Feliza Mirasol. Chemical Market Reporter New York:Sep 5-Sep 11, 2005. Vol. 268, Iss. 7, p. 28 (1 pp.)
SANOFI-AVENTIS stands to lose ground to competitors should generic formulations of its blockbuster antithrombosis drug Lovenox (enoxaparin sodium) get final approval from the Food and Drug Administration (FDA). Both Teva Pharmaceutical Industries Ltd. and Amphastar Pharmaceuticals Inc. are currently awaiting the FDA's review of their respective Abbreviated New Drug Applications (ANDAs).
Lovenox leads the market for Low-Molecular-Weight Heparins (LMWH) and achieved euro1.9 billion ($2.3 billion) in sales last year, reflecting year-over-year growth of over 20 percent, according to Sanofi-Aventis. The product ranks at the top of the company's 15 leading marketed drugs. Since its launch in 1987, Lovenox has become the leading LMWH in all major world markets and a leader in terms of market share, says Sanofi-Aventis.
Despite a losing record in recent court battles to uphold patent protection, and despite the December 2004 expiration of Lovenox's major patent, the fight has just begun for Sanofi-Aventis.
In June, a California district court ruled in favor of Amphastar and Teva in a patent suit filed against them. The courts ruling would lift a 30-month stay on FDA approval, which was set at the start of litigation in 2003. But Sanofi-Aventis has stated it will appeal the ruling, if formally entered as the courts final judgement, and "vigorously defend its intellectual property rights covering Lovenox."
Sanofi-Aventis also announced in March that it will file suit in federal court in Canada against Novopharm Ltd., a wholly owned subsidiary of Teva, which has obtained marketing approval in Canada for a generic product claiming to be enoxaparin. Teva has not yet disclosed a timeframe for possible FDA approval or commercial launch in the US.
Even as Sanofi-Aventis battles to preserve its Lovenox position from Teva and Amphastar, yet another challenger has lined up at the mark-Cambridge, Mass.-based biotechnology firm Momenta Pharmaceuticals Inc.
Last week, Momenta filed its own ANDA with the FDA seeking marketing approval for its generic Lovenox version, M-enoxaparin. Momenta is developing M-enoxaparin in collaboration with Sandoz, the generics division of Novartis. The ANDA submission marks a major milestone for Momenta and is the company's first marketing application with the FDA for a product based on its sugar-sequencing technology.
"The technology was developed out of MIT over the last 15 years. It enables the comprehensive analysis and sequencing of complex sugars," says Valerie Threlfall, associate director of strategic product development, Momenta. Threlfall explains that the technology can be applied to enoxaparin, which is a complex mix of sugars, to characterize the compound.
"One of the challenges to developing a generic enoxaparin has been that heparins have been traditionally difficult to fully characterize scientifically. Our technology can be applied towards that," she says.
Momenta is also looking to apply the technology broadly to improve other existing drugs or to develop new products, in addition to applying the technology towards understanding the role that sugars play in disease biology and mechanisms. The company, started up in 2001, has thus far created a diversified pipeline of near-term product opportunities, novel development products and discovery candidates.
Analysts are bullish on Momenta's prospects with M-enoxaparin. As it stands, this candidate may well be the one deemed identical to Lovenox according to FDA specifications. "M-enoxaparin could produce #350 million in profits to Momenta in its third year on the market," says SG Cowen analyst Eric Schmidt.
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Saturday, September 17
Generics to challenge Lovenox
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Alex Hsieh on behalf of Professor Henry Wang
on Sat 17 Sep 2005 11:10 PM EDT
Pfizer Completes Puerto Rico Expansion
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Alex Hsieh on behalf of Professor Henry Wang
on Sat 17 Sep 2005 11:05 PM EDT
Emory Pulmonologists Study Effect Of Ozone Levels On Asthma
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Alex Hsieh on behalf of Professor Henry Wang
on Sat 17 Sep 2005 11:03 PM EDT
Healthorbit.ca
CDERWEEK 9/12 - 16/2005
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Alex Hsieh on behalf of Professor Henry Wang
on Sat 17 Sep 2005 11:01 PM EDT
Opportunity beckons from Japan
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Alex Hsieh on behalf of Professor Henry Wang
on Sat 17 Sep 2005 02:06 PM EDT
Clay Boswell. Chemical Market Reporter New York:Sep 5-Sep 11, 2005. Vol. 268, Iss. 7, p. 20-23 (4 pp.)
