BS B2B Bureau | Mumbai April 12, 2016 Last Updated at 10:27 IST
read original article at
/////inhaler, Novartis Healthcare, Sequadra, indacaterol, glycopyrronium inhaler, Lupin, inhaler, brand name, Loftair, India
Vinita Gupta, 43, Group President and CEO, Lupin Pharmaceuticals and Director, Lupin
Feb 2015….India-based drugmaker Lupin has signed an agreement with Polish biopharmaceutical firm Celon Pharma to develop a fluticasone / salmeterol dry powder inhaler (DPI).
Under the deal, Lupin will take the responsibility for commercialisation of the product, which is a generic version of GlaxoSmithKline’s (GSK) Advair Diskus.
Lupin CEO Vinita Gupta said: “We are very pleased to partner with Celon given their experience in the development and manufacturing of fluticasone/salmeterol DPI in Europe…………..http://www.pharmaceutical-technology.com/news/newslupin-celon-pharma-partner-generic-version-gsks-advair-diskus-4514718?WT.mc_id=DN_News
Ms. Vinita Gupta is the CEO of Lupin Pharmaceuticals Inc, USA, (LPI) and Group President, Director on the board of Lupin Limited and a Director on the Board of Lupin’s Japanese subsidiary Kyowa Pharmaceuticals. Ms. Gupta is responsible for the North American and European business of the company.
Ms. Gupta joined Lupin in 1992 and developed Lupin’s entry strategy into US and Europe. Under her leadership Lupin has emerged as a leader in the US generic market as well as the only company from India to have a successful brand business in the US. As part of her responsibility she built the entire management team for the US and European business and supervised the development of the company’s pipeline.
Ms. Gupta holds a Bachelor’s degree in Pharmacy from the University of Mumbai and MBA from J L Kellogg Graduate School of Management, Northwestern University.
“A good year” is how Vinita Gupta, Group President and CEO at Lupin Pharmaceuticals, describes her company’s performance at a time when unsettling news was the key takeaway for pharma companies. Lupin grew by an impressive 35.9 per cent globally and 24 per cent in India. New product launches helped it grow its generics business by 52 per cent, making it the sixth-largest generics pharmaceutical company globally by market capitalisation and the third-largest Indian pharmaceutical company by revenues. “I can’t think of any challenges that affected Lupin’s performance during the last fiscal year,” says Gupta, 44. The company’s strategy now is to focus strongly on building its branded business globally.
Vinita Gupta, 43, Group President and CEO, Lupin Pharmaceuticals and Director, Lupin, is based in the United States, but has been in India a lot in the past one year.
With an expanding role in Lupin’s universe, Vinita has been spending more time outside the US, at times taking her six-year-old son, Krish with her. “He is getting exposure at a much younger age,” she says. Gupta herself was exposed to business at the age of 11 by her father Desh Bandhu Gupta, Lupin’s founder and Chairman.
“We almost had a family board at home, discussing work,” she says. Currently work goes well indeed, with Gupta taking new initiatives in India and also making the business more global. “I am focusing on drivers for growth in our business for the next five years,” she says.
Gupta is married to US-based businessman Brij Sharma.
She was 13 when she travelled to Switzerland with her father, to watch him position the family-run Lupin Limited, to negotiate and to strategise. It was enough to get her hooked. Enough for her to move away from a childhood fascination for art and enter the world of pharmaceuticals. Group president and CEO, Lupin Pharmaceuticals, and director on the board of Lupin Limited, Vinita Gupta has never regretted that decision. The 41-year-old is responsible for creating a substantial international presence for the company that was born in Mumbai in 1968 and named after a leguminous flower.
The Lupin group produces affordable generic and branded formulations in the world with a significant presence in cardiovasculars, diabetes, asthma, pediatrics and anti-infectives. But Desh Bandhu Gupta, her father, wanted the company to make an impact in the western market.
