You’ve spent millions on developing your drug or device, and even more on getting through to later-phase clinical trials, so now that its time to bring it to market through partnering, be sure that you choose a data room that can accelerate the due diligence process while keeping your intellectual property secure. A good virtual data room can help you to cast a broader net so that you can court multiple worldwide partners, while keeping detailed tracking information as your potential partners review your clinical trial information, research data and other critical documents. Once you have struck a deal with your definitive partner(s), you can retroactively revoke access even to the documents already downloaded. Compared to alternative methods of distributing the due diligence materials, ShareVault provides a number of important benefits:

Present your due diligence documents in a well-organized, professional structure
Streamline the due diligence process by placing your documents in a structured hierarchy. Only ShareVault allows you to structure your documents using tags, rather than folders. Often, the same document needs to be placed in multiple locations in the due diligence index. With ShareVault, just apply multiple tags to the document. No other data room provider offers this simple, yet powerful, capability:

• No need to replicate files in multiple locations
• No paying for additional pages in replicated documents
• No need to combine document access statistics for multiple instances of the same file

Secure your valuable information without slowing down document access
ShareVault automatically converts your documents to an encrypted PDF format that provides the industry standard document viewing experience, including continuous scrolling and high-speed rendering. Some competing VDRs, because they use the dated TIFF document standard, will slow down document review due to sluggish page rendering, lack of continuous scrolling and inability to view more than one page at a time. The PDF document encryption used by ShareVault allows you to revoke access to any document at any time, even if the document has been downloaded. Sharevault also provides you with the ability to apply additional security attributes, including inhibiting document download, preventing printing, applying secure dynamic watermarks, identifying the user, and blocking screenshots.

Accelerate the due diligence phase
ShareVault supports PDF streaming, so that documents open to the first page instantly, even if there are many thousands of pages – such as a large clinical trial results document. Most competing virtual data rooms suggest that you break up large documents into smaller volumes so that they’ll load more quickly, but with ShareVault you can keep document review moving quickly without getting bogged down by large documents.

Respond efficiently and securely to questions from potential partners
The easy-to-use ShareVault Q&A facility further streamlines the due diligence process by optimizing the response to questions from your potential partners. Questions can be asked privately from right within the data room, so that you and your team can easily respond from the centralized Q&A module. With the optional Q&A workflow feature, questions can be routed to the appropriate expert, and then back to the Q&A moderator for approval before posting the final response. You can also change the privacy level on each question so that other users can refer to questions that you have already answered.

Prepare quickly for due diligence
As you prepare for partnering due diligence, the last thing you need is a complex and lengthy process for preparing your data room. ShareVault customers are consistently impressed by the intuitive simplicity of inviting users, creating the due diligence structure, uploading documents and setting permissions / policies. From drag-and-drop user/group management, to the unique in-browser drag-and-drop uploader and automated PDF conversion pipeline, ShareVault has been designed for rapid, streamlined deployment.

Find documents quickly through indexed full-text search
Your users will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps prospective partners quickly answer the questions they have about your company, reducing the length of the document review phase.

Gain valuable insight into the due diligence process through detailed reporting
As the due diligence process unfolds, having a clear picture of how potential partners are spending their time in ShareVault can provide key insights into their level of interest, and can help you understand their areas of concern. The ShareVault reporting module provides high-level metrics such as number of pages viewed and/or amount of time spent by each user group in each section of the data room, as well as detailed metrics such as specific pages viewed, and the amount of time spent within each document by each user. The combination of both fine-grained and summary information with interactive filtering and intuitive query tools, allows you to quickly and easily answer any question you might have about partner activity within your ShareVault.

Count on our high reliability and 24/7/365 support team
With over 99.9% up-time, you can be confident that your documents can be accessed from anywhere in the world, around the clock. Our 24/7 support hotline is answered by experts with the ability to not only respond to technical questions, but also to provide pro-active, knowledgeable advice on how to use ShareVault to streamline your project. Each member of our support team can also initiate a remote screen- sharing session so they can work virtually by your side to answer your questions, provide advice or resolve an issue.

Get started early, and be ready for your transaction
Ask any experienced business development executive about when to get started preparing for your partnering deal, and you’ll get the same answer: “As early as possible”. Being prepared for due diligence is easily done using ShareVault Ever Ready, a special configuration that gives you a very affordable way to get your documents organized and secured in a ShareVault, so when you’re ready to start your deal, the due diligence can start right away, without delay.

With the experience of hundreds of transactions worth tens of billions of dollars, you can rely on ShareVault to securely share the due diligence documents for your next partnering transaction.

