Jury finds Lallemand Did Not Willfully Infringe DSM’s Patent

MONTREAL, May 18, 2018 /PRNewswire/ — As part of an ongoing intellectual property dispute between DSM and Lallemand, a jury in Madison, Wisconsin this week delivered a verdict finding that certain Lallemand TransFerm® products infringe United States Patent No. 8,795,998. While Lallemand very much respects the legal process, we were surprised by this outcome and will vigorously contest it in further court proceedings.

Lallemand champions innovation and fair competition, and respects valid intellectual property rights. The jury in Wisconsin heard evidence of Lallemand’s position that it is practicing its own patented technology. As a result, the jury returned a verdict that Lallemand did not willfully infringe on the DSM patent, concluding that Lallemand reasonably believed that it used its own intellectual property.

Lallemand, through its Lallemand Biofuels & Distilled Spirits (LBDS) business unit, is a leading supplier of fermentation ingredients (yeast, yeast nutrients and antimicrobials) and value-creating services to biofuel producers. Through ongoing innovation and continuous learning about the value-drivers for our customers, Lallemand will continue to deliver products and services to the biofuels industry that drive results. The ongoing legal process cannot stop this continuing commitment to our customers.

About Lallemand

Lallemand Inc. is a privately-held Canadian company, and is a leading developer, producer and marketer of yeasts, bacteria and other microorganisms serving the baking, winemaking, distilling, ethanol, brewing, animal nutrition, dietary supplements, food, fermentation, pharmaceutical and plant care industries. Lallemand has more than 3,700 employees located in over 40 countries, and is active on all five continents. For more information visit www.lallemand.com.

About Lallemand Biofuels & Distilled Spirits

Lallemand Biofuels & Distilled Spirits (LBDS) is a business unit of Lallemand, Inc. Based in Duluth, GA, Lallemand Biofuels & Distilled Spirits is the leading supplier of fermentation ingredients and value creating services to the global fuel ethanol and distilled beverage industries. For more information on LBDS, please visit www.lbds.com.

Contact: 

Lallemand Inc.
Roberto Blanc, Marketing and Communications Director
Tel.: +1 (514) 906-9902
E-Mail: Marketing.Global@lallemand.com

Logo – https://mma.prnewswire.com/media/693405/Lallemand_Logo.jpg

Source: Lallemand Inc.

Homecare Robotics and APAC Push Consumer Robotics Market to 100 Million shipments by 2026

LONDON, May 16, 2018 /PRNewswire/ — The consumer robotics market is evolving rapidly and covers a wide array of products, from homecare systems to children’s toys to smart ‘humanoid’ robots that provide personal and social engagement. According to ABI Research, a market-foresight advisory firm providing strategic guidance on the most compelling transformative technologies, the entire consumer robotics market will reach 100 million shipments and US$23 billion in revenue by 2026.

Homecare robots are already the primary driver of revenue for the wider consumer robotics market. This trend is expected to increase, following a banner year of revenue and shipment growth from floor care market leader iRobot. From 2016 to 2017, iRobot’s yearly revenue jumped from US$2.93 billion to US$3.69 billion, a major increase on returns from previous years. While iRobot dominates the American and European markets, Chinese manufacturers such as Ecovacs are beginning to post comparable shipment figures, and long-term, Asia-Pacific (APAC) will closely match North America and Europe in market share for homecare robots.

“General improvement in global GDP growth and consumer confidence recovery, particularly in the U.S. market, have led to substantial revenue growth from market leaders, such as iRobot, Ecovacs, and Neato,” says Rian Whitton, Research Analyst at ABI Research. “In addition, niche segments, such as pool cleaning, have begun to expand in popularity. Israeli-centered market leader Maytronics has recently expanded into the American market and posting double-digit growth over a consistent time frame.”

By contrast, the toys and entertainment segment will decline in market share. Their share of shipments will decrease from 75% in 2014 to 47.1% in 2026 (still the largest segment), while their share of revenue will crater from 31.7% to 10% in the same period. The reason for this relative decline is in part a question of semantics. In this same period, personal/social robots are expected to increase their market share of revenue from virtually nothing to 21.3% in 2026.

“Over time, ABI expects these more sophisticated systems to colonize the traditional toys market and to replace rudimentary robotic toys with more sophisticated general-purpose smart devices. Mobile personal robots will resemble many of the higher-end entertainment robots in appearance, but will possess more advanced technologies, including cellular technology, Wi-Fi connectivity, and possibly even on-device machine learning,” concludes Whitton. There are several toys that could already fall under the definition of personal robots, such as WowWee’s Robosapien. A further example might be Anki’s Cozmo, an educational toy robot designed to teach coding principles to children.

These findings are from ABI Research’s Consumer Robotics report. This report is part of the company’s Robotics, Automation & Intelligent Systems research service, which includes research, data, and Executive Foresights. 

About ABI Research

ABI Research provides strategic guidance for visionaries needing market foresight on the most compelling transformative technologies, which reshape workforces, identify holes in a market, create new business models and drive new revenue streams. ABI’s own research visionaries take stances early on those technologies, publishing groundbreaking studies often years ahead of other technology advisory firms. ABI analysts deliver their conclusions and recommendations in easily and quickly absorbed formats to ensure proper context. Our analysts strategically guide visionaries to take action now and inspire their business to realize a bigger picture. For more information about ABI Research’s forecasting, consulting and teardown services, visionaries can contact us at +1.516.624.2500 in the Americas, +44.203.326.0140 in Europe, +65.6592.0290 in Asia-Pacific or visit www.abiresearch.com.

