecfidera and Tysabri for multiple sclerosis, and Spinraza for spinal muscular atrophy (SMA). However, most recently, the company has been in the headlines for its aducanumab for Alzheimer’s disease. The drug was declared a failure in March 2019, but was resurrected this year after some of the later trial data showed effectiveness at the highest dose. Still, it’s not a slam dunk to be approved by the FDA and there are plenty of skeptics.

Analysts expect Biogen to submit aducanumab to the FDA in a matter of weeks, although the company is being tight-lipped about the timetable.

Bayer. Based in Germany, Bayer is one of the largest pharma companies in the world. In 2018, Bayer acquired U.S.-based Monsanto, which no longer exists under the Monsanto name. The company’s business units include Bayer Crop Science, Consumer Health, Pharmaceuticals, Animal Health and Business Services.

On Jan. 16, 2020, Bayer sold one of its last Germany-based manufacturing facilities to Shanghai, China-based WuXi Biologics. The plant will be run by WuXi Biologics and act as a backup site for the manufacture of Bayer’s Kovaltry (antihemophilic factor). The primary site for Kovaltry product is Bayer’s facility in Berkeley, California.

Novartis. Based in Switzerland, Novartis has a well-known portfolio of drugs, including Clozaril, Voltaren, Tegretol, Diovan, Gleevec, and Ritalin. Its Sandoz Division is a global leader in generic drugs and biosimilars.

Last year, the FDA approved Zolgensma, a gene therapy for SMA, which was developed by its subsidiary, AveXis. Although there was some controversy over data manipulation in preclinical studies, it was determined not to affect the safety or efficacy of the therapy.

In late November 2019, Novartis acquired The Medicines Company for $9.7 billion, only a week after The Medicines Company announced positive data from its ORION-10 Phase III trial for inclisiran for lowering cholesterol.

GlaxoSmithKline. Headquartered in London, GSK markets drugs for numerous major diseases, such as asthma, cancer, infections, diabetes and mental health. Its best-known drugs include Advair, Augmentin, Flovent, Lamictal and others.

At the recent JP Morgan Healthcare Conference, Emma Walmsley, GSK’s chief executive officer,predicted it will have six regulatory approvals in the U.S. this year.

“I am pleased with the progress and the momentum that we’ve been able to make over the past couple years,” she told CNBC’s Jim Cramer.

Walmsley noted positive data for a number of programs, including ones gained from its $5.1 billion acquisition of Tesaro Oncology in 2018. She also noted a two-drug regimen for HIV that the company’s subsidiary ViiV Healthcare has been developing.

Genentech. Generally viewed as the first modern biotechnology company, Genentech is a subsidiary of Swiss-based Roche, although Genentech is based in South San Francisco. It has a laundry list of successful drugs, often in the oncology market, such as Avastin, Tarceva, Zelboraf, Kadcyla, Alecansa, Venclexta and Tecentriq. It also has antivirals, such as Xofluza, Hemlibra for hemophilia A, and Esbriet for idiopathic pulmonary fibrosis.

On Dec. 12, 2019, Genentech announced that its Phase III IMspire150 trial in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, hit its primary endpoint of progression-free survival (PFS). It showed adding Tecentriq to Cotellic and Zeleboraf decreased the risk of the disease getting worse or death, compared to placebo plus Cotellic and Zelboraf.

Amgen. Based in Thousand Oaks, California, Amgen’s best-selling products are Neulasta, an immunostimulatory for patients undergoing chemotherapy, and Enbrel, used to treat rheumatoid arthritis and other autoimmune diseases. Other products include Epogen, Aranesp, Prolia and XGeva.

On Nov. 1, 2019, the company expanded its presence in China by taking a 20.5% stake in China-based BeiGene Co. Amgen paid $2.7 billion in cash for the stake. As a result of the deal, BeiGene will commercialize Xgeva, Kyprolis and Blincyto in China.