The API market in Japan has been famously impenetrable, but the Japanese pharmaceutical industry is now reaching out, bearing the gift of outsourcing-friendly legislation. Clay Boswell reports With the second-largest pharmaceutical market in the world, Japan should be among the contract manufacturing sector's best customers, but the nation's peculiar drug laws and characteristic insularity have minimized the outsourcing of active ingredient manufacture to Western companies. Times are changing, however. An April 1 amendment to Japans Pharmaceutical Affairs Law (PAL) effectively opened the domestic market to qualified overseas manufacturers. Perhaps more importantly, Japanese pharmaceutical firms increasingly see their future in global terms. As a consequence they are not only merging to gain global scale, but also questioning their investment in manufacturing and looking for partners who can help them enter new markets-issues contract manufacturers have been tackling for Western pharmaceutical companies for over a decade. "The new Pharmaceutical Affairs Law will open access to more downstream materials for custom manufacturers that had previously been blocked, and hence has the potential to open up the Japanese market for custom manufacturing," comments Ralf Pfirmann, global business director of Clariant Pharmaceutical Fine Chemicals. "That being said, the more important force driving the change in the way that Japanese pharmaceutical companies operate is their drive toward globalization and to access the pharmaceutical markets of the entire world." Pharma firms are increasing their flexibility Mergers have come frequently of late. In April, Fujisawa and Yamanouchi merged to form Astellas, now the second-largest domestic player after Takeda, which now finds itself pressured to make an acquisition. Sankyo, displaced from the number-two position by the Astellas deal, has in turn moved to merge with Daiichi Pharmaceutical. And Dainippon Pharmaceutical and Sumitomo Pharmaceuticals are scheduled to merge in October. The amendment of the PAL is of a piece with these developments. Like the Food, Drug and Cosmetics Act in the US, the PAL provides a basic structure for the review and approval of drugs before marketing. Enacted in 1948 to ensure drug quality, it was first amended in 1961 to address safety concerns raised by thalidomide. GMPs were incorporated in 1975. The latest changes attempt to harmonize Japans regulations with those of Europe and the US. "It is a kind of globalization of regulation," remarks Akira Miura, director of the health and welfare department of the Japan External Trade Organization (JETRO) New York. "The main goal is the health of the nation," he explains. "To get that result, we have to make the industry more efficient and competitive." Japans solution has been to welcome foreign pharmaceutical companies by instituting regulatory practices more like those practiced in the other major markets-to globalize the domestic market. Japanese pharmaceutical companies have welcomed the transformation, recognizing that the potential for domestic competition would be more than offset by the increased flexibility of their manufacturing operations and the greater ease with which they will be able to enter more lucrative global markets. "The Japanese market is totally different from the US market," Mr. Miura notes. "The Japanese government sets the price of pharmaceutical products, and it is very hard to raise the price." Of the changes introduced to the PAL, two are particularly important to contract manufacturers, says Scott Wheelwright, president and CEO of Strategic Manufacturing Worldwide, a consulting firm focusing on pharmaceutical and biotech manufacturing. First, Japanese pharmaceutical companies are now free to outsource the entire manufacturing operation. Until April, companies that marketed drugs had also to manufacture at least a portion of the active pharmaceutical ingredient (API) and dosage form, so that they generally performed all of those functions themselves. The licensing system has been revised, however, so that manufacturing and marketing can be separated. Second, the rules for submission of Drug Master Files (DMFs) by foreign companies have changed. In the past, manufacturing and controls information accompanied the new drug application (NDA) submitted by the Japanese partner, but now the manufacturer submits that information directly to Japans Ministry of Health, Labor and Welfare, Wheelwright notes. "It allows the manufacturer to maintain some confidentiality about what else they're doing in their plant. There is a definite advantage to the manufacturer of that." Japanese pharmaceutical companies are responding to the new environment by shedding their manufacturing operations, he says. "There's an opportunity now to separate the lower margin manufacturing operations from the rest of the business." In February, for example, Chugai Pharmaceutical, which had already closed two plants in 2003, announced plans to consolidate its five remaining plants into two within the next five to six years. The company is also spinning off its production division as a separate company as of January 2006. Tanabe Seiyaku has likewise disclosed plans to spin off its Onoda plant as a new company, Tanabe Seiyaku Yamaguchi Co. Ltd., as of October 1. "The new production company will be established as a drug manufacturing company that can make its own business decisions quickly," Tanabe said in a statement. "By spinning out production, separating it clearly from R&D, the pricing of APIs will become, of course, more transparent," notes Stefan Peterli, director, marketing and sales Japan, at Siegfried. "What we think will be good for companies like ours is that we're going to have less in-house competition because they are going to give it to other people, be it domestic or overseas. Of course we're going to have more Japanese domestic competition [from the spin-offs], but