Forest Pays Almirall $75M Up Front as Part of Second Respiratory Therapies Agreement

Forest Laboratories is paying Almirall $75 million up front as part of a U.S. development, marketing, and distribution agreement for the latter’s once-daily, long-acting beta2 agonist, LAS10097. The deal covers development of LAS100977 in combination with an undisclosed corticosteroid for the treatment of both asthma and chronic obstructive pulmonary disease (COPD), using Almirall’s Genuair® inhaler. LAS10097 has already completed Phase IIa trials in asthma patients.

Under terms of the deal, Forest will be responsible for U.S. regulatory approval and commercialization of the LAS100977-based therapy. Almirall will receive milestone payments and sales-based royalties on top of the up-front fee.

The deal represents the second major respiratory therapies collaboration between the companies. In April 2006 Almirall and Forest signed a $60 million up front deal to develop, market, and distribute Almirall’s inhaled, long-acting muscarinic antagonist, aclidinium bromide, in the U.S. The drug is an anticholinergic bronchodilator, selective M3 muscarinic antagonist for the treatment of COPD.

The companies had originally anticipated filing an NDA in the fourth quarter of 2009 or the first quarter of 2010. However, in March 2009 the companies announced that after consultation with FDA, additional clinical studies with aclidinium bromide will need to be conducted to provide further support for the selected regimens, including higher and/or more frequent doses. EU filing of aclidinium bromide by Almirall is currently projected for 2011.

Commenting on the deal, Howard Solomon, chairman and CEO at Forest, said, “with the addition of LAS100977, Forest rounds out a broad COPD pipeline that was recently augmented with Daxas® (roflumilast) and will also gain access to the larger asthma market with a once-daily inhaled corticosteroid/LABA combination.”

P.S. Boost your natural immunity against Asthma by eating Vitamin C and Vitamin D rich foods and fruits.

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Smoke a testing time for asthmatics

THE National Asthma Council Australia is urging people with asthma in bush fire zones, or those planning summer holidays in the country, to ensure they have considered their asthma as part of their total summer survival plan.

“People with asthma are at particular risk from bush fire smoke, especially the very young and older people,” National Asthma Council Australia Director,Associate Professor Peter Wark.

“The best protection, where possible, is avoiding exposure to high levels of smoke and ensuring your asthma is well controlled from day-to-day.

“This means seeing your doctor to make sure you have an appropriate written asthma action plan to help you manage your asthma over summer as well as making sure you regularly take your preventer puffer,” Professor Wark said.

“If you live in a high risk fire zone, you should also ask for a prescription for a second emergency inhaler, which you should have ready to take with you if you evacuate.

“Keep your back-up medication with your most precious papers or photographs to ensure it goes with you if you decide to leave.”

The National Asthma Council Australia also stressed the need to follow the manufacturer’s storage recommendations for medications during the hotter summer months.

“Keeping a back up inhaler in your glove box may seem like a good idea, but the extreme heat may render your medication ineffective, or worse still, some medication canisters could explode under the intense heat conditions that will occur in cars this summer.”

People who live in built up areas also need to plan for days of smoke haze as winds can move bush fire smoke and harmful airborne particles over great distances.

Bushfire smoke contains particles of different sizes, water vapour and gases, including carbon monoxide, carbon dioxide and nitrogen oxides, which can trigger asthma symptoms, such as wheezing, coughing or chest tightness

Larger sized air-borne particles, containing burning debris, contribute to the visible haze when a fire is burning.

They are generally too large to be breathed into the lungs, but they can cause irritation to the lungs, throat and nose.

Finer particles and gases, however, are small enough to be breathed into the lungs.

“This is why we are cautioning people with asthma across Australia to be vigilant about their health as the 2009/10 bushfire season unfolds and Australia heats up.”

P.S. Boost your immunity against asthma by eating Vitamin C and Vitamin D rich foods and fruits.

