Bayer Schering

Bayer AG grabs Direvo in $298M buyout

John Carroll — Tue, 16 Sep 2008 11:58:57 -0400

Germany's Bayer AG has snapped up the protein engineering company Direvo for $298 million. The acquisition, one in a series of planned buyouts, is designed to bolster the biologics work being done by Bayer Schering. Direvo's protein engineering drug platform will be deployed to find new therapeutic candidates. Bayer says the work will be integrated into the company's existing R&D infrastructure. Analysts note that Bayer has said it wants to make a number of smaller purchases to complement its R&D efforts following the 2006 acquisition of Schering.

"Today Bayer Schering Pharma is among the top 10 (biological drug) companies in the world," said Arthur Higgins, the chief executive of Bayer Health Care said in the statement. "We are committed to further strengthen our biologicals portfolio, and Direvo's leadership in protein engineering provides promising opportunities for further business growth."

Bayer also announced that it has won its first regulatory clearance for the blood-thinning drug Xarelto in Canada.

- read the story from the International Herald Tribune

Epix regains commercialization rights to Vasovist

John Carroll — Thu, 04 Sep 2008 10:42:38 -0400

Bayer Schering Pharma is handing back the worldwide commercialization rights to Epix's Vasovist, an MRA agent that has yet to win FDA approval. Their deal ends on March 1, 2009 and Bayer Schering will continue to supply Vasovist to the 19 countries where it is marketed. The FDA had rejected Vasovist, saying that it needed additional testing. Epix resubmitted its NDA earlier this year.

"We are pleased to regain complete worldwide commercial rights for Vasovist which has a PDUFA date of December 31, 2008," said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. "Pending FDA approval, Vasovist is positioned to become the first MRA contrast agent approved in the United States and it could be launched in 2009. Our goal remains to maximize the commercial value of Vasovist and we are committed to executing our monetization strategy which includes finding a marketing and commercialization partner for Vasovist."

- here's the release from Epix
- read the story from the Boston Globe

Bayer strikes deal for Nycomed cancer therapies

John Carroll — Fri, 08 Aug 2008 10:20:58 -0400

A Swiss company's decision to drop its cancer programs will help Bayer beef up its oncology pipeline. Bayer has agreed to buy Nycomed's preclinical cancer therapies in a deal worth up to €52 million. The deal covers two preclinical drug candidates and back-up therapeutics that target a kinase involved in the growth of cancer cells. Bayer Schering Pharma assumes full development and marketing rights.

Bayer discovery chief Andreas Busch says that the acquisition is complementary to the pharma company's oncology work. Bayer's Nexavar is a kinase inhibitor that helps prevent the growth of new blood vessels that feed tumors. Nycomed announced earlier this year that it was getting out of the cancer arena to focus on other programs. 4SC bought eight of its oncology programs in June.

- read the AFX report
- read the report from PharmaTimes

CHMP recommends Bayer's Xarelto

Maureen Martino — Fri, 25 Jul 2008 11:35:46 -0400

CHMP announced today the recommendation of Bayer's Xarelto, known generically as rivaroxaban. Xarelto, a blood-thinning pill to prevent clots in patients bedridden after major orthopedic surgery, is being developed jointly with J&J in the U.S. The companies recently announced the results of a study in which rivaroxaban was better than Sanofi's blockbuster Lovenox in preventing venous blood clots in knee replacement patients. The drug is one of Bayer's great pipeline hopes, and could have sales exceeding €2 billion in Europe if approved there.

"The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development program. We received it only nine months after the submission--very fast compared to average," said Dr. Kemal Malik, a member of the Bayer HealthCare Executive Committee. Final approval of the drug is expected in the next several months.

- see Bayer's release
- read this report form Forbes

Bayer dumps Titan drug on mid-stage failure

John Carroll — Wed, 02 Jul 2008 10:55:28 -0400

Titan Pharmaceuticals announced this morning that its Parkinson's drug Spheramine failed to hit primary and secondary endpoints in a Phase IIb trial for moderate to advanced Parkinson's disease. Researchers said there was no significant difference in response between the Spheramine group and the placebo arm. Titan says that it will analyze the data gathered on the 71 patients in the study.

