Daiichi Sankyo

Daiichi, ArQule ink $75M development pact

Maureen Martino — Mon, 10 Nov 2008 10:38:44 -0500

ArQule and Daiichi Sankyo have formed an R&D partnership with two separate agreements. First, Daiichi will give ArQule $60 million up front and additional sales and milestone payments to co-develop ARQ 197, a cancer treatment. The companies will collaborate on the drug in the U.S., Europe, South America and the rest of the world, excluding certain parts of Asia where Kyowa has exclusive rights to the drug.

In addition, Daiichi will pay $15 million for use of ArQule's kinase inhibitor discovery platform to develop new cancer therapies. Daiichi will have the option to license two compounds directed to targets identified using this discovery platform.

"For ArQule, this strategic relationship will achieve several product development, scientific and financial objectives," said Paolo Pucci (photo), chief executive officer of ArQule. "First, it will allow us to optimize a clinical program with ARQ 197 that elicits the full therapeutic potential of this highly selective c-Met inhibitor. Second, it supports and further validates the application of our proprietary technology platform to the discovery of a new generation of selective inhibitors of kinases implicated in cancer. Finally, it provides meaningful, non-dilutive infusions of cash, as well as an opportunity for cost sharing."

- see this release for more

Daiichi, Lilly: still no word on prasugrel

Maureen Martino — Fri, 17 Oct 2008 10:44:50 -0400

Responding to "recent media speculation regarding the status of the prasugrel new drug application," Eli Lilly and Daiichi Sankyo said they still have received no word about the fate of prasugrel, a potential blockbuster anti-clotting drug that would compete with Plavix if approved. "If approved" being the key words there. The companies have been waiting for some time for an answer. In September, the FDA once again delayed a decision after initially postponing it in June. Clinical data on prasugrel showed the drug outperformed Plavix but also increased the the risk of bleeding.

"Daiichi Sankyo and Eli Lilly reiterated today that they continue to have discussions with the FDA regarding the review of this application. The companies have not been notified of any regulatory action for the new drug application or of any decision to have an advisory committee to review prasugrel," the companies said in a joint statement.

- see the release for more

FDA again delays prasugrel decision

John Carroll — Mon, 29 Sep 2008 12:51:26 -0400

Analysts were in for a surprise with the news that the FDA is once again delaying any decision on prasugrel, a potential blockbuster anti-clotting drug developed by Eli Lilly and Daiichi Sankyo. The agency said last June it would need three extra months to review the drug, and now it says regulators need even more time.

Some of the analysts haven't lost hope, though, saying that absent an agency request for more data, any delay should be relatively short. But J.P. Morgan's Chris Schott has been sounding a cautionary note on that score. The Wall Street Journal, meanwhile, notes that the folks at Sanofi-Aventis and Bristol-Myers can only be ecstatic to hear that Plavix gets another stay on any new competition.

- check out the Lilly and Sankyo release
- read the report from the Wall Street Journal

Daiichi Sankyo and Ranbaxy - Billion-dollar deals

Maureen Martino — Wed, 23 Jul 2008 08:41:17 -0400

Who: Daiichi Sankyo
With: Ranbaxy
What: $4.6B buyout

Scoop: Takeda wasn't the only Japanese drugmaker to ink a billion-dollar deal. In a $4.6 billion deal, Daiichi Sanyko bought Indian powerhouse Ranbaxy. That move positions Daiichi Sankyo to become a major supplier of low-priced generics to Japan's aging population and accelerates a trend by Japanese pharma companies to enter emerging Asian markets, where they see much of their future growth. Ranbaxy, as part of Daiichi, will get to further expand its efforts to become a research-based drug developer.

FDA delays review of Eli Lilly’s would-be blockbuster

John Carroll — Tue, 24 Jun 2008 10:24:40 -0400

Shares of Eli Lilly slipped slightly after the FDA announced that it would extend its review of the closely watched anti-clotting drug prasugrel by three months. Daiichi Sankyo and Lilly both believe they have a potential blockbuster on their hands. And the two companies also confirmed plans to launch a late-stage trial that would compare the effectiveness of prasugrel with Plavix, the standard therapy in the field.

