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Tag Archives: India

Biotech Trends Update — IP Constituencies: Indian Industry Lobbies to Keep IP Out of Free Trade Agreement with EU

An article in yesterday’s Hindu Business Line says the Indian Drug Manufacturers’ Association is lobbying heavily to keep data protection and other innovator-friendly IP provisions out of the free trade agreement being negotiated between India and the EU. But, with Glenmark and Jubilant on the rise, and with even Biocon carrying the R&D water in its deal with Pfizer, demands for IP protection from domestic constituents are bound to be increasingly loud.

Keep an eye on the progress of the free trade talks, continuing with the India-EU summit this week. Apparently, the main gaps are: the percentage of tradable goods that are tariff-free; a sustainable development clause; and the IP issues noted above. We’ll see how hard India pushes to keep IP out of the picture.

Friday Science Review: May 21, 2010

A slightly different FSR this week with a spotlight on Global Health, right on the heels of the recent Grand Challenges Canada announcement.  An interesting report in Nature Biotechnology, led by Drs. Abdallah Daar and Peter Singer at the McLaughlin-Rotman Centre for Global Health, mapped the collaborations between health biotech companies in developing countries.  The study is a first for tracking “South-South” partnerships and they offer some interesting insights:

South-South collaborations have become a widely chosen path for health biotech companies:

  • About a quarter (27%), participate in collaborations with another developing country and many (21%) are involved in multiple initiatives.
  • South-North collaborations with developed countries are still more common (53%).
  • The most active countries with the highest percentage of firms engaged in South-South collaborations are Cuba (~75%) and South Africa (~45%), followed by Egypt, Brazil, India, and China.
  • These leading developing countries in health biotech make up the majority of the linkages (see figure below)
  • Many of the collaborations are within their own regions such that they are establishing free trade zones to encourage trade with one another.

South-South Collaboration Network

Some of the motivations for companies in developing to collaborate include:

  • Minimizing risk and cost by sharing the burden with a partner.
  • Expanding their potential markets with an easier or facilitated access to a foreign market.
  • Gaining specific knowledge or skills, particularly since there are many specialized skills and technologies involved in biotech research that may not be available locally.

The nature of the collaborations, however, is mainly end-stage commercialization agreements rather than R&D.

  • Distribution agreements (72%) and marketing activities (34%) account for the majority of the collaborations with only 13% involving R&D and 9% involving clinical trials activities.
  • Innovation based knowledge sharing would likely have greater long-term benefits and future policies should encourage more of these types of collaborations.

To further promote such initiatives, Government organizations and other third parties can, and should, play a larger role to cultivate joint ventures since the majority of the South-South collaborations were initiated by the participating companies themselves.  It is important to realize that  South-South collaborations in the biotech sector are just as valuable as North-South collaborations to sustain a growing culture that addresses global health issues.

Also note that this study follows a pair of Nature Biotechnology publications last year by the same group at MRC – one explores “South-North” health biotech collaborations and the other focuses on Canadian biotech collaborations with developing countries.

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Biotech Trends Update — IP Constituencies: India’s Courts Nix Drug Patents while India Courts Innovation

world_map_2002This blog has been tracking increasing innovative activity in India and China as part of our Biotech Trends series, the idea being that as innovative activity increases, the host countries will take a kinder view of property rights.

The trend toward innovation in India is undeniable — as the WSJ’s Venture Capital Blog noted recently, India even has its own version of  Y Combinator, an incubator/early-stage fund.  India also has many notable successes in pharma and biotech innovation, including Jubilant and Glenmark.

Yet, as Ronald Cass notes in a WSJ editorial, the groundswell of Indian innovation hasn’t yet worked its way up through the legal system.  Citing a Delhi High Court decision that allowed generic copies of Merck’s cancer drug Nexavar, Cass infers that India does not “want drug innovation.”

I disagree.  India does want drug innovation.  Like everyone else, India wants lucrative knowledge economy jobs.  But even with a broad desire for policy change, turning a judicial ship is a slow process in a common law jurisdiction. 

My bottom line: It will likely take time, and may take facts more sympathetic than Merck’s, to break with precedent and habit and to develop a more innovation-friendly jurisprudence in India.  Make no mistake, though, that’s the direction India is heading.  Patience, but not complacence, is the order of the day.

