We're Going to Vegas

We have many reasons to be excited by this report in this morning's VentureWire Lifescience about Nerites Corp. hiring its first CFO, former NimbleGen Systems Inc. exec David Schneider.

First, it's always nice to see someone hiring in this economy.

Second, the company confirmed the addition of Schneider is part of a broader plan to raise a Series B round later this year. Nerites was among the handful of companies we considered for our Series A Deals of the Year featured in last month's Start-Up. The company earned a mention in the article (find it here) but didn't make the final list, but we still care.

Third, we're going to get to hear the company's entire story at our upcoming IN3 West conference in Las Vegas.

Nerites will be among 50+ of the industry's choice start-ups presenting to a collection of biz dev and VC folks hoping to place the best bets (or best buys) in this tricky environment.

And those folks will give as well as take. The conference agenda includes discussions with senior level VCs from blue chip venture firms Frazier Healthcare Ventures, New Leaf Venture Partners, Versant Ventures and MedVenture Associates as well as seasoned medical device executives who have weathered some tough times in this industry.

And the fourth, final and probably least important (to you) reason we're excited: writing this blog post reminds us that IN VIVO Blog will be escaping the frigid East Coast for Vegas in just a few short weeks.

Hope to see you in Vegas!

Wyeth Worries Over Supreme Court Pfizer Holdings

Why should the drugmaker be anxious? And why should one of its attorneys write the US Supreme Court clerk about its deal with Pfizer?

As you know, Pfizer plans to acquire Wyeth, which has a closely watched case before the court involving preemption - the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. The case involves a Vermont musician, Diana Levine, who lost part of her arm after being administered a Wyeth drug, and the ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

Here's the rub: Chief Justice John Roberts sat out a case involving lawsuits against Pfizer because his May 2007 financial disclosure form indicated he held Pfizer stock between $10,000 and $50,000 (back story). The recusal yielded a 4-4 deadlock that upheld the rights of 27 Michigan residents to sue drugmakers for defrauding the FDA in winning product approvals.

As a result, the court left intact a lower-court ruling allowing the Michigan lawsuits to proceed. Had Roberts not recused himself, some observers believe he may have voted in favor of the pharmaceutical industry. Wyeth apparently fears a repeat in the Levine case, and so a Wyeth attorney wrote a letter on Wednesday to the clerk of the Supreme Court to argue that Roberts' Pfizer stock should not prevent him from voting.

Why? The acquisition won't close until at least July 31, after the court is expected to decide the case. "Wyeth does not believe the proposed acquisition warrants amendment of the corporate disclosure statement in its previously filed briefs," writes Seth Waxman, of Wilmer Hale, who represents Wyeth.

image from flickr user dbking used under a creative commons license.

Vatican Radio Pulls The Plug On Dan Vasella

File this one under 'preventive measure.' The Vatican had invited the Novartis ceo to be its 'Commentator of the Week' this month, but yesterday did an about face after learning the drugmaker's Hexal subsidiary makes....drum roll...contraceptives.

"The approach of the Vatican to artificial contraception cannot be subject to the smallest doubt," Vatican Radio said on its website, according to Reuters. "We ask Mr Vasella and our listeners to understand this decision. We have only just learnt from the press that Novartis also produces contraceptives...There can be no doubt as to the Vatican's position regarding artificial contraception."

Dan, by the way, was supposed to have held his fireside chats each Saturday about different themes from an "ethical perspective," but was under no obligation to express the Vatican's viewpoint, according to Swissinfo. Perhaps he can start a blog instead.

image from flickr user Katie Dureault used under a creative commons license.

A Friend in High Places

VCs finally seem to have a friend residing in the White House. The Venture Capital Journal declared so in its cover story, and, as this picture shows, Steve Jurvetson, managing director of VC firm Draper Fisher Jurvetson, connected with then Presidential Candidate Obama back in 2007.

The new president appears to understand and appreciate the need for innovation. This friendship could be tested because while people love innovators, they don't always have the same regard for the investors in innovation. That sentiment is beginning to shine through, at least in Congress.

First, the Senate is pondering a "Hedge Fund Transparency" bill that lumps those investors in with private equity firms and, gasp, venture capital funds. Clearly, venture firms and hedge funds have completely different charters (although there might have been some blurring over recent years) but the Senate apparently doesn't have the appetite or insight to sort them all out.

