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Friday, 22 September 2017

ASM International NV (NL) - ASM INTERNATIONAL N.V. ANNOUNCES DETAILS OF SHARE BUYBACK PROGRAM

ASM International NV    

Published: 07:58 CEST 22-09-2017 /GlobeNewswire /Source: ASM International NV / : ASM /ISIN: NL0000334118


 

 

Almere, The Netherlands

September 22, 2017

 

 

 

ASM International N.V. (Euronext Amsterdam: ASM) ("ASMI") today announces that it will commence a share buyback program of ASMI's common shares up to €250 million.

 

 

This program follows on ASMI's announcement on April 24, 2017, that the proceeds of approximately €248 million of the partial secondary placement of shares of ASM Pacific Technology Ltd are intended to be used for a new share buyback program. The previous €100 million share buyback program that was announced on October 26, 2016, was completed on August 31, 2017.

 

This share buyback program will be executed by a third party. The program will commence on September 21, 2017, and will end as soon as the aggregate purchase price of the common shares acquired by ASMI has reached €250 million, but ultimately on November 25, 2018. ASMI strives to complete the program well before that date. The program will in any event take place within the mandate given by the shareholders during the Annual General Meeting of Shareholders of May 25, 2017.

 

ASMI has the intention to reduce its capital by withdrawing the repurchased shares after having received the approval from its shareholders. The repurchase program is part of ASMI's commitment to use excess cash for the benefit of its shareholders.

 

ASMI will update the market on the progress of the share buyback program on a weekly base. This information will also be published on the ASMI website (www.asm.com).

 

 

About ASM International

ASM International NV, headquartered in Almere, the Netherlands, its subsidiaries and participations design and manufacture equipment and materials used to produce semiconductor devices. ASM International, its subsidiaries and participations provide production solutions for wafer processing (Front-end segment) as well as for assembly & packaging and surface mount technology (Back-end segment) through facilities in the United States, Europe, Japan and Asia. ASM International's common stock trades on the Euronext Amsterdam Stock Exchange (symbol ASM). For more information, visit ASMI's website at www.asm.com.

 

Cautionary Note Regarding Forward-Looking Statements: All matters discussed in this press release, except for any historical data, are forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These include, but are not limited to, economic conditions and trends in the semiconductor industry generally and the timing of the industry cycles specifically, currency fluctuations, corporate transactions, financing and liquidity matters, the success of restructurings, the timing of significant orders, market acceptance of new products, competitive factors, litigation involving intellectual property, shareholder and other issues, commercial and economic disruption due to natural disasters, terrorist activity, armed conflict or political instability, epidemics and other risks indicated in the Company's reports and financial statements. The Company assumes no obligation nor intends to update or revise any forward-looking statements to reflect future developments or circumstances.

 

CONTACT

Investor contact:

 

Victor Bareño

T: +31 88 100 8500

E: victor.bareno@asm.com

 

Media contact:

 

Ian Bickerton

T: +31 625 018 512




Press Release Details of Share Buyback Program



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: ASM International NV, Postbus 60165, Almere 1320 AE, Nederland
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Monobank ASA: MONO-ME Issuance of shares under incentive scheme

Monobank ASA    

Published: 07:31 CEST 22-09-2017 /GlobeNewswire /Source: Monobank ASA / : MONO-ME /ISIN: NO0010752231

Monobank ASA: MONO-ME Issuance of shares under incentive scheme

Bergen 22 september 2017
 
Reference is made to Monobank ASA's (the "Bank") share incentive 
scheme approved by the Annual General Meeting in 2016 and as 
described in the Bank's admission document dated 15 February 2017.
 
The Bank's Board of Directors has today resolved to issue 222,220 
shares to employees of the Bank in accordance with the share 
incentive program, each share with a nominal value of NOK 1 and at an 
exercise price of NOK 2,80 per share. The share capital increase pertaining to 
the share issue will be made on the basis of the board authorisation 
granted by the Annual General Meeting in 2016.
 
