B I O T E C H ’ S M O S T R E S P E C T E D N E W S S O U R C E F O R O V E R 1 5 Y E A R S T H E D A I L Y B I O T E C H N O L O G Y N E W S P A P E R KAI’s PKC Program Nabs Tioga’s Series A Round: $24M $340M Deal With Sankyo For Phase IIb Trial Of IBS Drug
KAI Pharmaceuticals Inc. signed a potential $340 mil-
Six months after licensing a promising early stage
lion deal expected to be announced today with Daiichi
product for irritable bowel syndrome, Tioga Pharmaceuti-
Sankyo Co. Ltd. for the global development and commer-
cals Inc. raised $24 million in a Series A round to launch
As KAI’s first pharma alliance since mid-2003, when it
The product, asimadoline, is a small molecule licensed
was founded on protein kinase C (PKC) modulation tech-
from its discoverer, Merck KGaA, of Darmstadt, Germany.
nology licensed from Stanford University, the deal with
Proceeds from the financing will fund a 600-patient Phase
Sankyo not only provides the privately held South San
IIb study of asimadoline for irritable bowel syndrome (IBS)
Francisco-based company with an up-front cash infusion
and a 130-patient Phase IIa trial for postoperative ileus.
of $20 million, but also “paves the way for us to commer-
“The money will take the company through to the com-
cialize our own products someday,” said Steven James,
pletion” of those trials, said Stuart Collinson, Tioga’s acting
KAI will retain the right to co-promote products in the
By taking the numbers of patients with IBS and making
North American acute care and hospital market.
“some assumptions about pricing in line with currently
How Leukemia Cells Rule Millennium’s CEO Pledges Neighbors: With Iron Fist Still More Velcade Growth
“The transition from a normal to a cancer cell takes
Millennium Pharmaceuticals Inc. provided a confer-
many steps,” Michael Green told BioWorld Today. But for
ence call update in which the firm again predicted prof-
chronic myelogenous leukemia, one major step is the gen-
itability in 2006, and forecast annual sales of its multiple
eration of the tyrosine kinase Bcr-Abl, a constantly active
myeloma drug Velcade in the range of $225 million to
$250 million – a revenue goal that raised the eyebrows of
In the Dec. 29, 2005, issue of Cell, Green and his col-
leagues from the Howard Hughes Medical Institute and
But the company’s president and CEO, Deborah Dun-
University of Massachusetts Medical School in Worcester,
sire, said she intends to hit those numbers, and referred to
reported on one molecular mechanism by which Bcr-Abl
the proteasome inhibitor as “a terrific product that hasn’t
contributes to leukemia. The experiments are part of
yet made the most out of all the data” supporting it, even
broader work teasing apart the complex interplay between
iron, gene expression, cell death and a secreted protein
The company’s stock (NASDAQ:MLNM) closed Friday at
INSIDE:OTHERNEWSTONOTE(JAPAN’SCANBASRAISES$20M).2-5,7
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com.
Intersouth Partners, of Durham, N.C.; Polaris Venture Part-ners, of Waltham, Mass.; Boston Millennia Partners, of
Boston; Hunt Ventures, of Dallas; and Eastman Ventures, ofKingsport, Tenn. Proceeds will go toward advancing the
• Acacia Research Corp., of Newport Beach, Calif.,
company’s products through field trials and onto registra-
said that its CombiMatrix group signed a nonexclusive
tion. Athenix focuses on discovering genes and proteins
agreement with the University of Colorado Health Sciences
to develop enhanced plants, microbes, enzymes and pro-
Center under the company’s CombiCore access program.
Under the agreement, all University of Colorado
• Athersys Inc., of Cleveland, extended its existing
researchers can purchase, through their microarray facility,
alliance with New York-based Bristol-Myers Squibb Co.
