Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf Cooperation Council countries and South Africa

Acino gains commercial rights for EXBLIFEP® (cefepime/enmetazobactam) within the member states of the Gulf Cooperation Council (GCC) and South Africa. EXBLIFEP® has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of severe infections earlier in 2024.

Saint-Louis, France and Weil am Rhein, Germany and Zurich, Switzerland, June 24, 2024 (GLOBE NEWSWIRE) — Allecra Therapeutics (“Allecra”) and Acino today announced the signing of an exclusive licensing agreement under which Acino gains the rights to commercialise Allecra’s antibiotic drug EXBLIFEP® (cefepime/enmetazobactam) within the Republic of South Africa and the member states of the GCC alliance, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, effective from 12 June 2024. In addition, the companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the above territories.

“Acino has established itself as a leader in South Africa and the GCC region. They are an ideal partner to support us as we build towards commercialisation of EXBLIFEP® following our regulatory approvals in the US and EU,” stated Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics. “This agreement reflects the understanding that there remains a significant global need to address the dangerous increase of resistance to standard-of-care antibiotics, and we look forward to working with Acino to address this.”

“At Acino, we are dedicated to providing novel healthcare solutions to physicians and patients, aiming to alleviate the health burden in emerging markets. We are incredibly excited to partner with Allecra to offer access to this innovative product in two key geographic regions and, potentially, beyond,” said Andrew Bird, CEO (ai) at Acino. “We are committed to expediting the registration process in these designated markets to ensure hospitals’ swift access to EXBLIFEP® as they continue to fight against high-risk infectious diseases in patients.”

About EXBLIFEP® (cefepime/enmetazobactam)

EXBLIFEP® is an intravenous antibiotic fixed-dose combination of enmetazobactam, a novel extended-spectrum β-lactamase inhibitor belonging to the penicillanic acid sulfone class, with the fourth-generation cephalosporin cefepime. Enmetazobactam has been shown to restore the efficacy of cefepime against some multi-drug resistant bacteria, including ESBL-producing pathogens alone or in combination with some resistant β-lactamase mutations as OXA-48 or AmpC, which are increasing in Europe and for which there are few therapeutic alternatives.

EXBLIFEP® demonstrated statistically significant superior overall treatment success in Allecra’s pivotal Phase III ALLIUM trial, which compared 1034 randomized patients receiving either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g every 8 h as 2 h continuous intravenous infusion in a multi-centre, randomized, controlled, double-blind, global study in 112 sites within nineteen countries.

In February 2024, the U.S. Food and Drug Administration (FDA) approved EXBLIFEP® as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in patients 18 years and older. In March 2024 the European Commission (EC) granted marketing authorisation for EXBLIFEP® for the treatment of adult patients with cUTI, including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed previously.

About Allecra Therapeutics

Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate EXBLIFEP® (cefepime/enmetazobactam), has successfully completed a randomized, controlled, double-blind, global Phase 3 trial compared to standard of care in patients with complicated urinary tract infections (cUTIs). Based on these results, the company has received FDA marketing approval in the U.S. and announced approval in the European Union for EXBLIFEP® earlier this year.

Allecra has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors include Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit www.allecra.com for further information.

About Acino

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. For more information, please visit www.acino.swiss.

Acino is part of Arcera, a global company in the life sciences sector headquartered in Abu Dhabi, United Arab Emirates. Arcera was established by ADQ, an Abu Dhabi-based investment and holding company, to build a global life sciences powerhouse poised to make significant contributions to realising the UAE’s aspiration to emerge as a frontrunner in science and technology. To learn more about Arcera, please visit www.arceralifesciences.com.

Attachments

For Allecra Therapeutics:
Andreas Kranzusch, Chief Financial Officer and Managing Director
[email protected]

Gretchen Schweitzer, Trophic Communications, +49 172 8618540
[email protected]

For Acino: 
Larisa Bernstein, Global Head of Communications
[email protected]

GlobeNewswire Distribution ID 9157528

Agency welcomes efforts to fight cross-border crimes


The Cross-Border Road Transport Agency (C-BRTA) has welcomed the recent 53-year conviction of cross-border vehicle hijacker and smuggler, Sipho Mhlanga.

Mhlanga was sentenced to 53 years by the Mtubatuba Magistrates Court on Wednesday, 19 June.

