YoNaturals Healthy Vending Launches in Chattanooga, Tennessee Offering Healthy Snacks and Drinks at Chattanooga Choo Choo Holiday Inn and Chattanooga School for the Liberal Arts
* Friday December 26, 2008, 5:09 pm EST
* Yahoo! Buzz
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SAN DIEGO--YoNaturals Inc., the nation's leading healthy vending leader, announced today the addition of various Chattanooga, TN area venues to its fast growing list of locations nationwide to offer its YoNaturals healthy vending program.
"This is a tremendous opportunity for YoNaturals in Tennessee," said Mark Trotter CEO of YoNaturals. "Schools are a major focus for YoNaturals and we see other Tennessee schools following the Chattanooga lead. YoNaturals has now grown to hundreds of locations in over 135 cities nationwide,” said Mark Trotter.
"Due to new nutritional guidelines being implemented in States across the country, School Districts are looking for vending solutions that offer drink and snack vending machines that feature healthy snacks and drinks and YoNaturals meets or exceeds this criteria in every case," said Trotter.
"The receptive response to our healthy menus in the machines has been fantastic and we receive emails and calls from both students, parents and faculty every week supporting YoNaturals efforts."
The YoNaturals combination drink and snack vending machines are state-of-the-art, and designed with ultimate convenience in mind for both the customers and operators. The YoNaturals vending solutions feature colorful graphics, cashless payment systems for debit/credit cards, and are temperature controlled to service both fresh food and drinks simultaneously. The healthy and organic products sold at each location are specially selected from a list of over 500 "better for you" products on the YoNaturals e-commerce website.
Based in San Diego, YoNaturals is the nation's fastest growing healthy vending company with locations in over 135 cities across the U.S. The Company's multi-channel business model includes schools, hospitals, health clubs and office locations nationwide. YoNaturals mission is to become the leading branded provider of healthy vending machines and natural and organic products to schools, corporate customers, health clubs and healthcare facilities in selected markets nationwide.
Contact:
YoNaturals Inc.
Mark Trotter, 858-794-9955
mark@yonaturals.com
Sunday, December 28, 2008
FDA Issues Complete Response Letter to GlaxoSmithKline for Eurand's EUR-1048
PHILADELPHIA, Dec. 26, 2008 Eurand N.V. a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced that it has been advised by GlaxoSmithKline that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter for the New Drug Application (NDA) for EUR-1048. EUR-1048 is an orally disintegrating tablet (ODT) formulation with an undisclosed active compound co-developed by Eurand and GSK.
GSK also has informed Eurand that it submitted its response to the Complete Response letter on December 24th and anticipates that the FDA will take up to 60 days to review the response and take action on the NDA.
Separately, the FDA also has advised GSK that the review of another collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is an AB-rated generic equivalent to Inderal LA.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four partnered products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles, taste-masking/orally disintegrating tablet (ODT) formulations and drug conjugation.
Eurand is a global company with facilities in the U.S. and Europe. For more information, visit Eurand's website at http://www.eurand.com.
GSK also has informed Eurand that it submitted its response to the Complete Response letter on December 24th and anticipates that the FDA will take up to 60 days to review the response and take action on the NDA.
Separately, the FDA also has advised GSK that the review of another collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is an AB-rated generic equivalent to Inderal LA.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four partnered products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles, taste-masking/orally disintegrating tablet (ODT) formulations and drug conjugation.
Eurand is a global company with facilities in the U.S. and Europe. For more information, visit Eurand's website at http://www.eurand.com.
King Pharmaceuticals Initiates Phase II Clinical Trial Evaluating T-62 as a Treatment for Neuropathic Pain
Dr. Eric Carter, Chief Science Officer of King, stated, “T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body’s endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition.”
The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in up to 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a 7-day screening period, a 28-day treatment period, and a 14-day post-treatment period.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company’s focus in specialty-driven markets, particularly neuroscience, hospital and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market.
The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in up to 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a 7-day screening period, a 28-day treatment period, and a 14-day post-treatment period.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company’s focus in specialty-driven markets, particularly neuroscience, hospital and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market.
Video: Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) -- First and Only Treatment Approved by the FDA for Hypotric
New Prescription Product Increases Length, Thickness and Darkness of Eyelashes
IRVINE, Calif., Dec. 26 Allergan, Inc. announced the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE(TM) is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.
