Daily Archives: September 2, 2019

Helsinn signs exclusive distribution and license agreements with Blanver and Varifarma for Pracinostat in South America

Lugano, Switzerland, São Paulo, Brazil, and Buenos Aires, Argentina, September 2, 2019 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, together with Blanver Farmoquímica e Farmacêutica S.A., a Brazilian company focused on innovative products with high quality medicines and active pharmaceutical ingredients, committed to expand patient access, and Laboratorio Varifarma SA, a company focused on complex therapies and orphan diseases, and devoted to improving the patient’s quality of life today announce they have signed exclusive distribution and licensing agreements for Pracinostat in South America.

Under the terms of the agreements, São Paulo-based Blanver will register, promote, distribute and commercialize Pracinostat in Brazil, while Varifarma, located in Buenos Aires, will cover Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru, and Uruguay. Helsinn will retain all international development rights, including clinical development activities, and the supply of Pracinostat.

Blanver and Varifarma recently agreed a strategic alliance in Latin America, in order to create a portfolio of medicines for the treatment of diverse pathologies, including hematology and oncology.

Pracinostat is a pan histone deacetylase inhibitor. The compound is currently under development in  a multi-national phase III trial in combination with Azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive induction chemotherapy; Pracinostat is also being tested in an open label phase II study in combination with Azacitidine for the treatment of naïve patients with high risk myelodysplastic syndromes (MDS).

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “We’re delighted to have signed these agreements with two expert partners in Latin America, with the local market experience to help to broaden the potential reach of Pracinostat to the patients who need it most. A key factor when choosing our partners is to make sure they share our principles, values and ethics and they have a focus on quality, results orientation and social responsibility – both Blanver and Varifarma share this vision and we look forward to working with them.

Sergio Frangioni, Blanver Group CEO, commented: “Innovation is part of Blanver’s DNA, with this characteristic, we are proud to bring Pracinostat and honored to have Helsinn as our partner in Brazil, where we share the same values and strategic vision, bringing innovative treatments that will surely benefit patients.”

Marcelo Conti, Laboratorio Varifarma Director, commented: “It is a great satisfaction for Varifarma to have been chosen to represent Helsinn and its product Pracinostat, for Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru and Uruguay. We take this challenge with great commitment and the responsibility we use to work with. Sharing the same values and ethics, we look forward to start a successful venture together providing care and novel products to more patients in our region.”

About Pracinostat

Pracinostat is an oral HDAC that is in a pivotal Phase III study in combination with Azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (“AML”) who are unfit for intensive induction chemotherapy. It is also being evaluated in a Phase II study in patients with high risk myelodysplastic syndromes (“MDS”). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

In 2016 Helsinn obtained global rights to Pracinostat from MEI Pharma, Inc. under an exclusive license, development and commercialization agreement, the terms of which are not altered by the sublicense agreement, which also included the right for Helsinn to grant sublicenses to third parties.

Exclusive licensing rights for all territories excluding US, Canada, Japan and South America were granted to Menarini, the Italian biopharmaceutical group, in December 2018.

Pracinostat is an investigational agent and is not approved for commercial use in the U.S. and any other country worldwide.

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com

About Blanver

A Brazilian company, founded in 1984, which develops, manufactures and commercializes medicines and active pharmaceutical ingredients (APIs). In medicines, we develop and manufacture high quality products in the HIV, hepatitis and osteoporosis segments. In Hematology and Oncology, we have established strategic alliances with international partners of recognized quality, to license and commercialize innovative and established products. Blanver develops, produces and incorporates quality and competitive innovative products, always seeking to promote people’s health, quality of life and wellbeing. We are based in Sao Paulo, with a corporate headquarters and two production plants: pharmaceutical and API unit.

