Yesterday, 2:02 PM
- The FDA approves the use of Bristol-Myers Squibb's (BMY +3.7%) Opdivo (nivolumab) for the treatment of patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
- Opdivo is a PD-1 inhibitor, a protein on cells that blocks the ability of the immune system from attacking and killing cancer cells.
- NSCLC is the most common form of lung cancer, affecting almost 90% of lung cancer patients. There are ~225K new diagnoses of lung cancer in the U.S. each year and ~160K deaths.
- Opdivo was previously approved for the treatment of metastatic melanoma.
- This was an extraordinarily quick approval even under Priority Review. The agency accepted the Biologics License Application (BLA) only six days ago on February 27. The PDUFA date was June 22.
- Previously: FDA accepts Bristol-Myers' Opdivo BLA for lung cancer (Feb. 27)
Yesterday, 7:52 AM
- Bristol-Myers Squibb (NYSE:BMY) acquires an option to license and commercialize Kvistgaard, Denmark-based Bavarian Nordic's Prostvac, Bavarian's investigational prostate-specific antigen (PSA)-targeting cancer immunotherapy currently in Phase 3 development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
- Under the terms of the agreement, Bavarian will receive an upfront payment of $60M, an additional $80M if BMY exercises its option based on the results of the Phase 3 trial, incremental payments starting at $50M that could increase to more than $230M if the median overall survival (OS) benefit of Prostvac exceeds the efficacy demonstrated in a Phase 2 study, regulatory milestones of $110M, up to $495M in sales-based milestones and tiered double-digit royalties on net sales. Bavarian will responsible for commercial manufacturing of Prostvac.
- A new Phase 2 trial is in the planning stages to assess the combination of Prostvac with BMY's Yervoy (ipilimumab). The firms have also signed an agreement under which they may conduct one or more exploratory combination studies of Prostvac and agents from BMY's immuno-oncology portfolio.
Tue, Mar. 3, 7:25 AM
- Privately-held Boehringer Ingelheim files applications for marketing approval in the U.S., Europe and Canada for idarucizumab, a rapid reversal agent for its anticoagulant, dabigatran, the active ingredient in Pradaxa, a prescription blood thinner.
- The FDA designated idarucizumab a Breakthrough Therapy in June of last year. The company will pursue accelerated reviews with all three regulators.
- Blood thinner-related tickers: (NYSE:JNJ) (OTCPK:BAYRY) (NYSE:PFE) (NYSE:BMY)
Mon, Mar. 2, 4:36 PM
Mon, Mar. 2, 11:05 AM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) supplemental Biologics License Application (sBLA) seeking approval for the use of Yervoy (ipilimumab) as adjuvant treatment for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection. The PDUFA date is October 28.
- Patients in this category ave a poor prognosis. Once the cancer returns, the survival rates are only 11 - 20%.
- Yervoy is currently cleared for the treatment of adults with metastatic or unresectable melanoma.
- Ipilimumab is a human monoclonal antibody that blocks the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a protein receptor that downregulates the immune system.
Fri, Feb. 27, 1:56 PM
- The FDA accepts under Priority Review Bristol-Myers Squibb's (BMY -0.4%) Biologics License Application (BLA) for the use of Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The PDUFA date is June 22.
- The company stopped the Phase 3 trial early based on the recommendation of the independent Data Monitoring Committee after the study met its primary efficacy endpoint of superior overall survival compared to docetaxel.
- Nivolumab is a human programmed death receptor -1 (PD-1) inhibitor currently currently approved for the treatment of metastatic melanoma.
- Previously: Bristol-Myers stops cancer trial early after Opdivo meets efficacy endpoint (Jan. 11)
Thu, Feb. 26, 4:23 PM
- A Phase 3 trial (ALLY-2) evaluating a once-daily regimen of Bristol-Myers Squibb's (NYSE:BMY) NS5A inhibitor, daclatasvir, in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) in patients co-infected with HCV and HIV achieved a 97% cure rate (n=149/153) as defined by SVR12 (sustained virologic response 12 weeks after completing therapy).
- The study met its primary endpoint, with 96% (n=80/83) of treatment-naive HCV genotype 1 patients achieving SVR12.
- High SVR rates were observed among all patients for 12 weeks regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen or race. The cohort of African-American patients (34% of participants) demonstrated an SVR12 rate of 98% (n=49/50). The cohort of HCV genotypes 2,3 and 4 demonstrated a 100% SVR12 rate (n=26/26).
- ALLY-2 also included an eight-week arm where 38 of 50 patients achieved SVR12, but investigators concluded that additional studies are needed to fully assess the potential of shorter-duration all-oral regimens.
Tue, Feb. 24, 8:14 AM
- Merck (NYSE:MRK) extends a royalty-free license to the Medicines Patent Pool (MPP) for its pediatric formulations of raltegravir (marketed as Isentress in the U.S.) for the treatment of HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP's first agreement that provides access to an HIV integrase inhibitor for use in combination HIV therapy for patients in this age range.
- Raltegravir is the only integrase inhibitor cleared for use in infants and children as young as four weeks in the U.S. and European Union. Pediatric formulations are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).