To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/latisse/36439/
"LATISSE(TM) fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker and darker," said Scott Whitcup, M.D., Allergan's Executive Vice President of Research and Development. "As the global leader in medical aesthetics, LATISSE(TM) exemplifies our continuing commitment to developing innovative treatments that are studied in well-controlled clinical trials, manufactured to pharmaceutical standards, appropriately labeled for use, and available to consumers as a prescription product."
Available only through a doctor, LATISSE(TM) is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. LATISSE(TM) users can expect to experience longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain effect, continued treatment with LATISSE(TM) is required. If use of LATISSE(TM) is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months (average eyelash hair cycle).
Similar to Allergan's other medical aesthetic offerings, the benefits of LATISSE(TM) are derived from scientific evidence, its quality formulation, and medical origin. LATISSE(TM) was clinically tested in a pivotal Phase III, multi-center, double-masked, placebo-controlled study to assess its safety and efficacy in which all endpoints (improved eyelash prominence, length, thickness and darkness) were met. In addition, like BOTOX® (botulinum toxin type A), which was first approved by the FDA as a medical treatment for eye disorders and was later found to have an aesthetic benefit, bimatoprost, the active ingredient in LATISSE(TM), was first approved in 2001 as a medical product to lower intraocular pressure in people with open-angle glaucoma or ocular hypertension. Patients treated with bimatoprost for this specific eye condition experienced eyelash growth as a side effect. The long-term safety of bimatoprost for therapeutic use has been recognized by the medical community and well established based on use in 32 clinical trials involving more than 5,700 glaucoma patients and more than 13 years of clinical trial experience. Given the existing and substantial clinical and post-marketing safety data with bimatoprost solution 0.03%, coupled with the positive results from the Phase III LATISSE(TM) study, LATISSE(TM) provides patients a clinically meaningful aesthetic benefit with a favorable safety profile.
Bimatoprost is the active pharmaceutical ingredient in the formulation of LATISSE(TM) and is a structural prostaglandin analog, a lipid compound derived from fatty acids designed to bind to prostaglandin (PG) receptors. PG receptors are present in hair, particularly in the dermal papilla and outer root sheath. Although the precise mechanism of action is unknown, PG receptors are thought to be involved in the development and regrowth of the hair follicle,(i) by increasing the percent of hairs in, and the duration of, the anagen or growth phase.
"As an oculoplastic surgeon who has treated both medical eye conditions as well as aesthetic needs, I have extensive knowledge of and experience with the established therapeutic safety profile for bimatoprost," said Steven Fagien, M.D., F.A.C.S., in private practice at Aesthetic Eyelid Plastic Surgery in Boca Raton, Florida, and LATISSE(TM) clinical investigator. "In the clinical study with LATISSE(TM), I observed statistically significant differences in eyelash growth and resulting patient satisfaction. Now that LATISSE(TM) is FDA approved, I look forward to prescribing it to my patients who will enjoy the benefits of more prominent eyelashes while I remain confident in the treatment's favorable safety profile."
LATISSE(TM) will be available in the United States by prescription only and is subject to all U.S. guidelines applicable to dispensing a prescription product. Based on today's FDA approval, Allergan expects to launch the product nationwide in the first quarter of 2009. Doctors and consumers are encouraged to visit www.latisse.com for further product and prescribing information.
Allergan estimates global peak sales of LATISSE(TM) could exceed $500 million per year. As the exclusive U.S. and foreign patent owner, Allergan obtains the rights to the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate eyelash growth.
LATISSE(TM) Clinical Development Program
In the pivotal Phase III study, 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence were randomized to apply either LATISSE(TM) or vehicle to both upper eyelid margins once daily for 16 weeks. The primary efficacy endpoint was overall eyelash prominence at the end of the 16-week treatment period as measured by a > or = 1-grade improvement on a 4-point Global Eyelash Assessment Scale. Secondary efficacy endpoints were eyelash length, thickness, and darkness as determined by Digital Image Analysis of patient photographs taken in a standardized manner.
All of the endpoints in the LATISSE(TM) pivotal trial were met. By the end of the 16-week treatment period, patients treated with LATISSE(TM) experienced statistically significant greater improvement (p < 0.0001 for each endpoint) than those in the vehicle group in the measurements of eyelash prominence, length, thickness and darkness. LATISSE(TM) was also well tolerated with the most commonly reported adverse events being non-serious and cosmetic in nature. Common adverse events observed in the clinical trial included eye redness (3.6%), itchy eyes (3.6%) and skin hyperpigmentation (2.9%).
