Key Developments For Momenta Pharmaceuticals, Inc.
Momenta Pharmaceuticals, Inc. (MNTA.O) (Consolidated Issue listed on NASDAQ Global Market)
Teva Pharmaceutical Industries Ltd. Wants To Add 3 More Patents To Suit Against Momenta Pharmaceuticals, Inc. and Novartis AG's Sandoz over Copaxone-AP
The Associated Press reported that Teva Pharmaceutical Industries Ltd. said it plans to expand a suit against Momenta Pharmaceuticals Inc. and Novartis AG's Sandoz Inc., which are hoping to market a generic version of Teva's multiple sclerosis drug Copaxone. Teva is now saying the two companies are violating ten patents on Copaxone, up from seven claimed in a lawsuit filed by Teva in fiscal 2008. Teva wants to amend its lawsuit to include the additional patents. Copaxone is under patent protection until 2014, and the three extra patents do not expire until after that, Teva said.
Momenta Pharmaceuticals, Inc. Announces Closing of Offering and Exercise of Over-Allotment Option
Momenta Pharmaceuticals, Inc. announced the closing of its underwritten public offering of 4,600,000 shares of its common stock, which includes the full exercise of the underwriter's over-allotment option of 600,000 shares. After underwriting discounts and commissions and estimated offering expenses, Momenta received net proceeds of approximately $46.7 million. Leerink Swann LLC acted as sole book-running manager for the offering. The shares were sold pursuant to the Company's existing shelf registration statement, base prospectus, and prospectus supplement as filed with the Securities and Exchange Commission.
Momenta Pharmaceuticals, Inc. Prices Underwritten Offering of Common Stock
Momenta Pharmaceuticals, Inc. announced the pricing of an underwritten offering of 4,000,000 shares of its common stock at a price of $10.75 per share. After underwriting discounts and commissions and estimated offering expenses, Momenta expects to receive net proceeds of approximately $40.6 million. All of the shares are being sold by Momenta. In addition, Momenta has granted the underwriter a 30-day option to purchase up to an additional 600,000 shares of the Company's common stock to cover overallotments. The offering is expected to close on September 28, 2009. Leerink Swann LLC is acting as sole book-running manager for the offering.
Momenta Pharmaceuticals, Inc. Announces Top-Line Results From the M118 EMINENCE Trial
Momenta Pharmaceuticals, Inc. announced top-line results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) phase 2 multicenter study of the intravenous formulation of M118. EMINENCE was designed to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable coronary artery disease (CAD) undergoing a percutaneous coronary intervention (PCI). Approximately 500 patients with stable coronary artery disease undergoing elective PCI were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH). The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction, repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group. The incidence of serious and non-serious adverse events was comparable in all treatment groups.
Momenta Pharmaceuticals, Inc. Presents Preclinical Data For Oncology Compound M402
Momenta Pharmaceuticals, Inc. announced results from a preclinical study of its novel oncology drug candidate, M402. The data showed that M402 in combination with chemotherapeutic agents inhibited spontaneous tumor metastasis in a murine metastatic breast carcinoma model. M402 is an HSGAG mimetic engineered from low molecular weight heparin (LMWH) to have potent anti-metastatic properties and low anticoagulant activity. Anti-tumor efficacy was first evaluated in an experimental murine melanoma metastasis model. The data demonstrated that a single dose of M402 administered prior to tumor inoculation significantly reduced tumor colonization in the lung in a dose-dependent manner. Based on these findings, the anti-tumor efficacy of M402 was then assessed for the ability to inhibit spontaneous metastasis in an orthotopic murine metastatic breast carcinoma model. In this model, M402 in combination with cisplatin was shown to significantly inhibit tumor cell metastasis to the lung compared to animals treated with cisplatin alone. Subsequent immunohistological analysis showed a decrease in microvessel density in both primary tumors and lung metastases in the M402 treated group, suggesting that anti-angiogenesis may contribute to the anti-tumor effect of M402.
