Showing posts with label Daiichi Sankyo. Show all posts
Showing posts with label Daiichi Sankyo. Show all posts
May 12, 2013
$PVCT India Bound
Peter leaves for India this week for business development activities with prospective regional pharma partners. Ultimately, he will endeavor to determine which entity or entities are appropriate to enter into an MOU regarding PV-10. It would/could be reasonable to expect he'll meet with Ranbaxy Laboratories (majority owned by Daiichi Sankyo), Sun Pharmaceutical Industries (because folks visited the blog from offices in Mumbai's Acme Plaza) and Pfizer India (well, you know my thoughts about Pfizer...), among others.
Sun Pharma is India's largest pharmaceutical company by market capitalization. A Sun Pharma PR last week noted Sun Pharmaceuticals recent market cap was greater than Dr Reddy’s Laboratories, Cipla and Lupin's combined capitalizations.
April 26, 2013
Daiichi Sankyo: A Dark Horse Challenger to Big Pharma Buying $PVCT
Earlier this month I identified visits from Daiichi Sankyo in Tokyo spending many, many hours on the blog. Later, I confirmed visits from Daiichi's U.S. headquarters in Parsippany, New Jersey. I think Daiichi Sankyo is interested in a multi-faceted relationship with Provectus.
Plexxikon reported interim analysis of its MM Phase 3 trial for vemurafenib (Zelboraf) in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. When a corporate approaches a target, the dance generally begins with an introduction typically 3 to 6 months or more before an acquisition, if achieved, is announced. By this math, Daiichi may have begun speaking with Plexxikon around mid-2010. Plexxikon treated the Phase 3 trial's first patient in January 2010.
Daiichi, one could argue, acted aggressively. "Just a few months after Daiichi Sankyo Co. Ltd. purchased biotech Plexxikon Inc. of Berkeley, Calif., for nearly $1 billion, the Japanese pharmaceutical company is reaping the benefits. A drug developed by Plexxikon and now owned by Daiichi, vemurafenib, was approved for treating metastatic melanoma by the U.S. Food and Drug Administration, the company said Wednesday." (Source here)
Think about it. Daichii approaches Provectus before Moffitt's data has been presented at AACR in April. Before Provectus' contemplated pivotal MM Phase 3 trial is finalized -- where "finalization" means the receipt of the SPA -- and well before enrollment is commenced. That should come as no surprise because PV-10 is far superior to vemurafenib (Zelboraf) and has more multi-indication potential already (whereas vemurafenib did not).
Daiichi has the balance sheet to pay what Provectus desires. In 2008 Daiichi announced that it would pay up to $4.6 billion for a controlling stake in Ranbaxy Laboratories, one of the largest manufacturers of drugs in India; this deal valued all of Ranbaxy at $8.5 billion (a 31% premium to its stock market capitalization prior to the announcement).
Daiichi also has a Japanese cultural approach to M&A that might force Pfizer's hand. That is, it could push Pfizer to act because it has to act to protect an asset (Provectus) it values but heretofore has no impetus to acquire.
"Global studies of M&A point out that once executives dive into the transaction process, they often become so invested in the deal that they cannot pull out even when necessary. In most markets today, however, common wisdom prevails that being able to walk away is a hallmark of M&A sophistication. That notion is rare among Japanese practitioners of outbound M&A." (Source here)
"The demands of Japanese-style consensus building, requiring the hard-won agreement of many parties, make abandoning a deal particularly hard. The potential loss of face in such a decision makes participants reluctant to suggest it, even if the logic of proceeding is undermined by new information."
Daichii was agressive in acquiring Plexxikon, paying more for the company than anyone else offered or was willing to pay. From all accounts, the acquisition is or eventually should be accretive.
If Daiichi executives set their mind to licensing PV-10 (or PH-10) or acquiring Provectus, then Big Pharma (including, in particular, Pfizer) might lose the asset to the Japanese if they're not willing to counter bid.
Plexxikon reported interim analysis of its MM Phase 3 trial for vemurafenib (Zelboraf) in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. When a corporate approaches a target, the dance generally begins with an introduction typically 3 to 6 months or more before an acquisition, if achieved, is announced. By this math, Daiichi may have begun speaking with Plexxikon around mid-2010. Plexxikon treated the Phase 3 trial's first patient in January 2010.
Daiichi, one could argue, acted aggressively. "Just a few months after Daiichi Sankyo Co. Ltd. purchased biotech Plexxikon Inc. of Berkeley, Calif., for nearly $1 billion, the Japanese pharmaceutical company is reaping the benefits. A drug developed by Plexxikon and now owned by Daiichi, vemurafenib, was approved for treating metastatic melanoma by the U.S. Food and Drug Administration, the company said Wednesday." (Source here)
Think about it. Daichii approaches Provectus before Moffitt's data has been presented at AACR in April. Before Provectus' contemplated pivotal MM Phase 3 trial is finalized -- where "finalization" means the receipt of the SPA -- and well before enrollment is commenced. That should come as no surprise because PV-10 is far superior to vemurafenib (Zelboraf) and has more multi-indication potential already (whereas vemurafenib did not).