Whether you’re involved in in-licensing or out-licensing copyrights, trademarks, technical know-how, patented inventions, software, or any other technology, you will need to share documents for due diligence. The potential licensee(s) will need to conduct extensive due diligence in order to fully understand the risks and rewards of the potential licensing deal, and the licensor needs to be assured that the due diligence documents remain secure. Distributing the materials using email, CDs/DVDs, FTP sites or general purpose file sharing sites do not provide the needed functionality, so a virtual data room is required. Choosing the right virtual data room can significantly accelerate the licensing due diligence phase. ShareVault provides a number of important benefits for both the licensee(s) and licensor:

Present your due diligence materials in a well-organized, professional structure
Put your intellectual property documents in the best possible light by placing your documents in a structured hierarchy that streamlines the due diligence process. Only ShareVault allows you to structure your documents using tags, rather than folders. Often, the same document needs to be placed in multiple locations in the due diligence index. With ShareVault, just apply multiple tags to the document. No other data room provider offers this simple, yet powerful, capability:

• No need to replicate files in multiple locations
• No paying for additional pages in replicated documents
• No need to combine document access statistics for multiple instances of the same file

Secure your valuable information without slowing down document access
ShareVault automatically converts your documents to an encrypted PDF format that provides the industry standard document viewing experience, including continuous scrolling and high-speed rendering. Some competing VDRs, because they use the dated TIFF document standard, will slow down document review due to sluggish page rendering, lack of continuous scrolling and inability to view more than one page at a time. The PDF document encryption used by ShareVault allows you to revoke access to any document at any time, even if the document has been downloaded. Sharevault also provides you with the ability to apply additional security attributes, including inhibiting document download, preventing printing, applying secure dynamic watermarks, identifying the user, and blocking screenshots.

Accelerate the due diligence phase
ShareVault supports PDF streaming, so that documents open to the first page instantly, even if there are many thousands of pages. Most competing virtual data rooms suggest that you break up large documents into smaller volumes so that they’ll load more quickly, but with ShareVault you can keep document review moving quickly without getting bogged down with large documents.

Respond efficiently and securely to questions from potential licensees
The easy-to-use ShareVault Q&A facility further streamlines the due diligence process by optimizing the response to questions from your potential licensees. Questions can be asked privately from right within the data room, so that you and your team can easily respond from the centralized Q&A module. With the optional Q&A workflow feature, questions can be routed to the appropriate expert, and then back to the Q&A moderator for approval before posting the final response. You can also change the privacy level on each question so that other users can refer to questions that you have already answered.

Prepare quickly for due diligence
As you prepare for licensing due diligence, the last thing you need is a complex and lengthy process for preparing your data room. ShareVault customers are consistently impressed by the intuitive simplicity of inviting users, creating the due diligence structure, uploading documents and setting permissions / policies. From drag-and-drop user/group management, to the unique in-browser drag-and-drop uploader and automated PDF conversion pipeline, ShareVault has been designed for rapid, streamlined deployment.

Find documents quickly through indexed full-text search
Your users will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps prospective licensees quickly answer their own questions about your IP, reducing the length of the document review phase.

Gain valuable insight into the due diligence process through detailed reporting
As the due diligence process unfolds, having a clear picture of how the licensee teams are spending their time in ShareVault can provide key insights into their level of interest, and can help you understand their areas of concern. The ShareVault reporting module provides high-level metrics such as number of pages viewed and/or amount of time spent by each user group in each section of the data room, as well as detailed metrics such as specific pages viewed, and the amount of time spent within each document by each user. The combination of both fine-grained and summary information with interactive filtering and intuitive query tools, allows you to quickly and easily answer any question you might have about user activity within your ShareVault.

Count on our high reliability and 24/7/365 support team
With over 99.9% up-time, you can be confident that your documents can be accessed from anywhere in the world, around the clock. Our 24/7 support hotline is answered by experts with the ability to not only respond to technical questions, but also to provide pro-active, knowledgeable advice on how to use ShareVault to streamline your project. Each member of our support team can also initiate a remote screen- sharing session so they can work virtually by your side to answer your questions, provide advice or resolve an issue.

Get started early, and be ready for your transaction
Ask any experienced licensing executive or IP attorney about when to get started preparing for your licensing deal, and you’ll get the same answer: “As early as possible”. Being prepared for due diligence is easily done using ShareVault Ever Ready, a special configuration that gives you a very affordable way to get your documents organized and secured in a ShareVault, so when you’re ready to start your transaction, the due diligence can start right away, without delay.

With the experience of hundreds of transactions worth tens of billions of dollars, you can rely on ShareVault to securely share the due diligence documents for your next licensing deal.

