Galderma to gain rights to Restylane, Perlane, Sculptra and Dysport in the United States and Canada

Galderma to gain rights to Restylane, Perlane, Sculptra and Dysport in the United States and Canada

MAY 29, 2014

• Galderma positioned to commercialize Restylane®, Perlane®, Emervel®, Sculptra®, Dysport® in
  the U.S. and Canada
• Galderma reinforces long‐term commitment to meet physician and patient needs in aesthetic and corrective dermatology worldwide

Fort Worth, Texas (May 28, 2014) – Galderma Laboratories, L.P. (“Galderma”) announced today that Nestlé S.A., Switzerland, one of Galderma’s shareholders, has entered into an agreement with Valeant Pharmaceuticals International, Inc. and related entities (“Valeant”), through which Galderma will become the distributor of several key products in aesthetic dermatology. Galderma will gain full rights to
commercialize Restylane, Perlane, Emervel, Sculptra and Dysport for use in aesthetic dermatology in the U.S. and Canada.

Humberto C. Antunes, President & CEO of Galderma worldwide, based in Lausanne, Switzerland, expressed, “We are very grateful that Nestlé has continued to support Galderma through this transaction. The U.S. and Canada represent more than 50 percent of the fast growing global medical aesthetics market. This move secures Galderma’s continued ability to invest in product innovation, medical education, customer service and consumer awareness. Thanks to this agreement with Valeant,
Galderma will be able to provide this best‐in‐class portfolio of fillers and muscle relaxant for aesthetic and corrective dermatology also in the United States and Canada.”

Stuart Raetzman, CEO of Galderma Laboratories, L.P. and Galderma North America, said from Fort Worth, Texas, “This further marks the commitment of Galderma employees in the United States and Canada to aesthetic and corrective dermatology. We all work together to maintain the industry’s highest standards of clinical safety and efficacy, to bring a wide range of scientifically advanced and clinically proven medical solutions to physicians. Our portfolio of products, combined with exclusive services and medical training programs, positions Galderma as the preferred partner of dermatologists, plastic surgeons and aesthetic physicians.”

Restylane, Perlane and Emervel are manufactured by Galderma and sold by its subsidiaries globally, except in the U.S. and Canada, where Valeant holds the distribution rights under terms of a pre‐existing agreement with Medicis, which was acquired by Valeant in 2012. Through this transaction, Galderma will be able to further develop and supply these innovative and leading brands globally.
Sculptra is owned by Valeant. Through this transaction Galderma is acquiring this product and will commercialize it in the U.S. and Canada and select other markets around the world.

Dysport (branded Azzalure in Europe) is marketed by Galderma for aesthetic dermatology indications in many markets around the world. Valeant holds the distribution rights for the aesthetic dermatology indications under a similar agreement with Ipsen. Through this transaction, Galderma will gain the right to commercialize Dysport for aesthetic dermatology indications in the U.S. and Canada.

This transaction is also subject to regulatory clearance and other customary closing conditions. Credit Suisse acted as financial advisors, and Debevoise and Plimpton as legal advisors to Galderma.

In February 2014, Nestlé announced that it had entered into an agreement with L’Oreal S.A. under which it will acquire the remaining 50 percent of Galderma owned by L’Oréal. The transaction between Nestlé and Valeant is subject to regulatory clearance and certain other conditions, and is expected to close in July.

see original article here 

http://www.galderma.com/News/articleType/ArticleView/articleId/59/Galderma-to-gain-rights-to-Restylane-Perlane-Sculptra-and-Dysport-in-the-United-States-and-Canada

Is your Botox authentic?

By Amy FrazierUpdated: Tuesday, February 11, 2014, 6:43 pmPublished: Tuesday, February 11, 2014, 3:26 pm

PORTLAND, Ore. (KOIN) — Marilyn Dawkins said she has Botox to thank for never having to admit she’s 67.

“I have a fake ID that says I’m 48, and I’m sticking to it,” she said.

She always trusted she was getting the real FDA-approved Botox — until KOIN 6 News showed her some documentation.

A statement issued by the FDA in November 2013 announced the agency alerted 230 medical practices over the summer – including some local practices – about distribution of “fraudulent and unapproved versions of Botox.”

The FDA sent a letter to specific doctors that said their practice may have purchased or received unapproved, fraudulent versions of Botox which “may cause harm to patients.” The letter told the doctors to stop using it if they had it.

