New Senate Bill Takes Shortcuts on Path to Biosimilars

Senators Charles Schumer, Sherrod Brown, Susan Collins and Mel Martinez have introduced a bill regarding the approval process for the approval of Biosimilars.

However, according to Biotechnology Industry Organization President Jim Greenwood, the bill proposed by Senators Schumer et. al. is essentially a recipe for disaster.

According to Greenwood:

“While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins and Martinez follows its companion bill in the House (H.R. 1427, The Promoting Innovation and Access to Life-Saving Medicine Act) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs.

“The legislation short cuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases, such as cancer, Alzheimer’s, Parkinson’s and multiple sclerosis.

“As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to replicate accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. With this in mind, any biosimilars legislation should mandate that FDA approval of a biosimilar include clinical trial data demonstrating its safety, purity and potency. Yet this bill includes language that would discourage the FDA from conducting certain clinical trials.

“More, the bill unfairly tilts the playing field toward biosimilars manufacturers. This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs. Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.

“A successful pathway to biosimilars must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS and unmet medical needs. The bill introduced today fails to meet this reasonable metric.

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures.”

This topic is sure to be hotly debated over the coming months.....Stay tuned.

The Struggle for Baby Biotechs

Sally Church has a great post on her blog about the coming cash crunch for baby Biotechs.
You can read it here.
Actually you should visit Sally's blog often. Her posts are consistently top-notch.

Contradictory Supreme Court Decision and the Costs to Society

According to an article in the New York Times here - today's Supreme Court decision sets the following scenario:

An injured consumer can sue a drug maker — but not a medical device maker?

That seemed to be the contradictory result of a decision Wednesday by the Supreme Court, ruling that federal law does not protect drug companies from product liability suits in state courts.

In contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.

While legal eagles will debate the nuances of today's decision - here is the real issue:

"[Today's]....decision would make companies more reluctant to produce beneficial drugs that come with higher risks."

Everything you ingest, whether it is Steak, Peanut Butter, Aspirin, and even Water, carries with it an element of risk. you cannot eliminate risk.
As a society, the cost of not developing life saving but potentially risky drugs, is a cost that we cannot afford to bear.

Genentech: Worth More Than Pfizer?

I am going to have to file this post under the Category of things I never thought I would be writing - but according to an blog post on the Forbes website last Friday - Genentech is worth more [in terms of Market Cap] than Pfizer.

Matthew Herper writes here that:

"Check this out: This morning, Genentech's market capitalization of $91 billion exceeds that of much-bigger Pfizer ($84 billion.) Pfizer has annual sales of $48 billion, compared to $13 billion for Genentech....Over the past two years, Genentech shares have been basically flat, but Pfizer's stock has plunged more than 40%."

Who would of thought this was possible?

Publish Post

Pfizer wants to become more like J&J - easier said than done

Jacob Goldstein posts at the Wall Street Journal Health blog that Pfizer's Jeff Kindler is quoted by Bloomberg as saying that:

“We are breaking the company down into smaller units so we aren’t dependent on any single product. I am a great admirer of J&J and Abbott’s business model.”

While Kindler expresses admiration for J&J and Abbott, the article goes on to stress that Pfizer is a long way from replicating the business models of those two companies.

Goldstein goes on to write:

If you were about to lose a $12 billion-a-year blockbuster, you too would be eager to be less dependent on any single product. J&J is indeed a famously decentralized company, and Kindler last year said he would reorganize Pfizer into smaller business units.

What’s more, the Wyeth acquisition will help Pfizer diversify into businesses such as animal health, consumer products and vaccines.

But the buy will hardly turn Pfizer into another J&J. Pfizer will likely pull in less revenue from Wyeth’s consumer health division (which includes brands such as ChapStick and Advil) than it drew from its old consumer health business, which it sold in 2006 to J&J.

What’s more, Pfizer still won’t be a player in the medical device business, which has been central to Abbott’s growth and a key piece of J&J’s revenues.

Way back in the ’90s, Pfizer had its own medical devices unit. But the prescription drug business was booming at the time, so the company sold off its medical device business.

The question now is - Does Pfizer intend to go out an acquire a Medical Device company in a bid to remake their company?

Thomas Friedman - Invest in Biotech, Nanotech and Clean Tech

Thomas Friedman has a great piece in yesterday's NY Times. In a nutshell, Friedman thinks we should not be bailing out the economy's losers. Friedman writes:

"Our motto should be, 'Start-ups, not bailouts: nurture the next Google, don’t nurse the old G.M.’s.'"

Friedman elaborates his point when he writes:

"Yes, we have to shore up the banking system, which underpins everything; and finding a fair way to prevent hardworking people, who played by the rules, from losing their homes to foreclosure is both right and essential for stability. But beyond that, let’s think, talk and plan in more aspirational ways. We’re down, but we’re not out. As we invest taxpayer money, let’s do it with an eye to starting a new generation of biotech, info-tech, nanotech and clean-tech companies, with real innovators, real 21st-century jobs and potentially real profits for taxpayers."

Phenomenal stuff...and as usual Friedman is spot on in his assessment of what we need to do as we move forward to the Next Economy.