It was a challenge that seemed perfect for Gupta who graduated in pharmacy from the University of Mumbai and then spent a year working at the company in Mumbai. She then moved to the US for an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University, following it with a brief stint in a US pharma company. But she didn’t want to be a mere “cog in the wheel”, returning to India to take up that initial challenge-to create a business strategy that would allow Lupin to enter American and European markets.
Today, Lupin is the ninth largest generics company in the US. It is also one of India’s top five pharmaceutical players and one of the fastest growing top 10 generic players in Japan and South Africa. The US arm of the business, Gupta’s baby, contributes to over 30 per cent of Lupin’s revenues, a company that clocked in close to Rs.4,000 crore in 2008-2009. Nine out of the 23 generic products Lupin has in the US market are at the number one position giving consistent competition to larger US pharma companies.
With brother NileshThe beginning however was difficult. After all, India wasn’t very well known in the US market. “We realised that we had the aspirations but not the infrastructure in the form of facilities to meet US and European requirements and standards,” she remembers. So she spent three years building the infrastructure, creating a process that would be acceptable to these regulated markets. The break came with Suprax, a pediatric antiinfective drug that was valued at nearly $60 million in the US market. Gupta had already filed for a generic of the brand. “Suddenly, we had the opportunity to brand the generic, so we licensed the brand name from the innovator as he had left the market,” she remembers. It was a three-person team with 40 outsourced sales people.
Today, the product’s sales are at $74 million. It has been satisfying, she says. “The innovator was in the market with a sales force of 300 people. We are 60.” The aim, she says, has always been to balance branded products as well as generic. The success, her father and chairman of the company, Desh Bandhu Gupta, says, stems not just from her determination. “It’s also her intimate understanding of the entire pharma spectrum with the motivation to see it through,” he says.
This determination became obvious when she managed to persuade the dean at Kellogg to give her admission, even though she was 19 and perhaps the youngest in her class. It was a challenging time as she learned to balance her work and household chores. “At that time in India, everything was handwritten. I had to do every single thing using the computer,” says Gupta who often bribed her friends with homemade Indian food to type out her projects. It taught her to be independent.
But it was perhaps, two months ago, when Gupta a bigger challenge. A deal that made tough seem an understatement. For Antara, an anti-cholesterol drug. “It was very much like Suprax, that was serendipity,” says Gupta. It was a large product with high potential. But the company was in bankruptcy. “I was sure we could do things differently with the product,” she says.
Gupta says Lupin was the first to file for the generic brand. But they couldn’t own the generic and the brand. She had six weeks to sell the generic, win the bid in the US bankruptcy court and buy the brand. She did it. At $38 million, one-third its market value. It’s a deal that Nilesh, her brother and group president and executive director, believes displayed his sister’s meticulous calibre. “There were three sets of negotiations going on at the same time. And while there were others involved, this deal was Vinita all the way,” he says.
Kamal Sharma, managing director, Lupin Limited, has watched Gupta transform from a teenager learning the ropes of a business to the successful go-getter that she is today. “She values, teaches and encourages her people to deliver consistent results year after year,” he says. It’s an attitude that is apparent from the get-go.
(L-R) With Richa, Kavita, Anuja and NileshAt the Trident, Mumbai, for the photo shoot, Gupta is comfortable surrounded by people, even though she is a little hesitant in front of the camera. It’s here that she actually seems to shed the image of an ultimate powerhouse, a businesswoman driven to succeed. It is here that she becomes the Mumbaikar who prefers a masala chai over brewed coffee and a plain tee over a designer label. In some ways, she is still the girl who grew up in a housing society near the airport in Vile Parle, Mumbai. It’s the kind of place where people still keep their doors open and where one can walk into a neighbour’s house without having to knock. Things weren’t handed to her on a golden platter, she admits. In fact, she says, their father taught them that, “as a family we would have to work harder to earn and deserve our right more than what other professionals do.”
As a child, she remembers sharing a room with her four siblings, Kavita, Anuja, Nilesh and Richa. She didn’t like that very much. “But now, when I think of it, I feel it was an amazing life,” she says. Her father adds that he always took his children to different countries, either on work or otherwise. It was his way of showing them the world and different experiences.