Data on prasugrel indicates that the drug can work better than Plavix in preventing clots, but it also increases the risk of bleeding in some patients. For analysts, that kind of safety risk is likely to lead the FDA to limit use of the drug to a more narrowly defined patient population. But the market potential remains large.

- read the release on the delay
- check out the Dow Jones report

Relaed Articles:
Prasugrel gets priority review
Lilly submits prasugrel NDA
Lilly drug outperforms Plavix, but there's a catch
Doubters see big obstacles for Lilly's prasugrel
Lilly pits drug against Plavix in trial

Report: Pfizer makes counter-offer for Ranbaxy

Maureen Martino — Fri, 13 Jun 2008 10:06:09 -0400

Pfizer may be crashing Daiichi Sankyo's party. Business Standard is reporting that Pfizer is considering a counter-offer for Ranbaxy, India's largest drugmaker. The rumor comes on the heels of the $4.6 billion offer Daiichi made just two days ago. Sources say Pfizer may "make a bid for 41.3 percent of the company from institutions and another 21.2 percent from individual shareholders." None of the companies involved have confirmed the rumors.

So why would Pfizer be interested in Ranbaxy? It turns out that there are plenty of reasons. An acquisition of Ranbaxy would give the world's largest drugmaker a big slice of the hot generic drug market. The other big reason? Lipitor. Ranbaxy is planning to launch a generic version of the $10.1 billion-a-year earner in 2010, and wouldn't it be nice for Pfizer if it could control that bit of competition? There's no word on what Ranbaxy's thoughts are on the deal. Ranbaxy says the deal is already done and that it's too late for Pfizer to make a bid, but this battle may just be getting started.

- read the WSJ report
- here's a Forbes article for more

Daiichi Sankyo acquires Ranbaxy in $4.6B deal

John Carroll — Wed, 11 Jun 2008 11:12:29 -0400

Ranbaxy's drive to become a research-based drug developer and major manufacturer has led it straight into the welcoming arms of Japan's Daiichi Sankyo, which announced it is buying a majority stake in the Indian pharma company. After Sankyo completes a buyout of the founding Singh family's stake in the company, Ranbaxy will become a subsidiary operation. The deal is valued at $4.6 billion and will create a combined company worth about $30 billion.

That move positions Daiichi Sankyo to become a major supplier of low-priced generics to Japan's aging population and accelerates a trend by Japanese pharma companies to enter emerging Asian markets, where they see much of their future growth. The acquisition stunned investors and analysts alike, who were caught off guard by a bold move from a conservative player in the industry.

- check out this release for more on the deal
- read the report from The Times

Daiichi snares Germany's U3 in $235M acquisition

Wed, 21 May 2008 06:59:58 -0400

Daiichi Sankyo is buying Germany's U3 Pharma for $235 million in cash. The Japanese pharma company gains a developer that's been winning kudos for its work developing antibodies to fight a variety of cancers. And its lead program is bound for the clinic later this year.

Edmond de Rothschild Investment Partners has been backing U3 since 2003, when it was won over by the research work of Axel Ullrich of the Max Planck Institute. Ullrich's research has helped create such cancer blockbusters as Herceptin and Sutent.

"Our acquisition of U3 Pharma is an ideal strategic fit for our oncology portfolio," said Takashi Shoda, president and CEO of Daiichi Sankyo. "We currently have three human monoclonal antibodies in development. Additionally, in March, 2008, we announced that we were expanding our joint research venture with another German company, MorphoSys, for its advanced Human Combinatorial Antibody Library and its phage display technologies."

- check out the press release
- read the AFX report

ALSO NOTED: FDA OKs Novalar therapy; StemCells files new patent suit; and much more...

