• Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said the FDA is reviewing the new drug application for lomitapide in homozygous familial hypercholesterolemia (HoFH) under the standard review classification. Lomitapide is a small-molecule microsomal triglyceride transfer protein inhibitor that has orphan drug status for HoFH in the U.S. Shares of Aegerion (NASDAQ:AEGR) gained $1.44, or 10.4 percent, to close Thursday at $15.30.

• Alexza Pharmaceuticals Inc., of Mountain View, Calif., and Grupo Ferrer Internacional SA, of Barcelona, Spain, said they amended their commercial deal for Adasuve (Staccato loxapine) to expand the partnership, with Ferrer becoming an Alexza stockholder. Ferrer will purchase about 2.42 million shares of Alexza stock priced at $1.24 per share. That will eliminate a future milestone payment under the firm's collaboration. During 2012, Ferrer could purchase up to an additional $8 million of Alexza stock, which would eliminate additional milestones. The Adasuve partnership includes Europe, Latin America, Russia and the Commonwealth of Independent States countries. The companies also disclosed Ferrer's intent this year to submit product registrations for the product in Brazil and Mexico, representing Ferrer's first two non-European filings.

• Celgene Corp., of Summit, N.J., said it completed its acquisition of Avila Therapeutics Inc., of Bedford, Mass., in a potential $935 million deal that calls for $350 million in cash up front. Payments of up to an additional $195 million are tied to milestones related to development and approval of Avila's lead product, Bruton's kinase inhibitor AVL-292, and another $380 million in potential milestones are contingent upon development and approval of other candidates generated from Avila's Avilomics platform. (See BioWorld Today, Jan. 27, 2012.)

• Lipid Therapeutics GmbH, of Heidelberg, Germany, said it inked a licensing deal granting Dr. Falk Pharma GmbH, of Freiburg, Germany, rights to lead product LT-02 for ulcerative colitis. Specific terms were not disclosed, but Lipid will receive an up-front fee and be entitled to potential milestones and royalty payments. Dr. Falk will assume full responsibility for further development of the drug, a delayed-release formulation of phosphatidylcholine designed to improve the barrier function of the mucosal layer in the colon. A Phase III study of LT-02 is planned to start in Europe in the second half of this year.

• MediGene AG, of Martinsried, Germany, said marketing applications for its Veregen ointment received positive opinions in 17 additional European countries. The successive launch of the drug for genital warts is anticipated to start by the end of 2012. Veregen previously gained approval in the U.S., Germany, Austria and Spain.

• NeurogesX Inc., of San Mateo, Calif., said in its fourth-quarter earnings that it received a complete response letter for its supplemental new drug application for Qutenza for the management of pain associated with HIV-associated peripheral neuropathy. The FDA asked for additional clinical data from at least one adequate and well-controlled trial to support approval in that indication. NeurogesX said it will work with the FDA to "better understand the requirements for potential approval," but it does not anticipate investing in further clinical studies of Qutenza at this time. The company, which reported $34.3 million in cash at the end of 2011 , also said it was restructuring operations to minimize cash burn, eliminating 43 full-time positions, or 57 percent of its work force. That move is expected to decrease 2012 operating expenses by 32 percent. NeurogesX will focus in the near term on preparing for Phase III testing of NGX-1998, a topical liquid formulation of high-concentration capsaicin for postherpetic neuralgia, and securing additional resources, either through financings or partnerships. Shares of NeurogesX (NASDAQ:NGSX) fell 13 cents, or 19.8 percent, to close Thursday at 53 cents.

• Promedior Inc., of Malvern, Penn., said the FDA granted orphan drug status to PRM-151 , a recombinant form of human Pentraxin-2, in idiopathic pulmonary fibrosis. Orphan designation provides regulatory assistance and would guarantee seven years of marketing exclusivity upon approval.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and partner Bayer AG, of Leverkusen, Germany, said Australian regulators approved Eylea (aflibercept) injection for treating neovascular age-related macular degeneration. Bayer plans to launch Eylea in Australia in the second half of this year. Eylea gained approval in the U.S. late last year. (See BioWorld Today, Nov. 22, 2011.)

• XOMA Corp., of Berkeley, Calif., said a study of XMetA in a mouse model of diabetes showed the reduction of elevated fasting blood glucose levels and normalized glucose tolerance. After six weeks, there was a statistically significant reduction in hemoglobin A1c levels compared to controls. Improvements in elevated non-HDL cholesterol levels also were found.