Daiichi has the balance sheet to pay what Provectus desires. In 2008 Daiichi announced that it would pay up to $4.6 billion for a controlling stake in Ranbaxy Laboratories, one of the largest manufacturers of drugs in India; this deal valued all of Ranbaxy at $8.5 billion (a 31% premium to its stock market capitalization prior to the announcement).
Daiichi also has a Japanese cultural approach to M&A that might force Pfizer's hand. That is, it could push Pfizer to act because it has to act to protect an asset (Provectus) it values but heretofore has no impetus to acquire.
"Global studies of M&A point out that once executives dive into the transaction process, they often become so invested in the deal that they cannot pull out even when necessary. In most markets today, however, common wisdom prevails that being able to walk away is a hallmark of M&A sophistication. That notion is rare among Japanese practitioners of outbound M&A." (Source here)
"The demands of Japanese-style consensus building, requiring the hard-won agreement of many parties, make abandoning a deal particularly hard. The potential loss of face in such a decision makes participants reluctant to suggest it, even if the logic of proceeding is undermined by new information."
Daichii was agressive in acquiring Plexxikon, paying more for the company than anyone else offered or was willing to pay. From all accounts, the acquisition is or eventually should be accretive.
If Daiichi executives set their mind to licensing PV-10 (or PH-10) or acquiring Provectus, then Big Pharma (including, in particular, Pfizer) might lose the asset to the Japanese if they're not willing to counter bid.
April 25, 2013
The Date $PVCT Will Be Acquired Is...
Getting a dramatic blog post title out of the way, three precedent transactions provide insight into the end-game (under certain circumstances or along one of several potential paths).
Precedent transaction #1: Plexxikon reported interim analysis of its MM Phase 3 trial in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. Transaction #2: BioVex commenced its MM Phase 3 trial in April 2010. In January 2011, Amgen announced it was acquiring BioVex, by which time the trial was about 90% enrolled.
Think about this information in the context of a PV-10 MM Phase 3 trial under SPA with the FDA commencing enrollment in mid-2013 (i.e., late-Q2 or early-Q3): Enrollment might take one or several quarters, and Interim analysis could be available 12 months after enrollment is completed (patients would be treated as enrolled).
Between somewhere in enrollment and interim analysis, after the SPA is received. Drawing out the numbers, the time frame to acquisition through the running of a Phase 3 trial, generally speaking, could be H2 2013 through H2 2014'ish. This back-of-the-envelope "time framing" examines a Phase 3 trial under SPA, with no benefit of an accelerated pathway to market (via accelerated approval or a more precise (shorter) SPA via breakthrough therapy designation).
Receiving an accelerated path to market through receipt of the breakthrough therapy designation -- either accelerated approval or a more precise (and thus shorter or faster) SPA -- certainly would change the timeframe. Of course, the rate limiting step here is clarity on timing and detail of the accelerated path.
Somewhere after the receipt of breakthrough therapy designation ("BTD") is announced, when and if BTD is achieved. Drawing out the numbers in this case, the time frame to acquisition could be H2 2013 through H1 2014'ish.
Precedent transaction #1: Plexxikon reported interim analysis of its MM Phase 3 trial in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. Transaction #2: BioVex commenced its MM Phase 3 trial in April 2010. In January 2011, Amgen announced it was acquiring BioVex, by which time the trial was about 90% enrolled.
Think about this information in the context of a PV-10 MM Phase 3 trial under SPA with the FDA commencing enrollment in mid-2013 (i.e., late-Q2 or early-Q3): Enrollment might take one or several quarters, and Interim analysis could be available 12 months after enrollment is completed (patients would be treated as enrolled).
Between somewhere in enrollment and interim analysis, after the SPA is received. Drawing out the numbers, the time frame to acquisition through the running of a Phase 3 trial, generally speaking, could be H2 2013 through H2 2014'ish. This back-of-the-envelope "time framing" examines a Phase 3 trial under SPA, with no benefit of an accelerated pathway to market (via accelerated approval or a more precise (shorter) SPA via breakthrough therapy designation).
Receiving an accelerated path to market through receipt of the breakthrough therapy designation -- either accelerated approval or a more precise (and thus shorter or faster) SPA -- certainly would change the timeframe. Of course, the rate limiting step here is clarity on timing and detail of the accelerated path.
Somewhere after the receipt of breakthrough therapy designation ("BTD") is announced, when and if BTD is achieved. Drawing out the numbers in this case, the time frame to acquisition could be H2 2013 through H1 2014'ish.
There's yet another way to look at Provectus' endgame, too. Transaction #3: Bristol Myers acquired Medarex on the basis of the latter's MM Phase 2 data and a strong understanding of ipilimumab's mechanism of action. Dr. Jeffrey S. Weber, MD, PhD of Moffitt Cancer Center was highly involved in the elucidation of ipi's anti-tumor response. Dr. Weber also did translational research on vemurafenib (Zelboraf), Plexxikon's drug that was acquired by Daiichi Sankyo.