Contact Info

Global                                         

Deborah Petrara                           

Christopher Leary

Tel: +1.516.624.2558                     

Tel: +1.516.624.2544

pr@abiresearch.com                       

leary@abiresearch.com

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Merck Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline

DARMSTADT, Germany, May 17, 2018 /PRNewswire/ —

Not intended for UK- or US-based media 

ASCO Abstract #
ERBITUX® (cetuximab): 3521, 3534, e15711; avelumab: 9507, 9537, 9090, 9008, 8563, 3057, 4544, e21531, e13603, e18932, e21623, e21620, e21544; tepotinib (c-Met kinase inhibitor): 9082, 9016; M6620 (ATR inhibitor): 2549, e21048; M3814 (DNA-PK): 2518 M7824 (TGF-ß trap/anti-PD-L1): 3007, 9017, 2566; M2698 (dual p70S6k/Akt inhibitor): 2584

  • Two-year safety and efficacy data in mMCC for avelumab from pivotal JAVELIN Merkel 200 trial 
  • Further data reinforcing commitment to precision medicine and position of ERBITUX® (cetuximab) as a standard of care in mCRC 
  • Early clinical activity in advanced NSCLC and HPV-associated cancers for investigational bifunctional immunotherapy, M7824 
  • Encouraging interim analysis of Phase II data in NSCLC sub-population for c-Met inhibitor, tepotinib 
  • Record number of abstracts accepted across oncology, immuno-oncology and DNA Damage Response (DDR)  

Merck, a leading science and technology company, today announced new data from a number of high priority clinical development programs across its oncology portfolio to be presented at this year’s American Society of Clinical Oncology Annual Meeting (ASCO), June 1-5, 2018, Chicago, IL. Abstracts representing seven therapeutic agents and eight tumor types will highlight Merck’s position as a key emerging player in oncology.

“This year’s data at ASCO demonstrate the potential of our pipeline to really deliver transformative advancements in cancer care,” said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. “With our strong commitment and focus on the areas we believe in most, Merck’s oncology and immuno-oncology pipeline is demonstrating significant potential in the near term with our later-stage priority programs and, in parallel, our early pipeline includes truly innovative programs that could make a real difference for patients.”

Data for the legacy brand ERBITUX® continue to build on Merck’s heritage in oncology reinforcing its role as a standard of care in RAS wild-type metastatic colorectal cancer (mCRC), the standard of care in first-line recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), and a standard of care for patients with locally advanced SCCHN (LA SCCHN), who may not be able to tolerate cisplatin-based regimens in full.

New data for avelumab* (BAVENCIO®), which is being jointly developed and commercialized with Pfizer, include an oral presentation on two-year results from the pivotal JAVELIN Merkel 200 trial. These long-term results include data on avelumab’s duration of response and represent the first study to report long-term survival data for an immunotherapy in metastatic Merkel cell carcinoma (mMCC).

The company will also present further evidence for M7824, an investigational TGF-ß trap/anti-PD-L1 bi-functional immunotherapy fusion protein, from expansion cohorts of the ongoing M7824 Phase I clinical trial (NCT02517398) program. TGF-β, a cytokine released by cells (including tumor cells), suppresses anti-tumor immune responses through a vast number of mechanisms leading to uninhibited tumor growth and metastasis. These data include results in patients with human papillomavirus (HPV)-associated cancers (presented in collaboration with the National Cancer Institute) and data in patients with advanced non-small cell lung cancer (NSCLC). In second-line (2L) NSCLC, signs of clinical activity were seen across PD-L1 expression levels. At the recommended Phase II dose, a confirmed overall response rate (ORR) of 40.7% (11/27) was observed in PD-L1+ patients (>1%), and in patients with high PD-L1 expression (80%; Ab clone 73-10 [>80%=>50% with 22C3]), the ORR was 71.4% (5/7). These data signal the potential of M7824 and provide evidence that combining a transforming growth factor-β (TGF-β) trap with the anti-PD-L1 mechanism in one molecule may generate anti-tumor activity in these patient groups with significant medical need. Treatment with M7824 was well tolerated in both studies and safety data were consistent with that observed in the overall Phase I clinical program. No new safety signals were identified.

For tepotinib**, an investigational highly selective small molecule inhibitor of the c-Met receptor tyrosine kinase, new data to be presented include promising initial results from an ongoing Phase II VISION study providing further indication for the potential of tepotinib in patients living with advanced NSCLC harboring MET exon 14 skipping mutations. Alterations of the c-Met signaling pathway are found in various cancer types and correlate with aggressive tumor behavior and poor clinical prognosis. Based on investigator assessment of data from 15 patients in the study, 60% (9/15) had a confirmed partial response (PR) and 20% (3/15) had stable disease (SD). In addition, independent assessment of 13 patients demonstrated treatment with tepotinib led to a confirmed PR in 46.2% (6/13) and SD in 7.7% (1/13) of patients. In this study, the safety data are consistent with that observed in previous studies and confirm that treatment with tepotinib is well tolerated; no new safety signals were identified.

