Astellas

Maxygen inks $180M deal with Astellas

John Carroll — Fri, 19 Sep 2008 09:50:02 -0400

Maxygen is pocketing a $10 million upfront fee from Japan's Astellas for marketing rights to its Maxy-4 therapies--a preclinical program focused on developing a next-generation CTLA4-Ig protein for autoimmune diseases. Astellas will also pay up to $160 million in milestones while Maxygen retains an option on North American co-promotion rights. If Maxygen chooses to take the co-promotion option, the two companies will share profits in place of a royalty payment. Astellas will also foot the first $10 million for certain preclinical development costs and the two companies will split the remaining expenses.

The Maxy-4 proteins in development are intended to reduce T cell activation, reducing the immune response that plays a role in rheumatoid arthritis, transplant rejection and more.

"Our MolecularBreeding platform has yielded promising candidates for the treatment of autoimmune disease and transplant rejection," said Russell Howard, chief executive officer of Maxygen. "Astellas is an excellent partner to help us develop and commercialize this program."

- check out Maxygen's release
- read the AP story

Cardiome shares plunge on approvable letter

John Carroll — Mon, 11 Aug 2008 11:41:46 -0400

After riding high on the news of positive data from a recent Phase IIb trial, shares of Cardiome Pharma swiftly sank 30 percent after investors heard that the FDA's "approvable" letter for Kynapid (vernakalant)--co-developed with Astellas--included a request for more information on the drug's impact on a subset of patients in trials and a safety update on users.

"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, CEO and chairman. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."

- check out the Cardiome's release
- read the report from the Globe and Mail

Astellas inks $537M deal for Agensys

Tue, 27 Nov 2007 06:59:58 -0500

Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. The deal gives Astellas new antibody technology for combating cancer. Agensys has a Phase Ib trial underway for one antibody plus several more preclinical candidates. Astellas is betting that antibodies will play an ever-growing role in cancer treatments, which are expected to command a $32 billion market by 2015.

"Agensys will be the cornerstone of our biologics efforts and an integral component of building our oncology efforts within our franchise," explained Masafumi Nogimori, CEO of Astellas.

- see this release for more
- check out the report on the deal

Related Articles:
Astellas faces FDA delay on reformulated Prograf. Report
Cardiome, Astellas get panel date. Report
Agensys gains $41M in venture funds. Report

FDA wants more data on Theravance antibiotic

Mon, 22 Oct 2007 06:59:54 -0400

The FDA outlined new information it would need from Theravance and Astellas before it can fully approve telavancin, a new antibiotic that can be used against 'superbug' staph infections. But researchers say that the companies would not need to mount a new clinical trial in order to satisfy the FDA's demands. The FDA's letter includes a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices.

"We are committed to submitting a timely and complete response to this approvable letter," said Rick E. Winningham, the chief executive of Theravance. "We will work with the FDA to resolve the outstanding issues and to ensure a label that accurately reflects the data from our clinical studies, which included the largest group of patients with cSSSI and the largest group of patients infected with MRSA (superbug staph) ever studied." Theravance was a 2003 Fierce 15 company.

- take a look at the release

Related Articles:
Theravance trumpets positive results of mid-stage trial. Report
Astellas take a pass on Theravance's drugs. Report
CDC estimates 94,000 staph infections occurred in 2005. 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

Nereus gains $45M in D-2 round for cancer drugs

Thu, 09 Aug 2007 06:59:54 -0400

Nereus Pharmaceuticals gained $45 million in new backing in what is billed as a "D-2" round. The lead investor in the San Diego-based developer of novel cancer therapies was BankInvest Biomedical Venture of Copenhagen. Six new investors, BankInvest, Roche Venture Fund, Astellas Venture Management, Boston Life Science Venture Corporation, Taiwan Global Biofund and Eminent Venture Capital Corporation, joined the round.

The money will be drawn down in two tranches and used to complete Phase I and begin Phase II clinical trials for Nereus' two drug candidates. The first compound, NPI-2358, is being evaluated for the treatment of solid tumors and lymphomas in Phase I clinical trials. It is a selective tumor vascular disrupting agent, a class of compounds that represents a novel approach to disrupting the intrinsic tumor blood flow, which leads to tumor cell death. NPI-2358 has favorable preclinical characteristics, such as a longer duration of action on tumor blood flow, activity against multi-drug resistant tumor cell lines and a favorable preclinical toxicology profile. The compound is one of 200 analogues that were produced after finding activity and novel chemistry from a marine fungal extract.

