Mon, Sep. 28, 7:53 AM
- The Japanese Ministry of Health, Labour and Welfare approves Teva Pharmaceutical Industries' (NYSE:TEVA) COPAXONE (glatiramer acetate injection) 20 mg for the prevention of relapse of multiple sclerosis (MS). The product will be commercialized there by Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY).
- COPAXONE is Teva's biggest seller by far, generating $4.2B in sales over the past four quarters.
Wed, Sep. 23, 10:08 AM
- Orexigen Therapeutics (OREX +2.7%) receives the first of three potential $15M anniversary milestone payments from U.S. partner Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) related to the commercialization of Contrave (naltrexone HCl and bupropion HCl extended release). Two additional $15M payments are expected from Takeda in Q4 2016 and Q4 2017.
- Orexigen has also received a $7M upfront payment from Seoul, South Korea-based Kwang Dong Pharmaceutical related to the distribution of Contrave in Korea. If approved there, commercialization will commence in H2 2016.
Mon, Sep. 21, 4:45 PM
- Intra-Cellular Therapies (NASDAQ:ITCI) announces that it is assuming sponsorship of the clinical studies supporting ITI-214's IND for schizophrenia, after licensee Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) apparently declined to proceed with development. Intra-Cellular is evaluating ITI-214 for several indications including cognition in patients with Parkinson's disease, dementia. schizophrenia and other disorders.
- ITI-214 inhibits an enzyme called phosphodiesterase type 1 (PDE1), which plays a key role in the regulation of multiple physiological processes. Inhibiting PDE1 inhibits the metabolism of the secondary messengers cAMP and cGMP thereby prolonging their effect in cell signaling.
- ITCI shares are unchanged in after hours trading.
Fri, Aug. 21, 7:37 AM
- The European Medicines Agency (EMA) validates for review the Marketing Authorization Application (MAA) from Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) seeking approval for ixazomib for the treatment of relapsed/refractory multiple myeloma (MM). On July 23, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for ixazomib.
- Ixazomib inhibits the action of proteasomes, cellular complexes that break down proteins, like the tumor suppressor gene p53. It is designated an Orphan Drug in Europe for the treatment of MM and systemic light-chain (AL) amyloidosis. In the U.S. it is designated an Orphan Drug for MM and a Breakthrough Therapy for AL amyloidosis.
- In Europe, Orphan Drug status provides for a 10-year period of market exclusivity for the indication, if approved. In the U.S., the exclusivity period is seven years.
Tue, Aug. 11, 7:30 AM
- The FDA accepts for review the supplemental New Drug Application (sNDA) from Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) seeking clearance to add clinical data to its label regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The PDUFA date is March 28, 2016.
- Depression involves a number of cognitive symptoms such as difficulty concentrating and thinking, indecisiveness and forgetfulness. These symptoms are very common and often persist between major depressive episodes.
- The sNDA is based primarily on two studies, FOCUS and CONNECT, which assessed the effect of Brintellix on certain aspects of cognitive function in adult patients.
- The FDA originally approved Brintellix on September 30, 2013 for the treatment of MDD in adults. It is currently cleared in 55 countries.
- 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.
Mon, Jul. 27, 7:55 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) grants accelerated assessment to Takeda Pharmaceutical Company's (OTCPK:TKPYY) (OTCPK:TKPHF) ixazomib, an investigational oral proteasome inhibitor for the treatment of relapsed/refractory multiple myeloma (MM). The company expects to submit its Marketing Authorization Application (MAA) in the next few weeks.
- The submission is supported the results from the Phase 3 TOURMALINE-MMI study that evaluated ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone in patients with relapsed/refractory MM.
- The EMA grants accelerated assessment to drugs regarded as therapeutic innovations and of major public health interest.
Wed, May 13, 7:25 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) sends Orexigen Therapeutics (NASDAQ:OREX) a dispute letter seeking termination of their collaboration agreement in response to cessation of The Light Study citing a material breach of the contract.
- Apparently, Takeda wants Orexigen to pay the entire cost of the new CV outcomes trial which is slated to start later this year and run until 2022. According to RBC Capital Markets analyst Simos Simeonidis, the study will cost ~$200M. Under the terms of the agreement, the companies will split the costs. Also, Takeda has promised as much as $900M in milestone payments to Orexigen and has already committed $45M. The firms will now enter a dispute resolution process that may include arbitration.
- Previously: Then, again, maybe Contrave doesn't prevent heart attacks (May 12)
- Previously: Orexigen's Contrave data release may have not have been a good idea (March 3)
- OREX is down 11% premarket on light volume.
Tue, May 12, 7:31 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) announces the enrollment of the first patient in a Phase 3 trial, TOURMALINE-MM4, assessing oral ixazomib in patients with multiple myeloma (MM). The primary endpoint is progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who have responded to initial therapy and have not undergone an autologous stem cell transplant (ASCT). Secondary endpoints are overall survival (OS) and safety.
