Takeda Pharmaceutical Co., Ltd. ADROTCPK - Current
Today, 2:23 PM
- Investors are selling the news as they mull what's next after Synergy's (SGYP -6.8%) successful Phase 3 trial for plecanatide. There's another Phase 3 trial, but those results aren't to be released for several weeks.
- Also an issue is who might step up for a buyout given the costs associated with bringing the drug to market.
- Citi's Liav Abraham sees Takeda Pharmaceutical (OTCPK:TKPYY +1.5%) as the most likely buyer in her coverage universe, and the FT today reported the company as willing to spend up to $15B in acquisitions to boost its U.S. presence. Abraham retains her Neutral rating and $4 price target (current price is $5.15).
- Source: TheFly
- Related tickers: Ironwood Pharma (IRWD +2.3%), Sucampo Pharma (SCMP +4.3%)
Mon, Nov. 28, 7:19 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) announces that the European Commission has granted conditional marketing authorization for Orphan Drug-tagged NINLARO (ixazomib) capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. The decision to approve NINLARO follows a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in September.
- The data supporting the approval was generated from the pivotal Phase 3 TOURMALINE-MM1 trial, which demonstrated that NINLARO plus lenalidomide and dexamethasone increased the length of progression-free survival by about 6 months, or 40%, in patients with relapsed and refractory multiple myeloma when compared with placebo, lenalidomide and dexamethasone.
- The study also showed that the progression-free survival benefit observed in the NINLARO regimen extended across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017.
- NINLARO (ixazomib) is an oral proteasome inhibitor which is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain (AL) amyloidosis. NINLARO is FDA approved and was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011.
Tue, Nov. 8, 9:26 AM
- A total of 452 patients have been enrolled in a global Phase 3 clinical trial, ECHELON-2, assessing Seattle Genetics (NASDAQ:SGEN) and Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab vedotin), in combination with chemotherapy, in treatment-naive patients with CD30-positive mature T-cell lymphoma (MTCL).
- Participants will be randomized 1:1 to receive either ADCETRIS plus the chemo regimen CHP (cyclophosphamide, doxorubicin, prednisone) or the chemo regiment CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), the standard-of-care frontline treatment for MTCL. The primary endpoint is progression-free survival. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2017. The estimated study completion date is December 2019.
- ADCETRIS, an antibody-drug conjugate, is being co-developed by the two companies. Seattle Genetics has commercialization rights in the U.S. and Canada and Takeda has commercialization rights elsewhere. It is currently approved in the U.S. for the treatment of certain types of lymphoma.
Tue, Nov. 1, 3:41 PM
- Battered and bruised Valeant Pharmaceuticals (VRX +16.3%) shows some life. Shares are up on increased volume in response to the news that the company is in talks to sell its Salix unit to Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) for $10B.
- Valeant bought Salix last year for $158 per share which valued Salix at $14.5B at the time.
- If the transaction goes through, it will go a long way towards easing Valeant's $30B debt burden.
- Update: In a statement, Valeant confirms that it is in discussions with third parties related to certain divestitures including, but not limited to, Salix.
Fri, Oct. 28, 3:39 AM
Tue, Sep. 27, 7:46 AM
- A Phase 3 study, CLARION, assessing the combination of Amgen's (NASDAQ:AMGN) KYPROLIS (carfilzomib), melphalan and prednisone (KMP) compared to Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE (bortezomib), melphalan and prednisone (VMP) over 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem cell transplant failed to achieve its primary endpoint of a statistically valid increase in progression-free survival (PFS).
- Subjects receiving KMP experienced median PFS of 22.3 months versus 22.1 months for VMP. The data for overall survival is not yet mature but the hazard ratio was 1.21 (there was a 21% higher risk of death or disease progression with KMP).
