September 10, 2009

Drug discovery paradigm shift

Nayantara Som
Thursday, September 10, 2009

A convergence between the pharma and biotech sector will gradually see both parties leveraging their strengths in drug development, commercialization, discovery and manufacturing capabilities thus delivering innovation and changing the whole landscape of M&A deals.


Global pharmaceutical companies have been swimming in troubled waters for quite some time but the good news is that they are now on the proactive mode.
Big pharma’s acquisition spree started making big news since 2008. In January 2009, Pfizer acquired biotech big-wig Wyeth for $68 billion, followed by Roche ending its long drawn hostile battle with Genentech by buying the remaining 44 percent stake, thus acquiring the latter for $46.8 billion. This was followed by Merck’s announcement in March to acquire Schering Plough for $41.1 billion. Other big deals include: El Lilly’s purchase of ImClone Systems last year, Japanese giant, Takeda Pharmaceutical’s acquisition of Millennium Pharmaceuticals and Cephalon’s takeover of Australia’s Arana Therapeutics.

Convergence is the trend
Analysts claim that convergence between pharma and biotech companies is not a new trend and will continue to do so. Sujay Shetty, associate director, Pharma Life Sciences Advisory, PricewaterhouseCoopers (PwC), says, “From a global perspective, these big acquisitions have been taking place for the obvious reasons like the R&D pipeline drying up, and at the same time, biotech companies are either discovering a new molecule or a drug platform which could help replenish that pipeline. Deals like the Takeda-Millennium, ImClone-El lilly, Roche-Genentech will continue as long as big pharma sees the need to augment its pipeline which is not created in-house.”
Patent expirations will open the way for a fierce generic competition.
“A lot of drugs are going to be off patent in future and will face fierce competition from the generic companies, thus will marginally reduce the revenue of the pharma companies. Increasing issues on drug safety norms delaying entry of new drugs into the market due to the stringent regulations in the clinical trials are some of the other reasons for pharma and biotech companies coming together,” says Bibhuti Bhusan Kar, program manager, South Asia & Middle East, Healthcare –Pharmaceuticals & Biotechnology, Frost & Sullivan. Hence, industry experts claim that convergence between the two will drive the wheels of the much needed innovation for the industry. It is a healthy market which will be the apt solution for big pharma’s reeling woes.
A PwC report on ‘Lifting big pharmas prospects with biologics’ , mentions that it will primarily be the biologics sector which will drive the M&A activity with protein-based therapeutics, MAbs and vaccines being hailed as promising sectors for growth. The same report also goes on to mention that in 2008, the therapeutic monoclonal antibodies sub-sector drew increased investment of $640 million in 46 deals, up from $477 million with 41 deals in 2007. Four of the top 10 human biotech deals in 2008, were companies focusing on therapeutic MAbs. It is also estimated that the market for MAbs is estimated to grow at a CAGR of 16.9 percent between 2006-12. Vaccines also drew in a considerable amount of investment of $494 million from 31 deals in 2008.
“In many therapeutic areas like CNS, Alzheimer’s and diabetes, we have seen that further meaningful innovation is not happening. Companies have been shifting their focus now on the root cause of any disease and understand the corrective measures to be taken more at the genetic level. Hence, a convergence between biotech and pharma will result in newer ways of finding curative therapies than the traditional synthetic ways,” opines Nair.
Moreover, maintaining an almost perfect balance between innovation on one hand and cost-efficiency on the other, it becomes the center of attention for strategy teams. Shetty mentions, “Pharma is on the lookout for new pipeline drugs. They have typically addressed that and are going out and buying companies. Companies are now saying that by 2012, they are to lose revenues and their scientists are not coming up with anything innovative. Therefore, buying a biotech company is the best option to keep those revenues flowing in.”
“As far as cost-reduction is concerned, pharma has got a huge infrastructure for R&D. Now there is a hope for them to do it more efficiently, not just in R&D but also for the ground level and fast-end clinical works,” he adds. To keep their business up and running, companies are now drawing up biological strategies which also include tapping emerging markets. The nature of competition is such that one day a company’s revenue might be $10 billion and with patent expiry, it is zero. “This does not happen in any industry. So the challenge is always on the innovation part of it, and cost comes after that,” observes Shetty.
The recent trend of convergence has thus changed the rules and landscape for M&A deals in the life sciences industry.
Sudeep Krishna, co-lead, Healthcare and Life sciences, Deloitte India, says, “The recent convergence trend has changed the rules of M&A activities, in the sense that traditionally we’ve seen that a pharma company acquires a biotech company having one or two blockbuster drugs with the deal around Rs 100-200 crore. Now, we see them acquiring big biotech companies having a whole pipeline of promising targets because big pharma has the money. The interesting aspect we’ve to look out for is the manner in which they integrate the entities especially the talent pool from both the entities.”

