AV Therapeutics Inc., of New York, said it entered into an agreement with Davospharma to assist in the good manufacturing practices (GMP) synthesis of its lead drug candidate Capridine. The manufacturing of the drug is expected to be completed in the second quarter.

Biobersys AG, of Basel, Switzerland, and Saromics Biostructures AB, of Lund, Sweden, are collaborating to address antimicrobial resistance in an international project supported by the European initiative Eurostars. The companies will drive the drug development process of initial hit molecules toward fully characterized lead molecules that qualify for preclinical testing.

Innate Pharma SA, of Marseille, France, said it has acquired full development and commercialization rights to the anti-NKG2A antibody, a first-in-class immune checkpoint inhibitor ready for phase II development in oncology from Novo Nordisk A/S. It reported that Novo Nordisk conducted a large phase I safety trial with anti-NKG2A in patients with rheumatoid arthritis, that demonstrated a good safety profile for both IV and SC routes at single and multiple administrations. However, Novo has decided to advance other compounds in inflammation, including anti-NKG2D1, currently in phase II development and generated within the collaboration. Novo Nordisk will receive €2 million (US$2.7 million) in cash and 600,000 shares from Innate in return for the license to anti-NKG2A. Novo also will be eligible to a total of €20 million in potential registration milestones and single-digit tiered royalties on future sales.

Macrogenics Inc., of Rockville, Md., said partner Les Laboratoires Servier, of Suresnes, France, exercised its exclusive option to develop and commercialize MGD006, a humanized dual-affinity re-targeting molecule targeting hematologic malignancies that recognizes both CD123 and CD3. Servier will gain exclusive development and commercial rights outside the U.S., Canada, Mexico, Japan, South Korea and India, where Macrogenics will retain development and commercialization rights. Macrogenics will receive a $15 million payment from Servier as part of the option exercise. In addition, the investigational new drug application for MGD006 cleared the 30-day review period by the FDA, triggering an additional $5 million payment by Servier to Macrogenics, which expects to initiate a phase I study in the second quarter in relapsed and refractory acute myeloid leukemia. On Wednesday, shares of Macrogenics (NASDAQ:MGNX) slid $1.31, or 3.60 percent, to close at $35.11. (See BioWorld Today, Sept. 20, 2012.)

Omeros Corp., of Seattle, said the FDA granted fast track designation to OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor, to treat cognitive impairment in patients with Huntington’s disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a range of diseases that affect cognition, including Huntington’s disease and schizophrenia. Omeros expects to begin enrolling patients this quarter in its phase II trial evaluating OMS824 in Huntington’s disease.

Regulus Therapeutics Inc., of La Jolla, Calif., renewed its strategic alliance with Sanofi SA, of Paris, to discover, develop and commercialize microRNA therapeutics, focusing on orphan disease and oncology targets. Regulus will lead development of its fibrosis programs targeting microRNA-21 (miR-21) in Alport syndrome and in oncology. Sanofi retained its interest in these microRNA-21 programs and gained rights to Regulus’ preclinical program targeting microRNA-221/microRNA-222. Regulus will advance the clinical candidates in these programs to proof of concept, where Sanofi has an exclusive option to take over further development and commercialization of each program. Regulus retained the option to co-promote any microRNA therapeutic product in the U.S. Sanofi increased its ownership stake in Regulus through an additional $10 million common stock investment at $7.67 per share, representing the volume-weighted average share price over the last 30 trading days. Under the original $750 million agreement between the companies, Sanofi gained rights on up to four microRNA targets, including Regulus’ lead fibrosis program targeting miR-21. The companies expanded the alliance in 2012 and again last year. On Wednesday, shares of Regulus (NASDAQ:RGLS) fell 43 cents, or 4.98 percent, to close at $8.20. (See BioWorld Today, June 23, 2010, and Aug. 16, 2012.)

The Medicines Co., of Parsippany, N.J., said its subsidiary, Rempex Pharmaceuticals Inc., of San Diego, was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), valued at up to $90 million, to support the development of Carbavance, a combination of a carbapenem antibiotic with a beta-lactamase inhibitor to treat multi-drug resistant gram-negative infections. The BARDA contract includes nonclinical development activities, clinical studies, manufacturing and associated regulatory activities designed to gain FDA approval of Carbavance for serious gram-negative infections. Studies also are planned to assess the potential usefulness of Carbavance to treat certain gram-negative bioterrorism agents. The contract includes an initial commitment of $19.8 million and subsequent option periods over five years.

Sonrgy Inc., of San Diego, said it entered into an exclusive license agreement with the University of California for the company’s core technology, an ultrasound drug delivery platform. The agreement grants the company the sole rights to develop and market the technology worldwide. The preclinical stage company is developing a targeted chemotherapy delivery platform using nanocarriers to transport chemotherapy drugs to cancer tumors and release high doses in response to a focused beam of ultrasound.

Zosano Pharma Inc., of Fremont, Calif., inked an agreement with Novo Nordisk A/S, of Bagsvaerd, Denmark, to develop a transdermal formulation of semaglutide, an investigational proprietary human glucagon-like peptide-1 (GLP-1) analogue, to be administered once weekly using Zosano’s microneedle patch system to treat type 2 diabetes. Initially, the companies will work collaboratively to execute preclinical experiments to verify delivery of semaglutide using the microneedle patch system. Novo Nordisk received a worldwide, exclusive license to develop and commercialize its GLP-1 analogues using Zosano’s microneedle patch system. Novo Nordisk assumed responsibility for commercialization of products developed under the agreement and agreed to make an undisclosed up-front and additional payments to Zosano based on preclinical, clinical, regulatory and sales milestones. Payments could total more than $60 million for the first product and $55 million for each additional product, according to Zosano, which also is eligible for royalties on product sales of products and will receive development support and reimbursement of development and manufacturing costs.