Dr. Muhammad Pate, the Coordinating Minister of Health and Social Welfare, who went on to preside over the ceremony, said that it was a direct outcome of the high-level discussions that took place between President Bola Ahmed Tinubu as well as Luiz Inácio Lula da Silva, the President of Brazil.

Pate, while speaking at the ceremony, reaffirmed the determination of the government to reposition the health industry of Nigeria for self-dependence along with global competitiveness.

This kind of strategic collaboration crops up from the high-level engagements that have taken place between President Bola Ahmed Tinubu and his counterpart from Brazil, President Luiz Inácio Lula da Silva at recent official by President Tinubu visit to Brazil, where both the leaders committed themselves to expanding their cooperation when it comes to vaccine production and pharmaceutical development, along with a much wider industrial growth.

The MoU that has been signed to push local pharma manufacturing is indeed a concrete expression of their commitment when it comes to making the local manufacturing of vaccines and essential medicines more robust. It transforms the presidential-level commitments into operational partnerships, which advance the health security of both the nations and also speed up the industrial development under the gamut of the Renewed Hope Agenda.

By way of the Nigeria Health Sector Renewal Investment Initiative – NHSRII, they are indeed systematically unlocking the healthcare value chain, expanding technology transfer, and decreasing the dependence on imports, and at the same time, positioning Nigeria as a regional manufacturing powerhouse.

Daju Kachollom, the Permanent Secretary, FMOH, stressed the prominence of the partnership and also the commitment by the Ministry when it comes to driving certain reforms that are impactful.

He added the day indeed goes on to mark yet another important step when it comes to the journey of Nigeria towards building a much more resilient as well as competitive health industry. This collaboration happens to reflect their collective determination in order to strengthen local manufacturing, widen the access to essential health commodities, and also make sure that the government-led reforms go on to translate into real opportunities for their people.

Kachollom further said that they welcome their partners from Brazil and also the private sector and look forward to a collaboration that is productive and is going to unlock novel possibilities throughout the healthcare value chain.

When it comes to his part, the National Coordinator of PVAC, Dr. Abdul Mukhtar, underscored the role of the initiative in addressing the systemic challenges. He said that the PVAC was established in order to unlock the bottlenecks that are prevalent in the healthcare value chain of Nigeria. This collaboration is indeed a major leap towards attaining sustainable, local vaccine and pharmaceutical production, which goes on to meet the national and regional requirements.

Mr. Ricardo Marques representing the Brazilian partner EMS Brazil went on to express his confidence when it comes to the joint effort, stating that Brazil is indeed proud to work alongside Nigeria when it comes to this transformative initiative. Their collaboration is going to strengthen the industrial linkages, support the long-term goal of pharmaceutical independence in Nigeria, and also deepen the technical cooperation.

Oaks Medical Limited’s Dr. Ayotunde Oyedeji stated that the MoU does align with the ambition of Nigeria so as to build a robust and more resilient pharmaceutical manufacturing base. They are indeed pleased to be part of this endeavour to give sustainable access when it comes to medical products that are high-quality.

The mRNA vaccine facility will rely on BioNTech’s “BioNTainers,” modular units that can be set up quickly and adjusted to produce different mRNA vaccines. Built to be flexible and scalable, it meets health challenges while helping expand the local vaccine network. If successful, the Kigali site could become the continent’s first commercial mRNA vaccine manufacturing facility.

“This manufacturing site is about empowering Africa with the tools and expertise to tackle health challenges independently,” said Karl Nehammer, EIB Vice-President responsible for health. “By working with BioNTech and the European Commission, we’re supporting a future where vaccines are produced in Africa, for Africa. This partnership is a major step forward for health, jobs, and innovation across the continent.”