- check out the release on the round

ALSO: Waltham, MA-based Adnexus Therapeutics raised $15.5 million in its third round. Release

Theravance trumpets positive results of mid-stage trial

Tue, 26 Jun 2007 00:01:34 -0400

Theravance says that its experimental therapy for chronic constipation met its endpoints for all three doses tested in a mid-stage, 400-patient trial. A total of 61 percent of the patients taking the 50 mg dose of TD-5108 responded with increased spontaneous bowel movements as did 60 percent of the patients take a 15 mg dose and 42 percent taking a 30 mg dose. In the placebo arm, 22 percent of patients responded. No serious adverse effects were recorded and headache, diarrhea, nausea and vomiting were listed as the most common side effects. GlaxoSmithKline has a license option for the therapy that dates back to 2004.

- see the release
- read the AP report on the data

Related Articles:
Theravance declares success in antibiotic trial. Report
Theravance, Astellas ink $65M deal. Report

Press Release: AtheroGenics to Present at JPMorgan Healthcare Conference

Maureen Martino — Fri, 05 Jan 2007 11:28:47 -0500

AtheroGenics to Present at JPMorgan Healthcare Conference on Wednesday, January 10, 2007

ATLANTA, GA -- January 04, 2007 -- AtheroGenics, Inc., a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced that Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer, will be presenting a company overview and update at the 25th Annual JPMorgan Healthcare Conference on Wednesday, January 10, 2007, at 10:30 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco, Calif.

A live audio webcast of the presentation will be available on the AtheroGenics Investor Relations Events website at http://www.atherogenics.com. A replay of the presentation will be available on the Company's website approximately twenty-four hours after the presentation and will be archived for thirty days.

About AtheroGenics

AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including heart disease (atherosclerosis), rheumatoid arthritis and asthma. The Company has two drug development programs currently in the clinic. AtheroGenics' lead compound, AGI-1067, is being evaluated in the pivotal Phase III ARISE clinical trial as an oral therapy for the treatment of atherosclerosis, in collaboration with AstraZeneca. AGI-1096 is a novel, oral agent in Phase I that is being developed for the prevention of organ transplant rejection in collaboration with Astellas. AtheroGenics also has preclinical programs in rheumatoid arthritis and asthma utilizing its proprietary vascular protectant® technology. For more information about AtheroGenics, please visit http://www.atherogenics.com.

Cardiome, Astellas revise deal for RSD 1235

Mon, 10 Jul 2006 20:01:35 -0400

Cardiome and Astellas have revised their development pact on RSD 1235, an experimental therapy for atrial fibrillation, the most common form of arrhythmia. The FDA had rejected their application for the drug last spring, citing inconsistencies and omissions in the data they provided. Developers blamed a clerical error. In the new agreement, Astellas will pay Cardiome $10 million when it files with the agency and will cover all the costs of revising the application. In their original agreement, Cardiome was to receive $10 million only if the FDA accepted the application for review. Cardiome CEO Bob Rieder called the new agreement an indication of Astellas' confidence in the therapy. Analysts have been waiting for upcoming data on a mid-stage clinical trial of an oral formulation of RSD 1235.

- here's the article on the deal from the Globe and Mail

ALSO NOTED: Group backs Gardasil; Astellas halts program; and much more...

Thu, 29 Jun 2006 20:00:50 -0400

> A key federal advisory group has endorsed Merck's cervical cancer vaccine, Gardasil. The vote by the Advisory Committee for Immunization Practices makes it likely that the government will covering the cost of the shot. Insurers like Wellpoint have already begun to issue coverage approvals, setting up Gardasil as a blockbuster with an estimated potential of $3 billion a year. Report

> Astellas has pulled the plug on the experimental immunosuppressant drug FK778 after disappointing Phase II data failed to demonstrate clear superiority over other therapies. Report

> Skyepharma has licensed the European rights to DepoBupivacaine. Release

> Par Pharmaceuticals has received FDA approval for a generic version of GSK's depression drug Parnate. Report

