Some interesting points:
1. Gattex launch is one of the top five best rare disease launches in US
2. ADH patient population is 2000-3000 worldwide. Results from phase 2 study of NPSP795 in ADH are expected in 1stQ 2015
3. Top line results from Phase 3 study in pediatric SBS are expected in 2014
4. Sensipar-backed debt will be paid off in 3dQ 2015.
November 7, 2014 9:58 PM EDT by Editor Ben Weinberg in Exclusively Published, Healthcare
In a research note issued today, H.C. Wainwright analyst Reni Benjamin reiterated a Buy rating on Spectrum Pharma (NASDAQ:SPPI) with a $15 price target, following the company’s release of its third-quarter results.
Benjamin wrote, “A major highlight of the third quarter was Spectrum’s decision to advance SPI-2012, a long-acting granulocyte colony-stimulating factor (GCSF), into Phase 3 clinical trials after achieving positive Phase 2 results. Spectrum currently boasts a portfolio of five marketed oncology products, including: Fusilev, Zevalin, Folotyn, Marqibo, and most recently, Beleodaq. With approximately $148 MM in cash and a diverse pipeline of assets in clinical development, we believe Spectrum represents an undervalued player with significant upside for the long-term investor.”
The analyst continued, “We view the decision to continue SPI-2012 development as great news for the company and investors alike as management targets chipping away at Amgen’s (AMGN; not rated) lucrative $3.5 billion (US sales in 2013) franchise. With relatively high neutropenia US prevalence rates and pegfilgrastim pricing exceeding $11,000 per patient, the potential US market for SPI-2012 exceeds $1 billion. Spectrum hopes to begin Phase 3 registration trials in 2015 after meeting with the FDA to discuss study designs before the end of 2014.”
November 14, 2014 9:10 AM EDT by Editor Jason Cohen in Exclusively Published • Healthcare
Roth Capital analyst Ed Arce reiterated a Buy rating on Xoma (NASDAQ:XOMA) with a $9 price target, which represents a potential upside of 127% from where the stock is currently trading. The report follows the company’s third-quarter results, posting diluted loss of ($0.17) per share, excluding warrant revaluations, versus Roth’s ($0.15) per share estimate, on revenues of $5.1M versus Roth’s $6.0M estimate.
Arce observed, “Last Friday (11/7), XOMA shares slipped 7.5% following disclosure that some exacerbations in the pivotal EYEGUARD-B trial were found to be non-protocol and will not count in the final efficacy analysis. However, newly-occurred per- protocol exacerbations match the number of those removed. The net result is a now thoroughly validated data set and, we believe, positive top-line results are still likely by late January 2015. We recommend accumulation of shares at these levels.”
The analyst added, “Based on our discussions with management, we model a $15M upfront payment for licensing XMet A in 1Q15, a $10M upfront payment for licensing XMet S in 3Q15, and a $10M upfront payment in 4Q15 for signing a gevokizumab commercial partner for Japan.”
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.
1. 3dQ results
2. ASH abstracts publication. New data on Belinostat, Marqibo, Folotyn, Zevalin.
3. CE-Melphalan NDA submission.
First two will happen on November 6 for sure. Third one has a good chance to be delivered on same date too.
Natpara is a replica of human parathyroid hormone (PTH). Lack of PTH causes hypoparathyroidism. Adding back PTH fixes problem and prevents multiple serious complications. Such type of treatment is called hormone-replacement therapy. Many diseases caused by hormone deficiency are treated by hormone-replacement therapy. Hypoparathyroidism is the last condition for which hormone-replacement therapy is not available. NPSP offers it with Natpara. What better treatment can you possibly offer for patients? It is not a drug invented by scientists. It is a molecule that is produced by our body. Think about insulin and diabetes. What can you offer for patient with Type 1 diabetes? Insulin, a hormone replacement therapy. Insulin has multiple side-effects. For example, too much of it causes coma and death but nobody is going to remove insulin from the market. It is the best treatment available. Natpara is the best treatment for hypoparathyroidism and should be approved.