Tepotinib is an important part of Merck’s strategic focus on precision medicines and these results reinforce the company’s progress in delivering treatments to those patients more likely to benefit, in order to achieve the best possible outcomes. Both M7824 and tepotinib were discovered in-house at Merck.

Further pipeline updates include Phase I dose escalation data for the investigational DNA-dependent protein kinase (DNA-PK) inhibitor M3814, Phase I triplet therapy with ATR-inhibitor, M6620 +veliparib+cisplatin in advanced solid tumors, and Phase I data for M2698, a potent and selective dual inhibitor of p70S6K and AKT1/3 in the PAM pathway (PI3K/AKT/mTOR pathway). The PAM pathway regulates cell survival and growth and this pathway often displays unusual activity in many human cancers.

*Avelumab is under clinical investigation for treatment of NSCLC, metastatic urothelial carcinoma (mUC) and mesothelioma and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for NSCLC, mUC and mesothelioma by any health authority worldwide.

**Tepotinib is the recommended International Nonproprietary Name (INN) for the c-Met kinase inhibitor (MSC2156119J). Tepotinib is currently under clinical investigation and not approved for any use anywhere in the world.

Tepotinib, M7824, M3814, M2698 and M6620 are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Notes to Editors 

Accepted Merck-supported key abstracts slated for presentation are listed below. In addition, a number of investigator-sponsored studies have been accepted (not listed).

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

Erbitux (cetuximab)

Poster Sessions

Impact of primary tumor
side on outcomes of
every-2-weeks (q2w)
cetuximab + first-line
FOLFOX or FOLFIRI in
patients with RAS wild-
type (wt) metastatic
colorectal cancer
(mCRC) in the phase 2
APEC trial.

Timothy Jay
Price, MBBS,
FRACP, D.H.Sc

3534

Sun, Jun 03, 8:00 AM – 11:30 AM

Hall A

Final overall survival
(OS) analysis of first-line
(1L) FOLFOX-4 plus or
minus cetuximab (cet) in
patients (pts) with RAS
wild-type (wt)
metastatic colorectal
cancer (mCRC) in the
phase 3 TAILOR trial.

Shukui Qin, MD,
BA

3521

Sun, Jun 03, 8:00 AM – 11:30 AM

Hall A

Publication

Cost-effectiveness (CE)
of FOLFIRI (F) +
cetuximab vs F +
bevacizumab in the first-
line treatment of RAS
wild-type (wt)
metastatic colorectal
cancer (mCRC) in
Germany: data from the
FIRE-3 (AIO KRK-0306)
study

Stintzing S, van
Oostrum I,
Pescott CP, et
al.

e15711

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

Avelumab

Oral Presentations

Two-year efficacy and
safety update from
JAVELIN Merkel 200 part
A: A registrational study
of avelumab in
metastatic Merkel cell
carcinoma progressed on
chemotherapy.

Paul Nghiem,
MD, PhD

9507

Mon, Jun 04, 10:12 AM – 10:24 AM

Arie Crown Theater

Avelumab (anti-PD-L1)
in combination with
crizotinib or lorlatinib in
patients with previously
treated advanced
NSCLC: Phase 1b results
from JAVELIN Lung 101.

Alice Tsang
Shaw, MD, PhD

9008

Fri, Jun 01, 4:30 PM – 4:42 PM

Hall D1

Poster Sessions

Avelumab (anti-PD-L1)
in patients with
platinum-treated
advanced NSCLC: 2.5-
year follow-up from the
JAVELIN Solid Tumor
trial.

Arun Rajan, MD

9090

Sun, Jun 03, 8:00 AM – 11:30 AM

Hall A

Phase 1b study of
avelumab in advanced
previously treated
mesothelioma: long-
term follow-up from
JAVELIN Solid Tumor.

Raffit Hassan,
MD

8563

Sun, Jun 03, 8:00 AM – 11:30 AM

Hall A

Second-line avelumab
treatment of patients
(pts) with metastatic
Merkel cell carcinoma
(mMCC): Experience
from a global expanded
access program (EAP).

John WT
Walker, MD,
PhD

9537

Mon, Jun 04, 1:15 PM – 4:45 PM

Hall A

Association of efficacy
and adverse events of
special interest of
avelumab in the JAVELIN
solid tumor and JAVELIN
Merkel 200 trials.

Karen Kelly,
MD, FASCO

 

3057

Mon, Jun 04, 8:00 AM – 11:30 AM

Hall A

SPEAR-bladder (study
informing treatment
pathway decision in
bladder cancer): First-
through third-line time
to treatment failure in
the US.