Raising capital for your project, firm or organization always requires due diligence document review so that investors can understand the risk and rewards associated with their decision to invest. The right virtual data room can help streamline this process, while keeping documents secure. ShareVault is ideally suited for presenting investor documents for due diligence, providing significant advantages when compared to distributing investor materals using email, CDs/DVDs, or FTP/filesharing sites:

Organize your investor materials in a structured hierarchy for a professional presentation of your firm
By organizing your documents according to a well-structured due diligence list, you can put your company in the best possible light, and streamline the review process. Only ShareVault allows you to organize your documents using tags, rather than folders. Frequently, the same file needs to be placed in multiple locations in the due diligence index. With ShareVault, just apply multiple tags to the document. No other data room provider offers this simple yet powerful capability:

• No need to replicate files in multiple locations
• No paying for additional pages in replicated documents
• No need to combine document access statistics for multiple instances of the same file

Secure your valuable information without slowing down document access
ShareVault automatically converts your documents to an encrypted PDF format that provides the industry standard document viewing experience, including continuous scrolling and high-speed rendering. Some competing VDRs, because they a’re based on the dated TIFF document standard, will slow down document review due to sluggish page rendering, lack of continuous scrolling and inability to view more than one page at a time. The PDF encryption used by ShareVault allows you to revoke access to any document at any time, even if the document has already been downloaded. Sharevault also provides you with the ability to apply additional security attributes, including inhibiting preventing document download, prohibiting preventing printing, applying secure dynamic watermarks, identifying the user, and blocking screenshots.

Accelerate the due diligence phase
ShareVault supports PDF streaming, so that documents open to the first page instantly, even if there are many thousands of pages. Most competing virtual data rooms providers suggest that you break up large documents into smaller volumes so they’ll load quickly, but with ShareVault, you can keep document review moving fast without getting bogged-down with large documents.

Respond efficiently and securely to questions from investors
The easy-to-use ShareVault Q&A module further streamlines the due diligence process by optimizing the response to questions from your potential investors. Questions can be asked privately from right within the data room, so that you and your team can easily respond from the centralized Q&A module. With the optional Q&A workflow feature, questions can be routed to the appropriate expert, and then back to the Q&A moderator for approval before posting the final response. You can also change the privacy level on each question so that other users can refer to questions that you have already answered.

Prepare quickly for due diligence
As you prepare for investor due diligence, the last thing you need is a complex and lengthy procedure for preparing your data room. ShareVault customers are consistently impressed by the intuitive simplicity of inviting users, creating the due diligence structure, uploading documents and setting permissions / policies. From our drag-and-drop user/group management tool, to the unique in-browser drag-and-drop uploader and automated PDF conversion pipeline, ShareVault has been designed for rapid, streamlined deployment.

Find documents quickly through indexed full-text search
Your users will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps prospective investors quickly answer the questions they have about your company, compressing the timeframe of the document review phase.

Gain valuable insight into the due diligence process through detailed reporting
As the due diligence process unfolds, having a clear picture of how your investors are spending their time in ShareVault can provide key insights into their level of interest, and can help you understand their areas of concern. The ShareVault reporting module provides high-level metrics such as number of pages viewed and/or amount of time spent by each user group in each section of the data room, as well as detailed metrics such as specific pages viewed, and the amount of time spent within each document by each user. The combination of both fine-grained and summary information with interactive filtering and intuitive query tools, allows you to quickly and easily answer any question you might have about investor activity within your ShareVault.

Count on our high reliability and 24/7/365 support team
With over 99.9% up-time, you can be confident that your documents can be accessed from anywhere in the world, around the clock. Our 24/7 support hotline is answered by experts with the ability to not only respond to technical questions, but also to provide pro-active, knowledgeable advice on how to use ShareVault to streamline your project. Each member of our support team can also initiate a remote screen- sharing session so they can work virtually by your side to answer your questions, provide advice or resolve an issue.

Get started early, and be ready for your transaction Ask any experienced CEO or CFO about when to get started preparing for your next round of financing, and you’ll get the same answer: “As early as possible”. Being prepared for investor due diligence is easy using ShareVault Ever Ready, a special configuration that gives you a very affordable way to get your documents organized and secured in a ShareVault, so when you’re ready to start your fundraising, the investor due diligence can start right away, without delay.

With the experience of hundreds of transactions worth tens of billions of dollars, you can rely on ShareVault to securely share the due diligence documents for your next fundraising transaction.

As you prepare your firm for reviewing the due diligence documents for a potential acquisition target, you’ll need to determine which data room to choose. The right data room can help you accelerate the transaction and track the due diligence process, while keeping a detailed audit trail. ShareVault provides the ideal platform for reviewing your target’s due diligence materials during a buy-side M&A transaction, providing important benefits throughout the entire process, from initial document review through to post-merger integration.

To learn how Varian Medical recently used ShareVault for several buy-side M&A transactions, click here: Varian Medical adopts ShareVault™ virtual data room for acquisition due diligence

Find documents quickly through indexed full-text search
Your entire due diligence team will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps your due diligence team more quickly answer the questions they have about your company, compressing the timeframe of the document review phase.

