Archive for June, 2008

Jun 18 2008

ISTA Pharmaceuticals Announces New Phase III Clinical Findings To Support Bepreve NDA Filing

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ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), announced positive results from
the preliminary analysis of its second and final Bepreve(TM) (bepotastine
ophthalmic solution) Phase III clinical study. Buy propecia without prescription The U.S. multi-center
conjunctival allergen challenge (CAC) study evaluated the onset and
duration of effect of two Bepreve concentrations in 130 patients with a
history of
ocular allergies. Both concentrations demonstrated highly
statistically significant reductions in the primary study endpoint of
ocular itching. In addition, both concentrations produced highly
statistically significant effects on the rapidity of response and in the
secondary endpoints measuring additional signs and symptoms of ocular
allergy, as well as improvement in total nasal symptoms. There were no
serious ocular adverse events reported in patients dosed with Bepreve.
The Phase III study was a multi-center, double-masked,
placebo-controlled study. It was designed to evaluate the onset and
duration of effect of Bepreve in two concentrations and in two dosing
schedules, once-daily and twice-daily. Of the 130 patients enrolled, 117
completed the study. Patients were randomized 1:1:1 to receive one of two
concentrations of Bepreve. They were evaluated on 3 separate visits for
their response to the dose administered, which would allow for the
determination of the time to onset, response at 8 hours and at 16 hours.
Both statistical significance and degree of clinical response, were
measured. The strongest clinical effect achieved was with twice-daily
dosing of either concentration. Further, the higher concentration of
Bepreve demonstrated a once-daily clinical effect that was comparable to
the published literature for FDA-approved once-daily ophthalmic solutions
studied in patients with ocular allergies.
The data announced today mirror the results from the 107-patient,
single- center Phase III Bepreve study, announced May 8, 2007, which used
the same study design. ISTA currently is analyzing the results of an ocular
safety study in approximately 850 patients, with preliminary results
anticipated before the end of the second quarter of 2008. Once the Company
completes its analysis of the full dataset, ISTA expects to file a New Drug
Application (NDA) with the FDA during the second half of 2008. ISTA plans
to discuss the study results with the FDA to determine what, if any,
additional information would be required in order to obtain approval for
both a once-daily and twice- daily form of Bepreve.
About Bepreve(TM) (bepotastine ophthalmic solution)
Bepreve has three primary mechanisms of action: it is a non-sedating,
highly selective antagonist of the histamine 1 (H1) receptor, it has a
stabilizing effect on mast cells, and it suppresses the migration of
eosinophils into inflamed tissues. The compound’s primary mechanisms of
action are believed to make it an effective treatment against the signs and
symptoms of allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the
treatment of allergic rhinitis and urticaria/pruritus in July 2000 and
January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma
Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name
TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries,
Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju
Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of
certain Asian countries, to develop, manufacture, and market bepotastine
for ophthalmic use. In 2006, ISTA licensed from Senju the exclusive North
American rights to an eye drop formulation of bepotastine for the treatment
of allergic conjunctivitis.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA’s
products and product candidates addressing the $4.7 billion U.S.
prescription ophthalmic industry include therapies for inflammation, ocular
pain, glaucoma, allergy, and dry eye. The Company currently markets three
products and is developing a strong product pipeline to fuel future growth
and market share. The Company’s product development and commercialization
strategy is to launch a new product every 12 to 18 months, thereby
continuing its growth to become the leading niche ophthalmic pharmaceutical
company in the U.S. For additional information regarding ISTA, please visit
ISTA Pharmaceuticals’ website at
Any statements contained in this press release that refer to future
events or other non-historical matters are forward-looking statements.
Without limiting the foregoing, but by way of example, statements contained
in this press release related to bringing a new product to market every 12
to 18 months, completing the preliminary analysis of the data from the
Bepreve ocular safety study in the second quarter of 2008, filing the
Bepreve NDA with the FDA in the second half of 2008, and becoming the
leading niche ophthalmic pharmaceutical company are forward-looking
statements. Except as required by law, ISTA disclaims any intent or
obligation to update any forward-looking statements. These forward-looking
statements are based on ISTA’s expectations as of the date of this press
release and are subject to risks and uncertainties that could cause actual
results to differ materially. Important factors that could cause actual
results to differ from current expectations include, among others: timely
and successful implementation of ISTA’s strategic initiatives; delays and
uncertainties related to ISTA’s research and development programs
(including the difficulty of predicting the timing or outcome of product
development efforts and the FDA or other regulatory agency approval or
actions); uncertainties and risks regarding market acceptance of and demand
for ISTA’s approved products and the impact of competitive products and
pricing; uncertainties and risks related to ISTA’s ability to properly
manage its growth; uncertainties and risks regarding the continued timely
performance by ISTA’s strategic partners of their respective obligations
under existing collaborations and licensing arrangements; uncertainties and
risks related to the continued availability of third party sourced products
and raw materials on commercially reasonable terms, or at all;
uncertainties and risks related to successful compliance with FDA and or
other governmental regulations applicable to ISTA’s facilities, products
and/or business; uncertainties and risks related to the scope, validity,
and enforceability of patents related to ISTA’s products and technologies
and the impact of patents and other intellectual property rights held by
third parties; and such other risks and uncertainties as detailed from time
to time in ISTA’s public filings with the U.S. Securities and Exchange
Commission, including but not limited to ISTA’s Annual Report on Form 10-K
for the year ended December 31, 2007.
ISTA Pharmaceuticals, Inc.

