• Aoxing Pharmaceutical Co. Inc., of Jersey City, N.J., said it received notice from NYSE MKT LLC that it is not in compliance with listing requirements, based on a review of its recent financial statements. The firm submitted a plan and has until March 1 , 2014, to regain compliance.

• Biomarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a new drug application to Canadian regulators for Vimizim (elosulfase alfa) under priority review status. In the U.S., Vimizim, an enzyme replacement therapy for the treatment of patients with lysosomal storage disorder Morquio A syndrome, also called mucopolysaccharidosis Type IVA, recently received a positive recommendation from an FDA advisory committee and has a PDUFA date of Feb. 28, 2014. (See BioWorld Today, Nov. 20, 2013.)

• Cell Therapeutics Inc., of Seattle, reached a reimbursement-price agreement with the National Association of Statutory Health Insurance Funds in Germany for Pixuvri (pixantrone), the first medicinal product approved in the European Union for patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy. The drug is already available in Germany for health care professionals to prescribe in accordance with local guidance.

• DSM Pharmaceutical Products, of Parsippany, N.J., the manufacturing and technology business of Royal DSM, signed an agreement with Tunitas Therapeutics, of San Francisco, to begin process development for Tunitas’s lead Fc-fusion protein for asthma and other allergic diseases. The agreement calls for use of DSM’s Groningen, the Netherlands, facility for development and DSM’s Brisbane, Australia, facility for manufacturing.

• Enzymotec Ltd., of Midgal Ha’emeq, Israel, and Polar Omega A/S, of Esbjerg, Denmark, said they signed a joint venture agreement for the commercialization of Omega PC, a fish-based omega-3 product. Financial terms were not disclosed.

• Flag Therapeutics, of Raleigh, N.C., licensed a portfolio of an anti-angiogenic/anti-tubulin (AA/AT) compound and folate-targeted anti-cancer (FTAC) compounds. The AA/AT compounds are designed to combine two cancer treatment mechanisms in a single molecule, and the FTAC compounds are designed to combine an anti-cancer agent with a targeting agent to destroy tumor cells and leave normal cells unharmed. Preclinical studies support potential for the AA/AT compound and FTAC compounds in multiple types of cancer.

• Genmab A/S, of Copenhagen, Denmark, said it expanded its collaboration with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to create and develop bispecific antibodies using the Duobody technology platform. The original agreement called for Janssen to work on up to 10 Duobody programs, while the amendment gives Janssen rights to work up to 10 additional programs. Genmab will receive an initial payment of $2 million. For each of the 10 additional programs Janssen successfully initiates, Genmab will be entitled to milestone and license payments of up to about $174 million to $219 million, depending on the date each program is initiated. In addition, Genmab will be entitled to royalties on any sales. The original deal, inked in 2012, called for Genmab to get $3.5 million up front and up to $175 million in milestones and license payments per product, plus royalties. (See BioWorld Today, July 16, 2012.)

• Kinex Pharmaceuticals, of Buffalo, N.Y., received orphan drug designation for KX02 for treatment of gliomas. In brain tumor animal models, KX02 consistently cleared brain tumors after four weeks of therapy in 30 to 60 percent of treated animals. It also induced more necrosis than Temodar and generated an immune response to the glioblastoma tumor cells.

• Medunik Canada, of Blainville, Quebec, and Lucane Pharma SA, of Paris, concluded a collaboration agreement giving Medunik Canada exclusive Canadian rights to market and distribute an oral therapy for patients with urea cycle disorders. Financial terms were not disclosed.

• Melior Discovery Inc., of Exton, Pa., signed a licensing agreement with Bukwang Pharmaceutical Co. Ltd., of Seoul, South Korea, to develop, manufacture and commercialize its lead compound, MLR-1023, a first-in-class oral insulin sensitizer to treat Type II diabetes. Bukwang received an exclusive license to MLR-1023 and related compounds for certain countries in the Asia-Pacific region, excluding Japan. Melior will receive an undisclosed up-front cash payment and additional payments upon achievement of development and regulatory milestones. Bukwang also will support preclinical and clinical studies in the U.S. and South Korea aimed at bringing MLR-1023 through Phase IIb proof-of-concept trials. The agreement included an option for Bukwang to access Melior technology related to the underlying mechanism of action for MLR-1023. The compound improves glycemic control by directly and selectively activating the Lyn tyrosine kinase enzyme, which has been shown to modulate insulin-signaling pathways independently of PPAR mechanisms.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., received 510(k) clearance from the FDA for its Microcyn scar management hydrogel. The product is designed to manage old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds. The company’s U.S. dermatology partner, Quinnova Pharmaceuticals Inc., of Newtown, Pa., plans to commercialize the product in the first half of 2014. Oculus is working with international distributors and partners to introduce the product in other markets, with commercialization in Mexico also expected in 2014, followed by launches in other Latin American countries, in Asian markets and in certain Middle East countries. A 40-patient, randomized, double-blind, multicenter study of Microcyn demonstrated equivalency to a predicate device in scar management, including linear or widespread hypertrophic or keloid scars ranging in age from three months to one year. On Wednesday, the company’s shares (NASDAQ:OCLS) more than doubled, gaining $2.41 to close at $4.74, with nearly 18 million shares traded.

• Orion Corp., of Espoo, Finland, said that it repurchased 49,000 shares of stock at a total cost of €918225.70 (US$1248235.43). It now holds 533.991 B shares as treasury shares including the shares repurchased.

• Sirona Biochem Corp., of Vancouver, British Columbia, and Bloom Burton & Co., of Toronto, entered a joint venture to conduct collaborative research aimed at developing and commercializing multiple therapeutics in the areas of inflammation and infectious disease. Sirona will be responsible for the chemistry, using its expertise in fluorination technology. Bloom Burton will be responsible for financing, clinical validation and commercialization. Financial terms were not disclosed.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, disclosed an agreement concluded earlier in the year granting Takeda a license in Japan to commercialize Teva’s glatiramer acetate (active ingredient) formulation to treat multiple sclerosis. Takeda will submit a new drug application to register glatiramer acetate in Japan. The companies said they are working on additional agreements in connection with activation of the license. Financial terms were not disclosed.