Bi-directional publishing and asymmetric inter-group privacy
You need your acquisition target’s employees to be able to publish documents directly into the data room, but you need to be sure that you don’t reveal private information to your target. ShareVault allows for bi-directional publishing and asymmetric inter-group privacy so that you can quickly and easily get all the content uploaded and tagged by your acquisition target, and then assign the appropriate teams to review each section of dataroom containing the documents that respond to each question in your due diligence questionnaire.

Quickly create a due diligence questionnaire so that the target's documents are well-organized and easy to review
Have your target place their documents in a structured hierarchy that streamlines the due diligence process. Only ShareVault allows you to structure your documents using tags, rather than folders. Often in a buy-side scenario, the same document will answer multiple questions in the due diligence questionnaire. With ShareVault, your targe just applies multiple tags (questions) to the document. No other data room provider offers this simple yet powerful capability:

• No need to replicate files in multiple locations
• No paying for additional pages in replicated documents
• No need to combine document access statistics for multiple instances of the same file

Accelerate the due diligence phase
ShareVault supports PDF streaming, so that documents open to the first page instantly, even if there are many thousands of pages. Most competing virtual data rooms suggest that you break up large documents into smaller volumes so that they’ll load more quickly, but with ShareVault you can keep document review moving fast without getting bogged-down with large documents.

Respond efficiently and securely to questions from your due diligence teams
The easy-to-use ShareVault Q&A module further streamlines the due diligence process by allowing your due diligence team to efficiently ask questions of the target, allowing your corporate development department to act as a moderator. Questions can be asked securely from right within the data room and then, with the optional Q&A workflow feature the corporate development team can route the questions to the appropriate expert(s) within the target’s organization, and then back to the Q&A moderator for approval before posting the final response to your internal team. You can also change the privacy level on each question, so that information pertaining to sensitive matters, such as Human Resources, can be tightly controlled.

Prepare quickly for due diligence
As you work with your acquisition target to prepare for due diligence, the last thing you need is a complex and lengthy process for preparing your data room. ShareVault customers are consistently impressed by the intuitive simplicity of inviting users, creating the due diligence structure, uploading documents and setting permissions / policies. From our drag-and-drop user/group management tool, to the unique in-browser drag-and-drop uploader and automated PDF conversion pipeline, ShareVault has been designed for rapid, streamlined deployment.

Find documents quickly through indexed full-text search
Your users will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps prospective buyers to more quickly answer their own questions about your company, compressing the timeframe of the document review phase.

Gain valuable insight into the due diligence process through detailed reporting
As the due diligence process unfolds, having a clear picture of how the buy-side teams are spending their time in ShareVault can provide key insights into their level of interest, and can help you understand their areas of concern. The ShareVault reporting module provides high-level metrics such as number of pages viewed and/or amount of time spent by each user group in each section of the data room, as well as detailed metrics such as specific pages viewed, and the amount of time spent within each document by each user. The combination of both fine-grained and summary information with interactive filtering and intuitive query tools, allows you to quickly and easily answer any question you might have about the buy-side user activity within your ShareVault.

Count on our high reliability and 24/7/365 support team
With over 99.9% up-time, you can be confident that your documents can be accessed from anywhere in the world, around the clock. Our 24/7 support hotline is answered by experts with the ability to not only respond to technical questions, but also to provide pro-active, knowledgeable advice on how to use ShareVault to streamline your project. Each member of our support team can also initiate a remote screen- sharing session so they can work virtually by your side to answer your questions, provide advice or resolve an issue.

Get started early, and be ready for your transaction
Ask any experienced CFO or Investment Banker about when to get started preparing for your M&A transactions, and you'll get the same answer: "As early as possible." Being prepared for due diligence is easily done using ShareVault Ever Ready, a special configuration that gives you a very affordable way to get your documents organized and secured in a ShareVault, so when you're ready to start your transaction, the due diligence can start right away, without delay.

With the experience of hundreds of transactions worth tens of billions of dollars, you can rely on ShareVault to securely share the due diligence documents for your next buy side M&A transaction.

Choosing the right virtual data room is just one of the important decisions that you will make as you ready your firm for sale. The right data room can help you accelerate the transaction, while assuring the security of critical business documents. ShareVault provides the ideal platform for securely presenting a company's due diligence materials during an M&A transaction, providing important benefits throughout the entire process, from initial marketing phases to potential buyers, through to post-term sheet due diligence.