While the FDA told KOIN 6 News the investigation is ongoing, the agency confirmed an unlicensed company — using names like “Online Botox Pharmacy,” “onlinebotox.com” and “onlinebotox” — sold something to medical practices labeled as Botox which could have “harmful ingredients” and hasn’t had the safety testing and oversight required by US law.  Investigators said medications from this firm may be from foreign or unknown sources.

The FDA urged the health care community to examine its purchasing practices.

“Anybody that chooses to buy outside of the legitimate drug supply chain is going to run the risk of receiving unapproved or counterfeit medicines,” an FDA spokesperson said by phone.

A vial of real Botox (KOIN 6 News, file)

Allergan, the manufacturer of authentic Botox, told KOIN 6 News doctors should purchase Botox directly from the company or its authorized distributors.

The FDA said the unlicensed supplier sent out mass faxes to clinics selling products at “prices below those of FDA-approved products.”

Dr. Roger Dailey, with the Casey Eye Institute’s Aesthetic Facial Surgery Center at OHSU, helped start the Physicians Coalition of Injectable Safety seven years ago, in part to raise awareness and prevent this type of situation.

“I know for sure that some providers in some spas are giving what they believe to be the actual product,” Dailey told KOIN 6 News. “I think the people who buy it, it’s hard for me to imagine that they don’t know that it’s not FDA-approved.”

Using a list from the FDA’s website, KOIN 6 News checked with some of the medical practices in Oregon that received the FDA’s warning letter about possible fraudulent Botox.

On the list were Aestheticare and Laser Wellness Center, 1246 NE 7th Street in Grants Pass, Bridgeport Laser and Wellness Center, 7180 SW Hazelfern Road in Tigard and the Oregon Headache Clinic, 15259 SE 82nd Drive in Clackamas.

Spokespeople for each location told KOIN 6 News they only get their Botox from Allergan, the manufacturer, but declined to answer questions on-camera. They all said they were not concerned about the products they were using on their patients.

In a statement, Bridgeport Laser and Wellness Center said, “We were contacted by the FDA in July 2013 after our name and number were found in another physician’s office. In speaking directly with the FDA, we discovered that the company “Online Botox” had used our practice name in reference as a way to help sell its products based on our large number of online 5-star reviews. We have never done business with “Online Botox” and only use Allergan products.”

The FDA would only say to KOIN 6 News that it sent letters to certain medical practices “based on information indicating that the facility purchased or received product from the supplier identified in the letter.”

If doctors are found to have used fraudulent Botox there can be serious consequences.

“If you administer a non-FDA approved medication to a patient, the medical board can take away your license,” Dr. Dailey said, “and it’s a federal offense punishable by prison time.”

The FDA told KOIN 6 News the agency notified the Oregon Medical Board about the letters it sent to physicians.

The OMB declined a request for an on-camera interview. In a written statement, Operations and Policy Analyst Nicole Krishnaswami said the board’s investigations department “contacts the physician to determine what steps are necessary.”

The investigations are confidential and what steps might be taken were not divulged. But if disciplinary action is taken, “the board’s action becomes public record.”

At this point, no disciplinary action has been taken.

A vial of real Botox (KOIN 6 News, file)

On its website, Allergan clearly states how anyone can verify they are receiving authentic Botox:

“You’ll see a US license number listed beneath the copyright information. … Look for a holographic film on the vial label. Allergan should appear within the rainbow lines. If you do not see the rainbow lines or the name Allergan does not appear, do not use the product.”

Anyone who thinks they may have received fraudulent Botox — either it didn’t work right or led to a bad reaction — is asked to report that to theFDA.

Now that Marilyn Dawkins knows, she said it is “something to be aware of and now check.”

She’s only had good experiences with Botox and wants to keep it that way.

“This is my face, you know.”

http://koin.com/2014/02/11/botox-authentic/

Experts Concern over trend for dangerous at home treatments

How DIY Botoxers risk PERMANENT facial paralysis: Experts' concern over trend for dangerous at-home treatments

• Around 4% of people having non-surgical treatments self-administer
• Some 11% of patients receive treatments from hairdressers
• And 21% would undergo laser hair removal from non-qualified practitioner
• Two-thirds of patients do not think that the industry is regulated enough
• One-third have felt nervous or frightened before, during or after procedure

Experts have issued a health warning against carrying out non-surgical cosmetic procedures on yourself or allowing untrained friends to do them, saying doing so risks permanent facial paralysis.

