Yesterday, 11:53 PM
- An interim analysis of a Phase 3 clinical trial comparing Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib) to Takeda's (OTCPK:TKPHF) (OTCPK:TKPYY) Velcade (bortezomib) in patients with relapsed multiple myeloma (MM) met its primary endpoint of progression-free survival (PFS).
- Patients treated with carfilzomib plus dexamethasone lived twice as long (median PFS: 18.7 months) as those treated with bortezomib plus dexamethasone (median PFS: 9.4 months).
- The carfilzomib cohort also demonstrated superiority over bortezomib in the secondary endpoints of higher overall response rate and lower neuropathy events. Investigators continue to monitor overall survival (OS) data because it is not yet mature.
- Full data will be submitted for presentation at the American Society of Clinical Oncology meeting, May 29 - June 2, in Chicago.
- Velcade is ranked in the top 50 of the best-selling drugs in the world, generating $2.7B in sales in 2013. The FDA approved it in 2003 for progressive MM after previous treatment, in 2005 as a second-line treatment for MM and in 2008 as a first-line treatment of MM.
- The FDA approved Kyprolis in July 2012 for the treatment of patients with MM who have received at least two prior therapies, including bortezomib and an immunomodulatory agent.
Tue, Feb. 10, 7:17 AM
- Based on a pre-planned interim analysis, a 722-subject Phase 3 study assessing Takeda's (OTCPK:TKPHF) (OTCPK:TKPYY) oral proteasome inhibitor, ixazomib, for the treatment of patients with relapsed or refractory multiple myeloma (MM) achieved its primary endpoint of improving progression-free survival. Patients receiving ixazomib plus lenalidomide and dexamethasone lived significantly longer without their disease worsening than those receiving placebo plus lenalidomide and dexamethasone.
- The company plans to use the data in its regulatory applications worldwide.
- Ixazomib is an Orphan Drug for the treatment of MM and systemic light-chain (AL) amyloidosis in both the U.S. and Europe. It is a Breakthrough Therapy in the U.S. for the treatment of relapse/refractory AL amyloidosis.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity in the U.S. and ten-year period of market exclusivity in Europe, if approved.
Dec. 31, 2014, 7:38 AM
- Health Canada accepts Sucampo Pharmaceuticals' (NASDAQ:SCMP) New Drug Submission (NDS) for Amitiza (lubiprostone) 24 mcg capsules for the treatment of adult patients with chronic idiopathic constipation and adults with opioid-induced constipation with chronic non-cancer pain.
- Takeda Pharmaceutical Company (OTCPK:TKPHF) (OTCPK:TKPYY) is the exclusive distributor of Amitiza in all markets except Japan and China. It is currently available in the U.S., Japan, the U.K. and Switzerland.
Dec. 29, 2014, 8:31 AM
- AMAG Pharmaceuticals (NASDAQ:AMAG) and Takeda Pharmaceutical Company Limited (OTCPK:TKPHF) (OTCPK:TKPYY) mutually agree to terminate their license, development and commercialization agreement for ferumoxytol. Under the contract, Takeda had exclusive marketing rights in the European Union, Switzerland and certain other territories under the brand name Rienso. In Canada, the brand name is Feraheme.
- Under the terms of the termination, AMAG will regain all worldwide rights to Faraheme/Rienso. Takeda will make a payment to AMAG related to the termination and provide certain transition services to AMAG for up to 180 days after the marketing authorization transfer in each territory.
- Takeda was commercializing the product for the treatment of iron deficiency anemia in patients with chronic kidney disease.
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%)
Dec. 1, 2014, 10:26 AM
- The FDA designates Takeda Pharmaceutical Company's (OTCPK:TKPHF) (OTCPK:TKPYY) investigational oral proteasome inhibitor, ixazomib, a Breakthrough Therapy for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. It is the first proteasome inhibitor and the first investigational therapy for AL amyloidosis to receive the status.
- Among the benefits of BTD are more intensive FDA guidance, the involvement of senior agency managers and a rolling review of the NDA.
Nov. 11, 2014, 11:22 AM
- Takeda Pharmaceuticals (OTCPK:TKPHF) (OTCPK:TKPYY) and GE Healthcare form a partnership focused on hepatic fibrosis research and development. Under the terms of the alliance agreement, GE will provide diagnostic imaging technology to Takeda for use in generating a liver stiffness map that the latter is developing as part of its research. The objective is to leverage the strengths of the two companies to develop new therapeutics and diagnostic technologies for liver diseases.
- One goal is to develop a way to measure the relative stiffness of liver tissue without having to perform a biopsy. MR elastography, for example, has the potential to be a reliable non-invasive way to do this.
