Kenyan medical firm receives Sh339 million boost

Kenyan firm joins global manufacturers of syringes and key medical supplies

• Asia Africa Investment and Consulting Pte Ltd (AAIC) and Ohara Pharmaceutical Company Ltd have jointly invested USD3 million into Revital Healthcare.

•The Kilifi-based manufacturer is one of 25 auto-disable syringe manufacturers pre-qualified by the World Health Organisation (WHO) and the only one in Africa.

Kilifi-based medical supply manufacturer, Revital Healthcare EPZ Ltd, has received a further injection of capital from two Japanese firms that will boost its production capacity.

Asia Africa Investment and Consulting Pte Ltd (AAIC) and Ohara Pharmaceutical Company Ltd have jointly invested USD3 million (approximately Sh339 million) into Revital Healthcare.

This will see means the Kilifi-based manufacturer, one of 25 auto-disable syringe manufacturers pre-qualified by the World Health Organization (WHO) and the only one in Africa enhance its production capacity from 75 million syringes to more than 400 million annually.

This follows another investment of Sh440 million into the firm from the Bill and Melinda Gates Foundation which the firm’s sales, marketing and product development director Roneek Vora said will boost production to at least 300 million syringes a year from 2022.

Revital estimates that the support will lead to the creation of over 100 direct new jobs and over 5,000 indirect jobs out of which Revital has committed to ensuring that at least 50 per cent of new hires are women.

Global demand for auto-disable syringes has grown greatly as the rollout of COVID-19 vaccines progresses globally. Recent estimates from PATH, a global non-profit organisation improving public health, projecst that there will be a shortage of over 2.2 billion units of the 0.5ml vaccine syringes in 2022.

This will acutely impact the Covid-19 vaccination drive, child immunisation along with inoculation of the new malaria vaccines, in low and middle-income countries, especially across Africa.

Currently, Revital manufactures 45 essential medical disposables ranging from syringes, Rapid Diagnostic Test Kits for Covid and Malaria, PPE kits, surgical face mask and viral transport medium kits. The investment comes at a time when the Omicron variant of Covid-19 is fast spreading across the globe, prompting countries to re-introduce drastic measures like lockdowns to try and contain infection.

“Expanding manufacturing capacity in Africa for critical supplies such as syringes is essential to ensure adequate supply for the continent,” said Vora in a statement. He said the firm is proud to be part of the global efforts to ensure Africans have access to life-saving vaccination syringes.

Revital Healthcare chairman Rajni Vora said with the investment from Bill and Melinda Gates Foundation, AAIC and Ohara Pharmaceuticals, the manufacturer intends to expand into the diagnostics line, laboratory consumables and other more essential medical supplies.

Marksans Pharma acquires Dubai-based Access Healthcare for Rs 27 cr.

Marksans Pharma signed a share purchase agreement to acquire a 100% stake in Access Healthcare for Medical Products L.L.C, a Dubai-based front-marketing and promotion company for a cash consideration of AED 13 million.

This transaction was approved by the board of Marksans Pharma on 23 April 2022. The acquisition is expected to be completed by 30 June 2022. Access Healthcare for Medical Products (Access Healthcare) provides pharmaceutical companies innovative marketing and sales solutions in the MENA (Middle East & North Africa) region. The company supplies these products in the UAE and other neighboring countries.

In the UAE market, Marksans Pharma supplied products through the Dubai Health Authority (DHA). It has market authorizations by the UAE regulatory authorities for various products. For the year ended December 2021, Access Healthcare for Medical Products registered a revenue of AED 12 million (Rs 25 crore) and a profit after tax ofAED 4.5 million (Rs 9.40 crore). The company has no debt on its books.

As per the company’s press release, this deal will enable the company to use the front-end sales and marketing infrastructure of Access Healthcare for marketing its products manufactured in the India, UK, and USA regions. It will bolster Marksans Pharma’s presence in the Middle East and North African regions by leveraging Access Health’s knowledge of local business cultures and access to a network of partners and distributors in those regions.

The shareholders of Access Healthcare will receive a cash consideration of AED 13 million (Rs 27.10 crore) on closure of the transaction, which is subject to regulatory approvals. The transaction will be funded from internal accruals, as per the company’s exchange filing.

On a consolidated basis, the company reported a 18.1% fall in net profit to Rs 48.27 crore on a 1.2% rise in net sales to Rs 362.63 crore in Q3 FY22 over Q3 FY21.