CombiMatrix’ CustomArrays and Catalog Arrays, including
to provide BMS with additional validated drug targets for
array processing services performed at the university
high-throughput screening and lead optimization in multi-
ple therapeutic areas. The new agreement will extend the
• Affymetrix Inc., of Santa Clara, Calif., said it expects
alliance for up to three years, with a guaranteed minimum
that product and product-related revenues will be about
number of targets to be supplied by Athersys annually.
$15 million below previous guidance for the fourth quarter,
Under the terms, Athersys is entitled to license fees, as well
due to low instrument sales for the quarter and delays in
as milestones and royalties on compounds developed by
completing genotyping processing under a service con-
tract. Previous guidance projected product revenue for the
• Avant Immunotherapeutics Inc., of Needham,
three months ending Dec. 31 at $120 million. Shares of
Mass., said data from a Phase III study of Rotarix, its two-
Affymetrix (NASDAQ:AFFX) fell $3.63 Friday, to close at
dose oral rotavirus vaccine, demonstrated safety and effi-
cacy. Results were published in the Jan. 5, 2005, issue of the
• Arginox Pharmaceuticals Inc., of Menlo Park, Ill.,
New England Journal of Medicine. Rotarix is partnered with
appointed Robert Terifay as president and CEO. Terifay
London-based GlaxoSmithKline plc for worldwide com-
most recently served as commercial leader on the execu-
tive management team of Synta Pharmaceuticals. Arginox
• BioDelivery Sciences International Inc., of Mor-
is focused on medicines to treat hospitalized patients.
risville, N.C., submitted an investigational new drug appli-
• Asuragen Inc., of Austin, Texas, said it will fund
cation for its BEMA Long Acting Analgesic (LA) product
activities with $35 million in proceeds from the Dec. 23,
aimed at offering an alternative administration of an exist-
sale of Austin, Texas-based Ambion Inc.’s research prod-
ing marketed narcotic for moderate to severe pain. BETA LA
ucts division to Applied Biosystems Group, of Foster
will be formulated using BDSI’s BEMA technology platform,
City, Calif. Recently established, Asuragen is led by Matt
consisting of a fast-dissolving mucoadhesive disc
Winkler, founder and CEO of Ambion, and is comprised of
designed to deliver the active ingredient across the buccal
three business units: Molecular Diagnostics (formerly
Ambion Diagnostics Inc.), Molecular Biology Services (for-
• BioMS Medical Corp., of Edmonton, Alberta, exer-
merly Ambion Services) and the research and development
cised its option to purchase additional equity in BioCyDex
Inc., also of Edmonton, bringing BioMS Medical’s total equity
• Athenix Corp., of Research Triangle Park, N.C.,
position to 49 percent. BioCyDex is developing a drug deliv-
raised $1 3 million in a Series C round led by new investor
ery technology to deliver both existing and new antiviral and
Finistere Partners, of San Diego. Other investors were
chemotherapeutic compounds directly into cells.
BIOWORLD® TODAY (ISSN# 1541-0595) is published every business day by the BioWorld® Publishing Group,
Please call (800) 688-2421 to subscribe or
a division of Thomson BioWorld®, 3525 Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305 U.S.A.
if you have fax transmission problems. Out-
Opinions expressed are not necessarily those of this publication. Mention of products or services does not
side U.S. and Canada, call (404) 262-5476.
constitute endorsement. BIOWORLD® and BIOWORLD® TODAY are trademarks of Thomson BioWorld®. Copy-
Our customer service hours are 8:30 a.m.
right 2006 Thomson BioWorld®. All Rights Reserved. No part of this publication may be reproduced with-
out the written consent of Thomson BioWorld®. (GST Registration Number R128870672).
Brady Huggett, (404) 262-5408 ATLANTA NEWSROOM:
Managing Editor: Brady Huggett.
Aaron Lorenzo, (202) 719-7816
Staff Writers: Karen Pihl-Carey, Karen Young, Jennifer Boggs.
Jennifer Boggs, (404) 262-5427
Senior Production Editor: Ann Duncan. Editorial Coordinator: Kay Torrance.