- The study complements the ongoing Phase 3 TOURMALINE-MM3 trial which is assessing oral ixazomib in patients who do receive ASCT.
- TOURMALINE-MM4 is the fifth ixazomib Phase 3 trial in various multiple myeloma settings and in relapsed/refractory systemic light-chain (AL) amyloidosis, a rare and severe plasma cell disorder.
- Ixazomib is an investigational oral proteasome inhibitor, the first to enter Phase 3 development. Proteasomes are cellular complexes that play a key role in cellular metabolism by breaking down old/unwanted proteins. Cancer cells depend on the proteasome to regulate their growth and survival.
- Ixazomib is an Orphan Drug for MM and AL amyloidosis in the U.S. and Europe and a Breakthrough Therapy for relapsed/refractory AL amyloidosis in the U.S.
Wed, Apr. 1, 7:31 AM
- In an effort to avoid any more large verdicts against it, Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) offers to pay more than $2.2B to settle 8,000+ lawsuits accusing the company of hiding the cancer risks of its Actos diabetes drug. Patients allege the company ignored/downplayed the cancer risks of Actos prior to its launch in 1999 and misled regulators about the drug's risks. The deal would amount to a payment of ~$275K per case and would bring the three-year litigation fight to an end. Its offer pertains only to patients who have already sued or who have already hired a lawyer to file a suit.
- A jury award in a Louisiana federal court last year provided substantial motivation for Takeda to settle the cases. A shopkeeper who blamed Actos for causing his bladder cancer was awarded $9B, later reduced to $36.8M by the judge.
- Unsurprisingly, some attorneys feel that $2.2B falls short of adequate compensation to the patients who developed bladder cancer after taking Actos. More than 3,500 cases have been consolidated under U.S. District Court judge Rebecca Doherty in Lafayette, LA. Another 4,500 cases are pending in four other states.
- Actos sales peaked in the year ended March 2011 at $4.5B, representing 27% of Takeda's revenue. Eli Lilly (NYSE:LLY) was Takeda's commercial partner beginning in 1999, but the partnership ended in 2006 with Lilly retaining the rights to Actos in parts of Asia and Europe and in Canada and Mexico. Lilly says Takeda agreed to cover all legal costs regarding Actos sales in the U.S.
Tue, Mar. 31, 11:30 AM
- Infinity Pharmaceuticals (INFI +0.1%) exercises its option to buy out all future royalty obligations due to Takeda Pharmaceutical Company Limited (OTCPK:TKPHF) (OTCPK:TKPYY) on sales of duvelisib (IPI-145) in oncology indications for an exercise fee of $52.5M. Infinity purchased the option in July 2014 for $5M.
- Duvelisib is an investigational inhibitor of Class 1 phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma being jointly developed by Infinity and AbbVie (ABBV +0.6%). The PI3K pathway plays a key role in regulating the growth and survival of certain blood cancers. Inhibiting PI3K-delta and PI3K-gamma signaling blocks the growth and survival of tumor cells. Duvelisib is in Phase 2 development for refractory indolent non-Hodgkin lymphoma and Phase 3 development for previously treated follicular lymphoma and relapsed/refractory chronic lymphocytic leukemia.
Mon, Mar. 23, 7:47 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY), through its Millennium Pharmaceuticals subsidiary, licenses exclusive rights to use ImmunoGen's (NASDAQ:IMGN) antibody-drug conjugate (ADC) technology to develop and commercialize targeted cancer therapeutics for up to two undisclosed targets, with an option for a third target for an additional upfront fee.
- Under the terms of the agreement, ImmunoGen will receive $20M upfront for each target, milestones up to $210M and royalties on net commercial sales of any resulting products.
- An antibody-drug conjugate is a cytotoxic agent attached to an antibody that binds to a target antigen found on cancer cells. This delivers the agent specifically to the cancer cells where it kills them.
- IMGN is up 23% premarket on robust volume.
Tue, Mar. 3, 1:03 PM
- Orexigen Therapeutics (OREX +53%) short sellers are licking their wounds today. Shares are up on a whopping 22x surge in volume in response to the news that patients taking its obesity med Contrave (naltrexone HCl/bupropion HCl) may reduce their risk of having a heart attack by almost 50%.
- The data behind the news comes from an interim analysis of the 9,000-patient LIGHT study which is being conducted to determine the heart-safety profile of the obesity med. The analysis showed patients receiving Contrave experienced 35 major adverse cardiac events (MACE) compared to 59 for those taking placebo. The benefit was statistically significant. A MACE is a heart attack, stroke or heart-related death.
- The company will conduct a second interim analysis of the data at 50% of events, which should happen in the next several weeks. Orexigen is also required to run a second heart-safety study as a condition of its clearance by the FDA in September 2014.
- Contrave is sold in the U.S. by Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY).
- According to Yahoo Finance, almost 42% of Orexigen's float (more than 38M shares) was sold short as of February 13.
- Related tickers: (VVUS +4.3%)(ARNA -5.5%)
Sun, Mar. 1, 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.
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