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Biotech Trends Update: Jubilant’s R&D Success Continues Drive Toward Innovation in Asia

world_map_2002One of the biotech trends we’re following in 2010 is the increasing innovative activity in India and China.  Both are booming not only as low cost manufacturing centers but also as innovative hubs adding R&D expertise and specialized know-how.

This week, the Indian company Jubilant and Endo Pharmaceuticals announced that they are expanding thier partnership following early and rapid success by Jubliant’s team.  Jubilant has been developing pre-clinical candidates for Endo’s oncology pipeline.  As Endo’s R&D VP says, they are executing on a “strategy of building Endo’s pipeline using a virtual discovery approach” as a complement to their in-licensing strategy.

Jubilant has been running with these types of “virtual discovery” deals, including its collaboration with AstraZeneca that we noted at the time (even as AZ is shedding in-house capacity today), a successful partnership with Lilly and tie-ups with academic institutions including Duke University and UAB.

FierceBiotech reports that Biocon’s Kiran Mazumdar-Shaw predicts a $5 billion Indian biotech business in 2011 that will “double to $10 billion by 2015″ based on “opportunities in clinical trials, manufacturing and more.” 

The greater the contribution R&D makes to India’s growth, the better positioned the country (and the region) will be in the coming years to lead the global industry forward.

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Biotech Trends Update — IP Constituencies: Innovators and Generics Continue to Blur Pharma Lines

Two stories noted by the WSJ’s Health Blog highlight the trend we’ve been following of blurring lines between branded/innovator pharma and generics companies:

The biggest development I’d cite is Pfizer’s deal to sell 40 generics made by India’s Strides Arcolab and South Africa’s Aspen.  This deal seems to go a step farther than other innovator/branded deals with generics in that it treads on U.S. soil.  The Pfizer Established Products Business Unit has in-licensed more than 200 products and has an overall portfolio of approximately 600.

“Generics” companies are not sticking to their traditional role either.  Noting Teva’s projected growth and market cap, Jacob Goldstein says that “[i]t’s no longer correct to think of generics manufacturers as scrappy little competitors nipping at the heels of big pharma,” especially where 30% of their revenue comes from branded drugs. 

Add those to increasing innovation in India and China and in collaborations with companies there, and the whole global industry is starting to look a bit more homogeneous.

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Trends Update — IP Constituencies: Novartis CEO Vasella Calls Upcoming Gleevec Decision a “Turning Point” for R&D in India

B&W_BlankMap-World-nobordersIndia and China both ranked in the third quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 for protection of IP rights.  In an earlier post, we predicted that this ranking would change rapidly, with both countries strengthening their IP regimes as their domestic R&D capacity ramped up.

Both countries have continued to win R&D collaborations and make investments in research, most recently including an Indian R&D park project by Alexandria (a U.S. developer) and Novartis’ $1 billion investment in R&D in China

However, China and India may not be moving at the same pace.  Novartis is facing its final appeal of lower court rulings in India denying it patent protection for Gleevec, and CEO Daniel Vasella calls the pending decision “the turning point” for Indian R&D in a recent article in The Economic Times (picked up by FierceBiotech).  He also reportedly says the decision to invest in R&D in China is “not driven by its bad experience with Gleevec in India.” 

Vasella has a dog in the fight, of course, but that’s the point.  The correlation between R&D spending and IP enforcement couldn’t be clearer.

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Trends Update — IP Constituencies: India’s Glenmark Pharmaceuticals Sets an Example for Canadian Innovation

This blog has been following the increasing innovative activity taking place in India’s and China’s biopharma industries, and Glenmark Pharmaceuticals is a great example of this trend.

Forbes profiled Glenmark this week (H/T FierceBiotech), noting that it started in 1978 as a generics firm but now has 7 clinical-stage compounds and has partnerships with Forest Labs in the U.S. and Teijin Pharma in Japan.