Important LATISSE(TM) Safety Information
LATISSE(TM) solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes. DO NOT APPLY to the lower eyelid. If you are using LUMIGAN® or other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE(TM) under the close supervision of your doctor.
LATISSE(TM) use may cause darkening of the eyelid skin which may be reversible. Although not reported in clinical studies, LATISSE(TM) use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.
It is possible for hair growth to occur in other areas of your skin that LATISSE(TM) frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using LATISSE(TM).
The most common side effects after using LATISSE(TM) solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE(TM) solution may cause other less common side effects which typically occur on the skin close to where LATISSE(TM) is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids.
If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your doctor's advice concerning the continued use of LATISSE(TM) solution.
Full prescribing information is available at www.latisse.com and www.allergan.com.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Information
BOTOX® is approved for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is approved for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
And BOTOX® is approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 - 65.
Important Safety Information
Who should not be treated with BOTOX® and BOTOX® Cosmetic
BOTOX® injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX® product.
Warnings
Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reaction, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.
Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.
Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX® and BOTOX® Cosmetic.
Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.
Precautions
Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.
Side Effects
Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.
In cervical dystonia, the most common side effects following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
In blepharospasm, the most common side effects following injection include ptosis (20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).
In strabismus, the most common side effects following injection include ptosis (15.7%) and vertical deviation (16.9%).
In severe primary axillary hyperhidrosis, the most common side effects (3-10% of patients) include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.
The most common side effects following BOTOX® Cosmetic injections include temporary eyelid droop and nausea.
Please see full product information at www.botox.com and www.botoxcosmetic.com.
IRVINE, Calif., Dec. 26 Allergan, Inc. announced the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE(TM) is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.
To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/latisse/36439/
"LATISSE(TM) fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker and darker," said Scott Whitcup, M.D., Allergan's Executive Vice President of Research and Development. "As the global leader in medical aesthetics, LATISSE(TM) exemplifies our continuing commitment to developing innovative treatments that are studied in well-controlled clinical trials, manufactured to pharmaceutical standards, appropriately labeled for use, and available to consumers as a prescription product."
Available only through a doctor, LATISSE(TM) is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. LATISSE(TM) users can expect to experience longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain effect, continued treatment with LATISSE(TM) is required. If use of LATISSE(TM) is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months (average eyelash hair cycle).
Similar to Allergan's other medical aesthetic offerings, the benefits of LATISSE(TM) are derived from scientific evidence, its quality formulation, and medical origin. LATISSE(TM) was clinically tested in a pivotal Phase III, multi-center, double-masked, placebo-controlled study to assess its safety and efficacy in which all endpoints (improved eyelash prominence, length, thickness and darkness) were met. In addition, like BOTOX® (botulinum toxin type A), which was first approved by the FDA as a medical treatment for eye disorders and was later found to have an aesthetic benefit, bimatoprost, the active ingredient in LATISSE(TM), was first approved in 2001 as a medical product to lower intraocular pressure in people with open-angle glaucoma or ocular hypertension. Patients treated with bimatoprost for this specific eye condition experienced eyelash growth as a side effect. The long-term safety of bimatoprost for therapeutic use has been recognized by the medical community and well established based on use in 32 clinical trials involving more than 5,700 glaucoma patients and more than 13 years of clinical trial experience. Given the existing and substantial clinical and post-marketing safety data with bimatoprost solution 0.03%, coupled with the positive results from the Phase III LATISSE(TM) study, LATISSE(TM) provides patients a clinically meaningful aesthetic benefit with a favorable safety profile.
Bimatoprost is the active pharmaceutical ingredient in the formulation of LATISSE(TM) and is a structural prostaglandin analog, a lipid compound derived from fatty acids designed to bind to prostaglandin (PG) receptors. PG receptors are present in hair, particularly in the dermal papilla and outer root sheath. Although the precise mechanism of action is unknown, PG receptors are thought to be involved in the development and regrowth of the hair follicle,(i) by increasing the percent of hairs in, and the duration of, the anagen or growth phase.
