Welcome to CI2E Quarterly! We are delighted to bring to you the second issue of this newsletter for professionals in the life science and chemical industries. CI2E Quarterly is being shared with over 5000 "select" industry professionals and offers a quality publication that you will crave to read!

Developed by ROW2 Technologies, a company with expertise in synthetic organic chemistry and knowledge on the global chemical industry, CI2E Quarterly provides:

• News about ROW2 and its offerings of interest to you.
• Key articles and information on the pharmaceutical/chemical industries, written by renowned thought leaders.
• "MyForum", a unique opportunity to interact with ROW2's global customers and readers.
• Entertainment through chemistry-related humor and fun trivia to make you laugh and relax.

• ROW2 World: Updates on our company & offerings
• Article: Biogenerics: The Next Frontier?
  
• Links: to various articles and upcoming events
• MyForum: How will India fair against China?
• Humour: Fun trivia & chance to win a Prize… read on!

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ROW2 World - This Quarter's Highlights:

ROW2 News

• Katrina Hurricane Relief: ROW2 was deeply saddened by this tragedy. All ROW2 employees have voluntarily donated a day's earnings towards the American Red Cross Society's relief efforts.



• Upcoming Events: ROW2 will exhibit at the CDMA 2005 Fall Meeting, Sept. 27-29, PA USA, will speak on "Designing Novel Routes Faster: A new Outsourcing Model" at the Process R&D Summit, Oct. 24-25, PA USA, and will attend the 12th Int'l Conference on Organic Process R&D, Nov. 15-18, Naples, FL USA.



• Web Seminar: In response to industry professionals' request, ROW2 hosted a web seminar entitled “Outsourcing Trends: A Strategic ‘CRAMS’ Destination - India” on June 9th. The event featured Dr. Prabhakar, Head of Strategic Planning for the API div. of Dr. Reddy's Labs and was successfully attended by over 30 people from worldwide organizations. To see the event recording or obtain the slides click here.
  
  "ROW2's web seminar gave us interesting information and made us reconsider this country and the opportunities it may offer. I look forward to future events." - Global EM&S Work Process Leader at Specialized Chemical Company.
  
  
• Our Customers: ROW2 is proud to announce that this quarter 18 NEW companies from USA, Germany, Italy, Czech, Netherlands and India have become customers of our offerings. Thank you for your trust and support!

• RapidFire - Coming Soon! New enhancement will allow SmartChem users to filter and select multiple suppliers/potential customers of interest and quickly send email requests to them. This new tool will help reach target companies faster and with less effort.



• Suggestion Week: At ROW2, we value and seek customer suggestions to constantly improve our offerings. We take pleasure in announcing our first "Suggestion Week" (Oct. 17-21, 2005) for SmartChem users. This eventful and action-packed week will provide various activities including a direct interaction with our COO and the opportunity to win a reward for the "Best Suggestion of 2005"!



• New Referral Program: This program will allow SmartChem users to share with industry contacts their experience about SmartChem and win great rewards for them and their organization.

---------------------------------------------------------------------- Featured Article

Bio-generics: The Next Frontier?
Article written by Mr. Ravi Raghavan, Editor, Chemical Weekly.

Approximately 25-years ago, the first biopharmaceutical products were patented in the US, where much of the innovation in biotechnology continues to happen till date. Over the next few years, a significant number of these drugs will go off-patent, including some which are among the most expensive in the world. According to an estimate made by Kalorama Information, a consultancy, the world market for generic biopharmaceutical products, better known as bio-generics or bio-similars, has the potential to reach $5.4-bn in 2008 (from virtually nothing now). In anticipation of this, a handful of companies are focusing on development and commercialisation of bio-generics. So far, their plans have been stymied by the lack of an adequate regulatory system in the two most important markets - the US and Europe.

Read more here.

---------------------------------------------------------------------- ROW2 picks of the quarter

In order to keep track of the latest industry/chemistry news, our research and commercial teams review several journals, publications and websites per month. Here are some interesting picks, which will be of relevance to you. Let us know what you think of our selections!

The eSourcing Revolution: Impacts and Advantages
Published in: American Pharmaceutical Outsourcing, Jul/Aug 2005 Issue
Interesting article that offers key information about electronic sourcing and how it's changing the buying process.

Top Pharmaceuticals - A look at drugs that changed our world Published in: C&E News, June 20, 2005.
Great historical retrospective of the pharmaceutical industry and overview of drugs that have made an impact on our health.

23rd SCI PROCESS DEVELOPMENT SYMPOSIUM
Event on: December 7-9, 2005 in Cambridge, UK
This event brings together a wide range of international speakers from across the Life Sciences and Fine Chemicals industries, who will describe major advances in new processing technologies and innovative science.