Karen Young, (404) 262-5423 Kay Torrance, (404) 262-5454 WASHINGTON BUREAU: Washington Editor: Aaron Lorenzo.
Fax: (404) 814-0759 WEST COAST BUREAU: Editor: Randall Osborne.
Randall Osborne, (415) 384-0872 EAST COAST BUREAU: Science Editor: Anette Breindl.
Anette Breindl, (304) 296-1160 VP/Group Publisher BUSINESS OFFICE:
Vice President/Group Publisher: Donald R. Johnston.
Donald R. Johnston, (404) 262-5439
Marketing Manager: Chris Walker. Account Representative: Bob Sobel. DISPLAY ADVERTISING: For ad rates and information, please call Stephen Vance at (404) 262-5511
or email him at stephen.vance@thomson.com. REPRINTS:
For photocopy rights or reprints, please call our reprints department at (404) 262-5479.
Irritable bowel syndrome, or IBS, affects about 10 million
people in the U.S. and is a chronic condition marked by
approved therapies,” he told BioWorld Today, “you can quite
abdominal pain and disturbed bowel function. Health care
quickly get to a market size of about $10 billion [worldwide]
costs associated with the disease exceed $25 billion annually.
Some companies have found IBS to be a difficult dis-
Tioga operates as a virtual company based in San
ease to treat. Pain Therapeutics Inc., of South San Francisco,
Diego and was founded as a Merck spinout in July. Forward
terminated development last month of its IBS drug, PTI-901,
Ventures founded it, convincing Merck that asimadoline
which showed a statistically meaningful relief in the sec-
had a better chance of succeeding as the sole focus for
ond month of treatment in a Phase III trial, but not in the
Tioga than it would sitting on a shelf at a large pharma-
third month of treatment, which was the primary endpoint.
ceutical company. Merck retained an equity interest in
(See BioWorld Today, Dec. 13, 2005.)
Tioga and, if asimadoline is approved, it is entitled to roy-
There are two products approved for IBS: Zelnorm, by
Basel, Switzerland-based Novartis AG; and Lotronex, by
“They publicly realigned the company into a couple of
London-based GlaxoSmithKline plc. Both carry warnings of
therapeutic areas, cardiometabolic and cancer,” said
adverse events, such as ischemic colitis, constipation and
Collinson, who also is a partner at Forward Ventures. “This
drug didn’t fit into [Merck’s] portfolio.”
“We hope that our medicine is going to have a better
After putting up the initial money for Tioga last sum-
profile,” Collinson said, adding that asimadoline, a kappa-
mer, San Diego-based Forward Ventures led the Series A
opioid agonist, has a different mechanism of action than
round and was joined by investors New Leaf Venture Part-
ners, of New York, and BB Biotech Ventures II, of Zurich,Switzerland.
Asimadoline has been tested in almost 800 people
and has demonstrated a promising safety profile andencouraging clinical efficacy for the treatment of irrita-ble bowel syndrome. It also appears to have potential
• Breakthrough Therapeutics, of Greenwich,
for treating other gastrointestinal diseases, such as
Conn., said interim Phase II data of VAX100 for patients
postoperative ileus, which is decreased or stopped
with persistent chronic myeloid leukemia (CML) who were
on imatinib mesylate (Gleevec, Novartis AG) demon-
Tioga may decide to in-license other products “if we
strated an immunological response in 17 of 18 patients
see something that is particularly attractive,” Collinson
who showed peptide specific T-cell response. The vaccine
said, but its main focus for now is on asimadoline, its only
has displayed a good safety profile with injection site
product. The Phase IIb trial in IBS will take about 18 months
reactions as the only side effect. VAX100 is a Bcr-Abl pep-
to complete and, at that point, Forward Ventures will make
tide vaccine designed to reduce persistent disease in
patients with CML whom have had stable disease during
It might decide to sell the company, enter a partnership
conventional therapy. The ongoing trial is being con-
or raise more money and take asimadoline into Phase III tri-
ducted at Memorial Sloan Kettering Cancer Center and MD
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com.
