Oral grass pollen vaccine Grazax

Press release September 26 2006

Grazax(R) Tablet-Based Vaccine Against Grass Pollen Allergy Approved in Europe
Authorities in 27 European countries approved ALK-Abelló's tablet-based vaccine against grass pollen allergy, Grazax® - the first allergy tablet to address the underlying cause of the disease.

Further information at http://www.wansford.co.uk/grazax/

ALK-Abelló expects to launch the innovative and convenient treatment on the first European markets by the end of 2006, ahead of the 2007 pollen season.

HØRSHOLM, DENMARK -- -- ALK-Abelló completed the European Mutual Recognition Procedure for Grazax, the company's tablet-based vaccine against grass pollen allergy, and authorities in 27 European countries have now approved the tablet treatment The Swedish authorities approved GRAZAXGrazax® in March 2006. The approval now also covers Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, the Czech Republic, the Netherlands and the United Kingdom..
"We are very pleased to complete the European Mutual Recognition Procedure with such a positive result. This is a decisive step towards the launch of Grazax. We now look forward to ensuring many more grass-allergic patients in Europe benefit from Grazax treatment, with reduced allergy symptoms and improved quality of life," says Jens Bager, CEO of ALK-Abelló A/S.

Grazax treats the cause of allergyGrazax is the first allergy tablet that improves patients' quality of life by treating the underlying cause of grass pollen allergy and not just the symptoms. Clinical studies show that Grazax has a good safety profile and provides significant efficacy within the first season of treatment. In a global evaluation of patients' perceptions of efficacy of Grazax® treatment, 82 percent of the patients felt 'better' or 'much better' in the first season of treatment, compared with the previous pollen seasons.
Grass pollen allergy is a health problem representing a significant social burden. At least 45 million people in Europe suffer from grass pollen allergy in the shape of allergic rhinitis (hay fever) or allergic asthma – or both.

The majority of patients are only offered symptomatic medications that do not treat the allergy itself. According to a survey conducted by the European Federation of Allergy and Airway Diseases Patients Associations (EFA), 70% of allergic patients feel that allergy limits their quality of life, and 60-68 percent perceive symptomatic medications to be in the range of 'not at all effective' to 'moderately effective' on individual symptoms.
For patients, Grazax is an innovative and convenient treatment formulated as fast-dissolving once-a-day sublingual tablets that can be taken at home. This convenient formulation means that many more patients are expected to be offered the possibility of a medicine that treats the underlying cause of their allergy.

ALK-Abelló expects to launch Grazax on the first European markets by the end of 2006, ahead of the 2007 pollen season. These launches may commence immediately upon receipt of local marketing authorizations and following finalization of price and subsidy negotiations with the respective authorities. The timing of this process will vary from country to country.
Grazax® is a trademark owned by ALK-Abelló A/S.

Further information at http://www.wansford.co.uk/grazax/

New guidance for treating heavy periods

Treatment and care for women with heavy periods
(updated 24th Juanuary 2007 - from NICE (National Institute of Clinical Excellence) Link to advice for Health professionals)
Are heavy periods disrupting your life?
Every woman is different and the amount of blood each woman loses during her period varies widely from one person to another. If heavy periods are disrupting your life, your doctor should be able to offer treatments to help.
First stop: your doctor
Your doctor will ask you about your periods, how much bleeding you have (how often you need to change your tampons/sanitary pads, whether you have clots or experience flooding) and how long your period lasts. If you bleed after sex or have pelvic pain or bleeding between periods, your doctor should offer to examine you to try and find out the cause.
Tests
Your doctor may offer tests to try and find out what is causing your heavy periods. A blood test will show the doctor if you have anaemia (not enough iron in your blood).
If your doctor is concerned about the cause of your heavy periods, you may be offered an ultrasound scan. If the scan doesn’t show anything is wrong or is unclear, you may be offered other types of tests. Your doctor may offer to refer you to a specialist if there seem to be large fibroids or other problems with your womb. (A fibroid is a non-cancerous growth in the womb.)

Drug treatments
If there are no obvious problems with your womb, your doctor will be able to offer a number of different drug treatments to help you. Some of the treatments are also contraceptives. The options are listed on the table on the next page in the recommended order. Your doctor should discuss the benefits and risks of each treatment with you. If the first treatment isn’t suitable for you, or if you try one treatment and it doesn’t work, it may be possible to try the next option. Some of the treatments make your periods lighter and some may stop the bleeding completely. You should be given information explaining the different options, and be allowed time to make your decision.