Bayer, for its part, swiftly washed its hands of the program. "We will not develop (this drug) further and we will not invest in it further," said Bayer spokesman Jost Reinhard.

- see Titan's release
- read the report from RTT News
- and check out the story from AFX

Related Articles:
Titan discontinues Phase II
The Biotech Haunted House

Maxygen inks $120M deal for hemophilia program

John Carroll — Wed, 02 Jul 2008 09:42:20 -0400

Maxygen has inked a deal to sell its hemophilia drug development program to Bayer for $90 million upfront and up to $30 million in milestone payments. The program is still in the preclinical stage, with the blood clotting protein MAXY-VII scheduled for Phase I human trials in a matter of weeks. Bayer also gained the nonexclusive use of Maxygen's MolecularBreeding technology for 30 specific gene targets.

"The agreement fits into our growth strategy for our specialty pharmaceutical business and builds on our expertise in the commercialization and manufacturing of protein therapeutics," said Gunnar Reimann, a member of Bayer's executive committee.

For Bayer, the development program offers a direct shot at building up its stock of therapies for hemophiliacs. Bayer already sells the blockbuster Kogenate, but the drug triggers an immune response in 20 percent to 30 percent of patients that makes the therapy ineffective. Bayer earned €233 million on Kogenate in the first quarter.

- here's the release
- check out the report from RTT News

Bayer, J&J tout rivaroxaban data

Fri, 30 May 2008 06:59:58 -0400

In a head-to-head study against Sanofi's Lovenox, Bayer and J&J's oral anti-clotting drug rivaroxaban proved superior in preventing venous blood clots in patients who underwent total knee replacement surgery. Lovenox, which is the current standard of care, is given twice daily. "Only 6.9 percent of patients treated with Rivaroxaban experienced thomboembolisms, compared with 10.1 percent for the comparison group...This reflects a 31 percent decrease in relative risk," noted Dow Jones. This was the third trial to demonstrate the drug's superiority over Lovenox. An NDA is planned for the third quarter of this year. The drug is also being developed for stroke prevention in atrial fibrillation and VTE treatment.

- see the rivaroxaban release
- here's the Dow Jones brief

ALSO NOTED: Arqule hires new CEO; Kosan launches mid-stage study; and much more...

Tue, 15 Apr 2008 06:59:50 -0400

> Is the U.S. drug industry bargain-basement land right now? Analysts say that the low, low dollar means low, low prices for pharma companies. Rivals in Asia and the Eurozone could snap up drug companies just like they've bought up Manhattan condos. Report

> Chutes & Ladders: Arqule has hired Paolo Pucci, currently president of the Bayer-Schering Pharmaceuticals Global Oncology/Specialized Therapeutics divisions, as its new CEO. Pucci is taking over in June, following Stephen Hill, who was named the new CEO of Solvay. Report

> Kosan Biosciences has launched a mid-stage study of an experimental therapy for non-small cell lung cancer. Release

> Innogenetics has completed a $9.5 million settlement and licensing agreement with U.S. group Abbott Laboratories, ending a lawsuit. Story

> Medivir has entered into a co-promotions deal with GlaxoSmithKline for the Swedish market. Release

> AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. Report

> Remember that drug-safety database Congress required the FDA to set up? Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth. Report

> A few prominent research doctors are saying "No, thanks," to any payments from drug and device companies. Report

> The FDA's China office is slated to open next month. Report

And Finally... Contrary to what most of us would like to believe, decision-making may be a process handled to a large extent by unconscious mental activity. Release

Onyx shares tumble after Nexavar failure

Thu, 21 Feb 2008 06:59:55 -0500

The Motley Fool has been counting the casualties since Onyx and Bayer halted their trial for Nexavar as a therapy for non-small cell lung cancer. Onyx's stock has shed 31 percent of its value since Monday, with more losses yesterday. Nexavar has now proven itself for liver and kidney cancers with disappointing results for skin and lung cancer, taking some of the luster off of the prospects of the one-time wonder drug. There are still distinct possibilities for the therapy in lung cancer, though. A number of analysts have noted that Nexavar appears to be particularly unsuccessful in cases involving squamous cell cancer and future trials could exclude that group. Meanwhile, companies like OSI and AstraZeneca, which sell therapies for lung cancer, are being benefited by the latest news on Nexavar.