Present your due diligence materials in a well-organized, professional structure
Put your company in the best possible light by placing your documents in a structured hierarchy that streamlines the due diligence process. Only ShareVault allows you to structure your documents using tags, rather than folders. Often, the same document needs to be placed in multiple locations in the due diligence index. With ShareVault, just apply multiple tags to the document. No other data room provider offers this simple yet powerful capability:

• No need to replicate files in multiple locations
• No paying for additional pages in replicated documents
• No need to combine document access statistics for multiple instances of the same file

Secure your valuable information without slowing down document access
ShareVault automatically converts your documents to an encrypted PDF format that provides the industry standard document viewing experience, including continuous scrolling and high-speed rendering. Some competing VDRs, because they are based on the dated TIFF document standard, will slow down document review due to sluggish page rendering, lack of continuous scrolling and inability to view more than one page at a time. The PDF encryption used by ShareVault allows you to revoke access to any document at any time, even if the document has been downloaded. Sharevault also provides you with the ability to apply additional security attributes, including inhibiting document download, prohibiting printing, applying secure dynamic watermarks, identifying the user, and blocking screenshots.

Accelerate the due diligence phase
ShareVault supports PDF streaming, so that documents open to the first page instantly, even if there are many thousands of pages. Most competing virtual data rooms suggest that you break up large documents into smaller volumes so that they’ll load more quickly, but with ShareVault you can keep document review moving fast without getting bogged-down with large documents.

Respond efficiently and securely to questions from potential buyers
The easy-to-use ShareVault Q&A facility further streamlines the due diligence process by optimizing the response to questions from your potential buyers. Questions can be asked privately from right within the data room, so that you and your team can easily respond from the centralized Q&A module. With the optional Q&A workflow feature, questions can be routed to the appropriate expert, and then back to the Q&A moderator for approval before posting the final response. You can also change the privacy level on each question so that other users can refer to questions that you have already answered.

Prepare quickly for due diligence
As you prepare for M&A due diligence, the last thing you need is a complex and lengthy process for preparing your data room. ShareVault customers are consistently impressed by the intuitive simplicity of inviting users, creating the due diligence structure, uploading documents and setting permissions / policies. From our drag-and-drop user/group management tool, to the unique in-browser drag-and-drop uploader and automated PDF conversion pipeline, ShareVault has been designed for rapid, streamlined deployment.

Find documents quickly through indexed full-text search
Your users will be able to instantly find documents that relate to relevant key words. Only ShareVault provides relevance ranking, in-place document synopses and zoomable first page thumbnails for each search result, so users can quickly and easily isolate the documents that contain the information sought. With its powerful search capabilities, ShareVault helps prospective buyers more quickly answer the questions they have about your company, compressing the timeframe of the document review phase.

Gain valuable insight into the due diligence process through detailed reporting
As the due diligence process unfolds, having a clear picture of how the buy-side teams are spending their time in ShareVault can provide key insights into their level of interest, and can help you understand their areas of concern. The ShareVault reporting module provides high-level metrics such as number of pages viewed and/or amount of time spent by each user group in each section of the data room, as well as detailed metrics such as specific pages viewed, and the amount of time spent within each document by each user. The combination of both fine-grained and summary information with interactive filtering and intuitive query tools, allows you to quickly and easily answer any question you might have about the buy-side user activity within your ShareVault.

Count on our high reliability and 24/7/365 support team
With over 99.9% up-time, you can be confident that your documents can be accessed from anywhere in the world, around the clock. Our 24/7 support hotline is answered by experts with the ability to not only respond to technical questions, but also to provide pro-active, knowledgeable advice on how to use ShareVault to streamline your project. Each member of our support team can also initiate a remote screen- sharing session so they can work virtually by your side to answer your questions, provide advice or resolve an issue.

Get started early, and be ready for your transaction
Ask any experienced CFO or Investment Banker about when to get started preparing for your M&A transactions, and you'll get the same answer: "As early as possible." Being prepared for due diligence is easily done using ShareVault Ever Ready, a special configuration that gives you a very affordable way to get your documents organized and secured in a ShareVault, so when you're ready to start your transaction, the due diligence can start right away, without delay.

With the experience of hundreds of transactions worth tens of billions of dollars, you can rely on ShareVault to securely share the due diligence documents for your next sell-side M&A transaction.

News Feed Source: FierceBiotech

• FDA panel overwhelmingly backs Vivus' diet drug
  February 22nd, 2012, 03:30 AM (PST)
  

  Who said this panel vote would be close? Non-agency experts gave strong support to Vivus' ($VVUS) quest to gain FDA approval for its diet pill Qnexa, voting 20-2 this afternoon to support the drug getting a green light to hit the U.S. market, TheStreet reported.

  The Endocrinologic and Metabolic Drugs Advisory Committee vote comes ahead of the FDA's decision, which is expected by April 17, on whether to stamp an approval on the Mountain View, CA-based developer's drug. If approved, Qnexa would be the first new diet pill to garner FDA approval in more than a decade. The agency, as many know, is not required to follow such panel's recommendations, but it often does.

