Accelrys Inc., of San Diego, a wholly owned subsidiary of Pharmacopeia Inc., of Princeton, N.J., and Personal Chemistry AB, of Uppsala, Sweden, entered a software licensing agreement and technology alliance. Accelrys will license the use of and provide integration support for Accord for Oracle and Accord Chemistry Control, an active X -based control that will be integrated into Coherent Synthesis to provide chemical computational and data management functions. Coherent Synthesis incorporates chemistry methodology, software, automation, microwave technology and reagents to speed up chemical reactions by between 10 and 1,000 times, often with an increased yield of the compound, the company said.
Altachem Pharma Ltd., of Edmonton, Alberta, said its proposed Beijing Erdos Altachem Pharma Ltd. joint venture with Erdos Cashmere Corp. is under regulatory approval by Chinese government authorities. The joint venture, to be located in Beijing, would be 51 percent owned by Altachem and 49 percent owned by Erdos. The platform would include Altachem's technologies for the treatment of blood and blood products to eliminate such pathogens as HIV/AIDS and hepatitis. The joint venture would have funding totaling $32.5 million.
Axcan Pharma Inc., of Mont Saint-Hilaire, Quebec, signed a co-development and license agreement with NicOx SA, of Sophia Antipolis, France, for NCX 1000, designed to treat chronic liver diseases including portal hypertension and hepatitis C. Axcan obtained from NicOx an exclusive license to commercialize NCX 1000 in Canada and Poland, as well as an option to acquire rights for the U.S. market. The option could be exercised at the completion of Phase II development. NicOx has rights in the rest of the world, except France, where Axcan has co-marketing rights. Axcan will pay NicOx $500,000 on or before Dec. 31, and options or milestones that could total $18.5 million. If approved, Axcan would pay royalties of up to 12 percent. The companies will share the costs of development through Phase II studies and Axcan will conduct Phase III trials and be responsible for regulatory filings in the licensed territories.
Bavarian Nordic A/S, of Copenhagen, Denmark, said it plans to raise DKK42 million to DKK83 million (US$5.2 million to US$10.3 million) in connection with the upcoming issue of 1,185,115 shares of DKK10 nominal value each at a price of DKK70 per share with pre-emptive rights for the existing shareholders. The money will be used to fund operations during the summer until the company has gathered the earnings from contracts and expected agreements of sales of both expertise and smallpox vaccine, the company said.
Beyond Genomics Inc., of Waltham, Mass., and Boston University School of Medicine entered a strategic research alliance that establishes collaborative research programs in multiple clinical areas, such as cardiovascular disease, oncology and central nervous system disorders. BUSM will provide access to its research faculty and clinical experts, while Beyond Genomics will provide access to its systems biology technologies and drug discovery research capabilities.
Biomira Inc., of Edmonton, Alberta, reviewed plans for its Phase III Theratope vaccine analyses for metastatic breast cancer at its annual meeting. The final analysis is expected to begin in the fourth quarter of next year. But its interim analysis, expected to begin in this year's third quarter, could determine whether to continue the trial to final analysis, continue the study but discuss results with regulatory agencies to file for approval, or halt the trial. Biomira and its collaborator, Merck KGaA, of Darmstadt, Germany, will remain blinded to the data until after an independent panel makes a recommendation.
Cell Therapeutics Inc., of Seattle, reported preliminary findings at the American Society of Clinical Oncology meeting in Orlando, Fla., that indicated that Trisenox (arsenic trioxide) injection was well tolerated in children with refractory acute promyelocytic leukemia at doses that induce complete remission. Five APL patients, ranging from 2 to 18 years old, have been enrolled in the study. No dose-limiting toxicities have been reported, and all four evaluable patients have achieved a complete morphologic remission. Three of the four achieved a cytogenetic complete remission.
Cellomics Inc., of Pittsburgh, launched KineticScan HCS Reader, a system optimized for studying the dynamics of living cells. The system includes validated biological applications, advanced control software, an integrated pipette system, a laser auto-focus device and an environmentally controlled chamber.
