Sat, Apr. 25, 7:30 PM
- A Phase 3 trial, ALLY-1, evaluating a 12-week regimen of the combination Bristol-Myers Squibb's (NYSE:BMY) daclatasvir and Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) plus ribavirin (RBV) for the treatment of HCV patients with advanced cirrhosis (n=60) or post-liver transplant recurrence of HCV (n=53) met its primary efficacy endpoints.
- Cure rates, defined as SVR12, were 83% (n=50/60) for patients with advanced cirrhosis; 94% (n=50/53) for those with post-transplant HCV recurrence; 95% for post-transplant HCV-1s and 82% for HCV-1s with advanced cirrhosis.
- The data were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
Sat, Apr. 25, 5:48 PM
- Preliminary data from a Phase 3 study, RUBY-1, evaluating AbbVie's (NYSE:ABBV) Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir), with or without ribavirin, for 12 or 24 weeks in treatment-naive, non-cirrhotic HCV-1 patients with severe renal impairment (stage 4 or 5), including those on hemodialysis, showed a 100% SVR4 rate (n=10/10) (sustained virologic response four weeks after treatment). Enrollment is 20 patients, but only half had reached week 4 post treatment at the data cutoff.
- The primary endpoint of the trial is the percentage of patients achieving SVR12. Cohort 1 consists of 20 patients without cirrhosis while cohort 2 has 20 patients with or without compensated cirrhosis.
- The data were presented at the 50th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY)
Fri, Apr. 24, 10:27 AM| 32 Comments
Fri, Apr. 24, 10:14 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Bristol-Myers Squibb's (BMY -0.2%) Opdivo (nivolumab) for both treatment-naive and treatment-experienced patients with advanced (unresectable or metastatic) melanoma. The final decision by the European Commission usually takes ~60 days.
- Opdivo is a PD-1 immune checkpoint inhibitor. PD-1 (programmed cell death protein 1), found on the surface of cancer cells, enables them to avoid detection by the immune system. Binding to PD-1 enables T cells to recognize and kill cancer cells.
- Opdivo was cleared in Japan in July 2014 followed by the U.S. in December for the treatment of melanoma. The FDA approved a label expansion last month for lung cancer.
- Previously: European approval of Bristol-Myers' Opdivo remains elusive (March 27)
Fri, Apr. 24, 9:05 AM
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
Tue, Apr. 21, 9:42 AM
- Bristol-Myers Squibb (BMY +1.3%) upgraded to Overweight with $80 (21% upside) by Morgan Stanley.
- Align Technology (ALGN +4.6%) upgraded to Overweight with a $79 (46% upside) price target by Morgan Stanley.
- Biocryst Pharmaceuticals (BCRX +4.5%) upgraded to Neutral with $12 (20% upside) by Bank of America.
- Rosetta Genomics (ROSG -1%) upgraded to Buy with $5.50 (32% upside) price target by Cantor Fitzgerald.
- Phibro Animal Health (PAHC -2.7%) downgraded to Underweight with $35 (3% upside) price target by Morgan Stanley.
- Impax Laboratories (IPXL +0.5%) downgraded to Sell with $36 (28% downside risk) price target by UBS.
Mon, Apr. 20, 8:10 AM
- At the American Association for Cancer Research Annual Meeting in Philadelphia, Merck (NYSE:MRK) presented data from three studies of its PD-1 inhibitor Keytruda (pembrolizumab).
- Early findings from the KEYNOTE-028 study in patients with advanced pleural mesothelioma show an overall response rate of 28% in patients with tumors that expressed PD-L1. The disease control rate was 76% (includes the 48% of patients with stable disease). These were the first data presented from the company's basket trial that is evaluating Keytruda in patients with 20 difficult-to-treat cancers.
- The Phase 3 KEYNOTE-006 study comparing Keytruda to Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) in patients with unresectable advanced melanoma was stopped early after the data showed that Keytruda was statistically superior to ipilimumab in progression-free survival, overall survival and overall response rate. Merck plans to submit a supplemental Biologics License Application (sBLA) to the FDA for the first line line treatment of advanced melanoma by mid-year.