 
This information is subject to the disclosure requirements in the 
Continuing obligations of companies admitted to trading on Merkur 
Market.
 
For further information please contact:
Lene Sjøbakk, CFO, +47 940 19 896
This information is subject to the disclosure requirements pursuant to section 5 -12 of the Norwegian Securities Trading Act.




This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Monobank ASA, Starvhusgaten 4, Bergen 5014, Norge
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Orion Pharma scientists led research group wins award for study paper on dexmedetomidine oromucosal gel for noise anxiety in dogs

Orion Oyj    



ORION CORPORATION            PRESS RELEASE        22 SEPTEMBER 2017 at 8.30 EEST          

 

Orion Pharma scientists led research group wins award for study paper on dexmedetomidine oromucosal gel for noise anxiety in dogs

Orion Pharma scientists led research group has been recognised for the impact of their research by leading industry journal. Dr. Mira Korpivaara (DVM) and Dr. Mirja Huhtinen (DVM, PhD) from Orion Pharma Research and Development with their collaborators have been awarded with the Veterinary Record Impact Award by the British Veterinary Associations's renowed weekly journal Veterinary Record. The impact award recognizes a research paper published in the journal within the previous 12 months that is considered to have the most potential contribution for changing veterinary practice.

 

The winning paper "Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs - a randomised, double-blind, placebo-controlled clinical study" by Mira Korpivaara, Mirja Huhtinen and their collaborators, veterinary behaviour specialists Karen Overall (University of Pennsylvania, USA), Barbara Schöning (Veterinary Specialty Practice for Behaviour, Hamburg, Germany) and Kaisa Laapas (Biostatistician), reported the results from a clinical study demonstrating that oromucosal dexmedetomidine gel at subsedative doses alleviates noise-associated acute anxiety and fear in dogs.

 

According to the reviewers, the paper is an important contribution to the literature on acute anxiety and fear associated with noise in dogs. The judges commended the study for being a randomised, double-blind, placebo-controlled clinical study of the appropriate power. In addition, the editorial accompanying the report in Veterinary Record highlighted the welfare aspect of the treatment, commenting: 'dexmedetomidine gel provides an important part of the arsenal of any welfare centred practice and extends the opportunity for veterinarians to more fully engage with the prevalent welfare problem of noise sensitivity.'

 

"We are very excited and proud of the recognition by the Veterinary Record. There is an unmet need for treatment options for dogs suffering from noise anxiety. Our study demonstrated that dexmedetomidine oromucosal gel provides veterinarians a treatment option for alleviation of acute anxiety and fear associated with noise in dogs", says Dr. Mira Korpivaara from Orion Pharma.

 

More information:

Mira Korpivaara, DVM, Development Leader, Orion Pharma Animal Health

tel. +41 79 196 35 47, mira.korpivaara@orionpharma.com

 

Link to research paper: http://veterinaryrecord.bmj.com/content/vetrec/180/14/356.full.pdf

 

 

Publisher:

Orion Corporation

Communications

Orionintie 1A, FI-02200 Espoo, Finland

Homepage: www.orion.fi

 

 

Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion developes inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2016 amounted to EUR 1,074 million and the company had about 3,500 employees. Orion's A and B shares are listed on Nasdaq Helsinki. Founded in 1917, Orion celebrates its centennial anniversary in 2017.





This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Orion Oyj, Orionintie 1, PL 65, Espoo 02101, Finland
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BGHL (GBP): NAV(s)

BOUSSARD AND GAVAUDAN HOLDING LIMITED (GBP)    

Published: 07:30 CEST 22-09-2017 /GlobeNewswire /Source: BOUSSARD AND GAVAUDAN HOLDING LIMITED (GBP) / : BGHS /ISIN: GG00B39VMM07

BGHL (GBP): NAV(s)

                                      BOUSSARD & GAVAUDAN HOLDING LIMITED

Ordinary Shares

 

The Directors of Boussard & Gavaudan Holding Limited would like to announce the following information for the Company.