Oct. 28, 2014, 8:26 AM
- U.S. District Judge Rebecca Doherty agreed withe jury that Takeda (OTCPK:TKPHF) (OTCPK:TKPYY) and Eli Lilly (NYSE:LLY) hid the cancer risks of its diabetes drug Actos (pioglitazone), but cut the punitive damages award from $9B to $36.8M, the maximum a jury could award under current U.S. law. The judge denied the firms' request for a new trial.
- Takeda faces more than 8,000 lawsuits in the U.S. accusing it of mishandling Actos.
Oct. 22, 2014, 11:31 AM
- The European Commission approves privately-held Switzerland-based Ferring Pharmaceuticals' Cortiment (budesonide) for the induction of remission in patients with active mild-to-moderate ulcerative colitis. Budesonide is a locally acting glucocorticosteroid.
- Ferring licensed Cortiment from Cosmo Pharmaceuticals SpA for the EU, Asia (ex-Japan), Australia, Canada, Latin America and Africa. The product is sold under the brand name Uceris in the U.S. by Salix Pharmaceuticals (SLXP -0.2%).
- UC-related tickers: (NASDAQ:VBLX) (RCPT)(OTCPK:TKPHF)(OTCPK:TKPYY +0.2%)(ATHX +2.3%)(SHPG +1.3%)(PFE +0.7%)(ABT -0.4%)(ABBV +1.2%)(CNDO +1.1%)(JNJ +1%)(SGYP -3.2%)
Oct. 21, 2014, 10:52 AM
- The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
- Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
- The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
- Diabetes-related tickers: (JNJ +0.4%)(OTCQB:ISLT)(OTCQB:BTHE +20%)(VTAE +2.5%)(NVO +0.5%)(MRK +0.9%)(NASDAQ:VKTX)(HPTX +0.4%)(ABT +1.2%)(OTCPK:TKPHF)(OTCPK:TKPYY -0.5%)(MDT +1.7%)(SNY -0.2%)(OTCQB:SNYNF -0.5%)(MNKD +2.4%)(ALR +1.4%)(TNDM +3%)
Oct. 15, 2014, 10:33 AM
- Orexigen Therapeutics (OREX +6.4%) earns a $70M milestone payment from Takeda Pharmaceuticals (OTCPK:TKPHF -0.8%)(OTCPK:TKPYY -0.7%) triggered by the shipment of Contrave (naltrexone HCI and bupropion HCI extended release) to pharmacy wholesalers in preparation for commercial launch. It earned a $30M milestone triggered by FDA approval on October 7.
- Orexigen expects to end 2014 with ~$190M in quick assets.
Oct. 9, 2014, 1:29 PM
- The FDA approves Takeda Pharmaceutical Compnay's (OTCPK:TKPHF)(OTCPK:TKPYY -1.2%) Velcade (bortezomib) injection for treatment-naive patients with mantle cell lymphoma (MCL). Velcade is the first treatment approved in the U.S. for this indication.
- The product was previously approved for the treatment of multiple myeloma and relapsed mantle cell lymphoma.
- Velcade is co-developed by Milliennium/Takeda and Janssen Pharmaceutical Cos. Millennium is responsible for its commercialization in the U.S. and Janssen ex-U.S.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 3, 2014, 4:34 AM
- From the press release: "Takeda (OTCPK:TKPHF, OTCPK:TKPYY) has previously openly addressed through announcements and press conferences that, regarding the CASE-J study, an investigator-initiated sponsored research (IISR) related to the Takeda's hypertension medicine Blopress (candesartan cilexetil), certain inappropriate promotional activities utilizing the results of this research were found to have occurred." See the PR for its plans for preventing further inappropriate promotion.
- "For related directors, depending on their individual scope of responsibility, a reduction of monthly remuneration within the range of 5% to 20% will be imposed for three months."
Jun. 19, 2014, 9:16 AM
- Citing a failure to demonstrate a statistically significant improvement in overall survival (OS), Takeda Pharmaceutical Company Ltd (TKPYY) terminates its orteronel development program for prostate cancer. The firm's decision is not unexpected considering its disclosure in 2013 that an interim analysis of the results of the Phase 3 ELM-PC5 clinical trial showed that orteronel would be unlikely to meet its primary endpoint of OS compared to placebo.
May. 23, 2014, 2:39 PM
- Takeda Pharmaceuticals (TKPHF, TKPYY) yesterday was found not liable for the bladder cancer of two women who used its Actos diabetes medication, as a Nevada jury agreed with the company that the drug did not cause the women’s disease.
- A jury last month ordered Takeda and partner Eli Lilly (LLY) to pay more than $9B in damages to a plaintiff - Takeda is appealing the verdict - but the company has won the other five cases that have gone to trial over Actos' alleged link to bladder cancer.
- Takeda still faces claims by more than 7,000 plaintiffs.
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