The Federal Trade Commission released a report on 10th June 2009 investigating the potential effects of follow-on biologic drug competition. The report concluded that developing a regulatory pathway to allow follow-on biologics would be an efficient way to bring lower-priced drugs to the market; this is not the most surprising conclusion that could be reached. However, the report did find that even with such a pathway, the competitive market between pioneer biologics and follow-on biologics would not be likely to follow the same course as the competitive market between branded and generic small molecule drugs, as fostered by the Hatch-Waxman Act. Follow-on biologics would be unlikely to enter the market for products with annual revenues less than US$250 million, and it would be likely that only two or three generic manufacturers would attempt entry for a given pioneer drug. Furthermore, given the costs involved in producing a follow-on product, drugs would be introduced with discounts no larger than between 10% and 30% of the pioneer’s product price. As a result, the pioneer could still expect to retain between 70% and 90% of market share, a far cry from the situation with traditional drugs, when generic entry can reduce market share by similar percentages as the FTC is estimating will be retained.
In that respect, the report does not seem to contain much bad news for the biologic drug industry. However, the industry’s association, BIO, responded to the report by saying that at first glance it was fundamentally flawed, and demonstrating a lack of understanding of the conditions necessary to drive biomedical innovation. This seems a somewhat surprising response to a report that suggests generic competition would not be as damaging to profits for the biologic industry as it has been for traditional medicines, with few competitors and relatively small price discounts. However, the cause of most concern may well reside in the report’s argument that a 12 to 14 year regulatory exclusivity period, as recommended in one of two bills in Congress attempting to create a regulatory pathway for follow-on biologics, would be too long to promote innovation. This appears to be a sticking point for BIO, which argues that even with the limited generic competition suggested by the report, other studies show that pioneer companies would be unable to recoup their costs without a 12 to 14 year exclusivity period. BIO claims to support the development of a regulatory pathway for follow-on biologics, and with two competing bills currently going through Congress to create a pathway, the question is more and more ‘when’ rather than ‘if’. However, as BIO’s response to this report shows, the biologic industry is determined over what form of pathway it will tolerate. The question will be how well the industry will fare in convincing Congress to agree with it.
Ian Platts - Editor, World Generic Markets
Friday, June 19, 2009
Friday, June 12, 2009
Sandoz acquires Ebewe; Pfizer expands generics agreements
Sandoz’ parent company, Novartis, announced on 20th May 2009 that it was to acquire the specialty generic injectables business of Ebewe Pharma, which would provide Sandoz an opportunity to create a global platform for future growth whilst improving access for patients worldwide to many generic oncology medicines. Under the terms of the deal, Novartis will acquire the business for 925 million euros (US$1.3 billion) in cash; the deal will exclude Ebewe’s separate injectable neurological products business. Sandoz is currently the second largest generic firm in the world, but still some way behind Teva Pharmaceutical Industries in terms of sales. According to Novartis, Ebewe Pharma’s net sales in 2008 were worth 188 million euros (US$267 million), so this acquisition is unlikely to see Sandoz push ahead past Teva. However, this is the firm’s first acquisition in a number of years, which must underline the firm’s belief that Ebewe represents a significant strategic fit.
Ebewe Pharma was founded in Vienna, Austria, in 1934, but relocated its headquarters to Unterach, Austria, in 1945. Between 1956 and 2001, it acted as an affiliate of the BASF Group, and also briefly for Abbott. However, in 2001, the company again became independent. The company specialises in technologies and applications in the fields of specialty pharmaceuticals, neurological products and contract manufacturing. With regard to its specialty products, the firm has focused on the categories of oncology and immunology, and claims to be one of the leading suppliers of parenteral specialty pharmaceuticals. Ebewe has research centres in Austria and the US, and the firm claims that in the area of oncology it offers one of the widest product lines in the industry. Ebewe sells its specialty pharmaceuticals through a network of 20 Ebewe country organisations as well as business partners in over 80 countries. The firm has had nine ANDAs approved in the US recently, between December 2007 and April 2009, with most of them being either CNS drugs or oncology drugs, including paclitaxel and methotrexate sodium.
Separately, but on the same day, Pfizer announced plans to expand its generics portfolio through two agreements with the Indian firm, Aurobindo Pharma and Claris Lifesciences. Pfizer previously entered into agreements with Aurobindo in July 2008 and March 2009, and this latest announcement effectively extends those into new areas. However, the agreement with Claris is new. Under the terms of the agreement, Pfizer has acquired the rights to 15 injectable products covering a number of therapeutic categories, including pain management and anti-infectives. Claris focuses on the production of injectables and claims a presence in over 76 countries. As with Ebewe, Claris has been active in the US generics market in recent years, gaining four ANDA approvals in March and April 2008 for ondansetron, ciprofloxacin and metronidazole. These agreements are an interesting move for Pfizer, which, although has a generics subsidiary in the form of Greenstone, has tended to be more averse to the generics industry than other branded pharmaceutical firms. Pfizer’s keenness to develop its presence in the generics market perhaps reflects difficulties the firm has seen with the branded industry in recent years. Although it has retained its position as the leading branded firm, Pfizer’s sales have been flat for the last few years, with increased generic competition for some of its key products sapping sales.
Ian Platts - Editor, World Generic Markets
Ebewe Pharma was founded in Vienna, Austria, in 1934, but relocated its headquarters to Unterach, Austria, in 1945. Between 1956 and 2001, it acted as an affiliate of the BASF Group, and also briefly for Abbott. However, in 2001, the company again became independent. The company specialises in technologies and applications in the fields of specialty pharmaceuticals, neurological products and contract manufacturing. With regard to its specialty products, the firm has focused on the categories of oncology and immunology, and claims to be one of the leading suppliers of parenteral specialty pharmaceuticals. Ebewe has research centres in Austria and the US, and the firm claims that in the area of oncology it offers one of the widest product lines in the industry. Ebewe sells its specialty pharmaceuticals through a network of 20 Ebewe country organisations as well as business partners in over 80 countries. The firm has had nine ANDAs approved in the US recently, between December 2007 and April 2009, with most of them being either CNS drugs or oncology drugs, including paclitaxel and methotrexate sodium.
Separately, but on the same day, Pfizer announced plans to expand its generics portfolio through two agreements with the Indian firm, Aurobindo Pharma and Claris Lifesciences. Pfizer previously entered into agreements with Aurobindo in July 2008 and March 2009, and this latest announcement effectively extends those into new areas. However, the agreement with Claris is new. Under the terms of the agreement, Pfizer has acquired the rights to 15 injectable products covering a number of therapeutic categories, including pain management and anti-infectives. Claris focuses on the production of injectables and claims a presence in over 76 countries. As with Ebewe, Claris has been active in the US generics market in recent years, gaining four ANDA approvals in March and April 2008 for ondansetron, ciprofloxacin and metronidazole. These agreements are an interesting move for Pfizer, which, although has a generics subsidiary in the form of Greenstone, has tended to be more averse to the generics industry than other branded pharmaceutical firms. Pfizer’s keenness to develop its presence in the generics market perhaps reflects difficulties the firm has seen with the branded industry in recent years. Although it has retained its position as the leading branded firm, Pfizer’s sales have been flat for the last few years, with increased generic competition for some of its key products sapping sales.
Ian Platts - Editor, World Generic Markets
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