 

Close of business 21 Sep 2017.

 

Estimated NAV

 

 

Euro Shares

Sterling Shares

Estimated NAV

€  23.6449

£  20.8575

Estimated MTD return

 -0.75 %

 -0.68 %

Estimated YTD return

 6.77 %

 7.29 %

Estimated ITD return

 136.45 %

 108.58 %

 

NAV and returns are calculated net of management and performance fees

 

Market information

 

Euro Shares

Amsterdam (AEX)

London (LSE)

Market Close

€  19.95

N/A

Premium/discount to estimated NAV

 -15.63 %

N/A

 

 

 

Sterling Shares

Amsterdam (AEX)

London (LSE)

Market Close

N/A

GBX 1,725.00

Premium/discount to estimated NAV

N/A

 -17.30 %

 

 

Transactions in own securities purchased into treasury

 

Ordinary Shares

Euro Shares

Sterling Shares

Number of shares

N/A

N/A

Average Price

N/A

N/A

Range of Price

N/A

N/A

           

                                           

Liquidity Enhancement Agreement

Euro Shares

Sterling Shares

Number of shares

N/A

N/A

Average Price

N/A

N/A

 

BGHL Capital

 

BGHL Ordinary Shares

Euro Shares

Sterling Shares

Shares Outstanding

 28,862,115

 528,912

Held in treasury

N/A

N/A

Shares Issued

 28,862,115

 528,912

 

Estimated BG Fund NAV

 

Class B Euro Shares (estimated)

€  187.7421

 

The Class B Euro Shares of BG Fund are not subject to investment manager fees, as the Investment Manager receives management fees and performance fees in respect of its role as Investment Manager of BGHL.

 

 

For further information please contact:

Boussard & Gavaudan Investment Management, LLP.
Emmanuel Gavaudan +44 (0) 20 3751 5389 Email :
info@bgam-uk.com

 

The Company is established as a closed-ended investment company domiciled in Guernsey. The Company has received the necessary approval of the Guernsey Financial Services Commission and the States of Guernsey Policy Council. The Company is registered with the Dutch Authority for the Financial Markets as a collective investment scheme pursuant to article 2:73 in conjunction with 2:66 of the Dutch Financial Supervision Act (Wet op het financieel toezicht). The shares of the Company (the "Shares") are listed on Euronext Amsterdam. The Shares are also listed on the Official List of the UK Listing Authority and admitted to trading on the London Stock Exchange plc's main market for listed securities.

 

This is not an offer to sell or a solicitation of any offer to buy any securities in the United States or in any other jurisdiction. This announcement is not intended to and does not constitute, or form part of, any offer or invitation to purchase any securities or the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issuance or transfer of the securities referred to in this announcement in any jurisdiction in contravention of applicable law.

Neither the Company nor BG Fund ICAV has been, and neither will be, registered under the US Investment Company Act of 1940, as amended (the "Investment Company Act"). In addition the securities referenced in this announcement have not been and will not be registered under the US Securities Act of 1933, as amended (the "Securities Act"). Consequently any such securities may not be offered, sold or otherwise transferred within the United States or to, or for the account or benefit of, US persons except in accordance with the Securities Act or an exemption therefrom and under circumstances which will not require the issuer of such securities to register under the Investment Company Act. No public offering of any securities will be made in the United States.

You should always bear in mind that:

all investment is subject to risk;

results in the past are no guarantee of future results;

the investment performance of BGHL may go down as well as up. You may not get back all of your original investment; and

if you are in any doubt about the contents of this communication or if you consider making an investment decision, you are advised to seek expert financial advice.

 

This communication is for information purposes only and the information contained in this communication should not be relied upon as a substitute for financial or other professional advice.

