• Actelion Ltd., of Allschwil, Switzerland, reported the analysis of long-term follow-up data of primary pulmonary hypertension patients from Tracleer pivotal registration studies suggested that the use of the oral dual endothelin receptor antagonist is associated with improved survival. Analysis at 36 months found a survival rate of 86 percent for patients treated with Tracleer compared to a predicted survival rate of 48 percent. The difference between observed and predicted values at six, 12, 24 and 36 months were statistically significant (p<0.001) in favor of treatment with Tracleer. The data were presented at the American Thoracic Society's International Conference in Seattle.

• Axcan Pharma Inc., of Mont St. Hilaire, Quebec, said it is increasing the price of its cash tender offer for all of the outstanding shares of common stock of Salix Pharmaceuticals Ltd., of Raleigh, N.C., to $10.50 per share. The offer price represents an increase of 20 percent from its prior offer of $8.75 per share and a 68 percent premium to Salix's average closing share price over the 30 days prior to Axcan's initial offer. Axcan also said it extended the expiration date of the offer to 5 p.m. June 27.

• BioBalance Corp., of Brooklyn, N.Y., reported pilot trial results at the Digestive Disease Week conference in Orlando, Fla., showing that a non-pathogenic strain of E. coli Probiotic oral suspension appeared to relieve the major clinical symptoms of inflammatory bowel disease. The strain of E. coli, ATCC20226 (Probactrix), is a proprietary formulation of M-17 E. coli and is approved as an over-the-counter pharmaceutical in Russia and as a food supplement in Israel. BioBalance said it plans to work with the FDA to eventually introduce Probactrix in the U.S. as a medical food.

• Cepheid Inc., of Sunnyvale, Calif., said the United States Postal Service awarded Northrop Grumman Corp.'s Security Systems LLC unit a contract to manufacture and integrate biohazard detection systems (BDS) designed to analyze and detect potential biological threats at mail sorting facilities nationwide. The value of the contract is about $175 million. Northrop Grumman is the prime contractor and systems integrator of the BDS, which uses polymerase chain reaction technology developed by Cepheid to analyze air samples taken from the mail sorting systems and detect trace levels of DNA from anthrax spores and other biological agents as it moves through the mail processing equipment. The BDS also incorporates Cepheid's GeneXpert modules.

• Cumbre Inc., of Dallas, was awarded a Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md. The Phase I grant, titled "Novel inhibitors of Mycobacterium tuberculosis RNA polymerase," was awarded to support the privately held company's studies to investigate the potential of a synthetic chemistry series for development as a new tuberculosis drug.

• CuraScript Pharmacy Inc., of Orlando, Fla., and Nova Factor Inc., a wholly owned subsidiary of Accredo Health Inc., of Memphis, Tenn., said they were selected as specialty pharmacy providers of Xolair (omalizumab). The injectable asthma drug, co-developed by Genentech Inc., of South San Francisco; Novartis Pharma AG, of Basel, Switzerland; and Tanox Inc., of Houston, recently received unanimous FDA advisory panel backing for moderate to severe adult and adolescent allergic asthma sufferers. (See BioWorld Today, May 16, 2003.)

• Eden Bioscience Corp., of Bothell, Wash., reported the reduction of 20 full-time positions, bringing the total post-reduction headcount to 38 full-time employees. Eden said it expects to incur a severance charge of about $200,000 this quarter. Eden is a plant technology company focused on developing, manufacturing and marketing natural protein-based products for agriculture.

• Embrex Inc., of Research Triangle Park, N.C., said its Newplex Newcastle disease vaccine received marketing approval from the U.S. Department of Agriculture. The vaccine can be delivered in ovo via the Embrex Inovoject system to prevent the disease. Embrex said it would pursue regulatory approvals in other worldwide markets.

• Encysive Pharmaceuticals, formerly named Texas Biotechnology Corp., of Houston, presented results from the STRIDE (Sitaxsentan To Relieve Impaired Exercise) trial in pulmonary arterial hypertension, a Phase IIB/III double-blind, placebo-controlled study. Researchers found that sitaxsentan 100 mg and 300 mg provided clinical benefit in those patients, while the 100-mg dose was better tolerated. Both doses showed equivalent and statistically significant improvements in six-minute walk distance (p<0.01 vs. placebo) and New York Heart Association functional class (p<0.02 vs. placebo), while improving cardiopulmonary hemodynamics. The results were presented at the American Thoracic Society's International Conference in Seattle. (See BioWorld Today, April 24, 2003.)

