A.P. Pharma Inc., of Redwood City, Calif., said findings published online in this month's issue of Nature Materials indicate that its polymer delivery system could advance the clinical use of DNA vaccines, as well as other nucleic acid-based therapeutics against viral infections and cancers. In the study, conducted at the Massachusetts Institute of Technology in Cambridge, a vaccine based on a model antigen elicited both an antibody response and a cellular immune response in mice when formulated in a specific type of poly (ortho ester) microsphere, resulting in suppression of the growth of tumor cells displaying the model antigen.
Access Pharmaceuticals Inc., of Dallas, completed a private placement of $9.7 million after offering about 1.8 million common shares priced at $5.40 apiece, about a 7.5 percent discount to the prior day's $5.84 closing price. The investors also received a five-year warrant to purchase an aggregate number of shares of common stock equal to 25 percent of the total number of shares sold at an exercise price of $7.10 apiece. SCO Securities LLC acted as the transaction's placement agent, and participants include SDS Merchant Fund, Baystar Capital and WPG Farber Funds, among others.
Adolor Corp., of Exton, Pa., said the FDA designated Entereg (alvimopan) as a fast-track product for the management of postoperative ileus. The company expects to submit a new drug application late in the first half of this year for the product, which is partnered with GlaxoSmithKline plc, of London.
Antisense Therapeutics Ltd., of Melbourne, Australia, said preclinical results showed that ATL1103 exhibited positive effects in animal models of diseases associated with excessive growth hormone action, including acromegaly, an abnormal growth disorder of organs, face, hands and feet; diabetic retinopathy; and wet age-related macular degeneration. ATL1103 is an antisense inhibitor designed to block the growth hormone receptor gene.
Applied Biosystems Group, of Foster City, Calif., said a federal court found in its favor in a patent suit. The U.S. District Court for the Central District of California rejected claims by scientist Henry Huang to having invented patented DNA sequencing technology used in DNA sequencing instruments belonging to Applied Biosystems. Three of the four disputed patents are owned by the California Institute of Technology and licensed by the company, while a fourth is assigned directly to Applied Biosystems.
Arena Pharmaceuticals Inc., of San Diego, began a UK-based Phase I trial of APD356, its lead anti-obesity compound. The study is expected to enroll 54 healthy overweight volunteers. The single-dose protocol should be completed in the first half of this year, and, if the results support further testing, Arena expects to begin a larger, multidose trial later this year.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said results of new studies support expansion of the potential clinical indications for its molecularly targeted product candidate, AP23464, to include specific difficult-to-treat solid tumors. The studies demonstrated that AP23464 blocks the proliferation of cancer cells, which are controlled by the key molecular targets of marketed oncology drugs and those in late-stage clinical development.
Attenuon LLC, of San Diego, signed a collaboration with Kirin Brewery Co. Ltd., of Tokyo, and its U.S. subsidiary, Gemini Science Inc., to develop fully human monoclonal antibodies for use as oncology therapeutic and diagnostic agents. The partners will combine privately held Attenuon's targeted approach to metastasis and angiogenesis with Kirin's KM Mouse technology to develop and evaluate fully human monoclonal antibodies for cancer treatment. Attenuon will receive funding from Kirin to support its collaborative research efforts and rights to any resulting products will be shared by the parties. Each company will maintain ownership of its technology and data, including patent rights and other intellectual property rights.
AusAm Biotechnologies Inc., of Santa Monica, Calif., was awarded a contract grant from the National Institutes of Health's Inter-Institute Program for the Development of AIDS-Related Therapeutics. AusAm will use the funding to accelerate development of DES10, its topical microbicide, as a prophylactic ointment against HIV and other sexually transmitted diseases. In previous NIH-sponsored studies, DES10 was shown to be an effective inhibitor of HIV and herpes, AusAm said.
AVAX Technologies Inc., of Overland Park, Kan., said its Genopoeitic subsidiary entered a contract manufacturing funding and alliance agreement with Opisodia SAS, a division of OPi SAS, of Lyon, France. The alliance will combine Genopoeitic's facilities, personnel and know-how in the cell and gene therapy area with Opisodia's facilities and personnel that have capabilities for fermentation, purification and know-how to produce purified solutions of monoclonal antibodies. Also, the alliance will produce OPi's Leukotac (inolimomab) anti-IL2 receptor antibody in Phase II trials for acute graft-vs.-host disease and AVAX's autologous cell vaccines for clinical and commercial purposes in Europe and the U.S. Avax will receive $1.5 million for each of the next two years.