  Industry watchers have been largely split on Vivus' chances of gaining a nod for its latest approval bid, as U.S. regulators have taken a tough stance on the safety of diet drugs because of their side effects. The FDA, which shot down Vivus' first bid for Qnexa's approval in 2010, released its staff review of the company's latest application, noting previous concerns about the cardiovascular side effects of the drug, as well as the risk of birth defects in the offspring of mothers on the treatment.

  During today's committee session, non-agency experts and company officials discussed having a risk evaluation and mitigation strategy for Qnexa to limit any ill effects of the drug on patients. Prior to today's panel vote, analysts had speculated from the tenor of the FDA's briefing documents that the agency might delay approval of Qnexa to seek additional safety information.

  Vivus has been among three drug developers including Arena Pharmaceuticals ($ARNA) and Orexigen ($OREX) that have been racing to gain approval for new weight-loss drugs. The panel's favorable vote on Qnexa appears to have spurred a jump in the stock prices of Arena (6%) and Orexigen (14%) in after-hours trading.

  There's no question that a stout market awaits new weight-loss drugs. Two out of three Americans are either overweight or obese, and drug developers have been vying to fill a gap in the market that isn't addressed with existing interventions such as dieting, exercise and bariatric surgery. The CDC has put the annual cost of obesity--which can lead to diabetes, heart attacks and other health problems--at $147 billion in the U.S. alone.

  - here's The Street's live blog
  - get more from Reuters
  - and here's more from the Los Angeles Times

  Related Articles:
  FDA notes concerns about Vivus diet pill safety ahead of panel
  Vivus buoyed by FDA's willingness to drop Qnexa restriction
   

• Eisai co-developing cancer drug fueled by bacteria; U.S. trials launch soon
  February 22nd, 2012, 03:30 AM (PST)
  

  Tokyo's Anaeropharma Science is launching U.S. clinical trials as early as March for a new stomach cancer drug fueled by bacteria. The biotech is partnering with Japanese drug giant Eisai to bring the treatment to market, according to the Daily Yomiuri. Testing will involve 60 patients over 3 ½ years. Anaeropharma loads the drug with bifidobacteria, which helps the drug both reach and build up within its tumor target because it is drawn to environments lacking oxygen, just like solid tumors. An anticancer agent taken by mouth then selectively targets those tumors after reacting to the drug, according to the article. Story

• Venture backer makes $7M bet on cardio drug tech that could rival stents
  February 22nd, 2012, 03:30 AM (PST)
  

  With drug delivery tech from a children's hospital in Philadelphia, Vascular Magnetics has pocketed a $7 million Series A round from lone investor Devon Park Bioventures. And the startup has ambitious plans to advance magnetic drug-loaded particles for the huge market to treat peripheral artery disease--offering a potential alternative to a range of existing interventions against the disease that affects some 10 million Americans, according to the company.

  The startup's tech is based on the published work of Dr. Robert Levy at The Children's Hospital of Philadelphia. The company proposes to develop Levy's magnetic drug-loaded particles to deliver treatments directly to diseased tissue with the aid of a magnetic catheter system and an external device to create a magnetic field, making the proposed product a true drug-device combo. The financing is expected to be enough to propel the company through preclinical development and an initial human trial, according to the company's COO and co-founder Richard Woodward.

  "Current treatments for PAD such as angioplasty, grafts and stents, including drug-eluting stents, are not durable, with arterial re-obstruction (restenosis) occurring frequently," company Chairman Georges Gemayel said in a statement. "Vascular Magnetics' innovative approach to enhance local drug delivery has great potential to transform PAD treatment by delivering anti-restenotic drugs specifically to diseased artery sites at higher concentrations than are possible with drug-eluting stents."

  Woodward stated that the startup aims to launch its maiden trial in 2014.

  - here's the release

• Collegium Pharma scores $22M round for abuse-preventing painkiller in Phase III
  February 22nd, 2012, 03:30 AM (PST)
  

  Venture backers have rallied behind Collegium Pharmaceutical to continue a late-stage trial for its extended-release version of oxycodone. The investors--led by Longitude Capital and Skyline Ventures, and including Frazier Healthcare Ventures and Boston Millennia Partners--are betting $22.5 million in the developer's Series B round.

  With traditional oxycodone offering a recipe for abuse, Collegium has a proprietary formulation of the popular pain drug dubbed COL-003 that aims to thwart the type of tampering such as crushing and snorting the drug that addicts employ. A late-stage trial for the company's lead drug is under way, and the fresh round of capital is expected to be enough to fund the developer through potential FDA approval of the treatment, according to the company's release. Collegium plans to file an application for U.S. approval of COL-003 in 2013.