there's going to be a bunch of opportunities for custom manufacturing, we believe, for intermediates mainly, sometimes for APIs, rarely for dosage forms." Many of these opportunities may not be immediately apparent to Japanese customers, given the constraints they have operated under. "We try to educate them on what we can do-not only what capabilities and capacities we have, but also how we do it and how they can benefit," says Peterli. Siegfried has put together case studies for the purpose. "I believe when we can show this in practical ways to the average Japanese company, they will be more and more convinced." Nick Green, president of Rhodia Pharma Solutions, says penetrating the Japanese market has been part of RPSs strategy for years, but the latest developments create new opportunities. "We believe PAL is causing forward-looking companies to have a more open-minded approach to outsourcing services similar to those provided by Rhodia Pharma Solutions." The company currently has 20 Japanese customers, although they account for less than 10 percent of its worldwide sales. "We expect to increase our market share in the coming years, however, especially in custom manufacturing," Green adds. "In five years' time, we hope our sales in Japan will double. We have seen some increased interest in our custom capabilities, both custom manufacturing and development services. We believe our growth will be driven by increasing our activity with some of our key accounts in the country." There is little incentive for contract manufacturers interested in serving the Japanese market to establish production in Japan itself, given the cost of doing business in the country. But local, native representation is essential, and a kilo lab nearby would be handy. Novasep's Tokyo sales office, for example, has been key, says Laurent Pinchard, director of business development Japan. "You have to have a local presence to really understand the needs of the Japanese customers and be quick to respond to their requests. A specific Japanese marketing action is key here," he says. Dynamic Synthesis, Finorga and Rohner, acquired by Novasep early this year, have operated in Japan for over a decade, and the company already has contracts with 15 companies for nonregistered materials. An emerging asset is Novasep's Shanghai lab, established about a year ago. Staffed by 20, it primarily serves the separations business in Japan and elsewhere in Asia with purification and quick chiral separation trials. "But we'd like to have also some chemical support there, just for reason of quickness and cost-effectiveness," Pinchard adds, noting that Novasep's Shanghai staff can respond to a Japanese customer's doorstep in two hours. The outlook for Western contract manufacturers in this market is uncertain. "Japan is a difficult, sui generis market, and if difficult to penetrate, customers remain very loyal-more than anywhere else in the world," says Guy Villax, chief executive of Hovione. The Portugese company has served the Japanese API market since the 1960s and 1970s, when Japanese export actually comprised the great majority of its production. Japan today accounts for 20 percent of the company's sales. "Unfortunately, the decade-long economic crisis that has engulfed Japan, marked by deflationary pressures, has hurt greatly the Japanese fine chemical sector, and business there is tough," he continues. "Significant competition has made the players very aggressive, and national solidarity has led to any new Japanese outsourcing business staying in Japan. I do not believe that a change in law will dramatically affect this state of affairs." The biotech sector, which in the West relies heavily on the services of contract manufacturers, may offer more hope. Biotech is just getting off the ground in Japan, encouraged by new laws allowing the faculty of national universities to receive funding for work independent of the Ministry of Education, according to Strategic Manufacturing Worldwide's Wheelwright. Prefectural governments are additionally providing incentives to support entrepreneurial businesses. "That definitely creates an opportunity for contract manufacturers," he notes. "There are a few contract manufacturers in Japan that focus on biopharmas. Capital is so hard to come by there that I would be surprised if these entrepreneurial firms didn't also go to contract manufacturers." Villax calls the biotech sector in Japan, which he estimates at 10 percent the size of its US cousin, "poised for significant growth." Biotechs in Japan will probably behave like start-ups in the IT sector, not only in terms of science but also in regard to how they do business, he adds. "We expect to see these companies be far more open, more international, and to be companies that expect their suppliers to be true partners that add value and contribute to setting strategy with their know-how in their different fields of expertise. Here Hovione feels its value proposition is ideally suited to the Japanese biotechs." Novasep's Pinchard sees opportunity in serving as a bridge to global markets, a point echoed by Clariant's Pfirmann. "While accounting for only 15 percent of global pharmaceutical sales, [Japan's] laboratories are responsible for 40 percent of the top 10 blockbuster drugs in the world," he says. "It stands to reason that as this industry looks to expand its ability to commercialize its innovation in the West and other parts of the world, it represents an excellent business opportunity for high-quality, experienced Western suppliers. We feel that with our global footprint, our experience in helping to commercialize drugs in all markets of the world and our flexible, comprehensive service and manufacturing offerings, we are in an excellent position to assist Japanese pharmaceutical companies in efficiently and economically introducing their products everywhere in the world." |
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