Mon, 12 May 2008 06:59:50 -0400

> The FDA has OK'd Novalar's OraVerse (phentolamine mesylate) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. Novalar release

> StemCells has filed its second patent suit against Neuralstem claiming two human neural stem cells patents were violated. Report

> Takeda and Affymax have posted more positive mid-stage data for their experimental anemia therapy. Release

> Pipex Pharmaceuticals is reporting that the FDA has provided orphan drug status for oral tetrathiomolybdate as a therapy for Idiopathic Pulmonary Fibrosis. Pipex release

> Forest Laboratories and Daiichi Sankyo have ended a co-promotion deal for Azor, a combo therapy of two antihypertensives. Forest release

> Big-name cholesterol meds are losing ground on two fronts. Report

> Politics are clouding the process of tracing contaminated heparin back to its source or sources--politics that go way beyond the typical Democrats-versus-Republicans grandstanding. Report

> With Big Pharma cutting back, CMOs are picking up the slack. The worldwide market for biopharmaceutical contract manufacturing reached $2.4 billion in 2007, a year-over-year leap of 14 percent. CMO report

> Back in 2005, Swedish pharma monitors raised a red flag on GSK's HIV fighter abacavir and its possible link to heart attacks, The Independent is reporting. Report

> According to India-based Dr. Reddy's CEO, the U.S.'s financing industry is "a complete mess." Report

And Finally... Depressed teens that self-medicate with marijuana only trigger more serious mental ailments. Release

Prasugrel gets priority review

Fri, 22 Feb 2008 06:59:56 -0500

The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. The NDA for prasugrel was submitted to the agency in December. Now the drugmakers can expect an FDA ruling in just six months, rather than the 10 months is usually takes for a drug to receive approval. Lilly has a lot riding on prasugrel's approval, as many industry watchers say the company has no other blockbuster hopefuls in its pipeline. Both companies' shares rose on the news.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

- see this release
- check out the Wall Street Journal article for more

Lilly submits prasugrel NDA

Fri, 04 Jan 2008 06:59:58 -0500

Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. In a recent study prasugrel was more efficient than Plavix at reducing the number of heart attacks and other significant events. However, an increased number of bleeding incidents among the prasugrel group cast a shadow over the results. 1.7 percent of patients taking Plavix experienced serious bleeding incidents, compared to 2.2 percent of prasugrel patients.

FDA approval is crucial for Lilly; analysts say the company has no other blockbuster hopefuls in its pipeline, and patent expirations could eat away at 60 percent of its revenue in the coming years. The hope is that the FDA thinks prasugrel's benefits outweigh the increased bleeding risk. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008," said one Lilly VP. If approved, the drug will be marketed under the name Effient.

- check out this release for more
- read this article from Forbes

ALSO: TAP Pharmaceutical has submitted an NDA for TAK-390MR for the treatment of acid related diseases. Release

PLUS: Takeda has submitted an NDA for its type 2 diabetes drug alogliptin. Release

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Doubters see big obstacles for Lilly's prasugrel. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Lilly suspends dosing in crucial drug trial

Thu, 25 Oct 2007 06:59:58 -0400

Eli Lilly and its partner Daiichi Sankyo moved swiftly to try and contain any damage from the news that they were suspending dosing in two small trials of the blood clot preventer prasugrel--one of Lilly's most closely watched experimental programs. Officials insisted that the suspension--which was made to consider an adjustment of dosages for certain patients--would have no effect on their development timeline. That wasn't enough for investors, though, who pushed down Lilly's stock by four percent on the news. Prasrugel is considered a key program for Lilly's future, with the potential to compete against the blockbuster Sanofi-Aventis' Plavix--which earned $6 billion last year.

- see Lilly's release on the suspended trial
- check out the report from Forbes

Related Articles:
Lilly pits drug against Plavix in trial. Report
Eli Lilly forges $1B diabetes deal. Report
Daiichi aims for 60 percent growth. Report
In speech, Lilly CEO calls for drug monitoring. Report
Lilly developing biotech drugs the old-fashioned way. Report

ALSO NOTED: Agensys gains $41M of venture funds; Endo patch fails trials; Barrier reports positive data; and much more...

