• Alexza Pharmaceuticals Inc., of Mountain View, Calif., will get $10 million up front in a deal that gives Grupo Ferrer International SA, of Barcelona, Spain, commercial rights in Europe, Latin America, Russia and the Commonwealth of Independent States countries for Adasuve (formerly AZ-004, Staccato loxapine). Adasuve is under FDA review for the rapid treatment of agitation in schizophrenia or bipolar disorder patients, and Alexza plans to file for approval in Europe by the end of the year. Grupo Ferrer will handle subsequent regulatory filings, and Alexza will receive milestone payments. (See BioWorld Today, May 4, 2011.)

• Biovest International Inc., of Tampa, Fla., said it is planning to request regulatory meetings in the U.S., Europe and Canada to discuss BiovaxID, its personalized cancer vaccine for follicular lymphoma, and that the first meeting has been scheduled to occur by year-end.

• Boehringer Ingelheim GmbH, of Ingelheim, Germany, granted Gilead Sciences Inc., of Foster City, Calif., exclusive worldwide rights for the research, development and commercialization of its noncatalytic site integrase inhibitors for HIV. The licensing agreement includes the lead compound BI 224436, which has been evaluated in a Phase Ia dose-escalation study. Boehringer will receive an undisclosed up-front payment and possible milestones and royalties. The agreement allows Boehringer to focus on developing other compounds in its virology pipeline, particularly those targeting hepatitis C, the company said.

• Celgene Corp., of Summit, N.J., amended the information from its Sept. 23 press release regarding the Committee for Medicinal Products for Human Use's Article 20 Review of multiple myeloma drug Revlimid (lenalidomide). The restated information provides more detail about the risk of second primary malignancies associated with Revlimid.

• Galenea Corp., of Cambridge, Mass., published data in PLoS ONE validating its MANTRA technology that enables high throughput screening of synaptic function directly on cultured primary neurons. The system can be used to identify drug targets and compounds.

• GeNOsys Inc., of Provo, Utah, through its wholly owned subsidiary Health Innovations Inc., entered two license agreements with Equity Labs Inc., giving the Salt Lake City company rights to manufacture and distribute some of the nitric oxide topical products developed by GeNOsys. One of the agreements grants an exclusive license for an acne product; the other is a nonexclusive license for a line of topical skin care products. Terms were not disclosed.

• Metabolic Solutions Development Co. LLC, of Kalamazoo, Mich., received a $1.1 million Small Business Technology Transfer Program grant from the National Institute on Alcohol Abuse and Alcoholism. The grant will be used to evaluate insulin sensitizing drug MSDC-0602 in animal models of fatty liver disease. The drug is also in Phase II trials for diabetes.

• Millennium Inc., of Cambridge, Mass., a unit of Takeda Pharmaceuticals Co. Ltd., is withdrawing its supplemental new drug application for the use of Velcade (bortezomib) for injection in combination with rituximab in patients with relapsed follicular lymphoma. The decision was based on discussions with external advisers and the FDA, the company said. Results from the LYM-3001 pivotal trial showed the addition of Velcade led to a 1.8-month improvement in median progression-free survival compared with rituximab alone. Velcade is approved in the U.S. for use in patients with multiple myeloma and for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. It is being evaluated in follicular lymphoma patient subgroups and is in ongoing trials in previously untreated mantle cell lymphoma and diffuse large B-cell lymphoma. (See BioWorld Today, April 11, 2008.)

• Paris-based Servier will pay Cortex Pharmaceuticals Inc., of Irvine, Calif., an additional $2 million, plus royalties and milestones, to exercise its option to obtain the remaining rights to their jointly discovered high impact Ampakine compound CX1632/S47445, being developed to treat memory and cognitive impairment in patients with Alzheimer's disease and other disorders. In exercising the option, which it purchased in June for $1 million. Servier now has exclusive rights to develop and market the compound worldwide. Cortex will retains all rights for its remaining compounds and Ampakine technology on a global basis. Servier has completed a Phase I trial of CX1632/S47445.

• With its shares closing below the minimum $1 bid price for the past 30 business days, Tengion Inc., of East Norriton, Pa., could face delisting on the Nasdaq Global Market if it doesn't regain compliance by April 2, 2012. The regenerative medicine company is considering options to resolve the deficiency and exploring listing alternatives. Tengion had been negotiating a stock-for-stock merger with an undisclosed company earlier this year, but the deal fell through when speculation resulted in an unexpected increase in Tengion's trading price and volume. Shares of Tengion (TNGN) closed at 49 cents Thursday, up 2 cents. (See BioWorld Today, March 2, 2011.)

• Theratechnologies Inc., of Montreal, reported it has discovered a new growth-hormone-releasing factor peptide with similar potency and efficacy to its lead compound, tesamorelin (Egrifta). The biotech is conducting preclinical studies to explore the peptide's potential to treat a broader range of indications, with more delivery options, than the injected tesamorelin, which has been approved in the U.S. to treat HIV lipodystrophy. Tesamorelin also is in a Phase II trial as a treatment for muscle wasting in chronic obstructive pulmonary disease patients.

• Unigene Laboratories Inc., of Boonton, N.J., and Nordic Bioscience AS, of Copenhagen, Denmark, are establishing a joint development vehicle (JDV) to advance up to three of Unigene's calcitonin analogues through Phase II proof-of-concept trials for the treatment of Type II diabetes, osteoarthritis and osteoporosis. Unigene and Nordic will each own 50 percent of the joint venture. Unigene will license, on an exclusive royalty-free basis, the analogues to the JDV. It also will supply the analogues for preclinical studies and then manufacture sufficient quantities of the selected lead analogue for clinical trials. Nordic is responsible for conducting and funding all preclinical, toxicology and clinical development through the Phase II trial for the diabetes indication. Shares of Unigene (OTC BB:UGNE) gained 16 cents, or 18.2 percent, to close at $1.04 on Thursday.