- read the report from MSNBC
- and here's the report from Thomson Financial

Related Articles:
Nexavar failure raises questions for developers. Report
Bayer stops Nexavar lung cancer trial. Report
Nexavar OK'd for use against liver cancer. Report
Bayer, Onyx tout Nexavar data. Report
Bayer, Onyx announce disappointing Nexavar results. Report

Nexavar failure raises questions for developers

Tue, 19 Feb 2008 06:59:57 -0500

Shares of Onyx Pharmaceuticals tanked on disappointing data from its latest cancer trial of Nexavar as a therapy for non-small cell lung cancer. With no hope of seeing data that patients lives were being extended, researchers shuttered a study of the drug. Forbes' Matthew Herper is raising a series of questions about the drug and the field. Should patients with squamous cell cancer have been excluded from the trial? Will the monitoring boards of two other lung cancer studies meet to review the consequences of this recent move? Should studies be modified to have a better chance of demonstrating a benefit to patients? Look for some answers as Onyx and Bayer, partners on the drug, address some severely disappointed investors.

TheStreet notes that Onyx has been the feel-good biotech story of 2007, seeing its stock rise a record 440 percent last year.

- see the release from Bayer
- check out the report from Forbes
- and here's the article from TheStreet

Related Articles:
Bayer stops Nexavar lung cancer trial. Report
Nexavar OK'd for use against liver cancer. Report
Bayer, Onyx tout Nexavar data. Report
Bayer, Onyx announce disappointing Nexavar results. Report

Dara BioSciences goes public in reverse merger

Wed, 13 Feb 2008 06:59:55 -0500

Dara BioSciences has completed a reverse merger with the nearly-defunct Point Therapeutics, taking the company public. In the deal Dara technically became a subsidiary of Point as a preliminary move to changing the combined company's name to Dara BioSciences. Point Therapeutics jettisoned its executive staff and all but two full-time employees after it shuttered a late-stage trial of talabostat for non-small cell lung cancer. Dara's shareholders control 96.4 percent of the combined company's stock.

- see this release
- read the report from MassHighTech

Related Articles:
DARA owners acquire troubled Point Therapeutics. Report
Dara licenses Bayer drugs. Report
More cuts at troubled Point Therapeutics. Report

Cell Therapeutics reorganizes, scales back R&D

Thu, 31 Jan 2008 06:59:58 -0500

Cell Therapeutics is scaling back its research plans for Xyotax and pixantrone, cutting one group of staffers and beefing up on the sales side as it concentrates on marketing its recently-acquired Zevalin cancer therapy. The move--designed to reduce operating expenses by 35 percent--leaves 31 staffers out of jobs, reducing its headcount to 133 after it fills 13 sales and marketing posts. The biotech says that they are still on track to file for European approval of Xyotax and evaluate pivotal data for pizantrone.

"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," said James Bianco, president and CEO. "It is with great disappointment that we must reduce head count elsewhere in order to meet these goals."

- see this release
- read the report from the Seattle Times

Related Articles:
Cell Therapeutics inks deal to buy cancer drug developer. Report
Cell Therapeutics inks deal for Xyotax. Report
Bayer Schering touts Zevalin study. Report
Cell Therapeutics makes bid to buy DOR. Report

FDA approves ZymoGenetics' rThrombin

Fri, 18 Jan 2008 06:59:57 -0500

ZymoGenetics has received FDA approval to market rThrombin, a surgical blood clotting product. The drug is a recombinant form of human thrombin; previous treatments were derived from human or animal blood. ZymoGenetics says that production of the new drug doesn't depend on the availability of animal or human blood and can therefore be scaled-up to meet market demand.