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Jun 18 2008

New International Field Of Research Established - Allergooncology

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Research into the correlations between allergies and the development of
tumours - and possible benefits for future cancer treatments - has finally
become an established research discipline in its own right. That was the
conclusion at the 2nd International AllergoOncology Symposium, which took
place in Vienna at the weekend. The symposium’s organiser, Prof.
Jensen-Jarolim, was extremely happy with the event, which was attended by
over 90 doctors and scientists from over 10 different countries. This
fascinating field of research, which she has succeeded in establishing with
support from the Austrian Science Fund FWF, has also been honoured with its
first review article in the international journal "Allergy".
Although scientists have been aware of the phenomenon for over 50 years, it
is only over the last three of these that there has been a dedicated field
of research looking into the influence of allergic reactions on the
development of tumours. Known as AllergoOncology, this discipline looks at
the ways that allergic reactions can inhibit the growth of cancer tumours.
This field of research was founded by Prof. Erika Jensen-Jarolim, head of
the Department of Pathophysiology at the Medical University of Vienna. Her
work on establishing AllergoOncology as a distinct field of medical research
began several years ago as part of a project run by the Austrian Science
Fund FWF.
Synergy & Symposium
Last weekend’s International AllergoOncology Symposium in Vienna, the second
to be organised by Prof. Jensen-Jarolim, provided a host of international
immunologists and oncologists with the ideal opportunity to discuss
potential synergies in their work. The broad spread of topics covered at the
event included a presentation by Prof. Chris Parish from the John Curtin
School of Medical Research in Australia. He referred to a project during
which resistance to certain chemically induced tumours was achieved in a
mouse model through the administration of white blood cells, which are also
associated with allergies.
"Even if results from animal models cannot be transferred directly to
humans, projects like Buy clomid pills Prof. Parish’s still demonstrate the enormous
therapeutic potential of AllergoOncology," comments Prof. Jensen-Jarolim.
Another project presented by Dr. Manuel Penichet, University of California,
which was carried out in cooperation with teams led by Prof. Hannah Gould,
King’s College, London, and Prof. Jensen-Jarolim sought to combat breast
cancer. To do this, the team used a key characteristic of the special
antibodies that are jointly responsible for allergic reactions - IgE
antibodies. These antibodies have a highly reactive and long-lasting effect
against proteins that the body classes as unwanted. This IgE response can
also be accurately directed against protein structures in certain tumour
cells. This characteristic is being used by the team and can even be
enhanced by making specific adjustments to the antibody structure.
However, Prof. Jensen-Jarolim also felt that the potential of
AllergoOncology should be critically scrutinised during the symposium, and a
debate involving a panel of specialists led by the life science journalist
Johanna Award-Geissler provided the ideal solution. Prof. Jensen-Jarolim
explains: "To ensure a field of research survives in the long term, we need
to have people who are willing to be critical and we must put in place
consistent checks. That’s why symposium participants were also presented
with data from a Viennese study of over 22,000 cancer patients, which had
been unable to identify any general link between mortality and the
concentration of IgE in serum, except in the case of lymphoma and leukaemia.
The reasons behind this will need to be analysed further."
A review article that was exclusively unveiled in advance at the weekend
showed just how much progress has already been made towards making
AllergoOncology an established field in international medicine and science.
The article is due to be published officially in the international journal
"Allergy" in a few weeks. From the FWF’s perspective, both the symposium and
the state-of-the-art article demonstrate that providing early support for
newly emerging interdisciplinary fields of research such as AllergoOncology
really does make sense.
The full programme of the 2nd International AllergoOncology Symposium can be
found at:
Medizinische Universit?¤t WienInstitut f??r Pathophysiologie
Austrian Science Fund FWF
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Jun 18 2008