- The incidence of Grade 3 or higher adverse events were similar between the groups, 74.7% for KMP and 76.2% for VMP. The incidence of treatment-related deaths were 6.5% for KMP and 4.3% for VMP. The incidence of Grade 2 or higher peripheral neuropathy (peripheral nerve damage) was 2.5% for KMP and 35.1% for VMP.
- EVP of R&D Sean Harper, M.D., says, "The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we've seen in the second-line setting. However, the myeloma landscape has changed dramatically since the design of the CLARION study (started in March 2013) with very few newly diagnosed patients treated with melphalan-based regimens, particularly in the U.S. We remain committed to exploring KYPROLIS in combination with other agents to advance the treatment of multiple myeloma."
- The data will be submitted for presentation at a future medical conference and for publication.
- Share are down 1% premarket on light volume.
Wed, Sep. 21, 8:20 AM
- Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY) inks a research collaboration with Nantes, France-based Affilogic to develop central nervous system (CNS)-targeted therapies based on Affilogic's Nanofitins platform. Takeda's objective is the ability to deliver biotherapeutics into the brain (crossing the blood-brain barrier).
- Nanofitins are tiny antibody-mimetics that can be conjugated to antibodies, small molecules and nanoparticles to enhance their action by virtue of their high affinity and specificity for capture, targeting and interaction with biomolecules.
- Under the terms of the agreement, Affilogic will receive an undisclosed upfront payment, research funding, development- and sale-related milestones and royalties on net sales. Takeda will have global rights to commercialize products incorporating the Nanofitins technology.
Fri, Sep. 16, 8:30 AM
- In a turnaround from a negative opinion in May, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) now adopts a positive opinion recommending conditional approval of Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) NINLARO (ixazomib), in combination with lenalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy.
- In a Phase 3 study, TOURMALINE-MM1, the addition of NINLARO to lenalidomide and dexamethasone significantly improved progression-free survival in MM patients compared to placebo plus lenalidomide and dexamethasone.
- The conditional approval requires Takeda to provide post-approval updates on the safety and efficacy analyses for TOURMALINE-MM1 and data from ongoing studies to show the drug's long-term effects.
- NINLARO is a proteosome inhibitor. It works by blocking certain enzymes from multiple myeloma cells which interferes with their ability to grow and survive.
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved NINLARO in November 2015.
- Previously: European Ad Comm rejects Takeda's marketing application for Ninlaro for multiple myeloma (May 27)
Wed, Sep. 7, 10:47 AM
- Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) commences a Phase 3 clinical trial assessing TAK-003's ability to protect people against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the person has been previously exposed to the virus.
- The study, called TIDES, will enroll ~20,000 healthy children between the ages of four and 16 in dengue-endemic countries in Latin America and Asia. It will assess vaccine safety and immunogenicity from two doses of TAK-003 compared to placebo administered 90 days apart.
- TAK-003 is a live-attenuated tetravalent dengue vaccine candidate based on serotype 2, the genetic "backbone" of the four serotypes.
- According to the World Health Organization (WHO), there are more than 360M dengue infections and 20K deaths globally each year.
Tue, Sep. 6, 8:33 AM
- Karyopharm Therapeutics (NASDAQ:KPTI) is down 6% premarket on increased volume in response to its announcement of results from a Phase 2b clinical trial, STORM, assessing lead product candidate selinexor for the treatment of multiple myeloma (MM). The primary endpoint was overall response rate (ORR) over five-to-seven months.
- The single-arm open-label study evaluated selinexor, in combination with low-dose dexamethasone, in heavily pretreated (not responding to other therapies) MM patients. The overall response rate (ORR) in 78 evaluable subjects (median of seven prior treatment regimens) was 20.5% (very good partial responders + partial responders). For comparison, the ORR for Janssen's (NYSE:JNJ) DARZALEX (daratumumab) in these types of patients was 20 - 21% while Sanofi's (NYSE:SNY) isatuximab showed 20%.
- The safety profile was similar to earlier trials. Additional data will be presented later this year.