On Jan. 13, 2020, the company inked strategic collaborations with Guardant Health and QIAGEN to develop blood- and tissue-based companion diagnostics for investigational cancer treatment AMG 510. AMG 510 is the first KRAS^G12C inhibitor to advance to the clinic for multiple cancer types.

Mainz, Germany-based BioNTech announced it was acquiring Cambridge, Massachusetts-based Neon Therapeutics in an all-stock deal valued at about $67 million.

Neon’s focus is on neoantigen therapies that have the potential to be both vaccines and T-cell therapeutics. Neoantigens are immune targets generated by mutations inherent in tumors. Its most advanced program is NEO-PTC-01, a personalized neoantigen-targeted T-cell therapy. It is derived of multiple T-cell populations that target the most relevant neoantigens from each patient’s cancer. The company is also working on a precision T-cell therapy program that targets shared neoantigens in specific, genetically defined patient populations. The lead program from that endeavor is NEO-STC-01, which targets shared RAS neoantigens.

Neon Therapeutics was founded in 2015 by Third Rock Ventures. The company was one of BioSpace’s NextGen Class of 2017 biotech startups to watch.

“This acquisition fits with our strategy to expand our capabilities and build our presence in the U.S. and further strengthens our immunotherapy pipeline,” said Ugur Sahin, co-founder and chief executive officer of BioNTech. “I am particularly excited about the adoptive T-cell and neoantigen TCR therapies being developed by Neon, which are complementary to our pipeline and our focus on solid tumors.”

Under the terms of the deal, after the acquisition Neon will merge with Endor Lights, a wholly-owned subsidiary of BioNTech incorporated in Delaware. It will then become a wholly-owned subsidiary of BioNTech. At the close of the deal, BioNTech will issue 0.063 American Depositary Shares (ADS) to Neon shareholders in exchange for each of their Neon shares. This exchange ratio implies a deal value of $67 million, or $2.19 per Neon share, based on BioNTech’s ADS closing price of $34.55 on Wednesday, January 15, 2020.

The deal has been approved by both companies’ boards of directors. It is expected to close in the second quarter of 2020.

BioNTech was founded in 2008 and focuses on personalized cancer treatments. Earlier this month the company announced publication in the journal Science data from preclinical research on its first-in-kind CAR-T cell therapeutic approach to solid tumors. The therapeutic, BNT211, is an autologous CAR-T cell therapy that targets the oncofetal antigen Claudin 6 (CLDN6). It is suggested that the company’s CARVac is a broadly applicable RNA vaccine.

CAR-T has been shown to be effective in blood cancers, but much more limited in solid tumors. BioNTech is focused on developing CAR-T therapies in multiple solid tumors in combination with an RNA vaccine.

In the published data, the therapy was studied in mice with human ovarian cancer transplants. In the research, CLDN6-CAR-T showed complete tumor regression of transplanted large human tumors within two weeks after treatment initiation. The combination with CARVac improved engraftment, proliferation and CAR-T cell expansion, all of which is promising for human studies, which the company plans to launch this year, with ovarian, testicular, uterine and lung cancer.

Of the merger with BioNTech, Hugh O’Dowd, chief executive officer of Neon, said, “We are very proud of all we have accomplished since we founded Neon and look forward to joining forces with BioNTech to continue to build a business that provides life-changing immunotherapy products to patients battling a variety of cancers.”

Eli Lilly’s senior vice president and chief financial officer Josh Smiley announced plans for the Indianapolis-based pharmaceutical company to spend from $1 billion to $5 billion each quarter this year as it plans to bolster its pipeline.

They’ve already gotten off to a good start. Last Friday the company announced that it was buying California-based Dermira for $1.1 billion in cash. The deal expands Lilly’s immunology pipeline with a late-stage compound for atopic dermatitis. In particular, Lilly picked up two assets with the company, lebrikizumab, a monoclonal antibody that binds to IL-13, a driver of atopic dermatitis. It is currently in two Phase III trials. It also gained Qbrexza (glycopyrronium) cloth, a medicated cloth the FDA approved for topical treatment of primary axillary hyperhidrosis, which is to say, uncontrolled excessive underarm sweating.

