Aspen Agrees to Make J&J Covid-19 Vaccine in South Africa

By Janice Kew 

November 2, 2020, 2:41 AM EST 

Updated on November 2, 2020, 5:57 AM EST 

Africa’s no. 1 drugmaker has deal for 300 million doses/year 

J&J’s candidate resumed clinical trials after pause last month 

Aspen Pharmacare Holdings Ltd. agreed to make the Covid-19 vaccine candidate being developed by Johnson & Johnson at a factory in South Africa, a move that could help with distribution on a continent with otherwise limited manufacturing capacity.

Africa’s biggest drugmaker has the capacity to produce 300 million doses a year at the plant in Port Elizabeth if the shot is approved, the company said in a statement on Monday. J&J’s experimental inoculation against the virus that’s swept the world this year is still in clinical trials, after a brief pause last month after a patient became sick.

 

The race to develop and gain regulatory approval for a Covid-19 vaccine is seen as a critical step toward controlling the pandemic, which has killed more than 1.2 million people around the world and shows little sign of dissipating. Yet there’s concern poorer nations will be left without due to the huge demand from richer countries from the U.S. to China.

“Johnson & Johnson’s public commitment has been really strong in terms of assisting developing countries,” said Aspen Chief Executive Officer Stephen Saad, who is self-isolating at home after two family members tested positive for Covid-19. “It’s good to get that manufacturing in South Africa.”

Aspen shares jumped as much as 8.1%, the biggest intraday gain in almost two months, and traded 6.7% higher at 112.64 rand as of 11:42 a.m. in Johannesburg.

 

South Africa had been looking to sign a deal to help produce a vaccine earlier in the year, when The Coalition for Epidemic Preparedness Innovations, a global organization funding vaccine development, said it was considering state-owned BiovacInstitute as a fill-finish site. South Africa is also a host country for clinical trials of various vaccines.

Read More: Vaccine Doubters Could Hamper Global Effort to Beat Coronavirus

“The fact that we are involved in all these trials is really positive about our ability to manage,” Saad said. “We’ve got good clinical expertise. I think a lot of it is built up around some of the communicable diseases we’ve had such as HIV/AIDS.”

 

J&J’s vaccine candidate would be made and packaged at a plant in which Aspen has invested about 3 billion rand ($184 million). The South African company relocated the production of drugs for late-stage cancer, Parkinson’s disease and some auto-immune illnesses to the southern coastal city of Port Elizabeth from Europe in 2018.

The deal remains subject to discussions around technology-transfer activities and commercial-manufacturing terms, Aspen said.

The move marks the second time the pharma group has found a way to generate business from the coronavirus. The company also makes the generic anti-inflammatory drug dexamethasone, which was found to be an effective treatment for Covid-19 earlier in the year.

 

— With assistance by Marthe Fourcade

(Updates with CEO comment in fourth paragraph)

 

Beta Healthcare International Ltd

Welcome to Beta Healthcare International Ltd, a renown pharmaceutical manufacturing company. Beta Healthcare International Ltd has its origins with UK's Boots International and joined the Shelys Group (Shelys Africa ) in 2003. The company has a wide range of product portfolio comprising of OTC'S, Prescriptions & Branded pharmaceutical products. Beta Healthcare's International Ltd domestic customer base is spread throughout Kenya. Export sales are generated from other parts of East and Central Africa, including Tanzania, Uganda, Rwanda, Dr Congo, Zambia , Malawi, Burundi, Among others.

Beta Healthcare International Ltd has its footprints in Eastern, Central and West African regions. Beta healthcare International Ltd is a pioneer in Kenya, developing lifestyle brands that are serving niche yet crucial needs of the Sub Saharan African population.

In 2012, Aspen Group acquired 100% of the share capital of Beta Healthcare International Ltd & Shelys Africa Limited, which has operations in East,Central & Western Africa. Kenyan-based Beta Healthcare International Ltd & Tanzania-based Shelys Pharmaceuticals Ltd are key players for the PHARMA, OTC, Prescriptions, Herbal & FMCG products in Sub Saharan Africa.

The alliance with Aspen Group provides the foundation for the expansion into the Sub Saharan African market and the establishment of an affordable quality generics brand presence on the African continent.

Aspen general facility Aspen Sterile Facility

 

Beta healthcareInternational - Plant shelys pharmaceuticals Kama Industries ltd

 

 

Beta Healthcare Uganda aspen pharmacare nigeria

 

Aspen Pharmacare  

The African continent offers a promising window of opportunity for pharmaceutical expansion.   South African-based Aspen Pharmacare, which has manufacturing facilities valued in excess of R1 billion and which produce approximately 6 billion tablets per annum, is suitably positioned to manufacture and supply a wide range of pharmaceutical products across Africa.