But a different side emerges as Gupta talks of the pharma industry. “I dreamed of taking what Dad had built and adding value to it in the western markets,” she says. “This is what I had always prepared myself for. I am living the dream.” And it isn’t as if there aren’t any downs. Six months ago, she remembers, the company received a warning letter from the Food and Drug Administration. She spent that time working to resolve their concerns. “And then three months later, we made one of our most attractive acquisitions. The industry is so quick changing, so dynamic. It always keeps you thinking,” she says.
For Nilesh though, Gupta is his sounding board, the eldest sister with whom he shares a relationship that complements their work profiles. And while Nilesh says with a laugh, Gupta doesn’t pull the bigsister act with him at work, home is a different story. Gupta admits with a mock sigh, “You can’t posture with your siblings. You can posture with anyone else, but not your siblings.”
With husband Brij and son KrishThe obvious downside, however, is family. Her work keeps her busy, sees her up and in office by 8 am, back just in time to spend about an hour with her four-year-old son Krish. “He was a very easy child till some time ago, but lately he has become very demanding,” she says with a smile. Just as Gupta was leaving her home in Baltimore, Maryland for her current trip to India, Krish demanded they go leaf-picking in their backyard. “More than anything, I loved watching the expression on his face while we were picking leaves. His smile brightens up my day,” she says.
As much as her job is a passion she tries to spend time with Krish and husband Brij Sharma, a businessman whom she met in the US. “My husband is a very good listener. I keep talking whenever I am with him and he listens even today,” she says with a laugh. A workout is a must, however, as Gupta heads to the gym every day, spinning the cycle even when she was eight months pregnant.
“My husband jokes that’s the reason why Krish thinks and behaves ahead of his age,” laughs Gupta. But biking near the waterfront with her son and spending time on her husband’s boat is an activity that wins hands down. As does time spent with her two sisters Anuja and Richa, who live in Chicago. While Anuja is a pediatric cardiologist, Anuja is into public health. They do plan vacations together, but she often discovers that her brother Nilesh refuses to talk to her over the weekend. “Probably because I always end up talking about work,” she says with a laugh. “It has become so much a part of our lives,” she says.
In June2012 , Vinita Gupta, CEO of Lupin Pharmaceuticals Inc, the Indian drug maker’s US unit, received the “Entrepreneur of the Year” award from Ernst & Young in the health services and technology category for Maryland state of the US. Over the past year, the US business of Lupin crossed the $500 million mark.
DB Gupta (centre) Chairman, Vinita Gupta (right) CEO and Nilesh Gupta
Lupin launches insulin glargine in India:
Indian pharma company, Lupin Limited announced a strategic distribution agreement with LG Life Sciences of South Korea to launch Insulin Glargine, a novel insulin analogue under the brand name Basugine™.
According to the agreement, Lupin would be responsible for marketing and sales of Basugine™ in India.
Lupin Limited
news
Expanding domestic portfolio, ability to maintain market share in current products and new launches are key growth triggers
The lipid control or cholesterol lowering segment is emerging as a key growth driver for Lupin’s sales in the US. The first among three products is Tricor. The Lupin stock had corrected about five per cent in May on the announcement that Mylan would launch the $1.2 billion (Rs 7,200 crore) drug in tablet form.
Lupin has been able to maintain its generic market share so far with a share of 34 per cent vis-a-vis Mylan (market share of one-two per cent). While Balaji Prasad and Rohit Goel of Barclays estimate the drug will contribute about $29 million to Lupin’s revenues in the June 2014 quarter, Ebitda margins are expected to expand by 210 basis points, feel analysts at Kotak Securities.
Though the launch of generics in capsule form by Mylan has to be watched carefully, Lupin’s Antara, along with authorised generics, continues to dominate with 70 per cent share, observes Hitesh Mahida at Fortune Research.
In addition to Tricor, two other products in the cholesterol lowering segment the company is eyeing are Trilipix and Niaspan. Instead of a launch in January 2014 as was anticipated earlier, the company is now likely to launch the generics version of this $550 million drug Trilipix this month.