Impact of convergence
Drug innovation: With the convergence, the industry will now see a gradual blurring of boundaries between the biotech and pharma sectors. Such a convergence will open up avenues in the drug innovation process, the most obvious reason being that biotech companies whose forte has been innovation will replenish the drying up pipeline of pharma companies. “I think that drug innovation will go through a positive transformation. Now the cure will be much more holistic,” says Nair. Genentech for example, has cutting-edge products in both biotechnology and cancer medicines – with blockbusters
Avastin, which churned a revenue of around $2 billion last year and Herceptin, an extensive portfolio of new drugs.
Over the past one year, the number of FDA approvals for biologics has seen a gradual rise. For example, in 2008, there were 20 new molecular entity (NME) and four new biologics as compared to 16 NMEs and two biologics in 2007. Says Sanjay Singh, associate director, corporate finance, KPMG, “Biotech will aid significantly in drug discovery research especially in target identification, and lead generation and optimization activities.”
Moreover, big pharma companies are cash-rich companies. Hence, investing in expensive assets such as biologics is a risk they’re willing to take, considering the returns they’ll reap at the end.
“With biotech companies focusing on molecular biology and genetic engineering approaches, and with pharma companies being the lavish spender in R&D for drugs with basic chemistry one can expect a larger success rate in terms of output from the biotech drug development rather than pharma,” says Kar.
The whole process of drug innovation is an expensive one which does require a continuous inflow of monetary funds, and convergence will be a solution to the problem.
Licensing deals: Typically, a biotech company is always on the lookout for revenue churning options. So licensing deals are the answer to the question wherein a biotech company can expect an inflow of cash returns in the form of upfront payments, milestone payments and royalties. Opines Krishna, “Licensing deals between pharma and biotech companies have been happening for a long time and will continue to do so. In fact, I would say that it was these licensing deals which was a stepping stone for a convergence of such a kind.” “Biotech companies had to out-license their molecules because of their limited market access, and pharma companies in-licensed molecules from biotech companies which looked promising. Later pharma companies went a step further and thought why not go in for an acquisition of these entities,” he adds.
An important fact to bear in mind is that big pharma’s primary capability is commercialization while biotech strength lies in discovery and manufacturing. “Big pharma has much deeper pockets. In the present global economic environment, biotech, which has traditionally been a beneficiary of venture capital (VC) and government funding, will have challenge in keeping the fund flow. Hence, a natural consequence of this will be licensing deals which focuses on leveraging each others strength for the best outcome,” adds Nair.
Outsourcing: Outsourcing projects on the other hand will either see a status quo or a gradual increase but not drop. Opines Singh, “It’ll lead to outsourcing of high-end preclinical research to Indian companies, though it’ll be a slow and gradual process as Indian companies will need to demonstrate their skill and knowledge base in high-end preclinical research areas.” VCs will also have a pivotal role to play. The VC market has supported the growth of the outsourcing market due to the fact that there’s a significant risk involved in bringing a drug to the market.
Manufacturing: Manufacturing is another area which will see a positive transformation with biotech being a catalyst in the transformation. The dynamics of biotech manufacturing is different from pharma manufacturing, hence, the former will remain as a separate unit post-integration. “A convergence will lead to a need to invest in specialized, high-end fermentation and purification units,” says Singh.
At a closer look, a pharma company will reap more benefits than its biotech counterpart. “If you look at the top 10 pharma companies, they have all made biotech investments but their manufacturing capabilities are limited. Hence, a biotech manufacturing facility will be an additional and useful asset to a pharma company,” adds Krishna.
Biosimilars: With biosimilars being the buzz word, and some movement happening in the US Congress for a regulatory pathway, analysts and industry experts are hopeful that such a convergence might boost up the biosimilars space. Above all, an important fact to bear in mind is that all pharma companies have a generic strategy in hand, which will be a big boost for the biosimilar space.
According to Nair, “All the big pharma companies are talking about emerging markets and all of them have a generic strategy now. With generics being the focus for pharma companies, I see a collaboration here which will immensely benefit biosimilars. That’s because biosimilars have much better margins than other generics which will attract big pharma, even while big pharma’s commercialization capabilities will give the access and reach to biosimilars.”
Integrating the two entities: A major task in hand would be integrating assets of two entities which are in all aspects poles apart from each other. Experts have unanimously opined that companies will prefer to keep assets pertaining to R&D and manufacturing independently.
Ideally, when a pharma company takes over a biotech organization, they try and preserve the culture of the latter, which is more entrepreneur-driven and polished compared to a pharma organization which is more process driven. Integration will ideally be seen in the shared services, human resources and the financial services. The Roche-Genentech integration is an apt example. “Genentech is a fiercely independent company, and even after Roche taking over, its R&D unit has been kept independent,” says Krishna.
Singh opines that integration could happen at the sales force and manpower level. “I see integration will mainly happen at the manpower level and sales force to a certain extent. Manufacturing will be a separate unit because you’ll need a different technology. Also, there could be a synergy at the development and regulatory level,” he adds.

