• AtheroNova Inc., of Irvine, Calif., said it entered a deal with OOO CardioNova, a Russian subsidiary of Maxwell Biotech Group, to license territorial development and commercialization rights for AtheroNova's AHRO-001 lead compound. Under a separate securities purchase agreement, CardioNova will become an equity investor in AtheroNova with an initial stock purchase of up to $267,000. Initial funding of $900,000 has been provided by Maxwell Biotech Venture Fund to CardioNova, which will support the initiation of Phase I trials in Russia. Terms of the license agreement call for AtheroNova to issue up to $3.8 million in common stock to CardioNova for Phase I and Phase II studies, to be issued in tranches based on progress.

• AVEO Pharmaceuticals Inc., of Cambridge, Mass., and Boehringer Ingelheim GmbH, of Ingelheim, Germany, inked an agreement for large-scale process development and clinical manufacturing of ficlatuzumab, AVEO's HGF inhibitory antibody in Phase II development for non-small-cell lung cancer. Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, Calif., with AVEO retaining all rights to the compound's development and commercialization. Financial terms were not disclosed. In June, AVEO raised more than $100 million to advance its pipeline, including ficlatuzumab, which it reacquired last year from former partner Merck & Co. Inc. last year. (See BioWorld Today, Oct. 1, 2010, and June 16, 2011.)

• BioMarin Pharmaceutical Inc., of Novato, Calif., said it completed the buyback of intellectual property (IP) related to Naglazyme (galsulfase) from SA Pathology, a unit of the Central Adelaide Local Health Network in Adelaide, Australia, in exchange for $81 million up front. The IP includes patents related to the purified form of Naglazyme and the method of using the enzyme to treat mucopolysaccharidosis VI that expire between 2022 and 2023. Prior the transaction, BioMarin licensed the IP from SA Pathology and paid a 5 percent royalty on net sales of the enzyme replacement therapy. BioMarin said the deal will allow the firm to generate about $10 million to $15 million in cash per year with no incremental operating costs.

• Emergent BioSolutions Inc., of Rockville, Md., said its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, for B-cell malignancies was granted orphan drug designation by the FDA for chronic lymphocytic leukemia (CLL). TRU-016, which is being developed in collaboration with Abbott, of Abbott Park, Ill., stems from Emergent's acquisition last year of Trubion Pharmaceuticals Inc. TRU-016 is currently in multiple Phase I studies for CLL and non-Hodgkin's lymphoma. (See BioWorld Today, Aug. 16, 2010.)

• Genetic Technologies Ltd., of Melbourne, Australia, said it executed a settlement and license agreement granting AutoImmun Diagnostika GmbH, of Strassberg, Germany, nonexclusive rights to a number of its patents relating to noncoding DNA technology. Financial terms were not disclosed.

• Shareholders of Myrexis Inc., of Salt Lake City, received a notice from P-Value Capital Management LLC that it plans to withhold votes from the company's nominees for the board at the annual meeting Dec. 8 to 'send an important signal' regarding the 'continuing inability of the company to create value.' Among its criticisms leveled at Myrexis, P-Value cited the falling share price, terminated programs, failure to find partners and failure to control cash spend, even with the recent head count and cost reductions. In its third quarter earnings, the biotech said it was suspending development of Azixa (verabulin) after concluding that an ongoing Phase IIb trial would require a 'disproportionate' investment and said it planned to focus resources on earlier-stage Hsp90 candidate MPC-0767. Last month, the biotech disclosed a corporate reorganization, which involved cutting 20 percent of its work force, bringing its total staff reductions for 2011 to more than 55 percent. Myrexis, formerly Myriad Pharmaceuticals Inc., was spun out of Myriad Genetics Inc., also of Salt Lake City, in 2009. (See BioWorld Today, July 2, 2009.)

• Protalix BioTherapeutics Inc., of Carmiel, Israel, said the Irish Medicines Board completed a successful GMP audit of the firm's manufacturing facility in Israel, performed as part of the European Medicines Agency's marketing authorization application review for Gaucher's disease candidate taliglucerase alfa. A new drug application for the drug also has been filed to the FDA, which set a PDUFA date of Feb. 1, 2012.

• Prosensa NV, of Leiden, the Netherlands, received $1.5 million from Charley's Fund, a charitable organization, for the development of drugs to treat Duchenne's muscular dystrophy (DMD). The agreement between the two organizations calls for Prosensa to identify antisense oligonucleotides that skip exon 52 in certain subpopulations of DMD, and to assess the safety and efficacy of those compounds in preclinical models.

• Stellar Pharmaceuticals Inc., of London, Ontario, said it acquired privately held Tribute Pharmaceuticals Canada Ltd. and Tribute Pharma Canada Inc., of Milton, Ontario, Combined revenues of the specialty pharma firms totaled about $12 million for the 12 months ending Oct. 31.

• Titan Pharmaceuticals Inc., of South San Francisco, said the final minutes of its pre-new drug application (NDA) meeting for Probuphine, a subcutaneous implant formulation of buprenorphine, confirmed the previously announced regulatory path for the program. Titan's Phase III program completed to date, along with an ongoing open-label safety study of re-treatment with Probuphine, expected to be completed at the end of this year, are acceptable to the FDA to support an NDA via the 505(b)(2) pathway.

• Transcept Pharmaceuticals Inc., of Point Richmond, Calif., said Purdue Pharmaceutical Products LP, of Stamford, Conn., exercised its option to commercialize insomnia drug Intermezzo (zolpidem tartrate) in the U.S. and plans to launch the drug in the second quarter. Transcept said Purdue will invest about $100 million to support sales and marketing during the first year of commercialization. The news, which sent its shares (NASDAQ:TSPT) soaring 21.7 percent, or $1.51, to close Thursday at $8.48, came less than two weeks after Transcept won FDA approval for Intermezzo, a sublingual version of zolpidem intended specifically for middle-of-the-night waking followed by difficulty returning to sleep. Under the companies' 2009 licensing deal, Transcept is eligible to receive up to an additional $80 million in sales- and intellectual property-related milestones and will earn a tiered base royalty on net sales of Intermezzo ranging from the mid-teens to mid-20s. The biotech also has a co-promotion option, which it can exercise as early as the first anniversary of commercial launch. Transcept retains rights to Intermezzo in the rest of the world. (See BioWorld Today, Aug. 4, 2009, and Nov. 28, 2011.)