Management discusses the new interim Poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study on a conference call to be held on September 24 at 4:30 pm. Weblink: https://edge.media-server.com/m6/p/rkpd2qij
Saturday, September 22, 2018
Baxter eyes big business opportunities in China
Baxter International Inc reported close to double-digit growth in core business revenue over the past few years, given the vast opportunities in the country’s healthcare market, according to its president of the Asia-Pacific region.
Andrew Frye, president of APAC at Baxter and senior vice-president of the company, said China is an “exciting” market.
“In terms of sales, China is the second-largest market for Baxter worldwide. It offers us big business opportunities. China’s acceleration has been dramatic.”
Last year, China contributed a decent portion of the company’s global revenue. The country was second only to Baxter’s home market of the United States, which contributed around 40 percent.
The US-headquartered company said it recognizes the Chinese government’s commitment to expand healthcare to all Chinese people, both rural and urban, as well as its commitment to drive innovation in manufacturing and product development.
“We move with the government initiatives, like the Healthy China 2030 strategy, as well as the increasingly higher-quality standards of products sold in China,” Frye said.
For rural areas in China where there is limited medical access, the company launched a program called “Study on the Accessibility of Peritoneal Dialysis Treatment to Patients with End-Stage Renal Disease and the Grass-Root Management Mode” in 2012, offering home therapy for end-stage renal disease patients.
Joining hands with the National Institute of Hospital Administration under the National Health Commission, Baxter’s dialysis products are delivered directly to patients’ homes in Liaoning, Jiangsu, Zhejiang, Henan, Hubei and Hunan provinces. The initial investment behind the project totaled $5 million.
This kind of home dialysis therapy improves patients’ quality of life, as they do not need to go to the hospital three times a week for dialysis.
“Many people really appreciate that, especially students and elderly people. We also educate doctors to help them teach patients to do the therapy at home.
“Baxter’s mission is to save and sustain lives. We help them to maintain not just their physical health, but their psychological health, so that they can still see friends, and don’t have to undergo blood purification at the hospital,” Frye said.
Fu Qiang, deputy director of the National Institute of Hospital Administration, said, “The program offers a great example of dialysis management. It increases patients’ quality of healthcare and life. It also improves the accessibility of medical care in rural areas.”
In 2017, the company’s sales revenue stood at $10.6 billion, growing 4 percent year-on-year.
On Sept 14, Baxter received the Aon Best Employer award in both China and the Asia Pacific region. The program was designed to improve employee engagement, leadership effectiveness, and employer branding and culture to drive high performance.
Novartis: to file for new Lucentis indication in retinopathy of prematurity
* In the Phase III RAINBOW study, despite marginally missing statistical
significance for the primary endpoint of demonstrating superiority of
Lucentis(®) to laser surgery, Lucentis was shown to be an efficacious, safe
and well-tolerated treatment for infants with ROP [1]
significance for the primary endpoint of demonstrating superiority of
Lucentis(®) to laser surgery, Lucentis was shown to be an efficacious, safe
and well-tolerated treatment for infants with ROP [1]
* Laser surgery, the current standard of care for ROP in infants, destroys
diseased retinal tissue responsible for elevated vascular endothelial growth
factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and
reduces VEGF[2]
diseased retinal tissue responsible for elevated vascular endothelial growth
factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and
reduces VEGF[2]
* With 80% of patients achieving treatment success with 0.2mg Lucentis versus
66% with laser, these data are clinically relevant[1]
66% with laser, these data are clinically relevant[1]
* Novartis plans to file ex-US for a new indication in ROP to bring
transformative treatment to premature infants facing severe vision loss –
the first anti-VEGF product to seek an ROP indication
transformative treatment to premature infants facing severe vision loss –
the first anti-VEGF product to seek an ROP indication
DAIICHI SANKYO to test cancer drug combo
Daiichi Sankyo has entered into a clinical trial collaboration agreement with a subsidiary of MSD to evaluate a potential new combination therapy for breast or lung cancers.
The combination consists of Daiichi Sankyo`s investigational HER2 targeting antibody drug conjugate DS-8201 and MSDs immunotherapy Keytruda.
Under the agreement, Daiichi Sankyo will carry out a two-part Phase Ib multicenter, open-label study to determine the safety, tolerability and dose of the combination and its efficacy in patients with HER2 expressing advanced/metastatic breast cancer and patients with HER2 expressing or HER2 mutant advanced/metastatic non small cell lung cancer (NSCLC).
The primary endpoints of the study are maximum tolerated dose/recommended expansion dose and overall response rate. Secondary endpoints include duration of response, disease control rate, progression-free survival, overall survival, time to response and safety, the firms said.