Boehringer Ingelheim To Acquire Actimis Pharmaceuticals

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Boehringer Ingelheim GmbH announced an agreement to acquire Actimis Pharmaceuticals, Inc., a privately owned biotech company based in San Diego. The acquisition will occur through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’ leading asthma compound AP768. If AP768, currently in phase I clinical development, is successfully advanced into a phase III, Boehringer Ingelheim will own 100% of Actimis’ shares. Upon successful completion of the entire development programme, the total deal will be worth US$ 515 million. Further financial details were not disclosed.
The compound AP768 interacts with CRTH21 , a novel target for asthma and allergic rhinitis. Previous to the currently ongoing phase I clinical trial, the compound has been shown to have a more effective mechanism of action across multiple available animal models compared to currently marketed leukotriene receptor antagonists.
"Actimis’ compound provides an innovative addition to Boehringer Ingelheim’s portfolio of development candidates for the potential treatment of respiratory diseases", said Dr. Andreas Barner, Vice-Chairman of the Board Corporate Division Pharma Research, Development and Medicine at Boehringer Ingelheim. "For many decades Boehringer Ingelheim has been advancing research and development in the respiratory area with new medicines, such as Spiriva®, which has significantly improved the treatment of COPD patients."
"Actimis and its investors are delighted with the highly innovative structure of this transaction with Boehringer Ingelheim" says Dr. Peter McWilliams, President and Acting CEO of Actimis. "The scientific team at Actimis, under the leadership of founder, Dr. Kevin Bacon, have done a great job in bringing the program into the clinic and we are excited to have consummated an agreement with a company possessing the expertise and capabilities of Boehringer Ingelheim and are convinced they will do a superb job in taking the compound through the critical and demanding further steps in development."
About Boehringer Ingelheim
Buy generic cipro The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
About Actimis Pharmaceuticals
Actimis is a privately held biopharmaceutical company focused exclusively on the research and development of small molecule therapeutics for severe respiratory, inflammatory and autoimmune diseases such as asthma, inflammatory dermatoses, inflammatory bowel disease and rheumatoid arthritis. Actimis was spun off from Bayer Healthcare AG in November 2004. Investors include Sanderling Ventures and Mitsui & Co. Venture Partners.
1 CRTH2: chemo-attractant receptor-homologous molecule expressed on TH2 mice cells
Boehringer Ingelheim
View drug information on Spiriva HandiHaler.
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Jun 18 2008

