• Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., and Optinose AS, of Oslo, Norway, said they inked an exclusive North American license agreement for the development and commercialization of Optinose's Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. Under the terms, Optinose received an up-front cash payment of $20 million and is eligible to receive certain shared development costs and up to an additional $90 million in total linked to clinical, regulatory and commercial milestones. Avanir also would make tiered royalty payments if the product is approved and sold in North America. Avanir assumes responsibility for regulatory, manufacturing, supply chain and commercialization activities for the product, now named AVP-825, and both parties will work together on the remaining activities in support of a new drug application submission, expected in early 2014.

• Bioalliance SA, of Paris, said it received almost €9 million (US$11.7 million) from Bpifrance through a Strategic Industrial Innovation program, with €4.3 million allocated directly to the company to accelerate industrial development of Livatag, a doxorubicin nanoparticle in Phase III testing in primary liver cancer.

• Blaze Bioscience Inc., of Seattle, and the Fred Hutchinson Cancer Research Center entered a collaboration and option agreement to support the Hutchinson Center's Optides Discovery Program and advance drug candidates identified using the platform. Short for "optimized peptides," optides are tiny molecules derived from natural organisms such as scorpions, violets and sunflowers that can be instructed to bind to particular kinds of cancer cells, disabling only those cells. They also can be attached to chemotherapy drugs, transforming them into precision therapies that spare healthy cells. Under the terms, Blaze will provide development and commercialization guidance, as well as access to its technology, and has the option to exclusively license commercial rights to the optide candidates that achieve certain criteria. The Hutchinson Center will receive technology access and support and will gain an additional equity stake in Blaze. It also could receive further payments from the biotech on each product candidate optioned.

• Cardiome Pharma Corp., of Vancouver, British Columbia, signed a deal with AOP Orphan Pharmaceuticals AG, of Vienna, to commercialize Brinavess (vernakalant intravenous) in select European markets. AOP will support Cardiome in obtaining product registrations required for marketing and sale of the atrial fibrillation product. Financial details were not disclosed, but AOP agreed to specific annual commercial goals for Brinavess. Last month, Cardiome adopted a decision by the European Commission to transfer marketing authorization for Brinavess from Whitehouse Station, N.J.-based Merck & Co. Inc., which handed back global rights to both the intravenous and oral versions of the drug last year after halting development. (See BioWorld Today, Sept. 27, 2012.)

• Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA accepted its biologics license application for obinutuzumab (GA101) and granted priority review in the treatment of chronic lymphocytic leukemia (CLL). The application is based on final Stage I data from the pivotal CLL11 trial, in which the drug demonstrated a statistically significant 86 percent reduction in the risk of disease worsening or death (p < 0.0001) when combined with chlorambucil chemotherapy vs. chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. The FDA confirmed an action date of Dec. 20. GA101, a clycol-engineered CD20 antibody, received breakthrough therapy designation in May.

• Nanobiotix SA, of Paris, said it secured €9 million (US$11.7 million) in funding from Bpifrance (formerly OSEO), of which €2.8 million is directly attributable to the company. The grant, awarded from Bpifrance's Strategic Industrial Innovation program, will accelerate the clinical and industrial development of the company's lead product, NBTXR3, in the new indication of liver cancer.

• Prolor Biotech Inc., of Ness-Ziona, Israel, presented preclinical findings of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation hemophilia therapy, providing additional evidence that the compound has the potential to be administered by subcutaneous injection as well as intravenous use, facilitating prophylactic use by patients. The findings were discussed in an oral presentation at the International Society of Hemostasis and Thrombosis congress in Amsterdam.

• Qu Biologics Inc., of Vancouver, British Columbia, said it started preclinical research to further demonstrate the mechanism by which its Site Specific Immunomodulators (SSIs) lead to the killing of cancer cells. The studies are designed to extend Qu's preclinical capabilities and provide new models in which to evaluate the molecular and cellular mechanisms of SSI cancer therapy.

• SK Biopharmaceuticals, of Seoul, South Korea, and emerging Korean biotech Aribio, entered a collaboration for SK's small molecule, SKL-G, in development for glaucoma. The companies agreed to complete preclinical development shortly and then start clinical trials following an investigational new drug application. They also are considering various strategic options for partnering and commercialization. Further terms were not disclosed.

• Transgene SA, of Paris, said it granted Ascend Biopharmaceuticals Ltd., of Melbourne, Australia, a license to develop and commercialize TG1042 in basal cell carcinoma and two other cancer indications. Financial terms were not disclosed, and Transgene retains rights to other indications. TG1042 is an adenovirus-based immunotherapy expected to start Phase I/II testing in nodular basal cell carcinoma in Australia later this year.

• Xoma Corp., of Berkeley, Calif., transferred U.S. development and commercialization rights to its perindopril franchise to Symplmed Pharmaceuticals LLC, which was formed by former Xoma employees Erik Emerson and Jeffrey Feldstein, who serve as the new company's CEO and chief medical officer, respectively, and August Troendle. Under terms of the agreement, Xoma received an equity position in Symplmed and is eligible for up to double-digit royalties on sales of the fixed-dose combination (FDC) containing perindopril arginine and amlodipine besylate, if approved by the FDA. Under a sublicense agreement, Symplmed assumed U.S. marketing responsibilities for Aceon (perindopril erbumine), while Xoma continues to manage and be reimbursed for sales and distribution within its established commercial infrastructure. Emerson and Feldstein managed the 837-patient Phase III PATH (Perindopril Amlodipine for the Treatment of Hypertension) trial, in which the FDC of perindopril arginine/amlodipine besylate showed statistically significant superiority to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. Les Laboratoires Servier SA, of Suresnes, France, markets the FDC product, branded as Coveram, in 91 countries outside the U.S. Symplmed intends to complete the new drug application for the FDC and submit it to the FDA for review by year-end. (See BioWorld Today, Nov. 26, 2012, and Jan. 19, 2012.)