There are two really interesting points raised in the article:

  1. Glenmark is using its revenues from generics to fund its innovative R&D programs. Biotech business models have long incorporated quick revenue as a funding source for long-term R&D; but the typical focus for the short term is on services revenue (because it typically leverages the platform they’re building anyway).  For long-term survival, though, nothing beats tearing a page out of Big Pharma’s playbook.  In Canada, Bioniche’s tenacity is fueled in no small part by animal health revenues, mimicking the Big Pharma animal health divisions.  Glenmark, similarly, has ridden into R&D on the back of the other Big Pharma cash cow — generics.
  2. Glenmark saw a strong IP regime as an opportunity. I’ve been hypothesizing that more innovative activity will drive more support for IP protection in India and China; but Glenmark is an example of the opposite causal relationship:

    “During his time in the U.S., Saldanha could see that India was likely to join the World Trade Organization and that meant come 2005 it would have to respect patent laws: ‘Generics generate cash, but we needed innovation to take us into the future.’”

My bottom line: Glenmark is a great example of how to look to the future and build for it.  Canada has an opportunity now, on a national scale, to deploy its revenue both within the biopharma industry (from our generics companies) and outside it (from our natural resources) to build for the future Saldanha saw.  We’d better seize that opportunity while we can.

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Trends Update — IP Constituencies: India M&A Spurs Pricing Concerns

world_map_2002We’ve been following the trend of increased innovative activity in developing countries, and have noted its likely effect on IP protection in those jurisdictions. In a variation on that theme, an article last Thursday in DNA suggests that

“Indian companies, which have been actively pursuing pre-grant and post-grant oppositions against the patents of MNCs, would become less aggressive after being acquired by Big Pharma.”

This seems like a plausible outcome, although it is counterbalanced by the increasing stake innovator companies are taking in generics and follow-on biologics companies.  It is also counterbalanced by statistics from Navroz Mahudawala at Ernst & Young (cited at the end of the article) showing that multi-national companies’ share of India’s pharma market has actually dropped by almost half over the last two decades. What is more interesting to me, though, is the nature of those investments, which appear to have been shifting to rely more heavily on India’s R&D capabilities. These domestic R&D capabilities will be the real driver of change in attitudes toward IP protections.

In light of shifting IP attitudes, the pricing of drugs is a legitimate concern, but consider what I’ll dub “the innovation cycle” — India’s increased R&D capabilities will fund higher incomes and help citizens afford higher-priced drugs, while countries that may have been importing India’s generics will be forced to develop their own generics production capabilities, which may eventually (as in India) lead to innovative R&D, etc., etc.

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Trends Update — IP Constituencies: Amylin Partners with Biocon, PerkinElmer Buys Access and Capacity in India and China

world_map_2002Following up on Sunday’s post noting the new survey of Canadian biotech collaborations with companies in the developing world, it’s worth paying attention to two U.S. deals from last week that emphasize the growing role of India and China in the drug development process:

  • Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Biocon Limited (NSE: BIOCONagreed to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes, and will share development costs; and
  • PerkinElmer did one deal each in China and India:
    • In China, they paid over $60 million for SYM-BIO Lifescience, a Shanghai, China-based diagnostics firm that will double its access to hospitals in China and provide it with “substantial” manufacturing plant capacity
    • In India, they picked up the genetic screening business of Surendra Genetic Labs, a lab in Chennai, India, that provides fetal, maternal, and newborn screening.

The McLaughlin-Rotman survey distinguishes (usefully) between R&D collaborations and marketing and distribution activities.  Although Ellen Licking wonders whether “cheaper off-shore manufacturing [is] a reason for the deal,” Amylin is clearly focused on Biocon’s R&D capabilities.  The press release quotes Amylin CEO Daniel M. Bradbury praising Biocon as a “biologics innovator.”

Even if not all transactions in India and China are innovation-centric (cf the PerkinElmer deals), all involvement by innovative companies shifts the incentives of China, India and other participating countries towards a more innovation-friendly IP regime.

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Trends Update — IP Constituencies: Rotman Article Explores Canadian Biotech Collaborations with Developing Countries

A very interesting article in Nature Biotechnology from a group at the McLaughlin-Rotman Centre for Global Health provides some empirical support for a trend we’ve been following of increased innovative activity in developing countries

According to the article, over 25% of Canadian biotechs collaborate with developing countries.  Of these, however, the vast majority of companies do so alongside collaborations with other developed country partners — only 4% collaborate exclusively with developing countries.  Also, gaining access to developing countries’ markets is the most frequent (66%) reason cited for collaboration.

