Astellas Pharma

Astellas faces new delay for Advagraf approval

Wed, 07 May 2008 06:59:54 -0400

Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised questions about the safety and efficacy of the drug for use in liver transplants. Last March the FDA issued an action letter regarding Advagraf for kidney transplants. The agency's action letters typically mean at least a six month delay before regulators will approve it.

Advagraf is already approved in Europe. Prograf earned $2 billion in sales last year.

- read the story in Yahoo News

Astellas pays $760M for Alzheimer's program

Fri, 25 Apr 2008 06:59:58 -0400

Another day, another big biotech deal. This time it's Japan's Astellas Pharma, which is paying $760 million for access to CoMentis's Alzheimer's drug. The development and commercialization agreement covers CoMentis' entire beta-secretase inhibitor program, which includes the company's CoMentis' lead Alzhiemer's compound CTS-21166. CoMentis lands an upfront payment of $80 million and an equity investment of $20 million. It could also receive up to $660 million in development milestones along with performance-based commercialization milestones.

"I strongly believe that CoMentis is very sophisticated in small-molecule drug discovery and development in CNS, the area of attention. Astellas is committed to developing the CNS therapeutic area as one of our prioritized therapeutic areas, and this partnership is expected to be a driving force to accelerate the establishment of our CNS infrastructure," said Hirofumi Onosaka, Astellas's Senior Corporate Executive.

The deal is one of several recent examples of collaboration between American and Japanese biotech companies. Takeda, of course, recently bid for $8.8 billion for Millennium Pharmaceuticals, Amgen bought Kyowa Hakko's antibody drug KW-0761, and in November Astellas also bought Santa Monica, CA-based Agensys.

- here's the Astellas release

CV scores $185M royalty deal on Lexiscan

Wed, 16 Apr 2008 06:59:58 -0400

Just a week after gaining regulatory approval for Lexiscan (regadenoson), an injection that increases arterial blood flow during heart tests, CV Therapeutics sold off a 50 percent interest in its North American royalties to TPG-Axon Capital for $175 million and a $10 million milestone payment. Astellas Pharma, which is marketing the drug, is paying CV a $12 million milestone payment on the approval. A European application for Lexiscan is expected later this year. Palo Alto, CA-based CV is scheduled to get an FDA decision on Ranexa for a subset of diabetes patients in July.

TPG-Axon was spun out of Texas Pacific Group and is led by Dinakar Singh, the former head of Goldman Sachs' Principal Strategies Department. Shares of CV Therapeutics shot up 19 percent in after-hours trading on the news of the deal.

- check out the release
- read the story in the San Francisco Business Times
- read the report in Wall Street 24/7

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CV, Astellas gain Leixscan approval

Fri, 11 Apr 2008 06:59:54 -0400

CV Therapeutics and Astellas Pharma have won FDA approval of Lexiscan, a A2A adenosine receptor agonist intended for use during heart stress tests. Almost half the patients undergoing cardiac stress tests are unable to exercise because of medical conditions; Lexiscan temporarily increases blood flow through the coronary arteries in order to mimic the increase in coronary blood flow caused by exercise. It works faster and has fewer side effects that Astellas' Adenoscan, the current market leader.

"We are extremely pleased that the FDA has approved Lexiscan, an exciting new option for diagnosing coronary artery disease in patients who cannot undergo an exercise stress test," said Yoshihiko Hatanaka, president and CEO of Astellas Pharma U.S. "We are preparing to launch Lexiscan soon after this approval." The approval triggers $12 million to CV, and the company could earn $35 million in royalty payments in 2009.

- see the release for more

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ALSO NOTED: Novartis sinks$816.5M into Italian vaccine plant; GSK, Astellas take a pass on Theravance's drugs; and much more...

Fri, 07 Sep 2007 06:59:50 -0400

> Novartis is pledging to sink €600 million ($816.5 million) into new and expanded facilities in Italy. FiercePharma

> GlaxoSmithKline won't exercise its option to license Theravance's Gastrointestinal Motility Dysfunction program, and Astellas Pharma has also decided not to license TD-1792 under the terms of the companies' 2005 agreement. Release

> GTC Biotherapeutics said that the FDA has given ATryn a Fast Track designation entitled to accelerated FDA review for the hereditary antithrombin deficiency indication. Report

> Senator Charles Grassley said he would, and now he has: The Republican introduced a bill Thursday that would require drug and medical device makers to report almost every cent they pay to doctors. FiercePharma

> Prominent British cardiac surgeon Magdi Yacoub says that he believes that scientists will quickly perfect the use of adult stem cells for growing a complete new ventricle for transplant, with human trials coming in three to five years. Report

> Researchers have found that a grape skin extract plays a key role in fighting prostate cancer. Report

And Finally... Merck can now say "Whew!" when the words "class action" are mentioned. Report

SPOTLIGHT: Cardiome, Astellas get panel date

Thu, 30 Aug 2007 06:59:53 -0400

The FDA as extended its review of a new therapy for abnormal heart rhythm and asked Cardiome and Astellas to sit in on a panel review of the drug. The panel review will be held on December 11 and 12 with a decision on the therapy by January 19, 2008. Astellas holds the U.S. marketing rights to the therapy. Release

Press Release: Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S.

