• aaiPharma Inc., of Wilmington, N.C., is amending and extending its pending solicitation of consents from holders of its 11.5 percent senior subordinated notes relating to certain proposed amendments to and waivers of the indenture governing the notes. Under revised terms of the solicitation, all holders of record who submit valid and unrevoked consents prior to 1 p.m. today will receive the consent fee of $20 in cash per $1,000 principal amount of notes for which consents have been delivered, subject to the terms and conditions of the solicitation.

• Aastrom Biosciences Inc., of Ann Arbor, Mich., raised $10 million through a registered direct placement of about 8.3 million of its common shares at $1.21 apiece. The company also agreed to issue four-year warrants for the institutional investors to purchase up to about 2.1 million more shares at $1.74 each. The warrants must be held by the investors for at least six months prior to exercise, and if exercised, could generate up to an additional $3.6 million in proceeds to Aastrom. Rodman & Renshaw served as the exclusive placement agent in the transaction, which is expected to be consummated within the next few days. Separately, the company signed a clinical trial agreement with the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany, to evaluate the safety and effect of its Tissue Repair Cells in the regeneration of peripheral vascular tissue to treat lower-limb ischemia in diabetic patients.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and its collaborators at the Mayo Clinic presented at the Society for Neuroscience's 34th annual meeting in San Diego data from cell culture models showing RNA interference-mediated reduction in the expression of alpha-synuclein. The preclinical results showed that the use of small interfering RNAs to target alpha-synuclein gene expression supports the development of RNAi therapeutics to treat Parkinson's disease, Alnylam said.

• Altana AG, of Bad Homburg, Germany, said enrollment will take longer than originally anticipated in its Roflumilast Phase III program in the U.S. for chronic obstructive pulmonary disease and asthma. While the product, a phosphodiesterase 4 inhibitor, has been studied in 16 clinical trials, data from those trials will be augmented by 10 additional Phase III trials involving 4,100 patients. Altana said the application for U.S. approval will occur later than the first half of 2005, as originally planned. A marketing authorization application for Roflumilast is under evaluation by European regulatory agencies. In the U.S., the product is being developed with New York-based Pfizer Inc.

• AltaRex Medical Corp., of Edmonton, Alberta, scheduled a Dec. 9 shareholder meeting to vote on its proposed acquisition by ViRexx Medical Corp., also of Edmonton. The companies first reported their plans earlier this month. AltaRex is focused on cancer therapies, and ViRexx is developing products for chronic hepatitis B and C infection and selected solid tumors. (See BioWorld Today, Oct. 18, 2004.)

• Amgen Inc., of Thousand Oaks, Calif., said Mimpara (cinacalcet) received European approval for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis, as well as for the treatment of elevated calcium levels in patients with cancer of the parathyroid gland. Clinical trials have shown the product lowers parathyroid hormone, calcium, phosphorus and calcium-phosphorus product levels resulting in a sevenfold increase in patients reaching K/DOQI target levels. The first-in-class oral calcimimetic already is approved in the U.S., where it is called Sensipar. (See BioWorld Today, March 10, 2004.)

• Attenuon LLC, of San Diego, was awarded a fast-track Phase I/II Small Business Technology Transfer grant from the National Cancer Institute of the National Institutes of Health in Bethesda, Md. Funding for the first year will be $358,000. Receipt of an additional grant award of $942,000 for years two and three is contingent on achieving certain research milestones. The study will evaluate derivatives of ATN-161 as agents for positron emission tomography imaging. ATN-161 is a five-amino-acid peptide that has demonstrated anti-angiogenic, anti-metastatic and antitumor activity in tumor models.

• Benitec Ltd., of St. Lucia, Australia, said it granted Artemis Pharmaceuticals GmbH, of Cologne, Germany, a worldwide nonexclusive commercial license to use its ddRNAi technology in Artemis' transgenic mouse and rat model development business. Artemis provides advanced mouse models for basic research and drug discovery. It also is developing methods to genetically modify rats. The license from Benitec is for the life of its ddRNAi patent estate. Benitec will receive an up-front license fee and ongoing royalties.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said interim Phase II data reported at the Annual Meeting of the International Society for the Study of Women's Sexual Health in Atlanta indicate that Tostrelle testosterone gel is an alternative for treating female sexual dysfunction. Specific results showed that following four-month daily application of the product, patients experienced a 95 percent increase in frequency of satisfactory sexual activity over baseline and a 45 percent increase over the placebo group of menopausal women suffering from sexual dysfunction.

