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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)
Thu, Feb. 4, 10:06 AM
- Seattle Genetics (SGEN +1.6%) receives a one-time $20M milestone payment from collaboration partner Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY) triggered by Takeda surpassing $200M in ADCETRIS (brentuximab) sales in its territory in 2015. SGEN will recognize the payment as royalty revenue in Q1.
- Under the terms of the companies' ADCETRIS collaboration agreement, SGEN has commercialization rights in the U.S. and Canada and Takeda elsewhere. SGEN is entitled to royalties of mid-teens to mid-twenties on Takeda's net sales in its territory in addition to certain milestones.
- ADCETRIS is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E (MMAE). The linker system it uses is designed to be stable in the bloodstream but releases MMAE when it binds to CD30-expressing cancer cells. It is cleared in the U.S. for the treatment of certain lymphomas.
Wed, Feb. 3, 11:54 AM
- Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) inks a new collaboration deal with privately held Mersana Therapeutics that grants Takeda the rights to Mersana's lead product candidate, XMT-1522, outside of the U.S. and Canada, expands its access to Mersana's Fleximer antibody-drug conjugate (ADC) platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of the programs in the U.S. In addition, the companies will co-develop new payloads for use with ADCs. This is Takeda's third collaboration with Mersana in less than two years.
- XMT-1522, which will be co-developed by the partners, is a Fleximer-based ADC that targets HER2+ tumors in breast, gastric and non-small cell lung cancers. Mersana intends to file its Investigation New Drug (IND) application with the FDA by mid-year. Clinical development can commence after approval.
- Under the terms of the agreement, Mersana will receive an upfront payment of $40M, an additional payment of $20M upon the clearance of the XMT-1522 IND, milestones of ~$750M and royalties on commercial sales. Takeda will also make a $20M equity investment in a future round of Mersana financing.
Wed, Feb. 3, 6:38 AM
Wed, Jan. 27, 12:41 PM
- The FDA approves a delayed-release orally disintegrating tablet formulation of Takeda Pharmaceuticals' (OTCPK:TKPHF)(OTCPK:TKPYY) Dexilant (dexlansoprazole), indicated for the treatment and relief of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) in adult patients.
- The product, branded as Dexilant SoluTab, features tablets that melt in the patient's mouth. The original formulation, which will continue to be sold, is a once-daily delayed-release capsule.
- Dexilant was initially approved by the FDA in January 2009 under the brand name KAPIDEX. The agency approved the name change to Dexilant in March 2010 in order to minimize the confusion with AstraZeneca's prostate med Casodex. There had been reports of dispensing errors despite the different uses of the drugs.
Mon, Jan. 25, 6:50 AM
- Affimed N.V. (NASDAQ:AFMD) and a subsidiary of Merck (NYSE:MRK) establish a clinical trial collaboration whereby Merck will supply KEYTRUDA (pembrolizumab) to Affimed in a Phase 1b clinical trial assessing the combination of the PD-1 inhibitor and Affimed's lead product candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) and Seattle Genetics' (NASDAQ:SGEN) ADCETRIS (brentuximab vedotin). The objective of the study, to be conducted by Affimed and expected to commence in H1, is to establish a dosing regimen of the combo as well as its safety and efficacy.
- In preclinical patient derived xenograft models, the combination eradicated up to 90% of tumors. The collaboration may expand to include a Phase 3 trial if the Phase 1b is successful.
- AFM13 is a bispecific antibody that binds to a protein expressed in a range of T-cell and B-cell lymphomas called CD30 and to a protein expressed on the immune system's natural killer cells called CD16A, both of which play key roles in the activation of the immune system to detect and kill cancer cells.
- Shares are up 13% premarket on average volume.
Fri, Jan. 22, 7:43 AM
- The European Commission approves a labeling update to Takeda Pharmaceutical's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab vedotin) to included data on the retreatment of adult patients with relapsed/refractory Hodgkin lymphoma or relapsed/refractory systemic anaplastic large cell lymphoma who previously responded to ADCETRIS but later relapsed.
- ADCETRIS was conditionally approved in the EU in 2012 for the treatment of relapsed/refractory CD30+ Hodgkin lymphoma following autologous stem cell transplantation (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and for relapsed/refractory systemic anaplastic large cell lymphoma.
- The updated labeling includes data from the Phase 2 SGN35-006 study that showed retreatment with ADCETRIS produced effective anti-tumor responses in the majority of relapsed/refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma patients.
- ADCETRIS is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E (MMAE). The linker system it uses is designed to be stable in the bloodstream but releases MMAE when it binds to CD30-expressing cancer cells.
- ADCETRIS was co-developed with Seattle Genetics (NASDAQ:SGEN) under a December 2009 collaboration agreement. SGEN has commercialization rights in the U.S. and Canada and Takeda has rights elsewhere.
Wed, Jan. 20, 8:41 AM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is up 20% premarket on increased volume in response to its announcement that it has completed its end-of-Phase 2 discussions with the FDA related to its gout candidate, arhalofenate, clarifying the design of the Phase 3 program.
- Late-stage development will consist of two Phase 3 studies of arhalofenate, in combination with febuxostat [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) ULORIC], in patients with chronic gout and a third Phase 3 in patients with more advanced disease called tophaceous gout. Total enrollment will be ~1,300. Each study will have a treatment period of at least 12 months. The co-primary endpoints will be responder rates and flare rates. The trials should commence later this year.
