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Nov. 12, 2015, 12:21 PM
- The U.S. Court of Appeals for the Federal Circuit validates the patent covering Merck's (MRK -0.9%) Cubicin (daptomycin for injection) that expires on June 15, 2016 but invalidates four additional patents that expire in 2019 and 2020. Its ruling affirms a lower court's decision made in December 2014 in a patent litigation suit between Cubist Pharmaceuticals, acquired by Merck in December 2014 and Hospira, acquired by Pfizer (PFE -0.7%) in September 2015.
- Merck is currently considering its options. The decision by the appeals court clears the way for generic competition next year. Cubicin is Merck's fastest growing drug, generating $187M, $293M and $325M in sales in Q1, Q2 and Q3, respectively.
Nov. 6, 2015, 3:38 PM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee votes in favor of approval of Merck's (MRK -0.8%) sugammadex, branded as BRIDION. The reversal agent for muscle relaxants used in surgery was developed by Schering Plough, acquired by Merck in 2009. It is currently cleared for sale in over 75 countries but the FDA rejected the company's NDA twice before. The PDUFA date is December 19.
- Previously: FDA Ad Comm review tomorrow for Merck's sugammadex; third time a charm? (Nov. 5)
Nov. 6, 2015, 11:25 AM
- Although not in Valeant's (VRX +1.5%) class, Eli Lilly (LLY -1.4%) and Merck (MRK -1.3%) disclose in their Q3 10-Qs that they have received inquiries over certain aspects of their drug pricing.
- Lilly's 10-Q (p. 48): "In September 2015, we were advised that the U.S. Attorney's office for the Eastern District of Pennsylvania and the Civil Division of the Western U.S. Department of Justice are conducting an inquiry concerning our treatment of certain distribution service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid drug rebate program. We are voluntarily responding to this request."
- Merck's 10-Q (p. 22): "The Company has received a civil investigative demand from the U.S. Attorney's Office, Eastern District of Pennsylvania which requests information relating to the Company's contracting and pricing of Dulera Inhalation Aerosol with certain pharmacy benefit managers and Medicare Part D plans. The Company is cooperating with the investigation."
Nov. 5, 2015, 4:04 PM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet tomorrow to review Merck's (MRK -0.9%) New Drug Application for sugammadex sodium injection, a reversal agent of the muscle relaxants rocuronium or vecuronium used in surgery.
- This is the third application from Merck unit Organon. It received its first CRL in July 2008 and the second CRL in April of this year. The agency wanted to see more data on potential allergic reactions to the product.
- FDA briefing doc
- Merck briefing doc
- Draft Questions
- Previously: Merck still on the sideline in the U.S. with sugammadex (April 28)
- Previously: Merck surprises some with its plan to seek marketing approval for two drugs despite safety concerns (May 6, 2014)
Nov. 4, 2015, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Nov. 3, 2015, 7:24 AM
- GlaxoSmithKline (NYSE:GSK) and Merck (NYSE:MRK) announce the initiation of a Phase 1 clinical trial assessing Glaxo's investigational GSK3174998 as monotherapy and in combination with Merck's KEYTRUDA (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumors that have progressed after standard treatment. The primary endpoints are adverse events and dose-limiting toxicities. According to clinicaltrials.gov, the estimated study completion date is January 2020.
- GSKJ3174998 is a humanized IgG1 anti-OX40 monoclonal antibody that was discovered via a collaboration with MD Anderson Cancer Center. OX40 is a tumor necrosis factor receptor found on the surface of activated CD4+ and CD8+ T cells. OX40 agonism stimulates the immune system while reducing the immunosuppressive effects of regulatory T cells sometimes found in tumors.
- KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
Nov. 2, 2015, 9:39 AM
- The FDA designates Merck's (MRK +0.3%) KEYTRUDA (pembrolizumab) a Breakthrough Therapy for the treatment of microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC), the third such designation for the PD-1 inhibitor [advanced melanoma and advanced non-small cell lung cancer (NSCLC)].
- Tumors with microsatellite instability have defective DNA mismatch repair (MMR) systems, a process whereby cells recognize and repair genetic mismatches generated during DNA replication. A defective DNA MMR system allows the mismatched mutations to persist. The average tumor has dozens of mutations, but those with DNA MMR deficiency may have thousands, in particular in regions of repetitive DNA called microsatellites, which is a condition called microsatellite instability. Tumors with microsatellite instability are considered DNA MMR-deficient or MSI high. About 20% of Stage 2 CRC cases, 10% of Stage III and 5% of Stage IV are MSI high. MMR-deficiency is present in up to 20% of non-hereditary CRCs and most hereditary CRCs associated with Lynch Syndrome.