At the time, Patrik Jonsson, president of Lilly Bio-Medicines, noted, “This acquisition provides an opportunity to add a promising Phase III immunology compound for atopic dermatitis, while also adding an approved dermatology treatment for primary axillary hyperhidrosis. We look forward to completing the acquisition and continuing Dermira’s excellent work.”

Over the last two years, Lilly has made several oncology acquisitions, including its $8 billion takeover of Loxo Oncology. In 2018, the U.S. Food and Drug Administration approved Vitrakvi, Loxo’s first commercial drug for a broad range of solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, or metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed after treatment.

In a presentation at this week’s JP Morgan Healthcare Conference in San Francisco, Lilly’s chief executive officer David Ricks indicated that most of the deals will be in oncology, but the company is interested in other areas as well.

Smiley said they were looking for late-stage assets, but that most opportunities for shareholders were for drugs in earlier stages of development. They’re also open to various approaches, such as licensing deals or outright acquisitions.

“We are looking at Dermira-like opportunities targeting assets in the $1 billion to $5 billion range,” Smiley said. “We’d like to do something in the range of one per quarter or so.”

The company projected higher-than-expected profits for 2020, noting high demand for its newer drugs like Trulicity for diabetes and Taltz for psoriasis and other autoimmune diseases. However, the diabetes market is notoriously facing pricing pressures in the U.S. as well as high rebates and discounts paid to pharmacy benefit managers.

Earlier this week, Lilly announced lower-priced versions of Humalog Mix75/25 KwikPen (insulin lispro protamine and insulin lispro injectable suspension 100 units/mL) and Humalog Junior KwikPen (insulin lispro injection 100 units/mL). They will both be marked down 50% compared to the branded versions and will be made available by mid-April. These insulin products are identical to the branded versions and may be substituted at the pharmacy. This move came as U.S. politicians continue to criticize the industry over the rising costs of insulin and prescription drug prices. Insulin for diabetic patients has become something of a flashpoint for the drug-pricing debate related to reports of patients rationing their insulin because of the increased costs.

This was Lilly’s second attempt at introducing lower-cost insulins. In May 2019, two months after regulatory approval, the company’s authorized generic formulation of Humalog went on sale at a 50% lower price than its branded form of insulin. However, an August analysis indicated patients weren’t getting the cheaper version, partly because of lack of awareness of the product.

Novo Nordisk’s Ozempic (semaglutide) won approval from the U.S. Food and Drug Administration (FDA) to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.

The company announced the approval of the new indication late Thursday. For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease (CVD) and type 2 diabetes. It is estimated that adults with type 2 diabetes are two to four times more likely to develop CVD than adults without diabetes. Additionally, CVD is the main cause of death and disability among people with type 2 diabetes.

The FDA based its decision on results from the SUSTAIN 6 cardiovascular outcomes trial (CVOT) which examined the cardiovascular safety of adding Ozempic to the standard of care in adults with type 2 diabetes. In the two-year study, Ozempic was shown to significantly reduce the risk of the occurrence of a three-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke compared to placebo and standard-of-care treatment. Novo Nordisk said the estimated relative risk reduction of MACE was 26% vs placebo. Ozempic, a glucagon-like peptide-1 (GLP-1) receptor agonist, was first approved in December 2017 and was launched for commercialization in the U.S. in early 2018.

Todd Hobbs, Novo Nordisk’s chief medical officer for its U.S. business, said cardiovascular diseases is one of the biggest concerns for type 2 diabetes patients – even when patients reach and maintain their blood sugar targets.

“Today’s milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease,” Hobbs said following the FDA approval.

