Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for BENLYSTA, a Potential New Treatment for Systemic Lupus Erythematosus

ROCKVILLE, Md. & BASEL, Switzerland–(Business Wire)–
Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza today announced an agreement
for the future commercial supply of BENLYSTA (belimumab), which is currently
under regulatory review in the United States and Europe as a potential new
treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by
HGS and GlaxoSmithKline (GSK) under a co-development and commercialization
agreement entered into in 2006.

“Our HGS large-scale manufacturing facility has ample capacity to provide
worldwide supply of BENLYSTA following approval, and for the first two or three
years following launch,” said Randy J. Maddux, Vice President, Manufacturing
Operations, HGS. “However, we believe that we will eventually require additional
capacity. After a careful review of proposals from a number of highly qualified
commercial manufacturing organizations, we have selected Lonza, a leader in
biologics manufacturing with a global network of large-scale production sites.
We are confident that Lonza is the right choice to fill this critically
important role.”

In June 2010, GSK submitted a Marketing Authorization Application to the
European Medicines Agency, seeking approval to market belimumab in Europe for
treatment of autoantibody-positive patients with SLE, and HGS submitted a
Biologics License Application (BLA) to the U.S. Food and Drug Administration
seeking approval to market belimumab in the United States. No new drug for lupus
has been approved by regulatory authorities in more than 50 years.

“We are enthusiastic about supporting the future production of BENLYSTA with our
cutting-edge capabilities and expertise in biopharmaceutical manufacturing,”
said Dr. Stephan Kutzer, Chief Operating Officer, Lonza Custom Manufacturing.
“Working on such an important new drug for lupus patients will be very rewarding
and the basis for a long-term, collaborative relationship with HGS.”

About BENLYSTA (belimumab)

Belimumab is an investigational human monoclonal antibody drug that specifically
recognizes and inhibits the biological activity of B-lymphocyte stimulator, or
BLyS. BLyS is a naturally occurring protein discovered by HGS that is required
for the development of B-lymphocyte cells into mature plasma B cells. Plasma B
cells produce antibodies, the body`s first line of defense against infection. In
lupus and certain other autoimmune diseases, elevated levels of BLyS are
believed to contribute to the production of autoantibodies – antibodies that
attack and destroy the body`s own healthy tissues. The presence of
autoantibodies appears to correlate with disease severity. Preclinical and
clinical studies demonstrated that belimumab reduced autoantibody levels in SLE.
The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrated
that belimumab reduced SLE disease activity.

About Lonza

Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare
and life science industries. Its products and services span its customers` needs
from research to final product manufacture. Lonza is the global leader in the
production and support of active pharmaceutical ingredients both chemically as
well as biotechnologically. Biopharmaceuticals are one of the key growth drivers
of the pharmaceutical and biotechnology industries. Lonza has strong
capabilities in large and small molecules, peptides, amino acids and niche
bioproducts which play an important role in the development of novel medicines
and healthcare products. Lonza is a leader in cell-based research, endotoxin
detection and cell therapy manufacturing. Lonza is also a leading provider of
value chemical and biotech ingredients to the nutrition, hygiene, preservation,
agro and personal care markets. Lonza is headquartered in Basel, Switzerland and
is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690
billion. Further information can be found at www.lonza.com.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring
innovative drugs to patients with unmet medical needs.

For more information about HGS, please visit the Company`s web site at
www.hgsi.com. Health professionals and patients interested in clinical trials of
HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at
(877) 822-8472.

HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences,
Inc. Other trademarks referenced are the property of their respective owners.

HGS Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The forward-looking statements are
based on Human Genome Sciences` current intent, belief and expectations. These
statements are not guarantees of future performance and are subject to certain
risks and uncertainties that are difficult to predict. Actual results may differ
materially from these forward-looking statements because of Human Genome
Sciences` unproven business model, its dependence on new technologies, the
uncertainty and timing of clinical trials and regulatory approvals, Human Genome
Sciences` ability to develop and commercialize products, its dependence on
collaborators for services and revenue, its substantial indebtedness and lease
obligations, its changing requirements and costs associated with facilities,
intense competition, the uncertainty of patent and intellectual property
protection, Human Genome Sciences` dependence on key management and key
suppliers, the uncertainty of regulation of products, the impact of future
alliances or transactions and other risks described in the Company`s filings
with the SEC. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of
today`s date. Human Genome Sciences undertakes no obligation to update or revise
the information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.

