In researching Provectus' China go-to-market strategy, I investigated Celsion's approach, among others. Other folks weighed in on their experiences and with their thoughts.
Celsion first partnered with local pharmaceutical manufacturer Zhejiang Hisun Pharmaceutical ("Hisun") in May 2012 on a commercial supply agreement. According to Celsion, Hisun would "...collaborate with Celsion around the regulatory approval activities for ThermoDox® with the China state Food and Drug Administration (SFDA). A local China partner affords Celsion access to accelerated SFDA review and potential regulatory exclusivity for the approved indication." An equity analyst covering the company noted "...partnering with a local company should foster
good relations with the government for Celsion." In January 2013 Celsion announced reaching terms with Hisum on a commercial license agreement. Step 1, commercial. Step 2, government.
Provectus did the China two-step in a more recognized fashion: Step 1, government. Step 2, commercial. It appears the company first established a strong, formal relationship with the government (e.g., Premier of the People's Republic of China, Ministry of National Defense, Ministry of Health, SFDA) directly and indirectly through Provectus' regional agent, culminating in Peter's November 2012 trip.
Peter's February 2013 trip should result in establishing a license relationship and agreement with a Chinese commercial partner and marketer, whether it is one of the companies in the table below or Hisun.
Showing posts with label Premier of the People's Republic of China. Show all posts
Showing posts with label Premier of the People's Republic of China. Show all posts
February 14, 2013
February 4, 2013
$PVCT: $CLSN, the @adamfeuerstein-Ratain Rule, and Provectus in China
Celsion's share price was obliterated last Thursday, down more than 81% and lower than price levels in 2012 before the stock made a dramatic run-up later in the year. On Friday, the stock dropped nearly 13% more. This morning it is down another 10%. Celsion “...announced what appeared to be an absolutely catastrophic failure from their
Phase III heat trial for ThermoDox,” and succumbed to the Feurstein-Rattain rule.
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| Adam Feuerstein's column here. |
The Celsion deal essentially was a license transaction call option owned by
Hisun. Positive ThermoDox results were necessary for Hisun to exercise its
option to further negotiate an eventual license transaction for China, Hong
Kong and Macau. While Hisun is not one of the top pharmaceutical
companies in mainland China (according to 2011 market caps), based on the table (below) I previously published, I must acknowledge I previously was incorrect about suggesting or implying the no name-ness of Hisun, which launched a joint venture with Pfizer in September 2012, Hisun-Pfizer Pharmaceuticals Co.
I am a big fan, proponent and practitioner of process. Good process doesn’t make a bad deal good, but can make a good deal great. In the case of Provectus, management’s good process could make a good China deal a great one.
Success in China for
Western companies appears based on working with that country's federal government as
a partner, rather than acting antagonistic, ignoring it or not involving it in
one's process.
Engaging in business in China as a foreign entity can be a very challenging endeavor for the largest of multinational corporations, let alone a small biotechnology company like Provectus. Two issues usually arise, the positive resolution of which typically bode well for success: the presence or lack of government support and, depending on the industry sector and business application, sufficient or insufficient intellectual property protection.
Many companies have enjoyed success because of a fruitful and “eyes wide-open” relationship with the Chinese state. When I traveled there a few years ago, that was the message of the CFO of Intel’s Dalian-based organization: see and seek the government as your partner, not your opponent. Just ask how successful Google and Paypal, among others, have been in trying to thwart or circumvent the Chinese government.
A nanotechnology company in which I am a very active shareholder spent a good amount of time, money and resources as it struggled to gain sufficient protection for its products, technologies and intellectual property as it hammered out a relationship with Foxconn to provide certain hand held electronics parts, componentry and coatings to several smartphone OEMs. The end consumer market was not China, but rather the company had to utilize China for manufacturing of products that ultimately would be sold in the U.S. and Europe. In the end, with the necessary support and promises of enforcement of its larger partners, the small nanotechnology company felt sufficiently comfortable and compelled to move forward in China. As a small company, time, money and resources are scarce and have to be adjudicated wisely, sometimes leading to nothing in the end.
