Bone and Spine

Napo Pharmaceuticals (LSE:
NAPL/NAPU) announces positive clinical data on the effectiveness of
crofelemer from a study for CRO-ID in treating severely ill cholera
patients in conjunction with an antibiotic and rehydration therapy.

A double-blind placebo-controlled study was conducted in one hundred
(100) patients with confirmed severe cholera. Patients were randomized to
placebo or 125 mg crofelemer every 6 hours or 250 mg crofelemer every 6
hours in a 1:2:2 randomization scheme. This single center trial was
conducted at the International Centre for Diarrhoeal Disease Research
(ICDDR, B) in Dhaka, Bangladesh, popularly known as the “cholera hospital”
for the state-of-the-art treatment of cholera patients.

The purpose of the trial was to obtain a therapeutic proof-of-concept
in the treatment of cholera, by a reduction in the life-threatening fluid
loss characteristic of cholera infection. In addition to receiving
crofelemer, all patients received a single oral dose of azithromycin and
rehydration therapy. These severely ill cholera patients, even when
receiving the antibiotic azithromycin and rehydration therapy (but not
crofelemer), averaged approximately 8.5 liters of stool volume output
during the first 24 hour period. The primary endpoint in this study was the
reduction in stool volume output normalized to the body weight of the
cholera patients.

Following the exclusion of three outlier patients, the data
demonstrates that a crofelemer dose of 125 mg every 6 hours reduced the
amount of stool volume output normalized to body weight by 32% (p=0.028,
Mann-Whitney test) in the first 6 hour period (0-6 hours). A 31% reduction
in normalized stool volume output was also observed during the first 12
hour period (0-12 hours) with crofelemer 125 mg every 6 hours (p=0.072,
Mann-Whitney test). The higher dose of crofelemer (250 mg every 6 hours)
also showed a trend towards significance in the first 12 hour period (0-12
hours, p=0.155, Mann-Whitney test). Crofelemer was well tolerated in
cholera patients. Crofelemer was safely and effectively used in combination
with the antibiotic, azithromycin, and rehydration therapy.

Both Napo and ICDDR, B, upon receipt of additional funding, would like
to continue with studies ranging to lower dosing regimens with crofelemer,
and also include the treatment of children with development of a pediatric
formulation of the product.

Elements of the cholera study in Bangladesh were funded by the National
Institutes of Allergy and Infectious Disease.

Napo is currently conducting a Phase 3 trial for crofelemer for chronic
diarrhea in people living with HIV/AIDS (“CRO-HIV”). This indication has
been fast-tracked by the FDA. Napo expects to file its first NDA around
mid-2009 for this indication, subject to the receipt of further funding.

Dr. Pradip Bardhan, Scientist and Head of Special Care Unit at ICDDR, B
and the principal investigator, commented that “Crofelemer produces an
impressive reduction in stool volume output within the first 12 hour
period. There is a clear need for new agents to produce reduction in stool
volume output in the first 12-18 hours, which is the period where the
patients are at maximum risk for dehydration. Both doses of crofelemer were
well tolerated and no drug related adverse events were observed in the
cholera patients in this study. As a novel antisecretory agent, crofelemer
represents a complementary mechanism to existing standard-of-care treatment
of cholera, which consists of administering rehydration therapy and
antibiotics, with the inherent risk of resistance generation.”

Lisa Conte, Napo’s CEO, commented, “Napo is so pleased to be reporting
this powerful clinical data relating to the treatment of one of the most
extreme cause of secretory/watery diarrhea with crofelemer. These results
extend the recent clinical data relating to the treatment with crofelemer
of acute infectious diarrhea of multiple etiologies in adult patients in
India (see announcement dated April 10, 2008). The mechanistic cause of
these diarrheas is similar to that which effects chronic diarrhea in people
living with HIV/AIDS, an indication for which Napo is in final Phase 3
development with crofelemer in the US (‘CRO-HIV’). Our business strategy
focus on diseases of both lucrative western markets and imperative global
health needs.”