In an alarming new trend for DIY Botox, some 13 per cent of people undergoing intense, non-surgical cosmetic treatments such as chemical peels or Botox injections have been treated by untrained friends, while four per cent are self-administering, according to research.

And despite 83 per cent of patients believing it is crucial a practitioner be adequately qualified, 21 per cent would undergo laser hair removal from an untrained person.

Furthermore, 11 per cent have been treated by a third party such as a hairdresser, and had no idea if they were appropriately trained to perform the procedure or not.

View Full Article here 

By MARTHA DE LACEY

http://www.dailymail.co.uk/femail/article-2517014/How-DIY-Botoxers-risk-PERMANENT-facial-paralysis-Experts-concern-trend-dangerous-home-treatments.html

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Botox jab could ease arthritis and cancer without side effects

Botox jab could ease arthritis and cancer without side effects: Single injection could offer pain relief for months

• New molecule created by Sheffield University's Professor Bazbek Davletov 
• Could provide pain-numbing effect of Botox without freezing the muscles
• Created by fusing elements of Botox with those from the tetanus bug

By FIONA MACRAE, SCIENCE CORRESPONDENT

PUBLISHED: 19:57 EST, 29 October 2013 | UPDATED: 22:33 EST, 29 October 2013

A new drug created from Botox by a Sheffield University researcher could provide months of pain relief (file photo)

Botox, best known for smoothing out wrinkles, could also help soothe the pain of cancer, arthritis and migraines – without any side effects. 

Sufferers of chronic back pain and women who have given birth by Caesarean section could also benefit from the ‘super-Botox’ jab.

A single injection could provide pain relief for months – removing the need for patients to take several daily doses of powerful tablets – and it could be injected into any part of the body. 

Charities said the drug, invented by a researcher at Sheffield University, could revolutionise the treatment of pain.

The main ingredient of the Botox used to prevent wrinkles is a bacterial poison known as botulinum.

It works by preventing nerve cells from talking to muscles, which in turn stops muscles moving and wrinkles developing.

It can also stop pain signals from being transmitted for months at a time. 

However, fears that it will paralyse the area being treated have prevented it from being widely used for pain relief.

To get round this, Sheffield University researcher Professor Bazbek Davletov took the pain-relieving part of Botox and ‘stapled’ it to a friendly part of a similar poison produced by the tetanus bug.

The tetanus toxin ferries the pain-reliever to the spinal cord, where it stops pain signals being sent to the brain.

The professor said: ‘In effect, we engineer pain relief by taking only good parts of toxic molecules.’ 

Animal trials have had encouraging results and, if large-scale trials on people are successful, the drug could be on the market in as little as three years.

Professor Davletov designed the drug while working at the MRC Laboratory of Molecular Biology in Cambridge.

Painkiller: The new 'super-Botox' drug could help treat sufferers of chronic pain (file photo)

He said: ‘Currently painkillers relieve lingering pain only temporarily and often have unwanted side-effects. An injection of this new molecule at the site of pain could potentially relieve pain for many months.’ 

And he added that a public which is willing to have injections for cosmetic purposes would not be squeamish about receiving medicine in the same way. 

Migraine sufferers are likely to be the first to benefit. 

Normal Botox can already be used as a treatment for crippling headaches, but fears that it will paralyse the face mean that many sufferers miss out. 

'An injection of this new molecule at the site of pain could potentially relieve pain for many months'
- Professor Bazbek Davletov, Sheffield University

Cancer patients would also be high on the list as the side-effects of powerful painkillers such as morphine can be unbearable.

Drugs widely used to ease the pain of arthritis can raise the risk of heart attacks and around one in five people who have a major operation are left in pain for several years.

Professor Davletov, who reports his research in the journal Bioconjugate Chemistry, hopes the drug will cost around £1,000 a year, making it cheap enough for use on the NHS.

Martin Ledwick, of Cancer Research UK, said: ‘Alongside developing new treatments for cancer, finding new and better ways of controlling pain is very important. 

‘If this new approach proves to be effective and have fewer side effects, it has the potential to be extremely useful to cancer patients and others with chronic pain.’ 

Dr Fayyaz Ahmed, a neurologist, is a trustee for charity The Migraine Trust and chairman of the British Association for the Study of Headache.

He said: ‘This sounds interesting and innovative, and if successful in what it is meant to achieve may revolutionise the way we currently treat pain and other neurological disorders.’ 

Many A-list celebrities, including Nicole Kidman, Jennifer Aniston, Cindy Crawford and Dannii Minogue, have admitted having Botox in the past.