The CEO of the C-BRTA, Lwazi Mboyi, said the agency notes the progress registered by law enforcement authorities in the country in the fight against cross-border crimes.

‘This is a step in the right direction because cross-border crimes and related syndicates frustrate South Africa’s efforts to improve and build a healthy trade between the country and neighbouring countries. It is for this reason that we commend the work that has been done thus far, and we would like to wish the South African Police well in their efforts to eliminate cross-border crimes,’ Mboyi said in a statement on Sunday.

Mhlanga’s arrest and subsequent conviction followed ‘sterling work’ by the South African Police Service (SAPS), who were deployed to the northern part of KwaZulu-Natal to clamp
down on cross-border criminality.

‘The C-BRTA, as the facilitator of the commercial transportation of passengers, goods and services across borders, welcomes and commends the SAPS for the work they have done in fighting and combating cross-border crimes in KwaZulu-Natal and in the country in general,’ the agency said.

The C-BRTA is a statutory body operating in a commercial environment, with government represented by the Minister of Transport being the shareholder.

The agency facilitates the unimpeded flow of freight and passenger cross-border movements and plays a critical role in the implementation of cross-border road transport agreements and issuing of cross-border operator permits.

Source: South African Government News Agency

Nigeria has 40.2m agriculture households – NBS

Nigeria has about 40.2 million agricultural households, the National Bureau of Statistics (NBS) has said.

This was made known at the unveiling of the National Agricultural Sample Census (NASC) 2022 in Abuja on Monday.

The News Agency of Nigeria (NAN) reports that the census was conducted by the NBS in partnership with the World Bank, Food and Agriculture Organisation and the Federal Ministry of Agriculture and Food Security.

The report revealed that out of the 91 per cent of agricultural households that cultivated crops, 35 per cent practised only crop cultivation while 48 per cent reported raising any type of livestock.

It showed that 16 per cent of the households raised 58 million cattle, while 41.2 per cent raised about 124 million goats.

‘While 42.5 per cent raised poultry, most commonly chickens, while five per cent practised fisheries.’

The report showed that the lowest percentage of agricultural households into Crop Cultivation was recorded in Lagos State at 48.0 per cent, while Ebonyi recorded t
he highest at 99.5 per cent.

It showed the highest percentage of agricultural households engaged in Livestock Production was reported in Jigawa at 84.2 per cent, followed by Bauchi at 79.7 per cent .

The report said for Poultry, the highest percentage of agricultural households was recorded in Benue at 65.2 per cent, followed by Ebonyi State at 63.3 per cent.

Bishop Ohioma, Assistant Director, Agricultural and Business Enterprises Statistics Department, NBS, while giving an overview of the report, said the survey has two components which include the listing component and the sample survey component.

Ohioma said the listing component was what was being unveiled while the sample survey component would be unveiled in a few months.

He said the census provided a robust dataset that would support agricultural interventions programmes, enhance food security, and promote sustainable agricultural practices.

He said the NASC listing was conducted using digitised Enumeration Area (EA) maps in all the 36 States of
the Federation and the FCT.

Ohioma said 767 Local Government Areas (LGAS) in the country were canvassed, however, seven LGAs were not covered as at the time of the Census, following insecurity concerns.

He said the uncovered LGAs were four LGAs in Imo state and three LGAs in Borno state.

Ohioma said 40 EAs were covered in each LGA and the number of EAs covered varied by state, both urban and rural EAs were covered.

‘In all, 30,546 EAs were covered nationwide out of the proposed 30,960. ‘

He said one of the recommendations from the report include the need for Government to allocate more resources to support the conduct of the quarterly and annual National Agricultural Sample Survey (NASS).

Ohioma said the report also recommended Technical and financial Partners to sustain support in the conduct of quarterly and annual surveys.

‘Technical and financial Partners to continuously provide support to build capacity of staff of the NBS in agricultural statistics production.

‘All hands must be on deck to ensur
e the sustainability of the NASC in Nigeria.’

Source: News Agency of Nigeria

FCT farming community begs Wike for access road, basic amenities

The Kungaboku rural community in the Bwari Area Council, has appealed to the FCT Minister, Mr Nyesom Wike for the construction of its access road and provision of potable water, other basic amenities.

Residents of the predominantly farming community, made the appeal in an interview with the News Agency of Nigeria (NAN) on Monday.