How To Do Your Spring Cleaning If You Suffer From Asthma

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Now that spring is officially upon us, it is that time of year when we all start to think about spritzing up our homes for the start of the new season but if you are one of the 5.2 million people in the UK who suffer from asthma, this is especially important.
Dust, dirt and allergens tend to collect over the winter months causing a potentially dangerous build up of asthma triggers in your home. 90% of people with asthma tell us that dust triggers their condition and in the UK alone over 200 people a day are admitted to emergency care with potentially life-threatening asthma attacks. Asthma UK is therefore providing some simple steps to help you protect yourself and your family from some of the common indoor asthma triggers.
Clear out old belongings
Recycling old belongings and collectables, or donating them to charity will cut down on dust throughout the house, making cleaning easier. Items that fit tidily into closets and drawers can be hidden neatly away so that they will not gather as much dust. Generic propecia pills no prescription A clutter-free environment is easier to clean - and easier to keep clean.
Dust everything!
Dust may have collected during the winter months so now is the perfect time to move aside furniture in order to reach every nook and cranny. Rarely vacuumed spots may not look dirty, but dust will have collected in the corners of rooms. Window blinds and curtains can also be dust traps so it is important to clean them thoroughly. Dot Russell, asthma nurse specialist on the Asthma UK Adviceline, says: ‘If you know house-dust mites trigger your asthma, you may be able to reduce some symptoms by damp-dusting all surfaces and vacuuming all areas frequently using a vacuum cleaner with good suction and a filtered exhaust. The filters on vacuum cleaners should be changed regularly and you may need to ask someone else to empty the machine.’
Dot adds: ‘Even though you may be spring-cleaning to help your asthma, take care as dust particles will be in the air for at least two hours after cleaning and this may trigger asthma symptoms. Ways to avoid this could be keeping the house well-ventilated while cleaning or asking someone else to vacuum whilst you are out of the room. Be aware that some chemicals in cleaning products and highly scented products may also bring on your asthma symptoms - vinegar is a good, natural alternative.’
Change all old filters
Don’t forget to change or clean the filters on air conditioners, air purifiers, dehumidifiers or vents so that the incoming air in your home is clean, fresh and breathable.
Get rid of indoor mould
Mould in the home can be a trigger for people with asthma and it thrives in damp environments. Ensure your home is well-ventilated and remove mould by washing and disinfecting rubbish bins, thoroughly scrubbing kitchens and bathrooms and cleaning or changing shower curtains.
Dot continues: ‘People with asthma need to be aware of what their triggers are and know how to avoid them. As part of a self-management plan this can help make life easier and may also enable asthma management with the least medicine possible. A written personal asthma action plan should be discussed and completed with your doctor or asthma nurse and contains the information you need to control your asthma. This includes details of your asthma medication, key things to tell you when your asthma is getting worse and what you should do about it, as well as emergency information on what to do if you have an asthma attack.’
Asthma UK is the charity dedicated to improving the health and well-being of the 5.2 million people in the UK whose lives are affected by asthma.

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Jun 18 2008

Wholesnax Recalls Some Products Because They Contain Soya Lecithin, Which Is Declared As Lecithin, UK

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Wholesnax has recalled some batches of its chocolate coated brazils, peanuts, raisins, peanuts and raisins and mixed nuts and raisins because they contain soya lecithin which is declared as lecithin in the ingredients list. generic cipro online buy The products, therefore, are unsuitable for people with a soya allergy. The Agency has issued an Allergy Alert.
Anyone with a soya allergy is advised not to eat these products.
Product details
Wholesnax chocolate coated;
– Brazils, 180g
– Peanuts, 180g
– Raisins, 180g
– Peanuts and raisins, 180g
– Mixed nuts & raisins, 180g
Best before dates: August 2008
The company has withdrawn the affected products to re-label. The company has issued point-of-sale notices for display in retail outlets, which inform customers of the reason for the re-labelling.
Allergy Alerts
Sometimes there will be a problem with a food product that means it should not be sold. Then it might be ‘withdrawn’ (taken off the shelves) or ‘recalled’ (when customers are asked to return the product). Sometimes foods have to be withdrawn or recalled if there is a risk to consumers because the allergy labelling is missing or incorrect or if there is any other food allergy risk.
In such situations the Agency will issue an Allergy Alert. It is also possible to subscribe to an email alert system to receive automatic messages whenever Allergy Alerts are issued. Click on ‘Get alerts’ in the box at the bottom of this page to find more details.
You can get details of all the latest allergy alerts as soon as they’re issued by getting the details sent as a SMS text message direct to your mobile phone.
To sign up to this free service, simply send the text message ‘START ALLERGY’ to the number 62372. To unsubscribe, just text ‘STOP ALLERGY’ to the same number.
You can also subscribe to our Really Simple Syndication (RSS) feed for food and allergy alerts. RSS is a format for distributing news content and is a simple way to keep up to date with the latest news on a website. When we publish via RSS, you can automatically get the updated content via a ‘news aggregator’ or ‘news reader’. Our RSS feed will contain a brief summary and link back to our web content. Click on ‘What is RSS’ on the left of this page for more details.
Wholesnax (Natural Products) Ltd withdraws several chocolate coated products due to a labelling error
Food Standards Agency (UK)
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