Multimillion-dollar partnership covers antibodies, protein therapies, and small molecules.

OncoMed Pharmaceuticals will receive $40 million up front from Bayer Schering Pharma in an alliance targeting the Wnt signaling pathway. The Wnt signaling pathway has been identified as an important target in halting cancer stem cell activity.

The collaboration includes OncoMed’s lead antibody, OMP-18R5, which is currently planned to enter clinical testing in 2011. The firms will work to develop additional antibodies, protein therapeutics, as well as small molecules.

The partnership could include up to five compounds. For each biotherapeutic successfully developed through Phase III trials and regulatory approval, OncoMed’s payments could total up to $387.5 million, including sales milestones. In addition, the company will be eligible to receive double-digit royalties on net product sales. The agreement also contains provisions under which OncoMed may co-develop antibody and protein therapeutics with Bayer.

OncoMed will utilize its human cancer stem cell models to discover and advance antibody and protein therapeutics through Phase I clinical studies. Bayer Schering Pharma receives an option to exclusively license antibody and protein therapeutic candidates at any point up to the completion of Phase I testing.

Additionally, Bayer will lead the discovery and advancement of small molecule therapeutic candidates that modulate the Wnt pathway signaling. OncoMed could receive milestone fees of up to $112 million per candidate with successful development, regulatory approval, and commercialization. OncoMed will also be eligible to receive single-digit royalties on net product sales.

Source: GEN

Popularity: 2% [?]

Bayer Schering Pharma has announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben PET imaging in the detection of beta-amyloid deposition in the brain.

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The trial will include both subjects with and without manifest dementia. In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-amyloid deposition in the brain as a pathological hallmark of disease in Alzheimer’s disease (AD) patients, said Bayer.

The pivotal Phase III trial is a worldwide open-label, multi-center, non-randomized single dose study to assess the safety and to determine the sensitivity and specificity of the visual and quantitative assessment of regional tracer uptake of florbetaben in the brain using positron emission tomography (PET) imaging.

Approximately 400 individuals are expected to be enrolled in this study. The florbetaben uptake pattern will be visually assessed by independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data. The images will be compared for the presence or absence of cerebral beta-amyloid respective to corresponding histo-pathological specimens.

Both volunteers without dementia and patients with dementia will be included, therefore, enrolling subjects with either a high probability of cerebral beta-amyloid deposition such as subjects with AD or a low probability of cerebral beta-amyloid deposition like non-demented volunteers.

The primary and secondary objectives of the trial are the evaluation of the sensitivity and specificity of the visual assessment of regional tracer uptake in the florbetaben PET images compared to histological verification as well as the quantitative assessment of regional tracer uptake. The primary completion of the study is anticipated for 2011. However, due to histopathology examinations, the study is not anticipated to be completed before 2014.

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Thomas Balzer, head of global clinical development diagnostic imaging at Bayer Schering Pharma, said: “Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease. This Phase III study could prove that florbetaben can be used as a new tool to detect beta-amyloid depositions in the brain in vivo. The ability to image beta-amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment.”

Source: Behavioral Health Central

Popularity: 2% [?]

Chinese regulatory authorities approved Bayer Schering Pharma’s interferon beta-1b, Betaferon®, as a treatment for relapsing-remitting multiple sclerosis (MS). Bayer says it plans to launch the drug in the country by mid-2010.

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The company separately reported exercising its option as per an agreement inked in January with Micromet to develop a new BiTE antibody against solid tumors. The decision triggers a €5 million (about $7.55 million) payment to Micromet.

Under the terms of the deal, the companies will jointly develop the BiTE candidate up to the end of Phase I trials, at which point Bayer will take over all further development and commercialization activities. Additionally, Micromet could receive milestones of up to €285 million (approximately $430.22 million) plus double-digit royalties on sales. The company will also have its R&D expenses reimbursed.

BiTE antibodies are designed to direct the body’s cytotoxic T cells against tumor cells. The molecules are designed such that one BiTE arm is specific for the T-cell receptor CD3 epitope, and the other is designed to bind to the target of interest. The resulting BiTE molecule induces an immunological synapse between the T cell and tumor cell in the same manner as that observed during physiological T-cell attacks, according to Micromet.

This mediates the delivery of cytotoxic proteins directly into the tumor cell, which induces apoptosis. The company also suggests that unlike existing T-cell therapies, the BiTE approach does not require antigen presentation or other elements of T-cell recognition. It thus has the potential to circumvent immune-evasion mechanisms that tend to limit existing T-cell therapies.

Source: GEN News

Popularity: 2% [?]

Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis.

On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (e.g. Alzheimer’s disease [AD]). In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients.

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“Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease,” said Dr. Thomas Balzer, Head of Global Clinical Development Diagnostic Imaging at Bayer Schering Pharma. “This Phase III study could proof that florbetaben can be used as a new tool to detect beta-Amyloid depositions in the brain in vivo. The ability to image beta-Amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment.”