Feel free to tip toe over to PEHub for details, but here's the gist: Venture capital firms, at least those with funds of larger than $50 million (so nearly all), will be required to make regular filings to the SEC, listing limited partners and aggregate values of portfolios. It doesn't sound like a big deal, but venture firms already are wrestling with the regulatory demands brought on by FAS 157, the fairly new requirement forcing VCs to regularly assess the values of their portfolios.

If VCs are successful in extricating themselves from the association with hedge funds, they might find themselves fighting a second front. A small business advocacy group, the American Small Business League, is casting the venture industry as predatory billionaires looking to snatch money away from hard-working small business owners. Lloyd Chapman, the group's leader and spokesman, is objecting to the proposed changes by the Small Business Administration that would once again allow companies with significant venture capital backing to apply for SBIR grants.

Through posts on Youtube.com, the Huffington Post and other venues, the group accuses the Obama administration of being in the pocket of the venture capital industry. It even takes aim at Karen Mills, the VC-turned-head of the Small Business Administration, which administers the SBIR program.

President Obama's appointment of multi-millionaire venture capitalist and heir to the multi-billion dollar Tootsie Roll fortune, Karen Mills to head the Small Business Administration (SBA), is seen as an indication he will support federal legislation and policies that could kill millions of middle class jobs by diverting billions of dollars in federal small business contracts to some of the nation's wealthiest venture capitalists.

The National Venture Capital Association issued a worthy rebuttal, pointing out that venture-backed companies are small, struggling ventures that need all the help they can get. Chapman's campaign seems to ignore the fact that venture-backed companies were eligible for the SBIR grants until 2003, when the SBA changed the rules. Congress loosened the requirements again last fall, opening the door for VC-backed companies. But it needs to reauthorize the act.

Like most conflicts, this one isn't necessary. No doubt, venture capitalists and Chapman could sing the same tunes about small businesses creating jobs. In fact, that's just the angle the NVCA pushed in its press release, funding small businesses as a method of getting people back to work. The pharma industry certainly has shed many workers lately, people who could help a small biotech. The two parties also agree that large corporations shouldn't be eligible for the grants, but Chapman's group apparently can't get past the personal wealth of the VCs that may be backing these small businesses, tossing out loaded terms like "wealthy" and "well heeled."

Things are bound to get uglier before they get better. Here's hoping VCs don't get smeared by the same mud brush being used on well-paid Wall Street type. Life sciences VCs, in particular, will need their public images relatively clean as the public discussion moves off the economy onto their new friend's real priority: health care reform and containing the cost of health care.

("Presidential Obama" courtesy of flickr use Jurvetson)

Bioidentical HRT: One Of Oprah’s “Favorite Things”

Wyeth has long fought pharmacies trying to convince women to buy compounded hormone replacement therapies in lieu of Premarin. The company now has a new nemesis: Oprah Winfrey.

The television celeb devoted an entire show last month to bioidentical hormone therapy, announcing that she was “opening a national conversation” about HRT. The dialogue continued two weeks later with guest and perennial pitchwoman Suzanne Somers, a long-time advocate of bioidentical hormone replacement therapy.

The February issue of Oprah Magazine also includes an article on the topic (the cover has the teaser “Hot Women! The stuff nobody’s telling you about hormones”) and a column by Oprah in which she describes her own experience with the treatment.

“After one day on bioidentical estrogen, I felt the veil lift,” she writes. “After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”

Oprah’s endorsement cast a spotlight on bioidentical HRT as an alternative treatment for menopause symptoms, and has garnered attention far, far outside her typical audience: the New York State Bar Association’s annual meeting. At the meeting, attorney Irving Wiesen said her endorsement would draw an avalanche of attention to compounding.

That comment prompted Geoffrey Levitt, Wyeth’s chief regulatory counsel, to acknowledge: “It’s really hard to go up against Oprah.”

Several years ago Wyeth filed a citizen petition with FDA asking the agency to take enforcement action against compounding pharmacies that were manufacturing or dispensing bioidentical hormone replacement therapy. And Wyeth won: FDA sent warning letters to seven compounding pharmacies for producing these products with unapproved ingredients and making false and misleading promotional claims (you can read all about that here).

Oprah acknowledged FDA’s concerns about the therapy. FDA said in a statement to the show that it does not recognize the term bioidentical. “Many compounding pharmacies use ‘bioidentical’ as a marketing term to imply that drugs are natural or have effects identical to those from hormones made by the body,” the agency said.

