Sanofi Sues to Stop Novartis, Momenta Copies of Blood Thinner Lovenox
Lovenox Sanofi-Aventis SA
JB Reed/Bloomberg
Syringes containing the anti-clot drug Lovenox made by Sanofi-Aventis SA.
Syringes containing the anti-clot drug Lovenox made by Sanofi-Aventis SA. Photographer: JB Reed/Bloomberg
Sanofi-Aventis SA, France’s leading drugmaker, sued the U.S. Food and Drug Administration to make it withdraw clearance of a lower-cost rival to the company’s Lovenox blood thinner.
Sanofi’s lawsuit, filed yesterday in a federal court in Washington, asks a judge to force the FDA to suspend its approval of the generic produced by Novartis AG’s Sandoz unit with Momenta Pharmaceuticals Inc.’s technology. Lovenox, an injection that helps prevent blood clots, was Sanofi’s No. 2 product last year, after the diabetes medicine Lantus.
Novartis, the Basel, Switzerland-based drugmaker, and Momenta, a biotechnology company in Cambridge, Massachusetts, won U.S. approval for a lower-cost copy of Lovenox on July 23, ending a five year wait to challenge the $3.9 billion-a-year product. In the complaint, Sanofi said the generic isn’t “clinically equivalent” to Lovenox, and the FDA’s decision may cause Sanofi “irreparable harm.”
The FDA’s approval “was not made in accordance with the agency’s statutory obligations,” Jean-Marc Podvin, a spokesman for Paris-based Sanofi, said in an e-mailed statement today. Sanofi “believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.”
Momenta fell $3.25, or 13 percent, to $22.86 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares had risen 9.8 percent on July 23 and 4.4 percent yesterday in the wake of the FDA clearance of the generic drug.
Path to Approval
The path for approval of Novartis and Momenta’s generic drug was cleared when Sanofi’s patent was voided last year. In April 2009, the U.S. Supreme Court left intact a lower court ruling that said the patent wasn’t enforceable because Sanofi had misled the U.S. Patent and Trademark Office. The Court rejected Sanofi’s appeal seeking reinstatement of the patent that could have prevented competition until 2012.
A federal judge said yesterday he would hold a hearing on the case on Aug. 17, Momenta said today in a statement. The court didn’t place any restrictions on the sale of the generic drug, according to the statement.
A different federal judge in Washington yesterday threw out a suit Sanofi filed over the FDA’s decision to approve applications for generic forms of its anti-cancer drug Eloxatin. Sanofi has settled with some of the generic-drug companies and has gotten a court order stopping Sun Pharmaceutical Industries Ltd. from selling generics.
The case involving Lovenox is Sanofi-Aventis U.S. LLC v. Food and Drug Administration, 10cv1255, U.S. District Court for the District of Columbia (Washington).
To contact the reporter on this story: Arielle Fridson in New York at afridson@bloomberg.net and Albertina Torsoli at atorsoli@bloomberg.net
Rate this Page