- There are ~3.2M children infected with HIV worldwide.
- The MPP, founded in 2010, is a United Nations-backed organization that aims to increase access to HIV medicines and technologies to people in developing countries. It has agreements with AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), Roche (OTCQX:RHHBY), NIH and ViiV Healthcare (NYSE:PFE) (NYSE:GSK).
Mon, Feb. 23, 9:21 AM
- Bristol-Myers Squibb (NYSE:BMY) enters into a collaboration agreement with Rigal Pharmaceuticals (NASDAQ:RIGL) to discover, develop and commercialize cancer immunotherapies based on Rigal's small molecule TGF beta receptor kinase inhibitors. The partnership will focus on developing immunotherapeutics as monotherapy or in combination with immune checkpoint inhibitors, including BMY's Opdivo (nivolumab) and Yervoy (ipilimumab).
- Under the terms of the agreement, BMY will have global rights to develop and commercialize small molecule therapeutics derived from Rigal's TGF beta library, including, but not limited to, those approved to treat cancer. Rigal will receive an upfront payment of $30M, potential milestones of more than $309M for a successful compound that is cleared for multiple indications and tiered royalties on net sales.
- Transforming growth factor (TGF) beta is a secreted protein that controls proliferation, differentiation and other functions in most cells. In the immune system, it plays an immunosuppressive role which can significantly dampen anti-tumor immune responses.
- RIGL is up 42% premarket on robust volume.
Mon, Feb. 23, 8:59 AM
- Bristol-Myers Squibb (NYSE:BMY) acquires privately-held San Carlos, CA-based Flexus Biosciences for as much as $1.25B. The transaction includes $800M in cash upfront and development milestones of up to $450M.
- Flexus develops anti-cancer therapeutics based on the modulation of tumor-infiltrating regulatory T cells. Its research programs focus on small molecule inhibitors against novel regulatory T cell targets. Its lead preclinical candidate is F001287, a small molecule IDO1-inhibitor that is planned for Investigational New Drug (IND) filing in H2.
- IDO and TDO are enzymes expressed by many cancer cells which suppress T-cell function by producing kynurenine, a potent immunosuppressive factor. This inhibits the immune system from identifying and destroying certain types of tumors. IDO/TDO inhibitors reduce kynurenine production enabling the immune system to attack cancer cells more effectively.
- The transaction should close this quarter.
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Fri, Feb. 6, 9:20 AM
- According to some observers, Pfizer's (NYSE:PFE) $17B takeout of Hospira (NYSE:HSP) is only a prelude to a bigger deal(s) considering that it was prepared to spend $120B for AstraZeneca (NYSE:AZN).
- According to Gabelli analyst Kevin Kedra, Actavis Plc (NYSE:ACT) is an attractive target, especially since nabbing Allergan (NYSE:AGN) and its fast-growing drug portfolio. A Pfizer takeover would be big enough to overcome the U.S. Treasury's stricter rules on inversions and lower its tax bill.
- John Boris of SunTrust Banks says GlaxoSmithKline (NYSE:GSK), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY) and Mylan (NASDAQ:MYL) may be on the radar as well.
- Pfizer had $33B in cash at the end of September which it will use a portion of plus debt to pay for Hospira.
Thu, Jan. 29, 3:53 PM
- The FDA approves Bristol-Myers Squibb's (BMY -0.3%) Evotaz (atazanavir 300 mg/cobicistat 150 mg) for the treatment, in combination with other retroviral agents, of adult patients with human immunodeficiency virus (HIV-1) infection.
- Atazanavir is sold as a single agent under the brand name Reyataz. Cobicistat is marketed as a single agent under the brand name Tybost by Gilead Sciences (GILD +1.6%).
Tue, Jan. 27, 8:13 AM
- Bristol-Myers Squibb (NYSE:BMY) Q4 results ($M): Total Revenues: 4,258 (-4.1%); Product Sales: 3,240 (-1.8%); Alliance & Other: 1,018 (-10.9%).
- COGS: 966 (-24.1%); R&D Expense: 1,189 (+24.2%); SG&A Expense: 1,364 (+3.2%); Net Income: 13 (-98.2%); EPS: 0.01 (-97.7%); Quick Assets: 7,435 (-10.1%).
- Gross Profit: 3,292 (+3.9%); COGS: 22.7% (-20.9%); Gross Margin: 77.3% (+8.4%); Operating Earnings: 739 (-16.9%); Operating Earnings Yield: 17.4% (-13.3%); Net Earnings Yield: 0.3% (-98.2%).
- Key Product Sales: Baraclude: 341 (-17.2%); Reyataz: 318 (-17.2%); Sustiva Franchise: 407 (-4.7%); Erbitux: 181 (+0.6%); Sprycel: 398 (+9.0%); Yervoy: 366 (+40.8%); Abilify: 476 (-25.0%); Orencia: 443 (+11.6%); Eliquis: 281 (+295.8%).
- 2015 Guidance: Revenues: $14.4B - 15.0B; Gross Margin: ~74%; GAAP EPS: $1.55 - 1.70; non-GAAP EPS: $1.55 - 1.70.
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