Why Seagreen launched Gvither Plus and Klovinal – Product manager
In this exclusive chat with Temitope Obayendo, a product manager with Seagreen Pharmaceuticals Limited, Pharm. Abiola Akinwunmi, explains the company’s vision for the health care needs of Nigerians and why it recently launched two key products into the Nigerian market. Excerpts:
Could you tell us a bit about Seagreen Pharmaceuticals Ltd?
Seagreen is a fully indigenous pharmaceutical company incorporated in Nigeria. The company commenced operations in 2010. We are a company wholly committed to enhancing the health and wellness status of the Nigerian society. We see a Nigeria where every individual has access to basic essential medicines regardless of their socio-economic status.
Seagreen Pharmaceuticals Limited specialises in manufacturer’s representation, maintenance of scientific offices, importation, distribution, sales and marketing of pharmaceutical products. Our product portfolio includes drugs for management of tropical diseases, anti-infectives, drugs for management of chronic diseases, paediatric health, obstetrics and gynaecology and daily healthy living products.
We continuously scan the health care landscape to come up with products that can deliver exceptional value to health professionals and patients alike, in terms of quality, efficacy and relevance to the health care burden of the society. We specially focus on key challenges in the management of common tropical diseases and essential medicines for women and children’s health needs. Recently, we launched two products to tackle highly prevalent conditions in Nigeria – Gvither Plus, for malaria and Klovinal, for female genital tract infections.
Could you further explain why you decided to produce Gvither Plus?
The endemicity of malaria in Nigeria, coupled with the high incidence of treatment failures, prompted our search for a solution. Seagreen consequently collaborated with a leading company in the antimalarial therapy field in Africa, Bliss GVS, to avail the society of an efficacious antimalarial product. Bliss GVS has evolved substantial expertise in the antimalarial market in Africa, being the company to pioneer the 80/480 Artemether-Lumefantrine formulation and also Dihydroartemisinin-Piperaquine combination. The company’s antimalararial brands are well known and trusted in over 40 African countries. Gvither Plus is a uniquely cost-effective combination of Artemether and Lumefantrine. Currently, Artemisinin-based combination therapies are the mainstay of malaria treatment and Artemether-Lumefantrine is a well-tolerated and effective ACT.
It is commonplace for an individual that is down with malaria to use three to four brands before getting well. What is responsible for this?
The need to repeat courses of antimalarial drugs could result from recurrence following treatment. Recurrence of malaria has been attributed to repeat infections, relapsing malaria and recrudescence. Recrudescence is caused by failure of a course of antimalarial treatment and it accounts for majority of cases of recurrence.
The WHO guidelines for malaria treatment notes that treatment failures could result from drug resistance, poor adherence and inadequate exposure to the administered agent. Here, we talk about low quality substitute drugs that, in themselves, promote drug resistance, sub-optimal dosing, and lack of dosing consistency and even outright use of the wrong drugs.
Treatment failures can be minimised by careful selection of antimalarial brands to guarantee quality and efficacy. Brand selection must take bioequivalence into cognisance. Not all substitute brands will achieve the same drug target concentrations as brands that have been tested and proven over the years.
Repeat infections can be reduced by eliminating or minimising exposures to the disease vector, mosquito bites. Proper hygiene and environmental sanitation go a long way to reducing breeding of mosquitoes. Use of insecticides and insecticide treated bed-nets is also a viable means of controlling malaria spread.
Self-diagnosis of malaria by patients is also rampant. Misdiagnosis is as such common, since symptoms of malaria may mimic symptoms of other common ailments such as influenza and typhoid fever. Rapid malaria diagnostic kits are now available to reduce misdiagnosis.
What are the properties inherent in Gvither Plus which make it unique compared to other antimalarial drugs?
Gvither Plus represents a solution to antimalarial treatment failure. The brands positive attributes include the manufacturer’s track record and competence, assured quality and convenience of administration.
The brand is manufactured by Bliss GVS, a company that has a track record as a leader in antimalarial therapy across Africa. The company manufactures the constituent drug molecules of Artemether and Lumefantrine; this eliminates inter-batch variability so the issues of bioequivalence and quality assurance are addressed.
Gvither plus also promotes dosing compliance. It is formulated as 80/480 tablets for adults. That means just a single tablet is required for each dose. This reduces the pill burden on the patient, provides convenience and promotes compliance.
Treatment failure in children is also common. Here lack of dosing accuracy and consistency plays a major role. The paediatric formulation of Gvither Plus is presented as pleasantly flavoured dispersible tablets. Children find this more palatable and so adherence is improved. Dosing variation and inaccuracy is usually due to human factors introduced by carers that administer the drug, Gvither plus dispersible eliminates this risk because each dose has been carefully measured into a tablet. No measurement is therefore needed on the part of the patient’s carer.