First treatment to consider

Second treatment to consider

Third treatment to consider
Drug treatments in recommended order of what to try first as long as it’s suitable for you
What is it?
How does it work?
Is it a contraceptive?
Could it affect my chances of getting pregnant in the future?
Possible unwanted effects (not everyone experiences these)
See note at bottom of table
Levonorgestrel-releasing intrauterine system
A small plastic device that is placed in the womb and slowly releases the hormone progestogen
Prevents the lining of the womb from growing quickly
Yes
No – not after you’ve stopped using this drug
Common: irregular bleeding that may last for over 6 months; breast tenderness, acne or headaches may occur but are generally minor and short lived
Less common: no periods
Tranexamic acid
Tablets taken from the start of your period for up to 4 days
Treatment should be stopped if symptoms don’t improve in 3 months
Helps the blood in the womb to form clots, which reduces the amount of bleeding
No
No
Less common: indigestion; diarrhoea; headache
Non-steroidal anti-inflammatory drugs (NSAIDs)
Tablets taken from the start of your period or just before, until heavy blood loss has stopped
Treatment should be stopped if symptoms don’t improve in 3 months
Reduce the body’s production of prostaglandin (a hormone-like substance linked to heavy periods). These drugs are also painkillers
No
No
Common: indigestion; diarrhoea
Combined oral contraceptives
Pills containing the hormones oestrogen and progestogen
One pill taken daily for 21 days, then stop for 7 days. Then repeat this cycle
Prevents the menstrual cycle
Yes
No – not after you’ve stopped taking this drug
Common: mood change; headache; nausea; fluid retention; breast tenderness
Oral progestogen (norethisterone)
Tablets taken 2 to 3 times a day from the 5th to the 26th day of your cycle (counting the first day of your period as day 1)
Prevents the lining of the womb from growing quickly
Yes
No – not after you’ve stopped taking this drug
Common: weight gain; bloating; breast tenderness; headaches; acne (usually minor and short lived)
Injected or implanted progestogen
An injection of the hormone progestogen. An implant is also available that releases progestogen slowly for 3 years
Prevents the lining of the womb from growing quickly
Yes
No – not after you’ve stopped using this drug
Common: weight gain; irregular bleeding; absence of periods; premenstrual symptoms (including bloating, fluid retention, breast tenderness)
Less common: bone density loss
Gonadotrophin-releasing hormone analogue
An injection that stops the body producing the hormones oestrogen and progesterone
Prevents the menstrual cycle
No
No – not after you've stopped using this drug
Common: menopause-like symptoms (for example, hot flushes, increased sweating, vaginal dryness)
Less common: osteoporosis
Note: The most common unwanted effects may be experienced by 1 in 100 women. Less common unwanted effects are those experienced by 1 in 1000 women. Rare unwanted effects are not shown here.
If you think that your care does not match what is described in this leaflet, please talk to a member of your healthcare team.Second stop: your specialist
If treatments offered by your doctor haven’t worked, or if you have large fibroids or other possible problems with your womb, you may be offered a referral to a specialist. Before your appointment you should be given this leaflet or other similar information.
Surgical treatments
Your specialist may offer you surgery. There are a number of different operations that can help (see the table on page 6). Your specialist should discuss these with you. You should be told about the benefits and risks of each option, and given enough time and support to help you make a decision. Some operations will affect your fertility, and before making a decision about these operations your specialist should discuss in detail the potential impact on you.
Your specialist should be competent in the procedures offered. If your specialist is not trained to undertake a particular treatment you should be referred to another specialist with this training.

Questions you might like to ask your doctor
Please give me more details about any tests I may need.
How long will it take to have the tests and get the results?
Please tell me why you have decided to offer me this particular type of treatment.
What are the pros and cons of having this treatment?
How will the treatment help me? What effect will it have on my symptoms and everyday life? What sort of improvements might I expect?
How long will it take before I notice a difference?
Are there any risks if I take this treatment?
What are my options for taking treatments other than the recommended treatment?
Is there some written information about the treatment that I can have?