“We are excited to pursue this opportunity to evaluate the safety, tolerability and activity of DS-8201 in combination with Keytruda and whether this combination may provide a potential new treatment approach for patients with HER2 expressing advanced breast and non-small cell lung cancer,” said Tom Held, vice president, head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo.
“Strategic collaborations like this support our goal to pursue, investigate and maximize the application of DS-8201 in combination with other compounds that target different pathways to address unmet needs of patients with cancer.”
STAAR Surgical to Launch New Permanent Contact Lens for Astigmatism
Parkhurst NuVision, a San Antonio, Texas-based vision correction facility, has been chosen to perform the highly anticipated national launch of a new permanent contact lens for myopia and astigmatism in one. Dr. Greg Parkhurst will be the first surgeon in the nation to offer the Visian toric ICL to his patients in November 2018. The Visian Toric ICL, a variant of Visian ICL technology created by STAAR Surgical, has been approved by the FDA and allows surgeons to treat astigmatism while simultaneously correcting vision.
The Visian ICL represents a permanent contact lens that has been available for over a decade. The procedure has helped hundreds of thousands of patients enjoy life free from glasses or contacts. However, it has not been a particularly good option for patients with significant astigmatismuntil now, says Greg Parkhurst, MD, a leading San Antonio LASIK specialist and one of the most experienced Visian surgeons in America. With the FDA-approved Visian Toric ICL, surgeons will now be able to use this excellent procedure to treat moderate and even high astigmatism during the vision correction process.
The Visian technology is similar to LASIK in that it is a long-term vision correction solution. During LASIK, the shape of the eyes surface (cornea) is changed to correct the patients vision. The Visian is made of a collagen co-polymer, similar to collagen in the rest of the body, so it is biocompatible. The permanent contact lens is placed just beneath the surface of the eye to achieve vision correction.
The FDAs approval of STAAR Surgicals Visian Toric ICL in the U.S. provides an intuitive treatment option for myopic patients with astigmatism in search of visual freedom, adds STAAR Surgicals President and CEO Caren Mason. We are thrilled to be offering this lens in the United States, and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients.
Bayer: Jivi Approved in Japan for Hemophilia a
Bayer announced today that the Japanese Ministry of Health, Labour and Welfare(MHLW) has approved Jivi(R) (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. The recommended usual dose for prophylactic regimens is twice weekly. Jivi can also be dosed once every 5 days or once a week in accordance with the patient’ conditions. Jivi is also approved for on-demand treatment and perioperative management of surgeries. Jivi is a site-specifically PEGylated recombinant Factor VIII (rFVIII) that delivers higher sustained levels of FVIII, which extends the blood’s ability to coagulate for longer.
“Nowadays, people with hemophilia can lead their daily lives with less worry thanks to factor VIII replacement therapies,” said Dr.Teruhisa Fujii, director of the Blood Transfusion Division at the Hiroshima University Hospital. “The approval of Jivi allows certain patients with hemophilia A to preserve coagulation factor levels to prevent bleeding with just one infusion per week. This represents an important improvement, allowing patients more flexibility in their lifestyles.”
“The MHLW approval makes Jivi available to patients with hemophilia A in Japan with an option for once weekly dosing dependent on patients’ individual needs. Jivi can be dosed flexibly based on their previous bleed episodes, whilst maintaining protection from bleeds across all approved regimens,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “Therefore, this approval is an important step forward for people with hemophilia A in Japan. This is the second major approval for Jivi this year following FDA approval in the U.S. in August.”
Bayer Receives Positive CHMP Opinion for Its Hemophilia a Treatment
Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended BAY94-9027 for the marketing authorization for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. The CHMP recommendation is based on results from the Phase 2/3 PROTECT VIII trial. BAY94-9027 recently received FDA approval in the U.S. where it is marketed under the brand name Jivi(R).
“For physicians treating hemophilia A patients with a range of individualized needs, it is important to have the opportunity to offer a treatment which delivers sustained levels of Factor VIII in the blood and thus providing good bleed protection,” said Prof. Dr. Oldenburg, Director of the Hemophilia Centre at the University Clinic in Bonn, Germany. “BAY94-9027 was engineered to have an extended half-life by harnessing proven PEG-technology, which could extend the blood’s ability to coagulate for longer.”
“BAY94-9027 is a uniquely designed recombinant Factor VIII molecule that has demonstrated efficacy and a good safety profile with the potential for reduced injection frequency in adults and adolescents,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “After the approval of BAY94-9027 in the U.S., the positive CHMP recommendation is an important step forward for people with hemophilia A in the European Union. Bayer has also submitted marketing authorization applications for BAY94-9027 in other countries.”
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