• EntreMed Inc., of Rockville, Md., raised $9 million in gross proceeds after selling 3 million common shares to a group of undisclosed institutional investors. The $3-per-share price reflected a 20 percent discount to Monday's $3.74 closing price of the company's shares, which were boosted after positive anti-angiogenesis news from Genentech Inc. On Tuesday, EntreMed's stock (NASDAQ:ENMD) fell 64 cents, or 17.1 percent, to close at $3.10. EntreMed said it expects the additional proceeds to fund operations into 2005. The sale of the shares, offered through a prospectus supplement to its effective shelf registration statement, comes less than a month after EntreMed raised gross proceeds of $10.25 million through the sale of 4.1 million common shares at $2.50 apiece. That price reflected a 15 percent discount to the prior day's closing bid. (See BioWorld Today, April 28, 2003.)

• Enzo Biochem Inc., of Farmingdale, N.Y., reported favorable results from its Phase I trial of a complex of autologous colon-specific antigens administered orally in Crohn's disease. All 10 subjects showed a clinical response to the treatment, with seven achieving clinical remission. The results were presented at the annual meeting of the American Association of Gastroenterology in Orlando, Fla.

• EpiTan Ltd., of Melbourne, Australia, reported the signing of an agreement with CollaGenex Pharmaceuticals Inc., of Newtown, Pa., and Thomas Sköld of Norrt lje, Sweden, to develop a topical formulation for its lead drug candidate, Melanotan. CollaGenex acquired the rights to the drug delivery system, known as Restoraderm technology, from Sköld, the inventor, in 2002. EpiTan has sublicensed the technology from CollaGenex. EpiTan is focused on the prevention of DNA and skin damage from ultraviolet radiation exposure.

• InterMune Inc., of Brisbane, Calif., reported interim 24-week data showing high early virologic response rates in a clinical trial of daily dosing and induction-dosing regimens of Infergen (interferon alfacon-1) in chronic hepatitis C patients unresponsive to pegylated interferon and ribavirin. Researchers reported that more than half, or 52 percent, of the nonresponders subsequently responded to treatment in the randomized, open-label trial conducted in 50 chronic hepatitis C patients. The data were presented at the Digestive Disease Week 2003 conference in Orlando, Fla.

• King Pharmaceuticals Inc., of Bristol, Tenn., reached an agreement with Elan Corp. plc, of Dublin, Ireland, that restructures the terms of the asset purchase agreement dated Jan. 30, 2003. The planned acquisition of Elan's primary care business in the U.S. and Puerto Rico is expected to close by the end of June, subject to certain contingencies, including approval by the holders of a majority of the outstanding stock of Elan. King and Elan also agreed to suspend litigation relating to the original agreement until the closing of the transaction, at which time the litigation would be dismissed. Elan's primary care business includes two branded prescription pharmaceutical products (Sonata and Skelaxin), as well as rights to potential new formulations of the products, and Elan's primary care field sales force of about 375 people. The total consideration paid by King at closing will equal about $750 million.

• Medivir AB, of Huddinge, Sweden, received a €6 million up-front payment after licensing MIV-210 to GlaxoSmithKline plc, of London. The latter said it plans to continue to develop the nucleoside analogue reverse transcriptase inhibitor for HIV, in which it has begun Phase I development. In cell culture and in vivo models, Medivir said MIV-210 has a unique resistance profile and is active against HIV strains resistant to other already marketed nucleoside analogue reverse transcriptase inhibitors. Glaxo, which will make milestone payments up to €86 million assuming positive progression of the program, gained exclusive worldwide rights to the compound except in Denmark, Finland, Iceland, Norway and Sweden. Medivir will receive undisclosed royalties on eventual sales.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said it began shipping Velcade to wholesalers and medical centers. The cancer product was granted priority review by the FDA on March 10 and was approved last week. (See BioWorld Today, May 15, 2003.)

• Neurocrine Biosciences Inc., of San Diego, reported Phase I data at the American Psychiatric Association meeting in San Francisco, showing that indiplon's pharmacokinetic profile was not affected by alcohol, contrasting previously published studies, in which alcohol is combined with other sedative hypnotics. Neurocrine noted that different pathways metabolize indiplon and alcohol. Neurocrine is studying indiplon in a battery of eight Phase III trials for insomnia. (See BioWorld Today, April 23, 2003.)