Engaging in business in China as a foreign entity can be a very challenging endeavor for the largest of multinational corporations, let alone a small biotechnology company like Provectus. Two issues usually arise, the positive resolution of which typically bode well for success: the presence or lack of government support and, depending on the industry sector and business application, sufficient or insufficient intellectual property protection.
Many companies have enjoyed success because of a fruitful and “eyes wide-open” relationship with the Chinese state. When I traveled there a few years ago, that was the message of the CFO of Intel’s Dalian-based organization: see and seek the government as your partner, not your opponent. Just ask how successful Google and Paypal, among others, have been in trying to thwart or circumvent the Chinese government.
A nanotechnology company in which I am a very active shareholder spent a good amount of time, money and resources as it struggled to gain sufficient protection for its products, technologies and intellectual property as it hammered out a relationship with Foxconn to provide certain hand held electronics parts, componentry and coatings to several smartphone OEMs. The end consumer market was not China, but rather the company had to utilize China for manufacturing of products that ultimately would be sold in the U.S. and Europe. In the end, with the necessary support and promises of enforcement of its larger partners, the small nanotechnology company felt sufficiently comfortable and compelled to move forward in China. As a small company, time, money and resources are scarce and have to be adjudicated wisely, sometimes leading to nothing in the end.
A regional oncology deal in China between Provectus and a Chinese Big Pharma company has been in the works for several calendar quarters. The making of a deal emerged earlier this year in the spring. The company has worked through a process of due diligence, evaluation and negotiation to arrive where it is today.
In late-November, after a good amount of groundwork was laid, Peter traveled to China to meet with potential strategic partners and a bevy of government officials. There are multiple prospective partners for now (all of whom apparently are on the list of the top local pharmaceutical companies according to market cap above), and Provectus still is assessing the optimal one. On the government side, Pete and his intermediaries met, differently, with senior leadership of the office of the Premier of the People’s Republic of China, the Ministry of Health, the Ministry of National Defense, and the State Food & Drug Administration.
In late-November, after a good amount of groundwork was laid, Peter traveled to China to meet with potential strategic partners and a bevy of government officials. There are multiple prospective partners for now (all of whom apparently are on the list of the top local pharmaceutical companies according to market cap above), and Provectus still is assessing the optimal one. On the government side, Pete and his intermediaries met, differently, with senior leadership of the office of the Premier of the People’s Republic of China, the Ministry of Health, the Ministry of National Defense, and the State Food & Drug Administration.
It appears he left China having established a good
working relationship with the government and government officials, a relationship that since has permitted Provectus and its advisors to now work with prospective strategic partners to finalize a license
transaction with a down-selected one on top-line terms and
conditions blessed by the government. Government support of Provectus, PV-10 and the business relationship between the company and the eventual strategic partner has been established, as I think has been the intellectual property protections afforded Provectus (with which I think management is mostly comfortable, or understanding or realistic of how the relationship might work in the context of their IP and its protection or lack thereof).
When Pete returns from his late-February trip to China (this assumes, of course, he does travel), he could bring home a signed deal and the contemplated upfront cash payment. These monies could fund the pivotal MM Phase 3 trial, to-be-finalized HCC (liver cancer) Phase 2/Phase 3 trial and, possibly, and one or two more Phase 1 trials, and contribute to other corporate use of funds.
An interesting situation arises, since the prospective partners all appear to be from the table above, with the China subsidiaries (WFOEs/WOFEs, which I think is unlikely, or acquired domestic subs) of key Western Big Pharma companies. I need to do more homework on this aspect or facet of a potential China deal.
Of course, Pete may not be successful. Deals break down or do not come to fruition for both substantive
and silly reasons. As cliched as the phrase is, only time will tell.