• Competitive Technologies Inc., of Fairfield, Conn., said it is demanding arbitration with Palatin Technologies Inc., of Cranbury, N.J., for material breach of the terms of its license agreement for the exclusive use of Competitive Technologies' sexual dysfunction technology used in the development of Palatin's experimental treatment for male and female sexual dysfunction. The agreement provides Competitive Technologies 20 percent of a full sublicense fee that Palatin receives, such as the recent $20 million license payment from King Pharmaceuticals Inc., of Bristol, Tenn. Under the license agreement, Competitive Technologies said it is owed $4 million by Palatin, which was due Oct. 17. Palatin signed the deal with King two months ago. (See BioWorld Today, Aug. 16, 2004.)

• Elite Pharmaceuticals Inc., of Northvale, N.J., said its former CEO, members of his family and their affiliates have sold all of their nearly 1.4 million common shares in the company in a private transaction to a group of purchasers. The controlled-release delivery company did not purchase any of the shares.

• France Biotech in Paris, that country's biotechnology industry association, and the Leem Biotechnology Committee, its pharmaceutical industry association, issued a series of joint recommendations intended to get France's National Research Agency to provide support for two or three bioclusters. They said the country needs to focus on life sciences and bio-nanosciences over the coming decade, among other recommendations.

• InfaCare Pharmaceutical Corp., of Neptune, N.J., said the FDA lifted a clinical hold on a study of Stanate, its first-in-class drug for hyperbilirubinemia in infants. Administered by an intramuscular injection, the product is designed to turn off the body's production of bilirubin and allows a baby's normal mechanisms to eliminate the bilirubin from the bloodstream.

• InterMune Inc., of Brisbane, Calif., said findings from investigations of the safety of Actimmune (interferon gamma-1b) in treating patients with idiopathic pulmonary fibrosis (IPF), the radiologic diagnosis of IPF and the effect of interferon gamma-1b on cellular models of lung fibrosis were reported at this week's American College of Chest Physicians meeting in Seattle. Among data reported, one analysis showed that the initiation of treatment with interferon gamma-1b did not appear to be associated with an excess of serious adverse events, respiratory serious adverse events or death in those with respiratory serious adverse events compared to the cohort of patients receiving long-term treatment. Consistent with findings from published reports of randomized, controlled trials of interferon gamma-1b in IPF, those data do not suggest an increased risk of acute respiratory decompensation associated with the initiation of interferon gamma-1b treatment, InterMune said.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., was notified by the FDA that its market exclusivity for Vitrase (hyaluronidase for injection; lyophilized, ovine) was extended from three years to five years for use as a spreading agent to facilitate the dispersion and absorption of other drugs. ISTA's U.S. market exclusivity now extends until May 5, 2009, it said.

• Lonza Group Ltd., of Basel, Switzerland, said its board approved plans to begin the installation of an additional 20,000 L mammalian cell culture bioreactor train within its existing large-scale manufacturing facility in Portsmouth, N.H.

• MDS Inc., of Toronto, said that Wilf Lewitt, executive chairman, will step down effective Sunday, but will continue as a member until the 2005 annual meeting, when he will not stand for re-election. John Mayberry, current board member and lead independent director, will succeed Lewitt as chairman. Mayberry retired as chairman and CEO of Dofasco Inc. in 2003. MDS provides enabling products and services for the development of drugs and the diagnosis and management of disease.

• MedImmune Inc., of Gaithersburg, Md., said FluMist has been included in the federal government's Vaccines for Children program as an alternative to the injectable flu vaccine beginning in the 2005-2006 influenza season. Healthy children ages 5 to 18 who meet the eligibility requirements might receive FluMist at no cost next season.

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., an emerging pharmaceutical company developing drugs for the treatment of pain, autoimmune disorders and inflammation, said its board appointed Richard De Schutter chairman. Constantine Anagnostopoulos, the current chairman, will remain a member of the board.

• Miraculins Inc., of Winnipeg, Manitoba, entered an agreement with the Winnipeg Clinic to provide the company access to additional clinical samples from prostate cancer patients. Miraculins noted that the expanded clinical sample base would further support its program to discover and validate protein and peptide biomarkers.