The facility is expected to not only produce vaccines for widespread use but also manufacture clinical trial materials for local partners, supporting skills development and job creation while strengthening Rwanda’s position as a hub for medical innovation. “We recognize that the challenges in global health are too vast for any single entity to solve alone. BioNTech is dedicated to working across the entire development chain, partnering with local communities, researchers, governments, and not-for-profit organizations to make a meaningful impact. The support by the European Commission, European Investment Bank and CEPI are an important contribution to the joint efforts of advancing and strengthening the implementation of a local mRNA vaccine ecosystem – covering the spectrum from clinical trials to commercial production,” said Sierk Poetting, Chief Operating Officer of BioNTech.

The initiative reflects close collaboration between BioNTech, the Coalition for Epidemic Preparedness Innovations (CEPI), and Team Europe partners, EC and EIB. It aligns with the EU’s Global Gateway strategy and supports the African Union’s goal of producing 60% of the continent’s vaccines domestically by 2040. Jozef Síkela, Commissioner for International Partnerships, said: “Global health is a key priority of the Global Gateway strategy, and the EU has already invested more than €1.9 billion in local vaccine and medicine manufacturing and affordable access in Africa. The agreement with BioNTech to support the advancement of its state-of-the-art mRNA manufacturing facility in Rwanda will boost expertise across the region and build increased independence from entities outside of Africa.”

CEPI’s backing, including a grant of up to €130 million announced in 2024, is intended to ensure that vaccines produced at the Kigali site remain accessible and affordable. Dr Amadou Sall, Executive Director of Manufacturing and Supply Chain at CEPI, added: “Establishing the pioneering Rwanda facility as the first mRNA vaccine manufacturing site in the region following the globally recognised Goods Manufacturing Practice will boost regional vaccine capacity to help more rapidly respond to public health threats, including new outbreaks that strike locally. The project will make an important contribution to Africa CDC’s goal for 60% of the vaccines needed by the continent to be produced on the continent by 2040, strengthening regional health security and global pandemic preparedness.”

Kåre Schultz, Teva’s President and CEO, said, “Teva is taking decisive and immediate action to address external pressures and internal inefficiencies. Our new company structure will enable stronger alignment and integration between R&D, operations and the commercial regions, allowing us to become a more agile, lean and profitable company.”

Schultz continued, “We will focus on driving sustainable value creation. The new management team will position Teva for turnaround in the short to medium term. We are already working on a detailed restructuring plan for Teva and will share it in mid-December. It remains our absolute priority to stabilize the company’s operating profit and cash flow in order to improve our financial situation, while being focused on short-term revenue and cash generation, and at the same time, ensure we deliver on our commitment to supply high-quality medicines to patients around the world.”

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in over 60 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva’s net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com

Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin C. Mannix,
215-591-8912
or
Ran Meir,
215-591-3033
or
Israel
Tomer Amitai,
972 (3) 926-7656
or
PR Contacts:
Israel
Iris Beck Codner,
972 (3) 926-7208
or
United States
Denise Bradley,
215-591-8974

These data demonstrate immune-stimulatory activity in solid tumor patients with highly-refractory malignancies, including patients who have failed prior checkpoint inhibitors. Also presented were pre-clinical data establishing the immune-modulatory and anti-tumor effects of RGX-104. The company presented the data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

RGX-104 is a liver X receptor (LXR) agonist that upregulates the expression of the target gene, Apolipoprotein E (ApoE), triggering several downstream effects via ApoE receptors. In pre-clinical data presented today, treatment with RGX-104 in mouse models resulted in dual effects on myeloid-derived suppressor cells (MDSCs) and dendritic cells (DCs), both innate immune cells that play a central role in regulating anti-tumor immunity and response to checkpoint inhibitors. Innate immune activation with RGX-104, coupled with a reduction in tumor blood vessels, resulted in anti-tumor activity as a monotherapy as well as synergy with checkpoint inhibitors (CPI) in several drug-resistant mouse models. These data provide rationale for Rgenix’s ongoing Phase 1a/b trial of RGX-104 in advanced cancer patients and support evaluation of RGX-104 as both a monotherapy as well as in combination with CPIs.

