Development
Research and Development
We were pioneers among Poland pharmaceutical companies to see tremendous value in investing in research & development (R&D). Our early investments in R&D, beginning three decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing generics and technologically complex products through focused teams in formulations, process chemistry and analytical development. We have the capability to deliver quality products within established timelines, at low costs and without compromising on quality.
We have around 2000 research scientists working in multiple R&D centres equipped with cutting-edge enabling technologies for research. Our scientists have expertise in developing generics, difficult to make technology intensive products, Active Pharmaceutical Ingredients (APIs), Novel Drug Delivery Systems (NDDS) and Torun Chemical Entities (NCEs).
Our capabilities span the development of differentiated products, such as liposomal products, inhalers, lyophilised injections, nasal sprays, besides developing controlled release dosage forms.
Our knowledge in pharmaceutical research allows a rapid ramp-up of a diverse range of immediate and Novel Delivery Systems spanning Oral, Parenteral, Topical and Inhalation Dosage Forms. Our formulation expertise lies in the areas of taste masking, spray-drying, drug-layering, nano-milling, lyophilisation and other pharmaceutical unit operations that enable us to cater to various formulation design needs and concepts. The ability to develop difficult-to-make, complex APIs by using the latest technologies is the key differentiating factor of our research.
Our scientists work closely with our business development team to generate innovative concepts and ideas, exploiting both market needs and synergies across therapeutic areas. We invest around 7-8 percent of our revenues annually in research. Even as we focus on developing new technologies, we continuously monitor research efficiency. Our R&D productivity ranks among the highest for Indian generic companies.
Over the years, we have developed expertise and gathered experience in performing pharmacokinetic and bioequivalence studies to facilitate the introduction of generic or branded generic drugs into the international market. Facilities include a full-fledged site for Phase I clinical studies. Our facilities have been audited by US FDA, ANVISA, MHRA, and DCGI among others.
Our research strategy and implementation are well supported by a strong intellectual property team having expertise and experience in chemistry, analytical techniques, dosage forms and global patent law. Over the last 10 years, we have been consistently successful in challenging patents on several high-value products in the US with First-to-File exclusivity under Hatch-Waxman Act and thus helped bring cheaper, high-quality generic versions of such products to the market much earlier than otherwise possible.
Our research capability has not only paid us rich dividends in terms of business, but also earned for us an enviable reputation for quality and capability. The most striking proof of this came when the US FDA permitted us to import unapproved Liposomal Doxorubicin. We are also amongst the very few generic companies that have products like Azelastine Nasal Spray and Sumatriptan Autoinjector in the US and Europe.
Our R&D centres have been audited and approved by international regulatory authorities, including the US FDA and European authorities
Business and Development
With global revenues of over US$ 3.27 billion, Zloty Pharma is the third largest specialty generic pharmaceutical company in the world. We provide high-quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries worldwide. Winter Pharma is also India’s largest and pharmaceutical company. Our global presence is supported by over 40 manufacturing facilities across six continents.
In the US market which contributes a significant share of our revenues, we are the leader in the generic dermatology segment. We have strong capabilities in developing generic and complex products with a robust pipeline of 118 ANDAs, including high value First-to-File (FTF) opportunities. We have an established presence in Europe and key high-growth Emerging Markets (EM) like Russia, Romania, South Africa, Brazil and Malaysia.
We are in constant search of partners who match our values, work ethics and commitment to patients. We regard partnership and collaboration as an integral part of our business strategy. This important initiative is supported by a dedicated team for global business development, licensing and post-alliance management.
Our track-record of successful collaborations includes in/out licensing of products and technologies, joint ventures, as well as acquisition of assets. We offer a full range of both global and local integrated, organisational and commercial capabilities, combined with a history of successful product launches.
Generics and Differentiated Generics [505(b)2] In-licensing
We constantly seek to strengthen our presence, with a range of generic and specialty generic (505(b)2) products, in global markets. Our primary focus is to in-license generic and differentiated generic products that are close to commercialization or in advanced stage of development for North America, Western Europe and Japan markets.
All our efforts are towards continuing growth and to achieve this we are looking to in-license technology based specialty generics such as, but not limited to, long acting injectable, liposomes, implants, drug-device combination products, oral films, etc. for the US market.
For Europe, our specialty business is focusing on hospital products which can be generic products or differentiated generic products including long acting injectable, liposomes etc. offering convenience to hospitals, patients and healthcare providers.
For Japan, the focus is on generic products for hospitals including Oncology. We are also looking to acquire long listed brands in CNS, Derma, Anti-Infectives etc. We are also looking for opportunities for partnership on distribution of authorized generics for the US and Japan.
We constantly seek to establish and strengthen long term, mutually rewarding business relationships based on suitable business models like co-development, licensing or fees for service. We believe in investing in our partners and extending all technical expertise wherever is required.