- Data from the Phase 1b KEYNOTE-001 study in patients with naive and previously treated advanced non-small cell lung cancer showed an overall response rate (ORR) of 45.4% in patients with at least 50% of tumor cells positive for PD-L1 expression (n=73), an ORR of 16.5% in patients with 1 - 49% of PD-L1-expressing tumor cells and an ORR of 10.7% in patients with <1% of PD-L1-expressing tumor cells. The company submitted an sBLA in December for this indication, tagged a Breakthrough Therapy by the FDA.
Fri, Apr. 17, 9:38 AM
- Based on an assessment by the independent Data Monitoring Committee, a Phase 3 clinical trial, CheckMate-057, evaluating Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) versus docetaxel was stopped early after the study met its primary efficacy endpoint. Patients with advanced non-squamous non-small cell lung cancer who received Opdivo demonstrated superior overall survival compared to those who received docetaxel. The company intends to share the data with health authorities soon.
- Opdivo is a PD-1 inhibitor approved for certain types of melanoma as well as metastatic non-small cell lung cancer with progression on or after platinum-based chemo.
Thu, Apr. 16, 12:53 PM
- Bristol-Myers Squibb (BMY +0.1%) and Eli Lilly (LLY -0.2%) agree to transfer the North American rights to Erbitux (cetuximab) from BMY to Lilly. The transition, including commercialization and manufacturing responsibilities, should be completed in Q4.
- Erbitux is approved for the treatment of certain head and neck and colorectal cancers. It was developed by ImClone Systems which Lilly acquired for $6.5B in 2008. ImClone and BMY entered into a co-development and co-promotion agreement covering the territory of North America in 2007. It generated $723M in sales for BMY the past four quarters.
Wed, Apr. 8, 10:38 AM
- A Phase 3 trial, called ANNEXA-A, evaluating Portola Pharmaceuticals' (PTLA +2.7%) andexanet alfa as an antidote to the anticoagulant Factor Xa inhibitor Eliquis (apixaban) successfully achieved all primary and secondary endpoints with high statistical significance. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban which was sustained for the duration of the infusion in healthy volunteers. Patients on anticoagulant therapy sometimes need a reversal agent in situations that present a risk of difficult-to-control bleeding, such as surgery or trauma.
- The company plans to submit the data from ANNEXA-A and ANNEXA-R (rivaroxaban) and initial data from a Phase 4 study as part of its Biologics License Application (BLA) to the FDA under an accelerated approval pathway by the end of this year.
- Eliquis is marketed by Bristol-Myers Squibb (BMY +0.7%) and Pfizer (PFE +0.3%). Rivaroxaban is marketed under the brand name Xarelto by Janssen (JNJ -0.1%).
Mon, Apr. 6, 8:12 AM
- Bristol-Myers Squibb (NYSE:BMY) and uniQure N.V. (NASDAQ:QURE) ink an agreement that provides BMY with exclusive access to uniQure's gene therapy technology platform for multiple targets in cardiovascular diseases. The collaboration includes the latter's proprietary gene therapy program for congestive heart failure that is designed to restore the heart's ability to synthesize S100A1, a calcium sensor and master regulator of heart function. The companies may collaborate on as many as 10 targets.
- Bristol-Myers will lead development and regulatory activities across all programs, including paying all R&D costs, and will be responsible for the commercialization of all products while uniQure will lead discovery efforts and will be responsible for manufacturing clinical and commercial supplies using its vector technologies and insect-cell-based manufacturing platform.
- Under the terms of the agreement, BMY will make near-term payments of ~$100M, including an upfront fee of $50M, $15M for the selection of three collaboration targets in addition to S100A1, and a 4.9% equity investment in uniQure at $33.84 per share (~$32M). BMY will acquire an additional 5% of uniQure before the end of 2015 at a 10% premium and will be granted two warrants to acquire up to another 10% of uniQure based on the addition of additional collaboration targets. uniQure will be eligible to receive research, development and regulatory milestones of up to $254M for S100A1 and up to $217M for each other gene therapy product candidate plus sales-based milestones and single-to double-digit royalties. A separate supply contract covers manufacturing by uniQure.
- The partnership will become effective in Q2 contingent on customary closing conditions including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
- QURE is up 42% premarket on average volume.