As part of the ongoing Phase 1a/b clinical trial, 15 patients with a variety of solid tumors have been treated with escalating doses of RGX-104 monotherapy. Patients treated with RGX-104 had a median of six prior therapies with a range of 1-12, highlighting a population of patients with profoundly resistant disease.

Activation of the LXR-ApoE pathway with oral administration of RGX-104 was associated with immune-stimulatory activity in 9 of 10 evaluable patients. This was demonstrated by an increase (up to 11-fold) in activated circulating PD-1+CD8+ T cells during treatment. T cell activation was observed in patients who experienced modulation of the innate immune system during treatment. The effect of RGX-104 on the innate immune system consisted of both MDSC depletion (up to 95% decrease) as well as DC activation as indicated by induction of PD-L1 expression (up to 100% increase). In most cases these effects were observed within two weeks of treatment initiation and generally preceded the onset of T cell activation.

Safety data demonstrate good tolerability with on-target safety findings in the first three dosing cohorts. One patient experienced a DLT of grade 4 reversible neutropenia – a known potential effect of LXR agonism – that reversed within one week, allowing the patient to subsequently tolerate a 50% dose reduction. No MTD has been reached to date. Stable disease has been observed in 4 of 12 evaluable patients, including three who have failed prior checkpoint inhibitor therapy, for periods of at least 8 weeks.

“We are very pleased to see robust evidence of immune stimulation in such highly-pretreated patients,” said Roger Waltzman, MD, MBA, and Chief Medical Officer of Rgenix. “CPI therapy is now commonplace but only a minority of patients derive clinical benefit. We hope the effects of RGX-104 on modulating barriers to innate and adaptive immune function will enable a larger number of patients to benefit from this therapy. These preliminary results also highlight the potential for development of RGX-104 as a monotherapy.”

Rgenix plans to enroll subsequent dose-escalation cohorts of the RGX-104 monotherapy trial in Q4 2017. Additionally, Rgenix is planning to initiate the Phase 1b expansion component of the study, comprised of disease directed cohorts receiving RGX-104 monotherapy as well as cohorts receiving RGX-104 combined with a CPI, projected to begin in 1H 2018.

“These preliminary data establish RGX-104 as a potential first-in-class oral immunotherapy agent with broad immune-stimulatory activity and a unique dual mechanism targeting innate immunity,” said Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix. “These results also further validate our discovery platform at Rgenix, as well as our pipeline of other drug candidates slated to begin entering clinical-stage development in 2018.”

The LXR-ApoE pathway was discovered as a cancer target using a microRNA (miRNA) based target discovery approach originally developed at The Rockefeller University and now exclusively licensed to Rgenix.

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, and Alexandria Venture Investments. For more information, please visit www.rgenix.com

Contacts
Media:
RooneyPartners
Marion Janic, 212-223-4017
mjanic@rooneyco.com

SPCI is developing Altemia™ as a treatment for pediatric patients with sickle cell disease.

The Company previously announced enrollment completion of the clinical trial, highlighting high retention rates and the possibility for patients to enroll into an open label extension that will collect long term safety data while continuing to monitor the effectiveness of the drug.

“We are excited that database lock, another key milestone for the study, is being achieved. We will discuss progress made in our sickle cell research initiatives with the scientific community at SCDAA. We expect to present all data available at future scientific events. Altemia™ has the potential to be an important new treatment option for people with sickle cell disease who experience devastating vaso-occlussive events, which can be extremely disruptive in their lives”, said Dr. Frederick D. Sancilio, President and Chief Executive Officer of SPCI.