 

 

 



Estimated NAV



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: BOUSSARD AND GAVAUDAN HOLDING LIMITED (GBP), One Vine Street, London W1J 0AH, UK
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BGHL (EUR): NAV(s)

BOUSSARD AND GAVAUDAN HOLDING LIMITED (EUR)    

Published: 07:30 CEST 22-09-2017 /GlobeNewswire /Source: BOUSSARD AND GAVAUDAN HOLDING LIMITED (EUR) / : BGHL /ISIN: GG00B1FQG453

BGHL (EUR): NAV(s)

                                      BOUSSARD & GAVAUDAN HOLDING LIMITED

Ordinary Shares

 

The Directors of Boussard & Gavaudan Holding Limited would like to announce the following information for the Company.

 

Close of business 21 Sep 2017.

 

Estimated NAV

 

 

Euro Shares

Sterling Shares

Estimated NAV

€  23.6449

£  20.8575

Estimated MTD return

 -0.75 %

 -0.68 %

Estimated YTD return

 6.77 %

 7.29 %

Estimated ITD return

 136.45 %

 108.58 %

 

NAV and returns are calculated net of management and performance fees

 

Market information

 

Euro Shares

Amsterdam (AEX)

London (LSE)

Market Close

€  19.95

N/A

Premium/discount to estimated NAV

 -15.63 %

N/A

 

 

 

Sterling Shares

Amsterdam (AEX)

London (LSE)

Market Close

N/A

GBX 1,725.00

Premium/discount to estimated NAV

N/A

 -17.30 %

 

 

Transactions in own securities purchased into treasury

 

Ordinary Shares

Euro Shares

Sterling Shares

Number of shares

N/A

N/A

Average Price

N/A

N/A

Range of Price

N/A

N/A

           

                                           

Liquidity Enhancement Agreement

Euro Shares

Sterling Shares

Number of shares

N/A

N/A

Average Price

N/A

N/A

 

BGHL Capital

 

BGHL Ordinary Shares

Euro Shares

Sterling Shares

Shares Outstanding

 28,862,115

 528,912

Held in treasury

N/A

N/A

Shares Issued

 28,862,115

 528,912

 

Estimated BG Fund NAV

 

Class B Euro Shares (estimated)

€  187.7421

 

The Class B Euro Shares of BG Fund are not subject to investment manager fees, as the Investment Manager receives management fees and performance fees in respect of its role as Investment Manager of BGHL.

 

 

For further information please contact:

Boussard & Gavaudan Investment Management, LLP.
Emmanuel Gavaudan +44 (0) 20 3751 5389 Email :
info@bgam-uk.com

 

The Company is established as a closed-ended investment company domiciled in Guernsey. The Company has received the necessary approval of the Guernsey Financial Services Commission and the States of Guernsey Policy Council. The Company is registered with the Dutch Authority for the Financial Markets as a collective investment scheme pursuant to article 2:73 in conjunction with 2:66 of the Dutch Financial Supervision Act (Wet op het financieel toezicht). The shares of the Company (the "Shares") are listed on Euronext Amsterdam. The Shares are also listed on the Official List of the UK Listing Authority and admitted to trading on the London Stock Exchange plc's main market for listed securities.

 

This is not an offer to sell or a solicitation of any offer to buy any securities in the United States or in any other jurisdiction. This announcement is not intended to and does not constitute, or form part of, any offer or invitation to purchase any securities or the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issuance or transfer of the securities referred to in this announcement in any jurisdiction in contravention of applicable law.

Neither the Company nor BG Fund ICAV has been, and neither will be, registered under the US Investment Company Act of 1940, as amended (the "Investment Company Act"). In addition the securities referenced in this announcement have not been and will not be registered under the US Securities Act of 1933, as amended (the "Securities Act"). Consequently any such securities may not be offered, sold or otherwise transferred within the United States or to, or for the account or benefit of, US persons except in accordance with the Securities Act or an exemption therefrom and under circumstances which will not require the issuer of such securities to register under the Investment Company Act. No public offering of any securities will be made in the United States.