About cholera

Vibrio cholerae is an intestinal infection which results in the abrupt
loss of large volumes of electrolyte rich watery stools and vomiting,
leading to severe and rapidly progressing dehydration and shock. Without
adequate rehydration therapy, the water loss associated with severe cholera
results in death for about half of affected individuals. The cholera toxin
causes the intestine to secrete watery fluid in volumes far exceeding the
intestinal absorptive capacity. Current standard-of-care therapy focuses on
rehydration therapy, either intravenous or oral, and antibiotic therapy to
target the infectious agent. There are no current therapies for cholera
which decrease the secretion of fluid into the small intestine. The
benefits of shorter and less severe duration of diarrhea include reduced
hospitalization time; reduced volume of necessary rehydration therapy; and
reduced V. cholerae infected faecal excretion, thereby reducing the risk of
transmission of infection to other family members and nosocomial infections
at clinic settings. Antibiotic resistance is a growing problem in cholera
infection, with one 2005 study in Bangladesh demonstrating multi-drug
resistance in 79% of the isolates from patients attending the ICDDR, B in
Dhaka.

Cholera, identified and detailed from the beginning of recorded
history, was initially endemic to the Indian sub-continent. The disease
began spreading almost 200 years ago, and is now pandemic and persists
primarily in the developing world. The bacteria spreads through
contaminated water and food. Because outbreaks can become massive
epidemics, it is a reportable disease, and is listed as a category B
bioterrorism agent/disease by the Department of Health and Human Services –
Centers for Disease Control.

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and
commercialization of proprietary pharmaceuticals for the global marketplace
in collaboration with local partners. Napo was founded in November 2001,
and is based in California, USA with a subsidiary in Mumbai, India.

Napo’s late-stage proprietary gastro-intestinal compound, crofelemer,
is in various stages of clinical development for four distinct product
indications, including a late-stage Phase 3 program:

— CRO-HIV for chronic diarrhea in people living with HIV/AIDS, Phase 3

— CRO-IBS for irritable bowel syndrome (“D-IBS”), Phase 2

— CRO-ID for acute infectious diarrhea (including cholera), Phase 2

— CRO-PED for pediatric diarrhea, Phase 1

The FDA has granted fast-track status to CRO-IBS and CRO-HIV.

Crofelemer, a proprietary patented agent, is extracted from Croton
lechleri, a medicinal plant which can be sustainably harvested from several
countries in South America. Napo also plans to develop an early clinical
stage product, NP-500, for the treatment of insulin resistant diseases of
Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic
syndrome). Additionally, Napo has a plant library of approximately 2,300
medicinal plants from tropical regions, and Napo has entered two screening
relationship associated with this collection. Currently, products are based
on the chemical and biological diversity derived from plants with medicinal
properties, but future products may be in-licensed from other sources.

Napo has partnerships with Glenmark Pharmaceuticals Limited of India
and AsiaPharm Group Ltd. of China. The Company has also established an
alliance with Direct Relief International to provide access to and
distribution of crofelemer for pediatric populations in disaster and
resource-constrained geographies, if the product achieves approval and
registration by the FDA. For more information please visit
napopharma.

About Crofelemer

Crofelemer, a proprietary patented agent, is extracted from Croton
lechleri, a medicinal plant which can be sustainably harvested from several
countries in South America. Crofelemer is in various stages of clinical
development for four distinct product indications, one in Phase 3, two in
Phase 2 and one in Phase 1.

Crofelemer has been tested in trials involving approximately 1900
patients in double-blind placebo-controlled, mostly published trials of
AIDS diarrhea, diarrhea-predominant IBS, and acute infectious diarrhea. It
is generally well tolerated and has shown significant anti-diarrheal
activities and improvement in gastrointestinal symptoms. Crofelemer
produces several effects when administered orally providing for activity in
several disease indications. Crofelemer’s first in class anti-secretory
mechanism reduces excess fluid secreted into the gastro-intestinal tract,
while its anti-inflammatory and analgesic activity may provide the
rationale for its significant benefit in abdominal pain. Crofelemer acts
locally in the intestines, with limited systemic exposure.