Still, some of the data reflects the growing importance of developing country collaboration (China and India in particular):

  • Canadian firms’ collaborations with India (17) and China (22) nearly equal the number of collaborations with Japan (18) and Germany (23); and
  • Accessing knowledge from developing countries’ partners (24%) is approaching providing knowledge to developing countries’ partners (37%) as a reason for collaboration.

How do these collaborations look overall?

Collaborations article - nbt0909-806-F4

The figure from the paper on the left shows the geography of, and rationale for, the collaborations. Part “a” shows marketing and distribution collaborations, and part “b” shows those involving an R&D component.

 

What is the effect of all this activity?

Well, it’s hard to quantify, but the authors review revenue data from public company respondents and find that:

“average total revenues of firms that have North–South collaborations are nearly four times higher than firms that do not have such partnerships.” 

My bottom line: causal or not, that’s a correlation that should cause all biotech companies to take note.

Trends Update — Shifting IP Constituencies: Perkin Elmer and Mylan in India, Branded Generics Everywhere and China’s R&D Budget all Point to Change

world_map_2002In our continuing Trends in 2009 series on shifting IP constituencies, we’ve been following increasing innovative activity in the developing world, and innovator pharma’s increasing moves towards generics and biosimilars.  This week saw updates on both fronts:

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Trends Update — IP Constituencies: Rumors about GSK-Shantha Biotech

B&W_BlankMap-World-nobordersSince we’ve been following innovative activity in India and China as part of our Trends in 2009 series, we had noted a report at the end of March that GlaxoSmithKline and Sanofi-Aventis were each in talks to buy a majority stake in the Indian company Shantha Biotech from France’s Merieux Alliance, which owns 80 percent of the company.

A report in India’s Economic Times today, picked up by FierceBiotech, says that Sanofi had dropped out and that the deal with GSK has “[o]nly a few matters relating to the valuation” remaining.  This is a bit like saying Israel and the Palestinians are close to a peace accord with only a few matters related to borders remaining.  Hopefully GSK and Shantha/Merieux are closer (and friendlier) than that, but valuation is obviously a big issue, so I wouldn’t be counting any biosimilars before they hatch.

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Trends Update — Shifting IP Constituencies: AstraZeneca’s R&D Investment in India’s Jubilant

world_map_2002One of our trends in 2009 series is following the increasing innovative activity in India and China, which has the potential to reshape WTO debates around IP protection.

Yesterday, FierceBiotech picked up a Reuters report that AstraZeneca will be funding five years’ work in neuroscience R&D at India’s Jubilant Organosys.  Jubilant was… well … very happy about the deal, which could lead to up to $200 million in milestone payments.  Jubilant also works with Eli Lilly on drug discovery and partnered drug development.  Interestingly, the article juxtaposes Jubilant’s R&D deal with its Monday FDA approval for a generic product.

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Trends Update: ChinaBio and Shantha Biotech

One of our Trends in 2009 posts last week talked about the increasing innovative activity in India and China and increasing generics activity among innovator pharma.  This week starts with a relevant update on each front:

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Wednesday Brain Dump: Around the World Edition

Science and Technology in India’s Election

Trends in 2009 post this week noted the increasing innovative activity in India and China.  Further evidence of that trend comes from a ScienceInsider report today that support for science and technology has taken a prominent place in the ruling Congress Party’s election manifesto.  The party notes that in the last two years it has opened:

eight new Indian Institutes of Technology, seven new Indian Institutes of Management, five new Indian Institutes of Science Education and Research, 30 new Central Universities, 20 new Indian Institutes of Information Technology, and 374 new colleges in educationally deprived districts.

Onward and upward in the IPRI Report

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Trends in 2009: Shifting IP Constituencies as Innovator Pharma Buys Generics and Asia Turns to Innovation

Growing industrial and geopolitical realignment of economic interests has the potential to re-define intellectual property constituencies in 2009.

