Gena Pharmaceuticals Ltd: The Polypill – Coming Soon

Gena Pharmaceuticals Ltd: The Polypill – Coming Soon

The concept of a fixed-dose combination pill-or ‘polypill’- for cardiovascular disease prevention

GENA a ISO 9001:2000 and WHO-cGMP certified company engaged in development, production, marketing and distribution of world-class pharmaceutical products in various dosages and forms, in specialized areas of i.e. Cardiovascular / Urology pursuing world-class standards in our People, Products, Processes, Partnerships and Performance offers the end users reliable, world-class quality formulation drugs to make a difference to the Quality of Life by reducing the burden of disease. Provide innovative healthcare solutions to address prevention, diagnosis and treatment of diseases.

It is with the unwavering ‘ dedication ‘ and the ‘will to win ‘ that we have traversed this journey so far. The next league is a greater challenge, as we have another milestone to achieve. Whilst we continue to enhance the momentum of our business in our key geographies, parallel to that we have to build our specialty pharmaceuticals business that will be initiated shortly. This would see us emerge as a serious player in this segment in time to come.

We have always believed that it is the people that make the organization and as we move ahead towards our mission to become a Research driven Global Pharmaceutical Company.

Gena has world class state of art facility in Kolkata, West Bengal, India and now another facility being set up at Martam in East Sikkim at a cost of Rs. 55 billion. The new manufacturing facility being set up at Sikkim would comply and obtain UKMHRA and USFDA approvals. The facility would house Beta Lactum and Non Beta Lactum sections to gain more mileage and expand the product portfolio.

Creation of intellectual wealth, as we move up the pharma value chain is critical to our business

In our quest to be a global player in the international pharmaceutical space, GENA has partnered with talented, high performing people and companies. GENA prides itself for a rich talent base that can successfully propel the company to even greater heights in an increasingly competitive global platform.

The structuring of our product portfolio into primary, secondary and tertiary brands will help to create power. New products have a sharper focus with a specialized management team looking into opportunities and launches. GENA will grow market share through a combination of new products, innovative selling and brand management.

In licensing and Alliances remain an important component of our strategy for the near to medium term. Given its importance in our strategy, our company has a dedicated management team to source new product and alliances opportunities, both domestically and globally.

With a field force, our sales, marketing and distribution network will be IT enabled and segregated into discrete divisions with a disease focus to improve customer coverage. The size of the field forces and the strong training and motivation inputs that will be continually provided will enable the company leverage scale and penetration significantly. This will be seen from the fact that despite severe competition across the market, our company will be committed to maintain its Prescription trend and price lines across key segments.

GENA will have strong brand and brand life-cycle management systems designed to derive competitive advantages in one of the most challenging pharmaceutical markets in the world. The company will have one of the widest product portfolios in India, spanning key therapeutic, areas, including Cardiovascular, Urology, Pain Management, Respiratory, Anti-infectives, Gastrointestinals, and Dermatology. The company proposes alliances across the globe in key therapeutic areas.

With a sharp focus on disease areas, the company will have specialist field forces that will cover all key doctor segments. Each high growth area like Cardiovascular, Central Nervous System, Gynecology, Dermatology, will have a dedicated field force that is highly trained. The multi-specialty approach to mass consumption brands and products, which require considerable reach and penetration across the country, will enable GENA to derive considerable advantages from skill, scale and size.

Our field force will implement best-in-class practices, including knowledge management support for doctors. The field forces will be IT enabled to improve customer-servicing capabilities. CRM investments in the field force will be augmented considerably. We will invest in augmenting our field force to strengthen doctor coverage and sharpen our divisional focus.

The size of the field forces and the strong training and motivation inputs that will be continually provided will enable the company leverage scale and penetration significantly. This can be seen from the fact that despite severe competition across the market, our company will be committed to maintain its prescription trend and prices across key segments, will help to have a substantial niche in the market.

While the Company would continue to enhance its momentum in the generics business, for long-term value building in the medium term are the key anchors of future growth.

The Company’s vision is to achieve significant business in proprietary by 2015.

To translate these objectives into reality and to optimize value creation, the Company has adopted a multi-pronged strategy. Together with the commitment of multicultural workforce, GENA will pursue its strategies to become a Research Driven Global Pharmaceutical Company.

