Search This Blog

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.
“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.

CVS Health Eases Concerns About Aetna Deal

CVS Health Corp. delivered stronger-than-expected results in its first quarter as a combined health-care company, taking a step toward selling skeptical investors on its acquisition of insurer Aetna Inc.
The Woonsocket, R.I.-based company, which completed the nearly $70 billion takeover in November, said the insurance business performed well while the company saw stronger profits on brand-name drugs and increased sales at its drugstores.
The results mark a shift from February when the company offered a downbeat earnings projection for 2019 that sent shares tumbling. The performance also distinguishes CVS from rival Walgreens Boots Alliance Inc., which reported weaker profits in the most recent quarter and lowered its forecast citing smaller profits from generic drug sales.
The company is under pressure from investors, who are pushing for a clearer picture of its growth prospects. Investors’ focus will now shift to the company’s planned investor day set for June 4, when it has promised to give a more detailed look at its plans.
The Aetna acquisition created an industry giant that combines a retail pharmacy, pharmacy-benefit manager and Aetna’s insurance businesses.
CVS shares had lost a third of their value since it completed the Aetna deal, erasing roughly $34 billion of market value. Shares were up about 5% in afternoon trading.
“None of us are happy with where our stock price is,” CVS Chief Executive Larry Merlo said in an interview. “From our perspective we’re very early. We’re creating a pathway that no one has gone on in an effort to make health care more local and make it more simple.”
“Considering that expectations have been low, we see this as the first positive catalyst that restores investor confidence in this Management team and drive multiple expansion,” SVB Leerink analyst Ana Gupte said.
One sign of investors’ discontent came at a lunch meeting that Mr. Merlo and finance chief Eva Boratto held with investors in early March. The meeting was tense, according to an investor who attended, with the audience pressing the company for a clearer picture of its financial projections for future years. In a note describing the March meeting that came out soon after it occurred, UBS analyst Kevin Caliendo wrote that there appeared to be a “growing credibility issue with investors on how the company is framing the organic path forward for the retail, and consternation that synergy realization isn’t flowing enough to the bottom line to generate accretion from the deal.”
The first-quarter CVS results and call with analysts “will help investor sentiment,” Mr. Caliendo said Wednesday. “The next big hurdle is going to be visibility on 2020 earnings and earnings growth.”
Analysts said that many of the challenges facing CVS are tied to the nature of its core businesses and the policy landscape, and similar issues have hit its competitors.
The health-insurance sector has also recently seen shares slump even among companies with strong earnings results, due to investor worries about policy matters including some Democrats’ interest in universal government-provided health insurance.
CVS has said its deal to bring together drugstores, a pharmacy-benefit manager and an insurer would help it cut health-care costs and improve care. Mr. Merlo has talked about how the merged company will help smooth the fragmented health-care experience for consumers.
CVS is also remaking some of its stores into new health hubs, offering a broader range of services, many aimed at people with chronic health conditions such as diabetes. The company has said it hopes to save money and bolster care by improving patients’ adherence to their prescriptions and pushing care to lower-cost sites, reducing use of emergency rooms.
“Our first full quarter of combined operations was a success in many ways,” Mr. Merlo said in a statement.
On Wednesday, the company reported a first-quarter net income of $1.4 billion, or $1.09 cents a share, up from a profit of $998 million, or 98 cents a share, a year earlier.
The company, which realigned its reporting segments to reflect the combined company, said Aetna contributed $16.6 billion in revenue to its health-benefits segment that was bolstered by strong sales of Medicare products.
CVS reported stronger retail sales from its drugstore chain, which it attributed to success in selling more health-focused offerings, and an increase in pharmacy claims. Prescription volume grew 5.5% from the same period a year ago.
Same-store sales increased 3.8%, beating the FactSet estimate of a 1.2% increase. The retail business will continue to be challenged by lower margins on prescription drugs that will last throughout the year, Mr. Merlo said.
CVS raised it forecast, saying it expects adjusted earnings per share of $6.75 to $6.90, up from $6.68 to $6.88. The improved outlook remains below analyst expectations headed into 2019.

Teva launches generic version of Letairis

Teva Pharmaceutical Industries (TEVA) announced the launch of a generic version of Letairis Tablets, 5 mg and 10 mg, in the U.S. Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. In combination with tadalafil, ambrisentan is indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. For all female patients, ambrisentan tablets are only available through a restricted program called the Ambrisentan Risk Evaluation & Mitigation Strategy due to the risk of fetal harm. Letairis has annual sales of nearly $247 million in the U.S., according to IQVIA (IQV) data as of February 2019.

So-Young IPO: What You Need To Know

This online medical marketplace wants to help beautify China, and it’s looking for investors to help beautify its strategy.

The IPO

So-Young International Inc. will issue 13 million shares on the Nasdaq under ticker SY, according to the firm’s F-1 filing. Priced between $11.80 and $13.80, the offering represents 100 percent of outstanding shares and is expected to bring in about $206.31 million.
Lead underwriters include Deutsche Bank and CICC.
The company qualifies as an emerging growth company and foreign private issuer in the U.S., which exempts management from certain SEC disclosure requirements.

The Company

Launched in 2013, the online platform services as a marketplace for China’s 10,000 plastic surgery service providers. Its site allows users to discover, assess and set appointments with the region’s aesthetic medical professionals.
The company reported 240 million average monthly views in the final quarter of 2018. Through the entire year, it facilitated $306.6 million in transactions representing nearly a third of medical aesthetic treatments booked online.
Estimates suggest China is the second largest medical aesthetic service markets and is positioned to take first by 2021. Total industry revenues are forecasted to reach $52.4 billion by 2023.
As of last year, service providers spent 25.8 percent of revenues, or $4.6 billion, on customer acquisition, with $2.6 billion concentrated online. That rate is projected to grow to $7.2 billion by 2023

The Finances

In 2018, So-Young recorded 138-percent year-over-year revenue growth and 220.2 percent net income growth. Revenue came in at $89.8 million with a net income of $8 million.