"It sounds like they are going for 1/3 Neulasta dose at comparable efficacy"
Their Phase 2 trial has four arms. One is Neulasta at 6 mg dose which translates into 85 ug/kg and three arms with SPI-2012 at 45 ug/kg, 135 ug/kg and 270 ug/kg doses. Most likely, in phase 3 study Spectrum will use SPI-2012 at a dose which is comparable or even higher than Neulasta dose.
Also the event would be a publication of the results from Phase 2 trial showing that SPI-2012 is better or at least equivalent to Neulasta.
PARIS & COPENHAGEN, Denmark, Aug 28, 2014 (BUSINESS WIRE) -- Regulatory News:
OnxeoSA (ONXEO) (nasdaq omx:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen - ONXEO), an innovative company specialized in the development of drugs for orphan oncology diseases, today announced that the U.S. Patent Office will grant a new patent for Beleodaq® (Belinostat U.S. commercial name) on September 16th 2014.
In addition to the existing patent, covering the chemical structure of Beleodaq®, this new patent also covers the formulation of the product, strengthening and expanding significantly its industrial property protection until October 2027 in the U.S.
“This new patent significantly increases the value of our product”, commented Judith Greciet, CEO of Onxeo. “Indeed, it extends the period of market exclusivity, and it will foster the initiation of other promising indications’ development with our U.S. partner Spectrum Pharmaceuticals”.
"In light of cutting back on several P3 studies i.e. the Zevalin study mentioned at the Q2 CC and Folotyn in Undiagnosed PTCL (new info, I don’t think this has been mentioned yet)"
I was also surprised by termination of Folotyn phase 3 trials since they were required by FDA for acelerated approval. Found an answer in July's 8-K. It states "On July 3, 2014, the Company received further notifications from the FDA regarding the post marketing requirements (“PMRs”) for each of Beleodaq and Folotyn ® . With respect to Folotyn, the two previous Folotyn PMRs for the Phase 3 PTCL trial and the Phase 3 cutaneous Tcell
lymphoma (“CTCL”) trial have been released by FDA. The new PMRs for Beleodaq and Folotyn include a main study that evaluates the comparative efficacy and safety of Folotyn when used in combination with the treatment regimen cyclophosphamide/
vincristine/doxorubicin/prednisone (“CHOP”) or the combination of Beleodaq plus CHOP, versus CHOP alone for the initial therapy of patients with PTCL".
NEW YORK and BOULDER, Colo., July 10, 2013 /PRNewswire/ -- Loxo Oncology, Inc., a biopharmaceutical company recently established and funded by Aisling Capital, and Array BioPharma Inc. (NASDAQ: ARRY) today announced a multi-year license and collaboration agreement for an Array-invented preclinical development candidate and related intellectual property. In addition, Loxo and Array will collaborate to discover and develop small molecule drugs for mutually agreed upon novel oncology targets.
Under the terms of the agreement, Loxo will fund Array's preclinical research, providing access to Array's world-class discovery platform and scientists, and will be responsible for target selection and conducting clinical trials. Array is eligible to receive up to $434 million in milestone payments and to receive royalties on sales of any resulting drugs. In further consideration of the rights granted to Loxo under the agreement, Array also received shares of stock in Loxo.
You aren't serious, are you? Primary endpoint of the trial is duration of severe neutropenia. Following your logic, longer the trial, longer the duration.
Balugrastim is not a biosimilar. It is just "me-too" drug like SPI-2012. Teva has another "me-too" drug called Lipegfilgrastim which is approved in Europe as Lonquex. Sandoz has a true biosimilar for Neulasta which already passed phase 3 stage and is ready for NDA. Do not forget that Amen is also in biosimilar business and will not give up on Neulasta even after 2015. All things considered, SPI-2012 should have clear advantages over Neulasta to compete.
Agree on CE-melphalan filing but why "go/no-go" decision is considered as a catalyst? What if it is "no-go"? And "go" means just start of a expensive phase 3 trials with not guaranteed outcome. Why TEVA withdrew its Blaugrastim BLA from the FDA review process?
Something is wrong then. Information about the trial was updated on Jul 17, 2014. Primary completion date and last follow-up date were not changed.
Agree that Marqibo revenue is low although it was expected. David Sobek from TheStreet predicted $5 million revenue from Marqibo in 2014. It is easily achievable with $2.9 million in the 1st half of the year. He predicts that drug peaks at $40 million in 2020 with a five percent annual decline until 2024. Nothing magic about Marqibo.
First, you need to pay attention to the primary completion date for primary outcome measure which is OS in the trial. It is December 2015. If positive, Spectrum could start to file sNDA. Second, you complained about length of the trial. It was designed and started by Talon, not Spectrum and Spectrum is obliged to run it now. Third, the results of this trial, if positive, will allow to submit MAA and sell Marqibo in Europe for 7 years due to orphan status of the drug there.
One Marqibo Phase 3 trial was started in March 2012 and will be completed in December 2015. It is not ridiculously lengthy. Spectrum needs to run it since it is a confirmatory trial required by FDA. Another Phase 3 trial is conducted by German High-Grade Non-Hodgkin's Lymphoma Study Group. They don't care about interests of Spectrum.
As I understand, the results of their study in elderly patients were published online ahead of print on May 13 in The Lancet. Also in Celgene's PR you can read "In DLBCL, REMARC, the company’s phase III study of lenalidomide maintenance compared with placebo following R-CHOP therapy completed enrollment in the first quarter of 2014"
Clinical Study in the Journal of Clinical Oncology Reports Patients with Diffuse Large B-Cell Lymphoma Receiving Oral REVLIMID with Standard R-CHOP Achieved 98% Overall Response Rate and 80% Complete Response Rate.
With Revlimid, Celgene has two Phase 3 trials in DLBCL and two Phase 3 trials in FL.
You mixed to NPS's drugs together. One of their drugs is GATTEX to treat SBS. It has nothing to do with calcium. Their second drug, Natpara, is a replica of parathyroid hormone (PTH) which regulates calcium metabolism. When parathyroid gland is damaged or removed by surgery, PTH is not secreted and blood calcium level is low. The condition is called hypoparathyroidism. The symptoms of hypoparathyroidism are managed with large doses of oral calcium and vitamin D. Patients need to take 30-50 pills of calcium a day which is quite a bit. Calcium has to go somewhere and patients suffer from kidney stones, leading to end-stage renal disease. They have deposits of calcium in their heart, so they have cardiovascular diseases mainly arrhythmias, calcium deposits in the brains and cataract. Basically, with Natpara, NPS is offering hormone-replacement therapy.
Made some changes:
1. Added last Q revenue numbers for each product
2. Removed information about Zevalin DLBCL trials
3. Changed filing timeframe for CE-Melphalan from 3dQ 2014 to 2ndH 2014
4. Filing NDA for apaziquone is expeced now in 2015, not in 2014