Shares of Marksans Pharma shed 1.97% to Rs 54.70 on BSE. Marksans Pharma is an Indian pharmaceutical company having a global footprint. The company’s strengths lie in research, manufacturing and marketing of finished dosage pharmaceutical formulations.

Ethiopia: Potential to capitalise on demand for affordable pharmaceuticals

According to a research, there are opportunities to produce specific pharmaceutical items in Ethiopia, a market that is now dominated by imports.

By 2025, Ethiopia’s domestic pharmaceutical business may be valued more than $1 billion. A increasing middle-income base and urbanisation at a rate of 5.4 percent per year are predicted to fuel growth, resulting in improved access to healthcare as cities improve their infrastructure and healthcare facilities.

Imports contribute for 65 percent to 75 percent of the Ethiopian pharmaceutical market, with India (22 percent), the Netherlands (20 percent), and Belgium accounting for the majority of the rest (13 percent ). Finished pharmaceutical items account for the majority of imports, accounting for over 80% of all pharmaceutical products imported in 2019. The following are some of the most important products imported into Ethiopia:

60% – anti-infectives
9% – central nervous system medicines
8% – water and acid base electrolytes
5% – endocrine disorder and contraceptives

The Ethiopian Pharmaceutical Supply Agency (EPSA) is the country’s single most influential buyer, accounting for 60% of overall pharma spending. Antivirals and antibacterials are common purchases in the public and social sectors.

There are just 11 manufacturers in the country, 45 percent of which are jointly held by international and local investors. With two joint ventures and one fully-owned enterprise, China is becoming a major player in Ethiopia’s pharmaceutical industry.

Ethiopia’s government has taken a number of steps to enhance the sector. It has devised a 10-year pharmaceutical production strategy and action plan. Kilinto Park is Africa’s first dedicated industrial park, spanning 279 hectares and dedicated to pharmaceutical manufacture on 136 hectares. The park is 15 kilometres from the city centre of Addis Ababa, 863 kilometres from the port of Djibouti, and a 10-minute drive from Bole International Airport. Investors are given serviced or ready-to-use land with shared infrastructure and services, allowing them to get started quickly.

Henlius Partners with Getz to commercialize Adalimumab Biosimilar

Shanghai Henlius Biotech has established a partnership with Getz Pharma Limited to commercialise Handayuan (HLX03), an adalimumab biosimilar, in numerous Asian and African countries.

Getz Pharma will be able to market the product in Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan, and Uzbekistan, as well as any other territories mutually agreed upon, under the terms of the licencing and supply agreement.

Henlius’ first monoclonal antibody for autoimmune therapy, HLX03, was self-developed. The biosimilar is based on Humira, which had sales of $20.7 billion in 2021, making it the highest-grossing medication in the world that wasn’t a COVID-19 vaccination. Humira has been approved for more than ten indications around the world, and it is a recommended medicine in North American and European autoimmune disease management recommendations.

The National Medical Products Administration (NMPA) of China has approved HLX03 for the treatment of rheumatoid arthritis, ankylosing spondylitis, uveitis, and plaque psoriasis. Jiangsu Wanbang is in charge of HLX03’s marketing in China.

“In the future, Henlius will actively collaborate with more global industry leaders, maximising the value of biosimilars and accelerating diversified innovation to develop more products based on clinical and market needs to deliver more affordable products to patients worldwide,” Henius said in a statement.

Over 100 million euros will be invested by the EU and the Gates Foundation to establish an African drug regulator

According to Reuters, the European Union and the Gates Foundation are due to announce financial assistance for fledgling plans to establish an African medicines regulator to enhance the continent’s drug and vaccine production.

The African Medicines Institution (AMA) treaty entered into force in November, although the agency is now only operational on paper. The treaty establishing the AMA has been ratified by just over half of the 55 African Union (AU) member nations so far.

The provision of financial and technical assistance to the new agency is considered as critical in assisting it in launching operations. This would help the continent’s vaccine and pharma industries, which relies on a reliable regulator to thrive.

A person familiar with the initiative told Reuters that the European Commission, Germany, France, Belgium, and the Gates Foundation will pay more than 100 million euros ($113.93 million) to support AMA and African national regulatory authorities.

The goal is for these organizations to reach Maturity Level 3 for vaccine manufacturing, which the World Health Organization (WHO) describes as “the minimum WHO standard for effective regulatory monitoring for quality local vaccine production,” according to the official.

According to an internal EU Commission paper with slides seen by Reuters, a portion of the funds will be distributed as grants, with the remainder going to the European Medicines Agency.