About Sickle Cell Disease (SCD)
Sickle Cell Disease (SCD) is a group of genetic disorders that results in dysfunctional hemoglobin (HbS) and a depletion of certain lipids in the walls of blood cells. These abnormalities create an inflammatory state and an increase in the red and white blood cell’s tendency to adhere to each other, resulting in episodic occlusions of blood vessels, reperfusion damage and excruciating pain. Ultimately, many children develop organ damage and strokes. There are approximately 100,000 cases of SCD in the United States. Treatment options are limited. The cost of care for this group may exceed $5BB.

About Sancilio Pharmaceuticals Company, Inc.
Sancilio Pharmaceuticals Company, Inc. (SPCI) is a fully integrated, specialty pharmaceutical company focused on developing, manufacturing and commercializing pharmaceutical products, including those based on our proprietary Advanced Lipid Technologies® (ALT®) platform. SPCI is pursuing treatments for sickle cell disease, short bowel syndrome and severe hypertriglyceridemia. We utilize our cGMP compliant facility to develop and manufacture our products. Our ALT® platform is designed to enhance the bioavailability, reduce the food effect and improve the efficacy of lipids and lipophilic active pharmaceutical ingredients (APIs). Lipids are hydrophobic or amphipathic molecules, including fatty acids, steroids (including hormones) and fat-soluble vitamins (such as vitamins A, D, E and K). Our business model is to apply our ALT® platform to lipids or lipophilic APIs to create unique product candidates that address the disorders and diseases resulting from imbalances of lipids in the body. In addition to our primary focus of developing our proprietary products using the ALT® platform, we make use of, and license rights to, our proprietary ALT® platform and other technologies to third parties, providing both development and subsequent soft gelatin encapsulation services. More information is available at: www.sancilio.com

Contacts

Sancilio Pharmaceuticals Company, Inc.
Marc Wolff, 561-847-2302
Executive Vice President & Chief Financial Officer

SHAPE (Selective 2′ Hydroxyl Acylation analyzed by Primer Extension), the most widely used approach for probing RNA secondary structure, was developed by Kevin Weeks, Ph.D., and colleagues at the University of North Carolina in 2005.1 SHAPE studies provide scientists with experimental assessment of predicted loops, bulges and pockets in the two-dimensional structures of RNA. The resulting integrated structural prediction enables biological insight into RNA function and detection of ligand binding sites within the RNA.

SHAPEware offers a standardized and modular set of tools for scientists to analyze data generated by SHAPE methodologies and was initially developed by Arrakis to streamline and standardize its own analysis of the SHAPE data that the company is generating in its proprietary drug discovery efforts to design RNA-targeted small molecules (rSMs).

“We are thrilled to share SHAPEware with the broader community of RNA experts,” said Russ Petter, PhD, Founder and Chief Scientific Officer at Arrakis. “The field of RNA structure is advancing rapidly and open-source software allows us to accelerate the best thinking from hundreds of potential users.”

SHAPEware will help researchers identify and evaluate the distinct characteristics of folded RNA through the following features and upgrades:

SHAPEware is designed to be highly modular and customizable, allowing users to evaluate and compare results from different analytic algorithms and SHAPE methodologies.
The initial launch of SHAPEware includes a module to analyze data from SHAPE-MaP (mutational profiling) experiments.

Arrakis continues to develop and adapt novel SHAPE methodologies to study RNA structure. It is anticipated that additional updates and modules will be added.

The SHAPEware open-source software can be downloaded at www.shapewareRNA.com, and the free license requires users to share feedback and any modifications or improvements with the community.

About SHAPE
SHAPE is an acronym for selective 2′-hydroxyl acylation analyzed by primer extension, developed by Kevin Weeks, Ph.D., and colleagues at the University of North Carolina in 2005, and describes the chemical reaction that is used to assess the flexibility of RNA at each nucleotide in any given sequence. This information can be used to establish the secondary structure of an RNA, to monitor structural differences between related RNAs or a single RNA in different states, and to infer ligand binding sites. Several SHAPE-based methodologies have been developed in academic laboratories: SHAPE-Seq, SHAPE-MaP (SHAPE followed by mutational profiling) and icSHAPE (in vivo click selective SHAPE), each requiring different experimental protocols and analysis software.