This announcement contains forward-looking statements relating to Napo
Pharmaceuticals and its products that involve risks and uncertainties,
including statements regarding future products and developments that are
not historical facts. Such statements are only predictions and the
company’s actual results may differ materially from those anticipated in
these forward-looking statements. These statements can be identified by the
use of forward-looking terminology such as “believe,” “expect,” “may,”
“will,” “should,” “could,” “project,” “plan,” “seek,” “intend,” or
“anticipate” or the negative thereof or comparable terminology and
statements about industry trends and Napo’s future performance, operations
and products.

Napo Pharmaceuticals, Inc.
napopharma

Blue Spoon Consulting Group, LLC, published a framework for
pharmaceutical companies to reshape the behavior of markets where drugs play
a central role. Available for download through the Blue Spoon Consulting
website, the approach applies ideas from
complexity science and systems theory to market creation, making an
evolutionary leap in thinking about competition and growth in an advanced
economy.

The future of the pharmaceutical industry is not in pharmaceuticals. It
lies in servicing health. Even more specifically, it lies in transitioning
from an industrial-era view of a business focused on manufacturing and
promoting physical products (i.e., drug brands), to a model based on
organizing business ecosystems from commodity inputs and an inexhaustible
flow of data. This is a dramatic shift in positioning using new assumptions
about value, new forms of organization, and a new frame of reference for
competitive strategy defined in 21st-century terms. For drug companies to
make this transition successfully, the metabolism of structural change in
the legal, regulatory, political and reimbursement systems that govern
health markets must accelerate – these institutions are also at a crisis
point, radically out of sync with snowballing transformation in a
globally-linked, knowledge-oriented society.

The shape and texture of a modern strategy involves working with
connectivity in a whole new way. There are more than 100 risk factors
associated with cardiovascular disease1; each risk factor operates as a
distinct market segment, with its own players and business dynamics. The
framework published today centers on the idea of risk-factor alignment
through marketspace alignment: a pharmaceutical component is positioned as a
keystone that links a set of economic actors to a new standard of care,
creating a new business ecosystem that incorporates inter-related product,
service, technology, and information components around a unified view of the
customer.2 The standard of care becomes a source for new value, comparative
advantage, and market development that spans industry environments.

Blue Spoon is a strategy and marketing consultancy for the pharmaceutical
industry. We are unique with a framework to shape tactical innovation,
strategic differentiation, and strategic imagination at a system level. Our
solutions transcend industries and technological contexts, breaking from
convention with a body of concepts that help companies becomes more agile,
creative, and focused on achieving results. Simply put, Blue Spoon is
different. Visit: bluespoonconsulting.

1 Atlas of Heart Disease and Stroke, World Health Organization
2 Actors linked in new business ecosystem: Pfizer, General Mills, Blue
Cross/Blue Shield, Cerner Corporation, Google

Blue Spoon Consulting Group, LLC

IBC Life
Sciences kicks off its annual BioProcess International(TM) Conference
& Exhibition in Anaheim, California. 1,500 pharmaceutical,
biotechnology, government and academic researchers, executives and
technology providers are expected to attend.

This year the event features six conference keynote presenters who
will provide inspiration for a streamlined industry. Keynote
presenters include senior executives from Genentech, Inc, Pfizer,
Inc, NASA Jet Propulsion Laboratory, Eli Lilly and Co., Genzyme Corp,
and Computer Sciences Corporation.

In addition, a special exhibit hall presentation will be delivered on
Wednesday evening, September 24 by Prof. Charles L. Conney from MIT
entitled “The Treacherous Path to Success in the Biotech Industry.”

