• A.P. Pharma Inc., of Redwood City, Calif., granted an exclusive license to develop and sell APF530 in China, Taiwan, Hong Kong and Macau to RHEI Pharmaceuticals Inc., of New Haven, Conn. The product is in Phase III trials in the U.S. for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. In return, A.P. Pharma will receive an undisclosed up-front payment and is eligible for milestone payments and double-digit percentage royalties on future net sales. On Monday, the company's stock (NASDAQ:APPA) gained 13 cents, or 12.2 percent, to close at $1.20.

• Acambis plc, of Cambridge, UK, is receiving $16.5 million for selling its Berna Products Corp. business to Crucell NV, of Leiden, the Netherlands. Acambis originally acquired Berna Products to help build a travel vaccines franchise in the U.S., where it sold an oral typhoid vaccine called Vivotif. But Acambis said it agreed to the divestiture because Berna Products is no longer a strategic asset following the termination of the Arilvax licensing agreement with Novartis AG, of Basel, Switzerland, announced last month.

• Accentia Biopharmaceuticals Inc., of Tampa, Fla., entered an agreement for a four-year term, $25 million exchangeable convertible debenture financing with several institutional investors. Proceeds will be used to strengthen the company's cash position, repay certain short-term debt, support commercialization of its specialty pharmaceuticals business and develop intranasal antifungals for chronic sinusitis. Rodman & Renshaw LLC acted as the sole placement agent for the transaction.

• Alfacell Corp., of Bloomfield, N.J., completed the nonclinical section of the rolling submission of a new drug application in preparation for its submission to the FDA for Onconase (ranpirnase), first in class in the ribonuclease family. The drug is undergoing Phase III trials in combination with doxorubicin as a potential treatment for patients with unresectable malignant mesothelioma.

• Edison Pharmaceuticals Inc., of San Jose, Calif., entered a collaboration to develop drugs targeting Leber's hereditary optic neuropathy (LHON) with the Institute of Vision, Federal University of Sao Paulo, Brazil. The inherited disease, which quickly leads to blindness, is caused by genetic defects in the mitochondria, and Edison's portfolio target inherited mitochondrial diseases.

• Epeius Biotechnologies Corp., of San Marino, Calif., received an R01 grant from the FDA to assist in the evaluation of a Phase I/II trial using Rexin-G for advanced or metastatic pancreatic cancer. The ongoing study is examining the safety and potential efficacy of repeated intravenous infusions of Rexin-G, a tumor-targeted gene delivery vehicle.

• Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., said the FDA approved two more uses for Rituxan (rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma. The first indication is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second is for low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy. Rituxan was first approved in 1997 for NHL. Genentech's stock (NYSE:DNA) closed Monday at $83.72, up $1.02. Biogen's shares (NASDAQ:BIIB) ended the day at $44.24, down 44 cents. (See BioWorld Today, Dec. 1, 1997.)

• Genzyme Corp., of Cambridge, Mass., won European approval to expand the CE mark label for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis of the ankle and shoulder. Approval will broaden the use of Synvisc beyond its established use in knee and hip OA patients. Synvisc has been shown in European clinical trials to provide up to 12 months of pain relief in knee OA.

• GTC Biotherapeutics Inc., of Framingham, Mass., and LFB Biotechnologies, a wholly owned subsidiary of French firm LFB SA, entered a collaboration to develop selected recombinant plasma proteins and monoclonal antibodies using GTC's transgenic production platform. The first program in the collaboration will focus on a transgenically produced recombinant form of human factor VIIa. The companies will form a joint steering committee, and GTC will retain exclusive commercial rights to the products in North America, while LFB will hold exclusive rights in Europe. Under the terms, LFB committed to purchase $25 million of GTC common and convertible preferred shares, and convertible debt, of which $19 million is subject to GTC shareholder approval. The investment would occur in three tranches that will result in the equivalent of about 18.2 million shares, or 19.9 percent of GTC's outstanding equity.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., secured a commitment for up to $150 million in a common stock equity financing facility with Azimuth Opportunity Ltd. During the two-year term, Onyx may sell at its discretion registered shares of its common stock to Azimuth Opportunity at an undisclosed discount to the market price. Onyx will determine, at its sole discretion, the timing and amount of any sales of its stock, subject to certain conditions. Onyx intends to use the proceeds to fund the commercialization and further development of Nexavar (sorafenib) tablets for cancer, as well as general corporate purposes.

• Oxford BioMedica plc, of Oxford, UK, signed a research and collaboration agreement with The Foundation Fighting Blindness to develop a portfolio of gene therapy products as eye treatments. The first product in the expanded portfolio is StarGen for Stargardt disease. The foundation and a consortium of investors will make an undisclosed up-front payment and also will subscribe for up to $3.9 million of Oxford's stock at 1 cent each to fund the product's development. In return, the foundation and other investors will receive a royalty on StarGen's sales.

• Oxxon Therapeutics Ltd., of Oxford, UK, said the Opposition Division of the European Patent Office has maintained key claims of Oxxon's European Patent EP0979284, despite challenges initiated by seven biopharmaceutical companies. The '284 patent, granted in January 2003, relates to Oxxon's Hi-8 PrimeBoost platform technology, in which recombinant replication-impaired poxviruses are used to boost a CD8+ T-cell immune response to disease.

• Vivus Inc., of Mountain View, Calif., filed a new drug application with the FDA for its investigational estradiol drug, EvaMist, as a treatment of vasomotor symptoms associated with menopause. The once-daily transdermal spray delivers the naturally occurring estrogen to treat hot flashes. The submission is based on Phase III results showing that EvaMist decreased the number of hot flashes by 78 percent, from 10.8 per day at baseline to 2.3 after treatment, a statistically significant decrease compared to placebo (p<0.0001).

• XOMA Ltd., of Berkeley, Calif., and Affimed Therapeutics AG, of Heidelberg, Germany, signed a cross-license and collaboration agreement for antibody-related technologies. The agreement provides XOMA with a license under Affimed's antibody library patents for antibody discovery purposes, as well as for the development and commercialization of antibodies. Also, Affimed has agreed to build two customized patient-derived human antibody phage display libraries according to XOMA specifications. Financial terms were not disclosed.

No Comments