HGS
Media
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
jerry_parrott@hgsi.com
or
Investors
Peter Vozzo
Senior Director, Investor Relations
301-251-6003
peter_vozzo@hgsi.com
or
LONZA GROUP LTD
Head Corporate Communications
Michael Frizberg
Tel +41 61 316 8624
Fax +41 61 316 9624
michael.frizberg@lonza.com
or
Media Relations
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
domink.werner@lonza.com
or
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
Fax +41 61 316 9549
dirk.oehlers@lonza.com

Copyright Business Wire 2010

Cell Therapeutics, Inc. (CTI) Advances Pixantrone Filing Process in Europe; Submits Expanded Pediatric Investigation Plan (PIP)

SEATTLE, July 6 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (“CTI”) (Nasdaq and MTA: CTIC) announced today that it has submitted an expanded Pediatric Investigation Plan (“PIP”) to the European Medicines Agency (“EMEA”), as part of the process for its submission for a Marketing Authorization Application (“MAA”) for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL). CTI intends to file the MAA later this year. The pediatric program will study pixantrone in pediatric patients aged 6 months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers.

CTI submitted the original PIP in September 2009. In April 2010, the EMEA Pediatric Committee (the “PDCO”) recommended CTI expand the PIP because of pixantrone’s potential, but unproven, clinical benefit to children in reducing long-term cardiotoxicity associated with current curative therapies. The recommendation from the PDCO came following discussions with CTI about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancer.

“Our discussions with the pediatric experts on the PDCO indicated that they agree with our belief that the need for a less toxic, more effective anthracycline-like agent is significant, not only in lymphoma, but potentially in other tumors. We were pleased to accommodate their suggestions and have adjusted the PIP accordingly,” said Jack Singer, Chief Medical Officer of CTI. “Filing the updated PIP puts us one step closer to completing the MAA submission process, and moves us towards our goal of making pixantrone available to suitable patients.”

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines–rather than intercalation with DNA–pixantrone alkylates DNA–forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production–both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at CTI’s Web site, http://www.CellTherapeutics.com/investors_alert

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMEA, that the EMEA may not accept the PIP, that CTI may not file the MAA later this year, that CTI’s MAA may not be approved by the EMEA by next year, that the current plans for the pediatric program may change, that the pediatric program may not determine the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers, and CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI’s filings with the Securities and Exchange Commission including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

E: deramian@ctiseattle.com

www.CellTherapeutics.com/press_room

Investors Contact:

Ed Bell

T: 206.282.7100

Lindsey Jesch Logan

T: 206.272.4347

F: 206.272.4434

E: invest@ctiseattle.com

www.CellTherapeutics.com/investors

Medical Information Contact:

T: 800.715.0944

E: info@askarm.com

SOURCE Cell Therapeutics, Inc.

OBI-1 Developed by Ipsen and Inspiration Has Obtained a Positive Opinion for the Orphan Drug Status in Europe

PARIS & LAGUNA NIGUEL, Calif.–(Business Wire)–
Regulatory News:

Ipsen (Euronext : FR0010259150; IPN) and Inspiration Biopharmaceuticals, Inc.
(Inspiration) announced today that the Committee for Orphan Medicinal Products
of the European Medicines Agency has issued a positive opinion on the granting
of orphan drug status for OBI-1 for the treatment of hemophilia. Final adoption
of the opinion is expected from the European Commission later this year and
subject to it being finally granted, the orphan drug status would trigger a
10-year market exclusivity to OBI-1 in the European Union after its marketing
approval. The FDA also issued an Orphan Drug Designation for OBI-1 in March
2004.

Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen said: “Our
transaction with Inspiration in late January of this year expresses Ipsen`s long
term strategy to create a world leading hemophilia franchise. We are honored
that the Committee for Orphan Medicinal Products of the European Medicines
Agency shares our view of the medical benefit provided by OBI-1 to the
hemophilia community.”

John Taylor, Co-Founder and Chairman of Inspiration added: “We are pleased with
the continued progress of OBI-1 as a new, innovative therapy in the treatment of
unmet medical needs in hemophilia.”

About Hemophilia

Hemophilia, congenital or acquired, is a bleeding disorder caused by low levels
or absence of a protein called a coagulation factor, essential for blood
clotting. The two most common forms of hemophilia are types A and B. Hemophilia
A is caused by a factor VIII deficiency and occurs in ~1 out of every 5,000 male
births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of
every 30,000 male births. Approximately 60% of persons with hemophilia have a
severe condition, which results in frequent spontaneous bleeding episodes in
addition to serious bleeding after injuries. The market for hemophilia treatment
is 7.5 billion dollars annually.