While the company says it is mulling options about the launch, Edelweiss analysts believe an early launch is likely to add $11 million in FY14 and about $15 million in FY15 to the company’s revenues. The third drug in this segment is Niaspan, to be launched in March 2014 and expected to add about $35 million to the company’s revenues in FY15. Together, the three cholesterol controlling drugs are expected to contribute $85-90 million to FY15 sales for Lupin.
Lupin Limited is a transnational pharmaceutical company based in Mumbai. It is the 2nd largest Indian pharma company by market capitalization;[14] the 14th largest generic pharmaceutical company globally[15] and; the 5th largest generic pharmaceutical company in the US by prescription-led market share.[16] It has the distinction of being the fastest growing generic pharmaceutical player in the two largest pharmaceutical markets of the world – the US[17] and Japan;[18] and is the 5th largest [19] and the fastest growing generic pharmaceutical player in South Africa.[20]
Market Position in the US gradually improving
Lupin 5thlargest generic company in the US in terms of prescriptions
14 products are market leader and 27 (among top 3) out of 30
| Type | Public |
|---|---|
| Traded as | BSE: 500257 NSE: LUPIN |
| Industry | Pharmaceuticals |
| Founded | 1968 [1] |
| Founder(s) | Dr. Desh Bandhu Gupta[2] |
| Headquarters | Mumbai, Maharashtra[3], India |
| Key people | Dr. Kamal K Sharma, Vice Chairman;[4] ……………………………………..Vinita Gupta, Chief Executive Officer, Lupin Limited;[5]
…………………. Nilesh Gupta, Managing Director;[6]
……………
…………………….
…………………….
New leadership team at Lupin from September 2013[10] |
| Products | Pharmaceuticals, branded andgeneric drugs, biotechnology, Advanced Drug Delivery Systems, New Chemical Entity Research, vaccines, Over-the-Counter drugs |
| Revenue |   9461 crore (US$1.5 billion) (2012-2013)[11][12] |
| Profit | 1314 crore(US$210 million) (2013) |
| Employees | 11355[13] |
| Subsidiaries | Lupin Pharmaceuticals, Inc. Kyowa Pharmaceutical Industry Co. Ltd. I’rom Pharmaceutical Co. Ltd. Pharma Dynamics Multicare Pharmaceuticals Generic Health Pte. Ltd. Hormosan Pharma GmbH |
| Website | www.lupinworld.com |
2012 .http://icra.in/Files/ticker/Indian%20Pharmaceutical%20Sector.pdf
Lupin was founded in 1968 by Dr. Desh Bandhu Gupta,[21] then an Associate Professor at BITS-Pilani, Rajasthan. Named after the Lupin flowerbecause of its inherent qualities and what it personifies and stands for, the company was created with a vision to fight life threatening infectious diseases and to manufacture drugs of the highest social priority.
Lupin first gained recognition when it became one of the world’s largest manufacturers of tuberculosis drugs.[22] The company today has a significant market share in key markets in the Cardiovascular (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments. It also has a global leadership position in the Anti-TB and Cephalosporin segments. The company’s R&D endeavours have resulted in significant progress in its NCE program. Lupin’s foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals. Its manufacturing facilities, spread across India and Japan, have played a critical role in enabling the company realize its global aspirations. Benchmarked to International standards, these facilities are approved by international regulatory agencies including the US FDA, UK MHRA, Japan’s MHLW, TGA Australia, WHO, and the MCC South Africa.
Lupin’s Research Program covers the entire pharma value chain. The company’s global R&D program is headquartered out of the Lupin Research Park located near Pune that houses over 1200 scientists. Lupin’s R&D covers:
Differentiation is the heart of our research efforts at Lupin. We have created a truly unique world-class research program, designed to ensure a sustainable pipeline of high-value opportunities to maximise growth.