Career Adventure Blog

I just discovered a great blog by Kristi Daeda called Career Adventure.
Kristi is an HR professional and a Career Coach who I met on Twitter.
The posts on her blog are excellent and full of specific and tangible information that will be of help to any job seeker. Go over to her site and take a look....you will definitely learn something.

Job Hunting is all about Networking

David Rosman writing in the Columbia Business Times has a great article about Job Hunting.
You can read the article here.
Rosman's main premise is that Networking is what is going to help the majority of people find jobs. He also talks about JobAngels, which is "a 'grassroots' non-profit organization whose mission is to connect talented career professionals with those searching for work."
The work of the people involved with JobAngels further underscores the importance of networking.
Rosman closes the article with some solid advice:
There are four “Rosman Maxims” concerning the planning and execution of a career hunt. First, your future employer only cares how you can make them money, save them money or save them time. What you want is not even on the radar.
Second, a résumé will never get you the interview. But a well written, documented and professional résumé will reduce the likelihood of being first on the rejection pile.
Third, “It you tell enough people what you want, you will eventually get it.” Network, network, network. The idea that the majority of jobs are never advertised may or may not be true. However, with many companies now looking for qualified professionals, the more people in the field who know you are available, the higher the likely hood you will hear about the opening.
Fourth, “SW/SW/SW/N.” This goes along with the “If at first you don’t succeed” idea. You are going to get rejection letters; that is a fact of life. Yet another fact, many potential employers may never get back to you. These are not personal rejections. Just put a smile on your face and remember, “Some will. Some won’t. So what. Next!”

Get a copy of The Innovator's Prescription

I am in the middle of a phenomenal book entitled The Innovator's Prescription by Clayton Christensen. The book provides a comprehensive blueprint for repairing our health care system.
I will discuss the book in more detail in later posts. But if you are involved in any way in the Pharmaceutical Industry...drop everything and get yourself a copy of this book. It is not an easy read. It will make you think. But it is absolutely brilliant!

Who is Sanofi-Aventis gonna buy?

Reuters reports that Sanofi-Aventis is in the market to make an acquisition.
The article states that:

Sanofi has been mentioned as a possible buyer of Dutch vaccines maker Crucell (CRCL.AS), which has a market value of about 1 billion euros, and there has also been speculation it could make a play for its U.S. partner Bristol-Myers Squibb (BMY.N), which has a market value of around $45 billion.

My gut feeling is BMS is not a target. BMS is too big. Various other news outlets speculate while Sanofi is willing to open up it's purse strings....their targets are more likely to be small and mid-level companies. And the word on the street is that Sanofi is content to leave the big mega-mergers to Pfizer.

P&G to exit the Pharma Industry

The Financial Times is reporting that P&G may be looking to exit the Pharma industry.
The article states that:

Mr Lafley [P&G's CEO] said that when P&G had been investing heavily in pharmaceuticals in the 1990s, the returns had been well above those from consumer products. “Today, pharma companies trade at multiples at or below consumer products,” he said.

He also drew attention to greater regulatory obstacles within the pharmaceuticals industry, and increased competition from generics that reduces the pay-off of companies’ research and development.

Mr Lafley said that in weighing potential divestitures, its primary focus in making decisions would be “creating maximum value for P&G shareholders”.

This is probably a wise move for P&G. The company never seemed fully committed to the Pharma industry. People in P&G's Pharma division have always told me that they felt that the Company's primary focus was on the Consumer Goods side of the business. P&G is a wonderful Consumer Prouducts company....but developing Pharmaceuticals is a whole lot different than making Shampoos.

Merck to go shopping?

It looks like Pfizer is not the only Pharma Company with it's checkbook out.
The Wall Street Journal quotes Merck's Chief Executive Richard Clark as saying that "Merck would look 'across the whole spectrum' of deals, including a major takeover. 'I don't think in today's world any CEO can categorically rule out any type of transaction,' "

Traditionally Merck has been proud of its internal R&D programs.
But now apparently Merck wants to go shopping too.

Pfizer / Wyeth - The Opportunity Costs for R&D

Derek Lowe has a great post over at SeekingAlpha.com about the drag on productivity that this merger is having on both Companies' R&D Departments. Derek writes:

I’d imagine that things have slowed down a great deal. No one knows what the future will be like, what parts of the company will stay, and which people will be asked to stay with them. How do you make plans under those conditions? For many people, the project they’re working on is now very much a secondary consideration.

Even outside the personal level, there are a lot of paralyzing influences. The same uncertainties about individual jobs apply to development projects. Some of what Wyeth is working on surely overlaps with what Pfizer’s already doing. So which project goes forward? Not both of a matched set, that’s for sure. There are some projects at both companies that are dead in the water, but no one can be sure which ones, and no one will know for some time to come....all this has a ferocious price, when you measure it in opportunity costs. The people caught up in all this could be doing something much more productive with their time, for sure. This sort of thing doesn’t show up on the books. And the longer the process drags on, the worse it’ll be.

Derek is correct....not every cost will show up 'on the books'. And this merger could ultimately prove to be extremely expensive for Pfizer....both in terms of Real Costs and Opportunity Costs.