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Just breathe - Buteyko Method

"When a person gets short of breath, intuitively the right thing to do seems to be to inhale deeply," says Margalit Noam. "But amazingly, if asthma patients are asked whether a deep breath helped them during an attack, the answer is unequivocally no. This is because people with breathing problems do not suffer from a lack of air, but from too much ventilation. They inhale too much air and the body has a hard time coping with that."

To anyone who's ever witnessed an asthmatic struggling to get air into his lung, this approach sounds contrary to logic. However Noam, a therapist who treats asthma using the Buteyko method, explains, "When you inhale too much, the concentration of carbon dioxide in the body dwindles and not enough oxygen reaches the tissues. Inhaling more air in order to provide more oxygen to the tissues not only does not help, it actually worsens the situation."


Professor Konstantin Buteyko, a Ukrainian doctor, derived this understanding from the findings of the physiologist Christian Bohr in the early 20th century. Bohr found that a decline in carbon dioxide levels in the body reduces the blood's ability to release oxygen to tissues and vice versa. Based on this phenomenon, known as the Bohr effect, Buteyko concluded that while in a state of shortness of breath, the body will benefit more from a reduction in the volume of air that enters the body. In the mid-20th century, Buteyko developed a unique method for treating patients suffering from asthma and other breathing passage problems, and patients of this method learn to slow the pace of their breathing.


Restoring balance

A shortage of oxygen is not the only problem related to over-breathing. "When there is too much air, the acidity level of the body drops [the PH level increases] and the body is not balanced," adds Noam. "In order to restore its acidity level, the body begins to secrete more lactic acid. This does not improve the situation and only causes fatigue. The breathing system enables the balancing of the acidity level in the body much more quickly than the body's other systems."

"For the sake of comparison," he continues, "the metabolism, the digestive system and kidney tract require several hours and sometimes even several days to restore the body's acidity levels to normal levels, whereas the breathing system can do so in minutes. Slowing the pace of breathing and sometimes even a brief halt in breathing reverses the process, and with a normal breathing pace the body returns to its desired acidity levels."

The treatment is sought primarily by asthmatics, but also helps people with allergies, anoxia, snoring, chronic runny noses, stuffed noses and sinusitis. The treatment is also sought by those with a tendency to suffer from anxiety and unease, high blood pressure and migraines. The direct connection between breathing and the improved conditions is explained by the following: after the breathing is relaxed, oxygen is released to the tissues, the blood vessels expand, pressure from them decreases and pain is reduced.


Learning to relax

Noam's patients attend six two-hour sessions, during which they improve their awareness of breathing difficulties, learn to identify situations where they over-breathe and learn how to relax the pace of breathing.

The Buteyko method is one of the most effective ways of treating asthma patients. In studies conducted in Canada and Australia, patients report a substantial reduction in the use of extenders, inhalers and inhalation machines (up to 96 percent after just 12 weeks) and in asthma prevention medications (49 percent). The reduction in the use of inhalers and medications is of greater significance for asthmatics who have become used to living alongside the inhaler and in many cases become anxious if they can't remember where they put it. Noam also reports improvements for those suffering from sleep disturbances such as apnea or snoring.

In Russia, the method is widespread and has been studied for over 50 years. In the West it is also starting to gain institutional recognition. In Australia, medical insurance covers some of the expenses of attending a Buteyko workshop, given the knowledge that it will save on other insurance costs. In England, a family doctor is authorized to recommend the method for treating breathing problems.

Dr. Avner Goren, a pediatrician and allergy, clinical immunology and asthma expert, as well as the director of the Maccabi health maintenance organization branch in Ramat Hasharon, says he frequently recommends the treatment, based on "the research results that indicate a substantial reduction in the use of medications and also because of the fact that I know for certain that they do not interfere in any stage of the patient's drug treatment."


P.S. Boost your asthma immunity by eating Vitamin C and Vitamin D foods and fruits.



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