scoobey-do
3 years ago
SPORT19, thanks for the Astellas link. I find this portion of the interesting:
"Partnering plays a tactical role as well as in-house research and development. Astellas will work with a variety of partners to provide medical solutions to our patients with high unmet medical needs.
"Astellas established dedicated management teams to strengthen our partnerships including the AIM (Astellas Innovation Management) team, which promotes intake early stage innovation, BD (Business Development) team, which finds potential partners and actively develops business, and AVM (Astellas Venture Management) team, which conducts private equity investments in early-stage biotech start-ups to foster its R&D and business for reinforcing Astellas’ pipeline. In the field of Rx+® business, the Rx+ BA (Rx+ Business Accelerator) team leads exploration of innovation, collaboration with partners, and investment in start-ups, dedicatedly and independently of prescription drugs. Working together with external partners, Astellas will turn innovative science into VALUE for patients."
I understand that Astellas does a lot of work with Stem Cells. PKTX's AAGP has been proven to prolong the life of a stem cell. I hope PKTX and ALPMY will find common ground to work together.
mlkrborn
10 years ago
competion is severe in lucrative market
Akebia snags $41M financing in anemia-drug race with GlaxoSmithKline, others
June 4, 2013 | By Ryan McBride
fiercebiotech
In a race with rival programs from GlaxoSmithKline ($GSK) and Astellas Pharma, the biotech startup Akebia Therapeutics has rallied venture investors to fund its charge toward late-stage development of a novel anemia drug. Today the company disclosed a $41 million Series C financing amid plans for a Phase IIb study later this year for AKB-6548, which is among a potential blockbuster class of oral drugs that could serve as safer alternatives to EPO therapies for anemia patients such as Amgen's ($AMGN) Aranesp.
Akebia, which spun off from the former pharma unit of Procter & Gamble ($PG) in 2007, raised capital for the third-round financing from a bevy of backers. The syndicate for the round includes lead investors Satter Investment Management and Novo A/S as well as Novartis Venture Funds, AgeChem Venture, Athenian Venture Partners, Kearny Venture Partners, Venture Investors LLC, Triathlon Medical Ventures, and Sigvion Capital Fund.
The Series C round follows Akebia's 93-patient Phase IIa study of AKB-6548, which showed dose-related increases in hemoglobin and red blood cell levels. Patients required low doses of iron to hit hemoglobin targets, according to the company, and safety of the experimental treatment was on par with placebo. The compound belongs to a class of drugs, known as inhibitors of hypoxia-inducible factor prolyl hydroxylase, which includes Glaxo's candidate known as GSK 1278863 and ASP1517 from Astellas and its partner FibroGen.
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The drugs mimic the reaction of the body to hypoxia, or low levels of oxygen, to generate the glycoprotein EPO, which controls production of red blood cells. Astellas and Fibrogen launched a Phase III program for their contender in anemia patients with chronic kidney disease in December. Like Akebia's, GSK's compound is in midstage development.
Cincinnati-based Akebia, which previously disclosed a $22 million Series B round and $25 million Series A round, expects its third round of financing to fund its planned Phase IIb study and work required to launch a Phase III study in anemia associated with kidney disease. Like its rivals, the company aims to highlight the safety of its drug relative to existing EPO therapies.
Akebia and its rivals have targeted patients with kidney disease. Amgen and others have recorded billions of dollars in revenue from sales of EPO therapies to those patients, yet their fortunes have dwindled after warnings from the FDA about increased cardiovascular and cancer risks from the treatments.
Akebia CEO Joseph Gardner wasn't immediately available to comment on the latest financing found this morning. He and fellow P&G veteran Robert Shalwitz, Akebia's chief medical officer, co-founded the company in 2007.
- here's the company's release
Related Articles:
Akebia lands $22M round for lead anemia program
Cincy biotech spinoff snags $27M A round for vascular drug work
Pharma giants' oral EPO alternatives could cater to dopers
Read more: Akebia snags $41M financing in anemia-drug race with GlaxoSmithKline, others - FierceBiotech http://www.fiercebiotech.com/story/akebia-snags-41m-financing-anemia-drug-race-glaxosmithkline-others/2013-06-04#ixzz2nSuQkwYS
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surf1944
11 years ago
8:15AM Astellas Pharma reports positive topline phase 3 results for antifungal isavuconazole; Isavuconazole phase 3 invasive aspergillosis study meets primary endpoint (ALPMY) 12.70 : Co announces positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE). The antifungal agent isavuconazole is being co-developed with Basilea Pharmaceutica.
The randomized, double-blind isavuconazole study achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population. The all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.
In addition, the key secondary endpoint of overall success rate (composite of clinical, mycological, radiological responses) at the end-of-therapy in patients with proven/probable disease was similar between isavuconazole and voriconazole (35.0% and 36.4%, respectively). This outcome was based on a blinded assessment by the Independent Data Review Committee.
johnsyn
11 years ago
yes it is: Astellas Announces FDA Approval of ASTAGRAF XL™ (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients
NORTHBROOK, Ill., July 19, 2013 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.
"Each transplant recipient is different and requires a personalized treatment approach. The approval of ASTAGRAF XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney transplant recipients," said Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc. "Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology."
ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients. ASTAGRAF XL offers a potentially promising treatment option for appropriate kidney transplant recipients as a core component of an immunosuppressive regimen for the prophylaxis of organ rejection.
The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf® in Europe in 2007 and under the trade name Graceptor® in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.
About ASTAGRAF XL (tacrolimus extended-release capsules)
ASTAGRAF XL extended-release capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant. ASTAGRAF XL is an extended-release capsule and is not the same as tacrolimus immediate-release capsules. Your doctor should decide what medicine is right for you.
ASTAGRAF XL is not for use with medicines called cyclosporine (Neoral®, Sandimmune®, Gengraf®). It is not known if ASTAGRAF XL is safe and effective when used with sirolimus (Rapamune®) in people who have had kidney transplants. It is not known if ASTAGRAF XL is safe and effective in children under 16 years of age who have had kidney transplants.
johnsyn
11 years ago
Medivation, Astellas Begin Mid-stage Study Of Enzalutamide - Quick Facts
By RTT News, June 26, 2013, 07:31:00 AM EDT
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(RTTNews.com) - Medivation, Inc. ( MDVN ), pursuant to its agreement with Astellas Pharma Inc.(ALPMF.PK, ALPMY.PK), Wednesday announced enrollment of the first patient in a global Phase 2 clinical trial evaluating enzalutamide as a single agent for the treatment of advanced, androgen receptor (AR)-positive, triple-negative breast cancer or TNBC. TNBC is a type of cancer which does not express any of the three most commonly targeted receptors in breast cancer; estrogen, progesterone and HER2.
Medivation added that there would be about 80 patients with AR-positive, TNBC enrolled for the trial, and each one of them will receive enzalutamide(an androgen receptor inhibitor) at a dose of 160 mg to be taken orally once daily. The primary endpoint of the trial is clinical benefit rate, defined as the proportion of patients with a best response of complete response, partial response or stable disease for 16 weeks or more than that, Medivation said.
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SPORT19
3 years ago
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