  "We believe that with the ongoing national epidemic of prescription drug abuse there remains a significant unmet clinical need for tamper-resistant formulations that can mitigate abuse/misuse of opioid products," Collegium CEO Michael Heffernan said in the release.

  A challenge for Collegium, naturally, will be setting itself apart from the pack of drugmakers in the pain field. Competitors are at various stages of advancing their own recipes for stymying abuse of pain pills. For instance, Purdue Pharma won FDA approval for a new formulation of OxyContin (oxycodone) in 2010 that offers controlled release of the drug and measures to prevent tampering.

  - here's Collegium's release

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• Biotech VCs wait for big checks from string of buyout deals
  February 22nd, 2012, 03:30 AM (PST)
  

  Holding most of the cards in M&A deals, drugmakers have increasingly scored biotech buyouts with much of the payments to startup investors delayed unit certain goals are met. The danger of the deals is that investors face slim odds of raking in all the milestone payments tied to the buyouts, as many of the programs that must succeed in order for payments to be made often fail. One biotech backer from Atlas Venture has taken a stab at calculating the actual earnings from a sample of such deals.

  Plucking numbers from a variety of public sources and data from individuals, Atlas Partner Bruce Booth writes that 24% of milestone payments were actually received from buyout deals involving drug developers from January 2005 to December 2009. Those payments amounted to $1.7 billion to biotech investors, and some of the milestone money remains on the table as related programs advance, but the figure illustrates how the big "potential" buyout figures seldom become real dollars. His research shows that 40% of the milestones from those 35 deals could be collected, yet 37% of the payments are out the window because programs to which they are tied have been tossed.

  The so-called "biobucks" tied to these deals are often overlooked in the press after the deals are closed, but biotech investors obviously pay close attention to how much money they will actually receive from M&A events. With VCs dropping from the ranks of potential sources of capital, hope that the "biobuck"-laden deals bear fruit for these investors and entice them to make more bets on biotech startups. With IPOs hard to come by for small drug developers, drugmakers might offer venture backers their best shot at returns on their biotech investments.

  Booth and his firm are among the ranks of VCs still waiting for big checks from drugmakers that have bought their portfolio companies. In the past two months, the VC firm has seen two of its drug developers--Stromedix and Avila--scooped up in deals that provided only part of the total payouts upfront. For instance, Biogen Idec ($BIIB) snapped up Stromedix for $75 million upfront and the lion's share of the potential payout, $487.5 million, tied to the success of the startup's fibrosis programs. Booth is asking his counterparts in the industry to help him compile a more complete picture of how much in the way of biobucks they are actually pocketing.

  - get more from Booth's blog

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• Genomics revolution ignites new M&A talk, showstoppers
  February 22nd, 2012, 03:30 AM (PST)
  

  Roche's $5.7 billion hostile bid to scoop up DNA sequencing machine maker Illumina ($ILMN) has triggered talk of further merger targets in the promising genomics arena. And the race to invent faster and cheaper ways of decoding the genome has pushed small companies to the cutting edge of the field, giving industry leaders such as Illumina and Life Technologies ($LIFE) a run for their money.

  While Swiss drug giant Roche continues its advance to gobble up a resistant Illumina, analysts have noted that rival Life Technologies could generate interest from other companies wanting a foothold in the blossoming market for DNA sequencers, Bloomberg reports. Genomics touches drug development, diagnostics and basic research. Other potential targets could be cancer test maker Genomic Health and Affymetrics, a maker of gene-analysis products, JMP Securities said, as quoted by Bloomberg.

  "Roche's hostile bid for Illumina sparked a lot of interest in the genetic sequencing space," Alex Morozov, a Morningstar analyst, told the news service. Buyers could "look to supplement their internal R&D with external candidates, especially if they see something that could potentially be promising."

  Both Life Technologies and Illumina announced last month their latest sequencers promise to push the cost of decoding a whole genome to the prized price tag of $1,000, making the technology more practical for screening patients' DNA for genetic clues about the best treatments. Drugmakers have seized the fruits of the technology as sequencers uncover new genetic targets for personalized drugs against cancer and genetic diseases.

  Roche, which is also a leading diagnostics company, has stood alone among the Big Pharma groups making bids for sequencing companies. Sanofi CEO Chris Viehbacher has already said his company would prefer to stick to partnerships to access such platform technologies. Rather, the large potential buyers include companies with diversified healthcare businesses such as General Electric ($GE) and Siemens, Bloomberg reported. Experts have pointed out the speed at which the genomics field is changing, potentially making the standout products of today obsolete in a short period of time.

  The field was reminded of this rapid change last week at a genomics meeting in Florida, during which Oxford Nanopore Technologies technology chief Clive Brown unveiled a sequencer that will cost just $900 and fit neatly in a device that is the size of a computer thumb drive, Xconomy reported.

