STALICLA signs exclusive in-licensing agreement for late-stage clinical neuropsychiatric and neurodevelopmental disorder treatment

PRESS RELEASE

STALICLA signs exclusive in-licensing agreement for late-stage clinical neuropsychiatric and neurodevelopmental disorder treatment

The transaction with Novartis reinforces STALICLA’s position as the leading developer of precision medicines for neurodevelopmental disorders and heralds the expansion of its portfolio into wider neuropsychiatric indications

Geneva, SWITZERLAND 9 January 2023, STALICLA SA, a clinical-stage biotech company advancing the first precision neurobiology platform for patients with neurodevelopmental disorders, today announced that it has entered into an exclusive in-licensing agreement with Novartis to develop mavoglurant as a treatment for substance-use disorder and neurodevelopmental disorders (NDDs).

Mavoglurant has previously been tested in more than 1,800 patients and demonstrated a good safety and tolerability profile. Following highly promising results from a Phase 2 study conducted with mavoglurant in cocaine-use disorder (CUD; NCT03242928), STALICLA is now preparing to advance mavoglurant into Phase 3 development for the treatment of CUD.

In parallel, STALICLA will leverage its precision neurobiology drug development platform (DEPI), which has demonstrated proof-of-concept in other neurodevelopmental programs, to detect subgroups of high responder patients with rare and common neurodevelopmental disorders where mavoglurant can be an effective treatment, as guided by earlier clinical studies.

The market potential of the CUD and NDD indications alone could top €2 billion globally.

Lynn Durham, STALICLA’s CEO & Founder, commented: This agreement with Novartis is a testament to the strength of our precision neurobiology medicine platform and we are excited about this transaction to further develop mavoglurant and to bring it to the right patients. STALICLA stratifies patient subgroups and identifies compounds that may provide medical benefit in neurodevelopmental indications with clear unmet need. Our unique model benefits all healthcare stakeholders and is a key driver of the Company’s rapid growth. With two Phase 2 and a Phase 3 trial slated to start within a year, alongside strong IP, we are well positioned to continue our exciting growth trajectory.

Under the terms of the agreement, STALICLA has acquired worldwide rights to mavoglurant for substance-use disorders, neurodevelopmental disorders, and other indications in exchange for upfront fees and equity, and development and commercial milestones of up $270m, plus royalties on sales.

About Mavoglurant

Mavoglurant is a selective non allosteric metabotropic glutamate receptor 5 (mGluR5) antagonist. mGluR5 has been tied to mood disorders, addiction as well as rare and common forms of Autism. In clinical Phase 2 studies, mavoglurant induces abstinence in CUD patients through inhibition of mGluR5, with no evidence of withdrawal liability.

About STALICLA

STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders.

STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience.

With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential.

The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates.

STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform towards revenue generation.

For further information, please visit: https://stalicla.com/

Contacts

STALICLA SA
Lynn Durham, CEO
Lynn.durham@stalicla.com
Media inquiries
Consilium Strategic Communications
stalicla@consilium-comms.com

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Home Ministry sets up special committee to look into citizenship issues

PUTRAJAYA, Jan 9 (Bernama) — The Home Ministry has set up a special committee to look into citizenship issues from all aspects in a comprehensive manner.

Home Minister Datuk Seri Saifuddin Nasution Ismail said issues to be given focus include delayed cases, children born abroad and local women married to foreign men.

“I will ensure the citizenship application process is made easier in a comprehensive manner without compromising aspects involving the country’s national security,” he told reporters after a working visit to the National Registration Department (NRD) headquarters here today.

Saifuddin was asked on Minister in the Prime Minister’s Department (Law and Institutional Reform) Datuk Seri Azalina Othman Said’s statement recently that the government will soon begin the process to amend the Federal Constitution to resolve the citizenship status issue of children born abroad to Malaysian women with foreign spouses.

Amendments to Part II of the Second Schedule of the Federal Constitution will allow these children to be given the right to Malaysian citizenship similar to those born abroad if the father is Malaysian.

“I can confirm Azalina’s announcement and the special committee will be fully focusing on citizenship issues,” Saifuddin said.

He said the working paper prepared by the special committee will be presented to the Cabinet next month at the latest.

Meanwhile, Saifuddin said the leave granted by the Federal Court to family rights group, Family Support and Welfare Selangor and Kuala Lumpur (Family Frontiers), and six other women to proceed with their appeal against the Appeal Court’s decision that their children could not obtain Malaysian citizenships will not interfere with the government’s commitment to go ahead with the proposed amendments.