Type 2 diabetes impacts more than 28 million people in the U.S. alone. Despite the available treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications.

In addition to the approval of a new indication for Ozempic, the FDA also added new details to prescribing information for Rybelsus, an oral-semaglutide approved for type2 diabetes. The updates prescribing indication includes an analysis from the primary endpoint of the PIONEER 6 CVOT showing the hazard ratio for time to first three-component MACE

Rybelsus was approved by the FDA in September as the first oral semaglutide for type 2 diabetes. Most GLP-1 drugs, like Ozempic, are injectable. Having an oral option is a game-changer for many diabetes patients. During 10 different Phase III clinical trials, Rybelsus was shown to reduce A1C and also help patients reduce their body weight.

Earlier this month, Novo Nordisk won approval for Fiasp, a mealtime insulin option for pediatric patients with diabetes. Fiasp won approval based on data from the onset 7 clinical trial, which confirmed the safety and efficacy of the medication in children. Fiasp is administered at the beginning of a meal or within 20 minutes after starting a meal.

VANCOUVER, British Columbia, Jan. 17, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”), a clinical stage pharmaceutical development company, is pleased to announce that it has appointed Novotech as the contract research organization (“CRO”) for the Company’s upcoming Phase 2 idiopathic pulmonary fibrosis and chronic cough study for the drug candidate NP-120 (Ifenprodil). The study is expected to start in Q2 of 2020. Novotech is an internationally recognized full service CRO with experience across Asia Pacific.

The Company is also pleased to announce that Novotech has signed a letter of intent (“LOI”) to make an equity investment in the Company. The Company anticipates issuing to Novotech, on a private placement basis, approximately CDN$220,000 of units of the Company (the “Units”) at the price of CDN$0.085 per Unit. Each Unit is comprised of one common share and one common share purchase warrant (a “Warrant”). Each Warrant is exercisable for one common share in the capital of the Company (each, a “Warrant Share”) at the price of CDN$0.12 per Warrant Share for a period of 30 months after the date of issue (the “Expiry Date”), subject to acceleration of the Expiry Date as described below.

If, at any time prior to the Expiry Date, the volume weighted average trading price of the common shares of the Company (the “Common Shares”) on the Canadian Securities Exchange, or other principal exchange on which the Common Shares are listed, is greater than $0.35 for 20 consecutive trading days, the Company may, within 15 days of the occurrence of such event, deliver a notice to Novotech accelerating the Expiry Date to the date that is 30 days following the date of such notice.

All securities issued pursuant to the private placement will be subject to a four month hold period under applicable securities laws in Canada. Closing of the Novotech private placement is expected to occur by January 31, 2020.

Novotech CEO Dr. John Moller said “We are delighted to be working with Algernon on their upcoming Phase 2 study and to have signed an LOI to participate in an equity funding round of Algernon. This is a unique model to support clinical trials in our region and we look forward to a close working relationship with the Algernon team”.

About Algernon Pharmaceuticals Inc.

Algernon Pharmaceuticals is a clinical stage pharmaceutical development company focused on advancing its lead compounds for non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD), inflammatory bowel disease (IBD), idiopathic pulmonary fibrosis (IPF) and chronic cough.

About Novotech

Novotech, awarded the Frost & Sullivan Asia-Pacific Biotech CRO of the year for the past 5 years, is internationally recognized as the leading Asia-Pacific full-service CRO. Established more than 20 years ago Novotech now has 13 offices across 11 countries in the Asia Pacific and 3 client-facing offices in North America.

Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the region.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, safety services, central lab services, report write-up to ICH requirements, project and vendor management.