• The Novartis Institutes for BioMedical Research, the research division of Novartis AG, of Basel, Switzerland, and the Broad Institute of MIT and Harvard University entered a joint project to decipher the genetic causes of Type II diabetes. Called the Broad-Novartis Diabetes Initiative, the public-private collaboration will place all findings freely available online. The initiative includes and builds upon prior collaborative work with researchers at Lund University in Sweden.

• PharmaMar SA, of Madrid, Spain, said that Kahalalide F, its marine-origin compound, entered Phase II trials in severe psoriasis. KF is undergoing Phase II trials in various tumors: melanoma, non-small-cell lung cancer and hepatocarcinoma. It is one of a family of peptides isolated from the Hawaiian mollusk Elysia rufescens.

• Protein Sciences Corp., of Meriden, Conn., received FDA clearance to conduct a Phase II/III proof-of-principle field study of FluBlok, its cell culture influenza vaccine. The trial will be conducted in 18- to 49-year-old subjects and will compare two different doses of FluBlok with a placebo group. Its primary endpoints are safety and establishing a commercial dose; a secondary endpoint is to establish efficacy under field conditions. FluBlok contains antigens that are derived from three strains of the flu virus selected for inclusion in the annual flu vaccine.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said it received fast-track designation for its lead product, VEGF Trap, for a specific niche cancer indication. As a result, Regeneron and partner Sanofi-Aventis Group, of Paris, plan to initiate a clinical trial in that indication in 2005. The companies are conducting a Phase I trial to test the safety and tolerability of intravenous delivery of the VEGF Trap in advanced cancer patients. The product also is in Phase I trials in eye diseases.

• Rice University in Houston received a five-year, $1.5 million grant from the National Institute of General Medical Sciences, a unit of the National Institutes of Health in Bethesda, Md., to develop a predictive framework for cellular heterogeneity. The project involves fundamental modeling studies in conjunction with a series of experiments on genetically modified strains of E. coli bacteria, and its researchers hope it will provide a clearer understanding not only of bacterial pathogenesis but also of other diseases such as cancer.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it will reduce its work force by 9 percent, saving the company $2.8 million net per year, as part of a restructuring plan to provide the funds needed to advance its product candidates Puricase and Prosaptide. The company previously announced plans to divest its Israeli business operations, including its subsidiary Bio-Technology General Ltd. If an offer is received and approved, the company expects the transaction could complete in the first half of 2005. The cost of the personnel reductions will result in a fourth-quarter charge of about $1.3 million. Savient is conducting a Phase II study of Puricase in patients with severe refractory gout, and a Phase II study of Prosaptide to treat neuropathic pain associated with HIV/AIDS.

• Targacept Inc., of Winston-Salem, N.C., said research findings reported at the Society for Neuroscience meeting in San Diego showed that TC- 2696 produced an analgesic effect and target selectivity in several animal models. In particular, the product showed potency comparable to, or greater than, the commonly used analgesics morphine and indomethacin in models of acute, chronic, inflammatory and neuropathic pain. The compound did not produce tolerance with repeated administration. TC-2696 did not interact with nicotinic receptors located in the muscles or ganglia, which are associated with nausea, vomiting and cardiovascular toxicity.

• Tercica Inc., of South San Francisco, said it dosed the first patient in a Phase IIIb study investigating the use of recombinant human insulin-like growth factor-1 (rhIGF-1) as a therapy for children with short stature caused by primary IGF-1 deficiency. The randomized, multicenter trial will enroll about 160 pre-pubertal children with primary IGFD whose height and serum IGF-1 levels are more than two standard deviations below normal. It is designed to evaluate rhIGF-1's safety and efficacy in promoting statural growth, and its primary endpoint is change in height standard deviation score over one year. The study is expected to take about two years. Earlier this year, the company reported prior Phase III data and new drug application plans. (See BioWorld Today, June 22, 2004.)

• Vivus Inc., of Mountain View, Calif., said Phase II results reported at the annual meeting of the International Society for the Study of Women's Sexual Health in Atlanta detailed the safety and efficacy of Alista (topical alprostadil) for female sexual arousal disorder in premenopausal women. Specifically, the study demonstrated that treatment with Alista significantly increased the number of successful and satisfactory sexual events by 48 percent over placebo (p<0.021) in the 25 women who completed at least six doses each of Alista and placebo. Also, the study showed that 64 percent of Alista doses resulted in satisfactory sexual events (p<0.05 when compared to placebo) in the 36 women who received at least one dose each of placebo and active drug.