1.  Industrial realignment: the entry of innovator pharma companies into the generics business.

This year has already seen Merck get into follow-on biologics by buying Insimed and Pfizer build its generics business with its Aurobindo deal.  As traditional innovator pharma companies become more invested in follow-on biologics and small molecule generics, they will have a greater (self-)interest in a functioning subsequent entry pathway. 

Watch how this is playing out in the follow-on biologics arena as two competing FOB bills make their way through Congress.  Right now, the 12-year exclusivity period in the Eshoo-Barton FOB bill and the 5-year exclusivity period in Waxman’s FOB bill are duking it out, and we’re already seeing increased industry flexibility.  Innovator pharma has historically insisted on a 14-year exclusivity period to accompany follow-on biologics legislation, but BIO has already indicated some willingness to support Eshoo-Barton, as has PhRMA

Dani’s the expert, but my layman’s guess is that we get a FOB pathway this time around, and that the exclusivity number lands somewhere in the 8-10 year range.  This is consistent with a Teva-promoted analysis and it’s easy to see that it covers the arithmetic middle ground.

2.  Geopolitical realignment: increasing innovative activity in Asia, which has historically focused more on generics.

In China, a recent deal between Lotus Pharmaceuticals, Inc. (OTCBB: LTUS) and Beijing Yipuan Bio-Medical Technology Co., Ltd. (“Yipuan”) to acquire the drug Yipubishan points to China’s interest in promoting innovation.  Yipubishan, which is used to treat the symptoms of gastric ulcers and hemorrhages of the upper digestive tract, was partly funded through the use of grants from the Innovation Fund for Small – Medium Technology Based Firms of the Ministry of Science and Technology of the PRC.  Yipubishan became the first prescription drug of its kind developed in China to be included in the National Torch Project, which recognizes and promotes commercialization of high-tech discoveries and encourages companies to use high technology.  The Torch Project is one of a series of PRC Science and Technology initiatives.

In India, Wockhardt’s pioneering efforts in biotechnology are among many signs of increasing innovative activity, and have attracted interest from Pfizer and Sanofi.  Wockhardt has set up a global-scale biopharmaceuticals manufacturing powerhouse, the Wockhardt Biotech Park, in Aurangabad, India. This state-of-the-art complex comprises six dedicated, manufacturing facilities, and is designed according to US FDA and EMEA standards. It will also house new biotechnology products that are currently in various stages of development. The complex has the capacity to cater to 10-15% of global demand for major biopharmaceuticals.

India and China are in the 3rd quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 but they are steadily increasing their innovative activity. 

Within a short span, I would expect them to rank more like Israel, which has a world-class innovative industry as well as a strong generics industry (Teva), or Taiwan, which recently announced an initiative to boost cleantech and biotech.  Both Israel and Taiwan are ranked 29/115 in the 2009 IPRI Report. 

Ups and Downs for Biotech Crops in the EU

Quite an a-maize-ing week (sorry) for biotech crops in the EU:

  • The European Commission announced a proposal to end Austria’s ban on biotech maizes MON810 and T25, saying that Austria had not supplied scientific evidence that the specific nature of Austria’s ecology justified the ban.
  • A report from the French food safety agency, Afssa, saying MON810 is as safe as conventional maize leaked to the press just a few days before Envirmonent Minister Jean-Louis Borloo was due to appear before a committee of European biotech experts to justify France’s ban.   This prompted French Prime Minister Francois Fillon to say Thursday that “France is maintaining the suspension while it awaits a (European) Commission decision which it will respect.”
  • When the committee of experts met Monday, they did not have the “qualified majority” (a population-weighted test) to overturn the MON810 bans in France or Greece, the same result as in December when the voting was to lift similar bans in Austria and Hungary.  Now all four cases will be addressed by the EU’s council of ministers on March 2.
  • This apparently emboldened Germany’s Agriculture Minister, who said the German government may revoke the license it already issued for the GM crop.
  • Last, but not least, today the European Court of Justice issued a ruling that requires EU governments to make the location of GM crop field trials public.  Hopefully long jail terms will deter the “activists” who will no doubt be among those accessing the information.

Meanwhile, in the rest of the world:

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