"As an oculoplastic surgeon who has treated both medical eye conditions as well as aesthetic needs, I have extensive knowledge of and experience with the established therapeutic safety profile for bimatoprost," said Steven Fagien, M.D., F.A.C.S., in private practice at Aesthetic Eyelid Plastic Surgery in Boca Raton, Florida, and LATISSE(TM) clinical investigator. "In the clinical study with LATISSE(TM), I observed statistically significant differences in eyelash growth and resulting patient satisfaction. Now that LATISSE(TM) is FDA approved, I look forward to prescribing it to my patients who will enjoy the benefits of more prominent eyelashes while I remain confident in the treatment's favorable safety profile."
LATISSE(TM) will be available in the United States by prescription only and is subject to all U.S. guidelines applicable to dispensing a prescription product. Based on today's FDA approval, Allergan expects to launch the product nationwide in the first quarter of 2009. Doctors and consumers are encouraged to visit www.latisse.com for further product and prescribing information.
Allergan estimates global peak sales of LATISSE(TM) could exceed $500 million per year. As the exclusive U.S. and foreign patent owner, Allergan obtains the rights to the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate eyelash growth.
LATISSE(TM) Clinical Development Program
In the pivotal Phase III study, 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence were randomized to apply either LATISSE(TM) or vehicle to both upper eyelid margins once daily for 16 weeks. The primary efficacy endpoint was overall eyelash prominence at the end of the 16-week treatment period as measured by a > or = 1-grade improvement on a 4-point Global Eyelash Assessment Scale. Secondary efficacy endpoints were eyelash length, thickness, and darkness as determined by Digital Image Analysis of patient photographs taken in a standardized manner.
All of the endpoints in the LATISSE(TM) pivotal trial were met. By the end of the 16-week treatment period, patients treated with LATISSE(TM) experienced statistically significant greater improvement (p < 0.0001 for each endpoint) than those in the vehicle group in the measurements of eyelash prominence, length, thickness and darkness. LATISSE(TM) was also well tolerated with the most commonly reported adverse events being non-serious and cosmetic in nature. Common adverse events observed in the clinical trial included eye redness (3.6%), itchy eyes (3.6%) and skin hyperpigmentation (2.9%).
Important LATISSE(TM) Safety Information
LATISSE(TM) solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes. DO NOT APPLY to the lower eyelid. If you are using LUMIGAN® or other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE(TM) under the close supervision of your doctor.
LATISSE(TM) use may cause darkening of the eyelid skin which may be reversible. Although not reported in clinical studies, LATISSE(TM) use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.
It is possible for hair growth to occur in other areas of your skin that LATISSE(TM) frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using LATISSE(TM).
The most common side effects after using LATISSE(TM) solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE(TM) solution may cause other less common side effects which typically occur on the skin close to where LATISSE(TM) is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids.
If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your doctor's advice concerning the continued use of LATISSE(TM) solution.
Full prescribing information is available at www.latisse.com and www.allergan.com.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Information
BOTOX® is approved for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is approved for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
And BOTOX® is approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 - 65.
Important Safety Information
Who should not be treated with BOTOX® and BOTOX® Cosmetic
BOTOX® injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX® product.
Warnings
Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reaction, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.
Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.
Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX® and BOTOX® Cosmetic.
Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.
Precautions
Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.
Side Effects
Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.
In cervical dystonia, the most common side effects following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
In blepharospasm, the most common side effects following injection include ptosis (20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).
In strabismus, the most common side effects following injection include ptosis (15.7%) and vertical deviation (16.9%).
In severe primary axillary hyperhidrosis, the most common side effects (3-10% of patients) include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.
The most common side effects following BOTOX® Cosmetic injections include temporary eyelid droop and nausea.
Please see full product information at www.botox.com and www.botoxcosmetic.com.
China Biopharma, Inc. Issues Corporate Information Update
HANGZHOU, China, Dec. 26 China Biopharma, Inc.
The Company had significant operational improvement after the start of corporate operational restructuring last year. For the nine months ended September 30, 2008, it has made approximately $5.4 million in sales, more than thirteen times the sales revenue made in the same period of 2007, which was approximately $0.4 million. It also made approximately $90,000 in net profit from the China operation, comparing to a net loss of approximately $0.35 million in the same period of 2007. The Company believes that the current operation will further improve as it finalizes the operational restructuring.
The Company has signed an agreement with Zhejiang Tianyuan Biopharma Co., Ltd. that the Company will increase its stakes from currently 65% to 100% in the joint venture, Zhejiang Tianyuan Biotech Co., Ltd. ("ZTBC"). ZTBC will become a wholly owned subsidiary of the Company, and will change its name to Zhejiang Kangchen Biotech Co., Ltd. It is waiting for the new business license.