Dive Brief:

• Medtronic announced late Wednesday it acquired Stimgenics, a Bloomington, Illinois-based startup that’s developed a novel spinal cord stimulation waveform Medtronic plans to deliver via its Intellis implantable neurostimulator to treat chronic pain. Medtronic expects the deal to be neutral to fiscal 2020 earnings and did not disclose other financial terms.
• The Stimgenics mechanism modulates both neurons and glial cells, the latter of which Medtronic says play a greater role in chronic pain than previously understood. In a randomized controlled trial with 250 participants, researchers are comparing Intellis recipients whose devices have standard programming versus Stimgenics programming. Medtronic plans to present three-month outcomes from the study at the North American Neuromodulation Society (NANS) meeting in late January, where it also said it will unveil the latest version of its spinal cord stimulator.
• Medtronic’s addition to the unit comes amid broad deceleration in growth of the SCS market, where it competes with the likes of Abbott and Boston Scientific.

Dive Insight:

Spinal cord stimulation is a treatment that thwarts pain signals before they reach the brain by using an implanted device to send electrical pulses to the spinal cord area. Medtronic received FDA approval for its Intellis stimulator in 2017. The addition of Stimgenics’ technology, which it calls differential target multiplexed (DTM) spinal cord stimulation, introduces a new mechanism of action for the device.

Specifically, Medtronic said the DTM waveform may modulate both neurons and glial cells. Medtronic said in its announcement that scientists now have a better understanding of glial cells’ role in the nervous system and believe they may contribute more to neural processing and chronic pain than previously thought.

“Stimgenics’ research is deeply rooted in clinical science that began with animal work more than a decade ago. Our preclinical data demonstrated that the modulation of both neurons and glial cells may return glial cells to their normal state and modify how they interact with neurons, which could normalize biological processes and break the pain cascade,” Stimgenics founder and lead investigator Ricardo Vallejo said in Medtronic’s announcement.

The study of the technology will continue through 12 months follow-up, Medtronic said.

In Medtronic’s most recently reported quarter, revenue in the pain therapies business grew slightly to $315 million. But Medtronic noted the gains were mostly thanks to balloon kyphoplasty and radiofrequency ablation products, offset by declines in pain stimulation “reflecting the slowdown of the spinal cord stimulation market.”

Incoming CEO Geoff Martha told investors in November that in pain stimulation, Medtronic anticipated a mostly flat market for the next couple quarters.

“I do think there’s things that can be done to better position SCS space with payers, but in the short-term it is an innovation-driven segment,” Martha said. “We do see it trending in the right way, but I don’t see it getting back to the high single-digits here for a bit.”

Reasons for slowdown in the spinal cord stimulation market likely include a lack of new product launches, price discounting, turnover among sales representatives and use of alternative pain treatments, according to analysis in 2019 by UBS’ healthcare research team.

On Boston Scientific’s most recent earnings call, CEO Mike Mahoney notedthat while its SCS results had improved, they were “clearly not to the market levels that we enjoyed in the past” but believe it “will be a mid to high single-digit growth market based on historical trends.”

Similarly, Abbott’s neuromodulation unit was down 3.7% as reported in its most recent quarter, which CEO Miles White attributed in part to sale force issues.

Elsewhere in Medtronic’s Restorative Therapies Group, the company said Thursday it received a CE mark for its Percept PC neurostimulator, a device meant to treat symptoms associated with Parkinson’s disease, epilepsy, obsessive-compulsive disorder, essential tremor and primary dystonia. Medtronic said the device is currently under FDA review.

Medtronic plans to present at the J.P. Morgan Healthcare Conference on Jan. 13.

Dive Brief:

• FDA has granted breakthrough device designation to a transcatheter aortic valve replacement system in development at JenaValve Technology, the company said Thursday.
• JenaValve is working to fill an unoccupied niche in the fast-growing TAVR market by winning approval for its system in patients with severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease at high risk for surgery.
• The news was part of a flurry of breakthrough device notices this week, when 3Derm Systems, KDx Diagnostics and Reflow Medical also revealed they have received the FDA designation.