Thu, 12 Jul 2007 06:59:50 -0400

> The therapeutic antibody company Agensys has raised $41 million in its fourth round of venture capital. Duquesne Capital Management and Jafco co-led the round. Release

> Endo Pharmaceuticals has had to withdraw its blueprint for developing a skin patch to treat pain and inflammation patch after it failed two late-stage studies. Endo had expected to file for approval in the first half of next year. Report

> Barrier Therapeutics announced positive results from its completed Phase 2 dose-finding study of Oral Rambazole in moderate to severe psoriasis. Release

> Germany's Eppendorf is taking New Brunswick Scientific private in a deal valued at $110 million. NBS is a provider of biotech research equipment. Release

> Bioheart has boosted the size of its IPO, increasing its expected gain to $45 million. Report

> Amgen has granted Daiichi Sankyo exclusive rights to develop and commercialize denosumab in Japan in post-menopausal osteoporosis and oncology with the potential for additional indications. Release

> Labopharm and Paladin Labs announced that they have completed a licensing and distribution agreement which grants Paladin the exclusive right to market Labopharm's once-daily tramadol product in Canada. Labopharm will retain co-promotion rights. Release

> Pharmasset earned a $7.5 million payday from Roche in their collaboration on a new therapy for hepatitis C. Release

> Genentech has once again beat The Street, seeing earnings swell 41 percent in the second quarter. Report

And Finally... A pilot program is paying doctors a bonus for saving Medicare money. Article

ALSO NOTED: Daiichi Sankyo files supplemental NDA; BioSante launches Phase III trial; and much more...

Mon, 01 Jan 2007 19:01:30 -0500

> Daiichi Sankyo has filed a supplemental NDA with the FDA, looking for approval to use WelChol to improve glycemic control. Report

> Antares Pharma's development partner, BioSante Pharmaceuticals, has initiated a Phase III safety and efficacy trial of Antares' transdermal testosterone gel for the treatment of FSD. Release

> pSivida has been released from a loan covenant. Release

> Biomira has begun enrolling patients for a Phase II pancreatic cancer study. Release

And Finally… Dr. Gilbert Welch says that part of what afflicts Americans is an epidemic of diagnoses. Editorial

DEALS: Ligand sells cancer drugs for $205M

Wed, 13 Sep 2006 20:01:32 -0400

Ligand sells cancer drugs for $205M

DEALS
WHO	WITH	WHAT	SCOOP
Ligand Pharmaceuticals	Eisai	$205M sale	Ligand Pharmaceuticals has sold a line of cancer drugs to Eisai.
Daiichi Sankyo	Kearney Venture Partners	$60M investment	The deal allows Daiichi to strike collaborations with the biotech companies who gain funds from the venture group.
Sankyo	Ajinomoto	Licensing deal	Sankyo has gained the exclusive global rights to develop, manufacture and market the new diabetes drug AJD101.
Omeros	Nura	Cash/stock buyout	Omeros' acquisition will add Nura's work in schizophrenia and Parkinson's disease. The three investors in Nura are making an unspecified but "large" investment in Omeros.
Genzyme	AnorMed	Hostile takeover	Genzyme says it will pursue a hostile takeover of AnorMed with a tender offer of $8.55 per share, a 70 percent premium on the Canadian biotech's trading price.

ALSO NOTED: Daiichi Sankyo invests in venture fund; ImaRx sets IPO terms; and much more...

Thu, 07 Sep 2006 20:01:30 -0400

> Daiichi Sankyo plans to invest $60 million into a $180 million, 10-year venture fund run by Kearney Venture Partners. The deal allows Daiichi to strike collaborations with the biotech companies who gain funds from the venture group. Release

> ImaRx Therapeutics has set the terms of its IPO of 5 million shares at $10 to $12 each. Much of the $49 million the company hopes to net will go to product development and debt repayment. Report

> Trimeris of Morrisville, NC and Roche have extended their research pact for two distinct peptide classes. Report

> Barr Pharmaceuticals has filed a new offer in the bidding war for Pliva. Report

> The board of Discovery Partners International has approved a four-to-one stock split linked to its merger with Infinity Pharmaceuticals. Report

> Labopharm is preparing to unveil new Phase III safety data for tramadol that it says will support its effort to gain approvals for the pain therapy. Release

And Finally... A new study from Mount Sinai Medical Center resolves any lingering doubt that may exist about the link between the dust kicked up by the World Trade Center attack and persistent illnesses suffered by rescue workers. Article

ALSO NOTED: FDA chief still faces obstacles; FDA approves Keppra; Northfield Labs finishes PolyHeme enrollment; and much more..