They urged the minister and other relevant bodies to safe them from being cut-off completely from the territory because of the bad state of the access road to the community.

Zephaniah Moses, the community youth leader said the only road leading to the community has been washed off by the rains making it very difficult for people to come in and go out .

‘When heavy rains fall, the river across the road will be filled up. We will have to wait for at least, five hours, for the water to go down, before anyone can go out or come into the community

‘What we need, is a bridge across the river. The palliative measures we have done on the road, through communal efforts have been washed o
ff with the coming of the rains,’ he said.

Moses also appealed for the provision of potable water, the rehabilitation of the only, LEA Primary School in the community, which he said the roofs of two of the blocks of classrooms, have been blown off by storm.

‘Whenever it rains during school hours, the pupils will have to cramp in the few classrooms covered with roof for the rain to subside.

‘The school also needs perimeter fencing to protect the pupils and their teachers from attack,’ he said.

Mr Rafiu Akintoye, a resident and farmer, who said he has lived in Kungaboku for 15 years described the community as peaceful and the indigenes, accommodating.

On the poor state of the road, Akintoye recalled an incidence when the river across it washed away a car trying to go out of the community when it was raining.

According to him, it took the intervention of able-bodied young men in the community to rescue the occupants of the vehicle down the river.

He said before the community carried out the palliative ma
intenance on the road, there were times they would have to remain in the community for two days whenever there was heavy downpour.

Akintoye said that the primary healthcare centre in the community is also in dire need of rehabilitation, health workers and drugs.

According to him, the health carecentre built by government and equipped by the Rotary Club many years back is in a sorry state at the moment.

He said health workers are not readily available, especially in the night, putting sick residents at risk and there are no drugs to be dispensed for patients.

A poultry farmer in the community, Mrs Anna Jonah narrated how the bad access road has affected her business negatively.

‘Coming in and going out of this community is the major challenge, especially for farmers who are dominant here.

‘You have to trek a long distance before you can get ‘okada or keke’ (commercial motorcycle or tricycle), many of them are not willing to come here.

On Saturday, I paid N5,000 to a ‘keke’ man who brought in my chicken
feeds, a distance of just 10 minutes. The fare will not have been up to that if the road is good.

People that come in here, to buy the birds also complain about the bad road and use the opportunity to underprice our birds,’ she said.

She appealed to the Minister, the Bwari Area Council and other relevant bodies to come to their aid in fixing the road for ease of doing their business.

Mr Omerigwe Bartholomew, who did his national youths service’s programme in a farm in Kungaboku some years back, said he has remained in the village doing his own farming.

He said some of the big farms in the village are being leased out by the owners because of poor infrastructure and unfavourable business environment.

‘I am into poultry, livestock and crops production. Right now, I am coming from my cassava farm

‘I choose to remain in this village, after my youth service, because the villagers are peaceful and accommodating.

‘We have not recorded clashes between farmers and herders here because we all live peacefully and
when there is misunderstanding, the community head resolve it amicably,’ he said.

Bartholomew appealed to the FCT administration to fix the infrastructure in Kungaboku village, particularly the access road, healthcare facility and potable water.

He also urged agricultural agencies to visit the village for possible establishment of farm clusters.

He assured that such development would boost agricultural production in the area and attract many youths to site more farm projects in the area.

Source: News Agency of Nigeria

Trade modernisation’ll boost efficiency in operations – expert

An expert, Mr Ibrahim Yahaya, says that the Trade Modernisation Project (TMP) being implemented in Nigeria will boost efficiency in trade facilitation.

Yahaya said this in an interview with the News Agency of Nigeria (NAN) on Sunday in Abuja.

NAN reports that TMP is the automation of the business processes of the Nigeria Customs Service (NCS) to simplify and enhance the experience of stakeholders in the trade value chain.

The project is a 20-year concession, with an execution agreement signed in May 30, 2022, between the Federal Government of Nigeria, represented by NCS Board, and the Trade Modernisation Project Ltd.

It aims to streamline the process of obtaining export and import clearances, ease the payment of duties, and facilitate the release of goods.

The project would deploy a software described as the Unified Customs Management system (UCMS), where trade operators have the advantage to also monitor all stages of their transactions.

It will equip the NCS with state-of-the-art technology infrastruc
ture and facilities, to transform the service into an organisation that provides efficient services to businesses and other government agencies.

