• Agile Therapeutics Inc., of West Conshohocken, Pa., completed a $12 million equity financing to further develop its low-dose transdermal contraceptive patch. The investment was led by ProQuest Investments, with participating from the Hillman Co., TL Ventures and PA Early Stage Partners.
• Avanir Pharmaceuticals Inc., of San Diego, completed its previously announced purchase of Los Angeles-based Alamo Pharmaceuticals LLC for $29 million up front, plus potentially $40 million in sales-related milestones. The acquisition provides Avanir with marketed product FazaClo (clozapine), as well as a sales staff of about 50 that will be needed to launch the company's emotional lability drug, Neurodex. That product is under review at the FDA. (See BioWorld Today, May 24, 2006.)
• BioLineRx Ltd., of Jerusalem, signed an exclusive, worldwide licensing agreement with Gevys Pharmaceuticals Ltd., also of Jerusalem, for the development and commercialization of BL-3010 in chronic pain. The agreement involves the use of Gevys technology combining approved drugs to increase the potency of micro-doses of existing pain medications. This technology resulted in the development of BL-3010, which is designed to deliver pain relief with significant reductions in toxicity and side effects. BioLineRx expects to initiate a Phase I/II study with the product. Financial terms were not disclosed.
• Ceptyr Inc., of Bothell, Wash., selected a small-molecule candidate to begin investigational new drug application-enabling studies in Type II diabetes. The molecule, CPT633, is an inhibitor of PTP-1B, a validated target for Type II diabetes and obesity, and has shown in preclinical rodent studies to significantly improve insulin sensitivity and reduce blood glucose and circulating levels of plasma insulin and leptin. Ceptyr expects to file the IND in the second quarter of 2007.
• Chemokine Therapeutics Corp., of Vancouver, British Columbia, closed a previously announced transaction with Pharmaceutical Product Development Inc., of Wilmington, N.C., and re-acquired its licensing rights on its compound CTCE-0214, with PPD retaining an interest in the program through potential future milestone payments. Under the terms, Chemokine paid to PPD $100,000 cash and will pay up to $2.5 million in clinical and regulatory milestones. As part of the deal, PPD converted its 2 million convertible preferred shares into 2 million common shares and sold them to third-party investors, for which Chemokine paid PPD a $237,600 fee.
• Encysive Pharmaceuticals Inc., of Houston, said it submitted a complete response to the FDA's March approvable letter for its oral pulmonary arterial hypertension drug Thelin (sitaxsentan sodium) 100 mg. The company's stock fell by half to close at $4.60 after reporting that the FDA requested more clinical work, though Encysive said it believed issues could be addressed without additional trials. The company expects to hear within 30 days whether the FDA accepts the submission for review. Encysive's stock (NASDAQ:ENCY) gained 63 cents Thursday to close at $4.46. (See BioWorld Today, March 28, 2006.)
• Genentech Inc., of South San Francisco, submitted a supplemental biologics license application with the FDA for Avastin (bevacizumab) in combination with taxane chemotherapy for patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer. The company has requested priority review of the application. Avastin is approved as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The sBLA submission is based on results from a 722-patient Phase III trial in which those treated with Avastin plus paclitaxel had a 52 percent reduction in the risk of disease progression or death, compared to those treated with paclitaxel alone.
• Illumina Inc., of San Diego, said underwriters of its previously announced public offering exercised in full their option to purchase up to 525,000 shares of common stock, for a total of about 4 million shares priced at $25.50 each. Net proceeds from the offering are estimated at $96.2 million and will support ongoing diagnostics work and general corporate purposes. (See BioWorld Today, May 22, 2006.)
• Insmed Inc., of Richmond, Va., said its Iplex (mecasermin rinfabate (rDNA origin) is available nationwide. The once-daily IGF-1 replacement therapy was approved in December as an orphan drug for growth failure in children with severe primary IGF-1 deficiency or growth hormone gene deletion who have developed neutralizing antibodies to GH. (See BioWorld Today, Dec. 14, 2005.)
• Metabolex Inc., of Hayward, Calif., said its partner, Astellas Pharma Inc., of Tokyo, initiated a high-throughput screen on a previously selected target and has chosen an additional validated target for drug screening and development, both of those triggering undisclosed milestone payments to Metabolex. The companies formed their collaboration in March 2002 and extended the agreement in March 2005 for one year to identify targets through Metabolex's human gene database and develop drugs against Type II diabetes, insulin resistance, impaired glucose tolerance and obesity.
• Seattle Genetics Inc., of Bothell, Wash., expanded its collaboration with Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., to include activities intended to accelerate the manufacture and development of Progenics' prostate-specific membrane antigen antibody-drug conjugate. Seattle Genetics will develop and optimize certain methods for manufacturing and testing PSMA ADC to support studies in humans. Progenics is responsible for fees and milestone payments in addition to those already provided under the parties' existing collaboration established in June 2005. Seattle Genetics also said it closed the sale of about 1.1 million shares to investment funds affiliated with Baker Brothers Investments at a price of $5.25 per share, for proceeds of $5.9 million. The sale was part of a stock purchase agreement made in connection with a public offering completed in April. Net proceeds from both offerings combined are about $43.1 million.
• The Global Alliance for TB Drug Development in New York said it is receiving $104 million from the Bill & Melinda Gates Foundation to advance over the next five years a pipeline of new tuberculosis drugs, with the aim of finding a faster and more effective cure. The grant will allow the alliance to advance moxifloxacin into Phase III trials, pursue nine preclinical projects, work with policy-makers to ensure drugs will be accessible in developing countries and analyze market conditions and compliance issues for adopting a new drug regimen once it is proved effective.
• Trinity Biotech plc, of Dublin, Ireland, signed a binding agreement to acquire the coagulation product line of Paris-based bioMerieux for a total consideration of up to $51.9 million. The product line comprises a portfolio of diagnostic tests and a range of automated instruments. Under the terms, Trinity will pay $40 million on closing, together with a maximum of $6.4 million after 12 months and a maximum of $5.5 million after 24 months. Of the combined deferred payments, $5.5 million is contingent upon the achievement of certain milestones for the product line during 2006. The transaction is expected to close in June.