You should always bear in mind that:

all investment is subject to risk;

results in the past are no guarantee of future results;

the investment performance of BGHL may go down as well as up. You may not get back all of your original investment; and

if you are in any doubt about the contents of this communication or if you consider making an investment decision, you are advised to seek expert financial advice.

 

This communication is for information purposes only and the information contained in this communication should not be relied upon as a substitute for financial or other professional advice.

 

 

 



Estimated NAV



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: BOUSSARD AND GAVAUDAN HOLDING LIMITED (EUR), One Vine Street, London W1J 0AH, UK
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Novartis and The Max Foundation transform pioneering cancer access program for people in lower-income countries

Novartis International AG    

Novartis and The Max Foundation transform pioneering cancer access program for people in lower-income countries

  • CMLPath to Care(TM) collaboration replaces Glivec International Patient Access Program (GIPAP) with a new, independent, patient-centered access model
     
  • GIPAP was introduced 15 years ago and has provided approximately 75,000 patients access to free, cancer treatment
     
  • The Max Foundation to lead program for patients and oversee supply chain management; Novartis to contribute funding and product donation

 

Basel, September 22, 2017 - Novartis announced a new collaboration with The Max Foundation to support continued access to treatment at no cost for nearly 34,000 current patients with chronic myeloid leukemia (CML), gastrointestinal tumors (GIST) and other rare cancers. The two organizations have been long-time collaborators in providing access to care for patients in lower-income countries through the Glivec International Patient Assistance Program (GIPAP), one of the most innovative patient assistance programs ever implemented on a global scale.

 

The new collaboration, called CMLPath to Care(TM), is an evolution from GIPAP, a partnership that provided Glivec® (imatinib)* at no cost to diagnosed patients in lower-income countries where there may not be access to reimbursement or funding mechanisms, and to those unable to pay for the medication. Under the new initiative, The Max Foundation, a global, patient-focused, non-governmental organization (NGO), will assume from Novartis the responsibility for delivering the treatment to these patients, including supply chain management. Novartis will provide funding and drug donation support. The collaborative agreement runs through Q1 2021 with an option to extend. During this timeframe, Novartis expects to donate more than $29 million to the collaboration, along with approximately 315,000,000 doses of medicine.

 

Novartis introduced GIPAP in 2002 after recognizing the impact of its breakthrough cancer therapy, Glivec. The program has served the CML treatment needs of approximately 75,000 people since its inception.

 

"Fifteen years ago, Novartis recognized the critical importance of ensuring patients in lower-income countries had access to breakthrough cancer therapy, and we partnered with The Max Foundation to develop a revolutionary global program to address this need," said Bruno Strigini, CEO of Novartis Oncology. "CMLPath to Care renews and extends our unique collaboration with The Max Foundation and builds on the strengths of both organizations to better serve these patients."

 

CMLPath to Care: A Patient-Centered Model of Access and Support 

The goal of CMLPath to Care is to help people living with CML by connecting them and their carers with effective treatments, professional medical capabilities, trained physicians and hands-on support. Under the previous GIPAP model, Novartis managed the entire supply chain for the medicine and interacted directly with local stakeholders (e.g., physicians, treatment centers, NGOs, private companies and governments) in more than 75 countries where it operated. The Max Foundation provided CML patients with psychosocial support and education, services that did not previously exist in certain countries. Over time, changes in local infrastructures and capabilities, new and innovative treatments, and the growth and impact of patient groups prompted Novartis and The Max Foundation to recognize that a new, more flexible approach to access was needed.

 

With CMLPath to Care, Novartis will provide access to Glivec in nearly 70 countries, and in a subset of countries second-line Tasigna® (nilotinib) therapy will be available for approved indications. The Max Foundation will manage the entire medicine supply chain and interactions with local stakeholders under the umbrella of Max Access Solutions, while continuing to provide hands-on, local patient support.