“FDA is not aware of credible scientific evidence to support these claims. There are potentially serious adverse effects associated with long term use of these products--even when consumers use FDA-approved hormone therapy drugs that have been proven safe and effective.”

Blah-de-blah-blah-blah. This is Oprah we're taking about. The woman elected a president, for goodness' sake! She's got far more power than FDA and Wyeth combined!

(Oprah photo courtsey of flickr user radiant guy)

-- Brenda Sandburg

The Next HHS Secretary: All Signs Point to Kansas

So we thought we would be done with this game, but apparently not. Now that Tom Daschle has withdrawn his nomination, the question on everyone’s mind is: Who will replace him?

All signs point to Kansas Governor Kathleen Sebelius. The Governor made a name for herself in her home state as an insurance reformer. She stopped Blue Cross Blue Shield from merging with another out of state company and she refused to accept contributions from insurance companies during her campaign.

She was a key surrogate for President Obama during his campaign and remains close to him. Maybe most importantly, she was already thoroughly vetted for Vice President and was thought by many to be a close second to Joe Biden. As a serving public official, she would bring none of the lobbying concerns that weighed down Daschle’s nomination and eventually torpedoed it.

If Sebelius is the pick, we imagine that Jeanne Lambrew will be named head of the White House Office of Health Reform and Sebelius will take on the more classic role of the HHS Secretary.

But…

If President Obama attempts to remake the pick in the mold of Daschle—a legislative general with knowledge of the issues—here’s our list of potential candidates.

Rosa DeLauro (US Congress): The Connecticut Congresswoman was originally a candidate the first time around, so why not the second? DeLauro currently chairs the agriculture appropriations subcommittee in the House, which among other things oversees FDA's budget. She's no fan of DTC ads, sloppy overseas manufacturing, or anything that looks like overly cosy relationships between industry and regulatory.

DeLauro knows as well as anybody the ins and outs of Congress and where the levers of power are.

And remember that cozy little Super Bowl Party President Obama threw at the White House for a select few members of Congress? Well, DeLauro was invited and attended. We’re just saying…The President may need her as part of the stimulus plan passage/maintenance/implementation but ignore her at your peril.

Ron Wyden (US Senator): Wyden, weirdly, has been one of the forgotten figures of health reform. However, he’s got a bill floating out there and he’s taken a long-term interest in health care. The Health Americans Act, co-sponsored by Utah Senator Robert Bennett, aims to get universal coverage by creating a new private insurance market and uses state-based purchasing pools.

Plus Wyden has served in both the House and Senate, so he knows both worlds well. Not only that, my friends (John McCain reference), but one Emanuel seems to really like his approach. That would be NIH’s Ezekiel Emanuel who is on detail at the Office of Management & Budget. But if one Emanuel likes your thinking, don’t they all?

Donna Shalala (former HHS Secretary): President Clinton had one HHS Secretary for all eight years: Donna Shalala. Is there anyone who knows HHS better? Or the lessons of the failed Clinton health reform plans?

She could step in from Day 1 and hit the ground running while coordinating seamlessly with the White House health care group. In addition, Shalala has spent her post-government life as a university president at the University of Miami.

She appears to garner wide respect from both sides of the aisle. President George W. Bush awarded her the Presidential Medal of Freedom last year. Shalala has also remained very engaged in the health reform debate showing up at reform meetings involving all of the critical stakeholders.

Jay Rockefeller (US Senator): If you can’t get a Kennedy, why not a Rockefeller? (that one goes to one of our blog colleagues). Rockefeller has been intensely engaged and personally moved by the health reform because of family experience. His stake in the Clinton Reform effort is well documented.

Rockefeller would carry the interest, knowledge, experience in the Senate, and gravitas to the position of HHS Secretary. And as Senate Finance Health Subcommittee Chairman, he has the right title.

He has been particularly visible during hearings on Medicare Part D drug prices over the last few years. Before you dismiss this one out of hand, we have it on good sources he considered the Major League Baseball Commissioner job very seriously many years ago because he loves new challenges. We would categorize health care reform and universal coverage as a challenge.

Richard Gephardt (former US Congressman): We think Gephardt would be perfect for the Daschle-like role of legislative general. He served in the House of Representatives from 1977 to 2005 and was both the House Majority Leader and Minority Leader.