Gurjyot K.
Doshi, MD

4544

Sat, Jun 02, 8:00 AM – 11:30 AM

Hall A

Publication

Avelumab in patients
with previously treated
metastatic melanoma:
phase 1b results from
the JAVELIN Solid Tumor
trial

Keilholz U,
Mehnert J,
Bauer S, et al.

e21531

Characteristics,
treatment patterns and
safety events from 4
cohorts of advanced or
metastatic cancer
patients based on
healthcare claims data

Russo L,
Esposito D,
Lamy FX, et al.

e13603

Healthcare resource use
and expenditures among
patients with Merkel cell
carcinoma by level of
comorbidity

Kearney M,
Thokagevistk K,
Boutmy E, et al.

e18932

Projecting long-term
survival for avelumab in
patients with refractory
Merkel cell carcinoma

Phatak H,
Proskorovsky I,
Lanitis T, et al.

e21623

Predicting overall
survival in patients (Pts)
with treatment-naive
metastatic Merkel Cell
carcinoma (mMCC)
treated with avelumab

Bullement A,
D’Angelo SP,
Amin A, et al.

e21620

A novel, open-access
data commons for
improved disease

management in Merkel
cell carcinoma patients

Murphy M,
Sartor O,
Bertagnolli M,
et al.

e21544

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

M7824 (beta-trap)

Oral Presentation

Safety and activity of
M7824, a bifunctional
fusion protein targeting
PD-L1 and TGF-beta, in
patients with HPV
associated cancers.

Julius Strauss,
MD

3007

Sat, Jun 02, 5:12 PM – 5:24 PM

Hall B1

Poster Discussion

Results from a second-
line (2L) NSCLC cohort
treated with M7824
(MSB0011359C), a
bifunctional fusion
protein targeting TGF-
beta and PD-L1.

Luis G. Paz-
Ares, MD, PhD

9017

Sun, Jun 03, 11:30 AM – 12:45 PM

Arie Crown Theatre

Poster Session

Selection of the
recommended phase 2
dose (RP2D) for M7824
(MSB0011359C), a
bifunctional fusion
protein targeting TGF-
beta and PD-L1.

Yulia
Vugmeyster,
PhD

2566

Mon, Jun 04, 8:00 AM – 11:30 AM

Hall A

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

Tepotinib

Poster Discussion

Tepotinib in patients
with advanced non-small
cell lung cancer (NSCLC)
harboring MET exon 14-
skipping mutations:
Phase II trial.

Enriqueta Felip,
MD

9016

Sun, Jun 03, 11:30 AM – 12:45 PM

Arie Crown Theatre

Poster Session

Can duration of response
be used as a surrogate
endpoint for overall
survival in advanced
non-small cell lung
cancer?

Boris M Pfeiffer

9082

Sun, Jun 03, 8:00 AM – 11:30 AM

Hall A

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

M2698

Poster Session

Precision oncology:
Results of a phase I
study of M2698, a
p70S6K/AKT targeted
agent in patients with
advanced cancer and
tumor PI3K/AKT/mTOR
(PAM) pathway
abnormalities.

Apostolia Maria
Tsimberidou,
MD, PhD

2584

Mon, Jun 04, 8:00 AM – 11:30 AM

Hall A

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

M3814

Poster Discussion

A phase Ia/Ib trial of the
DNA-PK inhibitor M3814
in combination with
radiotherapy (RT) in
patients (pts) with
advanced solid tumors:
Dose-escalation results.

Baukelien Van
Triest, MD, PhD

2518

Mon, Jun 04, 3:00 PM – 4:15 PM

S406

Title

Lead Author

Abstract #

Presentation
Date / Time
(CDT)

Location

M6620

Poster Discussion

Phase I trial of the triplet
M6620 (formerly VX970)
+ veliparib + cisplatin in
patients with advanced
solid tumors.

Geraldine Helen
O’Sullivan
Coyne, MD, PhD

2549

Mon, Jun 04, 8:00 AM – 11:30 AM

Hall A

Publication

Safety and tolerability of
intravenous M6620 (VX‑
970) administered with
gemcitabine in subjects
with advanced non-small
cell lung cancer (NSCLC)

Plummer R,
Cook N,
Arkenau H-T,
et al.

e21048

Mon, Jun 04, 8:00 AM – 11:30 AM

Hall A

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Avelumab 

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Approved Indications in the US 

The FDA granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label 

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or mUC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

About Erbitux® (cetuximab)  

Erbitux® is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Erbitux also targets cytotoxic immune effector cells towards EGFR expressing tumor cells (antibody dependent cell-mediated cytotoxicity, ADCC).

The most commonly reported side effect with Erbitux is an acne-like skin rash. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 100 countries world-wide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998.

About M3814 

M3814 is an investigational small-molecule which is thought to inhibit DNA-dependent protein kinase (DNA-PK). DNA-PK is a key enzyme for non-homologous end-joining (NHEJ), an important DNA double strand break (DSB) repair pathway. Clinical studies investigating combinations of M3814 with other commonly used DNA-damaging agents such as radiotherapy and chemotherapy are underway.

About M7824 

M7824 is an investigational bifunctional immunotherapy that is designed to bring together a TGF-β trap and ‘fuse’ it with the anti-PD-L1 mechanism. M7824 is designed to simultaneously block the two immunosuppressive pathways – targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is currently in Phase I studies for solid tumors.

About M2698 

M2698 is an investigational small-molecule which is thought to inhibit p70S6K and Akt. Both targets are part of the PI3K/AKT/mTOR (PAM)pathway, which is often dysregulated in solid tumors.

About tepotinib 

Tepotinib (MSC2156119J) is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase. Alterations of the c-Met signaling pathway are found in various cancer types and it is thought to correlate with aggressive tumor behavior and poor clinical prognosis.

