Replies to post #98234 on Biotech Values

[tony111]

Low dose Qnexa has efficacy in the same range of Lorcaserin not better, but Lorcaserin still got a better AE profile compared to low dose Qnexa. There is no doubt the drug is tolerable enough, (18% vs 8% placebo drop out rate) if you don't drop out during the titration period. However, there is no question Qnexa causes more side effects than Lorcaserin. My bet is doctors will try a drug with less side effects before moving patients to combo therapy that comes in with more side effects especially when patients need to go through a one month titration period.

[DewDiligence]

UK Approves Botox for Prevention of Migraine Headaches

[This is AGN’s first regulatory approval of Botox for migraine anywhere in the world. In the US, the Botox BLA for migraine is under review by the FDA; the exact PDUFA date has not been disclosed but it’s known to be in July, so a decision could come any day.]

http://finance.yahoo.com/news/BOTOX-Receives-First-bw-4234195924.html?x=0&.v=1

›Friday July 9, 2010, 5:29 am

MARLOW, United Kingdom--(BUSINESS WIRE)--Allergan is pleased to announce that BOTOX (botulinum toxin type A) has been licensed by the MHRA in the UK for the prophylaxis of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). This is the first licence worldwide of BOTOX for this indication, and is also the first prophylactic (preventative) treatment to receive a specific licence for patients with chronic migraine.

Chronic migraine can be a costly and disabling disorder that can have a devastating impact on the lives of an estimated 700,000 people in the UK suffering from the condition2, as well as their families. Patients suffering from chronic migraine are more likely to visit Accident and Emergency (A&E), general practitioners (GPs) or speciality care physicians than patients with less frequent episodes of migraine. However, although distinct from other types of migraine, approximately 80% of chronic migraine patients may not actually be diagnosed.3 Historically, treatment for chronic migraine has consisted of a combination of over-the-counter and prescription treatments such as triptans, tricyclic antidepressants, ß-blockers and anti-epileptics.

“There is an unmet need for effective and well-tolerated therapies specifically designed and studied for the prophylaxis of headache in chronic migraine” said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "The authorisation of BOTOX marks an evolution in medical care for the prevention of headache in adults with chronic migraine. It is also a significant milestone in the history of BOTOX and Allergan is proud to advance novel treatments in the field of neurology through our neurosciences research programme."

PREEMPT: the largest clinical trial programme in chronic migraine

The PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) programme evaluated the safety profile and efficacy of BOTOX as a prophylactic (preventative) headache treatment in chronic migraine patients.3 PREEMPT4 is the largest clinical programme in chronic migraine and consists of two phase III clinical trials involving 1,384 adults. Patients were eligible for the study if they had a history of migraine and experienced 15 or more headache days of which at least 50% were migraine or probable migraine during the 28 day baseline period. In a pooled assessment, two thirds of the patients had previously been treated with at least one other headache prophylactic medication and nearly two thirds of the patients were overusing acute medications. During the 28-day baseline period, patients reported suffering from an average of 19.9 headache days (headache for 4 or more hours in any calendar day), of which an average of 19.1 were migraine/probable migraine days (migraine headache on 4 or more hours in any calendar day).

At the end of the 28 day baseline period, patients were randomised to receive either 155 - 195 units of BOTOX administered as 31 injections (155 units) into 7 specific head and neck muscle with an additional up to 8 injections (up to 40 units) into 3 of these muscles that could be administered in a ‘follow the pain’ strategy, or placebo. Patients received 2 injection cycles in a 24 week double-blind phase and then 3 injection cycles in a 32 week open label phase.

• At baseline, patients in the BOTOX treatment group had an average of 19.1 days with migraine. Patients in the placebo treated group had an average of 18.9 days with migraine. By week 24 following treatment, BOTOX treated patients averaged 8.2 fewer migraine days, which was significantly greater than the change from baseline observed in placebo treated patients (6.2 days), p<0.001

• Patients treated with BOTOX experienced significantly fewer headache days compared to those patients treated with placebo (47.1% of BOTOX treated patients compared to 35.1% of placebo treated patients achieved >=50% reduction from baseline in the number of headache days at the week 24 primary timepoint, p<0.001)

• Following the open label phase of the trial (week 56), nearly 70% of BOTOX treated patients experienced >=50% reduction from baseline in migraine days

• Patients treated with BOTOX had significant improvement from baseline in their quality of life scores (MSQ scores) and in the amount of headache related disability (HIT6 scores) compared with those on placebo, indicating significant improvement in patients functioning, vitality, psychological distress, and overall quality of life


Throughout the PREEMPT trials including the open label phase, patients received up to 5 courses of treatment with BOTOX every 12 weeks. Most adverse events reported in the trials were mild to moderate and resolved without further problems. The treatment was generally well tolerated and the discontinuation rate was low in both treatment arms; 3.8% in the BOTOX treated arm and 1.2% in the placebo arm4.

“This is an important step forward in the management of chronic migraine and will hopefully bring additional recognition to this potentially disabling condition,” said Professor Peter Goadsby of the UCL- Institute of Neurology, London and University of California, San Francisco . “BOTOX treatment has been shown to reduce the frequency of headache/migraine, which can bring important benefits for patients. Patients with frequent, chronic migraine, have long required evidence-based approaches and this announcement offers them a new option, providing a real advance for patients often significantly impacted by their condition.”

…In the UK, BOTOX is also indicated for the treatment of:

• blepharospasm (uncontrolled blinking of the eyelids)
• hemifacial spasm (a neuromuscular disorder characterised by unpredictable and involuntary twitching of facial muscles on one side of the face)
• cervical dystonia (a muscle condition affecting the neck making it difficult to hold the head up straight)
• severe axillary hyperhidrosis (excessive sweating) of the armpits
• cerebral palsy (dynamic equinus foot deformity in paediatric patients aged two years and older)
• upper limb spasticity (wrist and hand disability associated with stroke in adults)

In addition, Allergan’s botulinum toxin type A is licensed under the brand name of VISTABEL for the treatment of glabellar lines (frown lines).

About Allergan, Inc.

Allergan, Inc. is a multi-specialty health care company established 60 years ago with a commitment to uncover the best science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have more than 8,000 highly dedicated and talented employees living in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.‹