• Abon Pharmaceuticals LLC, of Northvale, N.J., said it filed an abbreviated new drug application, with a paragraph IV certification, seeking approval to market its Clofarabine Injection 1 mg/mL, a generic equivalent of Clolar (clofarabine) sold by Genzyme, a unit of Paris-based Sanofi SA for treating pediatric patients with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Genzyme filed suit against Abon July 27 seeking to prevent the specialty pharma firm from commercializing the generic product prior to the expiration of U.S. Patent No. 5,661,136.

• AdeTherapeutics Inc., of Saskatoon, Saskatchewan, said it retained Beal Advisors, of San Francisco, to evaluate strategic options for partnering, licensing or seeking venture financing to advance its wound healing modulation technology. The company said it has been approached by pharma and biotech companies as well as venture firms interested in pursuing applications ranging from women's health to neurosurgery and ophthalmology.

• Anchor Therapeutics Inc., of Cambridge, Mass., said it entered an agreement with Kyowa Hakko Kirin Co. Ltd., of Tokyo, to use Anchor's pepducin technology to advance Kyowa's internal G protein-coupled receptor (GPCR) drug discovery portfolio. Under the agreement, the two firms will work jointly to discover and optimize pepducin research tools to further the molecular understanding of certain GPCR targets in Kyowa's portfolio. Kyowa will assume responsibility for application of the tools against the targets. Anchor will receive an undisclosed up-front payment, plus research funding and downstream milestones.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., submitted a new drug application (NDA) to the FDA for ponatinib for chronic myeloid leukemia and acute lymphoblastic leukemia, and has requested priority review for accelerated approval. The NDA is a rolling submission and will be completed with the addition of a final subset of chemistry, manufacturing and controls data in the third quarter. The FDA said it would begin immediate review. If approved, Ariad expects to launch ponatinib in the first quarter of 2013. (See BioWorld Today, June 5, 2012.)

• CMC Biologics Inc., of Seattle, acquired the Berkeley, Calif., manufacturing operations and affiliated assets of XOMA Corp., of Berkeley, and agreed to sublease XOMA's manufacturing facilities. Financial terms were not disclosed.

• FibroGen Inc., of San Francisco, said FG-3019, its human monoclonal antibody against connective tissue growth factor, was granted orphan drug designation by the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Early results from Phase II trials have suggested that sufficiently high bloodstream levels of FG-3019 antibody may prevent predicted decline in lung function and even increase lung capacity in some cases of IPF.

• Furiex Pharmaceuticals Inc., of Morrisville, N.C., said it completed the closings under its asset transfer agreement with ALZA Corp. and Janssen Pharmaceutica NV, divisions of New Brunswick, N.J.-base Johnson & Johnson, for worldwide Priligy (daoxetine) product rights and the license agreement with Menarini Group, of Florence, Italy, for Priligy commercialization in Europe, most of Asia, Africa, Latin America and the Middle East. Priligy is marketed for on-demand treatment of premature ejaculation in 15 countries and is approved for that indication in 50 countries. Under the terms, Furiex agreed to pay Janssen $15 million, with up to $19 million in potential ongoing clinical study costs, up to $1 million for reasonable out-of-pocket expenses over the transition period and fees related to the product sales and distribution activities that Janssen will perform on behalf of Furiex during that period. The transition is expected to take nine months to 12 months. Under the Menarini deal, Furiex will receive $15 million up front and $10 million in regulatory milestones, plus up to $19 million to fund ongoing clinical study costs, up to $10 million in launch milestones and up to $40 million in sales-based milestones, plus tiered royalties ranging from the midteens to midtwenties.

• Merck Serono SA, of Geneva, a division of Merck KGaA, created Prexton Therapeutics, a spin-off company resulting from its Entrepreneur Partnership Programme (EPP) launched in April. Prexton will be formed around Merck Serono's R&D portfolio in the field of Parkinson's disease and will focus on programs targeting the metabotropic glutamate receptors mGluR3 and mGluR4. Merck Serono will invest €2.1 million (US$2.6 million) as seed funding, managed by Merck Serono Ventures. EPP is part of a €30 million commitment aimed at reducing the impact on employment following the closure of Merck's Geneva headquarters. (See BioWorld Today, June 20, 2012.)

• Neura Therapeutik LLC, of Princeton, N.J., formed two strategic business units, Neura Group LLC and Neura Labs LLC, to pursue commercial services, in-licensing and joint venture opportunities in the analgesic marketplace, primarily in the nonsteroidal anti-inflammatory drug and opioid classes.

• Omeros Corp., of Seattle, said it believes it has identified the proteins that activate the alternative pathway of the complement system, which further expands its mannan-binding lectin-associated serine protease-2 (MASP-2) program and may permit the development of new antibodies to treat disorders that involve alternative pathway activation. Omeros' MASP-2 program has been focused on the development of antibodies that target MASP-2, and in vivo studies have suggested that MASP-2 inhibition may have a preventive or therapeutic effect in hemolytic uremic syndrome (HUS), atypical HUS, paroxysmal nocturnal hemoglobinuria, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders.

• OrPro Therapeutics Inc., of San Diego, received a National Heart, Lung and Blood Institute Small Business Innovation Research grant from the National Institutes of Health to advance development of its lead product, ORP-100, in cystic fibrosis. ORP-100 is a recombinant engineered variant of thioredoxin, a human lung protein that has demonstrated an ability to increase the fluidity of mucus. The award focuses on an inhaled formulation of ORP-100 for topical delivery to the lung surface. Terms were not disclosed.

• Pluristem Therapeutics Inc., of Haifa, Israel, said preclinical studies suggested its PLacental eXpanded (PLX) cells may be effective in reducing pulmonary fibrosis and improving lung function in a group of diseases collectively called interstitial lung disease, which includes the pulmonary insults that occur in the lung following its exposure to drugs, radiation or toxic chemicals and the pulmonary complications of systemic autoimmune diseases. Mice treated with PLX cells showed approximately a 70 percent statistically significant decrease in collagen protein deposition in the lungs in comparison to the control group.

• PolyMedix Inc., of Radnor, Pa., said it received the second phase of a grant from the National Institutes of Health, which will continue to fund collaborative work with the University of Pennsylvania to support the development of defensin-mimetic antimicrobial compounds for the treatment of malaria. The second phase provides funding of up to $1 million per year for three years to support the discovery of a lead anti-malarial candidate, and it was awarded following the completion of the first phase, which included generating proof-of-concept data through in vitro and in vivo testing.

• Prosetta Antiviral Inc., of San Francisco, said it executed a strategic alliance with Bristol-Myers Squibb Co., of New York, to further discover and develop select drug candidates representing new classes of antiviral drugs. The collaboration will include a research program focused on the discovery and advancement of compounds shown to block viral capsid assembly using Prosetta's drug discovery platform. BMS will have the right to develop and commercialize products arising from the program. Specific financial terms were not disclosed, but Prosetta will receive an up-front payment and multiyear research funding and also will be eligible for milestones and royalties.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., received a complete response letter (CRL) from the FDA for IL-1 blocker Arcalyst (rilonacept) subcutaneous injection for prevention of gout flares. The rejection had been expected, given the 11-0 vote against recommending approval during May's Arthritis Advisory Committee meeting. The CRL requests additional clinical data, and additional chemistry, manufacturing and controls related to the new dosage form. Arcalyst is approved for treatment of cryopyrin-associated periodic syndromes. (See BioWorld Today, May 9, 2012.)