WHO’s prequalification is gaining credence in the country, and the continuity of this trend may spell doom for pharma manufacturers without the qualification. Is there any plan to get the qualification for your brands?
Our mission at Seagreen is closely aligned with the WHO’s purpose for prequalification – provision of quality-assured priority medicines. With Seagreen, the goal is to make available good quality pharmacotherapy options for the management of prevalent healthcare challenges in the country. Hence the company adopted a proactive approach to quality right from inception. This has ensured that Seagreen’s activities would not be significantly affected by the prequalification requirements.
We maintain a stringent prequalification and selection process for our manufacturers. Our main manufacturer, Bliss GVS, operates a Total Quality Management (TQM) system that has been validated and accredited by WHO GMP, EU GMP, PIC/S, ISO and NAFDAC.
In this age of counterfeiting, how do you ensure quality for your customers?
At Seagreen, we hold quality close to our hearts. Apart from this, we have invested in the MAS. Gvither Plus comes with the scratch cards that enable verification of the authenticity of each product pack by the end user. We also invest in other quality monitoring and enhancement activities, including distribution channel and market surveillance.
Klovinal is another new product from Seagreen Pharma. Could you tell us more about it?
Research has it that, annually, up to 40 per cent of women would suffer episodes of non-sexually transmitted urogenital infections, leading to vaginitis; and over a million and half Nigerian women have recurrent fungal forms of vaginitis annually. These require at least four treatment courses annually.
Infective vaginitis is characterised by abnormal malodorous discharge, itch, burning sensation and dyspareunia. Mixed infections are common. Recurrence is a major challenge to the pharmacotherapy of vaginitis and recurrent vaginitis is a risk factor for sexually transmitted infections including HIV.
Seagreen, being a customer responsive company decided to respond to the yearnings of the health care industry for a solution that can provide sustained cure against vaginitis. This heralded the launch of Klovinal.
Klovinal is a brand of polyactive pessaries introduced by Seagreen in the course of the company’s last business year. It is specially designed and formulated for the management of vaginitis due to bacterial, fungal, protozoal organisms. Klovinal has a spectrum of antimicrobial activity that covers the three most prevalent forms of vaginitis, which are bacteria vaginosis, vaginal candidiasis and trichomoniasis. It is therefore suitable for empirical or syndromic management of vaginitis including mixed infections.
What elements distinguish Klovinal from competitive brands?
Klovinal is, indeed, a veritably unique product in its category. It represents a whole paradigm shift in the management of vaginitis. Moving from merely eradicating pathogenic species to a system where microbiological cure is augmented by re-establishing the dominance of the healthy normal flora.
Klovinal is different from other agents useful in the management of vaginitis by the following factors: Firstly is its unique composition. Klovinal consists of three active agents – Metronidazole, Clotrimazole and Lactobacillus spores co-formulated as pessaries. The first two actives confer efficacy against the common forms of vaginitis, while Lactobacillus is included as a probiotic. Probiotics, according to the WHO, are live microorganisms which are administered in adequate amounts for health benefits in the human host system. So we purposefully use a species of microorganism to inhibit other pathogenic species.
The essence of the combination is to achieve the dual purpose of achieving microbiological cure and restoring the dominance of the normal healthy vaginal flora with the same agent. The outcome is efficacy against mixed infection and minimisation of the risk of recurrence. This is the first agent available in Nigeria to achieve this.
Secondly, Klovinal is manufactured with outstanding attention to quality in the pessary laboratories of Bliss GVS. That manufacturing facility is WHO GMP compliant, EU GMP compliant, ISO14001 and PIC/S.
Thirdly, Klovinal is produced using a new and innovative formulation technique, termed, SMEDDS – Self Micro Emulsifying Drug Delivery System. SMEDDS guarantees that the pessary will melt rapidly at body temperature and uniformly coat the affected surface. So, with Klovinal, you are sure that the pessary releases the active drug to the site where it is required. Women will not wake up to find administered pessaries falling off wholly or partially without having elicited any effects.
What is your vision for these products in the next five years?
I sum that up as “sustained relevance”. Health care science and practice are dynamic. In five years, it is our desire that Seagreen attains greater relevance in the health care system; and we are vigorously pursuing this. We are also positive that the products would have attained full acceptance as veritable health care solutions and, barring any major evolutions in science and knowledge, that the health care community would find them dependable allies in the management of the disease conditions.