The epsilon PKC activator “would be targeted for pre-
Beyond the initial payment, KAI could receive develop-
conditioning, or protecting against ischemia in a number of
ment and commercialization milestones of up to $300 mil-
surgical situations, such as coronary artery bypass graft
lion for the first two indications for KAI-9803, plus mile-
stones for other potential PKC inhibitors and a double-digit
“If a surgeon knows they’re going to be creating
ischemia by clamping off an organ or causing potential
Tokyo-based Sankyo agreed to fund all future develop-
debris or emboli to go through the system and potentially
ment in exchange for global development and commercial-
block an artery, they can give this drug prior to that surgery
KAI also will continue to actively participate in further
KAI retains full ownership of the epsilon PKC program,
delta PKC inhibitor development. The company will have
and James said the company plans to advance it through
the option to perform certain clinical studies with KAI-
proof of concept as rapidly as possible.
9803, and KAI also could receive another $20 million over
“Our goal is to be a leader in approaching PKC modula-
five years from Sankyo to identify new delta PKC com-
tion,” he said. “The PKC family is involved in a number of
pounds, routes of administration and indications.
disease processes, and there’s a potential for a very deep
“This target is really kind of a pipeline in itself,” James
pipeline that we can develop in partnerships and on our
told BioWorld Today, “and it would be too difficult for us as
a small company to fully exploit it by ourselves.” The deal
Besides ischemia, drugs targeting PKC also could be
provides KAI with both “access to Sankyo’s deep cardiovas-
developed in neuropathic pain, oncology and inflammatory
cular expertise and the ability to conduct some develop-
The lead product, KAI-9803, a delta protein kinase C
inhibitor, was granted fast-track status by the FDA and
recently started enrollment in a 150-patient Phase I/II study(DELTA-MI) to evaluate the product’s safety and efficacy inpatients with acute myocardial infarction undergoing
• CanBas Co. Ltd., of Shizuoka, Japan, raised about
reperfusion via balloon angioplasty. Results from the trial
$20 million in its fourth financing round, which closed Nov.
are expected around the middle of the year.
30. The round was co-led by NIF SMBC Ventures and MVC
KAI-9803 is designed to reduce the damage from
(Mitsui Ventures), and included Nikko antfactory, MBL Ven-
reperfusion, or the reopening of blocked blood vessels, and
ture Capital, Mizuho Capital, Nomura Securities, and
Marubeni. CanBas develops drugs that target the G2 check-
When a patient arrives at the hospital with chest pains,
point, and are in Phase I studies with its lead compound,
and a blocked coronary artery is observed during an
angiogram, the patient requires a balloon angioplasty to
• Cardinal Health Inc., of Dublin, Ohio, entered a fea-
reopen the vessel and restore blood flow. But that reperfu-
sibility and commercial option agreement with Centocor
sion can “kick off a dual cascade of cell death, as well as
Inc., of Malvern, Pa., to develop cell lines using Cardinal
necrosis in that injured heart tissue, which can lead to con-
Health’s gene product expression cell line engineering
gestive heart failure, morbidity and, potentially, death,”
technology. Cardinal Health will use its patented GPEx tech-
nology to engineer cell lines expressing undisclosed Cen-
KAI-9803 is administered through the balloon
catheter directly into the coronary artery just prior to
• China Biopharmaceuticals Holdings Inc., of Nan-
jing, Jiangsu province, China, said that on Dec. 31 it entered
“What we showed in numerous animal studies is that
an agreement with the shareholders of Chengdu Tianyin
[KAI-9803] can greatly reduce those damaging effects,” he
Pharmaceutical Ltd. Co., of Chengdu, Sichuan province,
added. The drug showed an effect in size of the infarct and
China, to immediately assume operation control of Tianyin
area of tissue death, and “we found that we could reduce
in all aspects of its business operations and to acquire a 51
that by a significant amount, up to 70 percent.”