About M6620 

M6620 (previously known as VX-970) is an investigational small-molecule thought to inhibit ataxia telangiectasia and Rad3-related protein (ATR). ATR is believed to be a key sensor for DNA damage, activating the DNA damage checkpoint and leading to cell cycle arrest. Inhibition of ATR could potentially enhance the efficacy of DNA-damaging agents, but is also being investigated as a monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes.

About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. Almost 53,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck generated sales of € 15.3 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Contact: Gangolf Schrimpf, +49-6151-72-9591

Investor relations: +49-6151-72-3321

GC Healthcare presents a new paradigm for stem cell therapy product for erectile dysfunction

SEOUL, South Korea, May 16, 2018 /PRNewswire/ — South Korea has presented a new paradigm for stem cell therapy. GC Healthcare and Pharmicell have extended the application of CELLGRAM, a stem cell therapy product, for acute myocardial infarction, which is approved by KFDA, to erectile dysfunction. Its stem cell products were the world’s first commercialized stem cell therapy products in 2011.

Erectile dysfunction is one of the complications that is common and hard to treat after prostate cancer surgery. It is typically caused by a damage to the cavernous nerve running along the posterolateral aspects of the prostate. Stem cells stimulate the regeneration of damaged nerves, prevent cell apoptosis in the smooth muscles in the cavernous sinus, regenerate endothelial cells and help the formation of new blood vessels.

Since the completion of the clinical trial, Pharmicell has cooperated with GC Healthcare and started its service for those who have prostate cancer and come to South Korea to get treated.

GC Healthcare is one of the family groups of South Korea’s renowned pharmaceutical company, GC Pharma, and has focused on healthcare business for over 10 years. As Chinese patients’ demand for overseas treatment has increased, GC Pharma has established an international business department to recruit customers from abroad and has provided consulting services through the WeChat official account. GG Healthcare has been favorably commented upon for its satisfying services that have been provided for international customers over many years.


GC Healthcare wechat

www.1888gc.com 

For Media Enquiries:

Medical Tourism Team
+82-2-2040-9149
mt@gchealthcare.com

Photo – https://photos.prnasia.com/prnh/20180515/2133558-1-QR

Visitor registration has opened; get free access to Medtec China 2018 in September

SHANGHAI, May 16, 2018 /PRNewswire/ — Medtec China, the leading medical device design and manufacturing exhibition in China, will take place 26-28 September 2018 in Shanghai. More than 400 exhibitors will showcase their latest offerings at Medtec China 2018, and more than 10,000 decision makers, purchasing staff, R&D engineers, product engineers and quality inspectors from medical device manufacturers will congregate at the show. This year’s event is going to showcase exhibits on medical raw material, components, tubing and extrusion, manufacturing equipment, contract manufacturing services, and regulatory consultant services in China.

Medtec China 2018 Visitor registration is available now, please click here to register at the official website or call +86 10-5730 6163 to help complete registration. Click here to discover why Medtec China is a must-attend show.


Medtec China 2017

Medtec China 2017 one-minute video

Medtec China 2018 latest highlights:

Regulatory street debuts. This is a new launch zone at Medtec China 2018. With the exclusive support of Shanghai Pudong Medical Device Trade Association, consultant companies and keynote speakers from America, Europe and China will provide regulatory updates in China, the US and the EU in this zone.

The largest scale manufacturing equipment zone ever. International and domestic Chinese medical device manufacturing equipment suppliers from Switzerland, Singapore, Spain, Malaysia, Taiwan and mainland China will show up at Medtec China 2018 over an area of 2,000m², to provide a great experience for visitors.

5 reasons to attend Medtec China 2018

  1. Access to more than 2,000 global suppliers of medical device design and manufacturing from Medtech World
  2. Free access to advanced products/technologies/service for the medical design and manufacturing industry
  3. Resolve key technical challenges and problems in the processes of medical product development and manufacturing
  4. The opportunity to explore regulatory updates in China, the US and the EU
  5. Access to market trends and forefront business opportunities

400 Medical design and manufacturing suppliers; 14 exhibit zones for better visiting experience

For a superior visiting experience, Medtec China has set up 14 exhibit zones: Medical Manufacturing Automation; Moulding & Manufacturing Equipment; Medical Components; Electronic Components; Surface Treatment; Full Service Contract Manufacturing; Ultra-Precision Machining; Packaging, Sterilization, Labeling; Design, Research & Development, Software Regulations; Testing, Metrology & Inspection Supplies; Materials & Adhesives; Materials, Components and Process; and Dressing Materials and Process.


MDiT Forum and Regulation Summit 2017 onsite

2018 concurrent conferences help to access market trends

The MDiT Forum and Regulation Summit 2018 will discuss focused topics from four aspects: regulatory and policy; quality management; advanced technology; and market & investment.

Chinese Regulatory Updates and Compliance is always the most popular one. This year speakers are going to discuss the development prospects of the Chinese medical device industry, understanding of the medical device review and approval system by CFDA, and key points for the implementation of clinical trial quality management of medical devices in China.

The forum CFDA Flight Inspection and FDA Inspection, will invite global regulatory professionals and FDA officers to share their opinions on the implementation progress and information sharing of CFDA overseas inspections, and practical experiences of preparation and coping strategy for CFDA flight inspection and, from the view of medical device manufacturers, how to respond to FDA factory inspection programs and key points of reply to FDA483.