Wed, Apr. 1, 8:14 AM
- Racing rivals Bristol-Myers Squibb (NYSE:BMY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN) for a leadership position in immuno-oncology, Roche (OTCQX:RHHBY) says that finding combination therapies that attack cancer on different fronts would be "extremely important." CEO Severin Schwan confirms that his organization is ready to collaborate with competitors to develop these new treatments. "Partnering is absolutely fundamental," he says.
- Roche, with its robust internal product development capabilities, has not collaborated with other firms as readily as its rivals, choosing instead to acquire. Its most recent deal was buying a majority stake in Foundation Medicine, for example. Its collaboration with Exelixis (NASDAQ:EXEL) is bearing fruit, though. Last month, the FDA accepted their New Drug Application (NDA) under Priority Review for the combination of cobimetinib and Zelboraf (vemurafenib) for the treatment of advanced melanoma.
- Previously: Roche extends expiration of tender offer for Foundation Med shares (March 2)
- Previously: Roche's melanoma combo NDA gets Priority Review (Feb. 19)
Tue, Mar. 31, 12:37 PM
- Former Nomura analyst Amit Roy says the market for cancer immunotherapies called PD-1 inhibitors will only be ~$10B, far below the $20B - 30B forecasts being circulated today. He cites two main factors that could hamper growth: they only work for certain groups of cancer patients plus several layers of selection will be required for some cancers such as breast and colorectal, and there is a growing evidence that shorter therapy, cutting the treatment period to eight from 16 weeks, may be sufficient. If this comes to fruition, it would shrink the market by almost half (although a price increase could mitigate some of the shrinkage).
- PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer.
- Current FDA-approved PD-1 inhibitors are Bristol-Myers Squibb's (BMY -1.2%) Opdivo (nivolumab) and Merck's (MRK -0.7%) Keytruda (pembrolizumab).
- PD-1-related tickers: (MDVN -2.4%)(FPRX -1.2%)(CELG -3.1%)(OTCQX:RHHBY +0.6%)(AZN -1.7%)(SRNE +3.4%)
Fri, Mar. 27, 11:14 AM
- Despite being on the agenda at this month's meeting of the European Medicines Agency to review new drugs, committee members reached no decision regarding Bristol-Myers Squibb's (BMY +1.2%) Marketing Authorization Application (MAA) for Opdivo (nivolumab) for the treatment of advanced melanoma. Such delays occur when reviewers feel that they need more time to evaluate the drug. The MAA could be considered again as early as next month. The agency accepted the application for review in September 2014.
- The FDA approved Opdivo in December 2014.
- Previously: EMA accepts Opdivo MAA (Sept. 29, 2014)
Tue, Mar. 24, 9:08 AM
- A Phase 3 study (KEYNOTE-006) comparing Merck's (NYSE:MRK) Keytruda (pembrolizumab) to Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) in the first-line treatment of patients with advanced melanoma met its two primary endpoints of statistically significant improvements in progression-free survival (PFS) and overall survival (OS). Based on the recommendation of the independent Data Monitoring Committee, the trial will be stopped early. The results will be presented at the American Association of Cancer Research Annual Meeting in Philadelphia, April 18 - 22.
- The trial randomized 834 patients to receive Keytruda 10 mg/kg every three weeks, Keytruda 10 mg/kg every two weeks or four cycles of Yervoy 3 mg/kg every three weeks. Secondary endpoints were overall response rate, duration of response and safety.
- An earlier Phase 2 comparing the two in advanced melanoma also favored Keytruda. Yervoy is big seller for BMY, generating almost $1B in sales the past four quarters.
- Previously: Merck PD-1 inhibitor extends PFS in melanoma (Nov. 17, 2014)
Tue, Mar. 24, 8:40 AMBristol-Myers Squibb nabs exclusive license for autoimmune diseases discovery research program from Novo Nordisk
- Bristol-Myers Squibb (NYSE:BMY) acquires an exclusive global license to a discovery biologics research program from Novo Nordisk (NYSE:NVO) focused on modulating the innate immune system as a therapy for autoimmune diseases. Terms of the agreement are not disclosed.
- The innate immune system, or nonspecific immune system, is the body's first line of defense against pathogens. Cells of the innate immune system recognize and respond to pathogens in a generic way to provide immediate defense against infection.
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