The conference program runs September 22-26 and is divided into 3
pre-conference workshops on Monday, September 22 and 4 main
conference tracks that run concurrently on September 23-26. The four
conference tracks are: production & economics of biopharmaceuticals,
scaling up from bench through commercialization, cell culture &
upstream processing and recovery & purification.

The sold out exhibit hall is open September 23-25, with over 150
bioprocessing technology exhibitors. The exhibition opens Tuesday,
September 23 at 5:30 pm, with a welcome reception sponsored by SAFC
Biosciences. Hall hours are Tuesday, September 23, from 5:30 pm to
7:00 pm; Wednesday, September 24, from 9:45 am to 7:15 pm, and
Thursday, September 25 from 9:45 am to 4:00 pm. Exhibit hall viewing
passes are still available.

The event will take place at the Disneyland(R) Hotel on September
22-26, 2008. For complete event details visit
IBCLifeSciences/BPI/US.

About IBC Life Sciences

IBC Life Sciences is the worldwide leader in scientific,
technological and business conferences and courses for the life
science industry. To develop its programs, IBC actively researches
the advancements, technologies and trends impacting and driving the
race for new drugs and therapies. No other organization can make
claim to the breadth and quality that IBC Life Sciences delivers in
each event giving the company recognition around the globe for
quality, service and value.

IBC Life Sciences

Rep. John Dingell (D-Mich.) and members of the House Committee on Energy and Commerce on Friday sent a letter to Secretary of State Condoleezza Rice requesting information about alleged safety problems with antiretrovirals manufactured by the Indian generic pharmaceutical company Ranbaxy and distributed through the President’s Emergency Plan for AIDS Relief, the AP/International Herald Tribune reports (AP/International Herald Tribune, 9/19).

FDA last week announced that it has banned imports of more than 30 generic drugs — including antiretrovirals — that were manufactured by Ranbaxy, citing manufacturing deficiencies at two of the company’s plants. According to Deborah Autor, director of FDA’s compliance office, FDA inspections earlier this year found violations at Ranbaxy factories that could lead to contamination, allergic reactions and other problems, and the company has not taken proper steps to correct them (Kaiser Daily HIV/AIDS Report, 9/17).

The lawmakers in the letter requested a list of all nongovernmental organizations that have received antiretroviral drugs from Ranbaxy, as well as details of all medications the company supplied to PEPFAR, the Business Standard reports (Business Standard, 9/21). The lawmakers also asked Rice whether any countries or groups participating in PEPFAR have contacted the State Department with concerns about the safety or efficacy of antiretrovirals manufactured by Ranbaxy.

FDA officials said they are communicating with the World Health Organization and other representatives of groups responsible for antiretroviral distribution in Africa. In addition, the Department of Justice has launched an investigation into whether antiretrovirals manufactured by Ranbaxy were “weak or adulterated.” Dingell in a statement said, “It is important that the recipients of PEPFAR drugs know the FDA has done everything it should be doing to ensure the safety and effectiveness of these life-saving medications” (Favole/Mundy, Dow Jones, 9/19).

Ranbaxy has received an estimated $8.9 million from PEPFAR, the Business Standard reports (Business Standard, 9/21).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Urodynamix Technologies Ltd. (TSX-V:URO) announced that it has entered into an agreement with Pfizer Inc. to collaborate on a series of promotional programs to increase awareness of UroNIRS(TM) Bladder Monitor technology among urologists and medical professionals.

The program will be delivered to medical professionals in cities across the United States commencing in November 2008 and will feature Urodynamix’s UroNIRS technology – a new, non-invasive medical device that uses near infrared spectroscopy for diagnosis of LUTS, a major health concern related to BPH and prostate disease. Experts will discuss the current and future applications of UroNIRS technology for the diagnosis of urologic conditions including LUTS, BPH and erectile dysfunction (ED).

This program will be coordinated through Pfizer’s Urology sales force.