Research and Development is at the core and is the most critical part of any pharmaceutical company. At Lupin we see R&D differently. It is fundamentally about creativity, originality and being aware of what is really required. At Lupin, our Research & Development program has been the key to our sustained growth over the past ten years; growth that has made us one of the most exciting research driven pharmaceutical companies globally; a hotbed of differentiation and innovation. Today we are building the future by strengthening our research foundation through prudent investments that position us at the cutting-edge of technology, helping us deliver complex products that very few in the world can.
Headquartered at the state-of-the-art Lupin Research Park in Pune, India, the Company’s research program is home to over 1,400 scientists. The Company’s global research operations are spread over multiple research facilities in India and Japan. During FY 2013, the Company invested 7.5% of its net sales in Research & Development and related spends, amounting to 7,098 million. FY 2013 was a record year in terms of progress made all around, be it our pace of filing DMFs (Drug Master Files) and ANDAs (Abbreviated New Drug Applications), progress in our drug discovery and development program, milestones in our drug delivery program and approvals in our biotechnology program.
Long-term, one of the Company’s biggest differentiators will be its Novel Drug Discovery and Development (NDDD) program. The Program focuses on the discovery, development and commercialisation of new drugs that address disease areas with significantly unmet medical need. Lupin’s NDDD efforts are directed towards identifying and developing new therapies for disease areas that include metabolic/endocrine disorders, pain and inflammation, autoimmune diseases, CNS disorders, cancer and infectious diseases.
Scientists at NDDD have been able to create a portfolio of novel compounds that are moving through a robust pipeline from discovery to development. This steady movement will ensure that at least one compound enters the clinical phase in terms of first-in-human studies each year. Lupin has adopted a ‘Quick-win, fail-fast’ cost-efficient development approach, in which novel compounds are filtered at every stage before entering development and differentiated by efficacy with a focus on enhanced safety.
Highlights, FY 2013
Successfully completed Phase I studies in Europe for a program in the CNS area, which is being advanced to Phase II clinical trials in Europe now
Therapeutic Targets
| Therapy Area | Differentiated Pipeline |
| METABOLIC / ENDOCRINE DISEASES | NOVEL MECHANISMS FOR NEW ANTI-DIABETICS |
| PAIN / INFLAMMATION | HOLY GRAIL OF PAIN REMEDY |
| AUTO-IMMUNE DISEASES | TARGETED FOR RHEUMATOID ARTHRITIS AND OTHER IMMUNE DISORDERS |
| CNS DISORDERS | ROBUST TREATMENTS FOR COGNITIVE DEFICITS IN DIFFERENT CNS CONDITIONS |
| ONCOLOGY | HIGHLY DIFFERENTIATED ANTI-CANCER TREATMENT (HITTING ONLY CANCER CELLS) |
| INFECTIOUS DISEASES | HIGHLY POTENT ANTI-VIRAL THERAPY |
Lupin’s businesses encompass the entire pharmaceutical value chain, ranging from branded and generic formulations, APIs, advanced drug deliverysystems to biotechnology. The company’s drugs reach 70 countries[23] with a footprint that covers Advanced Markets such as USA, Europe, Japan,[24] Australia as well as Emerging Markets including India,[25] the Philippines and South Africa to name a few.
KEY MARKETS AND BUSINESSES
USA
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. (LPI), the company’s US subsidiary is a $ 706 million enterprise.[26] LPI has a presence in the branded and generics markets of the US. In the branded business, Lupin operates in the CVS and Pediatric segments. The company is the market leader in 24 products out of the 46 products marketed in the US generics market, of which it is amongst the Top 3 by market share in 37 of these products (IMS Health, March 2013): Suprax (Cefixime), a paediatric antibiotic, is Lupin’s top-selling product here. The company is also the 5th largest and fastest growing generics player in the US (5.3% market share by prescriptions, IMS Health). Lupin’s US brands business contributed 21% of total US sales whereas the generics business contributed 79% during FY 2012-13.[26]
In the US market, since December 2012, Lupin has posted a 40-80 per cent growth rate on the back of new launches, as well as growing sales of its existing drugs. For May, the company has posted growth of 50 per cent year-on-year in US sales. The outlook is also good. On the whole, Lupin has one of the strongest pipelines of 18-20 products for the US market over the next 18 months.