Biopure Corp., of Cambridge, Mass., said Thomas Moore resigned from his position as president, CEO and a member of the board. The company said Moore, who joined the company in July 2002, is stepping down to pursue other interests. Francis Murphy, Biopure's senior vice president of engineering and process technology and former chief financial officer, is serving as interim CEO until Moore's replacement is named. The company' stock (NASDAQ:BPUR) dropped 26 cents Tuesday, or 16.1 percent, to close at $1.36.
Competitive Technologies Inc., of Fairfield, Conn., signed an exclusive agreement with the University of South Carolina Research Foundation to license and commercialize the foundation's patented cancer treatment with dual-action capability against tumor growth. The company said the small-molecular-weight compound possesses anticancer activity against a variety of human tumor cells with low toxicity to normal cells. Financial terms were not disclosed.
Dharmacon Inc., of Lafayette, Colo., released its siGenome siRNA collection, a gene-silencing collection supporting various phases of research ranging from functional genomics and initial drug target identification to late-stage therapeutic development. The company said its product makes the silencing performance of SmartPool and SmartSelection technologies available for any targetable gene.
Dyax Corp., of Cambridge, Mass., and Debiopharm SA, of Lausanne, Switzerland, said preliminary Phase IIa results confirm the good tolerability of DX-890 and the expected pharmacological effect - inhibition of neutrophil elastase - in the sputum of pediatric cystic fibrosis patients when given as a nebulized formulation. A total of 34 children were recruited in the study conducted by Debiopharm, of which 27 completed the protocol and were assessable. Of them, 20 responded to treatment as demonstrated by decreases in human neutrophil elastase, an enzyme produced as part of the inflammatory response implicated in the loss of lung function in cystic fibrosis patients. There was a pronounced dose effect, and DX-890 (also called EPI-hNE4) was well tolerated. The partners are planning a larger Phase IIb study later this year to detect potential clinical benefit and to confirm tolerability of DX-890, a recombinant inhibitor of human neutrophil elastase discovered by Dyax.
Dynavax Technologies Corp., of Berkeley, Calif., said that underwriters of its previously reported initial public offering fully exercised their overallotment option for 900,000 additional shares, resulting in net proceeds to the company of about $6.3 million. Dynavax raised $45 million in its IPO. The company is focused on products to treat and prevent allergies, infectious diseases and chronic inflammatory diseases using approaches that alter immune system responses in specific ways. (See BioWorld Today, Feb. 20, 2004.)
Epoch Biosciences Inc., of Bothell, Wash., signed definitive agreements with institutional investors to raise about $6.2 million in gross proceeds in a private placement of common stock. Epoch will sell about 2.5 million shares at $2.50 apiece, and will grant the investors five-year warrants to purchase an additional 741,000 shares at an exercise price of $3.89 apiece. The transaction is expected to close in one or two days following satisfaction of certain customary conditions. Epoch develops and sells products with commercial applications in the genomics and molecular diagnostics fields.
Evogene Ltd., of Rehovot, Israel, completed a second closing of its initial private placement of $1.5 million, bringing the total for the first round to $3.5 million. The first closing took place in March. The second closing was restricted to the group of U.S., European and Israeli investors that participated in the first closing. Evogene is focused on integrating predictive computational biology and plant genomics with classical breeding to generate improved crops and new agricultural biotechnology products.
Forest Laboratories Inc., of New York, said data reported at the American Association for Geriatric Psychiatry meeting in Baltimore showed that patients with mild to moderate Alzheimer's disease treated with Namenda (memantine HCl) as monotherapy performed significantly better than patients who received placebo on both primary outcome measures of cognition and global functions. Results from a behavioral analysis of another study in patients with moderate to severe Alzheimer's disease demonstrated that treatment with Namenda and donepezil is associated with improvement in behaviors such as agitation, irritability and appetite changes in patients with moderate to severe Alzheimer's disease compared to baseline, while patients treated with donepezil and placebo declined relative to their baseline status.