• Oxford BioMedica plc, of Oxford, UK, said the U.S. Recombinant DNA Advisory Committee provided clearance to start a clinical trial with TroVax for the treatment of renal cancer. TroVax is the company's lead cancer immunotherapy product. It is designed specifically to stimulate an anticancer immune response and has potential application in most solid tumor types, the company said.

• Schering-Plough Corp., of Kenilworth, N.J., reported at the Digestive Disease Week conference in Orlando, Fla., that treatment with Peg-Intron (peginterferon alfa-2b) powder for injection combined with Rebetol (ribavirin) capsules is not impacted by steatosis. The fatty liver condition and its more serious counterpart, nonalcoholic steatohepatitis, can be brought on by abdominal area obesity in chronic hepatitis C patients. One investigator noted that though the extent of steatosis didn't affect the combination therapy's efficacy, higher-grade steatosis and superimposed nonalcoholic steatohepatitis were associated with having more advanced liver disease.

• SIGA Technologies Inc., of New York, and Plexus Vaccine Inc., of San Diego, said Plexus filed for a patent in Denmark covering a method of identifying and validating antigens, and the results obtained by analyzing the genetic variants of the severe acute respiratory syndrome agent. SIGA is in the process of acquiring all the assets of Plexus.

• Silicon Graphics Inc., of Mountain View, Calif., said the Beijing Genomics Institute is identifying variations of the genomic basis for variations of severe acute respiratory syndrome, and the Shanghai Institute of Materia Medica is searching for a vaccine or cure. Both entities are using Silicon Graphics servers to do their work.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., presented Phase III trial results that demonstrated SPI-0211, a chloride channel activator, performed significantly better than placebo for all constipation variables tested. The results demonstrated a significant increase in spontaneous bowel movement frequency and showed significant improvements in straining and stool consistency, the company said. The data were presented at the Digestive Disease Week 2003 conference in Orlando, Fla.

• Targeted Genetics Corp., of Seattle, said it was issued a patent related to its adeno-associated virus vector manufacturing process. U.S. Patent No. 6,566,118 is titled "Methods for generating high-titer helper-free preparation of released recombinant AAV vectors." The patent describes an AAV manufacturing process in which the growth conditions used to culture the production cells lead to the release of vector particles into the cell culture medium without the need for breaking open the host cell membrane. Targeted Genetics' stock (NASDAQ:TGEN) rose 39 cents Tuesday, or 55.7 percent, to close at $1.09.

• United Therapeutics Corp., of Silver Spring, Md., and Caremark Inc., of Birmingham, Ala., entered a distribution agreement for Remodulin in the U.S. Remodulin was approved in May 2002 for the treatment of pulmonary arterial hypertension in patients with New York Heart Association Class II-IV symptoms to diminish symptoms associated with exercise. Caremark is a pharmaceutical services company. (See BioWorld Today, May 24, 2002.)

• VaxGen Inc., of Brisbane, Calif., raised $5 million after selling 1,742,160 common shares to an unnamed institutional investor. The $2.87-per-share price reflected an 11.4 percent discount to Monday's $3.20 closing price of the company's shares. VaxGen said it would use the net proceeds to fund the development of vaccine candidates for anthrax and smallpox, other research and development and for general corporate purposes. The SEC declared the registration statement effective. In November, VaxGen filed a shelf registration statement for $150 million.

• Viragen Inc., of Plantation, Fla., saw its stock surge 258 percent after reporting that it filed a patent application covering the use of natural human leukocyte-derived alpha interferon for the treatment and prevention of severe acute respiratory syndrome. Viragen said previous studies in experimental coronavirus infections, the root of SARS, have found that a relatively high dosage of alpha interferon (9 MIU/day), begun shortly before virus challenge, provided protection against both infection and illness. The company said it is providing samples of its product to international research organizations for evaluation. Viragen's shares (AMEX:VRA) gained 31 cents Tuesday to close at 43 cents.

• Virtual Arrays Inc., of Sunnyvale, Calif., changed its name to Vitra Bioscience Inc. and appointed Andrew Whiteley president and CEO, electing him to its board as well. Most recently, he was the chairman and CEO at InforMax Inc., a supplier of informatics software to the life sciences industry that was sold to Invitrogen Corp., of Carlsbad, Calif. Vitra is developing technologies for parallel drug discovery.

No Comments