About RNA-targeted Small Molecules (rSMs)
Emerging insights and technologies focused on understanding the structure of RNA enable the design of RNA-targeted small molecules, or rSMs, a new class of medicines that directly bind and modify the biological function of RNA to treat disease. Unlike conventional drug discovery approaches that focus on proteins, an rSM is designed to modulate function of an individual RNA, and, in the case of mRNA, the expressed protein, by selectively binding to specific, predictable structures in functional regions in the RNA. This new drug discovery approach enables the design of small-molecule drugs that can unlock the therapeutic potential of well-known targets that are not accessible with today’s drugs, as well as identifying new drug targets to intervene in diseases in new ways.

About Arrakis Therapeutics
Arrakis Therapeutics is a biopharmaceutical company pioneering the discovery of a new class of medicines that directly target RNA. The company has developed a proprietary platform to identify new RNA targets and drug candidates to treat diseases not addressed by today’s medicines. Arrakis is building a proprietary pipeline of RNA-targeted small molecules (rSMs) focused on neurologic diseases, cancer, and rare genetic diseases.

Arrakis was founded in 2015 by Russell C. Petter, Ph.D., Alan Walts, Ph.D., Henri Termeer and Raj Parekh, Ph.D. with a vision to create a proprietary, transformational discovery platform that identifies small-molecule drugs that act directly on disease-causing RNA. The company was established with seed funding provided by Advent Life Sciences and Henri Termeer. The company brings together scientific leaders in RNA structure, chemistry and biology, along with a highly experienced management team and the backing of leading life sciences investors. The company is located in Waltham, Mass. Please visit www.arrakistx.com

Contacts

For Arrakis Therapeutics
Kathryn Morris, 914-204-6412
kathryn@theyatesnetwork.com

Avara Pharmaceutical Services has signed an agreement with GSK to acquire a GSK consumer healthcare manufacturing facility in Aiken, South Carolina. “This acquisition is an important component of our strategic plan and expands our services by adding additional solid dose capability in the United States, which is in very high demand,” stated Timothy C. Tyson, Chairman and CEO. The transaction is expected to complete on or before June 1, 2018.

Avara Pharmaceutical Services is a state-of-the-art contract manufacturing and technical services organization providing both API formulation and manufacturing, along with secondary formulation, manufacturing and packaging of small molecule drugs, including highly potent compounds. Avara has secondary manufacturing technologies including granulation, coating, blending, encapsulation, compression and drying of tablets and capsules. Avara also has sterile manufacturing capability.

Following completion of the transaction with GSK, Avara Pharmaceutical Services will have seven sites. Three in the US, including the corporate HQs; one in Puerto Rico, one in the UK, one in Ireland, and one in Italy.

Norwalk, CT (USA) – Corporate HQ
Arecibo, Puerto Rico – Secondary manufacturing and packaging
Shannon, Ireland – API formulation and manufacturing
Norman, OK (USA) – Secondary manufacturing and packaging
Avlon, United Kingdom – API formulation and manufacturing
Liscate, Italy – Sterile Manufacturing.
Aiken, South Carolina – Secondary manufacturing and packaging

“As we celebrate another important milestone, we continue with great confidence to add pharmaceutical services and capabilities with complementary offerings in key regions in this rapidly growing market. Each of our sites have significant professional experience, state of the art capability and a long history of delivering high quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements in every major market around the world. The people who are a part of the Avara team are the key to our long-term success,” said Tyson. “We are focused on delivering on our commitments and earning the trust of every customer we deal with.”

