Momenta Pharma's Three-Part Strategy Print E-mail
Thursday, 05 March 2009 18:59

Momenta Pharma (MNTA) is pursuing a three-part business model which includes complex generic equivalents in partnership with the Sandoz division of Novartis (NVS), proprietary compounds, and follow-on- biologics (FOB).  

Momenta is partnered with Sandoz to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company is set to expire on 4/1/09 for Amphastar + partner Watson Pharma (WPI). The other company with a pending ANDA for Lovenox is Teva Pharma (TEVA).


In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA regarding the potential for immunogenicity of their products. Sandoz submitted an amendment on 9/26/08 for the M-Enoxaparin ANDA to address these concerns, but is the Generic Drug Division of the FDA does not issue decision date deadlines.



{relatedquotes}39|40|{/relatedquotes}The issue of heparin suppliers is a major outstanding issue as a result of the global contamination crisis which affected hundreds of patients. The FDA is in the process of inspecting the plants of Chinese heparin suppliers, including facilities that supply the product to Sandoz for the manufacture of M-Enoxaparin. NVS recently reported that the FDA has already inspected two of its four Chinese heparin suppliers and projected the inspections would be completed later this month.





Sandoz has also filed an ANDA for a generic version (M356) of Teva's multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008) on 12/27/07 which was accepted for review by the FDA on 7/11/08. Sandoz is currently involved in litigation with Teva over M356 as a generic equivalent which was filed with a Paragraph IV Certification, which officially informed Teva that the M356 ANDA contains a certification of the patents listed for Copaxone in the FDA's Orange Book are either invalid or not infringed.   


In September 2008, Teva filed a Citizen’s Petition, requesting that the FDA not approve an ANDA or a 505(b)(2) application for a generic version of Copaxone without clinical studies due to the complexity of the drug. M356 cannot be launched until after the 30-month litigation stay expires (Feb. 2011), at which time an at-risk launch could occur if M356 receives FDA approval.



MNTA also has a proprietary anti-coagulant (M-118) in their pipeline, which represents the next-generation version of low molecular weight heparin (LMWH) blood thinners such as Lovenox. M-118 is currently being evaluated in Phase 2a EMINENCE trial versus unfractionated heparin with topline results expected in late 2Q09, which should also lead to a licensing deal if the results are positive.



The final opportunity for MNTA lies in FOB with several key elements to the strategy, including: global scale with partners such as Sandoz, high quality + low cost manufacturing partners, ability to differentiate FOB products from competitors, and achieving bio-equivalent products rather than bio-similar products. MNTA plans to apply their technology platform to characterize highly complex biological agents and reverse engineer the production process to generate equivalent, complex bio-generic products rather than products which are merely similar.



Momenta's revenue for 4Q08 was $2.9M versus $10M in the year-ago period due to lower reimbursable expenses associated with M-Enoxaparin development, which is also reflected in lower R&D expenses of $15.4M versus $19.6M in the comparable period last year. Net loss for 4Q08 was $18.4M and MNTA ended 2008 with $108.5M in cash. Cash burn for 4Q08 was $11M and MNTA guided for cash burn of no more than $55M for 2009, providing about two years worth of cash on hand to fund operations.



The major uncertainty for financial projections this year is the status and timing of the M-Enoxaparin ANDA approval and launch. MNTA is set receive much higher royalties (e.g. 40%-50%) if M-Enoxaparin is the only generic form of Lovenox which is approved, as opposed to much lower royalties (e.g. 10%-15%) if competing ANDAs by Amphastar/Watson and TEVA are approved. Also, Sanofi may choose to launch an authorized generic of Lovenox if one or more of the ANDAs are approved.



MNTA should have an inside track on its ANDA for Lovenox after working closely with the FDA on the tainted heparin crisis and

their proprietary drug candidate M-118 will have Phase 2a results and

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a possible partnership by late 2Q09. Legislation for FOB is not required for the two ANDAs or the proprietary blood thinner M-118, but would serve as an added bonus for MNTA and increase the value of their technology platform and
ability to create equivalent versions of highly complex biological agents.


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