About Varifarma

Focused on complex therapies and orphan diseases, Varifarma is a company which is devoted to improving the patient’s quality of life. It is our continuous commitment is with innovation and the search of new effective therapies what has placed us as market reference. We are renowned for our product’s high quality and our sustained commitment with the medical and scientific community. For over two decades, we have counted with distinguished professionals who have actively contributed to the search for the best solutions to patients, as well as for new challenges.

For more information:

Helsinn Group Media Contact

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Info-hhc@helsinn.com

For more information, please visit www.helsinn.com and follow us on TwitterLinkedIn and Vimeo

Blanver Media Contact

Patricia Rodrigues

Group Head of Communication

São Paulo, Brazil

Tel: +55 (11) 4138-8202

info@blanver.com.br

For more information, please visit www.blanver.com.br and follow us on Facebook and LinkedIn

Varifarma Media Contact

Luciana Conti

Group Head of Communication

Buenos Aires, Argentina

Tel: +54 (9) 11 67698047

lconti@varifarma.com.ar

For more information, please visit www.varifarma.com and follow us on  Facebook and LinkedIn. 

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Dr Mahathir: Muslims Must Be Industrious and Stop Being Dependent

PHNOM PENH, Tun Dr Mahathir Mohamad today urged Muslims to do away with the mentality of depending on others for aid and assistance.

The Malaysian prime minister said Muslims must constantly strive to be industrious, honest and efficient to enhance their socio-economic standing.

It is very sad when we find Muslims everywhere mired in poverty and dependant on aid from others. Why? That is because they do not make enough effort.

We know that when we own a trade or have a job, we do not have to rely on others.

However, what we are seeing is the opposite we have the intelligence and the skills but we are not taking advantage of them. That is why we have to return to the foundations of Islam, the premier said.

Earlier, Dr Mahathir received a courtesy call from Cambodian Muslim leader cum Senior Minister-in-charge of Islamic Affairs, Datuk Dr Othman Hassan.

The prime minister, accompanied by his wife, Tun Dr Siti Hasmah Mohd Ali, arrived in Phnom Penh today for a three-day official visit to Cambodia after 25 years at the invitation of his Cambodian counterpart Hun Sen.

At the same event, Dr Mahathir was honoured with the Muslim Exemplary Leadership award by the Cambodian Muslim Community in recognition of Malaysia’s role in assisting the Muslims in the country.

Later, Dr Mahathir and Dr Siti Hasmah attended a dinner with the Malaysian diaspora here.

Some 300 Malaysians working and residing in the Cambodian capital attended the dinner.

Source: Office of the Prime Minster Malaysia

Reply to Parliamentary Question on Erroneous Transfers of Monies by Bank Customers

Name and Constituency of Member of Parliament

Er Dr Lee Bee Wah, MP, Nee Soon GRC

Question:

To ask the Prime Minister (a) whether there is an increasing number of cases of monies wrongly credited by a person to a bank account of an individual; and (b) whether our banks are required to freeze such monies and return them to the rightful sender and, if not, why.

Answer by Mr Tharman Shanmugaratnam, Senior Minister and Minister in charge of MAS:

1. With the growth in electronic funds transfers, there have been some reported cases where monies were transferred by bank customers to unintended recipients. This can happen when a person makes typographical errors while setting out the e-payment instructions, but such instances are rare.

2. When such an erroneous transfer occurs, the bank should help by engaging the recipient’s bank, so that the recipient is informed and a refund can be initiated. It is an offence under the Penal Code for the recipient to retain or use the funds when he has been informed that it was sent by mistake. If the wrongful recipient refuses to return the erroneously transferred monies, the sender should make a police report.

3. Er Dr Lee asked whether banks are required to freeze and automatically return monies to a sender when a sender says the monies were wrongly transferred. It would not be appropriate to impose such an automatic requirement on banks. First, a bank cannot be sure that the sender made a mistake. Second, automatically returning the monies to the sender will run the risk of abuse, and does not encourage more careful use of e-payment and transfers.