December 29, 2012
$PVCT: China Process
Previously having written about the possible make-up of a potential deal here, below are thoughts about what the process might entail.
| Click figure to enlarge it. |
December 7, 2012
$PVCT: Will Management Get A Deal Done In China?
I previously wrote a blog post entitled Can Management Get A Deal Done In China? I used "can" because I thought management could be able to secure a deal; that is, there is the ability to get or the possibility of getting a deal in China done.
Time passes. More dots connect.
I think the question, for over the next few weeks to the next couple of months, now is: Will management get a deal done in China? I use "will" to query management's intention to do this deal, or another.
Existing shareholders and prospective investors, in my view (through discussions with a variety of them), thought or think of "can" as management's ability -- their skill set -- or PV-10's (or PH-10's) ability -- the facets and features of the drug(s). I have never thought that way. Rather, I have examined and focused on the whether management has the process and pieces of sufficient quality and quantity to get a deal or deals done.
Management has been approached and continues to be approached to do deals. Frankly, anyone can do a deal. The real question -- the real perspective -- is whether the deal is a good or great one. Lots of people can and do do bad deals all of the time. Provectus understands better than most, and now better than ever, the value of the company's portfolio of drug compounds.
It seems we are drawing closer and closer to a seminal event, or more.
There have been previous discussions across and around the table about licensing PH-10 and PV-10. I do not doubt those discussions involved numbers, terms and conditions; however, in my experience, such discussions become "more real" or advance when a term sheet materializes.
From what I can gather (and it may well be a rumor), a term sheet has materialized in China. The parameters probably are not too dissimilar from what I wrote here. There is of course lots we do not know.
Who is the prospective Chinese big pharma partner? For example, is the partner on the list below?
Is Pfizer involved in some way? Pfizer's presence in China, from sales to R&D to manufacturing, is notable.
I previously wrote that regulatory and governmental agency backing in China was crucial. What kind of backing does Provectus and its prospective Chinese pharma partner have? I had the good fortune of participating in a trade delegation to China several years ago (what a treat!), and met a senior member of the Premier's staff. For pharmaceuticals, I would assume the State Food and Drug Administration and the Ministry of Health are germane regulatory and governmental bodies, among others.
If management elects not to do a deal in China yet, what else is there to take its place?
Time passes. More dots connect.
I think the question, for over the next few weeks to the next couple of months, now is: Will management get a deal done in China? I use "will" to query management's intention to do this deal, or another.
Existing shareholders and prospective investors, in my view (through discussions with a variety of them), thought or think of "can" as management's ability -- their skill set -- or PV-10's (or PH-10's) ability -- the facets and features of the drug(s). I have never thought that way. Rather, I have examined and focused on the whether management has the process and pieces of sufficient quality and quantity to get a deal or deals done.
Management has been approached and continues to be approached to do deals. Frankly, anyone can do a deal. The real question -- the real perspective -- is whether the deal is a good or great one. Lots of people can and do do bad deals all of the time. Provectus understands better than most, and now better than ever, the value of the company's portfolio of drug compounds.
It seems we are drawing closer and closer to a seminal event, or more.
There have been previous discussions across and around the table about licensing PH-10 and PV-10. I do not doubt those discussions involved numbers, terms and conditions; however, in my experience, such discussions become "more real" or advance when a term sheet materializes.
From what I can gather (and it may well be a rumor), a term sheet has materialized in China. The parameters probably are not too dissimilar from what I wrote here. There is of course lots we do not know.
Who is the prospective Chinese big pharma partner? For example, is the partner on the list below?
![]() |
| Click figure to enlarge it. Source: China's Pharmaceutical Industry - Poised For The Giant Leap. KPMG, 2011. |
![]() |
| Click figure to enlarge it. Source: China's Pharmaceutical Industry - Poised For The Giant Leap. KPMG, 2011. |
If management elects not to do a deal in China yet, what else is there to take its place?
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