• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said Soliris (eculizumab) did not meet its primary endpoints in a an investigator-initiated exploratory study to treat nonexudative age-related macular degeneration (dry AMD). Alexion currently markets Soliris (eculizumab), a fully humanized monoclonal antibody targeted at complement protein C5, for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The dry AMD news was reported at the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Fla.

• Apricus Biosciences Inc., of San Diego, said Health Canada granted its request for a pre-new drug submission meeting to obtain regulatory guidance for Femprox, its topical alprostadil cream for treating female sexual arousal disorder. Apricus expects to obtain feedback from the agency regarding the suitability of its existing clinical, preclinical and chemistry data to support a regulatory application in Canada. Femprox previously completed a 400-patient Phase III trial, which met both primary and secondary endpoints.

• Cardiome Pharma Corp., of Vancouver, British Columbia, received notice that it's not in compliance with the minimum $1 price requirement for the Nasdaq Global Market. The company has until Oct. 29 to regain compliance. Shares of Cardiome (NASDAQ:CRME) dropped below $1 in March when Merck & Co. Inc., of Whitehouse Station, N.J., abruptly terminated development of oral vernakalant. Cardiome closed at 48 cents Monday, down 4 cents, or 7.2 percent. (See BioWorld Today, March 20, 2012.)

• Celsion Corp., of Lawrenceville, N.J., signed a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd., of Taizhou Zhejiang, China, to produce ThermoDox, Celsion's heat-activated liposomal encapsulation of doxorubicin. Financial details were not disclosed.

• Curis Inc., of Lexington, Mass., said partner Roche AG, of Basel, Switzerland, submitted an application seeking approval of Erivedge (vismodegib) in Australia for basal cell carcinoma (BCC). The submission triggered a $4 million milestone payment to Curis. Erivedge, a Hedgehog pathway inhibitor, gained FDA approval for BCC earlier this year. (See BioWorld Today, Jan. 31, 2012.)

• Enzon Pharmaceuticals Inc., of Piscataway, N.J., and Zhejiang Hisun Pharmaceuticals Co. Ltd., of Zhejiang, China, signed a long-term research, development and licensing collaboration focused on therapeutics using Enzon's PEGylation linker technology. Hisun will pay Enzon an undisclosed amount to apply its the linker technology, especially its releasable PEGylation technology, and know-how to the development of PEGylated versions of select therapeutic candidates within Hisun's pipeline. Once successfully PEGylated, Hisun will have the option to in-license the product candidates and will be fully responsible for funding development and commercialization of the products in the territory of China. Enzon is entitled to milestone payments and a high-single-digit royalty on net sales for any product developed and commercialized in China, in addition to retaining rights to all PEGylated compounds outside of China.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., reported data from preclinical studies of IMO-8400, a TLR inhibitor, that demonstrated a mechanism of action that may be applicable to the treatment of systemic lupus erythematosus and psoriasis. The data, presented at the American Association of Immunologists meeting in Boston, showed IMO-8400's inhibition of TLR7, 8 and 9 suppressed the cycle between autoimmune antibody production and tissue damage, leading to improved renal function in a lupus-prone mouse model. No treatment-related side effects were observed. Idera plans to submit an investigational new drug application for IMO-8400 to the FDA in the fourth quarter, with lupus as the initial indication.

• Intellect Neurosciences Inc., of New York, expanded its Alzheimer's pipeline with the exclusive license of two antibodies from Northwestern University. The tauC3 and TOC-1 antibodies target certain abnormal forms of tau protein implicated in the nerve cell death that's characteristic of Alzheimer's disease and other tauopathies. The licensing agreement includes clinical and regulatory milestones, as well as royalties. Financial terms were not disclosed.

• Keryx Biopharmaceuticals Inc., of New York, and Aeterna Zentaris Inc., of Quebec City, terminated their license deal for PI3K/Akt inhibitor perifosine (KRX-0401), which failed a Phase III colorectal cancer trial last month. Rights to the drug reverted back to Aeterna Zentaris, which assumed all costs moving forward and plans to continue a Phase III trial in multiple myeloma. Keryx would receive a low single-digit royalty on future net sales of perifosine in the U.S., Canada and Mexico. (See BioWorld Today, April 3, 2012.)

