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Wed, Apr. 22, 8:50 AM| 14 Comments
Dec. 19, 2014, 6:35 PM
- The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria."
- Cubist adds the FDA's decision was "supported by positive data from two pivotal Phase 3 clinical trials - one in patients with cUTI and the other in patients with cIAI."
- Cubist, still set to be acquired by Merck (NYSE:MRK) for $9.5B, is up 2% AH.
- Previous: PDUFA date approaches for Zerbaxa
Dec. 8, 2014, 6:11 PM
- The judge handling Cubist's (NASDAQ:CBST) infringement suit against Hospira (NYSE:HSP) over a generic version of Cubist's Cubicin has ruled several of Cubist's patent claims are invalid.
- Commenting on the ruling, Evercore ISI thinks Hospira will be able to launch a generic version of the drug by June 2016 in a "worst-case scenario." Cubist received a favorable ruling regarding its patent claims last year.
- Merck (NYSE:MRK), which announced this morning it's buying Cubist for $9.5B, is down 1.4% AH. Cubist is down 2.1%, and Hospira is up 2.3%.
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
Dec. 8, 2014, 12:45 PM
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Sep. 29, 2014, 6:07 PM
- Following a successful Phase 3 trial, the FDA has approved Relistor for "the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain."
- Salix (NASDAQ:SLXP) will sell Relistor under a license from developer Progenics (NASDAQ:PGNX). Many expected FDA approval to arrive following a favorable July ruling.
- PGNX +3.4% AH.
- Related tickers: (AZN)(CBST +0.9%)(SGYP -3.4%)(NKTR -0.9%)
Jun. 20, 2014, 6:14 PM
- The FDA has approved Cubist's (CBST) Sivextro for "the treatment of adult acute bacterial skin and skin structure infections."
- The company states Sivextro is "one of at least four antibiotics Cubist hopes to deliver" by 2020. A European Commission ruling on the drug is expected in 1H15.
- Shares rose 5.4% in regular trading following news the FDA had granted priority review to an NDA for Cubist's investigational antibiotic ceftolozane/tazobactam"
Jun. 17, 2014, 4:34 PM
- Shares of Endocyte (ECYT) crater after the close in response to its announcement that a Merck (MRK) subsidiary has decided to stop development of the cancer compound vintafolide and return the worldwide rights to Endocyte.
- The company will evaluate its options with the product candidate after it analyzes the results from the Phase 2b clinical trial in patients with non-small cell lung cancer. In March, the firms reported that ventifolide met its primary endpoint of progression-free survival based on interim data. Overall response rates and overall survival trends were positive.
- Vintafolide is an investigational small molecule drug conjugate (SMDC) consisting of folate linked to the vinca alkaloid chemotherapy agent desacetylvinblastine hydrazide. Vintafolide targets the chemo agent to rapidly growing cancer cells that actively take up folate via the folate receptor.
- In May, the companies withdrew their marketing authorization applications from the EMA for vintafolide for the treatment of ovarian cancer due to lack of efficacy.
- Shares are down 25% AH on heavy volume.
May 12, 2014, 9:26 AM
- Certain traders are apparently swinging from trees this morning as they pop shares of Alnylam (ALNY) 8% on modest volume in premarket action in response to its announcement of a significant reduction in HBV surface antigen in preclinical testing on four monkeys with its RNAi therapeutic ALN-HBV product candidate. The product reduced HBsAg as much as 2.3 log10 compared to 0.5 log10 which is the generally accepted minimum reduction indicating immunologic cure. While encouraging, a colossal amount of work and time remains before any such product will reach the market.
- Alnylam purchased the assets from Merck (MRK) in January for $175M ($25M cash + stock). Merck acquired the assets via its acquisition of Sirna Therapeutics in 2006 for $1.1B. Merck's exit at a significant loss is a clear signal that the road to commercialization will be long and arduous.
- Alnylam hopes to file an IND by the end of 2015.
May 2, 2014, 8:23 AM
- The Data Safety Monitoring Board completes its interim futility analysis of the PROCEED Phase 3 clinical trial of the Merck (MRK)/Endocyte (ECYT) cancer drug vintafolide. Since it did not demonstrate efficacy regarding its primary endpoint of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer, the Board recommends stopping the trial.
- The trial was evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive platinum-resistant ovarian cancer. The primary endpoint was PFS as measured by RECIST v1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by the imaging agent etarfolatide.
- The companies are in the process of notifying investigators that the trial will be suspended.
- Trading in ECYT was halted at ~7:56 am EDT this morning pending the news.
- Shares of MRK are down 0.2% premarket on light volume.
Feb. 4, 2014, 2:33 PM
- Novartis (NVS -0.7%) reportedly is drawing interest for its human vaccines unit as talks to swap its animal health business for assets from Merck (MRK +2.6%) slow down.
- While the vaccines unit was initially on the table with animal health as part of the possible trade for MRK’s over-the-counter drugs business, NVS may now sell the vaccines unit separately in a deal that could be valued at ~$1B.
- NVS and MRK are still talking but agreeing on valuation is proving difficult, so NVS has informally talked to Eli Lilly (LLY -0.1%) and Bayer (BAYRY, BAYZF) about the animal health business, according to the report.
Jan. 27, 2014, 12:32 PM
- Merck (MRK +2.8%) powers to new 52-week highs as Morgan Stanley upgrades shares to Overweight from Underweight, saying MRK’s prospects for its new MK-3475 cancer drug have improved and could bring $6B-plus in annual sales by 2020.
- The firm notes MRK’s decision to file for approval for the drug a year earlier than expected while Bristol-Myers Squibb (BMY -2.3%) expressed Friday its uncertainty about the readiness of its Yeroy/PD-1 drug combination as a competitor to MK-3475.
- MRK’s overall performance is improving too, the firm says, as cost cuts, R&D changes and potential for strategic action are boosting the company’s outlook.
Jan. 23, 2014, 4:01 PM| Comment!
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