• Aastrom Biosciences Inc., of Ann Arbor, Mich., received notification from Nasdaq that the company is in compliance with all Nasdaq SmallCap listing requirements, including the $1 minimum bid closing price requirement. Aastrom will remain listed on the NasdaqSC exchange. Aastrom is focused on human cell-based therapies.

• Axcan Pharma Inc., of Mont St. Hilaire, Quebec, said the FDA's Gastrointestinal Advisory Committee recommended its Photofrin PDT therapy after examining efficacy and safety findings related to the ablation of high-grade dysplasia associated with Barrett's esophagus. The decision stemmed from the committee's review of clinical data on Photofrin (porfirmer sodium) with photodynamic therapy. Axcan received both an approvable letter from the FDA late last year and Canadian approval for the same indication.

• BioTime Inc., of Berkeley, Calif., said it formed an interim office of the president to perform the duties of CEO following last week's unexpected passing of Paul Segall, its chairman and CEO. The office will include three founding executives: Judith Segall, vice president of operations and secretary; Hal Sternberg, vice president of research; and Harold Waitz, vice president of engineering and regulatory affairs.

• ConjuChem Inc., of Montreal, completed a C$12 million (US$8.9 million) private placement, placing 7.5 million shares on a bought-deal basis to a syndicate of underwriters led by Orion Securities (formerly Yorkton Securities Inc.). The original agreement, entered earlier this month, called for the syndicate to purchase up to 6.25 million shares at $1.60 a share and to have on option on 1.25 million shares at the same price. ConjuChem is developing long-acting therapeutic compounds based on bioconjugation platform technologies.

• Fluorous Technologies Inc., of Pittsburgh, raised $3 million after completing a Series A round of financing from a combination of corporate and angel investors. The company, which develops fluorous products to solve synthesis and separation problems in the drug discovery and development process, said it would use the funding to build out its contract chemistry services business. Existing shareholders included Albany Molecular Research Inc., of Albany, N.Y.; Alfred Bader, the founder of Aldrich Chemical Co. that now is part of Sigma-Aldrich Co., of St. Louis; and venture capital firm Innovation Works, of Pittsburgh. New investors included the Fairview Fund and other angels.

• Genentech Inc., of South San Francisco, said the FDA designated Avastin (bevacizumab, rhuMAb-VEGF) as a fast-track development program for the treatment of previously untreated, first-line metastatic colorectal cancer patients. Avastin is a therapeutic antibody designed to inhibit vascular endothelial growth factor, a protein that plays a role in tumor angiogenesis. The drug is in late-stage programs, including renal cell, breast and non-small-cell lung cancer.

• Genmab A/S, of Copenhagen, Denmark, filed a CTA in Europe to start an open-label Phase I/II trial using HuMax-EGFr to treat patients suffering from head and neck cancer. The trial is expected to include fewer than 40 patients. The primary endpoint will be to assess the safety of the treatment and the secondary endpoint to assess the efficacy of HuMax-EGFr. HuMax-EGFr is a human antibody that targets the epidermal growth factor receptor.

• Hydro Med Sciences Inc., of Cranbury, N.J., raised $12 million through a private placement of Series B preferred stock with both existing and new investors. The delivery firm, which has developed a drug distribution technology called the Hydron Implant, raised $7 million in its Series A financing early last year. Hydro Med said it would use the funds to accelerate development of several programs beyond its Phase III product, Histrelin Hydrogel Implant inserted once yearly for prostate cancer, for which the company expects to submit a new drug application later this year. The financing's lead investor was Corporate Opportunities Funds, an affiliate of investment bank Sanders Morris Harris, of Houston. The fund led the first round, while venture capital firm Wheatley Partners, of New York, also returned. Paladin Labs Inc., of Montreal, also participated. Paladin has Canadian rights to Hydro Med's Histrelin.

• Iliad Chemicals Pty. Ltd., of Sydney, Australia, raised A$2.25 million (US$1.5 million) in early stage funding, money the company plans to use to push its lead candidate into clinical testing. The tubulin polymerization inhibitor is designed to treat cancers resistant to current drugs. The funding came mostly from Start-up Australia Ventures Pty. Ltd., with an added contribution from the Australian government's Biotechnology Innovation Fund.

• Inspire Pharmaceuticals Inc., of Durham, N.C., submitted a new drug application to the FDA for diquafosol tetrasodium (INS365) eye drops in a 2 percent preservative-free solution. Diquafosol is designed to stimulate P2Y2 receptors located on the ocular surface and inner lining of the eyelid. The submission includes data from one Phase II and two Phase III studies involving more than 1,200 dry-eye patients, Inspire said. Data from the studies will be presented at the European Association for Vision and Eye Research meeting in Alicante, Spain, in October. The NDA submission triggers a milestone payment from Inspire's partner, Allergan Inc., of Irvine, Calif.