  - check out Bloomberg's article
  
- see Xconomy's report

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  Roche looks to snatch up Illumina for $5.7B

• Lee Hood startup grabs $10M to advance class of protein-capture agents
  February 22nd, 2012, 03:30 AM (PST)
  

  Biotech visionary Lee Hood's startup Integrated Diagnostics has reeled in fresh capital to roll into commercial mode with its novel protein-catalyzed capture (PCC) agents. The molecules are in development as diagnostic and therapeutic agents, with the bold goal of being able to simultaneously detect myriad markers in a patient's blood to detect diseases such as lung cancer and Alzheimer's.

  The Seattle-based company's $10 million tranche announced today wraps up its $30 million Series A round first revealed in 2009. With the company initially seeking to bring to market blood-based diagnostics, CEO Al Luderer told Xconomy that he expects the company's first commercial product to be available in a little more than a year. To bolster its commercial aspirations, the company has named Jim Garner its chief business officer and Guy Seaton as its CFO.

  "As InDi moves swiftly towards commercialization, the third tranche demonstrates the progress we've made in validating our in vitro diagnostic programs as well as our novel class of diagnostic and therapeutic molecules," Luderer said in a statement. "In two short years, we have met our two main objectives: define a new in vitro proteomic diagnostic platform capable of answering previously unanswerable diagnostic questions and; demonstrate the feasibility of a new in vivo molecular diagnostic and therapeutic molecular class: PCCs."

  The company's platform is based on work from Hood's lab at The Institute for Systems Biology and it has licensed tech from Caltech as well. Its lineup of venture backers includes InterWest Partners, The Wellcome Trust and the Grand Duchy of Luxembourg.

  - here's the release

  - get more in Xconomy's article

• FDA staffers advise agency to deny Chelsea's key drug
  February 21st, 2012, 03:30 AM (PST)
  

  There's no ambiguity about this FDA staff review. In briefing docs on Chelsea Therapeutics' ($CHTP) bid to gain approval of its hypotension drug Northera (droxidopa), agency staffers recommended against approval, confirming investors' worries about the drug's prospects in the U.S. market.

  The FDA staff noted the "worrisome" safety issues in clinical trials, including deaths, strokes, myocardial infarction and disease progression, according to the agency's briefing docs. Also sparking concern is a post-marketing study in Japan, where the drug is approved, that identified cases of a potentially deadly neurological condition known as neuroleptic malignant syndrome in patients who took the drug.

  "On the basis of the safety concerns compounded by absence of evidence of durability of effect, my regulatory recommendation is that we should not grant approval for droxidopa [Northera] at this time," FDA staffers said in their report.

  Chelsea's shares were down by 15.7% as of 11:46 am ET today. In fact, its share price has taken a beating since the company alerted investors last week the FDA had questions about the relatively small size of its clinical trials for the drug (along with other concerns). The drug is supposed to treat a drop in blood pressure that happens within three minutes of a patient standing up, Bloomberg reported, noting Dainippon Sumitomo Pharma markets the drug in Japan with annual revenue of $50 million.

  Non-FDA experts are due to meet Feb. 23 to review Chelsea's Northera application and decide whether to recommend approval. The FDA doesn't have to--but often does--take such panels' recommendations, and the agency is expected to decide whether to stamp an approval on the drug by March 28.

  - here’s the Bloomberg article

  - see the update from RTTNews

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• FDA raises cardio concerns on Forest's new COPD drug
  February 21st, 2012, 03:30 AM (PST)
  

  Forest Laboratories ($FRX) and Almirall got a thumbs up from the FDA for their efficacy data on a COPD drug candidate. But regulators want an upcoming panel review to closely explore cardio risks linked with the entire drug class it belongs to. One big issue is whether the companies designed large enough trials to accurately gauge the cardio risk. Story

• Novartis snags preclinical hep C drug in $440M Enanta pact
  February 21st, 2012, 03:30 AM (PST)
  

  Novartis ($NVS) has stepped up to the plate in the big hepatitis C game, signing a $440 million pact to license a preclinical NS5A drug from Enanta Pharmaceuticals.

  As part of the deal, Watertown, MA-based Enanta will get $34 million upfront, $406 million on a full slate of milestones, potential double-digit royalties on EDP-239 and some fresh backing on its related discovery work in the field. Novartis is taking on all development costs for the program.

  "We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans," says Enanta CEO Jay Luly, Ph.D., in a statement.

  The NS5A target is a hot one in hep C. Developers at this stage of the game are looking for treatments that have a broad effect across all three genotypes. They also want to find new cocktails that can beat down the virus and eliminate any signs of it without having to resort to interferon. That Holy Grail in R&D is the ticket to a multibillion-dollar market, a prize that has attracted a wide group of biopharma players.

  - here's the Enanta press release

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