Genencor International Inc., of Palo Alto, Calif., and the UK's Health Protection Agency reported findings at a Cambridge Healthtech Institute conference on transmissible spongiform encephalopathies in Washington pointing to their development of an enzyme-based method that effectively eliminates prions. They presented data highlighting their success in inactivating bovine spongiform encephalopathy prions using a thermostable Genencor protease enzyme, as demonstrated using an in vivo mouse model. They said the process is compatible with standard processes now used in hospitals to clean and sterilize surgical instruments, and Genencor plans to commercialize the technology in hospital and dental surgery settings upon regulatory approval.
GenVec Inc., of Gaithersburg, Md., said data reported at the Association for Research in Otolaryngology meeting in Daytona Beach, Fla., demonstrated the feasibility of using its platform technology in the inner ear for hearing and balance disorders. GenVec provided funding for research performed in a laboratory at the University of Maryland.
GlycoGenesys Inc., of Boston, filed counterclaims against Pro-Pharmaceuticals Inc., of Newton, Mass., and David Platt in connection with the lawsuit commenced earlier this month by Platt. The counterclaims include, among others, breach by Platt of his separation agreement with the company, tortious interference claims against Pro-Pharmaceuticals and misappropriation of proprietary rights claims against Platt and Pro-Pharmaceuticals. GlycoGenesys, which is developing carbohydrate-based drugs, seeks monetary damages and injunctive relief to prevent Platt and Pro-Pharmaceuticals from engaging in certain competitive activities relating to the use of polysaccharides to treat cancer, and further seeks the assignment by Platt and Pro-Pharmaceuticals of certain intellectual property to GlycoGenesys for which it claims rights.
Lilly ICOS LLC, of Bothell, Wash., said European regulatory authorities changed the label for Cialis (tadalafil) in that territory to indicate that the oral PDE5 inhibitor might be effective for up to 36 hours after taking the tablet for erectile dysfunction. The new label makes it generally consistent with product labeling throughout the world, including the U.S. Lilly ICOS is a joint venture between Eli Lilly and Co., of Indianapolis, and ICOS Corp., of Bothell, Wash.
NanoBio Corp., of Ann Arbor, Mich., received FDA approval to begin a Phase II trial of its first antimicrobial product, NanoHPX (NB001), for the topical treatment of herpes labialis (cold sores). Scheduled to begin early next month, the six-month trial is designed to confirm the safety, efficacy and dose ranging of the product. It will enroll 286 patients at 20 U.S. sites.
Nastech Pharmaceutical Co. Inc., of Bothell, Wash., began a Phase Ic study of its investigational PYY3-36 nasal spray for obesity. The study involves 36 normal, healthy male and female subjects between 18 and 65 years old with a body mass index of 30 kg/m2 to 40 kg/m2 who will be randomized to treatment groups, each of which will receive three daily administrations of various dose sequences of PYY3-36 or placebo over eight consecutive days.
PamGene International BV, of s-Hertogenbosch, the Netherlands, is integrating intelligent device management (IDM) software from Questra Corp., of Redwood City, Calif., into a microarray testing platform PamGene is designing for the drug development market. The PamStation96, a fully automatic 96-array platform for high-throughput applications in drug development, will be equipped with Questra IDM software that monitors the device's operations and performance.
Paratek Pharmaceuticals Inc., of Boston, received a grant from a nonprofit foundation, the Medicines for Malaria Venture in Geneva, as part of a partnership to discover new therapies to fight Plasmodium falciparum, a form of malaria. The project will investigate tetracycline derivatives that have shown activities against the malaria parasite.
Pivotal BioSciences Inc., of Los Angeles, raised about $1.4 million after closing a private placement of Series A voting preferred stock with a limited number of accredited investors. The proceeds will be used to fund the development of the company's lead compounds, which have been licensed from the University of Southern California. Its pipeline includes PB1, a low-toxicity version of interleukin-2; PB2, an anti-angiogenic and antimetastatic compound derived from the venom of the southern copperhead snake; and PB3, a fusion protein consisting of the liver-expressed chemokine and a cancer-targeting monoclonal antibody. The placement was arranged by Casimir Capital LP, of New York.