- A ongoing Phase 2 study, KEYNOTE-164, is assessing KEYTRUDA in previously treated MSI high CRC patients. A Phase 3, KEYNOTE-177, is planned for the treatment-naive population.
- KEYTRUDA is currently cleared for the treatment of melanoma and PD-L1-expressing NSCLC.
Oct. 27, 2015, 8:27 AM
- Merck (NYSE:MRK) Q3 results ($M): Total Revenues: 10,073 (-4.6%); Pharmaceutical: 8,925 (-2.3%); Animal Health: 825 (-6.8%).
- Net Income: 1,826 (+116.9%); EPS: 0.64 (+106.5%).
- Key Product Sales: Januvia: 1,014 (+8.7%); Zetia: 633 (-4.1%); Gardisil: 625 (+5.9%); Janumet: 562 (+11.3%); Remicade: 442 (-26.8%); Keytruda: 352 (+999%); Cubicin: 325 (+999%).
- 2015 Guidance: Total Revenues: $39.2B - 39.8B from $38.3B - 39.8B; EPS: $1.64 - 1.74 from $1.52 - 1.71; Non-GAAP EPS: $3.55 - 3.60 from $3.45 - 3.55.
Oct. 27, 2015, 6:54 AM
- Merck (NYSE:MRK): Q3 EPS of $0.96 beats by $0.04.
- Revenue of $10.07B (-4.6% Y/Y) in-line.
Oct. 26, 2015, 5:30 PM
- AHGP, AIXG, AKS, AME, AMTD, ARG, ARLP, AVX, AXE, BABA, BAX, BEAV, BMY, BP, BTU, CMCSA, CMI, CNC, CNX, COH, CPLA, CRY, CVLT, CYNO, DD, ERJ, F, FBC, FCH, FDP, FMER, GLW, GPI, GRUB, HCA, HUN, ICLR, IIVI, IMGN, IPGP, IPI, IR, JBLU, LPT, LRN, LXK, MAS, MDC, MDSO, MGLN, MMC, MNI, MRK, MSM, NCI, NVS, ONE, PCAR, PCH, PCRX, PFE, POL, POR, QSR, RAI, RDN, SAVE, SCHN, SEE, SIR, SPG, SPR, ST, SUI, TMUS, TREX, TXT, UPS, UTHR, WAT, WDR, WM, WSO, WYN, YNDX
Oct. 26, 2015, 4:49 PM
- Merck (NYSE:MRK) will report Q3 results tomorrow before the open. Consensus view is EPS of $0.92 (2.2%) on revenues of $10.08B (-4.5%).
Oct. 26, 2015, 10:27 AM
- Top-line results from a randomized, open-label Phase 2/3 clinical trial, KEYNOTE-010, demonstrated that Merck's (MRK -0.5%) KEYTRUDA (pembrolizumab) had a positive effect on delaying the progression of advanced non-small-cell lung cancer (NSCLC) compared to the commonly used chemotherapeutic docetaxel.
- The ~900-subject study assessed two doses of KEYTRUDA, the FDA-approved 2 mg/kg and the investigational 10 mg/kg, every three weeks versus docetaxel. Participants had failed prior systemic therapy for NSCLC and had PD-L1 tumor proportion scores (TPS) of at least 1%. Outcomes were assessed in all PD-L1-positive patients and those who were strongly PD-L1-positive (TPS of at least 50%).
- The top-line analysis showed that treatment with KEYTRUDA was associated with longer overall survival (OS) for both doses and both groups of PD-L1-positive patients, although it is unclear whether the effect was statistically significant. Treatment with both doses of KEYTRUDA showed superior progression-free survival (PFS) compared to docetaxel in patients with TPS of at least 50%. PFS in the KEYTRUDA cohort was numerically better but not statistically superior to docetaxel in the overall PD-L1-positive group (TPS at least 1%). The safety profile was consistent with previously reported studies in advanced NSCLC.
- The FDA cleared KEYTRUDA for the second-line treatment PD-L1-positive advanced NSCLC earlier this month. It was cleared for the treatment melanoma in September 2014.
- Previously: FDA clears Merck's Keytruda for second-line treatment of lung cancer (Oct. 2)
Oct. 23, 2015, 11:38 AM
- Results from a three-part Phase 2a proof-of-concept study assessing Bristol-Myers Squibb's (BMY +1.8%) second-generation HIV maturation inhibitor, BMS-955176, demonstrated encouraging antiviral activity and a favorable safety profile. The data were presented at the 15th European AIDS Conference in Barcelona.
- BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral life cycle when the virus breaks connections between structural proteins, which then undergo changes that produce fully mature infectious virus particles. This late-state disruption, which results in the release of immature HIV-1 particles that are unable to complete their life cycle, is a unique mechanism of action.