With its South African presence established, Aspen has been actively engaged in securing strategic alliances with international partners, including those based in Africa, in a bid to increase its geographic footprint in this territory.

Aspen’s position in Africa through its relationships with international pharmaceutical companies Gilead Sciences Inc and Tibotec Pharmaceuticals Limited, has positioned the company at the forefront of introducing first world technology to the continent to support the implementation of the latest guidelines and protocols for the treatment of HIV/AIDS.

Aspen’s strategic approach towards providing meaningful solutions against infectious diseases, as well as securing appropriate international partnerships, has created an opportunity for the Group to create a pharmaceutical legacy across the African continent. Aspen’s range of anti-retrovirals, which include treatment products such as Viread, Truvada and Prezista, has established the Group as a valued contributor in the fight against HIV/AIDS on the continent.

 

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Safety Health & Enviroment Management

Echo Balance

Eco-balance is a key issue in the current discussions and in saving our planet.

Depletion of fossil fuels CO2 emissions and global warming are a threat to our ecologic and economic balance.

Our company aims to contribute to ensuring eco-balance by taking initiatives towards energy saving and low carbon emissions.

Environmental management protocols are being developed in accordance with ISO 14001 to enable the company to participate in Carbon Disclosure Project (CDP) in a near future.

Water Conservation

Beta Healthcare takes water as a resource which is limited and therefore continually puts in measures to conserve water. It comes up with Environmental Management Programmes with set targets as part of its annual objectives in Water Conservation.

Process waste water is treated to ensure set parameters are met before the water is discharged into the public sewer as per the requirements of EMCA Water Regulations of 2006. The company has in place a waste water treatment facility with enough capacity to treat the waste water to the required quality as required under the Water Quality Regulations.

Carbon Disclosure

The company compiles its energy consumption for use in calculating its carbon emission equivalent. There are measures put in place to reduce carbon emissions as part of the company’s Annual Environmental Management Programmes.

Energy Conservation

Beta Healthcare has in place an energy policy. Energy audits have been carried out and energy conservation programmes initiated as per requirements under Energy Act. The energy conservation programmes are taken as part of annual Environmental management programmes and objectives are set with targets to be achieved in energy use. Continuous monitoring of the programmes is done to ensure achievement of the set objectives and targets.

Air Emissions

Air quality measurements are done on an annual basis to ensure that what is emitted is within required regulatory requirements. Exhaust emissions from the boiler, generator and industrial trucks are measured to ensure that emissions levels are within specified regulatory limits as provided under EMCA-Air Quality Regulations, 2015. Measurements are done for particulate and VOCs in the work stations to ensure personnel are working in a conducive environment as per the requirements under Occupational Health and Safety Act-Hazardous Substance Rules and WHO guidelines.

Waste Management

Structured waste management processes are implemented. Continual improvement initiatives are undertaken on the waste handling procedures.

As per the Cap 244, the Pharmacy and Poisons Act, Laws of Kenya, all pharmaceutical wastes must be handled responsibly owing to the security risk around pharmaceutical products. The pharmaceutical waste and other hazardous wastes are handled in accordance with the Environment Management and Coordination Act (EMCA), Waste Regulations of 2006.

The wastes are segregated, recorded, properly stored before they are disposed off. All wastes are disposed off using NEMA approved waste handlers for transportation and disposal sites. Waste recycling and reuse opportunities have been implemented for non-hazardous waste.

The central waste yard at Beta has been designed for more efficient handling and compliance to the Waste Management Regulations and to the Aspen standards for waste management.

Accident Rate

Beta Healthcare has under taken a comprehensive Hazard Identification and Risk Assessment and kept in place mitigation measures for the identified risks. This has been done to proactively prevent incidents at the workplace. All incidents are investigated and corrective actions proposed and implemented to prevent reoccurrence. Key performance indicators are in place to measure SHE performance in terms of accident rates. The company aims at having minimum cases of accidents in line with its SHE policy.

Compliance

Beta Healthcare takes compliance to regulatory requirements as key to its operations. It has a legal register which is updated quarterly and a legal unit which aids in updating the company on legal issues. Legal audits are done annually to check the level of compliance and propose corrective measures for any noncompliance noted.

Crisis Management

As part of its business continuity strategy, Beta Healthcare has identified the emergency situations it anticipates and kept in place emergency response plans. It has procedures for response to the emergencies and also tests these procedures periodically to ensure adequate preparedness. All employees are trained on steps to take during emergency situations.

Measures kept in place as part of emergency preparedness include having a fire safety policy in place.