“This exciting program allows us to collaborate with Pfizer and our leading distribution partners to deliver the message about the features and benefits of UroNIRS and future applications of our technology,” said Barry Allen, President and CEO of Urodynamix.

About Urodynamix Technologies Ltd.

Urodynamix Technologies is a Canadian medical device company developing and commercializing non-invasive medical technology based on proprietary applications of near-infrared spectroscopy (NIRS). The Company is currently focused on products that aid in the diagnosis and treatment of urinary incontinence, lower urinary tract symptoms, prostate cancer, benign prostatic hyperplasia, and traumatic increases in intra-abdominal pressure that cause abdominal compartment syndrome. Urodynamix’s breakthrough medical technology has the potential to beneficially affect more than 200 million people worldwide.

About Pfizer Inc.

Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. For more information visit pfizer

Certain information contained in this press release may be forward-looking and is subject to unknown risks, which could cause actual results to differ materially from those set forth or implied herein. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove correct. The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Urodynamix Technologies Ltd.

In a randomized placebo-controlled trial, patients smoking cannabis experienced a 34 percent reduction in intense foot pain associated with HIV – twice the rate experienced by patients who smoked placebo.

“This placebo-controlled clinical trial showed that people with HIV who smoked cannabis had substantially greater pain reduction than those who did not smoke the cannabis,” said study lead author Donald I. Abrams, MD, UCSF professor of clinical medicine. “These results provide evidence that there is a measurable medical benefit to smoking cannabis for these patients.”

The study, published in the journal “Neurology,” looked at 50 HIV patients with HIV-associated sensory neuropathy, a painful and often debilitating condition that is the most common peripheral nerve disorder that occurs as a complication of HIV infection. Occurring usually in the feet and characterized at times by tingling, numbness, the sensation of pins and needles, burning, and sharp intense pain, severe peripheral neuropathy can make walking or standing difficult.

Patients participating in the study were randomized into two equal groups – one assigned to smoke cannabis and the other assigned to smoke identical placebo cigarettes with the cannabinoids extracted. The patients smoked the study cigarettes three times a day for five days under supervision as inpatients in the General Clinical Research Center at San Francisco General Hospital Medical Center.

“Even though antiretroviral treatments have reduced the prevalence and severity of many HIV-related neurological complications, neuropathy continues to affect up to one of every three patients,” said co-author Cheryl A. Jay, MD, UCSF professor of clinical neurology. “There are no FDA-approved treatments for HIV-related neuropathy. This study suggests new avenues to manage neuropathic pain in this setting.”

The study also incorporated a pain model developed at UCSF that provided a standardized reference point. This model allowed researchers to compare relief of chronic HIV-associated neuropathic pain simultaneously with patient response to pain and skin sensitivity induced by heating and capsaicin application.

“The beauty of this study is the use of the pain model as a neutral and physiological anchor for pain measurement. Patients’ eyes were averted during the measurements and were uninfluenced by expectations. Smoked cannabis was shown to work on the pain system by shrinking the area of painfully sensitive skin created by the model. The response was comparable to strong pain relievers we have studied, such as morphine,” said co-author Karin L. Petersen, MD, UCSF assistant adjunct professor of neurology.

This study is the first to be completed of several clinical trials of medicinal cannabis being conducted under the auspices of the University of California’s Center for Medicinal Cannabis Research.

“It has been many years since clinical trials with cannabis have been conducted in the United States,” said Igor Grant, MD, professor of psychiatry at the UC San Diego School of Medicine and director of the CMCR. “As a result there has been insufficient light shed on the possible therapeutic value of cannabis. The results of this first study indicate that cannabis may indeed be useful in the amelioration of a very distressing, disabling, and difficult to treat complication of HIV. We look forward to the results of several additional CMCR studies nearing completion to continue clarifying cannabis’ possible role as a therapeutic agent.”