Read more: http://www.dailymail.co.uk/news/article-2479300/Botox-jab-ease-arthritis-cancer-effects.html#ixzz2jnaaGXc1

Allergan Licenses Rights To Medytox Candidates, In Up-To-$362M Deal

In a deal that could net Medytox up to $362 million, the Seoul-based company will license to Allergan exclusive global rights outside Korea to develop and commercialize unspecified neurotoxin product candidates now in development phases, including a potential liquid-injectable product, the companies said today.

In return for the license, Allergan will pay Medytox $65 million up front, up to $116.6 million in potential payments tied to undisclosed development milestones, and another up to $180.5 million in potential payments tied to undisclosed commercialization milestones, plus royalties on product sales.

According to its website, Medytox plans to grow into the global leader in the botulinum toxin pharmaceutical market by entering North America and the European Union markets during 2014.

Under the names Neuronox® and Siax®, Medytox markets botulinum toxin, a neurotoxin produced by Clostridium botulinum, with cosmetic uses in reduction of facial wrinkles as well as medical indications for relaxation of muscle spasms caused by blepharospasm,cerebral palsy and other disorders. Neuronox is sold in about 40 countries to users seeking either therapeutic or aesthetic treatments.

Allergan markets the prescription drug Botox® (onabotulinumtoxinA), now approved in some 85 countries for 25 different indications to help patients worldwide suffering from serious or debilitating conditions. In the United States, approved therapeutic indications include blepharospasm, cervical dystonia, chronic migraine, severe primary axillary hyperhidrosis, strabismus, upper limb spacticity, and urinary incontinence.

A related prescription product, Botox Cosmetic, is approved for injection into muscles to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age. Earlier this month, Allergan won FDA approval to market Botox Cosmetic for an additional indication to temporarily treat moderate to severe lateral canthal or "crow's feet" lines.

Botox is among pharmaceuticals, biologics, medical devices, and over-the-counter consumer products marketed by Allergan, whose specialties include eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesityintervention, and urologics.

original article can be loaded here 

http://www.news-medical.net/news/20130926/Allergan-Licenses-Rights-To-Medytox-Candidates-In-Up-To-24362M-Deal.aspx

Botulinum Toxin Type A New Information About an Old Medicine

Abstract

Now that several formulations of botulinum toxin type-A (BoNT-A) are on the market in North America and throughout the world, it is of great practical importance for those who administer these medications to be familiar with the differences between the formulations. These differences pertain to the stability of the medications, in particular during the period of time between reconstitution and administration, which may affect the degree of diffusion through various tissues after injection. A variety of relatively new uses of BoNT-A for dermatological conditions will be discussed.

Introduction

Medicines formulated from the highly purified, naturally occurring protein known as botulinum toxin type-A (BoNT-A) have been in use since 1980, when ophthalmologist Alan Scott used an injectable formulation of BoNT-A to treat strabismus and blepharospasm in humans. The first formulation of BoNT-A to become commercially available was onabotulinumtoxinA (BOTOX®), licensed in the United States in 1989 for treatment of three conditions: strabismus, blepharospasm, and hemifacial spasm. In recent years, two other formulations of BoNT-A have been licensed for use in the United States and a number of other countries: abobotulinumtoxinA (Dysport®) and incobotulinumtoxinA (XEOMIN®).

Those interested in BoNT-A should become familiar with the non-proprietary names for the various formulations of BoNT-A, because increasingly, presentations at meetings and in scientific publications are using the non-proprietary rather than the trade names for these products.^[1] A different non-proprietary name was assigned to each formulation of BoNT-A to reflect the fact that while the active ingredient in all three formulations is BoNT-A, the biological activity, in particular the stability and diffusion kinetics,^[2,3] of the active ingredient is modulated by the other components of the formulation, notably the protective proteins (hemagglutinins and non-hemagglutinins, which are associated with BoNT-A in onabotulinumtoxinA and abobotulinumtoxinA) and the amount and type of human serum albumin (added to the formulations to keep the BoNT-A in solution after reconstitution). Biological activity is also affected by the manufacturing process (as each BoNT-A formulation is manufactured differently), as well as other excipients in the vial (e.g., sodium chloride and sucrose). The effects (if any) on stability after reconstitution caused by the presence of trypsin-like proteolytic activity in incobotulinumtoxinA^[4] remain to be elucidated.

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Kevin C. Smith, MD, FRCPC (Dermatology)

Skin Therapy Letter. 2011;16(8)