- Gout is a type of arthritis caused by too much uric acid in the blood. Arhalofenate lowers serum uric acid by blocking the reabsorption of uric acid in the proximal tubes of the kidney by inhibiting the renal uric acid transporter, URAT1.
- Previously: CymaBay gout drug successful in Phase 2b study (Feb. 24, 2015)
Tue, Jan. 12, 6:20 AM
- Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) and Vancouver, BC-based enGene enter into a strategic alliance to discover, develop and commercialize novel therapeutics for specialty gastrointestinal (GI) diseases using enGene's "Gene Pill" gene delivery platform.
- Under the terms of the agreement, enGene will develop up to two undisclosed targets selected by Takeda through preclinical proof of concept and IND enabling studies. Takeda will then have the option to exclusively license the global rights to the product candidates. If Takeda exercises its option, it will be responsible for all clinical development and commercialization. EnGene will be eligible for various milestones and tiered royalties on net sales. Specific financial details are undisclosed.
- Takeda will also collaborate with enGene in developing Gene Pill into a platform for the oral delivery of antibodies. It has the exclusive option to the right of first negotiation for up to three antibody targets.
Dec. 28, 2015, 7:05 AM
- The joint venture in Japan between Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY), originally announced in November, should commence sometime around April. Teva will own 51% via Teva Takeda Pharma while Takeda will own 49% via Teva Takeda Yakuhin, both established by an absorption-type company split.
- Takeda will transfer products representing 7% of its revenue to the venture, including BLOPRESS, TAKEPRON and BASEN. As a result, Takeda's 2016 revenue will decrease by ~50B yen.
- The deal will be both EPS and cash flow accretive for Takeda in 2016 and thereafter and will be accretive to Teva's non-GAAP EPS this year and beyond.
- Previously: Teva and Takeda form JV in Japan to drive generics business (Nov. 30)
Dec. 16, 2015, 4:36 AM
- AstraZeneca (NYSE:AZN) has agreed to buy Takeda Pharmaceutical's (OTCPK:TKPYY) respiratory business for $575M, including expanded rights to roflumilast (Daliresp), a treatment for chronic obstructive pulmonary disease.
- Annual global sales of the three core medicines acquired, excluding sales of Daliresp in the U.S., were $198M for the period ending in March 2015.
- AZN +0.4% premarket
Dec. 5, 2015, 6:57 PM
- Amgen (NASDAQ:AMGN) submits a Variation to the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking clearance for the use of Kyprolis (carfilzomib), in combination with the corticosteroid dexamethasone, in adult multiple myeloma (MM) patients who have received at least one prior therapy.
- The data supporting the application was generated in the Phase 3 ENDEAVOR study that showed patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to patients who received Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone (18.7 months versus 9.4 months, respectively)(p<0.0001).
- The most common treatment-related adverse events (>25%) were diarrhea, anemia, fatigue, dyspnea (difficulty breathing), pyrexia (high temperature) and insomnia.
- Kyprolis is currently approved in Europe for the treatment of MM, in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone, in patients who have relapsed after receiving at least one prior line of therapy.
- Previously: Amgen's Kyprolis cleared in Europe for combo treatment of multiple myeloma (Nov. 19)
Dec. 1, 2015, 8:14 AM
- Revive Therapeutics (OTCQB:RVVTF) lead product candidate, Bucillamine (REV-002), performs as well as Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Colcrys (colchicine) in a Phase 2a proof-of-concept study for the treatment of acute gout flares.
- The objective of the trial was to assess the safety, tolerability and efficacy of two dosing regimens of oral Bucillamine over seven days of treatment compared to Colcrys. The primary endpoint was the proportion of patients who experienced at least a 50% reduction in target joint pain score from baseline at 72 hours post-dose without using a rescue drug. Subjects were randomized to receive either 900 mg (nine 100 mg tablets)(Arm A) or 1800 mg (18 100 mg tablets)(Arm B) of Bucillamine or 1.8 mg (three 0.6 mg tablets)(Arm C) of Colcrys over a seven-day period.
- In Arm A, 55% of subjects (n=12/22) achieved the primary endpoint. In Arm B, 46% (n=11/24) and in Arm C, 46% (n=13/28). There was a substantial difference in the duration of dosing however. Patients in Arm A received 9 tablets of Bucillamine over seven days while those in Arm B received 18 tablets of Bucillamine over seven days. Patients in Arm C received three tablets of Colcrys over only one hour. Patient compliance with a drug's recommended dosage regimen is essential to maximize the treatment benefit so a shorter simpler approach is always preferable. Bucillamine's value proposition versus Colcrys is unclear, but price could be an option.
- According to GlobalData 2014, the global gout disease treatment market is over ~$1B and is expected to grow to ~$2.3B by 2018. Gout affects ~8M Americans and ~15M people worldwide.
- Bucillamine is a disease-modifying anti-rheumatic drug currently marketed in Japan and South Korea for the treatment of rheumatoid arthritis.
Nov. 30, 2015, 6:51 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) form a joint venture in Japan with the aim of building a leadership position in the fast-growing generic medicines there. The government, trying to address the medical needs of its aging population, intends to reach 80% generic penetration in its drugs market by the end of fiscal year 2020.
- The new business, expected to start operating in Q2 2016, will leverage Teva's extensive generics portfolio with Takeda's brand presence and distribution capabilities. Teva will be the majority owner with a 51% stake while Takeda will own 49%.
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
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