• Alliqua Inc., of Langhorne, Penn., said it initiated a preclinical proof-of-principle study of a hydrogel patch containing lidocaine to explore its safety and tolerability in an animal model. The trial also will evaluate the pharmacokinetic profile to determine the amount of systemic absorption and local lidocaine concentration in the skin immediately beneath the patch.

• ANI Pharmaceuticals Inc., of Baudette, Minn., received a letter from Nasdaq stating that its application for initial listing of common stock on the Nasdaq Global Market was approved. The company's common stock will therefore continue to be listed. The listing application was submitted in connection with a merger, at which time it did not meet the minimum $4 bid price requirement. It effected a 1-for-6 split of common stock, enabling it to meet the minimum bid price requirement.

• Biogen Idec Inc., of Weston, Mass., said in a report by Reuters News (whose parent company, Thomson Reuters, recently acquired BioWorld Today) that the death of a patient who had taken its multiple sclerosis (MS) drug, Tecfidera (dimethyl fumarate), was unlikely to be linked to the compound. Biogen said it was made aware last week of the death of a 59-year-old woman who had been treated with Tecfidera, which was approved by the FDA in March, and that it was actively gathering facts about the case. In May, Biogen delayed the European launch of Tecfidera until the second half of this year to clarify the drug's regulatory data protection. The patient death sparked some comparisons to Biogen's MS drug Tysabri (natalizumab), which the FDA initially approved in November 2004. Biogen pulled Tysabri from the market the following year due to the infused alpha-4 integrin inhibitor's link with progressive multifocal leukoencephalopathy, a deadly brain infection. Biogen and Elan plc, of Dublin, which shared the compound 50/50 at the time, were able to persuade the FDA to allow sales to restart in 2006. Analysts seemed generally unconcerned about the report, with Credit Suisse analyst Ravi Mehrotra calling news stories "a storm in a tea cup." On Tuesday, Biogen's shares (NASDAQ:BIIB) fell $9.01, or 3.9 percent, closing at $222.65. (See BioWorld Today, June 6, 2006, March 28, 2013, and May 31, 2013.)

• Charleston Laboratories Inc., of Charleston, S.C., completed a scheduled pre-investigational new drug application meeting with the FDA for its new drug, CL-H1T, for patients with migraine pain and migraine-induced nausea or vomiting. The company said the meeting was positive and productive, and that questions raised in the briefing document were answered and clarified. It said it believes it will be able to submit an approvable 505(b)(2) new drug application.

• Galapagos NV, of Mechelen, Belgium, achieved a late-stage discovery milestone for small molecules against a novel target in the osteoarthritis alliance with Servier, of Paris. The milestone triggered a payment to Galapagos of €3 million (US$3.9 million) and will contribute to revenues in the first half of 2013. The pair has two agreements, having entered the second in 2011. (See BioWorld International, Oct. 5, 2011.)

• Imprimis Pharmaceuticals Inc., of San Diego, acquired intellectual property for IPI-120, a formulation of tranexamic acid and a derivative of lysine, and an antibiotic. The acquisition was part of an asset purchase agreement with Buderer Drug Company. The combination of tranexamic acid and antibiotic is designed to provide clotting plus protection against infection in transdermal, local, intra-wound applications or intracavity instillation formulations. Terms were not disclosed.

• Moberg Pharma AB, of Stockholm, said that Menarini Asia-Pacific, part of Florence, Italy-based Menarini Group, received exclusive rights to market and sell Kerasal Nail in China. The two companies will seek marketing authorization in China. The product has been developed as a nonprescription treatment for discolored and deformed nails resulting from fungal infection or psoriasis. It was launched in the Nordic region in 2011 and has been marketed in more than 25 countries, including the U.S.

• Nuvo Research Inc., of Mississauga, Ontario, said its licensing partner, Mallinckrodt LLC, of Hazelwood, Mo., completed a pharmacokinetic (PK) study comparing diclofenac sodium topical solution, 2 percent w/w (Pennsaid 2 percent) to original Pennsaid. The company received a complete response letter from the FDA on March 4, requesting that it complete the PK study. It said it will send the Pennsaid 2 percent resubmission to the FDA within the next 60 days.

• Quest PharmaTech Inc., of Edmonton, Alberta, entered a long-term strategic relationship with AD Biotech Co. Ltd., of Chuncheon, South Korea. AD Biotech has provided $2 million in clinical development funding to Quest and has agreed to provide up to $10 million more in return for Quest common shares and future revenue-sharing. The arrangement will enable Quest to fund its clinical development programs (including those for its newly acquired IgE technology), and also allows Quest access to AD Biotech's Antibody, Protein Transduction Domain and Manufacturing technologies.

• Xenoport Inc., of Santa Clara, Calif., said the active ingredient in Horizant (gabapentin enacarbil) was included as first-line therapy in treatment guidelines issued by the Task Force of the International Restless Legs Syndrome Study Group. The manuscript, published in Sleep Medicine, provides information for physicians determining treatment choices for restless legs syndrome/Willis-Ekbom Disease based on the long-term benefits and risks of each major class of medications. Horizant is the only nondopamine agonist and the only alpha-2-delta ligand approved by the FDA to treat moderate to severe primary restless legs syndrome in adults.