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About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 18,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology (including Transplantation) and Infectious diseases, Oncology, Neuroscience and DM Complications and Kidney diseases. For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and other medical conditions. Cytokinetics currently has three compounds in clinical development: omecamtiv mecarbil in Phase II for acute and chronic heart failure, tirasemtiv in Phase II for ALS and CK-2127107 progressing to Phase II in SMA. All of the company’s drug candidates have arisen from Cytokinetics' muscle biology focused research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at http://www.cytokinetics.com.
About Spinal Muscular Atrophy
Spinal Muscular Atrophy (SMA) is a severe neuromuscular disease that occurs in 1 in every 6,000 to 10,000 live births each year and is one of the most common fatal genetic disorders. Spinal muscular atrophy manifests in various degrees of severity as progressive muscle weakness resulting in respiratory and mobility impairment. There are four types of SMA, named for time of the initial onset of muscle weakness and related symptoms: Type I (Infantile), Type II (Intermediate), Type III (Juvenile) and Type IV (Adult onset). Life expectancy and disease severity varies by type of SMA from Type I, who have the worst prognosis and a life expectancy of no more than 2 years from birth, to the Type IV, who have a normal life span but with gradual weakness in the proximal muscles of the extremities resulting in mobility issues. Few treatment options exist for these patients, resulting in a high unmet need for new therapeutic options to address symptoms and modify disease progression.
About CK-2127107
Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction. It is a highly ordered cytoskeletal structure composed of several key proteins. Skeletal muscle myosin is the cytoskeletal motor protein that converts chemical energy into mechanical force through its interaction with actin. A set of regulatory proteins, which includes tropomyosin and several types of troponin, make the actin-myosin interaction dependent on changes in intracellular calcium levels. CK-2127107, a novel skeletal muscle activator arising from Cytokinetics' skeletal muscle contractility program, slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an increase in skeletal muscle contractility. CK-2127107 has demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with muscle weakness and fatigue. In non-clinical models of Spinal Muscular Atrophy, a skeletal muscle activator has demonstrated increases in skeletal submaximal muscle force in response to neuronal input and delays in the onset and reductions in the degree of muscle fatigue. CK-2127107 has been the subject of five completed Phase I clinical trials in healthy volunteers, which evaluated safety, tolerability, bioavailability, pharmacokinetics and pharmacodynamics.
Cytokinetics Conference Call / Webcast
Cytokinetics will host a conference call on January 5, 2015 at 8:30 a.m. Eastern Time. The conference call will be simultaneously webcast and will be accessible in the Investor Relations section of Cytokinetics’ Web site; for further information please go to www.cytokinetics.com. The live audio of the conference call is also accessible via telephone to investors, members of the news media and the general public by dialing either (866) 999-2985 (CYTK) (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 52398702. An archived replay of the webcast will be available via Cytokinetics’ website until February 5, 2015. The replay will also be available via telephone from January 5, 2015 at 11:30 a.m. Eastern Time until February 5, 2015 by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (International) and typing in the passcode 52398702.
Expanded Scope of Collaboration
Cytokinetics and Astellas entered into collaboration in 2013. Cytokinetics exclusively licensed to Astellas the rights to co-develop and commercialize CK-2127107, a fast skeletal troponin activator drug candidate, for potential application in non-neuromuscular indications under the collaboration agreement. In accordance with the initial scope of the collaboration, Cytokinetics completed Phase I clinical development activities and other Phase II readiness activities. In connection with the expanded collaboration, the companies have agreed to advance CK-2127107 into Phase II clinical development initially in SMA. The development program may include other neuromuscular indications as the companies may agree in the future. In connection with the expanded collaboration, Cytokinetics and Astellas have also agreed to extend their joint research program through 2016. Under the amended collaboration, Astellas has exclusive rights to co-develop and commercialize CK-2127107 and other fast skeletal troponin activators in non-neuromuscular indications and certain neuromuscular indications (including SMA) and other novel mechanism skeletal muscle activators in all indications, subject to certain Cytokinetics’ development and commercialization rights; Cytokinetics may co-promote and conduct certain commercial activities in North America and Europe under agreed scenarios. Outside the collaboration, Cytokinetics may continue to independently develop tirasemtiv, a fast skeletal troponin activator that recently completed a Phase II clinical trials program for the potential treatment of amyotrophic lateral sclerosis (ALS), in ALS and other neuromuscular indications subject to certain agreed limitations.
CYTOKINETICS AND ASTELLAS ANNOUNCE EXPANSION OF COLLABORATION FOR DEVELOPMENT OF CK-2127107 IN SPINAL MUSCULAR ATROPHY AND OTHER NEUROMUSCULAR INDICATIONS
Cytokinetics Expects to Receive Over $75 Million in Committed Capital and Reimbursements For Planned Activities; Companies Plan to Initiate Phase II Clinical Trial in 2015
South San Francisco, CA - December 23, 2014
Cytokinetics, Incorporated (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503, "Astellas") announced today an amendment to their collaboration agreement focused on the research, development and commercialization of skeletal muscle activators. The companies have been jointly conducting research and development activities with the objective to advance novel skeletal sarcomere targeted therapies for diseases and medical conditions associated with muscle weakness in non-neuromuscular indications. The collaboration has been expanded to enable development of CK-2127107, a fast skeletal troponin activator, in Spinal Muscular Atrophy (SMA) and potentially other neuromuscular indications. As the companies have agreed, Cytokinetics will conduct a Phase II clinical trial of CK-2127107 in patients with SMA, which is planned to begin in 2015. Cytokinetics and Astellas will jointly develop and may jointly commercialize CK-2127107 and other fast skeletal troponin activators in neuromuscular indications. The companies have extended their joint research program focused on the discovery of additional skeletal sarcomere activators through 2016.
