As I understand, biomarker analysis should allow you to decide whether to prescribe drug for certain disease or not. Beleodaq is for all types of R/R PTCL. AITL cannot be a biomarker for that reason.
There is more about milestone and royalty payments
On May 29, 2013, the Mundipharma Collaboration Agreement was amended and restated (the “Amended Munipharma Collaboration Agreement”), in order to modify the scope of the licensed territory and the respective development obligations. As a result, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and royalty and milestone rates were modified. We may now also receive potential regulatory milestone payments of up to $16.0 million and commercial progress and sales-dependent milestone payments of up to $107.0 million. We will also receive tiered double- digit royalties based on net sales of FOLOTYN within Mundipharma’s licensed territories consistent with the terms of the original Munidpharma Collaboration Agreement.
Is Spectrum involved?
21st SEC- (Oncology) meeting held on 13-01-2015 at CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi – 110 002
M/s. Hetero Drugs Limited has submitted an application for the grant of permission to manufacture and market Pralatrexate Injection 20mg/mL & 40mg/2mL indicated for the treatment of patients with relapsed or refractory peripheral T-cell Lymphoma (PTCL) without local clinical trial.
The firm has submitted that the drug was approved in USA & EMA as an Orphan drug after conduct of Phase II clinical trial to enable early access.
After detailed deliberation, the Committee observed that incidence of PTCL in the Country is very rare and is an Orphan disease. The Committee recommended that local clinical trial waiver may be granted for the said Indication with a condition that a PK study on 12 subjects should be conducted before issuing permission for marketing the drug in the country and a Phase IV post marketing trial should be conducted on 100 patients in the country. The Pk study data should be submitted before the Committee for review.
I can see only three indications: Braf mutant melanoma (LGX-818 and LGX-818 plus MEK-162, which are studied in a single phase 3 trial), Nras mutant melanoma (MEK-162) and ovarian cancer (MEK-162).
Only one phase 3 trial with LGX-818 is listed in ClinicaltrialsDOTgov. It is COLUMBUS trial where LGX-818 alone is used as one of three arms. Other arms are LGX-818 plus MEK 162 and Vemurafenib. Is it possible that this study will result in two NDAs?
Are you sure there is a phase 3 trial where LGX-818 is studied alone?
See company news from Jul 3, 2013.
"Under the terms of the agreement, XOMA will receive an equity position in Symplmed and up to double-digit royalties on sales of the fixed-dose combination ("FDC") containing perindopril arginine and amlodipine besylate, if it is approved by the U.S. Food and Drug Administration ("FDA")."
including Belinostat, Folotyn and Romidepsin. Striking results from combination of Folotyn and Romidepsin in a phase 1 study. Seven out of seven heavily pretreated PTCL patients had responses, three of them had complete responses. Wish it was a combination of Folotyn and Belinostat.
Last year, he participated in Bit's 7th Annual Congress. His presentation title was "A Novel and Highly Potent Long-Acting Granulocyte Colony Stimulating Factor". It is possible that BIT's 8th Congress is the place where he will show data from SPI-2012 phase 2 trial.
From 2015 presentation, slide 13.
On 11-20-14 and 12-29-14, Sucampo repaid two secured loans of ¥1.08B with MUFG Bank and The Mizuho Bank Ltd., approximating a total of $17M. These loan repayments released the total collateralized deposits of $26M.
Interesting 797 program update. Could be a valuable asset in ultra orphan space with short path to the market, no competition.
•Launch ZEVALIN in Hong Kong.
•File Import drug registration for ZEVALIN in China and Taiwan.
•File Import drug registration for MARQIBO in China, Hong Kong, and Taiwan.