The drug, to be sold under the name Recothrom, was acquired by Bayer last year in a $198 million deal. The FDA approval triggers a $40 million milestone payment to ZymoGenetics.

- see this release for more

ALSO: Check out the 17 new drugs that received FDA approval last year. List

Related Articles:
ZymoGenetics deal for rThrombin hits a hurdle. Report
ZymoGenetics inks $198M deal. Report
Pivotal Thrombin trial a success for ZymoGenetics. Report
ZymoGenetics builds cash reserves as it advances Thrombin. Report

10. Bayer - Top 15 R&D Budgets

Maureen Martino — Wed, 28 Nov 2007 10:19:15 -0500

Who: Bayer

Based: Germany

2006 Pipeline Budget: $3.58 billion (€2.45)

2007 Pipeline News: Early in 2007 Bayer announced that it would aggressively expand its biotech pipeline, concentrating on new development pacts in cardiology, hematology and oncology. Among its most promising drugs is rivaroxaban, a potential blockbuster anti-clotting therapy that proved considerably more effective than Sanofi-Aventis' Lovenox in a Phase III trial. Bayer expects to file for European approval later this year with an FDA application anticipated in 2008. Other promising new chemical entities include VEGF Trap-Eye for Wet AMD and alemtuzumab for multiple sclerosis, both of which are in Phase III trials. Currently, Bayer has 14 projects in Phase I, 17 projects in Phase II and 19 projects in Phase III. A further 8 projects have already been submitted for marketing authorization.

Pending approval:

> Fosrenol - CKD (Japan)
> rThrombin - Bleeding control
> Rivaroxaban - VTE prevention
> Menostar transdermal - VMS
> E2/LNG - HRT (Japan)
> Magnevist MRA - MRA
> Primovist - MRI
> Avelon - PID/New indications (EU)

Phase III:
> Rivaroxaban - Medical ill
> Rivaroxaban - Stroke prevention in atrial fibriliation
> Rivaroxaban - Deep vein thrombosis
> VEGF Trap-Eye - Wet AMD
> Alemtuzumab - Multiple Sclerosis
> Nexavar - Non-small cell lung cancer
> Nexavar - Melanoma
> Bonefos - Bone Met. prevention in breast cancer
> Yaz - Dysmenhorrea
> YAZ Flex - Fertility Control
> DUB-OC (E2/DNG) - FC - Uterine bleeding
> Mirena - Menorrhagia
> Angeliz low-low - Menopausal Management
> Visanne - Endometrosis
> Yasmin plus - Fertility control
> LCS (ULD LNG) - Fertility control
> Ultravist 370 - CT
> Avelox - Unspecified new indications
> Zevalin - IND/aggr NHL 1st line

Full Pipeline Site: Link

SPOTLIGHT: Dara licenses Bayer drugs

Wed, 17 Oct 2007 06:59:53 -0400

DARA BioSciences in Raleigh, NC has licensed in IP and compounds for type 2 diabetes and dyslipidemia from Bayer HealthCare AG. Bayer gets an undisclosed upfront fee along with a schedule of milestones and royalties on any approved products. Bayer also retains certain commercialization rights. Release

Onyx CEO to retire

Thu, 04 Oct 2007 06:59:54 -0400

Hollings C. Renton, CEO of Onyx Pharmaceuticals, announced plans to retire next year. He will remain chairman of the board of directors. The company has initiated a search for his successor. Onyx has promoted Laura A. Brege to the newly-created position of executive vice president and CEO and Randy A. Kelley to senior vice president of sales and marketing. Onyx, together with Bayer, developed Nexavar, an approved live cancer therapy that made waves at this year's ASCO conference.

