Dew - Does MNTA pay a fixed fee/royalty to Eli Lilly for use of GEMZAR with M402? Also - did MNTA have to receive FDA approval to use this combination in its initial stages?
Discovered and developed by scientists at Eli Lilly and Company, GEMZAR® (gemcitabine for injection) received its first FDA-approved indication in 1996. Today, GEMZAR has four indications:
GEMZAR is approved by the FDA in combination with carboplatin (another type of chemotherapy) for the patient with advanced ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.
GEMZAR is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.
GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
GEMZAR is approved by the FDA as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).
At 3/31/12, MNTA’s effective cash balance was $422M; this includes $382.2M of unrestricted cash and marketable securities, $17.5M of restricted cash (in support of the court bond in the Lovenox patent case), and $22M of A/R from Novartis for Lovenox royalties accrued during 1Q12 and paid during 2Q12.
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