- The company intends to expand STORM to include an additional 120 patients with penta-refractory (they basically haven't responded to anything) MM. Top-line data from the expanded cohort should be available in early 2018. The company plans to request accelerated approval by the FDA based on the results.
- It also plans to initiate a pivotal 360-subject Phase 3 study, BOSTON, evaluating selinexor, in combination with Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE (bortezomib) and low-dose dexamethasone compared to VELCADE and low-dose dexamethasone alone in MM patients who have had one-to-three prior lines of therapy. The study should commence in early 2017.
- Selinexor is a SINE (Selective Inhibitor of Nuclear Export) compound. It binds to and inhibits the nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression. It is also under development for the treatment of liposarcoma, diffuse large B-cell lymphoma and acute myeloid leukemia.
- Management will host a conference call this morning at 8:30 am ET to discuss the data.
- Previously: Karyopharm up 22%; selinexor data in multiple myeloma expected in September (Aug. 30)
- Update: Slingshot Insights has an expert interview on deck to discuss the Phase 2 data.
Thu, Sep. 1, 3:53 PM
- The Biomedical Advanced Research and Development Authority (BARDA), a subdivision of the U.S. Department of Health and Human Services, selects Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) Vaccine Business Unit to develop a Zika vaccine. Initial funding of $19.8M will cover expenses through Phase 1. The total contract could be worth $312M if BARDA exercises all options to fund the product through Phase 3 and a Biologics License Application (BLA) filing in the U.S.
Tue, Aug. 23, 7:35 AM
- Janssen-Cilag International NV (NYSE:JNJ) submits a Type II variation application to the European Medicines Agency (EMA) seeking approval of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy.
- DARZALEX is currently approved in the EU as monotherapy in adult patients with relapsed/refractory MM whose prior therapy included a proteasome inhibitor (i.e., VELCADE) and an immunomodulatory agent (i.e., REVLIMID) and experienced disease progression on the last therapy.
- In two Phase 3 studies, CASTOR and POLLUX, supporting the application MM patients who had received one or more prior lines of therapy who were treated with one of the combinations experienced greater than a 60% reduction in the risk of disease progression or death (hazard ratio less than 0.40).
Wed, Aug. 17, 4:08 PM
- Janssen Biotech (NYSE:JNJ) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the use of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) Revlimid] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- The FDA granted Breakthrough Therapy status for DARZALEX for this indication last month. Janssen has requested Priority Review of the filing.
- The FDA approved DARZALEX in November 2015 as monotherapy for MM patients who have received at least three prior lines of therapy.
Fri, Jul. 29, 5:43 AM
Wed, Jul. 6, 9:11 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) announces that the European Commission (EC) has extended the current conditional marketing authorization of ADCETRIS (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
- The approval was based on the Phase 3 AETHERA study which demonstrated a 75% improvement in progression-free survival (PFS) for patients treated with ADCETRIS as consolidation therapy immediately following ASCT.
- ADCETRIS, an antibody-drug conjugate, was co-developed with Seattle Genetics (SGEN) who has commercialization rights in the U.S. and Canada. Takeda has commercialization rights elsewhere.
Tue, Jul. 5, 7:06 AM
- Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY) inks an agreement with Belgian biotech TiGenix NV for the exclusive ex-U.S. rights to develop and commercialize the latter's Orphan Drug-tagged Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease.
- Under the terms of the deal, TiGenix will receive an upfront cash payment of €25M, milestones up to €355M and double-digit royalties on net sales. In addition, Takeda will make a €10M equity investment in TiGenix sometime in the next 12 months.
- The first milestone is €15M triggered by securing a Marketing Authorization for Cx601 in the European Economic Area. TiGenix retains the rights to Cx601 for other indications.
- Phase 3-stage Cx601 is a suspension of allogeneic adipose-derived stem cells that are injected directly into the lesions.
- A Phase 3 study should commence in H2 in the U.S. as well.