About Avara
Avara Pharmaceutical Services, Inc., based in Norwalk, Connecticut is an international pharmaceutical services company that delivers world-class contract manufacturing and technical services to the pharmaceutical industry. Avara has primary and secondary manufacturing facilities in North America and Europe and supplies products to all major markets around the world. Avara’s broad experience with supply chain, commercialization, product launch and product transfer allow us to sustain exemplary levels of product quality and regulatory compliance. The company is known to exceed customer service level expectations and consistently deliver on time, in full at a fair price.
For more information, please visit our website at www.avara.com

As pharmaceutical companies struggle with the increase in drug development cycle times and cost overruns, pressure mounts for better command of the data that runs their business to make the drug development processes more efficient. A major challenge for any pharmaceutical company is the ability to leverage all the data it generates and has access to, due to data silos produced by a multi-vendor business model and disparate trial management systems.

Saama’s suite of analytics, powered by its Fluid Analytics Engine®, integrates multiple sources of structured and unstructured data. The cloud-based solution has pre-built capabilities for data ingestion, integration, and analysis, which can be leveraged to generate real-time business insights within weeks. Saama’s clients benefit from faster time-to-market, reduced costs, and better patient and business outcomes.

“We are committed to bringing our signature innovation and deep expertise to driving more efficient, optimized business processes and outcomes in the Life Sciences industry,” said Suresh Katta, CEO and founder of Saama Technologies. “We have been in the business of delivering superior business results for our clients and have spent considerable time and effort in developing a framework that can solve any data challenge. The launch of our Life Science Analytics Cloud marks a significant milestone in the progression of our company.”

Saama Life Science Analytics Cloud Modules
Clinical Development Optimizer: Clinical Development Optimizer (CDO) is a data lifecycle management solution that specializes in integrating and harmonizing data from disparate sources to create a clinical data lake where all the data resides, prepped and ready for analytics. CDO allows a clinical research team to assess risks across all studies and to evaluate performance based on key metrics.

Trial Planning Optimizer: Trial Planning Optimizer (TPO) is the clinical trial feasibility solution that optimizes the processes governing enrollment, investigator identification, site selection, and patient burden. TPO uses Real World Data (RWD) to identify eligible patient populations and principal investigators. TPO evaluates and quantifies the likelihood of successful patient enrollment and site selection.

Cohort Builder: Cohort Builder is the cohort generation solution that identifies patient populations based on inclusion-exclusion criteria. It organizes real-world patient information based on diagnosis, drug therapy, and procedures, to pinpoint population groups that fit specified criteria. Cohort Builder summarizes incidence rates and comorbidities of a disease and various other target metrics across a target cohort.

Market Analyzer: Market Analyzer is the commercialization analysis solution that provides the therapeutic value of clinical products, within a market basket and across geographic areas. The solution allows companies to predict the reception of a drug or treatment in the market on the basis of claims/EMR data and mapping it across similar products, market trends, and competitor activity.

Patient Pathways: Patient Pathways is the patient journey tracking solution that facilitates the evaluation of treatments, disease progression, outcomes, and total economic costs. Patient Pathways leverages RWD to provide decision-making insight into how a given disease is treated and/or managed; drug lines of therapy; treatment options and outcomes; cost of therapy; treating physicians; disease progression and complications.

“Saama’s revolutionary Life Science Analytics Cloud incorporates the latest techniques of deep learning and machine learning along with the industry’s foremost data ingestion and harmonization engine to deliver game-changing results for the industry”, said Karim Damji, SVP of Product Management and Marketing at Saama Technologies. “The launch of our Life Science Analytics Cloud is a natural progression from our previously announced innovative Clinical Data Analytics and Management as a Service announcement (CDaaS.) The analytics suite builds on top of a new consumption model for managing complexities of trial data and allows trial teams to focus on research and analysis vs. data-wrangling.”

With the release of the Life Science Analytics Cloud, Saama significantly opens up new possibilities for how to manage data in the life science industry.

Hoffman La Roche AG completed the construction of phase one of their new vitamins and minerals premix plant at Isando, in the Republic of South Africa, in June 2002. The facility was inaugurated by Dr Marcus Altwegg, head of Hoffman La Roche Vitamins and Fine Chemicals division, on 25 June 2002.

