Abbott Laboratories, of Abbott Park, Ill., received approval from the European Commission to market Humira (adalimumab) to treat psoriatic arthritis and early rheumatoid arthritis in Europe. Humira will be available immediately in Germany, the UK, Spain, Finland and Denmark, and upon the adoption of pricing and reimbursement policies in other European Union countries. An FDA decision on the approval of Humira for those expanded indications in the U.S. is expected by the end of this year.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., was awarded a grant from The Michael J. Fox Foundation for Parkinson's Research in New York under its drug discovery and development program. Alnylam and scientific collaborators at Mayo Clinic in Rochester, Minn., are applying RNA interference technology toward the development of a therapeutic for treatment of Parkinson's disease using small interfering RNAs to achieve silencing of alpha-synuclein.
Ascentia Biomedical Corp., of Bellevue, Wash., formed an option agreement with the University of Washington in Seattle for a family of compounds for serious diseases. One compound has shown repeated efficacy in blocking tumors in a relevant, preclinical model of breast cancer. Other compounds will be developed for sepsis, for autoimmune disorders such as arthritis, and as an adjuvant for vaccines used in preventing multiple diseases.
Boston Life Sciences Inc., of Boston, said the FDA granted a new special protocol assessment for Altropane, the company's molecular imaging agent in development to aid in the differentiation of Parkinsonian syndrome tremors from non-Parkinsonian tremors. Under the terms of this agreement, the company can conduct two smaller Phase III trials, POET-1 and POET-2, rather than one large study, and will be permitted to include all subjects currently enrolled in the existing Phase III trial. In addition, the company has reduced its statistical endpoint threshold from p<0.02 to p<0.05 for both studies. Shares of Boston Life Sciences (NASDAQ:BLSI) jumped 82.4 percent Monday, gaining $1.59, to close at $3.52.
Cita NeuroPharmaceuticals Inc., of Mississauga, Ontario, formerly GB Therapeutics Ltd., delayed the pricing of its initial public offering and entered into discussions with an international pharmaceutical firm regarding potential acquisition. The company previously filed an IPO with the Canadian securities agency. Its prospectus said proceeds from the offering would be used to fund ongoing development of its Parkinson's disease drug, CNP1512, set to enter Phase III studies next year, as well as its products to treat neuropathic pain and Alzheimer's disease.
Coley Pharmaceutical Group Inc., of Wellesley, Mass., said the underwriters of its initial public offering exercised in full their overallotment option to buy an additional 900,000 shares at $16 each. That brings the total shares offered in the IPO and the simultaneous private placement to 7.25 million, and the gross proceeds to $120.4 million. Underwriters were Merrill Lynch & Co., JPMorgan Securities Inc., Lazard Freres & Co. and Leerink Swann & Co. (See BioWorld Today, Aug. 11, 2005.)
Connetics Corp., of Palo Alto, Calif., said a Phase III trial showed a robust and highly statistically significant treatment effect for Desilux (desonide) VersaFoam-EF, 0.05 percent, a topical steroid formulated to treat atopic dermatitis. The trial included 581 patients from age 3 months to 17 years. The proportion of patients achieving treatment success on the primary endpoint was 39 percent for Desilux and 9 percent for placebo foam. Data also showed that Desilux was safe and well tolerated.
Exelixis Inc., of South San Francisco, reported plans for Phase II programs for three of its most advanced internally generated development compounds, XL999, XL647 and XL784. XL999 and XL647 are anticancer compounds in late Phase I trials. The company intends to begin a Phase II program for each of those compounds before the end of the year. XL784 has completed a single-dose Phase I trial, as well as additional toxicology and formulation development in preparation for a Phase II program to test its use in diabetic nephropathy.
Gilead Sciences Inc., of Foster City, Calif., and Achillion Pharmaceuticals Inc., of New Haven, Conn., started dosing patients in a Phase I study of GS 9132, also known as ACH-806, in development for the treatment of hepatitis C. The Phase I trial will involve about 20 healthy subjects and evaluate the safety, tolerability and pharmacokinetics of single, escalating doses. Gilead and Achillion established an agreement in November 2004 granting Gilead worldwide rights for research, development and commercialization of certain Achillion compounds.
Kosan Biosciences Inc., of Hayward, Calif., said the Division of Cancer Treatment and Diagnosis at the National Cancer Institute is amending the protocols for its 17-AAG and DMAG (KOS-1022) clinical trials. The decision was made in response to five patients who showed EKG changes without clinically significant consequences after infusion of 17-AAG. Clinical investigators now will obtain electrocardiograms prior to treatment with 17-AAG or DMAG and after infusion in the initial cycle of therapy. The trials will exclude patients with certain histories of cardiovascular disease and the use of certain other medications.