4. For example, a person who pays for an online purchase could subsequently ask his bank to reverse the payment upon receipt of the goods, claiming that the transaction was in error, and the banks are none the wiser.

5. To address the concerns relating to erroneous transfers, MAS has issued a set of guidelines to protect e-payments users. Under the guidelines, consumers will need to play their part and be responsible for accurate payments. On the banks’ part, they have to make reasonable efforts to assist the sender, as I have mentioned. And in the case of fraud, consumers should report to the Police promptly.

6. MAS will continue to work with the industry to raise consumer literacy and awareness on how to minimise wrongful e-payments. As in the case of cheques, the banks’ role is to ensure that all properly authenticated payment instructions are processed effectively and efficiently. And as customers, we all know we have to write our cheques accurately and properly.

Source: Monetary Authority of Singapore

Reply to Parliamentary Question on the European Commission’s decision to repeal the equivalence status for Singapore credit rating agencies

Name and Constituency of Member of Parliament

Q3026. Dr Lim Wee Kiak, MP, Sembawang GRC

Q3027. Ms Tin Pei Ling, MP, MacPherson SMC

Question:

Q3026. To ask the Prime Minister (a) what will be the impact of the withdrawal of market access rights to the European Union on our financial institutions; (b) what is the Government doing to mitigate the impact; and (c) how rigorous is our regulation of crediting ratings agencies as compared with that of the EU.

Q3027. To ask the Prime Minister (a) what are the implications of the European Commission’s decision to withdraw some market access rights of Singapore; (b) how may this affect investor confidence; and (c) what may be the interpretations of this move against the broader developments around the world.

Answer Mr Tharman Shanmugaratnam, Senior Minister and Minister in charge of MAS:

1. Some media reports might have given the impression that the European Commission (EC) is reducing its market access to financial institutions in Singapore. This is not true. There continues to be no impediment, for financial services provided out of Singapore to customers in the European Union (EU). There has also been no impact on investors’ confidence in Singapore.

2. Let me explain. The EC’s decision covers only Credit Rating Agencies (CRAs) and does not extend to any other financial services. Further, the EC recognises CRAs in a third country through two approaches:

First, deeming the third country’s CRA rules as equivalent to EC rules. This is called the equivalence decision;

Second, an endorsement approach, where the CRAs in the third country rely on their related entities in the EU to endorse their ratings.

CRAs in Singapore have been using the endorsement approach, and the EC has confirmed that it will continue to recognise Singapore-based CRAs using this approach.

3. Having said that, equivalence is the highest form of market integration, which CRAs in Singapore, like those in several other jurisdictions, no longer enjoy. The reason has to do with the different approaches taken by major regulators internationally. Dr Lim asked how MAS’ regulations on CRAs compare to those in the EU. Mr Leon Perera also raised a similar question for the next Parliament Sitting.

4. MAS’ CRA regulatory regime is based on, and consistent with, standards promulgated by the International Organisation of Securities Commissions (IOSCO), which is the global standard setting body. The EC has assessed MAS’ CRA regulatory regime to be less prescriptive than EU rules in certain areas, such as in defining specific situations in which a conflict of interest for the CRA arises. MAS takes a more principles-based approach. It nevertheless requires conflicts of interest to be effectively addressed, and is fully in line with international standards and appropriate to our context and needs.

5. Singapore is in good standing with the EU. We have EC recognition on a broad range of other financial services, including for over-the-counter derivatives trading venues and central counterparties. In July 2019, we were one of the first two jurisdictions to obtain EC equivalence for financial benchmarks regulation. MAS will continue to closely engage our EU counterparts in reviewing our rules to ensure that financial institutions in Singapore continue to have access to the EU market in various financial services.

