Biotech Values

[DewDiligence]

FDA Approves Botox for Migraine

[This is a material approval for AGN insofar as the addressable market is large, the exiting therapies for migraine leave much to be desired, and the amount of Botox to treat a migraine patent requires at least two vials. The treatment regimen in the phase-3 studies consisted of 31 injections in the head and neck with 155 total units of toxin, which is 3-5x the typical amount used in cosmetic indications. As with all uses of Botox, the treatment effect lasts 2-3 months because that’s how long it takes the temporarily paralyzed muscles to regenerate themselves.

Please see the actual PR for an array of references furnished by AGN to support the assertions in the text below.]

http://finance.yahoo.com/news/BOTOX-onabotulinumtoxinA-FDA-bw-2829862549.html?x=0&.v=1

›BOTOX® (onabotulinumtoxinA) FDA Approved as Prophylactic Treatment Option for Adult Chronic Migraine Sufferers

Friday October 15, 2010, 5:30 pm

IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the prophylactic (preventive) treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer. BOTOX® is the first clinically studied prophylactic treatment to be approved by the FDA specifically for this debilitated patient population. When injected at labeled doses and in the recommended locations in the head and neck, BOTOX® is expected to produce results lasting up to three months depending on the individual patient.

It is estimated that Chronic Migraine impacts approximately 3.2 million Americans, and can leave sufferers in pain for at least half of every month. The World Health Organization (WHO) ranks migraine as the 19th most disabling disease and notes that a day lived with severe migraine can be more disabling than blindness, paraplegia, angina (after walking 50 meters) or rheumatoid arthritis.

Although Chronic Migraine occurs in both men and women, women are three times more likely than men to suffer from migraines. Sufferers often experience depression and anxiety as part of the condition. Chronic Migraine also can be influenced by life stress, sleep habits, diet and overuse of acute medications that relieve pain associated with symptoms of headache.

“Chronic Migraine is a debilitating but under-recognized neurological condition. Often times, Chronic Migraine patients mistakenly self-diagnose their symptoms as headaches or infrequent migraine and treat them with drugs that provide rapid, but temporary, relief rather than seeking an evaluation, diagnosis and treatment from a qualified headache specialist,” said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. “With BOTOX® approved by the FDA for Chronic Migraine patients, there is now a new preventive treatment option to reduce the days and hours spent in pain as a result of this condition.”

It is estimated that approximately 80 percent of those who meet the definition of Chronic Migraine have not received an accurate diagnosis and, as a result, may be unaware of their treatment options. This may be due to mischaracterization of Chronic Migraine as a less severe headache disorder.

“Patients who think they may have Chronic Migraine should seek advice from a medical specialist, such as a neurologist, headache or pain physician, who is qualified to evaluate, diagnose and properly manage this condition and see if BOTOX® treatment is right for them,” said Sheena K. Aurora, M.D., Director, Swedish Headache Center, Seattle, Washington. “Effective management of the Chronic Migraine patient requires an analysis of headache type, triggers, co-morbidities and current medications to develop an appropriate treatment plan. The FDA approval of BOTOX® offers a new, clinically evaluated and proven option to help Chronic Migraine sufferers reduce the number of hours and days they suffer from headache for up to three months per treatment.”

When treating Chronic Migraine, qualified medical specialists administer 31 injections of BOTOX® neurotoxin into seven specific head and neck sites for a total of 155U per treatment session.

PREEMPT: The Largest Clinical Trial Program in Chronic Migraine

BOTOX® (onabotulinumtoxinA) was approved by the FDA based on data collected in Allergan’s PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program. The program was designed to evaluate the safety and efficacy of BOTOX® as a preventive treatment of headaches in adults with Chronic Migraine.3,9 PREEMPT is the largest clinical program in Chronic Migraine, consisting of two double-blind, placebo-controlled clinical trials involving 1,384 adults from 122 study sites in North America and Europe. The PREEMPT studies were published in the March 2010 issue of Cephalalgia (available at: http://cep.sagepub.com/content/30/7.toc ).

In both PREEMPT studies, patients treated with BOTOX® experienced a significantly greater decrease in the frequency of headache days from baseline compared to patients treated with placebo at the week 24 primary endpoint (7.8 and 9.2 fewer days for the BOTOX® group, versus 6.4 and 6.9 days for the placebo group, respectively). Also at week 24, patients treated with BOTOX® experienced a total cumulative reduction in headache hours by 107 and 134 hours, respectively, compared to 70 and 95 hours, respectively, in patients treated with placebo. Patients treated with BOTOX® also had a significantly greater mean decrease from baseline in the frequency of headache days at most timepoints from week four to week 24 in the first study, and all timepoints from week four to week 24 in the second study, compared to patients treated with placebo.

In both PREEMPT studies, adverse reactions reported by greater than two percent of patients treated with BOTOX® and more frequent than in patients treated with placebo included headache, migraine and facial paresis, eyelid ptosis (eyelid drooping), bronchitis, musculoskeletal and connective tissue disorders, including neck pain, musculoskeletal stiffness, muscular weakness, myalgia (muscle pain), musculoskeletal pain and muscle spasms, injection site pain and hypertension. Severe worsening of migraine requiring hospitalization occurred in approximately one percent of patients treated with BOTOX® in both studies, usually within the first week after treatment, compared to 0.3 percent of patients treated with placebo. In general, BOTOX® treatment was well tolerated by the large majority of patients and the discontinuation rate due to adverse events was low in both treatment arms (four percent in the BOTOX® treated group and one percent in the placebo group). Full safety information is provided on page four of this press release [omitted in this post].

About BOTOX® (onabotulinumtoxinA)

BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX® neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three months depending on the individual patient. In the PREEMPT studies, none of the study participants suffering from Chronic Migraine demonstrated neutralizing antibodies to BOTOX® at study completion.

BOTOX® was first approved by the FDA 21 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries, benefiting millions of patients worldwide. In the United States, BOTOX® neurotoxin is also approved to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough, as well as for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity.

In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic (onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age. BOTOX® now approved by the FDA for the prophylactic treatment of headaches in adults with Chronic Migraine, marks the sixth therapeutic indication for the product in the United States since 1989.

In addition to 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 50 randomized, placebo-controlled clinical trials and in approximately 11,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.10 Worldwide, approximately 26 million vials of BOTOX® and BOTOX® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1989-2009).11 With approximately 2,300 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,12 BOTOX® neurotoxin is one of the most widely researched medicines in the world.‹