Cetek Corp., of Marlborough, Mass., signed a multiyear research agreement with Pharmacia Corp., of Peapack, N.J., to use Cetek's technology in screening new genomic targets. The companies entered their first research agreement in August 1999. The research phase was successfully completed at the end of 2001. Under the new agreement, Cetek will develop assays for Pharmacia's targets and screen against compound libraries from Pharmacia.
Emisphere Technologies Inc., of Tarrytown, N.Y., initiated a restructuring plan that will reduce its work force by 30 percent. Last week Emisphere said the Protect trial for liquid oral heparin did not meet its primary efficacy endpoint and the company would discontinue the program. Its cash balances will be used for existing development programs, including a solid form of oral heparin. Emisphere expects the restructuring to allow its cash and investments to fund operations for three years. (See BioWorld Today, May 15, 2002.)
Euroscreen SA, of Brussels, Belgium, entered a license agreement that gives Pfizer Inc., of New York, access to Euroscreen's CCR5 patent rights. The license covers various aspects of the chemokine receptor CCR5, a specific GPCR that plays a role in the mechanism by which HIV binds to and enters white blood cells. Financial terms were not disclosed.
Genaera Corp., of Plymouth Meeting, Pa., and collaborators presented interim results from Genaera's mucoregulator compound, Lomucin, in its first therapeutic clinical study in asthma. The open-label, single-center, randomized study of 60 patients was designed to assess the tolerance of Lomucin oral tablets in patients with chronic asthma. Interim results presented on the first 20 patients evaluated demonstrated that Lomucin was safe and well tolerated. The results were presented at the meeting of the American Thoracic Society in Atlanta.
Genetronics Biomedical Corp., of San Diego, arranged a private placement of $3.3 million. The private placement is of special warrants issued at 42 cents per warrant. Each special warrant is exercisable, without additional payment, into one common share and one-third of one common share purchase warrant. One common share purchase warrant is exercisable for 12 months to purchase a share at 70 cents. The company later added $900,000 to the financing.
Immune Network Ltd., of Vancouver, British Columbia, and Bridge Pharma Inc., of Sarasota, Fla., entered an agreement that terminates, back-dated to May 28, 2001, a previous joint venture agreement between them and provides for a 5 percent royalty interest for Immune Network in certain Bridge Pharma revenues. Bridge's asthma and eczema projects, formerly part of the joint venture with Immune Network, are among several projects in active development.
Microbiotix Inc., of Worcester, Mass., will receive funding under a Phase II Small Business Innovation Research award granted to GLSynthesis Inc., also of Worcester. The companies have an ongoing research collaboration to develop first-in-class antibiotics that target bacterial DNA polymerase. They plan to extend their research to new DNA polymerase inhibitors that Microbiotix will develop.
Nymox Pharmaceutical Corp., of Maywood, N.J., said it is planning to file an investigational new drug application with the FDA for NX1207. It has shown progress in preclinical studies, the company said, and is designed to treat benign prostatic hyperplasia. NX1207 also is being tested in other indications. Nymox focuses on the research and development of therapeutics and diagnostics for the aging population with an emphasis on Alzheimer's disease.
Orphan Medical Inc., of Minneapolis, said the FDA accepted the company's complete response to the approvable letter for Xyrem oral solution. The agency is expected to take action by July 17. Orphan Medical's response includes clarification of respiratory data and revisions to labeling as requested by the FDA. Xyrem (sodium oxybate) oral solution is designed to treat cataplexy associated with narcolepsy. Orphan Medical filed the new drug application for the product in October 2000. (See BioWorld Today, July 5, 2001.)
Panacos Pharmaceuticals Inc., of Gaithersburg, Md., was awarded a Phase I Small Business Innovation Research grant of $125,000 by the National Institute of Allergy and Infectious Disease in Bethesda, Md. The award will help support the preclinical development of PA-457, an inhibitor of HIV infection by a mechanism distinct from approved drugs. The compound is in preclinical testing, and the company anticipates filing an investigational new drug application to begin clinical trials within the next year.
