• Amylin Pharmaceuticals Inc., of San Diego, received FDA approval to broaden the use of Byetta (exenatide) in Type II diabetics who are using a thiazolidinedione alone or in combination with metformin but have not achieved adequate glycemic control. The label expansion is in addition to the subcutaneous injection's previously approved indication, as adjunctive therapy to improve glycemic control in Type II diabetics who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.
• Clinical Data Inc., of Newton, Mass., completed the transfer of the manufacturing technology for producing commercial supplies of vilazodone, a pivotal-stage dual serotonergic antidepressant, which triggered a milestone payment to Darmstadt, Germany-based Merck KGaA. That payment was made through the issue of 102,588 shares, 24,947 of which were issued when the company exercised its right to transfer the manufacturing technology in August. Clinical Data gained rights to vilazodone when it acquired Genaissance Pharmaceuticals Inc. in 2005.
• Crucell NV, of Leiden, The Netherlands, said the European Union awarded a grant to its subsidiary toward the development of a malaria vaccine. The €1.7 million (US$2.2 million) grant was given to a consortium of four leading groups in the field of malaria research including Etna Biotech, a fully owned Crucell group company in Catania, Italy. The malaria vaccine will be based on Crucell's recombinant paramyxovirus technology.
• Depomed Inc., of Menlo Park, Calif., and Esprit Pharma Inc., of East Brunswick, N.J., announced today that Esprit has paid Depomed the $10 million license fee payment due under the parties' license agreement for ProQuin XR, the extended-release formulation of the antibiotic ciprofloxacin developed by Depomed and exclusively licensed in the U.S. to Esprit. In addition, Depomed and Esprit have agreed to commence discussions toward a mutually agreeable restructuring of their license agreement after the new year. In the meantime, the existing agreement will remain in effect. Depomed agreed to withdraw the notice of breach and demand for arbitration related to the license agreement disclosed earlier this month. (See BioWorld Today, July 29, 2005.)
• EpiCept Corp., of Tarrytown, N.Y., raised $10 million in gross proceeds through a private stock and warrant sale to institutional investors. The specialty pharmaceutical company, which is focused on pain and cancer, will issue about 6.8 million shares at $1.46 apiece, and five-year warrants to purchase up to another 3.4 million shares at an exercise price of $1.47 each. The warrants will not become exercisable until six months after the closing, after which EpiCept will have about 32.4 million shares outstanding. Separately, the company entered a standby equity distribution agreement with Cornell Capital Partners LP, which has committed to purchase up to $15 million of discounted EpiCept common shares, to be calculated at the time of issuance, during the next three years. EpiCept will determine the exact timing and amount of any such financings, subject to certain conditions.
• Galapagos NV, of Mechelen, Belgium, entered a definitive agreement to acquire ProSkelia SASU, a French subsidiary of ProStrakan Group plc, of Galashiels, UK. The deal includes €12.5 million (US$16.4 million) of Galapagos stock and future payments of up to €14.5 million. The transaction also includes an exclusive option and license to oestradiol glucoside (E2G), a product that has completed a Phase IIa study for hot flashes, in exchange for €5 million to ProStrakan plus a fixed amount of licensing revenues receivable by Galapagos and single-digit royalties. ProSkelia, a 2002 spinout of the bone disease unit at the former Aventis SA, is engaged in drug discovery and development in bone diseases. Its portfolio includes three preclinical products for osteoporosis and bone metastasis, and another for cachexia. In conjunction with the acquisition, Galapagos raised €31 million through a private placement of new shares with institutional investors in the U.S. and Europe. The proceeds will be used to fund the further development of the company's broadened bone and joint disease portfolio through to clinical testing. Kempen & Co. advised Galapagos on the acquisition, and also served as a joint lead manager of the placement with Fortis and Whitaker Securities.
• ImmuPharma plc, of London, raised more than £4.71 million (US$9.2 million) through the issue of 4.4 million shares priced at 62 pence each and an interest-free unsecured bond with warrants. The funds will be invested in the company's clinical and preclinical pipeline, which includes IPP-201101, a long-term treatment for lupus. That product is set to start Phase II/III trials in 2007.
• NABsys Inc., of Providence, R.I., and GeneSpectrum Inc., also of Providence, said NABsys has acquired GeneSpectrum in an all-stock transaction. The combined company, NABsys, will pursue its Hybridization-Assisted Nanopore Sequencing platform for sequencing human genomic DNA, using GeneSpectrum's data and expertise in probe design and DNA hybridization.
• New River Pharmaceuticals Inc., of Radford, Va., and partner, Basingstoke, UK-based Shire plc said the FDA issued a second approvable letter for Vyvanse (lisdexamfetamine dimesylate, formerly NRP104) in attention deficit hyperactivity disorder. The agency did not request any additional studies, and the launch of Vyvanse still is expected in the second quarter of 2007. The companies submitted a complete response to the FDA's first approvable letter in October. (See BioWorld Today, Oct. 11, 2006.)
• Nuvo Research Inc., of Mississauga, Ontario, said Squire Pharmaceuticals Inc., a subsidiary of Montreal-based Paladin Labs Inc., exercised its right for a license to market and sell Pennsaid Plus as part of the companies' deal from January 2006, in which Nuvo sold a portion of its Canadian Pennsaid revenue stream to Squire. Pennsaid Plus is a follow-on product to Nuvo's Pennsaid, a topical NSAID for osteoarthritis.
• Protox Therapeutics Inc., of Vancouver, British Columbia, closed a second tranche of its previous private placement, placing an additional 1.8 million units with institutional and retail investors at a price of C50 cents per unit for gross proceeds of C$875,000 (US$756,000). Each unit comprises one common share and one-half of one common share purchase warrant. Funds will support Protox's ongoing development of PRX321 and PRX302 in cancer indications and for general corporate purposes. Jennings Capital Inc. and Canaccord Capital Corp. served as co-agents.
• QLT Inc., of Vancouver, British Columbia, said its wholly owned subsidiary, QLT USA Inc., completed the sale of its generic dermatology and manufacturing business in Fort Collins, Colo., to privately held Tolmar Inc. for $21 million, 60 percent of which was paid in cash at closing. The balance will be paid in two equal cash installments before the end of the first quarter of 2007. An additional $1 million payment is expected if commercial orders for Aczone are produced in the Fort Collins plant.
• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., closed its previously reported $9.55 million private placement of 5.3 million common shares at $1.80 apiece, with warrants for an additional 2.1 million shares exercisable at $2.75 each. The funding should allow the company to finish three Phase II studies of its synthetic peptide Thymosin beta 4 (TB4) in chronic dermal wounds. Participants in the financing included several new institutional investors, existing investors and affiliates of Sigma-Tau Group, the company's largest stockholder. Piper Jaffray & Co. acted as the transaction's sole placement agent.
• SemBioSys Genetics Inc., of Calgary, Alberta, disclosed the conclusion of its relationship with Lonza Inc., a unit of Lonza Group Ltd., of Basel, Switzerland, for the manufacture and sale of its DermaSphere Oleosome Technology. SemBioSys will continue to manufacture and supply DermaSphere to the personal care market to address the demand for the technology and the first-generation oleosome product, Natrulon-OSF, launched by Lonza in 2004. A readjustment in Lonza's strategic priorities and delays from the contract manufacturer in scaling up production to meet increasing demand led to a de-emphasis of the product in Lonza's portfolio, SemBioSys said.