The Company has signed an agreement to acquire 90% of Beijing Tiancheng Xinhai Pharmaceutical Co., Ltd. ("BTXP"), a regional pharmaceutical distribution company. The company now has full operating control in BTXP and is waiting for final governmental approval and new business license.
After completion of recent operational restructuring, the company is looking for future merge and acquisitions. The Company is projecting a 25% sales increase in 2009.
About China Biopharma, Inc.
China Biopharma, Inc. is a pharmaceutical company based in China. Through its operating subsidiaries, the company introduces and distributes biopharmaceutical and pharmaceutical products throughout the world's most populated country, China. Products include biopharmaceutical and other pharmaceutical drugs. Leveraging its local presence and the relationship with local Chinese pharmaceutical companies and international pharmaceutical companies, China Biopharma is building a highly-competitive platform for growth in China as well as in new world markets, including the U.S. and Europe. For more information, visit its website at HYPERLINK "http://www.chinabiopharma.net/"http://www.chinabiopharma.net.
Safe Harbor Statement
Some of the statements here discuss future events and developments, including the Company's future business strategy and its ability to generate revenue, income and cash flow, and should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements can generally be identified by words such as "expect," "anticipate," "believe," "estimate," "intend," "plan," and similar expressions. These statements involve a high degree of risk and uncertainty that exists in the Company's operations and business environment and are subject to change based on various factors that could cause actual Company results, performance, plans, goals and objectives to differ materially from those contemplated or implied in these forward-looking statements. Actual results may be different from anticipated results for a number of reasons, including the Company's new and uncertain business model, uncertainty regarding acceptance of the Company's products and services and the Company's limited operating history.
CONTACT:
China Biopharma, Inc.
Tel: +1 (609) 651-8588
ir@chinabiopharma.net
http://www.chinabiopharma.net
The Company had significant operational improvement after the start of corporate operational restructuring last year. For the nine months ended September 30, 2008, it has made approximately $5.4 million in sales, more than thirteen times the sales revenue made in the same period of 2007, which was approximately $0.4 million. It also made approximately $90,000 in net profit from the China operation, comparing to a net loss of approximately $0.35 million in the same period of 2007. The Company believes that the current operation will further improve as it finalizes the operational restructuring.
The Company has signed an agreement with Zhejiang Tianyuan Biopharma Co., Ltd. that the Company will increase its stakes from currently 65% to 100% in the joint venture, Zhejiang Tianyuan Biotech Co., Ltd. ("ZTBC"). ZTBC will become a wholly owned subsidiary of the Company, and will change its name to Zhejiang Kangchen Biotech Co., Ltd. It is waiting for the new business license.
The Company has signed an agreement to acquire 90% of Beijing Tiancheng Xinhai Pharmaceutical Co., Ltd. ("BTXP"), a regional pharmaceutical distribution company. The company now has full operating control in BTXP and is waiting for final governmental approval and new business license.
After completion of recent operational restructuring, the company is looking for future merge and acquisitions. The Company is projecting a 25% sales increase in 2009.
About China Biopharma, Inc.
China Biopharma, Inc. is a pharmaceutical company based in China. Through its operating subsidiaries, the company introduces and distributes biopharmaceutical and pharmaceutical products throughout the world's most populated country, China. Products include biopharmaceutical and other pharmaceutical drugs. Leveraging its local presence and the relationship with local Chinese pharmaceutical companies and international pharmaceutical companies, China Biopharma is building a highly-competitive platform for growth in China as well as in new world markets, including the U.S. and Europe. For more information, visit its website at HYPERLINK "http://www.chinabiopharma.net/"http://www.chinabiopharma.net.
Safe Harbor Statement
Some of the statements here discuss future events and developments, including the Company's future business strategy and its ability to generate revenue, income and cash flow, and should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements can generally be identified by words such as "expect," "anticipate," "believe," "estimate," "intend," "plan," and similar expressions. These statements involve a high degree of risk and uncertainty that exists in the Company's operations and business environment and are subject to change based on various factors that could cause actual Company results, performance, plans, goals and objectives to differ materially from those contemplated or implied in these forward-looking statements. Actual results may be different from anticipated results for a number of reasons, including the Company's new and uncertain business model, uncertainty regarding acceptance of the Company's products and services and the Company's limited operating history.
CONTACT:
China Biopharma, Inc.