About OBI-1

About a third of patients with congenital hemophilia A and patients with
acquired hemophilia develop an immune reaction to human forms of FVIII (hFVIII)
and can no longer respond to human Factor VIII. Since OBI-1 possesses low cross
reactivity to anti-hFVIII antibodies, it is expected that OBI-1 can provide
therapeutic benefits to patients who are not able to use hFVIII.

OBI-1, a recombinant B-domain deleted FVIII bioengineered for low cross
reactivity to anti-human FVIII inhibitors based on the porcine amino acid
sequence, has recently been tested in a Phase II trial. OBI-1 was administered
to patients with congenital hemophilia A complicated by the presence of human
FVIII inhibitors experiencing a non-life/non-limb threatening bleed. A total of
25 bleeding episodes in 9 patients were treated with OBI-1, and all were
successfully controlled. One subject had a mild infusion reaction andwhen
re-treated for a subsequent bleed the subject did not report any adverse event.
Eight out of nine (89%) subjects developed anti-pFVIII antibodies following
exposure to OBI-1 and in subjects receiving repeated OBI-1 treatment higher
anti-pFVIII titres did not affect efficacy or safety. The study demonstrated
that OBI-1 is well-tolerated and can be given as a short infusion. OBI-1 is
expected to enter phase III in 2010.

About Ipsen

Ipsen is a global biopharmaceutical group with total sales in excess of 1
billion euros in 2009, and total worldwide staff of more than 4,400. Its
strategy is based on fast growing specialty care drugs in oncology,
endocrinology, neurology and hematology, and primary care drugs, which
significantly contribute to research financing. This strategy is also supported
by an active policy of partnerships. Ipsen`s specific Research & Development
(R&D) centers and peptide & protein engineering platform give the Group a
competitive edge. Nearly 900 people are dedicated to the discovery and
development of innovative drugs for patient care. Nearly 900 people are
dedicated to the discovery and development of innovative drugs for patient care.
In 2009, R&D spend reached close to €200 million, representing more than 19% of
total Group sales. Ipsen`s shares are traded on Segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150). Ipsen`s shares are eligible to the
“Service de Règlement Différé” (“SRD”) and the Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary Receipt
(ADR) program, which trade on the over-the-counter market in the United States
under the symbol IPSEY. For more information on Ipsen, visit our website at
www.ipsen.com.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals was founded in 2004 with the mission to
revolutionize treatments for hemophilia. The Company is focused on developing
products that have the potential to broaden patient access to therapy, including
prophylactic use. Greater access and more frequent prophylactic therapy have
been shown to reduce complications of the disease and enhance patients’
long-term health and quality of life. Underlying the Company’s programs is a
novel, proprietary manufacturing technology that allows a greater yield of
high-quality protein. Inspirations` lead product candidate, IB1001 is an
intravenous recombinant factor IX product for the acute and preventative
treatment of bleeding in patients with hemophilia B. The development of
Inspiration`s lead product, IB1001 for the treatment of Hemophilia B and its
earlier stage coagulation factor product candidates have been partially funded
to date by Celtic Pharma, a global private equity and drug development firm.

Inspiration is utilizing its proprietary technology to develop a broad portfolio
of hemophilia and bleeding disorder products that address a $7.5 billion market
worldwide, which has grown historically at a 12% CAGR. With over 130 years of
combined management experience in commercializing hemophilia products at firms
such as Baxter and Bayer, Inspiration has been able to rapidly and efficiently
develop protein therapeutics for hemophilia.

Ipsen`s Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are
based on the Group`s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and potential
future acquisitions, which may alter these parameters. These objectives are
based on data and assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and not
exclusively on historical data. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. Furthermore,
the Research and Development process involves several stages each of which
involve the substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to a product in which it has
invested significant sums. Therefore, the Group cannot be certain that
favourable results obtained during pre-clinical trials will be confirmed
subsequently during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the product
concerned. The Group also depends on third parties to develop and market some of
its products which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the Group`s
activities and financial results. The Group expressly disclaims any obligation
or undertaking to update or revise any forward looking statements, targets or
estimates contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements are based,
unless so required by applicable law. The Group`s business is subject to the
risk factors outlined in its registration documents filed with the French
Autorité des Marchés Financiers.

Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Financial Community
David Schilansky
Vice President Finance
Tel.: +33 (0)1 58 33 51 30
Fax: +33 (0)1 58 33 50 63
E-mail: david.schilansky@ipsen.com
or
Pierre Kemula
Investor Relations Officer
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com
or
Inspiration
Media
Kathy Nugent, Ph.D.
Burns McClellan
Tel : +1-205-401-0260
Email: knugent@burnsmc.com
or
Company
Alison Arter
Senior V.P. and Chief Commercial Officer
Tel: +1-919-360-8611
Email: aarter@InspirationBio.com

Copyright Business Wire 2010

Pharming provides background information on recently completed private offering

LEIDEN, NETHERLANDS, Jun 15 (MARKET WIRE) —
Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM)
today announced that it has responded to a letter from the Dutch
Association for Private Investors (Vereniging Van Effectenbezitters or
“VEB”) to provide additional information to its shareholders on the
recently completed offering of new shares.

The VEB is a Dutch organization which represents the interest of private
investors. On June 2, 2010, Pharming received a letter from the VEB in
which they requested additional information on the recently completed
issue of 100 million new Pharming shares, as announced on May 28, 2010.
Pharming’s management has responded to these questions on June 9, 2010.
Both letters are in Dutch and can be found on the website of the VEB at
www.veb.net. The complete list of questions and answers in Dutch and
English can be found on Pharming’s website: www.pharming.com > Investor
Relations > Public Reports > Equity Fundraising May 2010.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of
genetic disorders, ageing diseases, specialty products for surgical
indications, and nutritional products. Pharming’s lead product Rhucin(R)
for acute attacks of Hereditary Angioedema has passed clinical
development stage and the Market Authorization Application is under
review with the European Medicines Agency. Prodarsan(R) – a product under
development by Pharming’s subsidiary DNage – is in early stage clinical
development for Cockayne Syndrome and lactoferrin for use in food
products. The advanced technologies of the Company include innovative
platforms for the production of protein therapeutics, technology and
processes for the purification and formulation of these products, as well
as technology in the field of DNA repair (via DNage). Recently the
partial spin- out of DNage was initiated. Additional information is
available on the Pharming website, http://www.pharming.com.

Contact:

Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431 or +31
(0)6 109 299 54

[HUG#1423882]

Press release (PDF): http://hugin.info/132866/R/1423882/372629.pdf

Copyright 2010, Market Wire, All rights reserved.

Pharming Group N.V.: Pharming provides background information on recently completed private offering

Leiden, The Netherlands, June 15, 2010. Biotech company Pharming Group NV (“Pharming”)
(NYSE Euronext: PHARM) today announced that it has responded to a letter from the Dutch
Association for Private Investors (Vereniging Van Effectenbezitters or “VEB”) to provide
additional information to its shareholders on the recently completed offering of new
shares.

The VEB is a Dutch organization which represents the interest of private investors. On
June 2, 2010, Pharming received a letter from the VEB in which they requested additional
information on the recently completed issue of 100 million new Pharming shares, as
announced on May 28, 2010. Pharming’s management has responded to these questions on
June 9, 2010. Both letters are in Dutch and can be found on the website of the VEB at
www.veb.net http://www.veb.net . The complete list of questions and answers in Dutch
and English can be found on Pharming’s website:

www.pharming.com http://www.pharming.com

> Investor Relations > Public Reports > Equity Fundraising May 2010.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic
disorders, ageing diseases, specialty products for surgical indications, and nutritional
products. Pharming’s lead product Rhucin for acute attacks of Hereditary Angioedema has
passed clinical development stage and the Market Authorization Application is under
review with the European Medicines Agency. Prodarsan- a product under development by
Pharming’s subsidiary DNage – is in early stage clinical development for Cockayne
Syndrome and lactoferrin for use in food products. The advanced technologies of the
Company include innovative platforms for the production of protein therapeutics,
technology and processes for the purification and formulation of these products, as well
as technology in the field of DNA repair (via DNage). Recently the partial spin- out of
DNage was initiated. Additional information is available on the Pharming website,

http://www.pharming.com http://www.pharming.com

.

Contact:
Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54

HUG#1423882

Press release (PDF) http://hugin.info/132866/R/1423882/372629.pdf

UPDATE 1-Roche wins wider EU label for arthritis drug

June 8 (Reuters) – Roche (ROG.VX) said on Tuesday the European Commission had extended the label for its drug Roactemra to reduce the rate of progression of joint damage and improve physical function in patients with rheumatoid arthritis, when given in combination with the older drug methotrexate.

The move had been expected following a positive recommendation from the European Medicines Agency in April.

The drug, which is known as Actemra in the United States, is currently approved for use in combination with methotrexate to treat adults with moderate to severe rheumatoid arthritis who respond inadequately to other treatments.

The new label extension is a recognition that Roactemra can also inhibit structural damage to joints, reinforcing its effectiveness.