He said the case will go ahead through the proper legal process but it will not stop the government from looking into the proposed amendments.

On Dec 14, Family Frontiers and six Malaysian mothers obtained leave to proceed with their appeal against a Court of Appeal’s ruling which denied automatic citizenship to children born overseas to Malaysian mothers with foreign spouses.

A Federal Court three-member panel led by Chief Judge of Sabah and Sarawak Tan Sri Abang Iskandar Abang Hashim also granted leave to appeal to India-born Mahisha Sulaiha Abdul Majeed, who is also seeking to be recognised as a Malaysian citizen.

On Aug 5, the Court of Appeal in a 2-1 majority decision overturned a High Court ruling that children born overseas to Malaysian mothers with foreign spouses were entitled to automatic Malaysian citizenship.

Source: BERNAMA News Agency

Melaka encourages wearing of face masks in public, crowded places

MELAKA, Jan 9 (Bernama) — The people are encouraged to wear face masks in public and crowded places in Melaka to prevent the spread of COVID-19, said Chief Minister Datuk Seri Sulaiman Md Ali.

He said the people including tourists should also adopt other preventive measures like physical distancing, using hand sanitisers and washing their hands frequently.

“We have not decided to make wearing of face masks compulsory as the daily COVID-19 cases in Melaka are still under control, with fewer than 50 infections reported in the past one week.

“However, we will continue to monitor the daily case loads and are encouraging locals and tourists to mask up,” he told reporters after performing the ground-breaking ceremony for the Melaka Flag Giant Monument project in Bukit Beruang here today.

He said face masks might be made compulsory if the COVID-19 situation worsened.

On the RM200,000 monument project, he said the Melaka flag would stand 166 metres above sea level atop the Bukit Beruang Forest Reserve.

Sulaiman said the monument would become Melaka’s latest tourist attraction when it was completed in about two years’ time.

“According to statistics from the Melaka Chief Minister’s Department Tourism Promotion Division, last year there were 771 places of attraction in Melaka covering 13 tourism sub-sectors.

“Increasing the number of tourism products is part of efforts to boost tourist arrivals in Melaka by 10 per cent every year,” he added.

He said recreational activities like hiking would not be affected by the monument construction work and that existing infrastructure such as hiking trails would be upgraded and new attractions like zip line and flying fox would be built.

Source: BERNAMA News Agency

KPI important in setting direction of country’s development – Analysts

KUALA LUMPUR, Jan 9 (Bernama) — The setting of key performance indicators (KPI) for every minister of the Unity Goverment Cabinet can bring about positive impact to efforts to strengthen the country’s development.

Economic analyst, Professor Emeritus Dr Barjoyai Bardai said the KPI will show the government’s clear direction under the leadership of Prime Minister Datuk Seri Anwar Ibrahim in strengthening the country’s economy, which will provide confidence to businesses and foreign investors.

He said a strong economy would lead to better performance of the stock market, foreign exchange and direct foreign investment.

“The best KPI for this Unity Government needs to involve three main components, which relates to what will be offered during the tabling of the Budget 2023, the implementation of the 15th general election (GE15) manifesto and the resolution of issues brought up during Parliament sessions.

“As the government is made of a pact between PH (Pakatan Harapan) and BN (Barisan Nasional), we can for instance, choose a middle area that focuses on what was emphasised in the manfestos of both these coalitions,” he told Bernama today.

Yesterday, Anwar said that a retreat would be held next week for the Cabinet to set the KPI for each ministry.

Barjoyai said the KPI would not be merely to measure the performance of each minister and ministry, but what was important was to use them as a guide to arrange short, middle and long term plans to realise them.

Meanwhile, Universiti Malaysia Kelantan Malaysian Graduate School of Entrepreneurship and Business Dean Prof Dr Roselina Ahmad Saufi said four main cores need to be stressed in creating a holistic and objective set of KPI.

She said the creation of a policy that sets the KPI and its implementation can be outlined by the Prime Minister’s Office involving the aspect of targets desired and the method of measurement.

“Second we see what the implications of the KPI will be, in this matter, the prime minister, as captain of the ship, needs to state clearly the vision, mission and direction of his administration for the short, middle term and of course, five years from now.

“This direction must be understood by all parties, especially the Cabinet ministers, so from there, each ministry can interpret them into an agenda or their respective KPI,” she added.

Roselina said that every ministry was urged to conduct engagement sessions with stakeholders and parties with interests, taking into consideration the aspirations and complaints from the people in outlining their KPI.