Tue, 01 Aug 2006 20:00:50 -0400

> Just because the FDA appears to be moving toward allowing Plan B to go OTC, don't expect Democrats to stop blocking Dr. Andrew von Eschenbach's nomination to run the agency. They want a firm decision on the contraceptive, saying they were misled in the past. Report

> UCB says that the FDA has approved Keppra intravenous for epilepsy. Report

> Northfield Laboratories had an uphill climb, but they finished enrolling for a late-stage trial of their controversial blood substitute PolyHeme. Report

> Japan's Daiichi Sankyo is suing Mylan over its plans to make a copycat version of its hypertensive drug Benicar. Report

> Cerexa says it received positive Phase II data on Ceftaroline for the treatment of complicated skin and skin structure infections. Release

> Pain Therapeutics and King Pharmaceuticals have commenced a Phase I trial of the pain therapy PTI-202. Report

> ISTA Pharmaceuticals has agreed to pay $6 million up front plus royalties for the North American rights to bepotastine from Senju Pharmaceutical. Report

And Finally… Researchers have been exploring testicular cancer at the molecular level to see why it responds so well to treatment when other metastatic cancers are resistant. Article

KAI garners $35M in VC

Mon, 01 May 2006 20:01:36 -0400

South San Francisco-based KAI Pharmaceuticals--a 2006 Fierce 15 company--has landed a $35 million Series B, primarily for the development of its protein kinase C therapeutics. KAI Pharmaceuticals' lead product, KAI-9803, is a selective delta PKC inhibitor designed to reduce ischemia and reperfusion injury as an adjunct to current treatments for acute myocardial infarction. The company recently completed enrollment of a 150 patient Phase I/II clinical trial for KAI-9803.

"This financing, at an increased valuation, and funding from our recent collaboration with Daiichi-Sankyo, position the company to meet its primary development goals, including the filing of an IND for at least one program each year through 2008," said Steven P. James, president and CEO of KAI Pharmaceuticals.

- here's the release on KAI's second round

DEALS: GSK, Sirna sign $700M development deal

Wed, 12 Apr 2006 20:01:32 -0400

GSK, Sirna sign $700M development deal

DEALS
WHO	WITH	WHAT	SCOOP
GSK	Sirna Therapeutics	Development deal	Sirna Therapeutics will develop RNAi therapies for respiratory diseases in a deal worth up to $700 million.
GSK	Pharmacopeia	Research agreement	GSK will pay Pharmacopeia $15 million and the companies will collaborate to deliver therapeutic candidates for development.
Abbott	Myriad Genetics	Research agreement	Abbott and Myriad Genetics have entered into a five-year research agreement to identify new therapeutic targets
Ono Pharmaceutical	Medarex	Development deal	The companies will develop a fully human anti-SDF-1 antibody.
EPIX	Predix	Merger	EPIX will pay $90 million for Predix and gain several advanced clinical programs.
Adventrx Pharmaceuticals	SD Pharmaceuticals	Buyout	Adventrx Pharmaceuticals will buy SD Pharmaceuticals for 2.1 million Adventrx shares. Adventrx will gain rights to eight oncology and infectious disease products.
Daiichi Sankyo	Astellas	Purchase	Daiichi Sankyo has purchased the OTC unit of Astellas for 20 billion yen.
Biogen Idec	Astellas Pharma	Sale	Biogen Idec sold its underperforming psoriasis drug Amevive for $60 million to Astella as part of Biogen's restructuring plan, announced last fall as it grappled with Tysabri problems.
GSK	Kissei	Licensing deal	GSK will pay up to $98 million for Kissei's experimental diabetes drug, which is still in the preclinical stage.
Santen Pharmaceutical	Oakwood	Licensing deal	Santen has licensed the microsphere formulation of a steroid (DE-102) for diabetic macular edema from Oakwood.
AlphaRx	Proprius Pharmaceuticals	Licensing deal	The companies have entered into a license agreement giving Proprius exclusive global rights to AlphaRx's topical NSAID, Indaflex, currently in Phase II trials for osteoarthritis.

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