Company strategies
Pfizer, which has now set its foot in biologics has majorly revamped its business strategies. Following the Wyeth acquisition, it will establish a unique research model designed to advance the strong scientific capabilities of both Pfizer and Wyeth, and to support the new company’s nine diverse healthcare businesses. In order to maximize new opportunities in biopharmaceutical research, Pfizer will form two distinct research organizations —the PharmaTherapeutics Research Group and the BioTherapeutics Research Group. The PharmaTherapeutics Research Group will focus on the discovery of small molecules and related modalities and the BioTherapeutics Research Group will focus on large-molecule research, including vaccines. The new BioTherapeutics Research Group will capitalize on Wyeth’s industry-leading expertise in biologics and build on the momentum established by both Pfizer’s Biotherapeutics and Bioinnovation Center (BBC), and centers of large-molecule research and pharmaceutical science excellence in PGRD, which will be a part of the new and larger group. This new group’s mandate will be to create a broad and deep pipeline in vaccines, antibodies, proteins, peptides, nucleic acids and other novel modalities.
“Creating two distinct but complementary research organizations, led by the top scientist from each company, will provide sharper focus, less bureaucracy and clearer accountability in drug discovery,” says Jeff Kindler, CEO, Pfizer, in a press release. The new Pfizer will consist of nine diverse global healthcare businesses. The convergence between the two entities is aimed to capture key therapeutic areas such as cardiovascular, oncology, women’s health, CNS and infectious disease; vaccines, biologics and small molecules; and animal health with products for companion animals, consumer health, biologics and anti-infective. Going into emerging markets like China, Latin America and the Middle East is also on the cards.
In order to preserve the ‘biotech’ work culture of the company rather than diluting it, Genentech’s research and early development will operate as an independent center. At present, Genentech’s Avastin has been approved in the US and clinical trials are in progress to investigate the efficacy of Avastin in several other tumors. The synergy target increased to one billion Swiss francs annually, and a total one-time integration costs of approximately three billion Swiss francs has been alloted. The combined company has development portfolios with 10 new molecular entities in ongoing or planned late-stage clinical development.
Following the Eli Lilly-ImClone systems deal last year, their combined oncology portfolio will target a broader array of solid tumor types including lung, breast, ovarian, colorectal, head, neck, and pancreas, thus positioning Lilly to pursue treatments of multiple cancers. Partnering with ImClone will expand Eli Lilly’s biotechnology capabilities. “We think very highly of ImClone’s ground-breaking work in oncology, particularly its success with Erbitux(R), a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline,” says John C Lechleiter, president and CEO, Eli Lilly. This will also help them broaden their portfolio of marketed cancer therapies and boost Lilly’s oncology pipeline with upto three promising targeted therapies in phase III in 2009. By bringing together ImClone’s and Lilly’s oncology products, pipelines and biotech capabilities, the company is taking a step forward in addressing the challenges of patent expirations.
The combined entity of Merck and Schering-Plough will bring in a combined portfolio of products in key therapeutic areas which include cardiovascular, respiratory, oncology, infectious diseases, neuroscience and women’s health. Moreover, Merck will now get a footing in the emerging markets and hence devise a strategy accordingly for these markets because of the fact that Schering-Plough generates more than 70 percent of its revenues outside the US with around $2 billion in revenues coming in from these markets.
The Indian vaccine sector is a growing market and post Shantha-Sanofi deal, analysts predict that there will more such deals in this space to follow suit.