 

"Since our founding 20 years ago, The Max Foundation has grown extensively in its efforts and ability to help people face cancer with dignity and hope," said Pat Garcia-Gonzalez, CEO of The Max Foundation. "We are proud of the thousands of patients' lives touched by our long-standing collaboration with Novartis and are pleased with our shared continued innovation, commitment and support for underserved patients with CML and other rare cancers in low resource countries."

 

Novartis and The Max Foundation Innovate with a Global Direct-to Patient Humanitarian Program: Reimagining What's Possible for CML Care

CMLPath to Care is one of the broadest cancer treatment access initiatives led by a patient-centered NGO. During the last 15 years, the Novartis-Max Foundation partnership created and maintained a standard of care in many lower-income countries that may not have otherwise been possible for people with CML. In this new model - as in GIPAP - the medicine is provided at no cost for individual patients. This contrasts with more traditional humanitarian programs that provide bulk donations of a medicine. The Max Foundation is unique among NGOs in its ability to manage the complex administration of individual patient care. The transition to CMLPath to Care includes The Max Foundation's assumption of program administration, supply chain management and oversight of the nearly 34,000 patients, 1,400 physicians, and 450 treatment centers in nearly 70 countries on four continents. 

 

The enduring partnership with The Max Foundation has been a key component of Novartis' long-term focus on bringing CML care to those who need the most support. The company is dedicated to transforming the lives of people with CML and holds an unwavering commitment to reimagining what is possible for CML treatment through scientific innovation and creative solutions that provide access to care regardless of geography or financial situation. 

 

To ensure a seamless transition for patients, the program will move from Novartis to The Max Foundation through the first half of 2018 on a country-by-country basis. Both organizations are represented on an operational committee that will meet four times each year to ensure the collaboration is meeting its goals and operating efficiently.

 

About CMLPath to Care

CMLPath to Care is a unique global initiative for people with CML. Developed and managed by The Max Foundation and supported by Novartis Oncology through drug donations and funding, CMLPath to Care connects people living with CML and their carers with effective treatments, professional medical capabilities, trained physicians and hands-on support. With origins in a novel collaboration between the two organizations beginning in 2002, the program has delivered individual care to approximately 75,000 patients in more than 75 countries.

 

About Glivec (imatinib)

Glivec (imatinib) is approved in more than 110 countries, for the treatment of adult patients in all phases of Philadelphia chromosome-positive (Ph+) CML, for the treatment of patients with KIT (CD117)-positive GIST, which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST.

 

Not all indications are available in every country.

 

Glivec Important Safety Information

Glivec is contraindicated in patients who are hypersensitive to imatinib or any of the excipients.

 

Glivec can cause fetal harm when administered to a pregnant woman. Women should not become pregnant, and should be advised of the potential risk to the unborn child.

 

Glivec has been associated with severe edema (swelling) and serious fluid retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are common, generally reversible and usually managed by withholding Glivec or dose reduction. Monitor blood counts regularly. Severe congestive heart failure and left ventricle dysfunction, severe liver problems including cases of fatal liver failure and severe liver injury requiring liver transplants have been reported. Caution in patients with cardiac dysfunction and hepatic dysfunction. Monitor carefully. Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TKI treatment.

 

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking levothyroxine replacement, GI perforation, in some cases fatal, tumor lysis syndrome which can be life threatening have also been reported with Glivec. Correct dehydration and high uric acid levels prior to treatment. Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use. In patients with hypereosinophilic syndrome and heart involvement, cases of heart disease have been associated with the initiation of Glivec therapy. Growth retardation has been reported in children taking Glivec. The long-term effects of extended treatment with Glivec on growth in children are unknown.

 

The most common side effects include fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash. Glivec should be taken with food and a large glass of water.

 

Please see full Prescribing Information available at www.glivec.com.

 

About Tasigna (nilotinib)

Tasigna® (nilotinib) is approved in more than 122 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec® (imatinib), and in more than 110 countries for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.