Tel: +1 (609) 651-8588
ir@chinabiopharma.net
http://www.chinabiopharma.net
Partners In Care President to Ring the NASDAQ Stock Market Closing Bell
Feed Information:
The Closing Bell is available from 3:50 p.m. to 4:05 p.m. on AMC-3/C-3 (ul 5985V; dl 3760H). The feed can also be found on Ascent fiber 1623. If you have any questions, please contact Robert Madden at (646) 441-5045.
Radio Feed:
An audio transmission of the Closing Bell is also available from 3:50 p.m. to 4:05 p.m. on uplink IA6 C band / transponder 24, downlink frequency 4180 horizontal. The feed can be found on Ascent fiber 1623 as well.
Webcast:
A live webcast of the NASDAQ Closing Bell will be available at: http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos:
To obtain a hi-resolution photograph of the Market Close, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market close of your choice.
About Partners In Care:
Partners In Care, a 501c3 community nonprofit, was founded to help older adults remain independent in their own homes. The MGCE grant values the organization's innovative volunteer engagement strategies. The group engages more than 2,500 volunteer members to help each other in a formalized program based on reciprocity. Using the service-exchange model, people contribute their time and talents to the 'community pool' to accomplish what needs to be done. Every person is encouraged to contribute what they can and to become part of the solution. In this way, assets already in the community are identified and utilized, accomplishing more than in traditional models. Participants enjoy parity, rather than charity. A network of care is developed and older adults are empowered to remain independent. The model is being replicated in numerous communities seeking to support aging populations.
PIC was founded in 1993 by three women with degrees in gerontology and health care administration who wanted to make a difference in their own community. They believed that every person has gifts and talents that the community needs and they developed a program for people to use their time and talents to help each other. The service-exchange / time-banking program helps people -- wherever they are along the continuum of life -- to remain independent in their own homes and in the community. Starting with a dozen initial participants, PIC has grown to include 2,500 members and is going strong!
About NASDAQ OMX:
The NASDAQ OMX Group, Inc. is the world's largest exchange company. It delivers trading, exchange technology and public company services across six continents, with over 3,900 listed companies. NASDAQ OMX Group offers multiple capital raising solutions to companies around the globe, including its U.S. listings market; NASDAQ OMX Nordic, NASDAQ OMX Baltic, including First North; and the U.S. 144A sector. The company offers trading across multiple asset classes including equities, derivatives, debt, commodities, structured products and ETFs. NASDAQ OMX Group technology supports the operations of over 70 exchanges, clearing organizations and central securities depositories in more than 50 countries. NASDAQ OMX Nordic and NASDAQ OMX Baltic are not legal entities but describe the common offering from NASDAQ OMX Group exchanges in Helsinki, Copenhagen, Stockholm, Iceland, Tallinn, Riga, and Vilnius. For more information about NASDAQ OMX, visit http://www.nasdaqomx.com
The Closing Bell is available from 3:50 p.m. to 4:05 p.m. on AMC-3/C-3 (ul 5985V; dl 3760H). The feed can also be found on Ascent fiber 1623. If you have any questions, please contact Robert Madden at (646) 441-5045.
Radio Feed:
An audio transmission of the Closing Bell is also available from 3:50 p.m. to 4:05 p.m. on uplink IA6 C band / transponder 24, downlink frequency 4180 horizontal. The feed can be found on Ascent fiber 1623 as well.
Webcast:
A live webcast of the NASDAQ Closing Bell will be available at: http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos:
To obtain a hi-resolution photograph of the Market Close, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market close of your choice.
About Partners In Care:
Partners In Care, a 501c3 community nonprofit, was founded to help older adults remain independent in their own homes. The MGCE grant values the organization's innovative volunteer engagement strategies. The group engages more than 2,500 volunteer members to help each other in a formalized program based on reciprocity. Using the service-exchange model, people contribute their time and talents to the 'community pool' to accomplish what needs to be done. Every person is encouraged to contribute what they can and to become part of the solution. In this way, assets already in the community are identified and utilized, accomplishing more than in traditional models. Participants enjoy parity, rather than charity. A network of care is developed and older adults are empowered to remain independent. The model is being replicated in numerous communities seeking to support aging populations.
PIC was founded in 1993 by three women with degrees in gerontology and health care administration who wanted to make a difference in their own community. They believed that every person has gifts and talents that the community needs and they developed a program for people to use their time and talents to help each other. The service-exchange / time-banking program helps people -- wherever they are along the continuum of life -- to remain independent in their own homes and in the community. Starting with a dozen initial participants, PIC has grown to include 2,500 members and is going strong!