Dive Insight:

TAVR has emerged as one of the hottest subsections of the medical device industry in recent years, with Edwards Lifesciences, Medtronic and Boston Scientific competing to change the treatment paradigm for heart valve disease. Edwards and Medtronic have devices approved by FDA for use in patients with severe aortic stenosis at low risk for major complications with open heart surgery. Boston Scientific, newer to the U.S. market, so far is only approved in patients with severe aortic stenosis who are at high risk with open heart surgery.

Conversely, JenaValve is looking to address the population with severe AR and AR-dominant mixed aortic valve disease who are at high risk for surgery. Last year, JenaValve presented 30-day data from a feasibility study of its TAVR system. All 12 patients survived and paravalvular leakage was minimal. Most patients improved on a heart failure scale.

JenaValve is using the data as a springboard for its long-running attempt to bring a TAVR device to the U.S. market. Work on JenaValve began in the 1990s and an earlier version of the device secured a CE mark. JenaValve has since redesigned the device, switching from transapical to transfemoral delivery.

Buoyed by the data to date, JenaValve plans to seek U.S. humanitarian device exemption in the second half of the year. In parallel, JenaValve will continue to enroll patients in a clinical trial designed to generate the data needed to win premarket approval. The breakthrough designation may aid these efforts by positioning JenaValve to receive extra input from FDA and an expedited review. 

JenaValve raised almost $14.5 million last year to fund the work. The financing added to the more than $100 million raised by JenaValve to date, most notably through a $72.5 million Series C financing round that attracted support of investors including Edmond de Rothschild Investment Partners and Atlas Venture Fund.

The news was sandwiched between a clutch of other breakthrough device notifications. On Tuesday, 3Derm said FDA had granted the designation to an algorithm designed to detect melanoma, squamous cell carcinoma and basal cell carcinoma in skin images. The next day, KDx said its urine-based bladder cancer test had received FDA breakthrough designation.

Reflow released the last in the recent series of statements about breakthrough designations. The cardiovascular disease specialist picked upbreakthrough status for a retrievable stent designed for use in below-the-knee peripheral artery disease.

After reporting a fourth-quarter revenue shortfall due to a slowdown in its cardiac rhythm management division, Boston Scientific on Tuesday said it aims to deliver revenue growth above its medtech peer group over the next three years by reshaping its portfolio in fast growing markets like structural heart, oncology, neuromodulation, endoscopy and prostate health.

The company is targeting a compound annual growth rate for organic revenue of 6% to 9% from 2020 to 2022, along with double-digit adjusted earnings per share growth, CEO Mike Mahoney said in a presentation at the J.P. Morgan Healthcare Conference in San Francisco. 

Among Boston Scientific’s immediate goals: turn its structural heart unit into a billion-dollar business in 2020. Product milestones anticipated for the second half of the year include FDA approval and U.S. launch of the next version of the Watchman FLX device. Mahoney said left atrial appendage closure could be a $1 billion business on its own by 2023. Further, the company expects to launch its latest Acurate Neo 2 transcatheter aortic valve replacement device in Europe in the latter half of 2020, with FDA approval estimated by end of 2021.

Boston Scientific is also betting on $175 million in cost savings over the next three years from its $4.2 billion acquisition of U.K.-based BTG, completed in August. Mahoney said the company projects a CAGR of 8% over that period for the line of venous disease and interventional oncology devices.

Another important catalyst could be the potential $2 billion-plus market opportunity in single-use endoscopes, designed to reduce infection. Boston Scientific’s Exalt Model D duodenoscope, an FDA-designated breakthrough device, gained U.S. marketing clearance in December. Mahoney said a limited first quarter launch is planned, with a scaled ramp-up each quarter throughout the year.

According to preliminary 2019 results, sales rose 9.3% to $10.74 billion, or up 7.3% on an organic basis. All of the company’s business segments except electrophysiology grew at a rate equal to or faster than the market in 2019, Mahoney said.