- see this release from Onyx

Related Articles:
Bayer, Onyx seek new Nexavar approval. Report
Bayer, Onyx tout Nexavar data. Report
Bayer, Onyx announce disappointing Nexavar results. Report

Celera acquires Atria assets for $33M

Thu, 20 Sep 2007 06:59:54 -0400

Celera will acquire all of the assets of Atria for approximately $33 million in cash. Atria has a line of human leukocyte antigen (HLA) testing products that are used for identifying potential donors in the matching process for bone marrow transplantation. "This acquisition gives us direct access to this important niche market area of tissue typing in transplantation and the bone marrow registry markets," said Kathy Ordonez, president of Celera.

- see the release for more on the deal

Related Articles:
Schering licenses Celera autoimmune program. Report
Celera moves to cut staff. Report

ALSO NOTED: Anadys names new CEO; Pfizer, Amgen gives to candidates; and much more...

Mon, 27 Aug 2007 06:59:50 -0400

> In the midst of a restructuring, Anadys Pharmaceuticals has named Steve Worland CEO. He had been head of pharmaceuticals. Release

> Amgen may have hit the ropes, but its ranks include some top donors to the presidential campaigns. Of course, a troubled Pfizer also made the top-donor list. Report

> Bayer and Onyx ended a late-stage trial of Nexavar for liver cancer in order to dispense the therapy to all the volunteers. Nexavar is approved for kidney cancer. Report

> India's Venus Remedies has inked a joint venture with Pharma Match R&D to sell a new generation carbapenem injectable in Europe. Report

And Finally… A slate of presidential candidates will use forums in Iowa next week to discuss cancer research. Report

ALSO NOTED: Pfizer's Lipitor patent request rejected; Spherix sells InfoSpherix; and much more...

Fri, 17 Aug 2007 06:59:50 -0400

> Pfizer's request for a reissued Lipitor patent was stamped "Rejected" by the U.S. Patent and Trademark Office--but the decision is only preliminary, so the drug maker can still hope for extended exclusivity on the cholesterol drug. FiercePharma

> Spherix's shareholders approved the sale of the company's InfoSpherix subsidiary to The Active Network for $17 million in cash. Release

> They weren't dishonest, just incompetent--or so says an outside investigator who's been looking into Bayer's Trasylol snafu. FiercePharma

And Finally... Japanese stem cell scientist Shinya Yamanaka conducts his ground-breaking research on lean budget. FierceBioresearcher

ALSO NOTED: Integra buys IsoTis for $49.3M; MannKind searches for insulin drug partner; and much more...

Tue, 07 Aug 2007 06:59:50 -0400

> Device maker Integra LifeSciences is buying IsoTis for $49.3 million. Release

> MannKind told investors on Friday that it faced an uncertain delay in finding a partner for its inhalable insulin candidate, and investors responded Monday by taking a bite out of the developer's share price. Adding to the uncertainty surrounding the company, MannKind says it is delaying the release of its second-quarter report until Aug. 9 and that CFO Richard Anderson is retiring. The monumental failure of Pfizer's Exubera--an inhalable insulin drug--to find a market niche may be making potential partners particularly skittish. Report

> KineMed has raised $15 million and plans to use the money to advance its lead drug candidate into clinical trials. Release

> Bayer Thai and Schering (Bangkok) have merged. Report

> Isotechnika announced that the FDA has granted fast track designation for its lead drug, ISA247. Release

> Entelos has struck a deal with the FDA to create a computer model for drug-induced liver damage. Release

> Abraxis BioScience has won regulatory approval to sell Oxytocin Injection in a 30 ml vial. Release

> In 2006, Pharma racked up a multibillion-dollar marketing bill. FiercePharma

> PricewaterhouseCoopers has released a study based on interviews with 185 top pharma execs in the Asia-Pacific region. The verdict? Not only are China, India, Singapore and their neighbors poised to become huge pharmaceuticals consumers, but big producers as well. FiercePharma

And Finally… Drinking more than three cups of coffee a day may help women delay memory loss. Report