 

IMPORTANT SAFETY INFORMATION for TASIGNA® (nilotinib) Capsules

Use with caution in patients with uncontrolled or significant cardiac disease and in patients who have or may develop prolongation of QTc. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Monitor closely for an effect on the QTc interval. Baseline ECG is recommended prior to initiating therapy and as clinically indicated. Cases of sudden death have been reported in clinical studies in patients with significant risk factors. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and 1 hour after taking dose. Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TKI treatment.

 

Use with caution in patients with liver impairment, with a history of pancreatitis and with total gastrectomy. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not use Tasigna. Tasigna may cause fetal harm in pregnant women. If pregnancy is planned during the treatment-free remission phase, the patient must be informed of a potential need to re-initiate treatment with Tasigna during pregnancy. Women taking Tasigna should not breastfeed.

 

Cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive disease, and ischemic cerebrovascular events have been reported. Serious cases of hemorrhage from various sites including gastrointestinal were reported in patients receiving Tasigna. Grade 3 or 4 fluid retention including pleural effusion, pericardial effusion, ascites and pulmonary edema have been reported. Cases of tumor lysis syndrome have been reported in Tasigna-treated patients who were resistant or intolerant to prior CML therapy.

 

Eligible patients who are confirmed to express the typical BCR-ABL transcripts, e13a2/b2a2 or e14a2/b3a2, can be considered for treatment discontinuation. Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation must be performed with a quantitative diagnostic test validated to measure molecular response levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL <=0.0032% IS). BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation. Loss of major molecular response (MMR=BCR-ABL/ABL <=0.1%IS) or confirmed loss of MR4 (two consecutive measures separated by at least 4 weeks showing loss of MR4 (MR4=BCR-ABL/ABL <=0.01%IS)) will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred. It is crucial to perform frequent monitoring of BCR-ABL transcript levels and complete blood count with differential in order to detect possible loss of remission. For patients who fail to achieve MMR after three months of treatment re initiation, BCR-ABL kinase domain mutation testing should be performed.

 

The most frequent Grade 3 or 4 adverse events are hematological (neutropenia, thrombocytopenia, anemia) which are generally reversible and usually managed by withholding Tasigna temporarily or dose reduction. Chemistry panels, including electrolytes, lipid profile, liver enzymes, and glucose should be checked prior to therapy and periodically. Tasigna can cause increases in serum lipase. The most frequent non-hematologic adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea.

 

Musculoskeletal pain, myalgia, pain in extremity, arthralgia, bone pain and spinal pain may occur upon discontinuing treatment with Tasigna within the framework of attempting treatment-free remission.

 

Please see full Prescribing Information including Boxed WARNING at www.tasigna.com.

 

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About The Max Foundation (www.themaxfoundation.org)

The Max Foundation is a non-profit global health organization that believes all people living with cancer deserve access to the best treatment, care and support.

The Foundation decreases premature mortality from cancer by channeling humanitarian donations of life-saving oncology products to underserved populations in countries where those products are not locally available. Our organization solicits in-kind donations of targeted oncology drugs from major pharmaceutical manufacturers and distributes them to verified patients in need using an innovative model that provides end-to-end supply chain controls.

By partnering with the major cancer institutions and patient associations in low- and middle-income countries, we enable effective solutions for access to treatment.

 

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

 

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*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel.

 

# # #

 

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

 

Eric Althoff

Novartis Global Media Relations

+41 61 324 7999 (direct)

+41 79 593 4202 (mobile)

eric.althoff@novartis.com

Mary Curtin Creaser

Novartis Oncology Communications

+1 862 778 2550 (direct)

+1 862 345 4102 (mobile)

mary.curtin_creaser@novartis.com

 

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

 

Central

 

North America

 

Samir Shah

+41 61 324 7944

Richard Pulik

+1 212 830 2448

Pierre-Michel Bringer

+41 61 324 1065

Cory Twining

+1 212 830 2417

Thomas Hungerbuehler

+41 61 324 8425

 

 

Isabella Zinck

+41 61 324 7188

 

 

 

 




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