Source: Monetary Authority of Singapore

Reply to Parliamentary Question on IMF’s assessment of Singapore’s financial system under the Financial Sector Assessment Programme

Name and Constituency of Member of Parliament

Mr Leon Perera, Non-Constituency Member of Parliament

Question:

To ask the Prime Minister in view of the findings in IMF’s Financial Sector Assessment Programme for Singapore, what resources and preparation are being applied by the MAS division that supervises payment systems to manage the broad scope of supervisory duties that it undertakes.

Answer by Mr Tharman Shanmugaratnam, Senior Minister and Minister in charge of MAS:

1. The IMF, in its recent assessment of the Singapore’s financial system under its Financial Sector Assessment Programme, reaffirmed Singapore’s financial sector oversight to be among the best globally.

2. Specifically, it concluded that MAS’ supervision of payment systems, namely – MEPS+, Fast And Secure Transfers (FAST), Inter-bank GIRO, Singapore Dollar Cheque Clearing, and the NETS Electronic Funds Transfer at Point of Sale (EFTPOS) – was in line with international standards, and appropriate and effective.

3. Notwithstanding, in anticipation of evolving systemic risks in the payments landscape, the IMF had recommended that MAS increase its resources for the supervision of payment systems. MAS’ thinking is the same as the IMF’s on this matter. MAS has indeed been allocating additional resources for supervision of payment activities and implementing enhancements to its supervisory programme. These include leveraging data analytics capabilities, and applying appropriate standards to retail payment systems in line with their changing systemic importance. MAS will continue to watch developments in the payments landscape and ensure its capabilities and supervisory approaches are appropriate.

Source: Monetary Authority of Singapore

ASEAN Remains Relevant, Should Forge Greater Cooperation to Face Superpowers – Dr M

PHNOM PENH, Malaysian Prime Minister Tun Dr Mahathir Mohamad today said that ASEAN has remained as a relevant regional grouping in the world and should continue to strengthen its cooperation in facing challenges and influences by superpowers.

He said many may claim that today’s ASEAN is not as active as before, but they could not deny the fact that the 10-member economic bloc is among the few regional groupings which had survived so far.

If one of us (ASEAN member countries) goes into international negotiation, it will not carry much weight and strength in the argument. Therefore, it is better we have discussions as ASEAN and go as a group representing all 10 member countries.

If you look at many regions in the world, however, you may find ASEAN is one of the few peaceful and stable regions in the world because we work together.

ASEAN is still very relevant and I hope it will continue to strengthen itself with greater cooperation among its member countries, he said today.

Dr Mahathir, who is on a three-day official visit to Cambodia starting today, said this at a dialogue session on Balancing Relations with the Superpowers in the Context of ASEAN at the Royal University of Phnom Penh (RUPP) here today.

Also present were Foreign Minister Datuk Saifuddin Abdullah, International Trade and Industry Minister Datuk Darell Leiking and RUPP’s Rector Dr Chet Chealy.

When asked on the possibility of ASEAN member countries to leave the bloc just like the United Kingdom leaving the European Union (EU), Dr Mahathir said, I don’t think it will happen.

He said ASEAN is an association of countries which retain their identity and their own way of doing things but the bloc would make common stands in terms of trade.

We are a loose association of countries. We live in peace and prosperity for all.

If a country were to leave ASEAN, it will not destroy ASEANI don’t think it will happen in ASEAN grouping, he said.

On the ongoing trade war between the United States and China, Dr Mahathir said it was a waste of time, money and a ‘very unproductive’ act.

Describing the trade war as silly, he said the United States and China should try to negotiate or have arbitration and settle things in the court of law.

After all, they are the people, especially the United States, that have been urging as to accept the rule of law. The trade war is not in accordance with the rule of law. So, I hope those who preach democracy and the rule of law should also abide by the same rule they propose for other countries, he said.

Meanwhile, Dr Mahathir was also conferred an Honorary Fellowship Award by RUPP for his outstanding achievement in decades for the betterment of the world and modernization of Malaysia as well as ‘curing’ the political, social and economic disease of Malaysia.

Source: Office of the Prime Minster Malaysia