> Eli Lilly and Company has licensed Admensa Interactive from Inpharmatica. Release

And Finally… The backlash against Europe's animal rights activists has set in. Article

Ilypsa signs $92 million licensing deal

Wed, 26 Apr 2006 20:01:38 -0400

Ilypsa of Santa Clara, CA has inked a $92 million licensing deal for the Japanese rights to its experimental drug for hyperphosphatemia. Astellas will pay $22 million of that up front for ILY101, with the rest in milestones as the drug advances. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. Ilypsa wrapped a Phase I safety study on ILY101 only days ago and plans to launch a mid-stage trial in the next few months. Biotech companies often start the licensing process in Japan, where drug makers have their own drug approval process to deal with. Astellas will start its own Phase I trial this year.

- read the release on the licensing pact

SPOTLIGHT: Daiichi Sankyo buys OTC business

Thu, 30 Mar 2006 19:01:33 -0500

Daiichi Sankyo has inked a deal to buy the OTC unit of Astellas--Zepharma--for 20 billion yen. Report

ALSO NOTED: J&J sent back to do more research; Barrier Therapeutics wins FDA OK; and much more...

Thu, 16 Feb 2006 19:00:50 -0500

> The FDA has determined that more study of blood clotting risks is needed before it can take action on Johnson & Johnson's birth control patch. Report

> The FDA has approved Barrier Therapeutics' Vusion for the treatment of diaper dermatitis complicated by candidiasis. Report

> DURECT announced that its ready to launch a Phase III trial of the pain therapy Remoxy following a special protocol assessment with the FDA. Release

> Medigene has earned a milestone payment from Astellas following the launch of Eligard for prostate cancer in France. Report

> The antibiotic Tequin from Bristol-Myers Squibb will carry stronger safety warnings. Report

And Finally... A group of states is considering laws requiring drug makers to disclose all the gifts they make to physicians, hospitals and pharmacists. Article

ALSO NOTED: Gilmartin to testify; Dr. Reddy's inks deal with Merck; and much more...

Tue, 31 Jan 2006 19:00:50 -0500

> Former Merck CEO Raymond Gilmartin has agreed to testify in an upcoming Vioxx trial. Report

> Dr. Reddy's has signed a deal with Merck to produce two authorized generics once the therapies come off patent. Report

> Symphogen of Denmark and Biovitrum of Sweden have entered into a co-development and commercialization agreement for Sym001, Symphogen's lead product. Release

> Astellas has inked a marketing deal with Ferring Pharmaceuticals for Ferring's prostate cancer drug. Report

> Altea Therapeutics has signed a licensing deal for Japan with Teikoku Seiyaku to develop and commercialize a new transdermal patch therapy that utilizes the Altea Therapeutics PassPort transdermal technology for Parkinson's. Report

> Bio-Bridge has released "encouraging" pre-clinical data for an experimental HIV vaccine. Release

And Finally... Researchers say that married women who touch their husband's hands during a time of emotional distress immediately feel comforted, which helps explain why married couples generally enjoy better health than singles. Article

DEALS: Astellas pays Theravance $65M for antibiotic

Wed, 09 Nov 2005 19:01:32 -0500

Astellas, Theravance sign co-development agreement

DEALS
WHO	WITH	WHAT	SCOOP
Astellas	Theravance	Co-development and marketing deal	The deal involves Theravance's antibiotic telavancin. Astellas will pay $65M upfront and up to $156M in clinical and regulatory milestones.
Kos Life Sciences	Jerini	Marketing and distribution deal	The companies will develop, market and distribute Jerini's compound, Icatibant, in the US and Canada.
DOR BioPharma	Gastrotech Pharma	Dor to buy Gastrotech for $9M in stock	Gastrotech develops therapeutics based on peptide hormones to treat cancer and gastrointestinal diseases.
Novartis	Senju	Co-development and marketing deal	Novartis announced that it has signed a deal with Senju Pharmaceutical to develop and market Senju's glaucoma treatment Y39983.
Introgen	Colgate-Palmolive	Co-development deal	Introgen and Colgate-Palmolive will develop a mouthwash therapy for pre-cancerous conditions of the mouth and oral cancer.

