As a generic version of Sanofi-Aventis' (SNY) blockbuster anticoagulant Lovenox inches closer to reality, investors are placing their bets on Momenta Pharmaceuticals Inc. (MNTA), one of the companies that is seeking approval for a generic Lovenox. In the last three months, shares of Momenta have gained over 35%, in sharp contrast to the S&P 500 Index, which has lost 2%.
Momenta's diversified product pipeline consists of both complex mixture generic and novel drugs. The company's proprietary technology is focused on probing the roles that complex sugars play in fundamental biological processes and the pathways of disease. Sugars, together with DNA and proteins, play a critical role in both normal biological processes and disease.
Momenta filed its Abbreviated New Drug Application for M-Enoxaparin, a generic version of injectable Lovenox in August 2005. The company has collaboration and license agreement with the Sandoz division of Novartis AG (NVS) for the development and commercialization of M-Enoxaparin.
As mentioned earlier, Lovenox, a blood thinner, manufactured by French drug giant Sanofi-Aventis, is a widely-prescribed low molecular weight heparin used for the prevention and treatment of DVT (deep vein thrombosis). The patent on the drug was supposed to run till 2012.
Israeli firm Teva Pharmaceutical Industries Ltd. (TEVA) and privately held Amphastar Pharmaceuticals Inc. were the first to challenge Lovenox patent in 2003 as they sought FDA approval for a generic version of the blood thinner. Though a district court invalidated Sanofi-Aventis' patent for Lovenox in June 2005, a federal appeals court reversed the decision in April 2006.
However, in February 2007, the District Court for the Central District of California ruled against Sanofi-Aventis due to inequitable conduct as the company withheld some information related to the patent in question. Sanofi-Aventis' efforts to seek a reprieve too failed because in April 2009, the U.S. Supreme Court refused to hear the company's appeal to extend the patent protection for Lovenox, thus putting an end to the six-year long patent infringement suit. The FDA has not yet approved a generic Lovenox.
Meanwhile in November 2007, Momenta and Sandoz, which were not parties to the patent infringement suit of Lovenox, were informed by the FDA that the Abbreviated New Drug Application for M-Enoxaparin was not approvable. The regulatory agency raised the concern of immunogenicity of the drug product.
In September 2008, Momenta's partner Sandoz submitted an amendment to the M-Enoxaparin ANDA addressing the FDA's questions concerning the immunogenic potential of M-Enoxaparin.
The FDA also inspected the Chinese facilities that supply heparin to Sandoz for the manufacture of M-Enoxaparin. Momenta and Sandoz obtain heparin from suppliers who in turn source the materials from other countries, including China.
With the patent hurdle removed and substantial progress with the regulatory review of its Abbreviated New Drug Application for generic Lovenox, including the completion of FDA's inspections of heparin manufacturing plants, Momenta Pharma expects a potential decision on its generic Lovenox coming soon.
Lovenox is Sanofi-Aventis' second best-selling product and the drug logged $3.04 billion in sales for the full year of 2009. Momenta Pharma foresees a significant market opportunity for generic Lovenox.
Yet another pending Abbreviated New Drug Application of Momenta is that of M356, a generic version of Teva's multiple sclerosis drug Copaxone. Momenta Pharma has collaboration with Sandoz for the development and commercialization of M356 too.
Momenta's partner Sandoz filed an ANDA for M356 in December 2007 and it was accepted for review by the FDA in July 2008. However, with patents covering Copaxone extending through May 24, 2014, Teva, the manufacturer of Copaxone, sued Momenta and its partner for patent infringement in August 2008. A *Markman hearing for the Copaxone patent suit was held last month and the court's ruling is expected in 60-90 days. (*pretrial hearing)
Momenta also has two other drugs in clinical development:
- M118, an anticoagulant designed for acute coronary syndrome, which has completed a phase IIa trial. The company is seeking a collaborative partner to finance and support further clinical development of M118.
- M402, an anticancer compound in pre clinical development.
The company is also applying its technology to the development of generic or biosimilar glycoprotein drugs. Examples of glycoprotein drugs are erythropoietin, blood clotting factors and interferon beta.
A potential decision by the FDA on M-Enoxaparin, the court's ruling on Copaxone patent suit, a collaborative partnership to advance clinical development of M118 and the advancement of its follow-on-biologics are some of the upcoming catalysts of Momenta.
Shares of Momenta, which have more than doubled in value from their yearly intraday low of $6.94 set last March, closed Tuesday's trading session at $14.63.
The company is scheduled to report its financial results for the fourth quarter and year ended December 31, 2009 on February 11. Stay tuned...
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.