###

Co-authors include Starley B. Shade, MPH; Hector Vizoso, RN; and Mary Ellen Kelly, MPH, from the UCSF Positive Health Program at San Francisco General Hospital Medical Center, and Michael C. Rowbotham, MD; Haatem Reda, BA; and Scott Press, BS, from the UCSF Pain Clinical Research Center.

The General Clinical Research Center at SFGH is funded by NIH.

The UCSF Positive Health Program is a program of the AIDS Research Institute at UCSF. UCSF ARI coordinates all of the HIV/AIDS research, treatment, and prevention activities at UCSF. Combining the best basic science, bench-to-bedside research, behavioral studies, direct care services, and policy development, the ARI at UCSF is one of the premier HIV/AIDS medical, education, and research institutions in the world.

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.

Contact: Jeff Sheehy

University of California – San Francisco

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced the introduction of Nicardipine Hydrochloride Injection, 2.5 mg/mL, which is AP-rated to EKR Therapeutics’ hypertension treatment Cardene® I.V. Teva’s product is the first alternative to the brand product, which had annual sales of approximately $181 million in the United States for the twelve months ended June 30, 2008, according to IMS sales data.

Teva is manufacturing and distributing the product, under license, as part of a license and distribution agreement entered into between Teva and Exela PharmSci, Inc., a Reston, VA based pharmaceutical development company.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe. tevapharma

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995

This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® , Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission (“SEC”).

Teva Pharmaceutical Industries Ltd.

View drug information on Allegra; Copaxone; Neurontin.

The Pharmaceutical Research and Manufacturers of America has contributed $11.3 million to the advocacy group America’s Agenda: Health Care for Kids for advertisements supporting SCHIP expansion, CQ HealthBeat reports. The ads will appear in at least 25 lawmakers’ states and congressional districts. The ads do not name SCHIP specifically but commend lawmakers who supported a bill (HR 3963) that would have expanded SCHIP. President Bush vetoed the bill, citing cost concerns (Jansen, CQ HealthBeat, 9/19).

The House in January fell 15 votes short of the two-thirds majority required to override President Bush’s veto of the legislation. The bill would have expanded SCHIP to cover 10 million children and increased spending on the program by $35 billion over five years, funded by a 61-cent-per-pack increase of the federal cigarette tax. It also would have limited coverage to children in families with annual incomes below 300% of the federal poverty level (Kaiser Daily Health Policy Report, 1/24).

The ads encourage viewers to contact their lawmakers and tell them to “keep fighting to insure our kids” (CQ HealthBeat, 9/19).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Genmab A/S (OMX:
GEN) announced it has completed recruitment of patients in the
pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab
refractory follicular non-Hodgkin’s lymphoma (NHL). Eighty-one patients
receiving treatment at the 1000 mg dose level of ofatumumab have been
recruited in the study. Data from these patients will be included in the
primary efficacy analysis. An additional 31 patients were recruited at a
500 mg dose level prior to amending the study design to include only one
dose. Data from these patients will be evaluated for safety and supportive
efficacy analysis.

“We have now recruited the last patient into the study and keenly await
the results which we hope will show a benefit for follicular NHL patients
who need a new treatment option,” said Lisa N. Drakeman, Ph.D., Chief
Executive Officer of Genmab.

Ofatumumab is an investigational, new generation, human monoclonal
antibody that targets a distinct membrane proximal, small loop epitope
(specific binding site)of the CD20 molecule on the surface of B-cells.
Ofatumumab is being developed to treat CLL, follicular non-Hodgkin’s
lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing
remitting multiple sclerosis under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. It is not yet approved for
sale in any country.

About the trial

Patients in this study will receive one infusion of 300 mg of
ofatumumab followed by 7 weekly infusions of 1000 mg of ofatumumab. Disease
status will be assessed every 3 months until month 24.

The objective of the study is to determine the efficacy and safety of
ofatumumab in rituximab refractory follicular NHL. The primary endpoint of
the study is objective response as measured over a 6 month period from
start of treatment assessed by an Independent endpoints Review Committee
(IRC) according to the standardized criteria for NHL.