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Powerful lobbying
The reluctance of regulators to approve bio-generics, as quickly as is done for small chemical entities, stems from powerful lobbying by innovator companies and the biotechnology industry. One of the primary arguments used by the biotechnology industry is that different cell lines cannot produce equivalent products. Put differently, it has been argued, 'the process makes the product', putting paid to equivalence of identity and efficacy. The generics industry argues there is now sound science, which can establish bio-equivalence, and that allegations of poor safety of copy-cat biologicals, amount to scare-mongering and are desperate attempts to put off the inevitable.

But things are about to change in so far as regulation of bio-generics is concerned in the two important markets of the world.

Just last December, the EU became the first region to consider licensing copies of biopharmaceuticals, after the regulatory authority, the EMEA, published draft guidelines that will, in essence, seek to establish equivalence of bio-efficacy between the biological drug going off-patent and the upcoming generic. The agency is now focussing on preparing detailed guidelines for four classes of products that are expected to be first off the mark -- recombinant human erythropoietin (EPO), granulocyte-colony stimulating factor (GCSF), human growth hormone (HGH) and insulin.

In the US too, the pieces are beginning to fall into place. Interest in Congress towards establishing regulations for approval of bio-generic as part of a comprehensive reform of the Waxman-Hatch framework appears to be growing. This important piece of legislation almost single-handedly provided the stimulus for growth of the conventional generics industry.

The issue of bio-equivalence has been refuted, ironically by Biogen - one of the biotech leaders in the US - whose drug (Avonex) was permitted for marketing, despite the fact that the clinical trials were conducted with product produced from a similar cell line. Furthermore, the US Pharmacopeia has also offered to set up standards for characterization of bio-generics, providing a highly respected, independent voice in favour of the concept.

With attention increasing on the high costs of drugs, in general, and the extremely high costs of biotech drugs, in particular, the political climate has also shifted toward making these drugs more affordable to the average citizen, by introducing generic competition.

First focus on non-regulated markets
While it is a matter of time before the issue is settled in these two large regulated markets, bio-generic companies, including a couple from India, have focused their attention on non-regulated markets. Teva, the largest generics producer in the world, has set up plants to manufacture HGH, interferon ?-2b and GCSF in Lithuania; while Dragon Pharmaceuticals, headquartered in Vancouver (Canada) has set up a plant in Nanjing (China) to make recombinant EPO. In India, Wockhardt and Biocon have set up plants to make insulin, EPO, HGH and GCSF and are excited about the emerging possibilities.

According to a study published by Datamonitor, a market research firm, companies that are actively marketing bio-generics in less regulated markets may have an advantage over 'wait-and-see' players, when it comes to regulated markets. These companies will have a chance to refine capabilities in manufacturing and also be in a favorable position of having recouped some of their investments, ahead of an entry into Europe or the US.

Fight on hand
Like in the conventional pharmaceuticals industry, innovator companies will not let go without a fight, for the simple reason that the stakes are huge: worldwide sales of biological products reached ~$50-bn in 2004, representing 10-15% of the total pharmaceutical market. Biologics also represent approximately one-quarter of the total industry's pipeline. Moreover, the 'Top-10' biotech companies have a market share of 84%, versus 51% for the 'Top-10' pharma firms - and because many only have one or two key products, they are prepared to fight tooth and nail to protect them. Consequently, many of the patent battles will end up in courts and will prove costly, time-consuming and a deterrent for all, but a handful of generic companies.

The introduction of second-generation products, often more effective and/or safer, as is done in the pharmaceuticals industry, will also thwart market penetration by older bio-generics. The pace of innovation in biotechnology is fast and industry observers cite more rapid product obsolescence than in conventional pharmaceuticals. As an example, they point to the irrelevance of introducing a generic interferon-? into regulated markets today, when a more efficacious (and still under patent), extended-release PEGylated variety is available.

Given the high costs of manufacturing and getting approvals, bio-generics, according to the Kalorama study, will not be priced 60-80% below the cost of the patented product it is challenging (as happens in conventional pharmaceuticals), but will be pegged about 10-20% lower. Whether this will be incentive enough to encourage patients and doctors to make the switch remains to be seen.

The science for evaluating bio-generics seems to be in place. The regulatory clarity, it now seems, will follow, sooner or later. When it does, a handful of producers will be ready to take on the battle at this the next frontier.

---------------------------------------------------------------------- About the author:
Mr. Ravi Raghavan

Mr. Ravi Raghavan is the Editor of "Chemical Weekly", one of the most widely circulated and reputed chemical publications, and Director of the Chemical Weekly Database P. Ltd. He is involved in extensive reporting of activities in the chemical industry and hence has an in-depth understanding of the complexities of this industry. He also heads the team of researchers that provide market assessment and entry-level strategies for companies looking to invest in the Indian chemical industry.

Mr. Ravi has very successfully organized the Chemical Weekly ChemExpo India 2001 and Chemspec India 2005 - two international exhibitions for the fine chemicals industry. He has received his Bachelor of Science (Technology) from Bombay UCDT in India and his M.S. in Polymer Science from Drexel University in Philadelphia, USA.

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