Pfizer - Wyeth - Bane for Small Biotechs???

The NY Times has an article today entitled "Wyeth Deal May Slow Pfizer Biotech Acquisitions".
The article states,

"Pfizer’s deal to buy a big pharmaceuticals rival, Wyeth, raises questions about how willing — or able — Pfizer will be to enter deals anytime soon with biotechnology companies, many of which are struggling to stay in business."

And, in the article, Oleg Nodelman, portfolio manager at the Biotechnology Value Fund is quoted as saying,

“There are probably 5,000 biotech companies out there that are waiting for a deal to save them."

However, Mr. Nodelman is not totally pessimistic regarding the future of the smaller biotechs.
The article closes by saying that fortunately -

"Big pharmaceutical companies are not the only ones who can buy companies or drugs. In some cases, mid-size biotech companies like Cephalon and Myriad Genetics are outracing larger companies to snap up some drugs.

That is why Mr. Nodelman, at the Biotechnology Value Fund, said he did not expect the Pfizer-Wyeth deal to have much of a braking effect on acquisitions of small companies or their drugs. “All it means is there is one less company that might do a deal with them.”

Geron's Embryonic Stem Cell Trial - Not exactly what the Media is touting

The FDA just approved the first human trial embryonic stem cell derived based treatment.
Geron Corp. has announced that the FDA approved its application to begin trials for an embryonic stem cell -derived treatment for spinal cord injuries.

The media is playing up this development as evidence of a 'Brave New World' with regards to Stem Cell research....that we are at the cusp of new research using Embryonic Stem Cells, and that the new Obama administration is shepherding in this new era in Research.
Forbes.com wrote:

The change has already begun. Just two days after his inauguration, President Barack Obama is set to clear the way for the first human testing of embryonic stem cells on people with spinal injuries, and biopharmaceutical firms like Geron are set to benefit.

Yet the facts say otherwise.

According to an L.A. Times article, even Dr. Thomas Okarma, Geron's CEO,...'the timing of the FDA's decision -- made late Wednesday but announced Friday by the company -- had nothing to do with the change of administrations in Washington....."We have no evidence that there was any political shadow over this process." '

Even more important according to Dr. David van Gend, National Director of Australians for Ethical Stem Cell Research, is the fact that Embryonic Stem Cells (ESC's) are not:

"....being given to patients at last. They are not. They never have been and never can be put into humans, because embryonic stem cells form tumors in animals. Only adult stem cells can be put into humans – and have been used now successfully in thousands of patients.”

Further reading shows that what Geron is actually doing is testing to see if their "hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury", actually works in humans.
Again the distinction is important.....they are not injecting actual ESC's into people....the cells are actually derived from ESC's.

So while the research Geron is conducting is absolutely exciting and promising.....it is not exactly what the Media is touting....

Pfizer and Wyeth - Misery loves company?????

Eben Tessari writes "5 Reasons Pfizer Shouldn't Buy Wyeth" over at SeekingAlpha.com.
You can read his complete post here.

And what is Eben's only justification for the proposed merger? - "Misery loves company."
Not exactly a stellar reason to consummate a $60 Billion merger.

Pfizer - Wyeth Merger - Is it a bad idea?

With all the talk about the proposed merger between Pfizer and Wyeth....I took the time to re-read an article from Fortune Magazine that I had saved on my computer. It was written in August 2007. You can read the article here.
Although some of the details and facts discussed in the article are dated [the article is 18 months old].....I wonder how many of you would agree with the author's conclusions. John Simons' closed his article by writing:

Pfizer could have an investor revolt on its hands if it does decide to propose a Wyeth acquisition. In recent years, top management has sworn off its appetite for big deals, promising a new focus on targeted acquisitions and alliances with smaller (read: more innovative) drugmakers and biotechs. Last winter, incoming CEO Jeff Kindler promised Pfizer would radically change the way it does business. That departure from the old way included a round of difficult cost cutting and "right-sizing" at the company. So, Pfizer needs to continue it's austerity campaign, and "oh yeah", in the meantime, conjure up some novel medicines.

The question is.....is John's assessment still correct in 2009....or is it time for Pfizer to do a deal?
Will this deal make Pfizer's problems go away?
What are your thoughts?...............

Merck goes hunting - Other deals pending???

Merck has made good on its promise to make deal making a priority in 2009.
Last Friday, just 9 days into the New Year, Merck announced that the company had signed a diabetes and obesity drug deal with Galapagos worth up to $233 million. You can read the specifics about the deal here.

And with Pfizer's Jeff Kindler telling the press that Pfizer is willing to do a deal with a big rival....Who knows....2009 may be a very active year on the M&A front.

Missing Pharmalot

Ed Silverman who runs the blog Pharmalot just posted a surprising announcement today.
He is shutting down Pharmalot. You can read his post here.

I thoroughly enjoyed reading Pharmalot daily and I learned a tremendous amount from Ed.
Ed is a tremendous writer and has a Herculean work ethic. As he jokes he lives tethered to his laptop.

Ed....we are going to miss you in the blogosphere. Best of luck!!!