Friday, September 21, 2018
Medtronic acquisition of Mazor not a surprise, says Piper Jaffray
Piper Jaffray analyst Matt O’Brien believes Medtronic’s (MDT) $1.64B acquisition of Mazor Robotics (MZOR) is not much of a surprise given the companies’ exclusive distribution arrangement and Medtronic’s existing minority stake. The deal will help Medtronic’s spine franchise business stay on the road to recovery, O’Brien tells investors in a research note. He keeps an Overweight rating on the shares with a $105 price target. Further, the analyst believes robot placements are “still in the early days” and that the acquisition will not “overly hurt” Globus Medical’s (GMED) ability to sell systems in coming quarters. As such, O’Brien thinks the Mazor Robotics takeover will unlikely have an impact on Globus’s Excelsius robot.
https://thefly.com/landingPageNews.php?id=2793565
BeiGene presents results on anti-PD-1 antibody tislelizumab at CSCO
BeiGene presented clinical data on tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with lung cancers, in two oral presentations at the 21st Annual Meeting of the Chinese Society of Clinical Oncology, or CSCO, in Xiamen, China. “Advanced lung cancer is one of our focus areas for development of tislelizumab, where we hope to have an impact on the way patients are treated both in China and worldwide. This complex and difficult-to-treat disease has proven to be susceptible to treatment with immunotherapies,” commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. “The preliminary data presented today demonstrate that tislelizumab is generally well tolerated and has antitumor activity both as monotherapy and in combination with several chemotherapy regimens used in small cell and non-small cell lung cancer patients. We are hopeful that further study of tislelizumab may lead to a new treatment option for a broad array of patients with lung cancers.” The multi-center, open-label Phase 2 trial in China of tislelizumab in combination with chemotherapy enrolled 54 patients with previously untreated locally advanced or metastatic lung cancer. All patients received tislelizumab at 200 mg every three weeks, plus platinum doublet until disease progression. Patients with non-squamous non-small cell lung cancer, or NSCLC, received pemetrexed plus platinum; patients with squamous NSCLC received either paclitaxel plus platinum or gemcitabine plus platinum; and patients with small cell lung cancer, or SCLC, received etoposide plus platinum. As of the June 5, 2018 data cutoff, 35 patients remain on treatment. Treatment discontinuation due to adverse events, or AEs, occurred in three patients. Fifty-one patients had at least one post-baseline tumor assessment and were evaluable for efficacy. Objective responses were observed in 56 percent of 16 evaluable patients with non-squamous NSCLC; 80 percent in 15 evaluable patients with squamous NSCLC, cohort A; 67 percent in six patients with squamous NSCLC, cohort B; and 82 percent in 17 evaluable patients with SCLC. Data continue to mature with follow-up. AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis. Five patients experienced at least one grade greater than or equal to3 AE that were considered to be possibly related to tislelizumab. Immune-related AEs occurred in 13 patients and included hypothyroidism, decreased tri-iodothyronine, hyperthyroidism, pneumonitis, pyrexia, and rash.
https://thefly.com/landingPageNews.php?id=2793569
Cara Therapeutics initiated at Cantor Fitzgerald
Cara Therapeutics initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald started Cara Therapeutics with an Overweight rating and $27 price target.
https://thefly.com/landingPageNews.php?id=2793573
Thursday, September 20, 2018
Avita Medical announces FDA approval of RECELL in burn treatment
AVITA Medica announced that the U.S. Food and Drug Administration approved the Company’s Premarket Approval application to market the RECELL Autologous Cell Harvesting Device to treat severe thermal burns in patients 18 years and older. The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin(TM) Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
https://thefly.com/landingPageNews.php?id=2793547
Medtronic to Acquire Mazor Robotics
Acquisition to Accelerate Medtronic’s Strategy to Transform Spinal Procedures
and Improve Outcomes Through Fully-Integrated Surgical Solutions
and Improve Outcomes Through Fully-Integrated Surgical Solutions
Medtronic plc (NYSE:MDT), a
global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR,
TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today
announced the companies have entered into a definitive merger agreement under
which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50
per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in
cash, for a total of approximately $1.64 billion, or $1.34 billion net of
Medtronic’s existing stake in Mazor and cash acquired. The boards of directors
of both companies have unanimously approved the transaction.
global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR,
TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today
announced the companies have entered into a definitive merger agreement under
which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50
per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in
cash, for a total of approximately $1.64 billion, or $1.34 billion net of
Medtronic’s existing stake in Mazor and cash acquired. The boards of directors
of both companies have unanimously approved the transaction.
Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global
leader in enabling technologies for spine surgery, and drives Mazor Robotics’
vision to bring its core technology to the forefront of the global market.
Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic
Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System
(Renaissance), are transforming spinal surgery from freehand procedures to
accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-
leading spine implants, navigation, and intra-operative imaging technology with
Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a
fully-integrated procedural solution for surgical planning, execution and
confirmation. The companies plan to showcase this technology integration at the
upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.
leader in enabling technologies for spine surgery, and drives Mazor Robotics’
vision to bring its core technology to the forefront of the global market.
Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic
Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System
(Renaissance), are transforming spinal surgery from freehand procedures to
accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-
leading spine implants, navigation, and intra-operative imaging technology with
Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a
fully-integrated procedural solution for surgical planning, execution and
confirmation. The companies plan to showcase this technology integration at the
upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.
“We believe robotic-assisted procedures are the future of spine surgery,
enhancing surgeons’ abilities to perform complex procedures with greater
precision, consistency and control. Medtronic is committed to accelerating the
adoption of robotic-assisted surgery and transforming spine care through
procedural solutions that integrate implants, biologics and enabling
technologies,” said Geoff Martha, executive vice president and president of the
Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds
robotic-assisted guidance systems to our expanding portfolio of enabling
technologies, and we intend to further cultivate Mazor’s legacy of innovation in
surgical robotics with the site and team in Israel as a base for future growth.”
enhancing surgeons’ abilities to perform complex procedures with greater
precision, consistency and control. Medtronic is committed to accelerating the
adoption of robotic-assisted surgery and transforming spine care through
procedural solutions that integrate implants, biologics and enabling
technologies,” said Geoff Martha, executive vice president and president of the
Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds
robotic-assisted guidance systems to our expanding portfolio of enabling
technologies, and we intend to further cultivate Mazor’s legacy of innovation in
surgical robotics with the site and team in Israel as a base for future growth.”
This transaction builds on a relationship originated in May 2016 under a multi-
phased strategic and equity investment agreement between Medtronic and Mazor. In
August 2017, Medtronic expanded the partnership to become the exclusive
worldwide distributor of the Mazor X system, leading to the successful
installation of more than 80 Mazor X systems since launch. With today’s
announcement bringing the two companies together, Medtronic aims to accelerate
the advancement and adoption of RAS in spine to the benefit of patients,
providers, and the healthcare system more broadly.
phased strategic and equity investment agreement between Medtronic and Mazor. In
August 2017, Medtronic expanded the partnership to become the exclusive
worldwide distributor of the Mazor X system, leading to the successful
installation of more than 80 Mazor X systems since launch. With today’s
announcement bringing the two companies together, Medtronic aims to accelerate
the advancement and adoption of RAS in spine to the benefit of patients,
providers, and the healthcare system more broadly.
“Today is a historic day for spine surgery and a defining event in the market’s
evolution, and I want to acknowledge and thank all of those whose contribution
and faith have been so critical and impactful to our success,” said Ori Hadomi,
CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration
into Medtronic will maximize our impact globally through Medtronic’s channels,
advance our systems’ leadership position in the marketplace, and drive the
realization of our vision to heal through innovation.”
evolution, and I want to acknowledge and thank all of those whose contribution
and faith have been so critical and impactful to our success,” said Ori Hadomi,
CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration
into Medtronic will maximize our impact globally through Medtronic’s channels,
advance our systems’ leadership position in the marketplace, and drive the
realization of our vision to heal through innovation.”
Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter
ending January 25, 2019, subject to the satisfaction of customary closing
conditions including receipt of regulatory clearances and approval by Mazor’s
shareholders. The transaction is expected to be modestly dilutive to Medtronic’s
fiscal 2019 adjusted earnings per share, but given the current strength of
Medtronic’s business, the company expects to absorb the dilution.
The acquisition is expected to close during Medtronic’s third fiscal quarter
ending January 25, 2019, subject to the satisfaction of customary closing
conditions including receipt of regulatory clearances and approval by Mazor’s
shareholders. The transaction is expected to be modestly dilutive to Medtronic’s
fiscal 2019 adjusted earnings per share, but given the current strength of
Medtronic’s business, the company expects to absorb the dilution.
Consistent with its long-term financial objectives, Medtronic projects the
acquisition to generate a double-digit return on invested capital (ROIC) by year
four, with an increasing contribution thereafter.
acquisition to generate a double-digit return on invested capital (ROIC) by year
four, with an increasing contribution thereafter.
Merck Gets Euro Panel Nod for Treatment of HIV-1 Infection
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. DELSTRIGO and PIFELTRO are currently under EMA review for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir. These two recommendations will now be reviewed by the European Commission for marketing authorization in the European Union. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Canada, Australia, and Switzerland.
“We are pleased with the CHMP’s positive opinion recommending approval of DELSTRIGO and PIFELTRO, which marks an important step forward in advancing new treatments for people living with HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories. “This represents another milestone in Merck’s more than 30-year commitment to HIV research and treatment, and advances our efforts to address the unmet needs of the HIV community worldwide.”
The CHMP positive opinion was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, evaluating the efficacy and safety of DELSTRIGO and PIFELTRO, respectively, in participants infected with HIV-1 with no prior antiretroviral treatment history. In DRIVE-AHEAD, DELSTRIGO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to efavirenz (EFV)/emtricitabine (FTC)/TDF. In DRIVE-FORWARD, PIFELTRO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to darunavir + ritonavir, each in combination with FTC/TDF or abacavir (ABC)/3TC.
The U.S. Food and Drug Administration approved DELSTRIGO and PIFELTRO on August 30, 2018. In the United States, both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B (HBV) infection. DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS.
Canada’s Canopy Rivers secures C$1.6 billion valuation in trading debut
Cannabis investor Canopy Rivers Inc, the venture arm of industry giant Canopy Growth Corp went public on Thursday in a debut that gave it a market capitalization of about C$1.6 billion ($1.24 billion), more than double its valuation prior to the listing.
Canopy Rivers listed on the Canada’s junior stock exchange through a reverse takeover of a shell company, a route preferred by the cannabis industry to tap the capital markets.
It is the latest in a string of public offerings of mostly Canadian cannabis companies seeking to profit from the imminent legalization of recreational weed in October and a raft of medical marijuana approvals around the globe.
The stock ended the day at C$8.75 on the TSX Venture exchange. The public offering was oversubscribed by more than three times, a source familiar with the situation said, declining to be identified as the information is not public.
The cannabis sector has witnessed frenzied activity that has sent valuations of the fledgling industry soaring.
Canopy Rivers has made about a dozen Canadian and international investments, which include licensed producers, pharmaceutical formulators and retail networks, according to its website.
The company allows investors to target a diversified basket of cannabis companies across a range of geographies.
The transaction was led by Canadian Imperial Bank of Commerce and GMP Securities L.P.. CIBC’s involvement marks a rare instance of a Canadian chartered bank playing a lead role in taking a cannabis company public.
Canopy Growth, which has a market value of C$15.4 billion, owns about 25 percent of Canopy Rivers. Shares of Canopy Growth closed up 6.5 percent at C$67.57 on the Toronto Stock Exchange.
“It’s Canopy Growth’s proxy for Google Ventures,” Bruce Linton, chief executive of both the companies, said in an interview with Reuters earlier this month.
Canopy Rivers is currently looking at investments in Europe and South America, Linton added.
A $4 billion investment in Canopy Growth by brewer Constellation Brands revived share prices late in the summer after a decline earlier in the year.
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