Next-Gen Design & New Technology can always easily attract engineers’ attention. Some advanced topics are going to be discussed at this year’s technology forum, for instance, getting the most of human factors engineering in medical device design, a case study on how to use disruptive design strategy in medical device design, and advancing medical devices by capturing the sense of visual and touch.


Medtec China 2017 Exhibitor Theater is full of visitors

Efficient way to network with industry peers through rich onsite activities

Every year Medtec China organizes difference onsite activities to fulfil customer needs, Business Match Making, Exhibitor Theatre, Quality Focus, Exhibitor Seminars, MDEA global medical design excellence awards which always attract plenty of visitor to participant. To learn more about onsite activities please click here.

How to register:

  1. Online Registration: Click the link to register on Medtec China official website: www.medtecchina.com
  2. Telephone Registration: +86 10-5730 6163
  3. Group Registration: If you are a group of more than five people visiting, please call us to simplify the process: +86 10-5730 6163

Media\Exhibit\Visit\Conference Contact:

Carina Li
UBM China
T: +86 10 5730 6163
E: carina.li@ubm.com 
Medtec China Organizing Committee

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The 3rd Annual iACD World Congress Will be Held from Oct 31 to Nov 2

-Innovative Team Approaches to Comprehensive Dentistry

SHANGHAI, May 15, 2018 /PRNewswire/ — The 3rd Annual iACD World Congress, hosted by UBM Showstar (UBM Sino Expo), will be held at same time as DenTech China 2018 from Oct 31 to Nov 2 at Shanghai World Expo Exhibition and Convention Center. The International Academy of Contemporary Dentistry (iACD) is the first professional dental association in the world with the mission of providing culturally specific services from bilingual and bicultural Asian dental professionals. The iACD brings together researchers, practitioners, and industry professionals committed to advancing oral health among Asia-Pacific countries and throughout the world. The mission at iACD is to provide a multidisciplinary oral health education platform for dentists with the desire to better the quality of life of their patients by improving both their oral care and their long-term physical health. Please visit http://www.dentech.com.cn/en-us/index for more information about this congress.


The Annual iACD World Congress

With 2016 in Hong Kong and 2017 in New York, the Annual iACD Congress has successfully held two editions. On the theme of Innovative Team Approaches to Comprehensive Dentistry, the 3rd Annual iACD Congress will be held at Shanghai World Expo Exhibition and Convention Center in October 2018. This highly anticipated platform for the dental industry includes an international lineup of experts including Dr. Jon B. Suzuki, Dr. Steve G.F. Shen, Dr. Stephen Wallace, Dr. Shohei Kasugai, Dr. Charles J. Goodacre, Dr. Su Yucheng, Dr. Hideo Kawahara and Dr. Paul P Chang, please visit http://www.dentech.com.cn/en-us/Speaker-Profiles for more information on guest speakers.

iACD recognizes the importance of facilitating the flow of ideas in a scientifically, linguistically as well as culturally inclusive manner. Through providing professional multilingual resources in Asia-Pacific where academics and practitioners can present their work in a contextualized setting. 16 popular featured topics including “Risk management when operating in the posterior mandible”, “Interdisciplinary management of Complex Implant Treatment”, “New strategy for bone regenerating: Respecting the healing ability of the body“, etc. will be presented by over 20 famous professional speakers at this congress. For more information on featured topics, please visit http://www.dentech.com.cn/en-us/The-3rd-Annual-iACD-Congress.

2018 iACD World Congress also provides programs, presentations and topics on dental hygienist. Dental hygienists are oral health professionals who are responsible for preventing and treating oral diseases. All dental hygienists must be licensed, which requires graduating from a college or university dental hygienist program and passing a written national board examination and state clinical examination. They are extremely important to the whole dental industry.


The presidents of iACD

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Cedrus Investments’ Chairman Mr. Rani Jarkas is Invited to Speak at the 121 Tech Investment Conference in Hong Kong on Life Sciences

HONG KONG, May 15, 2018 /PRNewswire/ — The Chairman of Cedrus Investments (“Cedrus”), Mr. Rani Jarkas, is invited to speak at the 121 Tech Investment conference to be held on 13th – 14thJune 2018 in Hong Kong.  At this event, senior executives from innovative industries, including life sciences and technology, and leading investors will discuss with other elites their unique observations and enlightening insights of the current market dynamics as well as prospects on future trends, with a focus on the most cutting-edge areas, including block-chain, smart cities and personalized medicines.       

Cedrus is among the leading experts and a longtime investor in life sciences, having an unparalleled advisory board in-house expertise consisting of world-renowned physicians and experts. Mr. Jarkas will join a panel discussion, sharing not only his knowledge and insights into some of the most innovative areas in life sciences such as gene editing, but also his experience in the active involvement in the rapidly-changing Chinese life sciences industry where investments in innovations and cross-border transactions are of top priority.  

