Neurology
Conferences
- FDA authorizes StemCells to conduct trial of product candidate in patients with age-related macular degeneration
- Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
- FDA removes clinical hold on trial of Idenix's investigational HCV therapy
- Discovery Labs' aerosol drug delivery system approved
- Merck's Janumet XR approved for type 2 diabetes
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
Impax obtains U.S. marketing rights to AstraZeneca's Zomig migraine therapy
What's This?
Impax Pharmaceuticals, the branded product business unit of Impax Laboratories Inc., entered into a distribution, license, development and supply agreement with AstraZeneca Plc granting Impax exclusive U.S. marketing rights to AstraZeneca's Zomig (zolmitriptan), which is approved to treat migraine in adults. The agreement covers all three formulations of the drug: tablets, orally disintegrating tablets and nasal spray. In addition, the agreement grants Impax nonexclusive rights to...
Impax Pharmaceuticals, the branded product business unit of Impax Laboratories Inc., entered into a distribution, license, development and supply agreement with AstraZeneca Plc granting Impax exclusive U.S. marketing rights to AstraZeneca's Zomig (zolmitriptan), which is approved to treat migraine in adults.
The agreement covers all three formulations of the drug: tablets, orally disintegrating tablets and nasal spray.
In addition, the agreement grants Impax nonexclusive rights to develop new zolmitriptan-containing products and to exclusively market these products in the United States in connection with the Zomig brand.
Under the terms of the agreement, Impax will make quarterly payments to AstraZeneca in 2012 totaling $130 million and will pay tiered royalties on future sales of zolmitriptan products thereafter.
Impax will receive the benefit of the gross profit on U.S. sales of Zomig as of Jan. 1.
"Zomig, with U.S. net sales for the 12 months ended Sept. 30, 2011, of $163 million, is a strong neurology brand, and the nasal spray form has U.S. patents expiring as late as 2021," said Michael Nestor, president of Impax Pharmaceuticals. "The Zomig product franchise fits well with the capabilities of our neurology-focused specialty sales force. It will support the growth of our commercial organization as we prepare for the potential launch of IPX066, our leading brand product candidate for Parkinson's disease, and beyond."
Larry Hsu, chief executive officer of Impax Laboratories, said the company expects that Zomig will "contribute meaningfully" to total revenue and earnings in 2012 and 2013, adding that Impax seeks to build sales of the nasal spray formulation to aid the longer term profitability of the firm's branded business.
Boehringer Ingelheim launches two Phase III studies of afatinib in patients with head and neck cancer 
What's This?
Boehringer Ingelheim GmbH initiated two Phase III trials to assess afatinib as a treatment for head and neck cancer. The LUX-Head & Neck 1 study is a randomized, open-label trial designed to evaluate the efficacy and safety of afatinib versus IV methotrexate in approximately 475 patients with recurrent and/or metastatic head and neck squamous cell carcinoma...
Biogen Idec, Elan conducting late-stage Tysabri study in patients with secondary progressive MS
What's This?
Biogen Idec Inc. and Elan Corp. Plc began a Phase IIIb trial of Tysabri (natalizumab) in patients with secondary progressive multiple sclerosis (SPMS). The ASCEND trial is expected to enroll approximately 850 patients in 15 countries. During the double-blind study, patients aged 18 to 58...
XenoPort accuses GSK of breach of contractual obligations related to Horizant
What's This?
XenoPort Inc. said GlaxoSmithKline Plc (GSK) breached its contractual obligations to sufficiently promote the firms' Horizant (gabapentin enacarbil) extended-release tablets, which were approved last April by the Food and Drug Administration to treat moderate to severe primary restless legs syndrome (RLS) in adults.In documents filed with the
UCB's Keppra approved as adjunctive therapy for partial-onset seizures in infants, young children
What's This?
UCB Inc.'s Keppra (levetiracetam) tablets and oral solution were approved by the Food and Drug Administration for the treatment of partial-onset seizures in infants and children aged 1 month or older with epilepsy, effectively expanding the drug's use for partial-onset seizures to include a younger patient population, according to the firm's parent company, 
AAN 2007 Annual Meeting
April 28 - May 5, 2007 Boston, MA- SleepMed Insomnia Index may help characterize insomnia symptoms in patients with RLS; scores correlate with RLS severity
- Undiagnosed sleep disorders appear common in patients with MS, fatigue, analysis reveals
- Adding eszopiclone to escitalopram improves insomnia symptoms in individuals with insomnia, GAD, study shows
- Sleep dysregulation common in patients with Huntington's disease
- Eszopiclone appears to improve sleep in people with primary insomnia without next-day impairments in cognitive, psychomotor performance, driving abilities
- Impax seeks approval of IPX066 for PD
- FDA approves Mylan's first-to-file generic Keppra XR
- Baxter seeks additional indication for Gammagard liquid
- Genzyme's MS drug candidate fails to show superiority to Pfizer, EMD Serono's Rebif in pivotal study
- FDA approves shared REMS for transmucosal immediate-release fentanyl products
- UCB, Otsuka discontinue immunology collaboration, focus on development of CNS drugs in Japan
- Merck dissolves AD agreement with Acumen, signs PI3K inhibitor agreement with Exelixis
- Switching to Lexapro more effective than switching to Effexor, Cymbalta for patients with MDD, study shows
- Santhera regains worldwide marketing rights to investigational PD drug from Ipsen
- BMS expands, extends agreements with Simcere, NeurOp