The TMP is an improvement on the current system, featuring advanced capabilities such as Artificial Intelligence (AI) to aid in the classification and validation of uploaded documents or data.

Yahaya, the Managing Director of Paynacle Digital Services, said that TMP would help reduce corruption in customs operations and ensure transparency and efficiency in their activities.

‘It will also cut the time used in document verification. TMP will speed up the process for those importing or exporting, something that used to take 20 days can now take one hour.

‘I believe that with AI in the system, it will help predict government revenue, and if there is any deficiency, it will address it,’ he said.

He said that the project would aid Nigeria’s budgetary system, considering that revenue generated from NCS is a crucial source of revenue for the country.

‘For Nigeria to
advance its economic diversification efforts, TMP is crucial to boosting its integrity in attracting foreign investment through international trade.

‘It will help in boosting Nigeria’s integrity in international trade because the system has undergone sanitisation,’ he said.

According to him, TMP will ensure transparency and efficiency in NCS activities, particularly in checking the issuance of fake customs duty documents.

‘We often see a lot of fake customs duty documents, and the mode of production and issuance is obsolete.

‘Traditionally, it makes it easy for people to manipulate, but automation will help address that and improve efficiency,’ he said.

Yahaya urged the engagement of experts in the implementation of the project, noting that the Public-Private Partnership would help sustain the project.

‘I suggest they hire experts in cybersecurity and private companies to maintain its services,’ he said.

NAN reports that TMP is implementing nine technical agreements with its technical and financial par
tners.

Access Bank Plc is the financial partner, Huawei, the lead technical partner, and CrossborderXP Ltd is the software development partner, among others.

Source: News Agency of Nigeria

Every effort must be made to ensure the GNU succeeds


President Cyril Ramaphosa says every effort must be made to ensure that the Government of National Unity (GNU) remains true to its founding spirit of collaboration in good faith to drive a programme that improves the lives of all South Africa’s people.

‘South Africans made clear with their votes in last month’s elections that they want their elected representatives to put aside narrow interests and work together to build the country,’ President Ramaphosa said.

In his weekly newsletter, President Ramaphosa said the formation of the second Government of National Unity (GNU) was a momentous development in South Africa’s democracy.

‘The success of the GNU will be measured by the extent to which we are prepared to focus not on who will govern, but on how we will govern, together,’ President Ramahosa said.

President Ramaphosa said the first GNU was established in 1994 to promote nation building and inclusivity from a racially divided past during a period of political transition.

‘Giving effect to the principle
s of that Constitution and the Bill of Rights must be the overriding focus of this GNU. This will be done by pursing a common programme to eradicate poverty and build a more equal society, to create jobs, and to make government truly work for the people.

‘The GNU Statement of Intent provides a solid base for genuine cooperation between parties across the political spectrum who have signed up of their own accord.

‘The Statement of Intent commits the signatories to a set of foundational principles that include respect for constitutionalism, accountability, transparency and community participation in government, evidence-based policy and decision-making, professionalisation of the public service integrity and good governance,’ the President said.

President Ramaphosa said the parties to the GNU have agreed on priorities for the incoming administration and that at the top of the list of priorities is the achievement of rapid, inclusive and sustainable economic growth to create jobs.

‘It will be critical that t
he GNU stays the course on the structural reform that is underway to improve the business operating environment and establish South Africa as an investment destination of choice.

‘These reforms are necessary to resolve longstanding challenges in key industries and create more jobs and opportunities. We will need to build on the progress that has already been made, while accelerating the pace of reform,’ the President said.

President Rmaphosa said the fact that there is broad consensus among the parties on the priorities of the incoming administration gives an encouragement that the GNU will indeed take the country forward.

‘Emanating from the priorities outlined in the Statement of Intent, the parties will further refine the GNU’s programme, including through the proposed National Dialogue process.

‘We remain committed to consensus-building and to the representation of a broad range of interests and viewpoints within government. At the same time, we are all keenly aware that South Africans expect action,
implementation and results,’ he said.

The President said the country’s hopes are pinned on the success of the GNU.

‘Our stated commitment to work together constructively and for South Africa’s benefit has generated a great deal of goodwill that we should not squander. South Africans are watching.

‘We should not waste our energies on those who stand in the way of our country’s progress or lose momentum over differences that can be resolved,’ the President said.

Source: South African Government News Agency