Wednesday, May 1, 2019
Sandoz in commercialization pact on breast cancer biosimilar candidate
Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar.
This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast and specific gastric cancer tumors.
The agreement between Sandoz and EirGenix, Inc, a biotechnology manufacturing and development company that aspires to provide high-quality medicines for individuals and society, aims to bring to market a proposed biosimilar trastuzumab. EirGenix will maintain responsibility for development and manufacturing, and Sandoz has the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.
According to the terms of the agreement, EirGenix will receive an upfront payment on signing, milestone payments, and is entitled to receive profit share payments for sales in the territories. This structure allows Sandoz to keep in-house resources focused on bringing forward a robust internal pipeline. The collaboration further expands the existing Sandoz oncology portfolio of four oncology biosimilar medicines, while enabling the company to further develop its strong hospital presence. Other specific terms of the agreement are confidential.
‘Every year, approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer, which tends to spread more quickly than HER2-negative tumors, making swift treatment important. While targeted therapy is available, high out-of-pocket costs lead to limited treatment in the US and reimbursement issues have resulted in varying uptake in Europe’,[1],[2] said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. ‘Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration.’
Medtronic: FDA OKs 1st Quadripolar Active Fixation Left Heart Lead
Medtronic plc (NYSE:MDT) announced it has received U.S.
Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. The lead will be commercially available in the U.S. in summer 2019.
Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. The lead will be commercially available in the U.S. in summer 2019.
“Appropriate placement of left heart leads during implantation of CRT devices is critical to achieve the clinical benefits of this therapy. Unfortunately, with present passive-fixation leads, we are not always able to position the lead in an ideal location due to variations in a patient’s anatomy and size of the target vessel. We also continue to see lead dislodgements that require reprogramming or repeat surgery for lead repositioning. Having a new active fixation left heart lead allows us to target the ideal location in the patient’s vessel with the confidence that the lead will remain in place to allow for continued effective delivery of CRT,” said Steven Zweibel, M.D., F.A.C.C., F.H.R.S., C.C.D.S., director of Electrophysiology at the Hartford Healthcare Heart and Vascular Institute.
CRT is a treatment for heart failure in which an implantable device sends low levels of energy through thin wires, called leads, to stimulate the heart muscle and potentially improve the heart’s pumping efficiency. With the introduction of quadripolar leads (leads with four electrodes), physicians can pace from different locations in the heart, but are limited in where they can place the lead. The Attain Stability Quad lead integrates the benefits of a quadripolar lead with a side-helix that allows physicians to fixate the lead precisely in veins of various sizes, including ones not typically amenable to positioning a passive lead. Additionally, patients with this lead and MR-conditional CRT devices are eligible for either 3 Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans, if needed.
Medtronic U.S. Commercial Launch of Solitaire X Revascularization Device
Medtronic plc (NYSE:MDT) today announced the U.S. launch of the Solitaire X Revascularization Device – and its first use in patients for the treatment of acute ischemic stroke.
For ten years, the industry-leading Solitaire Revascularization Device has enabled physicians in helping patients have a better chance at recovering from stroke. Solitaire X is a 4th generation device featuring an optimized delivery system for improved efficiency – while retaining the technical features that have made the Solitaire family of revascularization devices clinically proven and highly effective. In addition, Medtronic introduces Phenom 21 Catheter, a 160cm length microcatheter for the delivery of all sizes of Solitaire X.
The Solitaire X device mechanically removes blood clots from blocked vessels in the brain to restore blood flow in patients suffering an acute ischemic stroke with large vessel occlusion. When combined with Phenom 21, Solitaire X provides a low clot crossing profile, with smooth delivery to occlusions in distal vessels as small as 2.0mm. This compatible system reinforces Medtronic’s commitment to the fight against stroke.
‘Medtronic continues to deliver technological innovations to advance stroke treatment. As a long-time Solitaire user, I am impressed with the ease of the Solitaire X delivery,’ said Dr. Reza Jahan, professor of radiology and neurosurgery at UCLA. ‘I find that Solitaire X 6×40 device combined with Phenom 21 catheter provides smooth navigation especially when working with complicated anatomy.’
GSK sees shingles vaccine sales rising, as free cash flow concerns weigh
GlaxoSmithKline forecast on Wednesday that 2019 sales of its shingles vaccine would be more than £1 billion but the British drugmaker’s shares slipped on concerns about its pharmaceutical business and free cash flow.
Shingrix, the shingles vaccine launched in 2017, is an important source of growth for Chief Executive Emma Walmsley, as she strives to improve GSK’s commercial performance after streamlining its operations and spinning off or selling units.
“Shingrix has delivered another fantastic performance in the quarter,” Walmsley said on a media call.
The company said it expected sales of the vaccine to be “significantly” more than 1 billion pounds in 2019.
The strength in its vaccines unit, whose sales rose 20 percent in the quarter to the end of March, comes at a time when some of GSK’s major drugs face generic competition.
Walmsley, who took over as CEO of GSK in 2017, has been looking to re-energise the drugmaker’s pharmaceutical business, its biggest unit, buying U.S. cancer specialist Tesaro for $5.1 billion and giving it a presence in the oncology market.
“They are really refocusing into oncology and that’s going to take some time – to make that transition – so I think its going to be a difficult time for the pharma business,” said John Rountree, a partner at Novasecta Ltd, a biopharma consulting firm, adding that the vaccine business is growing.
GSK shares closed down 0.9 percent at 1,559.8 pence on Wednesday, with traders pointing to the company’s respiratory drug sales, which came in at 631 million pounds, below analysts estimate of 651 million pounds.
Also, weighing on the stock was a 50 percent drop in free cash flow to 165 million pounds in the quarter, partly due to the impact of generic competition for its asthma treatment, Advair.
“GSK has again struggled to turn profits into cash,” said Nicholas Hyett, equity analyst at Hargreaves Lansdown.
Net debt at GSK, which reiterated its 2019 forecast of a decline in adjusted earnings of 5 to 9 percent, hit 27.1 billion pounds at the end of the quarter from 21.6 billion pounds at the end of 2018, as the drugmaker completed its purchase of Tesaro.
“Investors should probably give GSK the benefit of the doubt, at least for now,” Hyett said.
Sales of Shingrix, which prevents shingles, a viral infection of the skin that causes painful rashes, were 357 million pounds in the three-month period, up 61.5 percent from the fourth quarter.
Analysts had expected quarterly sales of 249 million pounds and are forecasting 2019 sales of 1.17 billion pounds.
Shingrix sales were largely driven by the United States, which benefited from market growth in new patient populations covered by immunisation recommendations as well as growth in Canada and the drug’s recent launch in Germany.
But sales of Advair fell 15 percent to 486 million pounds, due to competition from a generic version.
GSK’s turnover rose to 7.66 billion pounds in the quarter, from 7.22 billion pounds a year earlier, and above a company-provided consensus https://www.gsk.com/en-gb/investors/analyst-consensus/analyst-consensus of analysts’ forecasts of 7.56 billion pounds.
Adjusted operating profit was 30.1 pence per share in the quarter, versus expectations of 26.1 pence per share.
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