About Genmab A/S

Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for unmet medical needs. Using
cutting-edge antibody technology, Genmab’s world class discovery,
development and manufacturing teams have created and developed an extensive
pipeline of products for potential treatment of a variety of diseases
including cancer and autoimmune disorders. As Genmab advances towards a
commercial future, we remain committed to our primary goal of improving the
lives of patients who are in urgent need of new treatment options. For more
information on Genmab’s products and technology, visit
genmab.

This press release contains forward looking statements. The words
“believe”, “expect”, “anticipate”, “intend” and “plan” and similar
expressions identify forward looking statements. Actual results or
performance may differ materially from any future results or performance
expressed or implied by such statements.

The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated
with product discovery and development, uncertainties related to the
outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market
acceptance of our products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our inability to
attract and retain suitably qualified personnel, the unenforceability or
lack of protection of our patents and proprietary rights, our relationships
with affiliated entities, changes and developments in technology which may
render our products obsolete, and other factors. For a further discussion
of these risks, please refer to the section “Risk Management”in Genmab’s
Annual Report, which is available on genmab. Genmab does not
undertake any obligation to update or revise forward looking statements in
this press release nor to confirm such statements in relation to actual
results, unless required by law.

Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R);
HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM);
HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all
trademarks of Genmab A/S.

Genmab A/S
genmab

Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOBs) and
biopharmaceuticals, and Premacure AB, a biopharmaceutical company dedicated
to the development of diagnosis and prevention of complications in neonates
due to premature birth, noted the presentation of clinical study
results demonstrating that Insmed’s IPLEX(TM) product, a complex of
recombinant human insulin-like growth factor (rhIGF-I) and its predominant
binding protein IGFBP-3 (rhIGFBP-3), increased serum IGF-I levels into the
normal range in significantly premature infants. Premacure is developing
IPLEX(TM) as a potential treatment for Retinopathy of Prematurity (ROP) via
a Material Transfer Agreement with Insmed.

These most recent study results were reported at the European
Society for Pediatric Endocrinology 47th annual meeting, Istanbul, Turkey,
by Investigators from the Harvard Medical School, Boston MA, and the
University of Gothenburg, The Karolinska Institute, Stockholm, Lund
University, Sweden, in a poster entitled “Pharmacokinetic study of
recombinant human (rh) insulin-like growth factor/rh IGFBP-3 complex
administered to very low birth weight infants.”

“The possibility of preventing ROP and other complications of
prematurity by replicating the in utero environment after infants are born
prematurely and lose the factors normally provided by the maternal
environment is very exciting,” said Lois Smith, Professor of Ophthalmology,
Harvard Medical School, Children’s Hospital Boston. “This work showing that
it is now possible to raise the serum level of IGF-1 and IGFBP-3 to normal
in utero levels in these fragile infants with IGF-1 / IGFBP-3 deficiency is
a critical step in the development of interventions that prevent ROP. Since
we have shown that low IGF-1 is associated with ROP, this offers the first
possible intervention to prevent this blinding disease.”

“Our research focuses on promoting neural, vascular and metabolic
development in premature infants,” said Ann Hellstrom, Professor in
Pediatric Ophthalmology, Sahlgrenska Academy, Gothenburg, Sweden. “While in
this study we are attempting to identify the benefits of IGF-I for ROP, our
findings are also likely to be applicable to many aspects of complications
of premature birth and could provide benefits for a lifespan.”

“This is a crucial step in the clinical development of a preventative
treatment against lifelong severe visual impairment or blindness in infants
born preterm,” said Jan Borg, CEO of Premacure. “Based in part on these
results, we intend to initiate a phase II multicenter trial in the ROP
indication during the fourth quarter.”