Maureen Martino — Wed, 24 Jan 2007 13:04:00 -0500

Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S.

Announced that its US subsidiary, Astellas Pharma US, Inc. received an action letter from the FDA for the New Drug Application (NDA) regarding its once daily immunosuppressant FK506 Modified Release formulation (generic name: tacrolimus) on January 19, 2007

TOKYO, Japan | Jan 23, 2007 | Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori) today announced that its US subsidiary, Astellas Pharma US, Inc.(headquarters: Deerfield, IL) received an action letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) regarding its once daily immunosuppressant FK506 Modified Release formulation (generic name: tacrolimus) on January 19, 2007 (local time).

The action letter addresses each of the three target indications, the prophylaxis for organ rejection in kidney, liver and heart transplant patients as follows:
- for prophylaxis of organ rejection in kidney transplant patients : Approvable
- for prophylaxis of organ rejection in liver transplant patients : Approvable
- for prophylaxis of organ rejection in heart transplant patients : Not approvable

In their letter, the FDA raises additional issues and questions for each of the three indications, Astellas is internally reviewing the comments outlined in the action letters and is working with the FDA to address any issues they have raised to secure approval of FK506 MR.

Tacrolimus is an immunosuppressant invented by Astellas. Its twice a daily formulation, Prograf® has been marketed about 70 countries around the world. The FK506 modified release formulation is a modified release version of Prograf that can be administered once a day.

The NDA of FK506 MR was submitted to the FDA in the U.S. in December 2005. Application for regulatory approval has also been filed in Japan and Europe.

Contacts for inquiries or additional information
Astellas Pharma Inc.
Corporate Communications
Tel: +81-3-3244-3201 Fax: +81-3-5201-7473
http://www.astellas.com

Astellas faces FDA delay on reformulated Prograf

Tue, 23 Jan 2007 19:01:36 -0500

The FDA has issued a nonapprovable letter to Japan's Astellas Pharma for a new formulation of its drug Prograf for heart transplant patients. But the agency also said that the drug was approvable for liver and kidney patients while asking for additional information before a final decision is made. That delay sent shares of Astellas down more than five percent, although company officials said they had not given up hope of an approval. The patent on Prograf, which earned $1.4 billion last year, expires in 2008. One analyst noted that if Astellas ended up with an approval for kidney and liver patients the company would be able to protect its market share.

- here's the release on Prograf from Astellas

ALSO: Kirin Brewery and Astellas have inked a deal to collaborate on the development of an anti-CD40 antagonistic monoclonal antibody. Release (.pdf)

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CV, Astellas present positive Phase III results

Sun, 03 Dec 2006 19:01:35 -0500

CV Therapeutics and Astellas Pharma have announced that the second of two Phase 3 clinical studies of regadenoson met its primary endpoint. A prior identically designed Phase 3 study, completed in 2005, also met its primary endpoint. Regadenoson is used in myocardial perfusion imaging studies. "With two identically designed Phase 3 studies having hit their primary endpoints, we are excited about the opportunity to pursue approval of regadenoson. We are also pleased that regadenoson once again demonstrated safety and tolerability," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. Based on the results of these two Phase 3 clinical trials, CV Therapeutics plans to submit an NDA to the FDA in mid-2007.

- for more, see this press release

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Press Release: Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical Trial

Maureen Martino — Sun, 03 Dec 2006 08:54:45 -0500

Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical Trial

Monday December 4, 7:00 am ET

- New drug application planned for mid-2007 -

PALO ALTO, Calif. and DEERFIELD, Ill., Dec. 4 -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) and Astellas Pharma US, Inc. announced today that the second of two Phase 3 clinical studies of regadenoson met its primary endpoint. A prior identically designed Phase 3 study, completed in 2005, also met its primary endpoint.

Based on the results of these two Phase 3 clinical trials, CV Therapeutics plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in mid-2007.

If regadenoson is approved by the FDA, Astellas Pharma US, Inc. will be responsible for all commercial activities for regadenoson in the United States. CV Therapeutics retains all rights to regadenoson outside of North America.