Challenges
Integration of assets of both the entities could be a challenge. Biotech is a different ball game and intellectually they’re different from their pharma counterparts. While biotech, which is still in developing stage, is science-driven, pharma is mainly commercialization-driven.
Kar says, “The biotech market is also much more concentrated than the pharma. “The biologics are costly as compared to the pharmaceuticals. We have to really see how pharma companies are moving ahead with the higher prices of biologics to make it a drug of choice, as the convergence will find the pressure both from the government and the consumer to slow down the growth of the healthcare costs,” Kar adds.

Looking ahead
With such a convergence, in the near future, one would see fewer pure biotech companies. “Pharma has the money, it has the need to reinvent itself and their solution being biotech and biotech has it own challenges. So, a convergence will be natural. Currently pharma and biotech is fairly distinctive and I see that line getting blurred,” adds Nair.
Singh maintains that a major trend would be companies would have a dedicated focus on biogenerics. “Another trend would be that within the fold of a pharma company there would be a separate business units which would focus on chemical as well as biopharma. The marketing strategies might differ because normally biological compounds are driven by value and not volume and there is a different logistics chain which is used for biological compounds,” he concludes.
Mixed reactions have emerged within the industry as to whether we can expect to see similar deals this year. There was talks of Pfizer buying out Biogen but the deal did not take off because of valuations. There were talks of Amgen being acquired as well as Bristol-Myers Squibb. “Small deals will continue to happen. However, I do not expect to see any big biotechs being up for sale. This is primarily because, they have the funds and are public entities,” said a research analyst. “ There are some big deals bound to happen this year. We can look out for some,” opines another analyst from a well-renowned firm.

- Source: BioSpectrum, Sept. 10, 2009
- Link: http://biospectrumindia.ciol.com/content/BioSpecial/10909102.asp

August 18, 2009

Big pharmas distribute Indian generics

Narayan Kulkarni

Aug 18, 2009: Pfizer, world’s No. 1 pharma company with revenues of $48.3 billion in 2008 as compared with 2007 full-year revenues of $48.4 billion announced that it has entered into licensing agreements with two Indian pharmaceutical companies namely Aurobindo Pharma and Claris Lifesciences strengthening its position in emerging markets and significantly expanding its portfolio of medicines in its Established Products Business Unit.

Similarly, GlaxoSmithKline, world’s No. 2 pharma company announced an agreement with Dr. Reddy’s Laboratories in June, to develop and market for selected products across an extensive number of emerging markets, excluding India.

Commenting on the deals with the Indian generic players, Jeff Kindler, Chairman and CEO of Pfizer said, “The announcement demonstrates Pfizer’s commitment to improving the global public health landscape by making needed quality medicines—in a range of disease areas—accessible to underserved populations worldwide. The off-patent marketplace worldwide too often suffers from quality and supply reliability issues. With our broad established medicines portfolio and our world-class manufacturing capabilities, Pfizer is in an ideal position to supply high-quality medicines at affordable prices to people around the world.”

Pfizer has been active in generic business through its subsidiary, Greenstone LLC, (the seventh-largest generic pharmaceutical company in the world by volume of prescriptions dispensed).

With the above deals, Pfizer has enhanced its offerings in the emerging markets that are experiencing growth of 12-13 percent to reach $85-90 billion by 2012. The growth is driven by greater access to generic and innovative new medicines. Pfizer hopes to expand its product offerings and pick up enough sales to help cushion the blow when Lipitor goes off patent in 2011.

It is the era of alliances and partnerships and with the big shifts happening in the global pharmaceutical industry, this relationship will keep Claris at the forefront of change. Through Pfizer, we will get access to extremely competent sales and marketing partner for our regulated markets strategy in order to enhance our existing presence in these markets,” said Arjun Handa, Managing Director and CEO, Claris Lifesciences.