Phase III Trial Design
The pivotal Phase III trial is a worldwide open-label, multi-center, non-randomized single dose study to assess the safety and to determine the sensitivity and specificity of the visual and quantitative assessment of regional tracer uptake of florbetaben in the brain using PET imaging. Approximately 400 individuals are expected to be enrolled in this study. The florbetaben uptake pattern will be visually assessed by independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data. The images will be compared for the presence or absence of cerebral beta-Amyloid respective to corresponding histo-pathological specimens. Both volunteers without dementia and patients with dementia will be included, therefore enrolling subjects with either a high probability of cerebral beta-Amyloid deposition (e.g. subjects with AD) or a low probability of cerebral beta-Amyloid deposition (e.g.non-demented volunteers).

The primary and secondary objectives of the trial are the evaluation of the sensitivity and specificity of the visual assessment of regional tracer uptake in the florbetaben PET images compared to histological verification as well as the quantitative assessment of regional tracer uptake. The primary completion of the study is anticipated for 2011. However, due to histopathology examinations the study is not anticipated to be completed before 2014.

Source: The FINANCIAL

Popularity: 3% [?]

Bayer and Algeta announced Thursday the signing of a global deal to develop and commercialise Algeta’s Alpharadin (radium-223 chloride), an experimental alpha-emitting radiopharmaceutical being developed to treat bone metastases. The agreement for the drug, which is currently in late-stage testing for hormone-refractory prostate cancer (HRPC) that has spread to the bone, is potentially worth more than 560 million euros ($800 million) for Algeta.

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Under the terms of the agreement, which includes an upfront payment of 42.5 million euros ($61 million) to Algeta, the companies will jointly develop Alpharadin, with Bayer contributing “a substantial majority of the costs of future development.” Algeta will receive payments upon the achievement of certain development, production and commercialisation milestones, and the company also has the option to co-promote the drug in the US under a profit-sharing arrangement. The Norwegian company could also receive tiered double-digit royalties on sales if the drug reaches the market.

Bayer Schering Pharma’s head of global development, Kemal Malik, said “we recognise the tremendous potential of Algeta’s Alpharadin as a possible treatment for bone metastases in cancer patients,” and added that “the data we have seen suggest that Alpharadin may represent a highly targeted treatment option that could potentially extend overall survival.” A spokesperson for Bayer indicated that initial results from the trial in patients with HRPC are expected in late 2011.

Commenting on the agreement, DnB NOR Markets analyst Espen Joergensen remarked that “this is an extremely positive deal, the size is significant and far larger than what we had expected.”

Source: FirstWord

Popularity: 4% [?]

Celera Corporation today announced an exclusive license agreement with Bayer Schering Pharma AG, providing Bayer Schering Pharma with access to five cancer-related targets for therapeutic development and in-vivo diagnostic imaging. These therapeutic targets are over-expressed on the surface of several different tumor cell types and were identified using Celera’s proteomics discovery platform.

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Under the terms of the agreement, Bayer Schering Pharma will pay Celera a one-time fee for the exclusive access to the five targets. Additional payments are due upon achievement of certain development and commercial milestones. Further, upon commercialization of a product Celera is entitled to royalties based on net sales of a product. Celera retains in vitro diagnostic rights, and it will be able to develop and commercialize related companion in-vitro diagnostics that are specific to therapeutic candidates arising from Bayer Schering Pharma’s program.

“This agreement combines the strength of our novel proteomics target discovery platform with Bayer Schering Pharma’s expertise in research and development,” said Steve Ruben, Ph.D., vice president of proteomic research at Celera. “We believe this new relationship with Bayer Schering Pharma allows us the flexibility to advance part of our broad pipeline of validated targets for additional future value.”

“This agreement allows us to expand our existing research portfolio in the area of cancer-related targets,” said Khusru Asadullah, MD, Head of Target Discovery at Bayer Schering Pharma. “We look forward to exploring the full potential of these promising target candidates with regard to therapeutic interference for anti-tumor therapy as well as in in-vivo diagnostic imaging.”

About Celera

Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “believe,” “expect,” “will,” “should,” “anticipate,” “may,” “could,” and “intend,” among others. These forward-looking statements are based on Celera’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Celera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of our business include, but are not limited to, the risks and uncertainties that: (1) the cell surface proteins discovered by Celera may not be suitable targets for therapeutics; (2) the risk that Celera will not receive milestone or royalty payments under the agreement; (3) the risk that products developed under this license agreement, if any, will not advance as anticipated, or may not receive required regulatory clearances or approvals; and (4) the uncertainty that any products developed under this license agreement will be accepted and adopted by the market, including the risk that that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans. The foregoing list sets forth some, but not all, of the factors that could affect Celera’s ability to achieve results described in any forward-looking statements. For additional information about the risks and uncertainties that Celera faces and a discussion of its financial statements and footnotes, see documents filed by Celera with the SEC, including its transition report on Form 10-KT and all subsequent periodic reports. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Source: Business Wire

Popularity: 2% [?]