BUSINESS SOLD TO DSM

The business was sold to the Dutch chemicals firm DSM in late 2002, in a deal worth $2.24bn. Early in July 2002 Roche instigated negotiations with DSM for the sale of its entire vitamin and premix manufacturing business. Roche, along with other European companies, was fined in the US and Europe after being found guilty of operating a price-fixing cartel for vitamin and nutritional products.

“Roche was fined in the US and Europe after being found guilty of operating a price-fixing cartel for vitamin and nutritional products.”

The sale went ahead with closure of the deal in October 2003. The sale price negotiated was $2.24bn (€1.750m) and 2.24 million shares in DSM to be issued to Roche. Roche had dropped the price by €200m because of the legal issues surrounding price controlling and also retained liability for court costs and compensation arising from these legal issues.
Roche holds 42% market share worldwide in this business and is the world’s leading supplier of vitamins and carotenoids. DSM had no other vitamin and premix business interest and so avoided monopoly investigations by European government bodies.

ISANDO FACILITY

The facility manufactures vitamin premixes for the food and pharmaceutical industry in South Africa and surrounding African nations, such as Nigeria, Ghana and Kenya. The facility works in cooperation with UNICEF in producing the vitamin premixes necessary to fortify basic foodstuffs in under-developed African nations.

ISANDO PREMIX PLANT PROJECT

Construction of the premix plant at Isando was started in the first half of 2000. The new facility entered full commercial scale production a little later than first planned in 2002. The plant was constructed at an estimated cost of 30m Rand ($2.7m).

This facility was the first phase of a larger project. The subsequent phase, which was completed in early 2004, manufactures vitamin premixes for animal nutrition. The total value of the entire project is estimated at $6m. The capacity of the first phase facility was 1,400t/y. The much larger second phase took production to 3,000t/y by mid-2004.

THE PREMIX MARKET BURGEONS

In the pharmaceutical industry, vitamins are used in supplement preparations such as tablets or capsules. Since companies have begun moving away from using single vitamins to fortify their products and towards multiplicity, the services of premix plants have been in great demand. This has strengthened the premix industry considerably. It is for this reason that a number of premix plant projects have been initiated by leading pharmaceuticals suppliers. These include new Roche premix plants in Poland and at El Salto, Mexico. The company has a total of 48 premix facilities around the world.

Problems have arisen in the vitamins market in recent years due to increased competition from vitamin manufacturers in China who can produce cheaper products and also by the increasing cost of raw materials. The price increases are inevitably linked to the price of crude oil.

TEAVIGO: A RECENT SUCCESS IN SOUTH AFRICA

“DSM is looking to boost revenue by producing products from plant raw materials. A recent success story is Teavigo.”
DSM is looking to boost revenue by producing products from plant raw materials. A recent success story is Teavigo, which is a purified, concentrated form of the green tea active epigallocatechin gallate (EGCG) known as a potent antioxidant. This was developed by Roche prior to the sale to DSM.

Teavigo has achieved GRAS (generally regarded as safe) status from the US FDA and is now being incorporated into a wide range of foods. Prior to this the compound was incorporated into commercial food stuffs in South Africa.

COMBATING THE HIDDEN HUNGER PHENOMENON

Vitamin and mineral deficiencies prevent some 30% of the world’s population from achieving their full mental and physical potential. This phenomenon is often referred to as ‘hidden hunger’.

Food fortification is designed to combat the ‘hidden hunger’ problem by delivering foods rich in micronutrients to large populations, especially in developing countries. The plant at Isando can now produce the necessary vitamin A, B and mineral premixes to supplement basic foodstuffs and reduce the ‘hidden hunger’ problem. The plant is responsible for the supply of vitamins and nutritional mixes to its neighbouring countries in Africa.