“The ability of IPLEX(TM) to raise serum levels of two key proteins
involved in the pathogenesis of ROP safely may offer a more effective
preventive option in at-risk infants than the highly invasive and
destructive treatment options of laser therapy or cryotherapy that are
currently utilized to stem disease progression only,” said Geoffrey Allan,
President and CEO of Insmed. “We are pleased that researchers at such
distinguished universities continue to see promise in IPLEX(TM) in ROP and
intend to continue evaluating the drug in this indication. Moreover, these
results serve as further evidence of the effectiveness of IPLEX(TM) in
potentially treating some of the most under-served therapeutic populations,
including Myotonic Muscular Dystrophy and Amyotrophic Lateral Sclerosis.”

Clinical Study Results

Low levels of IGF-I are known to contribute to the pathogenesis of ROP.
The objectives of this open label, investigator-sponsored clinical study
were to determine whether intravenous administration of rhIGFI/rhIGFBP-3
(IPLEX(TM)) could increase serum levels of these proteins in at-risk
infants to levels seen in normal infants, and to evaluate the drug’s safety
and tolerability. Due to consistency in response, the study was finalized
after five infants. The gestational age in these infants ranged from 26
weeks + 0 days to 29 weeks + 1 day (birth weight 810-1,310 g). Treatment
with IPLEX(TM) took place on the infant’s chronological age day 3 and the
investigators reported that the protein complex effectively raised serum
IGF-I levels into the physiological range and that the drug’s
administration was well tolerated, with no acute adverse events.

About IPLEX(TM)

IPLEX(TM) is a complex of recombinant human insulin-like growth
factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3).
The drug, approved in the United States in December 2005 for the treatment
of children with growth failure due to severe primary IGF-I deficiency, is
currently being investigated in MMD and ALS.

About ROP

ROP is a disease of the eye that affects prematurely born babies. It is
thought to be caused by disorganised growth of retinal blood vessels which
may result in scarring and retinal detachment. ROP can be mild and may
resolve spontaneously, but may lead to blindness in serious cases. It is
one of the most common causes of visual loss in childhood and can lead to
lifelong vision impairment and blindness. As such, all preterm babies are
at risk for ROP, and very low birth weight is an additional risk factor.

About Premacure AB

Premacure AB, based in Uppsala, Sweden is a biopharmaceutical company
dedicated to the development of diagnosis and prevention of complications
in neonates due to premature birth. The first of several indications to be
developed is Retinopathy of Prematurity (ROP) a retinal disease being one
of the major causes of blindness in infants throughout the world.

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process
development and manufacturing experience and a proprietary protein platform
aimed at niche markets with unmet medical needs. For more information,
please visit insmed.

Forward Looking Statements

This release contains forward-looking statements which are made
pursuant to provisions of Section 21E of the Securities Exchange Act of
1934. Investors are cautioned that such statements in this release,
including statements relating to planned clinical study design, regulatory
and business strategies, plans and objectives of management and growth
opportunities for existing or proposed products, constitute forward-looking
statements which involve risks and uncertainties that could cause actual
results to differ materially from those anticipated by the forward-looking
statements. The risks and uncertainties include, without limitation, risks
that product candidates may fail in the clinic or may not be successfully
marketed or manufactured, we may lack financial resources to complete
development of product candidates, the FDA may interpret the results of
studies differently than us, the FDA may not establish specific guidelines
for a pathway for the approval of FOB products, FOB products may not be
accepted by consumers, competing products may be more successful, demand
for new pharmaceutical products may decrease, the biopharmaceutical
industry may experience negative market trends, our entrance into the
follow on biologics market may be unsuccessful, our common stock could be
delisted from the Nasdaq Capital Market and other risks and challenges
detailed in our filings with the U.S. Securities and Exchange Commission,
including our Annual Report on Form 10-K for the year ended December 31,
2007. Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this release.
We undertake no obligation to publicly release the results of any revisions
to these forward-looking statements that may be made to reflect events or
circumstances that occur after the date of this release or to reflect the
occurrence of unanticipated events.

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