• MediGene AG, of Martinsried, Germany, received a €5 million (US$6.5 million) milestone payment from Astellas Pharma Inc. subsidiary Astellas Pharma Europe Ltd., of London, related to the transfer of European rights to prostate cancer drug Eligard (leuprolide acetate). MediGene sold Eligard to Astellas in 2010; the milestone payment completed the €25 million associated with the initial sale, although Medigene will continue to receive 2 percent royalties on net sales of Eligard.

• ProMetic Life Sciences Inc., of Laval, Quebec, and Hematech Biotherapeutics Inc., of Taipei, Taiwan, inked a deal for the co-development and co-exclusive commercialization, on a worldwide basis (excluding China), of a plasma-derived biopharmaceutical product targeting a rare medical condition. Hematech will pay $10 million ($1 million up front and $9 million in staged payments) to fund the unnamed orphan drug's development program up to regulatory approval. Assuming it's approved, the drug would be manufactured and commercialized jointly with both parties sharing profits equally. The agreement centers around ProMetic's Plasma Protein Purification System, which allows for the targeting and removal of multiple high-value proteins from a single plasma sample.

• Promedior Inc., of Malvern, Pa., presented data from preclinical studies of recombinant human Pentraxin-2 at the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Fla., highlighting its efficacy in suppressing choroidal fibrosis and subretinal vascular leakage in independent models of age-related macular degeneration and diabetic retinopathy. The data also confirmed the potent effect of Pentraxin-2 on induction of regulatory macrophage activity in the retina.

• Proteostasis Therapeutics Inc., of Cambridge, Mass., is collaborating with Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit drug discovery and development affiliate of the Bethesda, Md.-based Cystic Fibrosis Foundation, to research, develop and commercialize therapies to treat patients with Delta F508, the most common cystic fibrosis mutation. The collaboration will focus on identifying small-molecule modulators of protein homeostasis that will correct the folding, trafficking and functioning of the Delta F508 cystic fibrosis transmembrane conductance regulator protein, either alone or in combination with agents in development. Financial terms were not disclosed.

• pSivida Corp., of Watertown, Mass., said the UK's Medicines and Healthcare products Regulatory Agency granted marketing authorization for Iluvien as a second-line treatment for vision impairment associated with chronic diabetic macular edema. pSivida and partner Alimera Sciences Inc., of Atlanta, are seeking approval for the product in Europe through the decentralized procedure. Alimera expects Iluvien to be available in the European Union by the end of the year. In the U.S., Iluvien received a second response letter in November 2011. pSivida (NASDAQ:PSDV) closed at $2.22 Monday, up 10 cents. (See BioWorld Today, Nov. 14, 2011.)

• Repligen Corp., of Waltham, Mass., said it will support an amended proposal to increase the threshold necessary for calling a special meeting of stockholders to 30 percent. Originally, the proposal, submitted by stockholder Ronald Chez, would have set a 20 percent threshold. In an agreement with Repligen's board, Chez said he would vote all of his shares in accordance with the board's recommendations on various proposals to be acted on at the 2012 annual meeting. Shares of Repligen (NASDAQ:RGEN) gained 8 cents Monday, closing at $4.94.

• Talon Therapeutics Inc., of San Mateo, Calif., said the FDA extended its PDUFA date for Marqibo (vincristine sulfate liposomes injection) by three months, until August 12. Earlier this year, the FDA's Oncologic Drugs Advisory Committee voted 7 to 4, with two abstentions, that Marqibo demonstrated a favorable risk-benefit profile as a third-line treatment for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Talon said the FDA requested additional information unrelated to clinical trials, which the company has provided. Shares of Talon (OTCQB:TLON) fell 30 cents, or 28.5 percent, to close at 77 cents Monday. (See BioWorld Today, March 22, 2012.)