• InterMune Inc., of Brisbane, Calif., was named in a class-action lawsuit filed in the U.S. District Court for the Northern District of California on behalf of stock purchasers between Jan. 6 and June 11. The complaint charges that InterMune and CEO W. Scott Harkonen made false and misleading statements about Actimmune (interferon gamma-1b), alleging that they were aware of declining demand for the product given clinical data questioning its effectiveness for certain pulmonary diseases, increasing inventory levels and falling doctor demand. The company lowered its Actimmune sales guidance two weeks ago. (See BioWorld Today, June 13, 2003.)

• NexMed Inc., of Robbinsville, N.J., said it has regained compliance with Nasdaq's continued listing requirement. Accordingly, the company's oral hearing scheduled for July 10 will be considered moot and the hearing file will be closed. The company develops transdermal products based on its NexACT drug delivery technology.

• Orthovita Inc., of Malvern, Pa., said it would raise gross proceeds of about $13.7 million after entering agreements to sell about 4.9 million common shares. The investors also will receive five-year warrants to purchase about 979,000 common shares, exercisable for cash at $4 apiece. Orthovita, which develops tissue-engineering products, retains the right to call any unexercised warrants outstanding if the common stock volume-weighted average price exceeds $12 for 20 of 30 days. The company plans to use the funds to continue its Cortoss and Rhakoss clinical programs. The sale is scheduled on or before Wednesday. SG Cowen Securities Corp. acted as the offering's placement agent.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., received more than $4 million in cash through a private placement with institutional investors and the exercise of outstanding warrants. The proceeds will be used to fund operations, including the development of its vascular targeting agent. It believes it has cash to fund operations through the third quarter of its 2004 fiscal year. The company raised about $1.8 million with seven institutional investors and issued about 1.6 million shares at a price per share equal to an approximate 10 percent discount to the trailing three-day average closing price of its stock ended June 25, the date prior to the closing date. The shares were sold pursuant to a shelf registration. It also received about $2.2 million from the exercise of existing outstanding warrants issued in August 2002 for about 3 million shares. The company also granted the investors a six-month option to purchase additional shares under the same terms.

• Pharmacyclics Inc., of Sunnyvale, Calif., said results of its Phase III trial of Xcytrin (motexafin gadolinium) Injection in combination with whole-brain radiation therapy for the treatment of brain metastases were published in the July 1, 2003, issue of the Journal of Clinical Oncology, the journal of the American Society of Clinical Oncology. The study provided the rationale and basis for the company's ongoing pivotal Phase III trial evaluating the potential benefits of Xcytrin plus radiation for the treatment of brain metastases in patients with non-small-cell lung cancer.

• Rigel Pharmaceuticals Inc., of South San Francisco, raised $46 million after closing a private placement of common stock and warrants exercisable for additional shares of common stock. The company sold about 72 million shares at 64 cents apiece, with warrants to purchase another 14.4 million shares at the same price. MPM Capital, of Boston, led the round and named two partners to Rigel's board, with additional investments from Frazier & Co., of Seattle; Alta Partners, of San Francisco; and HBM BioVentures AG, of Zurich, Switzerland. (See BioWorld Today, May 1, 2003.)

• The Seattle Heart Alliance received a $4 million appropriation from the state of Washington to support its further development. The alliance is headed by Swedish Medical Center, which is looking to cull local heart programs to create an integrated heart and vascular research and treatment institute in the Emerald City, akin to its Fred Hutchinson Cancer Research Center.

• Tm Bioscience Corp., of Toronto, raised gross proceeds of about C$5 million (US$3.8 million) after closing its previously reported private placement of about 23.2 million units at C22 cents apiece. Each unit consists of one common share and a half-share purchase warrant, with each whole common share purchase warrant entitling the holder to acquire one common share at C30 cents until June 26, 2005. All securities issued in the placement are subject to a four-month hold period. The distribution was marketed on a best-efforts basis by way of a brokered private placement with Loewen, Ondaatje, McCutcheon Ltd. as lead agent and Harris Partners Ltd. as co-agent. Separately, Tm released its Tag-It Mutation Detection Kit for P450-2D6, a genetic test kit designed to identify the presence or absence of mutations common in patients with atypical drug metabolism.

• Vivus Inc., of Mountain View, Calif., said data on TA-1790, its oral phosphodiesterase type 5 inhibitor for treating erectile dysfunction, was featured at the Second International Consultation on Erectile and Sexual Dysfunction in Paris. A Vivus investigator presented results from Vivus' in-clinic RigiScan efficacy trial, as well as data from a recently completed pharmacokinetic study. Results from the study demonstrated that TA-1790 was absorbed after ingestion with median peak plasma levels achieved at 40 minutes.