Robust US sales continue
Despite the 51 per cent rise in share price over six months, most analysts continue to be bullish on the company due to its strong showing in the US market. Among leading Indian pharma majors, this geography contributes nearly 40 per cent of its revenues, second only to Sun (43 per cent) and a good performance rubs off well on the company’s overall show.
About half its US sales are contributed by Antara, the generic form of the cholesterol lowering drugTricor, antibiotics Suprax and Cefdinir and the generic form of antipsychotic drug Geodon. Among other segments expected to drive growth are oral contraceptives ($100 million estimated sales in FY14), dermatology, ophthalmology and asthama.
India Region Formulations (IRF)
Lupin’s IRF business focuses on lifestyle and chronic therapy segments. The company has emerged as one of the fastest growing players in therapies like Cardiology, Central Nervous System(CNS), Diabetology, Anti-Asthma, Anti-Infective, Gastro Intestinal and Oncology. The IRF business contributed 25% of the company’s overall revenues for FY 2012-13, growing by 24% and recording revenues of 2364 crore (US$380 million) for FY 2012-13 as compared to 1905 crore (US$300 million) for FY 2011-12.[26]
There are 9 manufacturing plant and 2 Research pant in India, such as Jammu(J&K),Mandideep & Indore(Madhya pradesh), Ankaleswar & Dabasa (Gujarat), Tarapur, Aurangabad and Nagpur (Maharastra) and Goa; where research centre at Pune and Aurangabad.[27] Among these the baby plant is Nagpur plant which will the the biggest formulation unit for Lupin in coming year.
Lupin is also gradually expanding its domestic portfolio through expansion into more segments and tie-ups. On Thursday, it announced a non-exclusive tie-up with US-basedMerck Sharp and Dohme (MSD) for marketing the latter’s pneumococcal vaccine (preventive care for diabetes and, chronic heart, lung and liver diseases) for adults.
Given its growth, Bank of America Merrill Lynch analysts believe the valuation multiple at 20 times FY15 earnings estimates is likely to expand (closer to larger peers) due to stronger and sustainable growth rates, both on the net profit front (22 per cent annually over the next two years) and return ratios, expected at 30 per cent versus 26 per cent for the peers. Most analysts have a target price of Rs 875-900 for the stock. Though a re-rating could be on the cards, given the surge in share price, investors should look at corrections to add the scrip to their portfolio.
Europe
Lupin’s focus in the European Union encompasses Anti-Infectives, Cardiovascular, and CNS therapy areas, along with niche opportunities in segments like Oral Contraceptives, Dermatology and Ophthalmics. The company’s presence in France is by way of a trade partnership; in Germany, it operates through its acquired entity Hormosan Pharma GmbH (Hormosan);[28] while the UK business is a direct-to-market initiative.
Japan
Lupin is the fastest-growing Top 10 generic pharmaceuticals player in Japan (IMS). Lupin operates in Japan through its subsidiary, Kyowa Pharmaceutical Industry Co. Ltd. (Kyowa), a company Lupin acquired in 2007,[29][30] and I’rom, Pharmaceutical Co. Ltd (IP), acquired in 2011.[31][32] Kyowa has an active presence in Neurology, Cardiovascular, Gastroenterology and the Respiratory therapy segments. I’rom is a niche injectables company with significant presence in the DPC hospital segment.
South Africa
Lupin’s South African subsidiary, Pharma Dynamics (PD)[33] is the fastest growing and the 5th largest generic company in the South African market (IMS). The company is a market leader in the Cardiovascular segment and has a growing presence in Neurology, Gastroenterology and the Over the Counter (OTC) segments.
Australia
Lupin entered the Australian market through its subsidiary, Generic Health Pte. Ltd. (GH).[34] It subsequently acquired the worldwide marketing rights to the over 100 year old Australian brand Goanna,[35] used for pain management.