PhotoCure ASA, of Oslo, Norway, received regulatory approval in Finland for its Metvix PDT (photodynamic therapy). Product specialists are marketing Metvix PDT in Sweden, while the company has begun pre-launch work in Norway, Denmark and Sweden. Outside the Nordic region, PhotoCure licensed marketing and sales rights to Galderma SA, a 50-50 joint venture of L'Oreal and Nestle, but PhotoCure maintains its rights in the region.
SuperGen Inc., of Dublin, Calif., said the FDA accepted as complete the company's amendment to its new drug application for MitoExtra (mitomycin). Barring any unforeseen delays, the company anticipates a decision from the FDA before the end of the year. SuperGen's patented Extra technology is designed to produce a stable, ready-to-inject anticancer solution with commercially attractive shelf life at room temperature. Most anticancer drugs are powders and must be mixed prior to injection, limiting shelf life and creating a sometimes risky process for the handlers, the company said.
Syngenta AG, of Basel, Switzerland, and the National Institute of Agrobiological Sciences in Tokyo entered an agreement to share the Syngenta rice genome draft sequence data with the International Rice Genome Sequencing Project. The Syngenta contribution is expected to accelerate completion of a finished sequence and reduce overall project costs.
Synsorb Biotech Inc., of Calgary, Alberta, said it received on May 16 a Nasdaq Staff Determination indicating it fails to comply with the minimum bid price requirements for continued listing set forth on the Nasdaq stock exchange, meaning its common shares are subject to delisting. Synsorb said it requested a hearing to review the determination, but there can be no assurance in granting its request for continued listing.
Tragen Pharmaceuticals Inc., of San Diego, formerly named Immunogenex Inc., in conjunction with researchers at the Rebecca and John Moores University of California at San Diego Cancer Center, launched a Phase II immunotherapy trial for patients with chronic lymphocytic leukemia. The study will evaluate the efficacy of ISF 154, which is designed to activate dormant leukemia B cells and rally T cells to selectively attack blood- and tissue-based leukemia cells.
Viventia Biotech Inc., of Toronto, received C$800,000 (US$521,880) in an unsecured interest-free demand loan from Leslie Dan, a significant shareholder of the company, to fund operations while the company seeks additional financing. The company is in discussions with certain of its significant shareholders to obtain additional funding. Viventia Biotech is developing therapeutics based upon the human immune response to cancer.
YM BioSciences Inc., of Mississauga, Ontario, reported at the American Society of Clinical Oncology conference news of TheraCIM, a humanized monoclonal antibody to EGFr (h-R3). A Phase I/II dose-escalation study showed that h-R3 could be safely administered with concomitant radical radiotherapy given in standard fractions. Toxicities were infrequent, mild and similar to other MAbs, with skin rash observed in a single patient and no anaphylaxis observed. In an open, Phase I/II, rising multiple-dose, sequential-block trial, 18 of 22 locally advanced head and neck cancer patients developed objective antitumor response after six doses of h-R3 plus standard radiation therapy. Eleven of 16 locally advanced head and neck patients treated with six doses of 200 or 400 mg of h-R3 showed complete antitumor response.
ZymoGenetics Inc., of Seattle, and Arriva Pharmaceuticals Inc., of Alameda, Calif., signed an agreement that grants Arriva a worldwide license to U.S. Patent No. 5,218,091, which covers production of recombinant alpha 1-antitrypsin (rAAT) in yeast. Arriva intends to develop AAT for the treatment of hereditary emphysema and other respiratory and dermatological indications. Arriva will pay ZymoGenetics an initial licensing fee along with maintenance fees, milestones and royalties. Earlier this month, Arriva completed a $28 million Series D round of financing. (See BioWorld Today, May 8, 2002.)