percent ownership interest in Tianyin. The company will be
Preclinical work also demonstrated the drug’s ability to
issuing 3 million shares of its common stock to the share-
improve microvascular blood flow following reperfusion.
holders of Tianyin, or their designees, and has agreed to
KAI-9803 also might be effective in other ischemic indi-
invest $2 million into Tianyin operations. An additional
300,000 shares of common stock will be issued to share-
KAI hopes to file an investigational new drug applica-
holders of Tianyin, or their designees, if Tianyin’s after-tax
tion this year for a second compound derived from its PKC
audited profit for the year ended Dec. 31 reaches at least
modulation platform. Unlike KAI-9803, which inhibits the
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com. Iron Fist
Intracellular iron levels, in turn, affect a cell’s penchant
for suicide, or apoptosis, in an inverse relationship; that is,
24p3 is a known pro-apoptotic protein, and the scien-
the lower the intracellular iron, the higher the likelihood of
tists wanted to investigate the relationship between 24p3
apoptosis. Green said that under physiological conditions,
and Bcr-Abl. “The simplest model that we imagined was
“the weight of the evidence” favors the idea that most
that Bcr-Abl was preventing 24p3 from being expressed,”
24p3s are empty and thus bind intracellular iron and
said Green, professor of molecular medicine and senior
remove it from the cell, lowering iron levels.
author of the paper. “That turned out to be 180 degrees
Green and his colleagues investigated the exact mech-
anism by which iron deprivation drives cells to suicide.
Instead, Bcr-Abl up-regulates 24p3, which should have
They were guided by the knowledge that interleukin-3
the opposite effect of the extended life span that leukemia
deprivation induces the pro-apoptotic protein Bim, a mem-
cells have. “These cells should be dead,” Green said.
ber of the well-known Bcl-2 family, which is already in the
The reason they are not is that Bcr-Abl, by an unknown
sights of biotechnology firms such as Berkeley Heights,
mechanism, also prevents the expression of the 24p3
N.J.-based Genta Inc. and Montreal’s Gemin X Biotechnolo-
receptor. That renders the cancerous cells resistant to their
gies Inc. (See BioWorld Today, Dec 13, 2005, and Dec 30,
own 24p3 and changes the balance of power between
leukemia cells and their normal neighbors.
Studies confirmed that “empty” 24p3 increased Bim
“Any normal cell in the vicinity gets killed because it
levels; interfering with Bim levels via RNA interference
has the 24p3 receptor,” Green said.
reversed the effects of 24p3, as did the addition of either
Novartis AG’s chronic myeloid leukemia drug, Gleevec
free iron or iron-bound 24p3, and prevented apoptosis in
(imatinib), blocks Bcr-Abl activity. As a result, several
biotechnology companies, including New York-based Inno-
Green’s lab is working on determining whether other
vive Pharmaceuticals Inc., as well as Structural GenomiX
oncogenic tyrosine kinases, like Bcr-Abl, alter the expres-
Inc. and Ambit Biosciences Inc., both of San Diego, are
sion of 24p3 and its receptor. While he described his own
working on treatments for Gleevec-resistant CML. There
space as a basic research lab, his group is “certainly inter-
also is Breakthrough Therapeutics, of Greenwich, Conn.
ested” in the clinical applications of the discovery.
(See BioWorld Today, Dec. 9, 2004, and Jan. 6, 2006.)
