Thu, Jun. 9, 1:04 PM
- Thinly traded nano cap SCYNEXIS (SCYX -23.8%) slumps on a 17x surge in volume, albeit on turnover of only 674K shares, in response to its announcement of results from a Phase 2 clinical trial assessing lead product candidate, Fast Track- and QIDP-tagged SCY-078, for the treatment of patients with acute vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection.
- The study randomized 96 women with moderate-to-severe VVC 1:1:1 to receive either of two dose regimens of SCY-078 or fluconazole, the standard-of-care prescription oral medication.
- Data from the Intent-to-Treat population all favored SCY-078, but the cure rate, defined by a negative culture, was only slightly better than fluconazole (70.3% versus 68.8%). The therapeutic cure rate, defined as a negative culture and the resolution of symptoms without further antifungal treatment (clinical cure), was identical (56.3%) for both.
- One significant negative was the "considerably higher rate of GI-related adverse events (diarrhea, nausea, vomiting, abdominal pain) in the SCY-078 arms compared to fluconazole. According to the company, they were "mild to moderate and transient in nature" with the majority lasting no more than one day after initiating SCY-078.
- SCY-078 inhibits an enzyme called glucan synthase. Its value proposition is comparable activity to echinocandins [e.g., Astellas' (OTCPK:ALPMF)(OTCPK:ALPMY) Mycamine (micafungin sodium) for injection] but available in an oral formulation and active against multi-drug-resistant pathogens, including those resistant to echinocandins.
Thu, Jun. 9, 8:31 AM
- FibroGen (NASDAQ:FGEN) announces that collaboration partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) has initiated a Phase 3 clinical trial in Japan evaluating roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) on hemodialysis. The action triggers a $10M milestone payment to FibroGen.
- Under FibroGen's 2004 license agreement with Yamanouchi (predecessor to Astellas), Astellas is responsible for the development costs of roxadustat in Japan and makes payments to FibroGen based on the achievement of certain milestones.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's (NYSE:JNJ) Procrit]
Thu, Apr. 28, 11:37 AM
- Credit Suisse claims Medivation (MDVN +8%) is worth $55 a share, ~5% above Sanofi's (SNY -1.1%) unsolicited bid of $52.50. It says much of the attention has focused on the prospects of prostate cancer drug XTANDI (enzalutamide), approved by the FDA in August 2012, which generated $1.15B in the U.S. last year as reported by development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). What appears to be underrepresented is the value of the company's pipeline, led by late-stage PARP inhibitor talazoparib.
- According to the analyst, other potential bidders include AstraZeneca (AZN -0.5%), Roche (OTCQX:RHHBY -0.5%) and Celgene (CELG +0.9%).
- AstraZeneca reportedly has held internal talks about an offer. Medivation rejected Sanofi's first approach several weeks ago, so the bidding could turn hostile if the board rejects $52.50, a likely scenario.
- Citi says Sanofi's offer is a bit light considering MDVN's 52-week high of $66.39, hit in June of last year. The board might reject the offer based purely on technical grounds.
- Previously: Medivation +9% AH on reported Sanofi takeover effort (April 12)
- Previously: Report: AstraZeneca held talks for Medivation bid (April 18)
Wed, Mar. 30, 8:22 AM
- The FDA designates Vical's (NASDAQ:VICL) VL-2397 for Fast Track review for the treatment of invasive aspergillosis, an infection caused by inhaling the ubiquitous Aspergillus fungus. It is inconsequential in people with a normally functioning immune system, but can be dangerous in those with weakened immunity such as those undergoing hematopoietic stem cell transplantation, chemotherapy for leukemia or with AIDS.
- VL-2397, based on an isolate from a leaf litter fungus Acremonium species collected in Malaysia, was initially developed by strategic partner Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY). A Phase 1 study was recently initiated.
- The FDA designated it a Qualified Infectious Disease Product in August 2015 and an Orphan Drug in January of this year.