Antisoma sold sanofi-aventis U.S. rights to the FDA-approved chronic lymphocytic leukaemia (CLL) drug oral fludarabine for $65 million. The deal roughly doubles Antisoma’s cash resources and means the company will be able to fund its operations including clinical and preclinical pipeline development until at least mid-2011.

This, according to CEO, Glyn Edwards, “is well beyond when we expect key Phase III results for our leading products, ASA404 and AS1413.” Both compounds are designed to treat cancer. At December 2008, Antisoma reported  £52.7 million, or slightly over $79 million, in cash resources.

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Antisoma acquired U.S. rights to oral fludarabine as part of its $52.2 million share-based buy-out of Xanthus Pharmaceuticals in June 2008. The drug was approved by the FDA as second-line therapy for CLL in December 2008. Xanthus had itself acquired exclusive U.S. rights to the drug from Schering (now Bayer Schering Pharma) in June 2006.

The agreement with sanofi-aventis calls for a $60 million up front and additional, staged payments amounting to $5 million. The money will be used to complete Phase III trials with ASA404 and AS1413.

ASA404 is a small molecule tumor-vascular disrupting agent (VDA) which is being developed initially against lung cancer. ASA404 is being developed worldwide by Novartis, which negotiated exclusive, worldwide rights to the drug from Antisoma in 2007. The deal was worth a potential $890 million in total up-front, development, regulatory, and sales-related milestone payments.

Novartis has indicated it plans to pursue clinical development of ASA404 against breast cancer as its next priority indication, according to Antisoma’s vp marketing and communications, Daniel Elger.

AS1413, a DNA intercalator in development against secondary AML, is being developed in-house. Elger also confirmed the company plans to keep hold of the drug for the U.S. market but will partner at some stage for other territories. Results from the Phase III trial of AS14132 are expected in late 2010 or early 2011.

Source: GEN News

Popularity: 4% [?]

An appraisal committee of the National Institute for Health and Clinical Excellence indicated that it does not recommend Bayer’s and Onyx’s Nexavar (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC), according to a document released by the agency on Thursday.

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NICE noted that the companies submitted evidence from three studies of Nexavar for the treatment of HCC, including data from the Phase III SHARP trial. One of the five key concerns listed by the committee in the document was “the generalisability of the SHARP population to the overall UK HCC population.” The committee indicated that it was aware that Nexavar is licensed in Europe for HCC without specific restrictions “however, the clinical effectiveness evidence from the SHARP study related to patients with advanced HCC for whom surgical or locoregional therapies had failed or were not suitable.”

In response to the news, Bayer said the decision conflicted with current medical guidelines. The drugmaker’s head of oncology in the UK, Nicole Farmer, remarked that “Bayer Schering Pharma is gravely disheartened by this latest NICE announcement.” A second meeting of the appraisal committee is scheduled for June 11.

Source: FirstWord

Popularity: 4% [?]

In an effort to gain cash and save it self from bankruptcy, Epix Pharmaceuticals is selling the U.S., Canadian, and Australian rights to MS-325, a magnetic resonance angiography agent, to  for $28 million in cash. Epix will also initiate an exchange offer for $100 million for 3% convertible notes due June 2024.

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Noteholders would receive $18 million and 33.9 million shares of common stock, or 44.7% of total outstanding shares of Epix. The firm notes reports that if the offer does not satisfy outstanding obligations, it may be forced to seek bankruptcy protection.

From the deal with Lantheus, Epix will have to pay Bayer Schering Pharma $10.5 million of the $28 million received as a result of a previous development agreement for MS-325, which expired February 28. Epix will retain European and other ex-U.S. rights excluding Canada to the technology.

Lantheus is expected to rename the product, formerly marketed as Vasovist, which is reportedly the only approved member of its class. Epix received FDA approval for MS-325 in December for evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.

“The acquisition of MS-325 reinforces our growth strategy to continue to bring to market breakthrough new imaging tools.” says Don Kiepert, president and CEO of Lantheus Medical Imaging. “MS-325 fits well within our current product portfolio of leading contrast imaging agents. As a first-in-class contrast agent, MS-325 provides a true advance in vascular imaging and may make it possible for physicians to detect peripheral vascular disease differently than X-ray angiography, which is invasive.”

Source: GEN News

Popularity: 3% [?]

Bayer announced Thursday that it plans to invest about 100 million euros ($128 million) over the next five years to establish an R&D centre in China. The facility will be a “key growth driver” for the company in the Asia-Pacific region, remarked Andreas Fibig, chairman of the board of management of Bayer Schering Pharma.

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With regard to the current global financial situation, Fibig noted that he was optimistic about China’s business development, adding that “in the health-care sector, we are seeing no effects at the moment.” Bayer HealthCare’s managing director in China, Liam Condon, said it was anticipated that the Chinese health-care market would grow more than 20 percent in the next few years and the drugmaker was expected to exceed that pace. In 2008, Bayer saw growth of more than 50 percent in the country, according to Fibig.

The company also explained that the centre will benefit Asian patients by “considering their clinical profile and medical needs early-on.”

Source: FirstWord

Popularity: 3% [?]