Philippines
Lupin’s Philippines subsidiary Multicare Pharmaceuticals (Multicare),[36] is a branded generic company focused on Women’s Health, Pediatrics, Gastro-Intestinal and Diabetes care. FY 2012 also marked its foray into the Neurology segment when it entered into a strategic marketing partnership with Sanofi.[37]
API and Global TB
Lupin is one of the most vertically integrated global generic majors and a global leader in Cephalosporins, Cardiovasculars and the anti-TB space. The company is also a strategic supplier of anti-TB products to the Global Drug Facility (GDF), with its formulations being supplied to more than 50 countries through GDF procurement.
Lupin is also a global leader in anti-TB APIs, and is associated with the Revised National TB Program of the Government of India, thereby partnering the Government in its fight against TB in the country. It also supplies to various Government agencies, the Stop TB Partnership and various other international agencies like Pan America Health Organisation (PAHO), Médecins Sans Frontières (MSF) and the Damien Foundation. Ethambutol, Rifampicin and Pyrazinamide are the company’s top selling TB molecules.
Biotechnology Research
The Lupin Biotechnology Research Group, based out of Wakad, near Pune is focussed on developing affordable, high quality biopharmaceuticals with an emphasis on biosimilars. As of May 2013, it has a pipeline of 10 biosimilar products under development, and is close to getting marketing authorization for 2 of its oncology products for the Indian market. Lupin has competencies for the complete development and manufacture of recombinant protein therapeutic products from high yielding and proprietary microbial and mammalian cell culture platforms. The Biotech R&D infrastructure offers a range of product development capabilities ranging from clone development, process optimization, analytical method development, bioassay, formulation, stability studies, non-clinical and clinical studies backed by a sound understanding of regulatory and IP aspects. The company’s biotech development programs are in compliance of and follow ICH, EMEA and Indian Regulatory guidelines.
To further its social responsibility objectives, Lupin established the Lupin Human Welfare & Research Foundation (LHWRF) on 2 October 1988. Its chief objective was to provide an alternative sustainable, replicable and ever evolving model of holistic rural development. LHWRF started with a few small rural development projects covering around 35 villages in Bharatpur District,Rajasthan. Its efforts have touched the lives of over a million people across 2,200 villages in the states of Rajasthan, Madhya Pradesh, Maharashtra and Uttarakhand.
ANKLESHWAR GUJARAT PLANT INDIA
LUPIN TARAPUR INDIA
LUPIN GOA INDIA
Oncologyand inflamation
Lupin is building a discovery pipeline with over seven to eight molecules targeting the oncology and inflammation segments.
Lupin is building a discovery pipeline with over seven to eight molecules targeting the oncology and inflammation segments. The company, producing both branded and generic drugs, is also planning an investment of $20 million to expand and build additional facilities and capacities exclusively for biologics in Pune in next two to three years.
“We have over seven to eight molecules in the pipeline. Of these, three are already undergoing clinical trials, while two are in pre-clinical stage. One more molecule will be entering pre-clinical stage soon,” Cyrus Karkaria, Lupin president said, adding that the company was gearing up to launch a new product this year. He also indicated that some of these lead molecules could be potential out-licensing targets at some point of time.
Biosimilar products include recombinant erythropoietin, recombinant granulocyte colony stimulating factor (G-CSF), interferon alpha and beta, human insulin, monoclonal antibodies and human growth hormone. These are used oncology, infectious diseases, chronic autoimmune diseases, growth-related deficiencies and haematology.
As part of its expansion, Lupin will be expanding facilities in Pune, which will be operational in next two to three years. “We currently have a production facility near the lab. We will be building additional facilities with about $20 million investment in next two to three years,” Cyrus explained. Last year, the company announced plans to invest over R450 crore towards capacity expansion and strengthening sales force. Lupin is also gearing up to launch its first biosimilar product in India by early next year besides targeting 5-7% of its business from biosimilar business.
The company had entered into a licensing agreement with Sydney-based NeuClone for cell-line technology which will provide exclusive proprietary cell-line technology to be developed into biosimilar drugs targeting cancer.