Commenting on the deal with Dr Reddy’s Labs, Mr Abbas Hussain, President Emerging Markets, GlaxoSmithKline said, “This is significant step forward in our strategy to grow and diversify GSK’s business in emerging markets. Growth in both population and economic prosperity is leading to increased demand for branded pharmaceuticals. This new alliance will combine Dr Reddy’s portfolio of quality branded pharmaceuticals together with GSK’s extensive sales and marketing capabilities. Together we’ll be able to deliver more medicines of value to more patients in these countries.” However, Mr GV Prasad, Vice-Chairman & CEO, Dr Reddy’s Labs said, “We combine forces with GSK to fully realise the potential of our strengths in technology, product development and manufacturing across a range of high growth emerging markets. We hope to take our purpose of providing affordable and innovative medicines to a much wider population through this partnership.”

Mr Sujay Shetty, Associate Director, Pharma Life Sciences, PwC, India said “It is a time for collaboration and partnership. In that direction the latest developments are positive developments for both Indian companies and MNCs. For generic companies, the tie ups will open up to offer their affordable and innovative medicines to a much wider population. Without reinventing the wheel, the MNCs can offer quality products by working with partners at affordable price in the emerging markets that are growing faster than the developed pharma markets.”

However, Mr Bibhuti Bhusan Kar, Program Manager, South Asia and Middle East, Healthcare-Pharmaceuticals & Biotechnology, Frost & Sullivan, India, said, “Drying pipeline of new drugs, increased R&D expenditure required to bring a drug to the market, increased pressure in the developed nations to bring down the health care costs are some of the factors that are responsible for the big MNCs to fine tune their business models to enter/increase their portfolio into the branded generics market.”

The other factor that is driving the big pharmas to look at branded generics is strategic shift in the healthcare reform in the US (world’s no 1 pharma market). The pharma majors joined hands recently to reduce the healthcare cost increases by $2 trillion over a decade. These companies can achieve this only by introducing branded generics in the US.

Mr Bhusan further said, “India being a low cost manufacture destination and the fact that India has highest number of US FDA approved plants outside the US and is more experienced meeting the regulatory requirements of the US and EU, Indian manufacturers are the preferred choice as a partner for sourcing the products.”

Reacting to the developments, Hitesh Sharma, Partner & National Leader, Health Sciences Practice, Ernst & Young India, said, “The Indian companies are into similar activities i.e, distributing the products of MNCs in India. Now, MNCs will distribute Indian generics. The companies are always scouting for opportunities for growth and mutual benefits. The deals will happen if it will be win–win for both the parties. However, it is difficult to say how many such deals one can expect in near future.”

“Looking at the present scenario, one can expect more such deals in future as well by these MNCs with generic players especially with the Indian manufacturers, because of their strengths in technology, diversified product portfolio and rich experience in the developed markets,” points out Mr Bibhuti Bhusan.

Entering the new markets, these kinds of deals will be an exciting opportunity for Indian generic companies like Cipla, Wockhardt, Lupin, Glenmark, Sun Pharma, Cadila as they provide stability towards their earnings and accelerate their growth plans.

India well positioned to leverage partnering options
Big Pharma has been under strain to sustain its existing revenue levels due to the challenges faced in terms of slowdown in new product launches and thinning of new product discovery pipelines clubbed with a large number of blockbuster drug patent expiries and increasing penetration of generics, particularly in the current market scenario. All this has led Big Pharma to aggressively look at building sustainable diverse business models by foraying into and strengthening new high-growth business.

Foraying into related sectors such as biotechnology, counted among the most promising sectors worldwide. Building generic product portfolios either through acquisitions (such as the Daiichi–Ranbaxy deal) or through strategic alliances (such as the recent GSK–Dr Reddy’s, Pfizer-Aurobindo and Pfizer-Claris deal).

Given the increasing use of generics globally, as governments worldwide as well as private healthcare payers look at controlling rising healthcare costs, the growth of this market outperforms the growth of the overall pharma market, making it an attractive investment opportunity. Further, strategic alliances are a less risky option than pursuing outright buy-outs and are hence emerging as a preferred route.

It may be observed that traditionally there have been similar examples where Big Pharma has built its presence in the generics market through focused business units. However, given the current unprecedented pressures that the Big Pharma is reeling under, this strategy has gained all the more importance and we can expect more such strategic alliances between the Big Pharma and generics players in the time to come.

