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.
Wed, Jun. 8, 4:23 PM
- Nano cap Orexigen Therapeutics (NASDAQ:OREX) was up 52% today on a 6x surge in volume in response to its announcement of a favorable Markman ruling related to the company and Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Contrave patent infringement litigation against Actavis (NYSE:AGN).
- A Markman or claims construction ruling, is a pretrial hearing in which a judge determines the meaning of the disputed patent claims in patent litigation. In this case, Judge Richard Andrews adopted Orexigen's proposed constructions for the majority of the disputed claims, a big win for the company and making it significantly more difficult for Actavis to prevail.
Wed, Jun. 8, 10:27 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) and Theravance Biopharma (TBPH -1.2%) announced that the companies have entered into a global license, development and commercialization agreement for TD-8954, a selective 5-HT4 receptor agonist being investigated for potential use in the treatment of gastrointestinal motility disorders, including enteral (passing through the intestine) feeding intolerance ("EFI").
- Under the terms of the deal, Theravance will receive an upfront cash payment of $15M, milestones and double-digit royalties on global sales by Takeda. The first $110M in milestones are related to the advancement in EFI. The transaction is expected to close this month.
- TD-8954 is being developed for the short-term use with EFI to achieve early nutritional adequacy in critically ill patients at high nutritional risk.
Tue, Jun. 7, 9:59 AM
- Ultragenyx Pharmaceutical (RARE -4.8%) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) form a strategic partnership to develop and commercialize therapies to treat rare genetic diseases.
- Ultragenyx will initially receive an exclusive license to one preclinical candidate from Takeda in a pre-determined area and will have an exclusive option to co-develop and co-commercialize the product candidate in additional therapeutic areas. During the five-year research collaboration, Ultragenyx will have the option to license up to five additional Takeda product candidates.
- Under the terms of the deal, Takeda will invest up to $65M in Ultragenyx in two tranches: the first consisting of a $25M purchase of shares along with a $15M cash premium and the second, an equity investment of $25M with no additional premium. A third equity investment is possible, contingent on Ultragenyx achieving a specific milestone on a second unspecified asset. Additional financial terms are not disclosed.
Fri, May 27, 10:27 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the extension of the current conditional approval of Takeda Pharmaceutical's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT), an approval first granted in October 2012.
- ADCETRIS, an antibody-drug conjugate, was co-developed with Seattle Genetics (SGEN +1.3%) who has commercialization rights in the U.S. and Canada. Takeda has commercialization rights elsewhere.
- A final decision from the European Commission usually takes ~60 days.
Fri, May 27, 8:30 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a negative opinion recommending against approval of Takeda Pharmaceuticals' (OTCPK:TKPHF)(OTCPK:TKPYY) NINLARO (ixazomib) for the treatment of patients with relapsed/refractory multiple myeloma. The company intends to appeal the opinion and request a re-examination of its Marketing Authorization Application (MAA).
- Takeda says the adverse decision will not affect its 2016 financials.
- The FDA approved NINLARO in November 2015.
Fri, May 27, 7:46 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib), in combination with dexamethasone alone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- The data supporting the application was generated in the Phase 3 ENDEAVOR study which showed MM patients treated with Kyprolis + dexamethasone achieved progression-free survival of 18.7 months compared to 9.4 months for those treated with Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone.
- Kyprolis is currently approved in the EU in combination with lenalidomide and dexamethasone for the treatment of MM patients who have received at least one prior line of therapy.
- A final decision from the European Commission usually takes ~60 days.
- Update: On July 4, the company announced that the European Commission approved the new indication.