Several drug companies, including Dr Reddy’s, Cipla and Biocon, among others, are eying the opportunity in biosimilars. Industry estimates global market for biosimilars or follow-on biologic drugs is about $100 billion and the Indian market is about R2,500 crore.
Meanwhile, the US Food and Drug Administration has issued three guidances on biosimilar product development to assist industry in developing such products in the US. These draft documents are designed to help industry develop
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by revenues. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended March 2013, Lupin’s Consolidated turnover and Profit after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242 million) respectively. Please visithttp://www.lupinpharmaceuticals.com for more information.
Mumbai, February 03, 2014: Pharmaceutical major Lupin Limited announced the acquisition of Nanomi B.V. in the Netherlands today. With this acquisition, Lupin has made its foray into the technology intensive complex injectables space.
Nanomi has patented technology platforms to develop complex injectable products. Nanomi has a rich talent pool of scientists who would be backed by Lupin’s global R&D and manufacturing teams.
Commenting on the acquisition Ms. Vinita Gupta, Chief Executive Officer, Lupin Limited said “We are very pleased with the acquisition of Nanomi. With the use of Nanomi’s proprietary technology platform, Lupin would be able to make significant in-roads into the niche area of complex injectables.”
Mumbai, Baltimore, December 18, 2013: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary Lupin Pharmaceuticals Inc. has launched its Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base) / 150 mg / 300 mg in the US after the US District Court for the District of Delaware ruled that the Lupin’s generic version of Trizivir® did not infringe on patents. Lupin had earlier received approval for the same.
Lupin’s Abacavir Sulfate, Lamivudine Zidovudine 300mg (Base)/150mg/300mg Tablets are the AB-rated generic equivalent of ViiV Healthcare’s (ViiV) Trizivir® Tablets, 300 mg (base) / 150 mg / 300mg and are indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.
Lupin is the first applicant to file an ANDA for Trizivir® Tablets and as such is entitled to 180 days of marketing exclusivity.
Trizivir® Tablets, 300 mg (base) / 150 mg / 300mg had annual U.S sales of approximately US$ 111.6 million (IMS MAT Sep, 2013).
Mumbai, Baltimore, December 12, 2013: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has launched its Duloxetine Hydrochloride Delayed-release (HCl DR) Capsules 20 mg, 30 mg and 60 mg strengths. The Company received final approval to market its Duloxetine HCl DR Capsules USP, 20 mg, 30 mg, 40 mg and 60 mg strengths from the United States Food and Drugs Administration (FDA) yesterday.
Lupin’s Duloxetine HCl DR Capsules 20 mg, 30 mg and 60 mg strengths are the generic equivalent of Eli Lilly & Company’s (Lilly) Cymbalta® Delayed-release Capsules 20 mg, 30 mg and 60 mg.
Duloxetine HCl DR Capsules are indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD) and management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy.
Cymbalta® Delayed-Release Capsules 20 mg, 30 mg and 60 mg strengths had annual U.S sales of approximately USD 5.43 billion (IMS MAT Sep, 2013).
|
Lupin launches Generic Trilipix® Delayed – Release Capsules 45 mg & 135 mg in the US |
|
Mumbai, Baltimore, December 06, 2013: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has launched its generic Fenofibric Acid Delayed‐Release Capsules 45 mg and 135 mg. Lupin had earlier received final approval from the US FDA for the same. Lupin�s Fenofibric Acid Delayed‐Release Capsules 45 mg and 135 mg are the generic equivalent of AbbVie Inc.�s Trilipix® Delayed‐Release Capsules 45 mg & 135 mg strengths are indicated as co‐administration therapy with statins for the treatment of mixed dyslipidemia, treatment of severe hypertriglyceridemia and primary hypercholesterolemia or mixed dyslipidemia. Trilipix® Delayed‐Release Capsules 45 mg & 135 mg strengths had annual U.S sales of approximately US$ 449.5 million (IMS MAT Sep, 2013). |