Upon execution of the amended agreement, Cytokinetics will receive $55 million from Astellas comprising $30 million as an upfront license fee, $10 million paid for Astellas’ purchase of Cytokinetics’ common stock and $15 million in a milestone payment in connection with the decision made by Astellas to advance CK-2127107 into Phase II clinical development. In addition, Cytokinetics expects to receive potentially over $20 million payable by Astellas to reimburse Cytokinetics for planned research and development expenses over the next 2 years. Under the amended agreement, Cytokinetics is eligible to receive over $600 million in pre-commercialization and commercialization milestone payments, of which over $100 million is payable for CK-2127107 in each of SMA and other neuromuscular indications. The agreed terms also provide for escalating royalties to Cytokinetics with increased sales. Cytokinetics retains the option to co-fund the development of CK-2127107 in SMA and other neuromuscular indications in exchange for increased milestone payments and royalties and, if Cytokinetics exercises its co-promotion option, Astellas will reimburse Cytokinetics for certain expenses associated with its promotion activities.
“We are pleased to expand our collaboration with Astellas to enable the joint pursuit of CK-2127107 in SMA and other potential neuromuscular indications as well as the indications which were the initial focus of our collaboration,” stated Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are impressed with Astellas’ strategic vision for skeletal muscle activators and look forward to increasing the scope of our activities to prioritize the treatment of neuromuscular diseases that may benefit from our novel mechanism approach to increased muscle function and time to muscle fatigue.”
“We are excited to expand our collaboration with Cytokinetics and to advance this drug candidate into Phase II,” stated Yoshihiko Hatanaka, Astellas’ President and Chief Executive Officer. “We are encouraged by the result of the completed Phase I studies for CK-2127107 and are hopeful for the future of this new frontier of muscle biology. The expansion of our alliance is a testament to our productive collaboration together and illustrates the broad potential that we envision for this program.”
2 da moon and beyond!
Thanks for the Christmas present for my grand-kids! Just snatched another 200K @ $0.0084!!!
Merry Christmas to all HHSE Longs!!!!!
We'll punch his ticket! All Aboard!
All Aboard!
Wonder if Eric is talking to his contacts @ SONY about getting "The Interview" on "VODWIZ" for Christmas!
Panic Selling Today?
My shovel remains ready! I need some last minute Christmas gifts! HHSE shares could be the perfect gift!
Business is strong! Expectations were unrealistic!
Worthington Industries Inc. (WOR) reported higher profit and sales in its fiscal second quarter as its steel processing operations continued to benefit from higher demand, particularly from the automotive sector.
Results missed the forecast on a per-share basis due to higher manufacturing costs and a product miss.
Great buying opportunity!!!
Any truth to the rumor that Eric is working with Sony to stream "INTERVIEW" via VODWIZ?
Today's chart looks like the stairway to heaven!
Will it get back above $1 today?
Did Travis Best get some of his NBA buddies to pony-up? This could POP!
What’s that? Ah — Selloffs? Don’t talk about — selloffs? You kidding me? Selloffs? I just hope we can stay above a penny! Another penny.
Welcome aboard! They held the train for you! Price will be going up shortly!
Merry Christmas to All!!!
Sorry, the train has left the station! It will open above a penny tomorrow and no looking back.
Last Call for Sub-Penny Price!
All Aboard the HHSE Train!!!
OMG it's 2:07pm and we are up 10+%!
Almost 2pm on 12/9/14 and no Form 10 yet!
Time to start panic selling?
If you don't like the blogs, don't read them! I like them and hope he keeps posting. I like to know what they are planning and trying to accomplish.
Did I miss the panic selling?
Eric retired as SUPERMAN, so now he is full time CEO of HHSE!
Where is the panic selling?
More than 1hr into the trading week and no panic selling. Some folks will wait and buy shares above .02! A day late and a penny short!
My gosh look at all that panic selling. Some folks try to buy high and sell low. Can't imagine why they are disappointed? Perhaps they should try a different stock, cause it doesn't work here!
My shovel is ready, so methodically sell them to me on the cheap.
Where is all the panic selling?
Gobbly Goop then, let the shoveling begin!
My shovel is ready, and I got a big shovel! Bring it on!!!
Things got exciting Friday (12/5), with less than 5 minutes of trading left! The price shot up to $11.53, before settling back to $9.73.
When will the panic selling start?
That makes no sense.
All bought out @ .01. Waiting for news or panic selling and I'm in no hurry either way. Been here a long time and I'm doing ok!
Some already have multi-million shares, but are willing to buy more for cheap! I'm waiting for more on the cheap!!!
Ok, so Eric is not Superman! I trust he is concentrating on the important business of making money. The Form 10 will get filed in due time!