Protez Pharmaceuticals Inc., of Malvern, Pa., acquired the assets of Influx Inc., of Chicago, in a transaction Protez said provides it with technologies for its antibiotic research and development initiatives. Its programs are targeted at the development of multiple antibiotic products with applications in difficult-to-treat infections, including multidrug-resistant infections; infections in immunocompromised patients; and recurrent and chronic infections. Also included in the Influx acquisition were several existing government grants that Protez will leverage in its ongoing discovery and development efforts. Protez, formed late last year with the support of BTG plc, of West Conshohocken, Pa., recently received $500,000 in seed funding from BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania. Financial terms of the acquisition were not disclosed.
Scolr Inc., of Bellevue, Wash., raised about $10.4 million after entering definitive agreements with existing and new institutional investors for the purchase of about 3.2 million common shares at $3.25 apiece. The investors also received five-year warrants to purchase an additional 801,635 shares at an exercise price of $4.75. Scolr said it would use the funding to accelerate its oral drug delivery development and work toward marketing products with its CDT Controlled Delivery Technology platform, which can be applied to pharmaceutical products through partnerships. Rodman & Renshaw Inc., of New York, served as the transaction's placement agent.
Seattle Genetics Inc., of Bothell, Wash., entered an agreement with Abbott Laboratories, of Abbott Park, Ill., for manufacturing of Seattle Genetics' SGN-30 monoclonal antibody product candidate. The antibody also is used in Seattle Genetics' SGN-35 antibody-drug conjugate product candidate. Abbott agreed to perform scale-up and GMP manufacturing for clinical trials, as well as supply commercial-grade material to support potential regulatory approval and commercial launch. Financial terms were not disclosed.
Serono SA, of Geneva, signed an agreement to gain exclusive worldwide rights to develop and commercialize Kappaproct, a product from InDex Pharmaceuticals AB, of Stockholm, Sweden, for the treatment of ulcerative colitis and potentially other inflammatory diseases. Kappaproct is an antisense inhibitor of the p65 protein, an activator of the pro-inflammatory NF-kappa B pathway. InDex will receive an initial fee and potential milestone payments related to development progress, regulatory submissions and approvals, as well as research and development funding. If Kappaproct is developed and registered worldwide in at least one indication, the payments could reach $35 million. InDex would also receive undisclosed royalties on sales of Kappaproct.
Sertanty Inc., of San Jose, Calif., sold a global license to its Kinase Knowledgebase to Aventis Pharmaceuticals Inc., a unit of Aventis SA, of Strasbourg, France. Aventis, which will use the product for its preclinical research programs in the field of kinases, also licensed Sertanty's Lucia technology, a web-based search interface that facilitates retrieval of relevant research information.
SuperGen Inc., of Dublin, Calif., secured European marketing rights for the anticancer compound Nipent (pentostatin for injection) from Pfizer Inc., of New York, and plans to retain the exclusive European distributor for Nipent for the near term. Nipent is approved as a single-agent treatment for patients with hairy-cell leukemia and remains under investigational study for a number of hematological malignancies. Financial terms were not disclosed.
Syngenta AG, of Basel, Switzerland, entered an agreement with SemBioSys Genetics Inc., of Calgary, Alberta, to gain access to the latter's oilbody-based Stratosome Biologics and StratoCapture Purification Systems for the development of Syngenta biologic products. The companies said the technologies hold the promise to reduce downstream purification costs of therapeutic proteins and monoclonal antibodies. Syngenta expects to use the technology across existing and future products in its biopharmaceutical pipeline. The agreement includes an up-front payment, option exercise fees, milestones and royalties for SemBioSys. More specific financial terms were not disclosed.
ViroPharma Inc., of Exton, Pa., began a Phase I program with HCV-086, a hepatitis C antiviral compound that the company is co-developing with Wyeth, of Madison, N.J. Initially, the parties will conduct a study to assess HCV-086 administered orally to healthy volunteer subjects. Should those data support further advancement, the companies plan to begin a multiple-dose study in patients with chronic hepatitis C virus infection to assess the compound's antiviral activity, safety, tolerability and pharmacokinetic profile.