(Writing by Ben Hirschler)

UPDATE 1-GSK seeks EU marketing approval for lupus drug

(Reuters) – GlaxoSmithKline Plc (GSK.L) has sought European regulators’ marketing approval for its experimental lupus drug Benlysta, being developed along with Human Genome Sciences Inc (HGSI.O), the companies said.

The submission to the European Medicines Agency (EMA) includes results from two late-stage trials, Human Genome said.

If approved, the drug will be the first treatment for lupus — a complex disease that causes the immune system to attack the body’s own tissue and organs — in 50 years.

GSK said it plans to submit a Biologics License Application for the drug to the U.S. Food and Drug Administration later this month.

Benlysta is being developed by GSK and Human Genome under a co-development and marketing agreement signed in 2006. (Reporting by Shailesh Kuber in Bangalore; Editing by Gopakumar Warrier)

Anti-obesity drug’s safety being reviewed amid liver damage fears

London, August 26 (ANI): Authorities in the U.S. probing whether an anti-obesity drug being sold over the counter may cause liver damage.

In April, chemists in the UK started selling Orlistat under the brand name Alli, without the need for a prescription.

Now, over 30 reports linking the drug to serious liver injury are said to have emerged in America.

Manufacturer GlaxoSmithKline, however, insists that there is no evidence the drug caused liver damage.

In six of the cases reported to the U.S. Food and Drug Administration (FDA), patients reportedly went on to develop organ failure.

According to reports, the agency received 32 reports of liver damage between 1999 and 2008, 30 of which occurred outside the US. Twenty-seven of those cases resulted in hospitalisation.

The agency is now said to be reviewing the safety of the drug, but stresses no definite association with liver damage has been established at this stage.

It has advised people who used orlistat to seek medical advice if they experience possible symptoms of liver injury, in particular weakness or fatigue, fever, jaundice, or brown urine.

Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) reported having received a total of 1,295 suspected adverse drug reaction reports associated with orlistat, including 137 involving suspected liver damage, since it was licensed in 1998.

The European Medicines Agency said that there was no plan to change the product information at present, but the situation was under review.

In a statement, GlaxoSmithKline (GSK) said that patient safety was its top priority, and reports of side effects were constantly monitored.

The statement added that the drug had been extensively tested in clinical trials involving 30,000 patients.

“Alli is a ‘non-systemically’ acting medicine – it is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with Alli,” the BBC quoted the company as saying in the statement. (ANI)

New drug for speeding up elimination of river blindness across Africa begins clinical trial

London, July 1 (ANI): A clinical trial is being launched in three African countries of a drug that could eliminate onchocerciasis, or river blindness, one of the leading infectious causes of blindness across Africa.

The drug, moxidectin, is being investigated for its potential to kill or sterilize the adult worms of Onchocerca volvulus, which cause onchocerciasis.

“This is a devastating illness that has plagued 30 African countries for centuries, in particular the populations in the most remote areas ‘beyond the end of the road’,” says Dr Uche Amazigo, Director of the African Programme for Onchocerciasis Control (APOC).

“Over 100 million people are at risk of infection with onchocerciasis in Africa and a few small areas in the Americas and Yemen.”

Onchocerciasis is also called river blindness because the blackfly which transmits the disease breeds in fast flowing rivers, and blindness is the most incapacitating symptom of the disease which also causes debilitating skin disease.

The development of moxidectin for onchocerciasis is being conducted through a collaboration of the Special Programme for Research and Training in Tropical Diseases, which is executed by the World Health Organization (WHO/TDR), and Wyeth Pharmaceuticals. The work ranges from the development of a formulation for human use and initial studies in healthy volunteers, to clinical studies and community studies in Africa. WHO/TDR, working in partnership with African investigators and institutions, is building the capacity and managing the conduct of the clinical trials conducted in Africa.

If the development is successful and results in a positive scientific opinion from the European Medicines Evaluation Agency, Wyeth, with the assistance of WHO, will request approval by national regulatory authorities in the countries where onchocerciasis is endemic.

Dr Henrietta Ukwu, Vice President, Wyeth Pharmaceuticals, says, “Wyeth is committed to improving access to innovative drugs and biologics around the globe including in the developing world. The moxidectin data have been promising so far, and as the programme moves into larger phase III studies, we are hopeful that moxidectin will constitute a significant advance against this devastating disease.”

In conducting this trial, TDR will be working with African investigators and institutions. Fifteen hundred people at 4 sites in Ghana, Liberia and the Democratic Republic of Congo will be enrolled in the study.

The trial will take place over the next two and a half years. Currently, the disease is controlled by ivermectin, which has been donated for more than 20 years by the pharmaceutical company Merck and Co. (ANI)