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.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 20, 1:02 PM
- According to Bloomberg, AstraZeneca's (AZN +2.6%) previously stated plan to increase revenue 75% by 2023 is looking a bit wobbly. In cancer, for example, it trails three competitors in immunotherapies for lung cancer. The FDA approved Bristol-Myers Squibb's (BMY +0.2%) Opdivo for the indication on March 4. AZN's candidate, MEDI4736, is still in clinical development with an NDA filing on tap for next year. Being late to the party means modest sales unless there is a profound advantage, something that MEDI4736 may not have unless combined with other drugs.
- If the company's sales growth fails to ramp, its valuation could slump and encourage another takeover bid. AZN currently sports a P/E of 79 versus the industry average of 25 (per msn money).
- Last year, CEO Pascal Soriot fought off a $117B bid from Pfizer (PFE +0.2%) telling investors that the firm could increase revenues to $45B by 2023. The company remains bullish, though. Spokesperson Esra Erkal-Paler says that the firm is making significant progress and that oncology drugs could represent 25% of sales by 2023, up from 12% in 2014. It is currently running clinical studies of AZD9291, a non-immune therapy, in lung cancer patients with a specific mutation who have relapsed after prior treatment. If it can beat rival Clovis Oncology (CLVS -2.4%) to the market, it could be worth as much as $3B per year.
- Mirabaud analyst Nick Turner says that even if all the drugs in the pipeline make it to the market, AZN will have to stretch to reach $45B in 2023 because two of its biggest sellers, Crestor (ttm sales=$5.5B) and Nexium (ttm sales=$3.7B), face declining sales from the loss of patent protection.
Thu, Mar. 12, 3:49 PM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) resubmitted New Drug Application (NDA) for daclatasvir in combination with Gilead's (GILD +0.8%) sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C (HCV) genotype 3. BMY amended the original NDA to include data from the Phase 3 ALLY-3 study which showed high cure rates for the regimen, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naive and 86% of treatment-experienced HCV-3 patients. The FDA will review the submission within a six-month time frame.
- HCV-3 is the second most common HCV genotype after HCV-1, affecting over 54M people worldwide compared to over 83M for HCV-1. HCV-3 is generally more aggressive and carries a higher risk of hepatocellular carcinoma (liver cancer).
- Daclatasvir is an nonstructural protein 5A (NS5A) replication complex inhibitor. The precise mechanism of action is unknown, but it is suspected that it deregulates the relationship between NS5A and intracellular HCV replication sites.
- Related tickers: (ABBV +2.4%)(MRK +0.1%)(ACHN +0.8%)(RGLS -3%)
Wed, Mar. 4, 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)
Wed, Mar. 4, 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.
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