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.
Tue, May 10, 2:24 AM
Mon, May 9, 6:44 AM
- Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY) receives a $38M grant from the Bill & Melinda Gates Foundation to fund the development, license and supply of at least 50M doses per year of Sabin-strain inactivated poliovirus vaccine (sIPV) to more than 70 developing countries.
- The vaccine will be manufactured at Takeda's Hikari, Japan facility. Its sIPV was originally licensed from the Japan Polio Research Institute.
Mon, May 2, 4:00 PM
- Takeda Pharmaceuticals (OTCPK:TKPHF)(OTCPK:TKPYY) and co-developer Lundbeck A/S will change the name of antidepressant Brintellix (vortioxetine) to Trintellix (vortioxetine) beginning in June. The reason for the name change is apparent confusion in the market with AstraZeneca's (AZN +1.1%) anti-clotting drug Brilinta (ticagrelor).
- The FDA approved Brilinta in July 2011 and Brintellix in September 2013.
Fri, Apr. 15, 10:14 AM
- In a regulatory filing, Orexigen Therapeutics (OREX -4.5%) reports that it has terminated the post-marketing study, CONVENE, a cardiovascular outcomes trial (CVOT) recently initiated by former Contrave (naltrexone HCl/bupropion HCl) commercialization partner Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY). The company believes taking over the 8,800-subject trial is too tall a task so a restart under its own IND is the plan. CONVENE was just starting as only 58 patients had been randomized.
- The CVOT study is a requirement stipulated the FDA. Final results are due by January 2022.
- Takeda returned its rights to Contrave to Orexigen last month. Valeant Pharmaceuticals (VRX +0.1%) has the rights in Central and Eastern Europe.
- Now read Orexigen: Contrave Sales Flatten Out At End Of Q1
Fri, Apr. 1, 10:13 AM
- Teva Pharmaceutical Industries (TEVA +0.5%) and Takeda Pharmaceutical Company Limited (OTCPK:TKPHF)(OTCPK:TKPYY) establish a venture in Japan with the aim of marketing off-patent (generic) drugs. The Nagoya-based company, called Teva Takeda Yakuhin Ltd., will be led by industry veteran Hiroshi Matsumori.
- Takeda expects the venture to be both earnings and cash flow accretive this year and thereafter. Teva expects accretion to non-GAAP EPS this year as well.
- Now read Teva: The Future is Generic
Wed, Mar. 30, 1:06 PM
- Johnson & Johnson (JNJ) unit Janssen Research & Development, LLC, announces that its Phase 3 clinical trial, MMY3004 (CASTOR), evaluating the combination of DARZALEX (daratumumab), Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE (bortezomib) and dexamethasone compared to bortezomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma met its primary efficacy endpoint and will be stopped early.
- The interim analysis, performed by the independent Data Monitoring Committee, found that the daratumumab regimen showed a statistically significant improvement in progression-free survival compared to bortezomib and dexamethasone alone (p<0.0001).
- The company intends to submit the results for presentation at a future medical conference and for publication. It will also initiate discussions with regulators regarding marketing applications.
- DARZALEX was approved by the FDA in November 2015 for the treatment multiple myeloma patients who have received at least three prior lines of therapy.
- Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16, 2015)
Tue, Mar. 29, 7:56 AM
- Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) receives a Complete Response Letter (CRL) from the FDA in response to its supplemental New Drug Application (sNDA) seeking clearance for the use of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
- Brintellix, discovered by Lundbeck A/S (OTC:HLUKF)(OTCPK:HLUYY) and co-developed with Takeda, is a serotonin (5-HT) reuptake inhibitor, although its antidepressant mechanism of action is not fully understood. Takeda holds the NDA in the U.S. The FDA approved it in September 2013 for the treatment of adults with MDD.
- The rejection comes despite an 8-2 Ad Comm vote supporting approval. The companies will assess their options after reviewing the contents of the CRL.
- Previously: Ad Comm review positive for Takeda's application for beefed-up label for Brintellix (Feb. 4)
Tue, Mar. 15, 7:28 AM
- Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) U.S. unit returns the rights to obesity pill CONTRAVE (naltrexone HCl/bupropion HCl) to Orexigen Therapeutics (NASDAQ:OREX). The transition back to Orexigen will take place over the next 180 days, during which Takeda will continue to market the product.
- Takeda's decision was based on its intent to focus on inflammatory bowel disease and major depressive disorder. CONTRAVE never gained traction, though. In Q4, it generated only $13M in sales.
- The FDA approved CONTRAVE in September 2014 for use as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in obese adults (body mass index > 30 kg/m2) or overweight adults (BMI at least 27 kg/m2) with at least one obesity-related comorbidity (e.g., hypertension, type 2 diabetes, high cholesterol).
- Previously: Orexigen books $2.6M in Contrave royalties in Q4 (Feb. 4)
Thu, Feb. 4, 11:46 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee convened on February 3 to discuss cognitive dysfunction in major depressive disorder (MDD) and to review Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) supplemental New Drug Application (sNDA) seeking to revise the labeling of MDD drug Brintellix (vortioxetine) to include the effect of the drug on certain aspects of cognitive dysfunction in adults with MDD. The committee voted 8 - 2 in favor of approval.
- The agency's action date (PDUFA) is March 28.
- The data supporting the sNDA was primarily generated in two studies, FOCUS and CONNECT, which demonstrated vortioxetine's superiority compared to placebo in improving cognitive function in MDD patients.
- Brintellix was discovered by Lundbeck A/S (OTC:HLUKF) (OTCPK:HLUYY) and was co-developed with Takeda, who holds the NDA in the U.S.
- Previously: Lundbeck and Takeda file sNDA with FDA seeking approval to add cognitive dysfunction data to Brintellix's label (Aug. 11, 2015)
Thu, Feb. 4, 11:16 AM
- In a regulatory filing, Orexigen Therapeutics (OREX +6.1%) discloses that commercialization partner Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) sold $13M of obesity med Contrave (naltrexone HCl and bupropion HCl extended-release tablets) in Q4. Concurrently, OREX booked $2.6M in Contrave royalties in Q4.
- According to IMS Health, almost 186K Contrave prescriptions were filled in the quarter.
- The companies established their partnership in September 2010 to develop and commercialize Contrave in the U.S., Canada and Mexico. Takeda returned the rights for Canada and Mexico to Orexigen in July 2015.
- Previously: Takeda - Orexigen partnership on the rocks after CV outcomes study halted (May 13, 2015)
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