- The study results demonstrated BMS-955176's antiviral activity against HIV-1 both as monotherapy and in combination with other antiretrovirals and across patient subtypes (B,C), including those infected with the HIV-1 virus with changes to a key protein (Gag polymorphisms) that enabled it to fend off the effects of a first-generation maturation inhibitor.
- Part A of the randomized trial assessed one of four once-daily doses (5, 10,20, 40 mg) of BMS-955176 as monotherapy or placebo in 40 HIV-1 subtype B patients. 20 additional patients were later randomized to receive 80 mg and 120 mg once daily. All doses showed greater antiviral activity on day 11 than placebo with the 80 and 120 mg doses showing the highest mean knockdown of HIV-1 RNA (~96%).
- Part B assessed BMS-955176 administered with atazanavir (ATV) with or without ritonavir compared to a standard-of-care regimen of atazanavir and ritonavir plus tenofovir disoproxil fumarate/emtricitabine after 28 days of therapy. The median knockdown of HIV-1 RNA of <99% was similar between the 80 mg dose + ATV and the standard-of-care regimen.
- Part C assessed BMS-955176 (40 mg and 120 mg) as monotherapy vs. placebo for 10 days in 19 patients infected with HIV-1 subtype C. On day 11, the median HIV-1 RNA knockdown was highest in the 40 mg arm (~94%).
- The company intends to advance BMS-955176 to Phase 3 development.
- Related tickers: (GILD -1.3%)(MRK +1.3%)(ABBV +4.2%)
Oct. 20, 2015, 7:29 AM
- Oncolytics Biotech (NASDAQ:ONCY) is set to submit its IND to the FDA for clearance to begin a Phase 1b study of Merck's (NYSE:MRK) Keytruda (pembrolizumab) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma.
- The open-label study will enroll adult patients with confirmed advanced or metastatic pancreatic adenocarcinoma who failed or did not tolerate first-line treatment. The primary endpoint is the safety and dose-limiting toxicities of REOLYSIN and chemo (gemcitabine or irinotecan or fluorouracil) in combination with Keytruda. Secondary endpoints include overall response rate, overall survival and progression-free survival. There will be an initial six to nine patient safety run-in followed by the enrollment of up to 15 additional participants.
- CEO Dr. Brad Thompson says, "This is the first study examining the effects of REOLYSIN in combination with a checkpoint inhibitor in human patients. It builds on our previous clinical work in pancreatic cancer as well as findings from multiple clinical and preclinical studies indicating the REOLYSIN can upregulate PD-1 and PD-L1.
- REOLYSIN has been designated an Orphan Drug for the treatment of pancreatic cancer by both the FDA and EMA.
Oct. 16, 2015, 7:55 AM
- Alios BioPharma, a unit of Janssen Pharmaceutical (NYSE:JNJ), initiates a Phase 2a clinical trial assessing the combination of AL-335, odalasvir (ACH-3102) and simeprevir (OLYSIO) in treatment-naive HCV-1 patients. Approximately 60 participants in the randomized, open-label, three-arm study will receive once-daily treatment for four, six or eight weeks. The primary endpoint is safety. Secondary endpoints include pharmacokinetics, the proportion of patients achieving sustained viral response (SVR) at four weeks, six weeks and eight weeks and the effect on the viral resistance profile after treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is February 2016. The estimated study completion date is August 2016.
- AL-335 is a nucleotide-based NS5B polymerase inhibitor. Odalasvir is an NS5A inhibitor and simeprevir is an NS3/4A inhibitor.
- In May Achillion Pharmaceuticals (NASDAQ:ACHN) granted Janssen an exclusive worldwide license to develop and commercialize HCV products and regimens containing one or more of Achillion's HCV assets, including odalasvir (ACH-3102), ACH-3422 and sovaprevir.
- Johnson & Johnson (JNJ) acquired Alios BioPharma in September 2014.
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NYSE:ABBV) (NYSE:BMY)
Oct. 13, 2015, 9:38 AM
- Incyte (NASDAQ:INCY) and Merck (NYSE:MRK) expand their ongoing clinical collaboration with a new Phase 3 trial assessing Incyte's selective IDO1 inhibitor, epacadostat, in combination with anti-PD-1 Keytruda (pembrolizumab), for the first-line treatment of advanced/metastatic melanoma. The co-funded trial should commence in H1 2016.
- Under the terms of their partnership, the companies have agreed not to initiate new pivotal studies of an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist in advanced/metastatic melanoma with a third party for two years. During the period, each company will offer the other the opportunity to collaborate on any new pivotal study involving the two product classes for types of melanoma as well as lines of therapy outside of their current collaboration agreement.
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