“We’d be happy to work with anyone who has a clinical
In the experiments presented in Cell, Gleevec increased
the expression of the 24p3 receptor in cells expressing theBcr-Abl kinase; as a consequence, the cells no longer wereprotected from 24p3’s apoptotic effects. Green said that “in
patients with leukemia, if you were able to intervene toinhibit 24p3,” – either through an antibody against circulat-ing 24p3 or via a small molecule at the transcriptional level
• Enzon Pharmaceuticals Inc., of Bridgewater, N.J.,
– “it could have a beneficial effect, particularly in instances
said it is returning its rights to ATG-Fresenius S, a poly-
clonal antibody preparation used for T-lymphocyte sup-
Green and his colleagues discovered 24p3 as a pro-
pression, to Fresenius Biotech GmbH, a subsidiary of Bad
apoptotic gene while studying how growth factor depriva-
Homburg, Germany-based Fresenius AG. The product
tion drives cells to suicide. In those studies, which were
was being evaluated in the prevention of organ graft
published in Science in 2001, they demonstrated that inter-
rejection in organ transplant patients. Enzon said its
leukin-3 deprivation leads to the up-regulation of 24p3,
decision to return product rights was based on its ongo-
and that 24p3 induced apoptosis. The details of the exper-
ing efforts to redirect research and development invest-
iments reported in Science led Green and his colleagues to
ments to projects aligned with its business objectives,
believe that there must be a cellular receptor for 24p3, and
with an increasing focus in cancer and adjacent thera-
the work described in Cell began with the isolation and
• Favrille Inc., of San Diego, secured a $20 million
At the membrane, the receptor can bind 24p3 whether
line of credit through loan and security agreements with
24p3 itself is bound to iron or not. In both cases, 24p3 is
General Electric Capital Corp. and Oxford Financial Corp.
taken up into cells, but with opposite consequences. Once
The debt financing will be used to fund the company’s
in the cell, iron-bound 24p3 will ditch its load (which actu-
facility expansion to support commercial-scale manu-
ally consists of a complex of iron with a so-called
facturing of FavId, Favrille’s lead candidate in Phase III
siderophore) and return to the membrane empty. An empty
trials for the treatment of follicular B-cell non-Hodgkin’s
24p3 molecule, in contrast, will acquire an intracellular
lymphoma. The company believes the expanded facility
iron-siderophore complex and extrude it from the cell
will be able to supply FavId for up to 4,000 patients per
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com. Millennium
When physicians know that, they think about Velcade dif-
Dunsire pointed to results offered at the recent Ameri-
Educating physicians with an expanded sales force –
can Society of Hematology in Atlanta testing Velcade alone
while making the most of the data now available and gath-
or in combination with other commonly used agents in pre-
ering more – will be Millennium’s main tasks.
viously untreated multiple myeloma, resulting in overall
For example, the company knows that “not all patients
response rates as high as 92 percent, with complete
are getting eight cycles [of therapy],” Dunsire said. “If you
want to buy in to the survival advantage, it comes with
Cambridge, Mass.-based Millennium also reported that
Velcade (bortezomib), used alone or in combination, in a
Among the skeptics is analyst Jim Reddoch, with Fried-
range of multiple myeloma populations showed overall
man, Billings, Ramsey & Co. in Arlington, Va., who called the
response rates of up to 78 percent in relapsed and refrac-
midpoint of Millennium’s Velcade sales guidance “tough to
tory patients, a population in which the landmark Phase III
achieve,” and noted in a research report that the firm
APEX trail demonstrated a median 30-month survival bene-
expects modest net income of up to $5 million this year,
“basically in line with previous guidance. Breakeven is
“We’ve known about [the potential as a combination
made achievable more by layoffs than top-line growth.”
therapy] all through Velcade’s life, but we really saw that at
In the works at Millennium is a Phase III trial with Vel-
ASH,” Dunsire told BioWorld Today. What’s more, it can be
cade comparing the compound with and without Rituxan
used across a broad range of patients, even those with
(rituximab), from South San Francisco-based Genentech
Inc., against relapsed/refractory, indolent non-Hodgkin’s
The compound won approval for third-line treatment
lymphoma, as well as a study in lung cancer.
