Healthy Skepticism Library item: 5949
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Publication type: news
Heuser S.
Small firm figures big in war of drug giants
The Boston Globe 2006 Aug 14
http://www.boston.com/business/globe/articles/2006/08/14/small_firm_figures_big_in_war_of_drug_giants/
Full text:
Small firm figures big in war of drug giants
By Stephen Heuser, Globe Staff | August 14, 2006
The Cambridge biotechnology company Momenta Pharmaceuticals Inc. may still be years away from having a product on the market, but its experimental drug has just triggered a legal battle between two global pharmaceutical giants.
The drug is a copycat version of Lovenox, a blood-thinning injection with annual sales of more than $2 billion. International generic drug maker Sandoz Inc. has a deal to sell Momenta’s version if it is approved and hopes to bring it to market as soon as next year. Sandoz was sued this month by Sanofi-Aventis SA, the French company that owns the rights to Lovenox and wants to keep any cheaper copies off the market as long as possible.
The lawsuit illustrates the high-stakes battles that erupt years before drugs lose their patent protection, as companies fight to protect their profitable name-brand franchises against cheaper generic competition.
It also opens a window on the key role played by small biotechnology companies in the fortunes of big pharmaceutical firms, which are increasingly reliant on biotech drug makers for new ideas to fill their pipelines with future products.
With only 150 employees, no profits, and headquarters in a Kendall Square building it shares with other biotech firms, Momenta is dwarfed by the two multibillion dollar companies fighting over its drug.
But with a unique technology invented at the Massachusetts Institute of Technology, Momenta also offers something that scares some drug makers and excites others: a way to analyze and copy drugs whose underlying makeup is more complicated than that of standard pills.
At the center of the legal fight is Momenta’s version of Lovenox, an injection that prevents dangerous blood clots and heart problems and has become Sanofi’s top-selling product.
Because it is derived from the intestinal lining of pigs, rather than from a traditional chemical mixture, Lovenox is a more complex substance than the prescription pills typically copied by generic drug makers. Using its MIT technology, Momenta created a precise copy of Lovenox and last year asked for Food and Drug Administration approval. The decision is still pending.
Generic drug maker Sandoz, which sees Momenta’s technology as a way to unlock the complexities of numerous difficult-to-copy drugs, signed a deal with Momenta in 2003 to help develop and sell its copy of Lovenox. This summer, the companies expanded their agreement and now plan to develop four generic drugs together.
But as with any generic, Momenta’s compound poses a serious threat to the original drug maker, which relies on the large profit margins on brand-name drugs. Sanofi-Aventis argues that a copy of Lovenox will violate its patents, and on Aug. 4 the company asked a federal court in New Jersey to block Sandoz from selling it.
The suit is not the first over generic Lovenox. Two other companies have already challenged the patent held by Sanofi-Aventis and are fighting a court battle that could overturn it. But many analysts believe that Momenta’s technology gives it a leg up in the difficult job of getting regulators to agree that copycat Lovenox is a safe, working version of the original.
Momenta itself was not named in the recent suit, because the new-drug application for generic Lovenox was officially filed by Sandoz. A spokeswoman for Momenta said the company would not comment on the suit, but called it ``a typical element of the process of seeking approval for generic drugs.”
Jennifer Chao, a biotechnology analyst for Deutsche Bank, said the case could have major implications for Momenta. Its generic Lovenox is by far the company’s drug closest to approval, and she estimates it could reach the market in 2007, if the patent is overturned and regulators sign off on the application. That one drug alone could bring Momenta a half-billion dollars in revenue by 2010, she estimates, but only if its introduction isn’t legally blocked.
According to the suit, a Sandoz executive wrote Sanofi-Aventis in June to notify the company that Sandoz was seeking approval for generic Lovenox and did not consider the Sanofi-Aventis patents enforceable.
In its lawsuit, Sanofi-Aventis says its patents extend until 2012. Sandoz has not yet officially replied, and representatives of Sanofi-Aventis and Sandoz said the companies had no comment on the suit.
Stephen Heuser can be reached at sheuser@globe.com.
© Copyright 2006 Globe Newspaper Company.