According to the statement, the EMA, which is now Africa’s only drug regulator, will “offer technical help to African counterparts via scientific collaboration, joint inspections, training, and notably the AMA.”

Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, asked African countries to support efforts to establish the regulator, saying it may aid in the fight against counterfeit and low-quality medications.

“I believe this institution will be extremely essential for the continent,” says the author “In Cape Town, he stated. “I’d like to (appeal) to all non-ratifying countries to ratify and expedite the creation (of AMA).”

Soumya Swaminathan, the WHO’s chief scientist, said the AMA could play “the kind of role that the European Medicines Agency has played in Europe — defining standards, helping countries develop their regulatory bodies” at a previous occasion.

ENDING DEPENDENCE

After the COVID-19 epidemic exposed the region’s reliance on imported vaccinations and other drugs, the race to establish the AMA has begun. Local production accounts for just over 5% of medications and 1% of vaccines consumed by the 1.2 billion-strong population.

Africa initially struggled to obtain COVID-19 vaccine shots due to limited supply being purchased by wealthy countries. Deliveries to Africa have since increased, yet only 10% of Africans are properly vaccinated.

Increased production is currently being pursued, however medicine approval requires the approval of a regulator.

Experts warn that preparing for future pandemics is simply one of the reasons why Africa needs a continental regulator.

Due to inconsistent legislation in 54 countries and a lack of transparency, several pharmaceutical companies have abandoned efforts to register their goods, resulting in limited access to vital medicines in many African countries.

Due to a lack of strict control, counterfeit pharmaceuticals have flooded African markets, resulting in unnecessary deaths and fueling scepticism of medicine.

According to EU officials in Brussels, the EU’s attempt to back the new regulator is part of a larger strategy to counter Chinese and Russian influence in Africa. In the last year, Brussels has provided hundreds of millions of doses of COVID-19 vaccination to Africa.

Vaccine access will also be a major topic at a Brussels conference of EU and African Union leaders.

Margaret Agama-Anyetei, a senior AU official leading efforts to establish the AMA, stated that obtaining more AU member states to sign and ratify the treaty is one of the most pressing tasks.

“There are a plethora of fake certificates, fake drugs, fake masks, and fake medicine across the continent,” she told Reuters by phone from Addis Ababa. “It’s really important that we have a continental agency that is complementary to all other national health institutions and invested in promoting the regulation of medical products across the continent,” she said.

WHO has identified 6 African countries that will receive technology for the production of mRNA vaccines

Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia will be the first six African countries to get the technologies needed to manufacture Moderna vaccines, according to the World Health Organization (WHO).

“At today’s European Union-African Union summit in Brussels, WHO Director-General Dr. Tedros Adhanom Ghebreyesus revealed the first six African countries to get the technology required to create mRNA vaccines. Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia all applied and were chosen as recipients,” Dr. Tedros Adhanom Ghebreyesus, the Director-General, revealed the first six African countries to get the technology needed to create mRNA vaccines. Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia all applied and were chosen as recipients, according to the World Health Organization.

According to the World Health Organization, the Moderna technology hub will assist vaccine makers by providing access to the essential operating procedures and know-how to mass-produce vaccines in compliance with international standards. The centre will also increase production capacity for other medical supplies that countries require to build their health systems, in addition to COVID-19 vaccines.

“The best way to address health emergencies and achieve universal health coverage in the mid- to long-term is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint,” said WHO chief Dr. Tedros Adhanom Ghebreyesus.

President Cyril Ramaphosa of South Africa said: “This is a project that would allow us to create our own vaccines, which is really essential to us. It entails mutual respect, acknowledgement of what we can all bring to the table, investments in our economies and infrastructure, and, in many ways, giving back to the continent.”

According to the announcement, the WHO and its African and European partners will work with the beneficiaries to build a plan and provide the necessary training and support so that the nations may begin vaccine manufacturing soon.

Despite the fact that COVID-19 vaccine supplies in Africa have expanded dramatically in recent months, immunisation rates on the continent remain quite low, with only roughly 11% of the population fully immunised.

27 pharma companies will supply generic COVID drugs to low-income countries

Twenty-seven pharmaceutical companies have agreed to produce a generic version of molnupiravir, Merck’s oral
antiviral for the treatment of COVID-19. The agreement will provide affordable access to the drug in 105 low- and
middle-income countries (LMICs) worldwide.