“For this Unity Government, the engagement session needs to be held with component parties that form the government, and perhaps even the Opposition,” she added.

She said that the last and most important core was the monitoring of the KPI’s implmentation so that it is in line with the vision and mission of the government and should be tabled at the Cabinet and broadcast to the public in an agreed and suitable time frame.

Source: BERNAMA News Agency

AG proposes BM text replace English as authoritative version of Federal Constitution

PUTRAJAYA, Jan 9 (Bernama) — Attorney-General Tan Sri Idrus Harun today proposed making the Malay translation replace the original English text of the Federal Constitution as the authoritative version.

To do so, he said the proposal requires the Yang di-Pertuan Agong’s approval.

“The Federal Constitution acts as our cornerstone in implementing the separation of powers. Therefore, for the year 2023, pursuant to Article 160A of the Federal Constitution, the Attorney-General’s Chambers (AGC) plans to reprint the Federal Constitution to incorporate the latest historic constitutional amendments.

“The AGC also plans to propose to the government that the prescription of the Federal Constitution in the national language to be the authoritative text in line with Article 160B of the Federal Constitution. These two plans are subject to the approval of the King,” he said in his speech at the opening of the Legal Year 2023 here, today.

Among the historic constitutional amendments made recently are the lowering of the voting age from 21 to 18 and automatic voter registration.

Apart from that, Idrus also said that the AGC has reprinted about 100 laws especially relating to the election in 2022 alone.

He said the constant amendments to the current laws reflect changes and that this was done to ensure that the most current and updated version of the laws is made available to the public.

“The revised and reprinted texts of laws are also available online via the Federal Legislation Portal Malaysia,” said Idrus.

Source: BERNAMA News Agency

Contractors who fail to start work on govt projects in S’wak within a month can be fired – Douglas Uggah

KUCHING, Jan 9 (Bernama) — Contractors awarded any government projects in Sarawak must start work within one month after officially given the contract and failure to do so would result in stern action, including termination.

Sarawak Deputy Premier Datuk Amar Douglas Uggah Embas said these were among the measures taken as the state government wanted to put an end to delayed or abandoned projects by imposing stringent conditions.

“We have noticed some contractors getting, for instance, 20 or more projects. We fear that these will be beyond their capacity to get all these done at one time.

“Then there is also fear of the process of repetitive subcontracting that can adversely affect the quality of the end product, or worse still, the projects end up as delayed and abandoned projects,” he said in a statement today.

Uggah who is also the Betong Division Development Agency (BDDA) Committee chairman, added that the people ended up suffering whenever such situations occurred and the government’s reputation and integrity would be at stake.

The Sarawak Infrastructure and Ports Development Minister also said that annual development budgets need to be spent within their specified period.

In the case of Betong Division, he said the BDDA had been allocated a development budget of RM1.5 billion, which should come as additional funding for the division.

“Thus, we need to utilise all this and the extra fundings as well. But if we continue to have non-performing contractors and delayed projects, then we are going to have more and more problems,” Uggah said.

He also called on the respective government departments and agencies to engage all elected representatives to assist in monitoring the implementation of projects.

Source: BERNAMA News Agency

Malaysia wants Saudi govt to inform in advance of this year’s haj cost

KUALA LUMPUR, Jan 9 (Bernama) — Malaysia has requested Saudi Arabia to inform in advance of this year’s haj pilgrimage cost to ensure good management of Malaysian pilgrims.

In a Facebook post today, TH said the matter was discussed by Minister in the Prime Minister’s Department (Religious Affairs) Senator Datuk Dr Mohd Na’im Mokhtar and the TH management during a meeting with Saudi Arabia’s Minister of Hajj and Umrah, Dr Tawfiq Fawzan Al-Rabiah.

Mohd Na’im and his delegation are currently on a working visit to Saudi Arabia to discuss matters pertaining the haj pilgrimage for the 1444 Hijrah/2023 season.

Also discussed in the meeting were the original quota of Malaysian pilgrims which had been reduced due to the COVID-19 pandemic and the Makkah Route programme.

The Makkah Route programme facilitates the entry of Malaysian pilgrims into Saudi Arabia as they are not required to go through the immigration and customs processes.

During the meeting, Dr Tawfiq commended TH for its best and systematic handling of Malaysian haj pilgrims.

The Malaysian delegation also expressed its gratitude to the Saudi Arabian government for the good services and facilities provided to haj pilgrims from other countries.

Source: BERNAMA News Agency