About NASDAQ OMX:
The NASDAQ OMX Group, Inc. is the world's largest exchange company. It delivers trading, exchange technology and public company services across six continents, with over 3,900 listed companies. NASDAQ OMX Group offers multiple capital raising solutions to companies around the globe, including its U.S. listings market; NASDAQ OMX Nordic, NASDAQ OMX Baltic, including First North; and the U.S. 144A sector. The company offers trading across multiple asset classes including equities, derivatives, debt, commodities, structured products and ETFs. NASDAQ OMX Group technology supports the operations of over 70 exchanges, clearing organizations and central securities depositories in more than 50 countries. NASDAQ OMX Nordic and NASDAQ OMX Baltic are not legal entities but describe the common offering from NASDAQ OMX Group exchanges in Helsinki, Copenhagen, Stockholm, Iceland, Tallinn, Riga, and Vilnius. For more information about NASDAQ OMX, visit http://www.nasdaqomx.com
U.S. Federal Trade Commission Provisionally Accepts Consent Decree and Terminates Waiting Period for King Pharmaceuticals Acquisition of Alpharma
Related:
* Alpharma, Inc.
* , King Pharmaceuticals Inc.
BRISTOL, Tenn. & BRIDGEWATER, N.J. King Pharmaceuticals, Inc. and Alpharma Inc. announced that the U.S. Federal Trade Commission has provisionally accepted a proposed consent order for public comment and has terminated the Hart-Scott-Rodino waiting period applicable to King’s proposed acquisition of Alpharma.
* Alpharma, Inc.
* , King Pharmaceuticals Inc.
BRISTOL, Tenn. & BRIDGEWATER, N.J. King Pharmaceuticals, Inc. and Alpharma Inc. announced that the U.S. Federal Trade Commission has provisionally accepted a proposed consent order for public comment and has terminated the Hart-Scott-Rodino waiting period applicable to King’s proposed acquisition of Alpharma.
Nihon Kohden Announces Acquisition of Neurotronics, Inc.
RVINE, Calif.Nihon Kohden Corporation today announced the mutual agreement of acquisition of a 100% share of Neurotronics Incorporated (Headquarters: Gainesville, Florida). Neurotronics becomes a subsidiary of Nihon Kohden Corporation on December 31, 2008.
Neurotronics Incorporated was established by Dr. Jack Smith to develop sleep analysis devices and software. Neurotronics develops, sells and services a sleep data management suite of programs, including the sleep brain wave analysis program Polysmith™ DMS. Neurotronics has gained a reputation for quality products and support in the U.S. market. Nihon Kohden will strengthen its position as a leader in the neurology business with the acquisition of Neurotronics.
Fumio Suzuki, President and Chief Operating Officer of Nihon Kohden Corporation commented, “Nihon Kohden and Neurotronics have been long-standing strategic partners in the sleep-respiratory business. Through this acquisition, we can synergize Nihon Kohden’s neurology diagnostics technology and Neurotronics’ sleep analysis expertise to strengthen our products and services in this growing sleep-respiratory market. We also expect to increase both companies’ sales by leveraging Nihon Kohden’s global distribution network.”
Through the combined efforts of both companies, Nihon Kohden expects to increase world-wide sales in sleep and set a foundation for its long-term strategy in the sleep and neurodiagnostic fields, with the continuing goal of improving the quality of medical treatment.
Background
Nihon Kohden is Japan’s leading manufacturer, developer and distributor of medical electronic equipment with subsidiaries in North America, Europe and Asia and distribution in over 100 countries. For more than 50 years, healthcare providers worldwide have relied on the quality and reliability of Nihon Kohden’s comprehensive and innovative line of neurodiagnostic and monitoring instrumentation to aid in the diagnosis, and treatment of their patients.
Sleep Apnea Syndrome (SAS) is a major driver of the sleep diagnostic business. It is estimated that 20 million Americans suffer from sleep apnea and 75% million remain undiagnosed. The sleep diagnostic equipment market has shown considerable growth in the last few years and that growth is expected to continue. Nihon Kohden hopes to better serve this market by combining the expertise of Neurotronics with their brain-wave measurement technology and world-wide sales network.
Contact:
Nihon Kohden America, Inc.