Types of surgery in recommended order – some types may not be suitable for you
What is it?
How does it work?
Could it affect my chance of getting pregnant in future?
Possible unwanted effects (not everyone experiences these)
See note at bottom of table
Surgery to remove the lining of the womb (endometrial ablation). There are several different methods. The following are recommended: • ‘thermal balloon endometrial ablation’ (TBEA) • ‘impedance-controlled bipolar radiofrequency ablation’ • ‘microwave endometrial ablation’ (MEA) • ‘free fluid thermal endometrial ablation’.
But other techniques (for example, rollerball ablation) may be more suitable if you have fibroids or other problems with your womb
In all of these techniques a device is inserted into the womb through the vagina and cervix. The device is heated using different methods (for example, using microwave or radio energy). This heat destroys the lining of the womb
Removing the womb lining should stop bleeding. In some women the lining grows back and the surgery may need to be repeated
This surgery is not suitable if you want to become pregnant at any time in the future
You will need to use contraception if you have sex
Common: vaginal discharge; increased period pain or cramping (even if no further bleeding); need for additional surgery
Less common: infection
Treatment to block the blood supply to fibroids (uterine artery embolisation or UAE)
Small particles are injected into the blood vessels that take blood to the womb
The blood supply to the fibroids is blocked and this causes them to shrink
You may be able to get pregnant after this procedure
Common: long-lasting vaginal discharge; pain; nausea; vomiting; fever
Less common: need for further surgery; premature ovarian failure particularly in women over 45 years; collection of blood
Surgery to remove fibroids (myomectomy)
This can be done either through a cut in your abdomen or through your vagina
When the surgery is done through the vagina, a thin telescope (called a hysteroscope) is used to see inside your womb
Fibroids can cause heavy periods, and removing them should reduce the amount of bleeding
You may be able to get pregnant after this procedure
Less common: internal scars (which may lead to pain and/or impaired fertility); need for additional surgery; recurrence of fibroids; perforation (hysteroscopic route); infection
Surgery to remove the womb (hysterectomy). There are two main ways of doing this depending on your individual circumstances.
Hysterectomy should only be considered when:• Heavy bleeding has a severe impact on your quality of life • Other treatments haven’t worked or are not suitable for you • You want your periods to stop completely • You fully understand the risks and benefits and ask for a hysterectomy • You don’t want to keep your womb or to have a child
Your ovaries should not be removed if they are healthy. If you or your specialist have concerns, or you are considering having your ovaries removed, all the options should be discussed. If you have a strong family history of ovarian or breast cancer you should be offered genetic counselling
• Vaginal hysterectomy: the womb and cervix are removed through the vagina• Abdominal hysterectomy: the womb is removed through the abdomen – In a ‘total’ hysterectomy, all of your womb and cervix is removed. In a ‘subtotal’ hysterectomy, just the womb is removed – In laparoscopic hysterectomy, a device with a camera and cutting tool is used
Removing the womb means you won’t have a period again
If you have fibroids there is an increased risk of complications, your specialist should discuss this with you
There is no chance of having a child after a hysterectomy
Common: infection
Less common: excessive bleeding during surgery; damage to other abdominal organs, for example, urinary tract or bowel; urinary dysfunction – frequent passing of urine and incontinence
With ovary removal at time of hysterectomy:
Common: menopausal-like symptoms (for example, hot flushes, increased sweating, vaginal dryness)
Note: The most common unwanted effects may be experienced by 1 in 100 women. Less common unwanted effects are those experienced by 1 in 1000 women. Rare unwanted effects are not shown here.This table does not cover all the pros and cons of each option. Your specialist should discuss both the short- and long-term effects in detail.
Your care
Your treatment and care should take into account your personal needs and preferences, and you have the right to be fully informed and to make decisions in partnership with your healthcare team. To help with this, your healthcare team should give you information you can understand and that is relevant to your circumstances. All healthcare professionals should treat you with respect, sensitivity and understanding and explain heavy periods and the treatments simply and clearly.
The information you get from your healthcare team should include details of the possible benefits and risks of particular treatments. You can ask any questions you want to and can always change your mind as your treatment progresses or your condition or circumstances change. Your own preference for a particular treatment is important and your healthcare team should support your choice of treatment wherever possible. You should be able to get a second opinion if an agreement between you and your healthcare professional on your treatment is not reached.
Your treatment and care, and the information you are given about it, should take account of any religious, ethnic or cultural needs you may have. It should also take into account any additional factors, such as physical or learning disabilities, sight or hearing problems, or difficulties with reading or speaking English. Your healthcare team should be able to arrange an interpreter or an advocate (someone who supports you in asking for what you want) if needed.

You should not be offered:
oral progestogens for use only in the second half of your menstrual cycle
drugs called danazol and etamsylate
dilatation and curettage (D and C, which involves scraping out the womb lining) – as a treatment or test
More information about heavy periods
The organisations below can provide more information and support for women with heavy periods. Please note that NICE is not responsible for the quality or accuracy of any information or advice provided by these organisations.
Fibroid Network, info@fibroid.co.uk, www.fibroidnetworkonline.com
The Hysterectomy Association, 0871 781 1141, www.hysterectomy-association.org.uk
Women’s Health Concern, 0845 123 2319, www.womens-health-concern.org
NHS Direct online (www.nhsdirect.nhs.uk) may be a good starting point for finding out more. Your local Patient Advice and Liaison Service (PALS) may also be able to give you further information and support.