In fact, we would think his Daschle-like temperament and experience would make him perfect for the job. Except for one thing: he’s been a consultant to DLA Piper and Goldman Sachs since he left public life. That probably sticks a fork in any chance of Gephardt getting the job even if he wanted it, but you never know. 

Prasugrel’s Magical Moment

We here at the IN VIVO Blog do love our advisory committee meetings. The anticipation. The preparation. The smell of the reams of briefing documents. And then, there’s the meeting itself, and we find ourselves waiting for that magical moment when the tide turns, and it becomes clear which way the committee is going to fall.

Sometimes a meeting can turn on a company presentation, like Biogen-Idec’s case for bringing Tysabri back on the market. Or the power of a single committee member, like the Cleveland Clinic’s Steven Nissen's tirade against attention deficit/hyperactivity disorder drugs. Or the strength of a risk management program, as with Pfizer’s inhaled insulin Exubera (the later commercial failure notwithstanding).

For Lilly and Daiichi Sankyo’s prasugrel, the key moment came from FDA itself.

Prasugrel didn’t come to the Cardiovascular & Renal Drug Products Advisory Committee without a few issues—all of which have been breathlessly reported by your friends here at the IN VIVO Blog. (Hey, when you have a company-saving drug that could replace a $5 billion blockbuster as the standard of care for platelet inhibition, that’s kind of an exciting story.)

Bleeding is a problem with prasugrel. As is the potential that prasugrel may stimulate the growth of existing malignant tumors. Drugs have been taken down for less, and when you put that profile in the context of the current drug safety environment, Lilly had a potential catastrophe on its hands.

We’ve already made the case for why we think FDA will approve prasugrel, but there was certainly still the potential that things could go terribly wrong at the advisory committee—especially given that one of the the drug’s biggest cheerleaders, cardiologist Steve Nissen, wasn’t there to wave his pom-poms and give a big shout-out to P-R-A-S-U-G-R-E-L.

Advisory committees are unpredictable. Anything can happen.

Prasugrel’s magical moment happened when Ellis Unger, the deputy director of FDA’s Cardiovascular and Renal Drugs Products Division, stepped up to the podium. Unger’s take on prasugrel’s risk-benefit profile—as well as his relaxed, often humorous, demeanor—put committee members at ease with the data. (You can read more about that in today’s issue of “The Pink Sheet” DAILY.)

FDA, Unger said, is confident that the bleeding risk is well-characterized and understood, and while there is a possibility that prasugrel stimulates tumor growth, it is not a carcinogen: “Does prasugrel cause cancer? We don’t think so.” Unger lauded Lilly for its presentation, and declared that prasugrel’s superiority over Plavix in preventing non-fatal myocardial infarction was “where the money is.”

But it wasn’t just what Unger said that was magical for prasugrel. It was the fact that he was the only one who said it. The decision to use Unger as the only formal FDA presenter on prasugrel (other senior officials were at the committee table) rather than a parade of statisticians and medical reviewers sent a clear, single message, and avoided the potential for muddying the waters. It was, in effect, the anti-Avandia.

FDA may be criticized for that later by those who believe that dissenting opinions from within the agency—like calls to severely limit prasugrel use—should have been heard. Those opinions were outlined in the briefing documents to the committee. But when it came time for the meeting itself, there was no question where FDA stood on the approvability of the NDA. And that made for a magical moment for prasugrel.

Sunrise photo courtsey of flickr user inanutshell.

It's the Post Where We Give Away Free 3-Month Subscriptions to Our Premium Content If You Fill Out a Short Survey

"Survey Says!?"

Ever thought to yourself, hey this IN VIVO Blog thing is just chock-full of sweet bloggy goodness, but I wish I could subscribe to IN VIVO magazine? Or The Pink Sheet? Or RPM? Or Start-Up? Or another one of the fine publications within the FDC-Windhover / Elsevier Business Intelligence fold? (Oh, there are many fine publications.)

Well, now you can. For free! Sort of.

Of course there's a very small catch. We'd like you to take a couple minutes to fill out a quick survey. See, nearly two years into this blogging experiment we are starting to wonder what you think of us. Does our ass look big in this blog? Go on, tell us. It only takes five minutes or so, and as a thank you we'd like to offer a free three-month subscription to the FDC-W / EBI publication of your choice.

ITS THAT SIMPLE. You can do it. Click the link, and take the survey. We know you can.