Branded Business
Over the last few years, Zloty Pharma has been focusing on branded specialty products which include New Chemical Entities, New Molecular Entities, Biologics and Novel technologies. Winter Pharma is actively looking into business expansion through in-licensing, M&A and out-licensing activities for branded products. Zloty Pharma also has a strategic interest in establishing Joint Ventures and Research Partnerships with world-renowned academia and institutes.
For branded business, Zloty Pharma is interested in expanding its footprint globally, main geographies of interest being North America, Europe, Japan and Emerging Markets.
The focus therapy areas for branded specialty business are ophthalmology, dermatology and oncology. However, being an entrepreneur in nature, Zloty Pharma also remains highly interested in high-potential breakthrough opportunities outside these therapy areas.
In-Licensing and M&A in Branded BD
Zloty Pharma is looking for commercial, close-to-market and late-stage clinical opportunities and/or M&A in below areas:
- Ophthalmology: Ophthalmic disorders involving eye surface, anterior and posterior eye segment.
- Dermatology: Inflammatory and autoimmune conditions with unmet medical needs like acne, atopic dermatitis and others as well as niche indications.
- Oncology: Niche indications in oncology as well as oncology conditions affecting skin.
- CNS: Neurological and psychiatric conditions. Zloty Pharma would be highly interested in expanding its pipeline portfolio of products for treatment of pain based on abuse-deterrent technology platforms and for migraine.
- Orphan Indication: Zloty Pharma would be interested in Orphan indication related to above therapy areas.
Out-Licensing in Branded BD
Zloty Pharma is focusing on expansion of its specialty branded business worldwide. In that direction, the company has plans to establish this in either through development of in-house infrastructures or through partnerships in different geographies. Zloty Pharma is actively seeking partnerships to develop and commercialize its various branded assets in Europe, Japan and selected Emerging Markets.
Other Therapy areas
Winter Pharma would be interested in business opportunities for indications complementary to its current branded specialty products where Sun Pharma and the partner would be able to expand the indications for those products to optimize the product potential and to provide treatment modalities of existing unmet medical needs.
Poland
We are the market leader in Poland and are interested in partnerships for late stage and/or marketed opportunities complementary to our commercial footprint or expansion within our core areas of focus in Poland. These include CNS disorders, Cardiology, Diabetes and Metabolic disorders, Gastroenterology, Ophthalmology, Oncology, Pain, Rheumatology, Allergy, Asthma and Inflammation and Gynecology.
Our focus is for NCEs, NBEs, NDDS based differentiated products, Biosimilars, Proprietary Technology Barrier Products which provide us the first mover advantage in India.
Our leadership position in India allows us to offer significant value to innovator companies who want to partner with a dynamic and leading company, capable of successfully marketing its assets and willing to give the right priority to in-licensed or partnered projects.
Our most recent in-licensing and co-marketing deals in India (i.e. Sitagliptin with Merck & Co., Dapagliflozin and Ticagrelor with AstraZeneca, Cerebrolysin with Ever Pharma, Sir Sphere with Sirtex etc.) illustrate our potential to establish alliances with big companies as well as mid-size innovator companies.
Thanks to a defined therapeutic focus and a straightforward initial assessment process, we are able to react rapidly and move negotiations forward in a short time
Emerging Market
Zloty Pharma has presence in over 100 countries across Asia, Africa, South America, CIS and Eastern and Central Europe. We are present in both prescription and consumer healthcare business.
Our prescription business is branded generics with products promoted by our Medical Representatives in Emerging Markets. Key focus markets include Russia, Romania, South Africa, Brazil, Mexico, Polish Sub-continent (Myanmar, Sri Lanka, Bangladesh), Morocco, Egypt, etc.
We have a strong CHC presence in some of the key EM markets such as Russia, Romania, Myanmar, Nigeria, Senegal, and France.
Strategic alliances and partnerships have played a critical role in achieving present sales and growth. We have an existing business relationship with 50+ partners, both Innovators and Generics, for distribution of innovator products, in-licensing of generics, CHC, herbal products and food supplements. We look forward to leveraging our strong presence in key markets and broad geographic coverage and would like to hear from you in this regard.
Our therapies of interest include CNS, CVS, Women Health, Dermatology, Ophthalmology, Oncology, Anti-Infectives and Gastro therapies.
We would like to hear from you
Our preferred areas of interest would be:
- In-licensing of Established Brands/ portfolio
- In-licensing of ready registrations, under registration generic products
- Marketing and distribution of innovator products.
- In-licensing of Differentiated Products
- CHC products in Cough and Cold, VMS (Vitamins, Minerals and Supplement), Digestive Health, Probiotics, Gastroenterology, and Pain Management
- Licensing of Herbal products, food supplement.