Mr. Jarkas said, “Life sciences has long been the most important strategic focus of Cedrus in particular in the Greater China region, and we have been engaging in this industry for over two decades. Our success in establishing a unique and multi-dimensional global network, comprising of pundits with deep industry experience and expertise, as well as our good relationships with local governments in China has resulted in a win-win situation for both our valuable global clientele and business partners in and outside of China. While Chinese investors and strategic partners are vigorously pursuing overseas cutting-edge technologies, western life sciences companies are keen to capture the business opportunities presented by China, the world’s second-largest pharmaceutical market. I am glad to be invited to participate in a panel discussion where I have the chance to exchange my thoughts with a few industry leaders in an effort to jointly explore and identify impactful life sciences investments that will ultimately become the new growth engines of the industry.”

About Cedrus Investments

Cedrus Investments is a global boutique investment firm that offers expertise in private wealth management, asset management and financial advisory services to a clientele of leading institutional investors, corporations, family offices and high net worth individuals around the world.

For further information about Cedrus Investments, please visit www.cedrusinvestments.com.

Media Enquiry:
Cedrus Investments Ltd.
Amy Sin
+852-3519-2828
information@cedrusinvestments.com

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Sichuan Kelun Pharmaceutical Automates Oncology Clinical Trial Set Up and Management with Clinical One Randomization and Supplies Management Cloud Service

CHENGDU, China, May 14, 2018 /PRNewswire/ — Oracle Health Sciences today announced that Sichuan Kelun Pharmaceutical Research Institute Co., Ltd (“Kelun”) has implemented Oracle Health Sciences Clinical One Randomization and Supplies Management Cloud Service to fully automate the set up and management of its multi-site, double blind colorectal cancer study. 

The China Food and Drug Administration (CFDA) has been driving reforms to improve the quality of drugs and to encourage innovation in the development of new drugs and medical devices. Kelun Pharmaceutical has been successfully conducting generics drug research since 1996 but recently launched its first, new oncology drug study. As with any new clinical trial, there is tremendous time and resources required to set up a new study including trial design and validation which can take weeks to months. ORS enables coordinators to quickly add patients to a trial, collect screening information and ensure eligibility for randomization in record time. In an effort to set up their own trial and eliminate manual, repetitive data entry, Kelun implemented Clinical One Randomization and Supplies Management Cloud Service.  

“We needed an established, standards-based cloud system to simplify the drug supply management process, and we have already determined we made a great choice by selecting Oracle’s Clinical One Randomization and Supplies Management. Within 29 days, we were fully implemented and are now in phase III of our oncology trial,” said Xiaoping Zhang, VP of Biostatistics and Data Management, Clinical Research Hub.

With Clinical One Randomization and Supplies Management, Kelun has been able to manage its trial supply and randomization more effectively and efficiently and has enabled its CRO partner and service providers, including its supply shipping specialist vendor, to automate their processes by leveraging Oracle Health Science’s cloud-based system. In addition to simplifying the drug supply management process, ORS has provided Kelun with role-based analytics to track and manage supply status in real time.

“Our eClinical platform, Clinical One and randomization and supplies management capability was designed for pharmaceutical and biopharma companies of all sizes, across all treatment areas and for all phases of research and development. We are excited to see Kelun leveraging technology to speed the setup and management of their trial and are hopeful that this oncology therapy will make it to market,” said Steve Rosenberg, general manager and senior vice president, Oracle Health Sciences.

Additional Resources

About Oracle
The Oracle Cloud offers complete SaaS application suites for ERP, HCM and CX, plus best-in-class database Platform as a Service (PaaS) and Infrastructure as a Service (IaaS) from data centers throughout the Americas, Europe and Asia. For more information about Oracle (NYSE:ORCL), please visit us at oracle.com

Trademarks
Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

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Purpose Driven Approach in Nutrition Spurs Herbalife Nutrition’s Southeast Asia Member Base to Be The Difference in Their Local Communities

SINGAPORE, May 14, 2018 /PRNewswire/ — As a company whose purpose is to make the world healthier and happier, premier global nutrition company, Herbalife Nutrition, has wrapped up Extravaganza, its annual education and training event for the Southeast Asia member community. The three-day event, at the Singapore Expo, began May 11 with the Herbalife Nutrition leadership team rallying more than 11,000 independent members to be the difference in each of their local communities by inspiring them to take steps towards positive nutrition for healthier, happier lives.


Over 11,000 Herbalife Nutrition independent members gather at the Singapore Expo to share their passion for building a heathier and happier world through positive nutrition and lifestyle changes.

“In the face of the global megatrends of high obesity rates, a rapidly aging population, increasing public healthcare costs, and a rise in entrepreneurial interests, we believe we can play an even greater role in providing practical solutions to help build a better future for us all,” said Stephen Conchie, senior vice president and managing director, Herbalife Nutrition Asia Pacific. “Extravaganza is the perfect platform to gather our members and equip them with the knowledge to build a healthier Southeast Asia.”  

Herbalife Nutrition’s members are trained and equipped to be at the frontline of nutrition conversations, providing personalized nutrition and fitness services to consumers. Through this personalized, face-to-face approach, members are able to customize specific nutrition programs for each individual, to meet consumers’ nutrition needs and spur them on towards their health and wellness goals.

“Our products, along with educated and trained members, provide consumers with an effective personalized solution to their nutrition and wellness goals,” Conchie added.

During the three-day event, Herbalife Nutrition’s member base had the opportunity to hear from nutrition experts and Rich Goudis, the CEO of Herbalife Nutrition, who delivered an inspiring keynote message that instilled a sense of purpose into the member community to empower them with the vision and ability to make the world a happier and healthier one.