Soon? Drawing out the numbers in this case, the time frame to acquisition could be the end of 2013.
Provectus will be acquired when it is acquired. I found it helpful to review some precedent transactions in order to understand where the company currently resides in the bigger scheme of things.
Soon? Drawing out the numbers in this case, the time frame to acquisition could be the end of 2013.
Provectus will be acquired when it is acquired. I found it helpful to review some precedent transactions in order to understand where the company currently resides in the bigger scheme of things.
April 16, 2013
$PVCT: What Could A Relationship with Daiichi Sankyo Mean?
Daiichi Sankyo's interest in Provectus might range from something simple or narrow to something more robust.
You can read about Daiichi Sankyo's new 5-year business plan here.
April 15, 2013
$PVCT: Big Pharma Interest
This blog is one of the primary sources of information about Provectus.
The blog can see, among several other things, where visitors come from (e.g., IP address, city, state/region, country, etc.) and how often they stay and read (page views, visits, visit lengths, etc.). Anytime you visit any destination on the world wide web, you are being tracked. Unless you use something like Tor to protect your privacy.
About 10 days ago I speculated about Daiichi Sankyo interest in PV-10. Why? Because...
First, folks from Daiichi Sankyo ("DS") in Japan visited multiple times and spent many, many hours on the blog. These visitors' IP address(es) originated from the pharmaceutical company's headquarters in Tokyo.
Then, folks from DS in the U.S. visited the blog. These visitors' IP address(es) originated from the pharmaceutical company's U.S. headquarters in Parsippany, New Jersey.
The next course action would be to ask various questions of Provectus management and gauge their responses, should of course they respond to questions about this topic.
At his presentation in New York in March, Craig noted Provectus was in the due diligence process of a pharmaceutical company for a global license. One presumes he did so because this Big Pharma had formally approached Provectus and were in formal due diligence with the company.
Is DS in formal due diligence with Provectus yet? If so, DS would make at least two Big Pharmas with a stated interest in the company.
If one assumes Pfizer has stated interest through Dr. Eagle's presence on Provectus' corporate advisory board, that would make three Big Pharmas.
There's a fourth. It's IP address(es) comes from...
The blog can see, among several other things, where visitors come from (e.g., IP address, city, state/region, country, etc.) and how often they stay and read (page views, visits, visit lengths, etc.). Anytime you visit any destination on the world wide web, you are being tracked. Unless you use something like Tor to protect your privacy.
About 10 days ago I speculated about Daiichi Sankyo interest in PV-10. Why? Because...
First, folks from Daiichi Sankyo ("DS") in Japan visited multiple times and spent many, many hours on the blog. These visitors' IP address(es) originated from the pharmaceutical company's headquarters in Tokyo.
Then, folks from DS in the U.S. visited the blog. These visitors' IP address(es) originated from the pharmaceutical company's U.S. headquarters in Parsippany, New Jersey.
So, I began connecting dots available to connect; those above, and others. I think DS has been informal (formal, in this context, means one engages the target company) doing due diligence on Provectus. Why? For one thing, simple activities like scouring web-based sources of information and data is merely one way of doing due diligence on a target, without directly engaging the entity in which you're interested. If you spend a lot of time reading a blog about a biotechnology company not written by said company, you're either really bored or really interested. For another, historical information about Daiichi Sankyo does suggest they can and will do global licenses. DS is a global Big Pharma company, with additional regional interests in Japan and India (through Rambaxy Laboratories) and maybe elsewhere in Asia Pacific. For example, in February 2011, Daiichi Sankyo announced its acquisition of Plexxikon for $805 million up-front and near-term milestone payments associated with the approval of PLX4032 (vemurafenib, now Zelboraf) for up to an additional $130 million. The deal closed in April.
The next course action would be to ask various questions of Provectus management and gauge their responses, should of course they respond to questions about this topic.
At his presentation in New York in March, Craig noted Provectus was in the due diligence process of a pharmaceutical company for a global license. One presumes he did so because this Big Pharma had formally approached Provectus and were in formal due diligence with the company.
Is DS in formal due diligence with Provectus yet? If so, DS would make at least two Big Pharmas with a stated interest in the company.
If one assumes Pfizer has stated interest through Dr. Eagle's presence on Provectus' corporate advisory board, that would make three Big Pharmas.
There's a fourth. It's IP address(es) comes from...
April 5, 2013
$PVCT: Daiichi Sankyo
In February 2011, Daiichi Sankyo announced its acquisition of Plexxikon for $805 million up-front and near-term milestone payments associated with the approval of PLX4032 (vemurafenib, now Zelboraf) for up to an additional $130 million. The deal closed in April.
Other acquisitions include Zepharma (2006), the OTC drugs unit of Astellas Pharma, a majority stake in Indian generic drug maker Ranbaxy (2008) valued at ~$4.6 billion, and U3 Pharma (2008) for the company's anti-HER3 antibody. (See Wikipedia)
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