of multiple myeloma in May 2003 on data from a 202-
Both of those ventures are “high risk,” in Reddoch’s
patient Phase II study known as the SUMMIT trial, showing
view, and he predicted no other Phase III studies by Millen-
median survival time in relapsed and refractory patients to
nium until at least 2007. Another candidate, MLN2704 for
16.4 months. They usually die six to nine months after they
prostate cancer, seems unlikely to reach Phase III, he added,
given the company’s “tepid comments” during the confer-
Cleared in the second-line setting in March, Velcade
sold $192 million last year, a jump of 34 percent over the
Dunsire said that when Millennium “put [MLN2704] in
previous year, Millennium reported, which means fourth-
Phase I proof of concept, we were looking for some activity,
quarter sales hit $52 million, in line with Wall Street esti-
which we did see, but we also saw some neuropathy
mates. Millennium has vowed to grow Velcade sales
develop. We’ve opened a final cohort and that’s what we’re
another 17 percent to 30 percent this year.
moving through now.” A decision on the next step is
“We have three front-line trials running,” Dunsire said,
expected in the first half of this year, she said.
and a label expanded to include those patients could mean
Another compound moving along, though, is
even better things for Velcade. “Any of those trials could
MLN1 202, the CCR2 blocker that in August began a 1 10-
patient Phase II trial in patients at risk for atherosclerotic
Meanwhile, Velcade finds itself under pressure from
cardiovascular disease. Two other proof-of-concept trials
Warren, N.J.-based Celgene Corp.’s Revlimid (lenalidomide,
are ongoing, as well, including one in rheumatoid arthritis
a derivative of Thalomid, the company’s brand name for
and one in multiple sclerosis. Another in sclerodoma will
thalidomide), which gained FDA clearance in late Decem-
ber for myelodysplastic syndromes. A supplemental NDA
“We should be able to look at RA and [the atherosclero-
filing is expected shortly, seeking the go-ahead to offi-
sis data] during the second half of 2006,” said Dunsire, who
cially target multiple myeloma. (See BioWorld Today, Dec.
took over during the summer as the replacement for Mark
Levin, who also is Millennium’s co-founder. She left her post
Dunsire was quick to point out that Velcade is “the only
as head of oncology operations in North America for Novar-
single agent ever shown to provide a survival advantage” in
tis Pharmaceuticals Corp., of East Hanover, N.J., the U.S. affil-
multiple myeloma, which she called “really a key driver. NOW AVAILABLE - THE BIOWORLD EXECUTIVE COMPENSATION REPORT 2006!
This top-selling report contains complete compensation information on CEOs, CFOs, VPs of R&D, Heads
of Business Development and Legal Counsels at 264 biotechnology companies. Order your copy today!
Call 1-800-688-2421 or 1-404-262-5476 for more information.
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com.
rants. The investors were also entitled to purchase addi-tional shares of SIGA’s stock for a gross amount of up to $2
million at an initial price of $1.10 per share for a period of 90trading days following the effectiveness of a registration
• Immunicon Corp., of Huntingdon Valley, Pa.,
statement. The event has pushed SIGA back in Nasdaq
entered a supply and marketing license agreement with
Kreatech Biotechnology BV, of Amsterdam, the Nether-
• Nobex Corp., of Research Triangle Park, N.C.,
lands, for Kreatech’s Universal Linkage System technology.
launched a marketing initiative to promote bidding on its
The agreement enables Immunicon to use ULS technology
intellectual property rights and other assets. The company
in conjunction with its own technologies, and develop
filed for bankruptcy protection Dec. 1, 2005, after 12 years
assays for use in confirming whether certain epithelial cells
of research operations. During that time, the company
are cancerous. Financial terms were not disclosed.
developed a portfolio of 300 patents and patent applica-
• Medicure Inc., of Winnipeg, Manitoba, expanded its
tions, including several protein and peptide product candi-
antithrombotic research collaboration with Jawed Fareed,
dates that have been in clinical study.
of the Loyola University Stritch School of Medicine in May-
• Perlegen Sciences Inc., of Mountain View, Calif.,
wood, Ill. The company’s antithrombotic agents have
began a collaboration with South San Francisco-based
demonstrated a dual antiplatelet/anticoagulant mecha-
Genentech Inc. to study the genetics of cancer. Findings
nism of action, indicating potential in the management of
from the study could potentially be applied to the discov-
cardiovascular and cerebrovascular diseases such as
ery and development of targeted medicines and molecular
myocardial infarction, stroke, pulmonary emboli and
diagnostics for the disease. Terms of the agreement were
peripheral arterial disease. The expanded collaboration will
involve a number of new preclinical studies with the objec-tive of moving a lead candidate into the clinic. Medicure’slead product in the antithrombotic program is MC-45308.