FDA Commissioner Update: Announcement Timing Provides Clues

Comments out of the White House that an announcement is imminent on President Obama’s choice for FDA commissioner indicate the pick is someone who has already been thoroughly vetted.

Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been formally interviewed for the job by HHS Secretary-designate Tom Daschle and would appear to be the two most serious names to make the final cut (“The Pink Sheet,” January 19, 2009, p. 3).

It’s understood that Califf has the backing of Senate Health, Education, Labor & Pensions Committee Chairman Ted Kennedy (D-Mass.) while Sharfstein is being vigorously supported by House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.).

“I know the President hopes in the next few days to announce a pick for commissioner at FDA,” Press Secretary Robert Gibbs said during a briefing on January 30 in response to a question regarding tainted peanut butter. To read the thoughts of our OTC friends on an agency review, click here. (For peanut-butter-jelly-time, click here.)

The timing of the announcement makes it less likely that a name to have emerged recently would be under serious consideration for the FDA post unless the individual had already been through an interview with either Daschle or White House personnel officials.

For example, former New York City health commissioner Margaret Hamburg’s name made the rounds of the Washington rumor mill over the last week. While Hamburg was a member of the HHS transition team, is a former high ranking HHS official, and could be considered for any number of health positions, it’s unclear whether she received anything more than a screening interview. To read more about Hamburg, click here.

Former FDA commissioner Jane Henney could be a strong fallback option if the administration feels Sharfstein and Califf don’t meet all of the necessary criteria for the job. Whether Henney ever went beyond the initial screening process, however, is unconfirmed.

Still, the FDA announcement could wait until the tax situation holding up Daschle’s confirmation becomes more lucid and predictable. President Obama told White House reporters he “absolutely” stands behind Daschle’s nomination for HHS Secretary.

In fact, the administration is proceeding as if the confirmation will be a forgone conclusion. Obama’s top FDA advisor in the Senate Dora Hughes is now at the White House working with the health policy group, presumably in the Office of Health Reform. Harvard economist and top Obama advisor during the campaign David Cutler is also moving to Washington to work on the administration’s reform agenda. To read more, click here.

NIH Department of Bioethics Chairman Ezekiel Emanuel is on detail to the Office of Management & Budget working with new health desk head Keith Fontenot on health reform issues. To read more about Fontenot, click here.

Emanuel, author of the health care book “Healthcare Guaranteed,” is the brother of White House Chief of Staff Rahm Emanuel.

While You Were Watching Super Bowl XLIII

By all accounts it was a phenomenal game down in Tampa, where the Steelers defeated the Cardinals in Superbowl XLIII in nailbiting fashion. We hope you prevailed in your Super Bowl pools, enjoyed home-made chili in excess, and rocked out to Springsteen at halftime. Surely you had no time to read the news while making guacamole and seventeen kinds of meat-based snacks. And that's where we come in.

So, while you were looking silly wearing those 3-D glasses and explaining Roman numerals to children ...

• GSK is axing 6-10,000 employees, says oh, just about every paper on the news-stands in Britain that isn't more concerned with Michael Phelps' bong hits. Lets pick ... The Observer.
  
• Aaand we swing to the right, across the political spectrum of UK papers now, where The Sunday Times carries a first-person account of genome-spelunking by Steven Pinker. Watch the sugar, Professor!
  
• The business models of health care in America are broken, reports the NYT--for example, "there is no financial incentive to keep patients healthy." Well, then, that's not very good. The Times talks to Clayton Christensen and prescribes disruptive innovation and "business school concepts." Everyone go borrow "The Innovator's Prescription" from your local libraries, STAT! (Or, you know, buy it.) We smell IN VIVO Blog Book Club on the horizon ... watch out, Oprah.
  
• Roche "confident" that it will succeed in its bid to take over Genentech, reports Swiss paper Basler Zeitung. (h/t Reuters) Meanwhile Astellas says on an earnings call today that we've seen its best offer for CV Therapeutics, and that it won't go hostile.
• Prasugrel is ready for its Tuesday close-up. The WSJ previews tomorrow's advisory committee meeting.
  
• And finally, the plot thickens over the future of Amylin, where hedge fund and 12.5% AMLN shareholder Eastbourne Capital Management proposes a new slate of directors for the biotech and backs fellow investor Carl Icahn in trying to shake things up, reports Bloomberg.

image by flickr user dianecordell used under a creative commons license.