Conchie also outlined his vision for the Southeast Asia member community to make a real difference in their respective communities by providing the right motivation and support to empower the people around them to make positive nutrition and lifestyle changes.

About Herbalife Nutrition

Herbalife Nutrition is a global nutrition company whose purpose is to make the world healthier and happier. The Company has been on a mission for nutrition – changing people’s lives with great nutrition products and programs – since 1980. Together with our Herbalife Nutrition independent members, we are committed to providing solutions to the worldwide problems of poor nutrition and obesity, an aging population, skyrocketing public healthcare costs and a rise in entrepreneurs of all ages. Herbalife Nutrition offers high-quality, science-backed products, most of which are produced in Company-operated facilities, one-on-one coaching with an Herbalife Nutrition independent member, and a supportive community approach that inspires customers to embrace a healthier, more active lifestyle.

Herbalife Nutrition’s targeted nutrition, weight-management, energy and fitness and personal care products are available exclusively to and through its independent members in more than 90 countries. Through its corporate social responsibility efforts, Herbalife Nutrition supports the Herbalife Family Foundation (HFF) and its Casa Herbalife programs to help bring good nutrition to children in need. Herbalife Nutrition is also proud to sponsor more than 190 world-class athletes, teams and events around the globe, including Cristiano Ronaldo, the LA Galaxy, and numerous Olympic teams.

Herbalife Nutrition has over 8,000 employees worldwide, and its shares are traded on the New York Stock Exchange (NYSE: HLF) with net sales of approximately US$4.4 billion in 2017. To learn more, visit Herbalife.com or IAmHerbalife.com.

Media Enquiries:

Daliea Mohamad-Liauw
VP, Corporate Communications, Herbalife Nutrition Asia Pacific
DID: +85235892643
Email: dalieal@herbalife.com

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Sinovac Forced to Temporarily Suspend Hepatitis A Vaccine Production Line Due to Disruptive Actions taken by Minority Shareholder of Sinovac Beijing

Actions of Aihua Pan continue to harm the Company’s shareholders and customers

BEIJING, May 8, 2018 /PRNewswire/ —  Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac ” or the “Company”), a leading provider of biopharmaceutical products in China, today announced it has been forced to suspend production at its plant for hepatitis A vaccine, and to destroy the bulk of its hepatitis A vaccines being produced at its Shangdi site, which is capable of producing approximately 3.5 million doses of finished product hepatitis A vaccines. The Company is not presently able to assess the impact on its sales of hepatitis A vaccine due to a lack of certainty regarding both the market’s reaction to this incident, as well as the schedule for resuming production.

Sinovac made this decision due to actions taken by Aihua Pan, the Chairman of the Board of the Company’s controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. (“Sinovac Beijing”), who was appointed by Sinobioway Biomedicine Co., Ltd. (“Sinobioway”), the minority shareholder of Sinovac Beijing.

Following the multiple disruptions of the Company’s power source by Sinobioway, Sinovac Beijing initiated its emergency response protocol and resumed production and quality management activities step by step. After hepatitis A vaccine production resumed on April 23, 2018, the quality assurance department performed several assessments of the production environment and vaccine safety. Unfortunately, it was determined that the quality and safety of the vaccines could not be sufficiently verified to the Company’s high standards. Given the fact that Sinobioway continues to disrupt operations at Sinovac Beijing, the Company has decided again to temporarily suspend the hepatitis A vaccine production plant and the production of bulk of hepatitis A vaccine. The Company will inspect the affected plant, fumigate and sterilize the facilities, and verify whether any equipment was damaged by the power outage in April.

On May 6, 2018 a group of approximately 20 people wearing security uniforms surrounded Sinovac Beijing’s office, and threatened and intimidated the Company’s employees. In the altercation, one of our employees was pushed to the ground and injured by a security guard working for Sinobioway. The Sinobioway security guard was detained by police for questioning, while the Sinovac Beijing employee was treated and discharged from the emergency center of the Red Cross.

Mr. Pan and others have taken a number of aggressive actions that continue to harm the Company’s shareholders and customers. These actions include intentionally interfering with the audit of the Company’s financials, forcibly taking control of Sinovac Beijing’s corporate offices and the Shangdi site, limiting the physical movement of the employees in Sinovac Beijing’s general manager’s office and finance department, cutting the power to the Shangdi site, disrupting Sinovac Beijing’s hepatitis A and seasonal flu vaccine production, and forcing the Company to destroy vaccines.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical Company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71, or EV71, hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), and mumps. Healive, the hepatitis A vaccine manufactured by the Company has passed the assessment under WHO Prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines to over 10 countries in Asia and South America.

Safe Harbor Statement

This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements.

Contacts:

Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
Email: ir@sinovac.com

Media
ICR Inc.
United States
Phil Denning
Tel: 1-646 277 1258
Email : Phil.denning@icrinc.com

China:
Edmond Lococo
Tel: +86 10 6583 7510
Email : Edmond.Lococo@icrinc.com

Investors:
ICR Inc.
Bill Zima
Tel: 1-203–682-8233
Email: william.zima@icrinc.com

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Source: Sinovac Biotech Ltd.

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