BioSpace BioPharm Exec
Tuesday, June 30, 2009
Sprinting to the Finish

Could it really happen this time? The Obama Administration is pushing health care reform forward with tremendous force and alacrity, such that we may know in the next couple months whether one of the fundamental goals of the Obama presidency is achieved or not. Obama has said he wants a House version of a bill passed before Congress's August recess--a stunning pace for reform that has been over 70 years in the making. But that's the point: Obama doesn't want anyone to debate this too long, doesn't want negative lobbying and campaigns to gain momentum, doesn't want red state (and other) legislators to spend too long getting an earful from constituents during recess.

While history would suggest that Obama faces long odds in getting any sort of reform passed (think of large-scale failures in the Clinton, Nixon, Truman, Eisenhower, and Roosevelt administrations), Obama may be enjoying a historical alignment of the stars that hasn't happened since Medicare and Medicaid were created under the Johnson Administration in 1965. Part of that is circumstance--Democratic majorities in both houses of Congress, a high level of dissatisfaction with the status quo, and a period where trillions are already flowing out of taxpayers' pockets--but part of it is also strategy. Obama is willing to let Congress iron out the details as long as they meet some broad principles, a far cry from the we-know-what's-best executive fiat that marked the effort of the Clinton Administration. More...

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"How can you mend...a broken heart?" the Bee Gees once asked. Well, not with Merck's rolofylline, apparently. The highly-touted acute heart failure drug, once considered to have blockbuster potential, failed to meet primary or secondary efficacy endpoints in an interim analysis from a phase 3 trial. And there was more heartbreak to go around this past month--at Osiris, Insmed, and Cephalon, certainly, with at least a couple stifled sobs among Exelixis shareholders (I'm one of them). As is so often the case, the encouraging news seems to be coming from earlier in the development cycle. But wait! Is that...good news from...from...Jazz Pharma?! -KT

Exelixis, Inc. (EXEL) and Bristol-Myers Squibb Company (BMY) (JOBS) Report Phase 2 Data for XL184 in Patients with Previously Treated Glioblastoma Multiforme; Results Not up Expectations

Merck & Co., Inc. (MRK) (JOBS) Heart Failure Drug Misses Goals in Study

Osiris Therapeutics, Inc. (OSIR) Reports Interim Data for COPD Stem Cell Study; Drug Fails to Improve Lung Function

Cephalon, Inc. (CEPH) Provides Clinical Update on Lestaurtinib in Relapsed Acute Myelogenous Leukemia; No Increased Benefit in Overall Survival

Jazz Pharmaceuticals, Inc. (JAZZ) Pain Drug Meets Late-Stage Study Main Goal

Medarex, Inc. (MEDX) Prostate Cancer Drug Shows Promise

Alnylam Pharmaceuticals (ALNY), Cubist Pharmaceuticals, Inc. (CBST) Say Respiratory Drug Meets Main Goal

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Hollis-Eden has found a new leader, three months after founder Richard Hollis was terminated under somewhat mysterious circumstances. He was fired "for cause," but the exact reason was never disclosed. Certainly the company hadn't flourished under his leadership, and nor is it flourishing now, having recently reported poor data for its diabetes drug. Richard Hollis won't be alone in unemployment, of course--the French newspaper La Tribune reported that the combined Merck and Schering-Plough will employ about 15% fewer people than the two companies separately, a big uptick in what had been a slowing rate of big pharma layoffs. -KT

Hollis-Eden Pharmaceuticals Inc. (HEPH) Announces Appointment of Dr. James M. Frincke President and CEO

Merck & Co., Inc. (MRK) (JOBS) to Shed 16,000 Jobs as It Buys Schering-Plough Corporation (SGP) (JOBS)

Insmed Incorporated (INSM) CEO Resigns Due to Health Concerns

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Compugen Ltd. (CGEN) Appoints Dr. Anat Cohen-Dayag and Martin Gerstel as Co-CEOs

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GlaxoSmithKline--you know, the big pharma company that's not in the midst of a merger--has been busy lately on the dealmaking front--not just with Chroma and Concert (detailed below), but in generics and vaccines with Dr. Reddy's and Shenzhen Neptunus, respectively. While these newer deals aren't quite the option alliances Glaxo and other big pharmas have come to favor lately, they do appear to be in the "show-me" category: Relatively modest upfront investments with the big payments pushed out into the future. I say they appear that way because Chroma offers zero details on the terms. It's a vaguely defined "$1 billion" deal that's all about hyperbolic biobucks and nothing about what the company is actually likely to get. The disintegration of Glaxo's partnership with Synta this month, less than two years after it began, illustrates the point: That was another "billion dollar" deal, but Synta didn't actually get a whole lot beyond its $80 million upfront payment and $50 million in milestones it achieved until now. And that was a single-product deal a whole lot more likely to reach its full potential than multiple-product target deals counting on multiple approvals.