- Shares are up 16% premarket on increased volume.
Thu, Mar. 24, 8:31 AM
- The first patient has been dosed in a Phase 3 clinical trial, ARCHES, evaluating the safety and efficacy of enzalutamide with androgen deprivation therapy (ADT) compared to placebo with ADT in metastatic hormone-sensitive prostate cancer (mHSPC) patients. The global, double-blind, placebo-controlled study will randomize ~1,100 mHSPC patients to receive a once-daily 160 mg oral dose of enzalutamide or placebo, administered with ADT. The primary efficacy endpoint is radiographic progression-free survival up to four years.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is April 2020. The estimated study completion date is December 2023.
- Enzalutamide, branded as Xtandi, is an androgen receptor inhibitor developed at UCLA by a team led by Distinguished Professor of Chemistry and Biochemistry Michael Jung. It was licensed to Medivation (NASDAQ:MDVN) in 2005 who sublicensed it to Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) in 2009. The FDA approved it in 2012. Xtandi generated $1.15B in sales last year for Astellas.
- Previously: UCLA sells Xtandi royalty rights to Royalty Pharma for $1.14B (March 4)
Fri, Mar. 4, 11:18 AM
- Privately held Royalty Pharma acquires UCLA's royalty interest in the prostate cancer drug Xtandi (enzalutamide) for $1.14B in cash. The rights were jointly owned by the university, researchers working at UCLA at the time of the discoveries and a research organization. UCLA will use its share, ~$520M, to support research programs, undergraduate scholarships and graduate student fellowships.
- Enzalutamide, an androgen receptor inhibitor, was developed at UCLA by a team led by Distinguished Professor of Chemistry and Biochemistry Michael Jung. It was licensed to Medivation (MDVN +7.1%) in 2005 who sublicensed it to Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) in 2009. The FDA approved it in 2012.
- Xtandi generated $1.15B in sales last year as reported by Astellas.
Mon, Feb. 29, 8:25 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Boehringer Ingelheim's Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed on or after treatment with platinum-based chemo.
- The data supporting the application was generated in the LUX-Lung 8 study that showed a 19% improvement in progression-free survival in patients treated with afatinib compared to Genentech (OTCQX:RHHBY) and Astellas' (OTCPK:ALPMF)(OTCPK:ALPMY) Tarceva (erlotinib).
- Giotrif is currently approved for the treatment of EGFR mutation-positive non-small cell lung cancer.
- A final decision from the European Commission usually takes ~60 days.
Wed, Feb. 24, 8:39 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) earns a $15M milestone payment from development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) triggered by the latter's filing of a new drug application in Japan seeking clearance of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). The milestone was stipulated in the companies' 2009 licensing agreement for the development of the product in Japan.
- Linaclotide, marketed in the U.S. under the band name Linzess, is a guanylate cyclase-C (GCC) receptor agonist. GCC is a key receptor for enterotoxins that cause diarrhea.
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)
Wed, Feb. 10, 9:29 AM
- Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) completes its tender offer for all issued and outstanding common shares of Ocata Therapeutics (NASDAQ:OCAT) at $8.50 per share.
- Previously: Astellas extends Ocata Therapeutics tender offer until February 9 (Jan. 22)
- Previously: Astellas Pharma buys Ocata Therapeutics for $8.50 per share in cash (Nov. 10, 2015)
Fri, Jan. 22, 9:37 AM
- In order to give Ocata Therapeutics (OCAT +1.6%) shareholders more time to tender their shares, Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) extends its offering period to 5:00 pm ET February 9. The most recent period expired yesterday at 5:00 pm ET. All terms and conditions remain as is.
- Previously: Astellas Pharma buys Ocata Therapeutics for $8.50 per share in cash (Nov. 10, 2015)
Fri, Jan. 22, 7:22 AM
- The Japanese Ministry of Health, Labour and Welfare approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have a high risk of cardiovascular events and do not adequately respond to statins.