AstraZeneca’s pharmaceutical production facility in Sixth of October City (Madinat Sittah Uktubar), near Cairo, produces a broad range of the company’s product portfolio including cardiovascular, psychiatric and cancer treatments. The plant was officially opened by Eyptian Health Minister Dr Hatem El-Gabaly on 11 December 2006.

AstraZeneca applied to the General Authority for Investment (GAFI) in Egypt for a license to build the plant in May 2004 and production began just a few months later in November. It was the firm’s first manufacturing investment in the Middle East, kicking off the company’s regional expansion strategy.

The new facility has 7,000m² of floor space and focuses on the three product lines. It cost $32m to construct and outfit.
“The new facility has 7,000m² of floor space and focuses on the three product lines.”

The initial products from the plant will be for sale in the Egyptian domestic market but further increases in production will supply nearby regions such as the European and Middle Eastern markets.

AstraZeneca hopes to gain a foothold in a potential expanding market which is worth an estimated $1.6bn annually. Up to 65% of the Egyptian market is supplied by multinational companies. Of this, 30% is through local manufacturing and 35% is through licensing agreements, according to AstraZeneca.

Employment at the AstraZeneca Eygpt Marketing Company more than doubled between 2005 and 2007 to a total 250 employees. It has now set up a regional office in Cairo responsible for the Middle East and North Africa.

AstraZeneca and Egyptian pharmaceutical market

Previously, AstraZeneca production in Egypt was carried out by a contract manufacturer under license and was only responsible for $12m of the company’s $18.8bn worldwide annual turnover.

The construction of the plant was helped by Eygpt’s adoption of the WTO ‘TRIPS’ agreement from 1 January 2005, which protects intellectual property rights.

Egypt is the largest producer and consumer of pharmaceuticals in the Middle East and North Africa (MENA) region with a 30% share of the supply in these markets. The region also absorbs most of Egypt’s pharmaceuticals exports. Egypt surely has a vested interest in attracting big pharmaceutical companies so that it can become a production hub for the future of the Middle Eastern and African markets.

AstraZeneca has identified Egypt as one of the key emerging markets for further development, together with such countries as China and Mexico.

Contractor and facility

The general construction contract was awarded to Orascom Construction Industries (OCI) of Egypt, who carried out construction of the main production building, support facilities, administration building, laboratories, packing, dispatching and warehouse facilities.

The internal design and outfitting contract was awarded to Uhde and Chemgineering. These two companies, based in Germany and Switzerland respectively, are responsible for the detailed design and planning of the production facility including definition of the process equipment (tablet and capsule production and packaging), cleanroom facilities, GMP concepts, master planning and technology transfer.

The Chemgineering / Uhde consortium also coordinated with a local pharmaceutical engineering / design contractor, Sabbour Associates, who was responsible for elements of plant design and construction and project management. Sabbour Associates have been the main contractor on two other pharmaceutical facilities for both Sedico and October Pharma in Sixth of October City and have plenty of experience of the region.

“The high-speed tablet presses are capable of producing up to 12,000 tablets per minute.”

The facility initally has a capacity of 250 million tablets per year, but the production lines and the attendant compounding, pressing, drying, packaging, warehousing and other production infrastructure will be arranged so that a future expansion (which is already on the drawing board) can allow the production of in excess of 400 million tablets per year.

Tableting process

The facility uses the latest state-of-the-art processes to produce solid dosage forms (tablets, hard and soft gelatine capsules and a variety of delayed release forms). The tablets will be produced where possible by wet / dry granulation methods, but also by direct compression if necessary.

The processes will allow for the production of extended and delayed release dosage forms of various designs and also micro particle coated capsules for incorporation in hard gelatine capsules.

The high-speed tablet presses are capable of producing up to 12,000 tablets per minute, but the average tablet press speed is 3,000 tablets per minute. Press speed requires powders / granules to have good fluid properties (product flowability) – if they do not the formulation needs to be modified by using additives (excipients) or the press speed may need to be slower.