With India already having made its mark in the global generics market as a supplier of high quality – low cost drugs and its strengths in terms of product development and manufacturing portfolios, niche therapeutic focus and well-balanced geographic mix focusing on both regulated and semi-regulated markets, it is well positioned to leverage the opportunity and further explore such partnering options. Additionally, these companies can strongly benefit in terms of financial support, brand name and well established marketing and distribution channels of the Big Pharma player.


- Source: BioSpectrum Asia Edition, Aug 18, 2009
- Link: http://www.biospectrumasia.com/content/060809IND10235.asp

August 3, 2009

The French connection





BV Mahalakshmi, Sudhir Chowdhary

Posted: Monday, Aug 03, 2009 at 2346 hrs IST
Updated: Monday, Aug 03, 2009 at 2346 hrs IST

Indian vaccine makers seem to have entered good times. As France’s largest drug maker, Sanofi-Aventis, agrees to buy a majority stake in Hyderabad-based Shantha Biotechnics, a sense of excitement combined with renewed confidence has rejuvenated the domestic vaccine makers.
Investor interest has shifted back to the vaccine sector and there is widespread excitement in industry circles that the product portfolios of Indian vaccine companies are niche and less susceptible to competition and are hence attracting global recognition. The Sanofi-Shantha deal has highlighted the increasing potential of Indian vaccine companies in the realm of drug research. Excitement is also on account of the fact that intellectual property and manufacturing facilities of Indian companies will attract strategic investors in the times to come.
The deal has again brought into focus the strong value proposition that Indian vaccine makers such as Serum Institute of India, Panacea Biotec, Indian Immunologicals, Shantha Biotechnics, Bharat Biotech bring with them in terms of strong discovery research, combined with good manufacturing capabilities. They have made their mark as reputed vaccine producers in the world, exporting to a number of countries. The fact that Shantha Biotech was able to attract Sanofi with its intellectual property and good manufacturing facilities is a sign of the maturity of the Indian vaccine industry.
No sooner was the deal announced that the stock prices of domestic vaccine makers skyrocketed, riding on investor interest. A rich product pipeline along with several vaccines under advanced stages of development at domestic companies add to the glitter. Indian vaccine makers have a long history of supporting WHO and UNICEF in developing and supplying affordable vaccines such as, oral polio, measles, combination vaccines etc. Products in the pipeline include vaccines for rotavirus, swine flu, typhoid, various forms of cancer and other adult vaccines.
Perceived as low growth and uneconomical earlier, vaccines have been in focus for global drug companies during the last few years; the sector is currently estimated at $20.6 billion and is said to be growing at 10% compared to the 3-4% growth for the overall global pharmaceutical industry. Hence global drug majors facing patent expiry and shrinking product pipelines are increasingly looking at this segment to maintain their topline and profitability. The vaccine segment continues to enjoy good profitability—thanks largely to the high entry barriers—and hence has been drawing renewed attention of the drug majors.
The US and European vaccine majors have targeted emerging markets as sales in the mature markets of America and Europe slow. For instance, Shantha’s buyout is part of Sanofi-Aventis CEO Chris Viehbacher’s strategy to aggressively grow the company’s vaccine business. As on date, he has inked four vaccine deals—three in emerging markets—since he became the company’s CEO last year. These include a deal for Mexico’s generic maker Laboratorios Kendrick, Brazilian generic drug company Medley, and California-based cancer specialist BioPar Sciences. Sanofi is trying to refill a development pipeline seen as lacking new drugs to replace blockbusters such as Plavix, which is used to prevent blood clots that will soon come off patent and face competition from generic drugs. Moreover, vaccines are considered to be increasingly important as they are typically ordered by governments in bulk and can be administered to large populations.
No wonder, the Shantha Biotechnics buyout did not surprise many. But what left many astounded was the size of the deal. At a buyout price of Rs 3,778 crore, the transaction even exceeded the combined Indian vaccines industry’s revenues of Rs 3,587 crore for the fiscal 2008-09. Equally shocking was the valuation more than eight times of its projected sales of Rs 440 crore for the current year. Analysts reckon the deal has catapulted Shantha Biotechnics into the big league. It is now one of the top 15 drug companies by market valuation, ahead of even the Indian subsidiaries of global vaccine majors in terms of market value.
“The deal sends a strong signal that Indian pharmaceutical and biotech companies are well respected. The high valuation is due to our quality conscious products at low prices. We have been focusing mainly on good quality and developing new products for affordable healthcare,” says KI Varaprasad Reddy, managing director, Shantha Biotechnics. “The valuation comes at a historical cost which created and then distributed wealth in the form of employee stock options. Even the lowest employee got about Rs 4-5 lakh on an average,” he adds.