In the fourth quarter, revenue came in $30 million below the midpoint of the company’s guidance range of 8% to 9% organic growth for the period. Mahoney attributed the underperformance primarily to deceleration in the U.S. defibrillator business in December. “We don’t like to miss guidance, so we’re not pleased with that,” he said, adding that the company is still sorting out the reason for the softness.

In recent memory, Boston Scientific missed its revenue goal in the first quarter of 2019 after a disruption to product sterilization processes, an FDA warning about paclitaxel-coated devices, and removal of certain pelvic mesh devices from the U.S. market.

Needham analyst Mike Matson, in a research note, said it remains to be seen if Boston Scientific lost share or the overall market slowed in fourth quarter. “While BSX faces tougher comps starting in 2H20, we believe a strong product portfolio (particularly BSX’s structural heart products) should enable BSX to sustain high single-digit organic revenue growth and double-digit EPS growth in 2020,” Matson said, reiterating a buy rating on the stock.

Focusing on the bigger picture, Mahoney emphasized the company’s improvement from a 6% organic CAGR between 2014 and 2016 to 7% between 2017 and 2019, and said Boston Scientific aims to deliver faster organic growth over the next three years. With tuck-in acquisitions, operational growth would exceed organic growth, the CEO said.

Dive Brief:

• Abbott announced Monday FDA approved a clinical trial the company hopes will lead to an expansion of MitraClip’s indication to include patients with moderate surgical risk. The transcatheter mitral valve repair device, used to treat primary mitral regurgitation (MR), is currently only indicated for patients at a prohibitive risk for surgery. 
• The prospective, randomized clinical trial aims to enroll 500 patients at 60 locations in the United States, Canada and Europe. It seeks to evaluate if MitraClip is effective for moderate-risk patients who would otherwise receive open heart surgery.  
• Abbott’s product, which primarily competes with Edward Lifesciences’ Pascal system, has been commercially available in the U.S. since 2013 and in Europe since 2008. 
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Dive Insight:

Abbott said the clinical investment is an effort to see if a minimally invasive procedure is as effective as open heart surgery and poses an opportunity to expand treatment to a new patient population. Mitral regurgitation, a common life-threatening heart valve disease, occurs when an individual’s mitral valve does not close properly, allowing blood to flow backward into the atrium.

“This is an important question since approximately 70% of people diagnosed with primary mitral regurgitation aren’t treated with open-heart mitral valve surgery today yet are in need of treatment and symptom relief,” said co-principal investigator of the REPAIR MR trial Patrick McCarthy, chief of cardiac surgery at Northwestern Medicine, in a statement.

MitraClip sales increased by more than 30% during Abbott’s 2019 third quarter to $176 million, with U.S. growth of 45.7%, compared to the previous year. The company announced in July 2019 FDA approved the MitraClip G4, which added additional device clip sizes and other features.

The product, which CEO Miles White called a key growth driver for Abbott, could benefit from a National Coverage Determination update by CMS. A proposed decision memo is expected by Feb. 14, 2020, with the national coverage analysis completion date expected by May 14, 2020.

“Reimbursement is going to be important, there will be definitely be an inflection point when we get it,” Abbott COO Robert Ford said on the earnings call. 

Barbara Calvert, Abbott director of medical product reimbursement, wrote to CMS urging the payer to expand reimbursement for MitraClip in comments on the proposal.

“Given the life-saving benefit of the MitraClip therapy, as demonstrated in COAPT, we urge CMS to move as quickly as possible,” Calvert wrote.

Cowen analysts predict MitraClip growth will continue when Abbott announces its 2019 fourth quarter results, noting it is set up to benefit from favorable tailwinds. 

“MitraClip growth continues to be fueled by the U.S. utilization ramp in the functional MR indication. Highly favorable COAPT results continue to resonate with clinicians in the form of improving procedure volumes even in front of CMS’ NCD update for FMR (likely by May 2020),” the analysts wrote in an equity research note.