Merck will licence the medication to companies that meet certain quality-assurance standards, according to the
Geneva-based Medicines Patent Pool, a United Nations-backed public health organisation. For as long as the World
Health Organization classifies COVID-19 as a public health emergency, neither Merck nor its development partners will
get any fees from the licences.

Now, 27 firms have met Merck’s requirements: five will make the drug’s basic ingredients, nine will produce the
completed product, and thirteen will produce both.

Merck Executive Director Charles Gore said in a statement, “We are encouraged by the huge number of new and
existing partners who have moved fast to gain a sublicense for molnupiravir through MPP.” “This is a key step toward
assuring global access to a critically needed COVID-19 treatment, and we are sure that the anticipated medicines will be
available in LMICs quickly because manufacturers are working closely with regulatory authorities.”

“Increasing access to quality-assured generic versions of molnupiravir has been a priority for MSD from the beginning,
which led us to partner with MPP on a licencing agreement to expand access to quality-assured generic versions of
molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director of Global Public Policy at
Merck. “We’re excited to see this ambition come to fruition, with MPP’s selected generic manufacturing sublicensees
offering a wide range of regional variety.”

The manufacturers involved in the deal are Pakistan’s Remington; Egypt and Jordan’s Hikma; Kenya’s Universal
Corporation; South Africa’s Aspen and CPT,;China’s BrightGene, Desano, Fosun Pharma, Langhua, and Lonzeal; South
Korea’s Celltrion, DongBang, and Hanmi; Bangladesh’s Beximco and Incepta; Vietnam’s Stella; Indonesia’s Kimia Farma;
and 10 Indian companies: Arene Lifesciences, BDR, Biophore, Laurus Labs, Lupin, MSN, Natco, Optimus, SMS, and
Strides.

Merck collaborated with Ridgeback Biotherapeutics and Emory University to develop the medication. Despite a decline
in published efficacy from 48 percent to 30 percent due to new trial results, it got approval from the UK’s Medicines
and Healthcare Products Regulatory Agency (MHRA) in November and emergency use approval from the US Food and
Drug Administration (FDA).

This licencing agreement, as well as one struck by Pfizer for its antiviral, go a long way toward improving parity in
COVID-19 treatment, although the Wall Street Journal recently noted that even reduced prices from generic
manufacturers could be an issue for very low-income countries. In addition, some countries have insufficient testing,
which may prevent the treatments from being used when they are most beneficial.

Strides Pharma Science signs a deal with MPP to market molnupiravir in international markets

Strides Pharma Science has partnered with Medicines Patent Pool MPP, based in Geneva, to commercialise the antiviral medication molnupiravir in worldwide markets.

According to a statement from MPP, the company and its affiliate, Universal Corporation (Kenya), have entered into a voluntary non-exclusive sub-license relationship covering 105 countries.

Strides and UCL will produce the product in India and Nairobi, Kenya, in WHO-approved facilities. One of the two WHO PQ facilities in Sub-Saharan Africa is owned and operated by UCL.

“While our 200mg strength was launched in India under the Stripiravir brand, this partnership will allow us to commercialise the 400mg dose alongside the 200mg dose for global markets, extending significant patient benefits with higher compliance and better administration,” said R Ananthanarayanan, MD and CEO of Strides Pharma Science.

Strides Group would continue to develop and produce high-quality generic medications that will help the healthcare system and patients, notwithstanding the challenging COVID scenario in various regions of the world, it added.

Molnupiravir is an orally given ribonucleoside derivative that inhibits SARS CoV2 replication and has been demonstrated to be effective against the most frequent COVID-19 variations in clinical investigations. Strides acquired an Emergency Use Authorization (EUA) from the DCGI in December 2021 to introduce molnupiravir 200mg in India.

Turkey has pledged 15 million doses of COVID-19 vaccine to Africa

President Recep Tayyip Erdogan stated at a major conference of African leaders that Turkey will deliver 15 million Covid-19 vaccine shots to the continent, calling the continent’s poor vaccination rates a “blot on humanity.”

During Erdogan’s tenure as Prime Minister and subsequently President of Turkey, which began in 2003, Ankara has made significant investments in building trade and diplomatic ties with the world’s poorest continent.

Erdogan told a crowd of hundreds of leaders and ministers that Turkey would provide 15 million doses of the Covid-19 vaccine to Africa, where cases are quickly increasing and immunisation rates are poor.

“We are aware of the global inequity in receiving the Covid-19 vaccine, as well as Africa’s unfair treatment,” Erdogan stated.