Kathy Hart, Director Neurology Business Group
949-580-1555 ext.3405
Kathy_Hart@nkusa.com
www.nkusa.com
Neurotronics Incorporated was established by Dr. Jack Smith to develop sleep analysis devices and software. Neurotronics develops, sells and services a sleep data management suite of programs, including the sleep brain wave analysis program Polysmith™ DMS. Neurotronics has gained a reputation for quality products and support in the U.S. market. Nihon Kohden will strengthen its position as a leader in the neurology business with the acquisition of Neurotronics.
Fumio Suzuki, President and Chief Operating Officer of Nihon Kohden Corporation commented, “Nihon Kohden and Neurotronics have been long-standing strategic partners in the sleep-respiratory business. Through this acquisition, we can synergize Nihon Kohden’s neurology diagnostics technology and Neurotronics’ sleep analysis expertise to strengthen our products and services in this growing sleep-respiratory market. We also expect to increase both companies’ sales by leveraging Nihon Kohden’s global distribution network.”
Through the combined efforts of both companies, Nihon Kohden expects to increase world-wide sales in sleep and set a foundation for its long-term strategy in the sleep and neurodiagnostic fields, with the continuing goal of improving the quality of medical treatment.
Background
Nihon Kohden is Japan’s leading manufacturer, developer and distributor of medical electronic equipment with subsidiaries in North America, Europe and Asia and distribution in over 100 countries. For more than 50 years, healthcare providers worldwide have relied on the quality and reliability of Nihon Kohden’s comprehensive and innovative line of neurodiagnostic and monitoring instrumentation to aid in the diagnosis, and treatment of their patients.
Sleep Apnea Syndrome (SAS) is a major driver of the sleep diagnostic business. It is estimated that 20 million Americans suffer from sleep apnea and 75% million remain undiagnosed. The sleep diagnostic equipment market has shown considerable growth in the last few years and that growth is expected to continue. Nihon Kohden hopes to better serve this market by combining the expertise of Neurotronics with their brain-wave measurement technology and world-wide sales network.
Contact:
Nihon Kohden America, Inc.
Kathy Hart, Director Neurology Business Group
949-580-1555 ext.3405
Kathy_Hart@nkusa.com
www.nkusa.com
Sosei Announces Buyback of the Commercialization Rights to AD 923 from Mundipharma
TOKYO, Sosei Group Corporation, a biopharmaceutical company, announces that it has re-acquired the rights for commercialization of AD 923 from Mundipharma International Corporation Ltd. ("Mundipharma").
AD 923 is an optimized, sublingual formulation of the strong opioid analgesic fentanyl for the treatment of cancer breakthrough pain. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosing.
In June 2006, Sosei entered into a licence agreement with Mundipharma, under which Mundipharma were granted the right to commercialize AD 923 in Europe and other international markets, excluding North America and Japan.
In February 2008, the programme entered Phase III clinical trials in Europe. However, due to a problem concerning a supplied component in the device used to deliver the fentanyl spray, the trial was temporarily halted in March 2008.
A solution to the technical problem with the device has since been identified, but Sosei is no longer in a position financially to continue with the programme and a new partner is being sought to progress clinical development.
The buyback of the Mundipharma rights now provides Sosei with the possibility of offering commercialisation rights on a global basis. The Mundipharma rights will be re-acquired for a mutually agreed sum of pounds sterling 2m, plus an additional 20% (up to a maximum of pounds 1.5m) of net receipts if Sosei enters into a new partnership agreement involving the Mundipharma territory.
AD 923 is an optimized, sublingual formulation of the strong opioid analgesic fentanyl for the treatment of cancer breakthrough pain. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosing.
In June 2006, Sosei entered into a licence agreement with Mundipharma, under which Mundipharma were granted the right to commercialize AD 923 in Europe and other international markets, excluding North America and Japan.
In February 2008, the programme entered Phase III clinical trials in Europe. However, due to a problem concerning a supplied component in the device used to deliver the fentanyl spray, the trial was temporarily halted in March 2008.
A solution to the technical problem with the device has since been identified, but Sosei is no longer in a position financially to continue with the programme and a new partner is being sought to progress clinical development.
The buyback of the Mundipharma rights now provides Sosei with the possibility of offering commercialisation rights on a global basis. The Mundipharma rights will be re-acquired for a mutually agreed sum of pounds sterling 2m, plus an additional 20% (up to a maximum of pounds 1.5m) of net receipts if Sosei enters into a new partnership agreement involving the Mundipharma territory.
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