Last week was dominated by updates and data presentation at the annual meeting of the American Society of Hematology (ASH). The meeting, which kicked off over the weekend, continued into the first two days of last week. Companies that were in the limelight thanks to encouraging data include Celgene (CELG), Pharmacyclics (PCYC) and Geron.
CELG Gains on Blood Cancer Data: Celgene’s shares inched up 2.15% on data presented by the company at ASH on its cancer treatment, Revlimid. Phase III data showed that continuous treatment with Revlimid + low-dose dexamethasone significantly improved progression free survival compared with the standard therapy – melphalan, prednisone and thalidomide. The study is being conducted in newly diagnosed multiple myeloma patients.
It is highly anticipated that the recently released data will help establish Revlimid as a standard for the continuous treatment of multiple myeloma patients. This would allow Celgene to rake in additional sales from Revlimid, which is already a blockbuster ($2.8 billion sales in the first nine months of 2013).
Others at ASH: There was huge attendance at ASH with several companies providing an update on their pipeline candidates as well as approved products. Pharmacyclics’ Imbruvica, which was approved recently, attracted a lot of interest with the company coming up with 40 clinical, non-clinical and pre-clinical presentations.
Incyte was also there with more than 35 analyses from studies conducted on Jakafi. Incyte also presented encouraging interim data on its oral JAK1 inhibitor, INCB39110.
Meanwhile, Geron presented data on its sole pipeline candidate, imetelstat, at ASH. Results from a Mayo Clinic study showed that 5 out of 22 patients experienced partial or complete remissions. 40.9% of the patients responded to the treatment. The data’s encouraging but the patient population is pretty small. So it remains to be seen whether Geron will move ahead with a larger study.
Infinity Pharmaceuticals presented phase I data on its chronic lymphocytic leukemia (CLL) candidate, IPI-145, which was found to be highly active in patients with relapsed/refractory CLL – nodal response rate was 89% and overall response rate was 48%. IPI-145 is currently in a phase III study and has also shown evidence that it can be active in other types of blood cancer including advanced T-cell lymphomas.
CytRx Jumps on Phase II Data: CytRx (CYTR) shares jumped 68.2% on highly positive top-line efficacy data from a phase IIb study. Results showed that patients with soft tissue sarcomas responded significantly better to treatment with CytRx’s aldoxorubicin compared to treatment with doxorubicin, a standard treatment for soft tissue sarcomas. This bodes well for the company and should increase interest in this candidate.
IMUC Shares Wiped Out: Investors were not impressed with phase II data presented by ImmunoCellular (IMUC) on its dendritic cell-based vaccine, ICT-107. Although ICT-107 achieved a statistically significant improvement in progression-free survival (PFS) in patients with newly diagnosed glioblastoma multiforme (GBM – a common and aggressive brain tumor), statistical significance was not achieved for overall survival (OS). OS remains an important criteria for studies being conducted on cancer drugs – it was not surprising to see IMUC shares decline 59.5% on the news.
Avanir Shares Tumble: Avanir shares lost almost 30% on disappointing data on AVP-923 from a mid-stage study. The company said that AVP-923 failed to meet the primary efficacy endpoint on the study that was conducted to treat central neuropathic pain in multiple sclerosis patients.
| Company | Last Week | Last 6 Months |
| AMGN | -1.72% | 14.84% |
| BIIB | -5.34% | 31.37% |
| GILD | -3.50% | 37.44% |
| CELG | -0.92% | 37.12% |
| REGN | -4.65% | 12.55% |
| ALXN | -1.40% | 32.42% |
| ^BTK | -2.80% | 14.63% |
Other Developments:
Yet Another Tivozanib-Related Setback for AVEO: AVEO’s shares fell 9% with the company saying that tivozanib would most likely not meet the primary endpoint in a phase II study (BATON) being conducted in colorectal cancer patients. This is not the first time that AVEO has received a tivozanib-related setback. Earlier this year, AVEO had discontinued the development of tivozanib for advanced renal cell carcinoma after the FDA refused to approve the candidate for this indication. Currently, expectations regarding the successful development of tivozanib are low.
VIVUS Collaborates with Sanofi for ED Drug: VIVUS (VVUS) has signed up Sanofi for the commercialization of its erectile dysfunction (ED) drug, Stendra, exclusively in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia. The agreement brings in funds for VIVUS in the form of an upfront payment and payments based on the achievement of regulatory and sales milestones and royalties. Moreover, Sanofi will be a strong marketing partner for VIVUS. VIVUS shares were up 6% on the news.
Emergent Up on Cangene Deal: Emergent BioSolutions’ shares were up 5.3% on news that the company will be acquiring Canada-based biotech company, Cangene, for $222 million. The acquisition, which will bring in revenue-generating products, is expected to be accretive in 2014.
Coronado Gains on TSO Data: Shares of Coronado Biosciences were up 20.9% on interim data from a pilot study conducted on oral TSO (Trichuris suis ova or CNDO-201) on autism. The treatment was well-tolerated and showed efficacy in the first 5 patients who completed the study.
The Week So Far:
Positive Data Buoys Agenus: Shares of Agenus were up 12% earlier this week with the company reporting positive phase II results on its brain cancer vaccine.
AcelRx Boosted by Agreement: AcelRx shares jumped 17.9% on an agreement with Grunenthal GmbH for the commercialization of Zalviso (pain treatment) in the EU, additional European countries and Australia. Zalviso is yet to gain regulatory approval.
Another Phase III Success for Cubist: Cubist (CBST) shares were up almost 6% as the company’s experimental antibiotic – ceftolozane/tazobactam came out with flying colors yet again in another phase III study – this time in patients with complicated intra-abdominal infections. So Cubist should now be in a position to file for FDA approval of the antibiotic for complicated urinary tract infections as well as complicated intra-abdominal infections next year.
Another Failure for Targacept: Targacept (TRGT) suffered a setback with its experimental drug, TC-5619, failing to meet the primary endpoint in a phase IIb study. Shares were down 34.3%.
Amgen Scores in Phase III Study: Amgen scored in the phase III MENDEL-2 study evaluating evolocumab in patients with high cholesterol. The market for this candidate, if developed successfully, will be huge. But, other companies like Sanofi and Pfizer also have experimental drugs in development targeting this lucrative market.
Coming Up
Later this week, the FDA is expected to deliver a decision regarding the label expansion of Amarin’s Vascepa for the ANCHOR indication. Currently, expectations for approval are pretty low with the FDA’s advisory panel having voted 9-2 against approval in October. Amarin will most likely have to provide cardiovascular outcomes data so that its cholesterol management drug can be used in a broader patient population.
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