Turkey is researching on its own vaccine, dubbed Turkovac, which is currently awaiting emergency use approval.

Erdogan stated that after any approval, it will be shared with Africa.

Turkey’s remarks did not make it clear whether it would deliver certain doses of the globally licenced vaccinations it is presently employing, including those made by Pfizer-BioNTech.

“Within our resources, we plan to share 15 million vaccine shots in the coming months to help to the settlement of this crisis,” he stated.

Soaring infection rates

According to AFP calculations based on government numbers, the number of new infections across Africa has increased by 57% in the last week.

The worst-affected country is South Africa, which was one of the first in the world to be infected with the new Omicron form, which is thought to be even more contagious than previous coronavirus strains.

Erdogan stated that Turkey wished to improve ties with Africa in a variety of areas, including health, defence, energy, agriculture, and technology.

“Our true potential goes much beyond the goals we’ve set,” he remarked.

Turkey and African countries agreed in a final agreement to deepen cooperation in a number of areas, including health, “via more health sector investments.”

“We decided on a road map to improve our relations with the declaration we approved at this summit and the joint action plan,” Erdogan said at a concluding press conference.

Focus on trade

In the last 20 years, trade between Turkey and Africa has increased from $5.4 billion to $25.3 billion (4.8 billion euros to 22.5 billion euros).

Erdogan claimed that it had reached $30 billion in the first 11 months of 2021.

Turkey has set a new trade volume target for the future: $75 billion.

The third Turkish-African summit, which is by far the largest to date, is being attended by 16 African presidents of state and 102 ministers, including 26 top diplomats, according to Turkish Foreign Minister Mevlut Cavusoglu.

Erdogan also met with African leaders one-on-one, including Ethiopian Prime Minister Abiy Ahmed and Nigerian President Muhammadu Buhari, all of whom have showed interest in Turkey’s defence industry.

The next Turkey-Africa conference will take place in an unnamed African country in 2026.

3 million US Dollars boost has been given to a Kenyan medical firm

Revital Healthcare EPZ Ltd, a Kilifi-based medical supplies manufacturer, has obtained a new round of funding from two Japanese companies, allowing it to expand its production capacity.

Revital Healthcare has received a USD3 million (Sh339 million) investment from Asia Africa Investment and Consulting Pte Ltd (AAIC) and Ohara Pharmaceutical Company Ltd.

The Kilifi-based business, which is one of only 25 auto-disable syringe manufacturers pre-qualified by the World Health Organization (WHO) and the only one in Africa, will increase its yearly production capacity from 75 million to more than 400 million.

This comes after the Bill and Melinda Gates Foundation invested Sh440 million in the company, boosting output to at least 300 million syringes per year by 2022, according to the company’s sales, marketing, and product development director Roneek Vora.

Revital believes that the support will result in the development of over 100 direct new employment and over 5,000 indirect new jobs, with at least 50% of new hires being women.

As the global rollout of COVID-19 vaccinations advances, demand for auto-disable syringes has risen.

According to PATH, a global non-profit organisation dedicated to advancing public health, there will be a scarcity of approximately 2.2 billion 0.5ml vaccine syringes in 2022.

In low and middle-income countries, particularly in Africa, this will have a significant impact on the Covid-19 immunisation effort, child immunisation, and inoculation of the new malaria vaccines.

Revital now produces 45 critical medical disposables, including syringes, Rapid Diagnostic Test Kits for Covid and Malaria, Personal Protective Equipment (PPE) kits, surgical face masks, and viral transmission medium kits.

The investment comes at a time when the Omicron variant of Covid-19 is rapidly spreading over the world, causing countries to reintroduce severe measures such as lockdowns in an attempt to limit the infection.

In a statement, Vora stated, “Expanding manufacturing capacity in Africa for crucial goods like syringes is essential to secure adequate supply for the continent.”

He expressed his pride in the company’s contribution to worldwide efforts to guarantee that Africans have access to life-saving immunisation syringes.

Revital Healthcare chairman Rajni Vora stated that the business plans to expand into the diagnostics line, laboratory consumables, and other more necessary medical supplies with the financing from the Bill and Melinda Gates Foundation, AAIC, and Ohara Pharmaceuticals.

President and CEO of Ohara Pharmaceuticals Ltd, Seiji Ohara, stated that the demand for medical syringes that protect African lives against not just Covid-19 but also other infectious diseases including malaria and HIV/AIDS will increase in the future.

“We are committed to and excited about this strategic relationship in addressing the current and future global health crises from Africa,” Handa stated.