Cardiome unveils dramatic results for atrial fibrillation therapy

Thu, 29 Sep 2005 20:01:38 -0400

Canada's Cardiome and development partner Astellas said that a new set of Phase III data for their heart drug RSD1235 shows that 52 percent of patients with abnormal heartbeats--or atrial fibrillation--developed regular heartbeats after taking the drug. Only 4 percent of the patients taking a placebo saw their heartbeats return to normal. Those results are in line with an earlier Phase III data and create a case the drug companies will now present to the FDA. Cardiome shares were boosted by the results, which were disclosed after markets closed on Thursday.

- read this feature from Canada.com for more

CV Therapeutics touts heart-imaging drug's Phase III data

Wed, 10 Aug 2005 20:01:37 -0400

Palo Alto, California-based CV Therapeutics announced that its heart-imaging drug met the primary endpoint in a Phase III pivotal trial. Regadenoson is intended to increase blood flow and dilate coronary arteries so that a scan will reveal any threatening blockages and restrictions. Many patients increase their blood flow for the procedure with exercise, but a large group are physically incapable of doing it. The trial compared Regadenoson to Adenoscan from Astellas, which is partnered with CV on developing Regadenoson. A second Phase III trial is currently underway.

- read this story from the San Francisco Business Times for more

ALSO NOTED: FDA accepts Tarceva sNDA; Verus licenses Twinject; StemCells gains stake in ReNeuron; and much more...

Tue, 05 Jul 2005 20:00:50 -0400

> The FDA has accepted OSI Pharmaceuticals' supplemental NDA for Tarceva -- with chemotherapy -- to treat pancreatic cancer. The FDA has six months to make a decision. Article

> San Diego-based Verus has licensed Twinject from Hollister-Stier Laboratories. Twinject -- approved by the FDA in 2003 -- is a novel epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions. Release

> StemCells has licensed its method for handling human neural stem cells to ReNeuron in exchange for a stake in the company. Story

> A judge has turned down Merck's bid for a two-month delay in the first trial over Vioxx, rejecting the drug giant's argument that news of the Texas attorney general's suit against Merck made it impossible to obtain a fair hearing of the issue. Story

> Schering-Plough has opened commercial operations in Pakistan and Korea. Release

> The standard test for prostate cancer is inaccurate and a poor tool for determining if men are cancer free, according to researchers. Article

> Toronto-based Lorus Therapeutics has wrapped a Phase III trial of Virulizin for pancreatic cancer. Results are expected in late 2005. Release

> Astellas has terminated a deal with QLT regarding the licensing and supply of the acne treatment Aczone in North America. Report

> West Pharmaceuticals is buying Medimop Medical Products, which makes devices for injectable drugs, for $40 million. Report

> In order to enhance the independence of Mylan's board of directors, two senior executives have resigned their posts on the board, leaving nine members. Article

And Finally... Health officials in the UK have produced a cancer "map" of the country, showing how high levels of smoking and drinking in some communities have triggered higher concentrations of the disease. Article

ALSO NOTED: FDA studies blindness; Roche gets OK for HIV drug; FDA approves Zemplar; and much more...

Thu, 26 May 2005 20:00:50 -0400

> The FDA is examining a handful of cases in which men taking Viagra have gone blind. The agency says that there is currently no known link, but that it will investigate. Story

> Roche has received European marketing approval for 500 mg formulation of the HIV drug Invirase. Story

> The FDA has approved Abbott's Zemplar (paricalcitol) for the prevention and treatment of secondary hyperparathyroidism. Release

> The FDA has approved Novartis Pharmaceuticals' extended release form of Focalin for ADHD, which is licensed from Celgene. Story

> Ariad has begun its first clinical trial of oral AP23573 in patients with relapsed or refractory cancers. Release

> NovaDel Pharma of Flemington, New Jersey, raised $7 million in a private placement. Release

> Santarus has filed an NDA for Zegerid chewable tablets. Release

> King Pharmaceuticals and Astellas have filed suit against several generic drug makers following their ANDA for Adenoscan, a pharmacologic stress agent. Release

And Finally... A group of scientists is challenging new research claiming that people who are slightly overweight live longer. Story