Regadenoson is a selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. Regadenoson has been designed to be delivered as a rapid bolus with no dose adjustment required by weight, and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation.

In this study, regadenoson met its primary endpoint by showing with 95 percent confidence that MPI studies conducted with regadenoson were comparable to MPI studies conducted with Adenoscan® (adenosine injection).

This multinational, randomized, double-blind Phase 3 study of 1231 patients undergoing MPI studies was designed to evaluate the comparability of MPI studies conducted with regadenoson and Adenoscan® (adenosine injection). Regadenoson was generally well tolerated. In the study, the most common adverse events reported in patients who received regadenoson were shortness of breath, chest pain, headache, flushing and gastrointestinal discomfort.

"With two identically designed Phase 3 studies having hit their primary endpoints, we are excited about the opportunity to pursue approval of regadenoson. We are also pleased that regadenoson once again demonstrated safety and tolerability." said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.

"The need for myocardial perfusion imaging tests as a diagnostic aid continues to increase in the United States. Our expertise as a leader in this category will help maximize our ability to offer regadenoson, once approved, as a viable option for patients and physicians," said Yoshihiko Hatanaka, president and chief executive officer of Astellas Pharma US, Inc.

Phase 3 Design

Patients 18 years or older with the clinical need for an MPI study were eligible to participate in the Phase 3 clinical trials. Individuals, who had an acute myocardial infarction or unstable angina within three months, or coronary revascularization within six months, were not permitted to participate in the study.

All study participants received a clinically indicated baseline MPI study using Adenoscan® (adenosine injection). Participants then were randomized in a double blinded fashion to receive either regadenoson or Adenoscan® (adenosine injection) in a second MPI study. Each patient's scans were classified as indicating normal, moderate or severe ischemia. Baseline and blinded scans then were evaluated to determine if the scans were comparable.

Myocardial perfusion imaging studies

MPI studies help detect and characterize coronary artery disease by identifying areas of poor blood flow in the heart. In 2005, approximately 9.3 million patients in the United States underwent MPI studies.

Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, more than 45 percent of the patients undergoing an MPI study are unable to exercise adequately because of medical conditions such as peripheral vascular disease, arthritis or other limiting medical conditions which prevent them from exercising on the treadmill. For these patients, a pharmacologic agent that temporarily increases coronary blood flow is used to mimic the increase in coronary blood flow caused by exercise. Regadenoson is being studied for potential use as a pharmacologic agent under these circumstances.

Astellas Pharma US, Inc. / CV Therapeutics Inc. Collaboration

Under a collaboration agreement providing Astellas with exclusive North American rights to regadenoson, CV Therapeutics manages the clinical development program and Astellas is responsible for all commercial activities for regadenoson in North America, if the product is approved for marketing. Under the arrangement, Astellas reimburses CV Therapeutics for 75 percent of development costs and CV Therapeutics will receive a royalty on product sales of regadenoson, if approved, and may receive a royalty on another product. CV Therapeutics owns the rights for regadenoson outside of North America.

About Regadenoson

Regadenoson is a selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in MPI studies. Regadenoson has been designed to be delivered rapidly as a bolus and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., a US subsidiary of Tokyo-based Astellas Pharma Inc., is a research-based pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Established on April 1, 2005, the company was formed through a merger that combined the outstanding research, development and marketing capabilities of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. Astellas ranks among the top 20 pharmaceutical companies in the world and will continue to grow as a competitive company in the world pharmaceutical market. For more information on Astellas Pharma US, Inc., go to www.astellas.com/us .

Astellas currently markets Adenoscan® (adenosine injection), the leading agent for MPI studies in the United States. Adenoscan is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The most common side effects include flushing, chest discomfort, and dyspnea. Less frequent side effects reported in patients administered Adenoscan include second and third degree AV block, fatal cardiac arrest, ventricular tachycardia, and nonfatal myocardial infarction. For full prescribing information, please visit www.adenoscan.com .

About CV Therapeutics

CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.

CV Therapeutics' approved product, Ranexa® (ranolazine extended-release tablets) is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.

CV Therapeutics also has other clinical and preclinical drug development candidates and programs, including regadenoson, which is being developed for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies and CVT-6883, which is being developed as a potential treatment for asthma and other conditions. Regadenoson and CVT-6883 have not been determined by any regulatory authorities to be safe or effective in humans for any use.

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including; the conduct and timing of studies; timing of regulatory submissions; timing of regulatory review and approval; commercialization of products; market acceptance of products; intellectual property protection and disputes; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.