Gena’s manufacturing strengths are planned in such a manner that through meticulous implementation produces branded formulations, keeping in mind and viewing the latest therapeutic requirements of various human diseases and its manifestation and thereby offering possible therapeutic solution at a affordable price, to reach to the mass. Needless to mention this very need is still unnoticed.

Gena has strong business association with the below companies for manufacturing of FDC. It is only company pioneering association with these companies in Eastern India:

  • CIPLA

  • RANBAXY

  • SANDOZ

  • AJANTA PHARMA

  • INTAS PHARMA

  • ALKEM

“Polypill” a combination of 3 or more drugs in a single pill for the prevention of cardiovascular disease (CVD). Based on theoretical considerations, it is projected that such a pharmaceutical product should enable the world’s healthcare systems to decrease the incidence of CVD by “more than 80%.” (Wald, NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80% BMJ. 2003; 326:1419-1423.)

Advantages of Polypill:

Reduce Cardiovascular disease by more than 80 % Cost Effectiveness.

The meta-analysis determined the effects of antiplatelet therapy among patients (acute Ml or ischemic stroke, unstable or stable angina, previous M stroke or cerebral ischemia, peripheral arterial disease or atrial fibrillation) at high risk of occlusive vascular events. The analysis included 287 studies involving 135000 patients. The results showed that among these high-risk patients, allocation to antiplatelet therapy reduced the combined outcome of any serious vascular event by about one-quarter; non- fatal myocardial infarction was reduced by one-third; non-fatal stroke by one quarter and vascular mortality by one sixth.

Aspirin was the most widely studied antiplatelet drug, with doses of 75-150 mg daily at least as effective as higher daily doses.

Evidence for the use of atorvastatin in the secondary prevention of CVD.

Multiple studies have demonstrated effectiveness of statin therapy in the secondary prevention of cardiovascular disease. Statins not only lower lipids but also have salutary effects on platelet adhesion, thrombosis, endothelial function, and inflammation and plaque stability.

We at Gena have developed FDC pill or “Polypill”. Cardiovascular disease (CVD) represents a major global burden. In comparing mortality data for 1990 versus estimates for 2020, developing countries will experience about a 100% increase in mortality due to CVII) For developed countries like the US, cardiovascular mortality is expected to increase by about 20% from approximately five million deaths annually in 1990 to six million in 2020. In terms of the combined incidence of coronary artery disease (CAD) and CAD mortality, in developed countries, for the same time period we expect to see a 29% increase among women and a 48% increase among men). In developing countries, it is astonishing; we expect to see a 120% increase in CAD and CAD mortality among women and 137% in men. Hence, the number of people with CVD is increasing faster in developing countries than in the developed world.

A recent analysis of the INTERHEART study revealed that the mean age for first myocardial infarction (MI) was lower in South Asians as compared to people from other countries explained by higher risk factors at younger ages. Further, Indians experience CVD deaths a decade earlier than their western counterparts and 52% of CYD deaths occur in those below 70 years compared to 23% in developed nations. A recent surveillance of CVD risk factors in 10 industrial centers in India comprising nearly 20,000 people aged 20-69 years revealed a high burden of CVD risk factors which is quite alarming. Hence, the need of the hour is the timely management of these risk factors to reduce the burden of CVD The past decade has seen a significant increase in pharmacological therapies with proven efficacy in reducing morbidity and mortality in patients with vascular diseases. Primarily, four classes of drugs have proven benefits in the secondary prevention of cardiovascular disease.

These include statins, aspirin, beta-blockers and angiotensin converting enzyme (ACE) inhibitors (or angiotensin II receptor blockers as a better tolerated alternative).

Proposed combination Each fixed-dose capsule contains: Aspirin 75 mg A.torvastatin 1.0 mg Atenolol 50 mg

Losartan 50 mg

And another combination is under development

Aspirin 75 mg A.torvastatin 1.0 mg Ramipril 2.5mg/5mg

Metoprolol 50 mg

GENA believes in the cult of excellence and Superior Product Value. It is this philosophy which permits the Organizations Entire Operations starting from procurement of Material to the Distribution of its Quality Product for guarding the health of millions of Gena’s endless fight against ill health, which has put it on the high pedestal of success.