There's other excitement this month as well, including a rare Genentech partnership and some intra-pharma relationships, and more! -KT

GlaxoSmithKline (GSK) Signs Potential $1 Billion Drug Deal with Chroma Therapeutics

GlaxoSmithKline (GSK) Signs Potential $1 Billion Deuterium Drug Deal with Concert Pharmaceuticals, Inc.

GlaxoSmithKline (GSK) Scraps Synta Pharmaceuticals Deal After Drug Disappoints

Bayhill Therapeutics, Inc. Enters Exclusive, Worldwide Collaboration with Genentech, Inc. (DNA) (JOBS) for BHT-3021 in Type 1 Diabetes; Deal Could Potentially Exceed $350M

AstraZeneca PLC (AZN) and Merck & Co., Inc. (MRK) (JOBS) Form Pioneering Collaboration to Investigate Novel Combination Anticancer Regimen

Adimab, Inc. Launches Novel Antibody Discovery Platform and Announces Discovery Programs with Merck & Co., Inc. (MRK) and Roche (RHHBY)

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Arena Pharmaceuticals could count its quarters of remaining cash on the good fingers of Django Reinhardt's left hand... That is, until Deerfield Capital swept in, as it so often seems to for the huddled masses of undercapitalized biotechs. Companies that could only raise debt, not equity, in a world that has grown to hate debt, have been in a tough place over the past few months, but things appear to be improving slightly, with more equity deals and even (gasp) an kinda-sorta biotech IPO. -KT

Arena Pharmaceuticals, Inc. (ARNA) to Receive $100 Million from Deerfield Management

Medidata Solutions, Inc. Prices Initial Public Offering

GlaxoSmithKline (GSK), Novartis Corporation (NVS) (JOBS), Roche (RHHBY) (JOBS), Eli Lilly and Company (LLY) (JOBS) Back Biotech Aileron Therapeutics in $40 Million Fundraising

Halozyme Therapeutics, Inc. (HALO) Raises $40 Million in Public Offering of Common Stock

Alios BioPharma Closes $32 Million Series A Financing

Jazz Pharmaceuticals, Inc. (JAZZ) Puts 3 Drug Candidates on Hold to Help Service Debt

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One of the big sticking points in the debate over a biogeneric bill (ahem, I mean legislation for an abbreviated regulatory pathway for follow-on biologics) concerns the exclusivity period that innovator products should enjoy. While Henry Waxman originally proposed a five-year period, most subsequent bills have settled on a 12-to-14 year timeframe. Now the Federal Trade Commission has come back and said that's too long. They suggest that most biogenerics won't be discounted more than 10% to 30% from the brandname drug price, that innovators will likely maintain strong market share even after the launch of follow-on products, and that the lengthy exclusivity period will stifle innovation. That's going to spark a whole new debate and perhaps kill chances of any kind of biologics bill getting attached to the larger piece of health care reform legislation that the Obama Administration (rather incredibly) hopes to pass before the August recess. I'm not sure what the right number is here, but the FTC does raise some interesting points. -KT

Federal Trade Commission Releases Report on "Follow-on Biologic Drug Competition"

U.S. Requests More Data on Merck & Co., Inc. (MRK) (JOBS), Schering-Plough Corporation (SGP) (JOBS) Merger

Biogen Idec, Inc. (Massachusetts) (BIIB) Announces Conclusion of Arbitration with Genentech, Inc. (DNA)

Pfizer Inc. (PFE) Conceals Study Data - Drug Manufacturer Hinders the Best Possible Treatment of Patients with Depression

University of Iowa Sues Abbott Laboratories (ABT) Claiming Humira Manufacture Infringes CMV Promoter IP

Irish Court Invalidates Patent on GlaxoSmithKline (GSK)'s Top Drug

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It's hard to overstate jut how critical prasugrel is to Eli Lilly. Lilly loses patent protection on its top seller, Zyprexa, in 2011. Its number two brand, Cymbalta, goes off patent in 2013. It hasn't launched a new drug in the U.S. since Byetta in 2005. Yet blood-thinner prasugrel looks like it could challenge mega-blockbuster Plavix and buoy Lilly's fortunes. The company already has a European approval under its belt, and a unanimous thumbs-up from an FDA advisory panel. Phew!

You can imagine, then, how Lilly CEO John Lechleiter must have felt when Victor Serebruany, one of the inventors of prasugrel, wrote a letter to FDA criticizing the studies used to support the application and urging the agency not to approve the drug. To make his missive, Serebruany teamed up with industry gadfly Public Citizen, which has a pretty spotty track record in its apparent mission to gut most of the U.S. pharmacopeia. Nevertheless, whether or not FDA lends an ear to Serebruany's warnings, it hardly tees up a nice launch for the drug. Execs at Bristol-Myers Squibb must be rubbing their hands in glee. -KT

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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at

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