- Repatha was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). The marketing application was filed in March 2015. It is the first PCSK9 inhibitor approved there.
- Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY) are playing catch up with Praluent (alirocumab). They reported successful Phase 3 data in July.
Thu, Jan. 21, 4:03 PM
- Micro cap XenoPort (NASDAQ:XNPT) spiked at the close to finish up 9% for the day, albeit on below average volume, on a rumor that it is exploring a sale.
- Its markets one commercial product: HORIZANT (gabapentin enacarbil), for restless legs syndrome (RLS) and postherpetic neuralgia. It is branded as REGNITE in Japan, where Astellas Pharma (OTCPK:ALPMY)(OTCPK:ALPMF) exclusively markets it. It was cleared for the treatment of RLS there in January 2012.
- Its two main pipeline candidates are XP23829 for psoriasis and multiple sclerosis and XP21279 for Parkinson's disease.
Wed, Jan. 6, 7:22 AM
- The FDA designates Vical's (NASDAQ:VICL) investigational antifungal candidate, VL-2397, an Orphan Drug for the treatment of invasive aspergillosis, an infection caused by inhaling the ubiquitous Aspergillus fungus. It is inconsequential in people with a normally functioning immune system, but can be dangerous in those with weakened immunity such as those undergoing hematopoietic stem cell transplantation, chemotherapy for leukemia or with AIDS.
- In preclinical studies, VL-2397 has shown faster fungicidal activity compared to currently marketed drugs and activity against azole-resistant fungal pathogens. It was initially developed by Astellas (OTCPK:ALPMF)(OTCPK:ALPMY), which granted Vical an exclusive global license to develop and commercialize it in March 2015. A Phase 1 clinical trial should commence in H1.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Mon, Jan. 4, 12:31 PM
- Cytokinetics (CYTK -4.7%) commences a Phase 2 clinical trial assessing CK-2127107 in patients with spinal muscular atrophy (SMA), a severe neuromuscular disorder characterized by progressive muscle weakness resulting in respiratory and mobility impairment. Treatment options are very limited for the condition.
- The double-blind, randomized, placebo-controlled study will enroll 72 SMA patients in two sequential, ascending dose cohorts of 36 subjects. Each cohort will comprised of 18 ambulatory and 18 non-ambulatory patients. The primary objective is the determine the pharmacodynamic effects of a suspension formulation of CK-2127107 following multiple oral doses. According to clinicaltrials,gov, the estimated study completion date is December 2016.
- CK-2127107, under development with Astellas (OTCPK:ALPMF)(OTCPK:ALPMY), is a skeletal muscle troponin activator that slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers. Calcium triggers muscle contraction.
Nov. 30, 2015, 4:38 PM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) and licensee Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) announce that a Japan-based Phase 3 clinical trial assessing linaclotide in patients with irritable bowel syndrome with constipation (IBS-C) successfully achieved its two co-primary endpoints. The first, the number of responders as measured by the Global Assessment of Relief of IBS Symptoms compared to placebo, was 34% and 18%, respectively (p<0.001). The second, Complete Spontaneous Bowel Movement Overall Responders also favored linaclotide 35% to 19% (p<0.001).
- Astellas, holder of commercialization rights in Japan, intends to file a new drug application with the Ministry of Health, Labour and Welfare in 2016. Under the terms of the companies' 2009 license agreement, the submission will trigger a $15M milestone payment to Ironwood. Regulatory clearance will trigger a second $15M payment.
- CSO and President of R&D Mark Currie, Ph.D., says, "Linaclotide has now met all primary endpoints in all eight of its Phase 3/3b clinical trials, spanning two indications, three doses and multiple countries. Our recent positive Phase 3 data in China and now Japan represent important achievements by Ironwood and our global partners toward bringing linaclotide to appropriate patients around the world, and we continue to innovate with linaclotide as part of our mission to address a broad spectrum of patient needs."
- Previously: Ironwood earns $15M milestone from Astellas (Nov. 20, 2014)
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