According to Nitin Deshmukh, head of private equity at Kotak Mahindra Bank, the valuation is justified and the Sanofi-Shantha Biotech deal is not a one-off deal. “Finally, there is recognition for intellectual property being generated by an Indian vaccine company. There are a number of biotech companies which are not in the public domain and yet, they are doing some significant work. As they approach the market with their product, I am sure we could expect similar valuations for them too,” he adds.
Without any doubt, the deal is seen as a strategic fit for both Sanofi-Aventis and Shantha. While the French firm would benefit by acquiring a slew of new vaccines under development at Shantha facilities, the Indian company would gain access to new technologies and the global market. “Shantha would provide Sanofi Pasteur with a portfolio of new vaccines in development which complement Sanofi Pasteur’s current vaccines, positioning the company to accelerate its growth in strategically important emerging markets,” says Viehbacher. “Shantha’s manufacturing facilities allow Sanofi Pasteur to gain high quality capacity in order to enable us to provide important vaccines at affordable prices to many people around the world,” he reiterates. Clearly, it is the lure of the rich product pipeline of Shantha Biotech which attracted Sanofi-Aventis to go for the acquisition. The Indian company is developing generic biologicals, therapeutic antibodies, proteins and vaccines in the fields of oncology, infectious diseases and platform technologies. The new products being developed at the Hyderabad facility include rotavirus vaccine for infant diarrhoea, conjugated typhoid vaccine and human papillomavirus vaccine for cervical cancer.
In addition, most of the existing vaccines in the Indian company’s pipeline are ready for use. Besides, Sanofi will also be able to take advantage of Shantha’s manufacturing facilities in Hyderabad. Nevertheless, this deal will definitely have a positive outlook for the Indian vaccine sector. There are other companies such as Biocon, Panacea Biotec, Serum Institute, Bharat Biotech to name a few among the major ones, which boast of a rich product pipeline.
Post Sanofi’s buyout of Shantha Biotech with such a good deal, other companies may not mind looking for such a deal if they get such a valuation, opines Bibhuti Bhusan Kar, programme manager, South Asia & Middle East, healthcare—pharmaceuticals and biotechnology, Frost & Sullivan.
Krishna Ella, chairman, Bharat Biotech says, “There is a good recognition for Indian vaccine manufacturers. Companies manufacturing vaccines from the country are being approached world over as there is a huge demand.”
The key drivers for global vaccines market has been mass immunisation programmes in emerging markets like Brazil, Cuba, India and Russia and various developed countries agencies stocking up in anticipation of diseases. Besides this, developments occurring in pediatric vaccines have been astounding.
The sector has also been boosted by funding from various governments and private agencies as well as better and more innovative combination products/delivery systems being developed, informs Navroz Mahudawala, associate director with Ernst & Young’s health sciences practice.

There are two important strategic reasons because of which the interest in India and Indian markets would continue. India is slowly emerging as a global manufacturing base for low cost vaccines. “From a demand angle, while the emerging markets currently represent around 75% of volumes; they actually contribute less than 25% in value. This dichotomy will get corrected over a period of time; with increasing purchasing power and increased spending from organisations like UNICEF,” says Mahudawala.
Besides most Indian manufacturers have a robust product pipeline with several products in advanced stages of development. This is expected to be well received in various developed markets.


The other factor is India’s domestic market potential itself. According to industry sources, the Indian vaccines market is currently Rs 3,587 crore in size and is expected to grow at a CAGR of 20-25% over the next few years. Although the size of the market is relatively low, it is expected to grow owing to factors like government immunisation programmes and increased disease awareness. India offers huge potential to offer products from their global portfolio. Given the above factors, it is expected that global vaccine majors will look to increasingly expand their presence in India either organically or through strategic alliances or even acquisitions. The action seems to have just begun.
- Source: The Financial Express, Aug 03, 2009