Compare royalty payments from Captisol-enabled drugs charged by Ligand.
Drug Company Royalty rate
CE-Melphalan Spectrum 15-25%
CE-Topiramate IV CURx 6-7.5%
CE-Lamotrigine CURx 4-7%
Kyprolis Amgen 1.5-3%
Wonder why Spectrum agreed to pay that much?
What other drugs and other things? They cancelled all studies with Zevalin. They cancelled Phase 3 study with Folotyn. They finished CE-Melphalan study and enrollment in SPI-2012 trial in the 2ndQ. They have nothing to report about Apaziquone and SPI-1620. My question was not answered.
4420 Liposomal Formulation of Vincristine Allows for Doubling the Dose Compared to Conventional Vincristine: Results of the First Futility Analysis of the OPTIMAL 60 Study of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL)
Results: In this planned futility analysis of the OPTIMAL 60 trial, we investigated the cumulative dose of liposomal (VLIP, Marqibo®) and conventional vincristine (VCR) and the neurotoxic effect of the first 105 patients. Fifty-three patients received VCR and 52 patients VLIP. In comparing the median cumulative dose received for each group. The median cumulative dose of VLIP group (10.09mg/m2) was nearly double the median cumulative dose of VCR group (5.42mg/m2) (p 60 study, the preset goals were met and the study will continue as planned. A total recruitment of 864 patients is necessary to demonstrate whether the double dose of VLIP will translate into a significantly improved outcome in 3-year PFS
1. To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer. Phase2. Sponsor: Spectrum. Completion date: December 2014.
2. Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma. Phase 3. Sponsor: Children's Oncology Group. Completion date: September 2014.
3. Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Phase 2, Sponsor: National Cancer Institute (NCI). Completion date: September 2014.
4. Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma. Phase 2. Sponsor: Spectrum. Completion date: December 2013. Safety data are already published. Waiting for efficacy results.
Interesting article was published in August "Lessons from the Leucovorin Shortages Between 2009 and 2012 in a Medicare Advantage Population: Where Do We Go from Here?"
Among other things it states "In 2014, the FDA has reported that the leucovorin shortage remains ongoing." Data was accessed on July 21, 2014. Didn't Raj mention a few times that Fusilev sales remain stable even without lecovorin shortage?
The results were published in Journal of Urology in 2012. Title:"Phase 2 Study of Adjuvant Intravesical Instillations of Apaziquone for High Risk Nonmuscle Invasive Bladder Cancer"
Decide yourself how exiting the data are:
The study results show that adjuvant intravesical instillations of apaziquone are in general well tolerated and side effects seem comparable to those of other chemotherapeutic drugs used for NMIBC. According to more recent guidelines, our study population was not purely high risk. Instead, it had an intermediate to high risk of recurrence, with corresponding predicted probabilities of recurrence of 24% to 61% at 1 year according to the
EORTC risk tables. We observed recurrences in 34.7% of patients after 12 months and 44.9% after 18 months. The study population also had an intermediate to high risk of progression, with corresponding
predicted probabilities of progression of 1% to 5% at 1 year. Only 1 of 53 patients (1.9%) had progression. The results of this phase 2 study can be considered promising and further study of adjuvant intravesical instillations of apaziquone is warranted.
•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.
May 6-9, 2015 Phoenix, AZ
Thursday, May 7
Non-CME Luncheon Session
Emerging Data for MARQIBO in Young Adult Patients with R/R Ph- ALL
This presentation will serve as a review of the subset data from the pivotal P2 study of MARQIBO specific to the management of R/R young adult acute lymphoblastic leukemia patients commonly treated by pediatric hematologists. Supported by Spectrum Pharmaceuticals, Inc. Seating is limited. Advanced registration is required.
Actually, reading another source about Phase 1 study I found an interesting observation: "In addition, lung cavitation suggesting necrosis at previous tumor sites was noted in responding patients.” Is it a hint?