The company raised C$12 million in a bought deal financ-ing earlier this month. (See BioWorld Today, Jan. 5, 2006.)
• NexMed Inc., of Robbinsville, N.J., received a notice
UCB, of Brussels, Belgium, appointed Bill Robinson
from Nasdaq indicating that it did not comply with the min-
and Bob Trainor as new members of the company’s execu-
imum $50 million market value of listed securities require-
ment for continued listing. Additionally, the company does
Vasogen Inc., of Toronto, appointed Terrance Gregg
not comply with the requirement that total assets and total
revenue of $50 million each for the most recently com-
VioQuest Pharmaceuticals Inc., of Monmouth
pleted fiscal year or two of the last three most recently
Junction, N.J., named Johnson Lau to its board.
completed fiscal years. Separately, SIGA Technologies
Vivus Inc., of Mountain View, Calif., appointed Wesley
Inc., of New York, entered a securities purchase agreement,
Day vice president of clinical development.
dated Nov. 2, with four investors for the issuance and sale
Xanthus Life Sciences Inc., of Cambridge, Mass.,
of 2 million shares of SIGA’s common stock at $1 per share
appointed Kris Piper vice president of regulatory affairs
for aggregate consideration of $2 million and certain war-
Millennium
cade traction before recommending the name.”
Analysts at Atlanta-based Suntrust Robinson
Humphrey downgraded Millennium from “buy” to “neutral”
iate of Novartis Pharma AG in Basel, Switzerland. Dunsire
in December. Last fall, Lehman Brothers in New York
worked for Novartis for almost 20 years. (See BioWorld
upgraded the firm from “underweight” to “equal weight.”
Reddoch said Velcade is “showing a plateau,” but Dun-
Reddoch, who maintains an “underperform” rating,
characterized Millennium as a “slowing-growth company
“Growth in 2005 vs. 2004 was very strong,” she said.
with a high valuation and an early stage pipeline.”
Along with the Rituxan combo trial, the company will sub-
Analyst Phil Nadeau at SG Cowen in New York remained
mit in the second half of this year a supplemental BLA filing
“neutral” on Millennium’s shares, citing in a research report
to explore Velcade against mantle cell lymphoma. But even
“many pipeline milestones in 2006, although none seem
without the new indications, “a number of myeloma
sufficient to spark investor interest.”
patients out there in the relapsed settings are getting some
Christopher Raymond, with Robert Baird & Co. in
old therapies, and there’s room for Velcade to penetrate
Chicago, also stayed “neutral,” and said in a research note
further. We have a really good base for a company that’s
that his firm “continue[s] to await signs of increased Vel-
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2006 Thomson BioWorld®. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com.
Go To www.healthyinformation.com to Subscribe for FREEType II Diabetes: The Preventable Epidemic!Recent statistics on the prevalence of type II diabetes in industrialized na-tions, show that it is on an epidemic rise. At present rates of acceleration,type II diabetes will exceed both heart disease, currently the number onecause of death and cancer as the leading cause of death from complicati
(Affix patient identification label here) Beneficence and Nonmaleficence Neurosurgeon and Spine Surgeon Carpal Tunnel Release A. Interpreter / cultural needs • Redness and peeling of the palm. This usually Uncommon risks and complications include: If yes , is a qualified Interpreter present? • Bleeding can occur and may require a return to the operating room. Bleeding