Labopharm Inc., of Laval, Quebec, and Purdue Pharma LP, of Stamford, Conn., signed an agreement for Labopharm, through its European subsidiary, to grant Purdue exclusive rights to market, sell and distribute its once-daily formulation of the analgesic tramadol in the U.S. Labopharm will receive payments of up to $170 million, including an up-front licensing fee of $20 million, a payment of up to $40 million upon regulatory approval, and payments for meeting certain sales targets. Labopharm also will receive royalties ranging from 20 percent to 25 percent of product sales, and will retain co-promotion rights for certain medical specialties. A new drug application for the tramadol formulation is expected to be submitted later this year.
Ligand Pharmaceuticals Inc., of San Diego, said that Nasdaq granted the company's request to extend the deadline to come into full compliance with requirements for continued listing related to filing of SEC reports. The new date is an extension from the July 29 date previously granted. To comply with the extended deadline, Ligand will need to file its form 10-K for the fiscal year ended Dec. 31, 2004 on or before Aug. 31. In addition, it will need to file its first-quarter and second-quarter reports by Sept. 9.
Meridian Bioscience Inc., of Cincinnati, said its board declared a 3-for-2 stock split of the company's common shares. The record date is Aug. 29, with the payment date set for Sept. 2. Cash will be paid in lieu of fractional shares. Meridian markets and distributes diagnostic test kits, purified reagents and related products.
Mesoblast Ltd., of Melbourne, Australia, appointed Michael Spooner as full-time executive chairman until June 30, 2006. The company also reported the promotion of Donal O'Dwyer to non-executive deputy chairman. Mesoblast is an adult stem cell company.
Nektar Therapeutics, of San Carlos, Calif., agreed to acquire Mountain View, Calif.-based Aerogen Inc., which develops products based on its OnQ Aerosol Generator technology to treat respiratory disorders, in a merger transaction valued at $32 million. The purchase is designed to add advanced inhalable liquid drug technology to Nektar's existing inhalable powdered drug platform. The agreement calls for Nektar to provide about $8 million in cash and about $24 million in stock. Upon completion of the acquisition, each share of common stock would be exchanged for a total of 75 cents per share, though Nektar could opt to pay the entire cost in cash, if the payment is made prior to Sept. 15. The transaction is expected to close during the fourth quarter. Aquilo Partners in San Francisco served as financial adviser to Aerogen during the transaction.
Pfizer Inc., of New York, and Bioren Inc., of San Carlos, Calif., completed the transaction in which Pfizer purchased all outstanding stock of Bioren for an undisclosed amount. Bioren is a privately held company specializing in technology for optimizing antibodies. Terms were not disclosed.
Phylogica Ltd., of Subiaco, Australia, and Mimotopes Pty. Ltd., of Melbourne, Australia, signed a partnership agreement to develop next-generation peptide drugs. Phylogica's Phylomer technology comprises peptides that block the harmful interactions between proteins involved in a range of diseases, including stroke, diabetes and asthma. Mimotopes Synphase platform incorporates complementary technology that will enable the rapid production and optimization of large libraries of the Phylomers identified by Phylogica as potential therapeutics.
Predix Pharmaceuticals Inc., of Lexington, Mass., initiated its first Phase III trial of PRX-00023, a 5-HT1A agonist, in patients with generalized anxiety disorder. The company is developing a statistical analysis plan at the FDA's request to complete the special protocol assessment of this study, which will evaluate the efficacy of the drug by measuring the change from baseline in the Hamilton Rating Scale for Anxiety. Up to 310 patients will be randomized to receive either PRX-00023 or placebo over an eight-week period. PRX-00023 is the first of Predix's 5-HT1A agonists developed using its GPCR modeling and screening technology to enter pivotal studies. The company recently filed for an initial public offering to raise as much as $70 million. (See BioWorld Today, Aug. 5, 2005.)
Savient Pharmaceuticals Inc., of East Brunswick, N.J., said the U.S. District Court for the District of New Jersey dismissed, without prejudice, the consolidated amended class-action complaint filed in December 2002 against the company and three of its officers. The complaint was originally filed against Savient, which was then called Bio-Technology General Corp., claiming that its financial statements were false and misleading because it restated year end and quarterly reports of its earnings for the years 1999, 2000 and 2001.
Tercica Inc., of Brisbane, Calif., said Insmed Inc., of Richmond, Va., filed a citizen petition asking the FDA to immediately deny approval of Tercica's new drug application for Increlex. The FDA said the content of the citizen petitition will be made public in about three days. Increlex, or recombinant human insulin-like growth factor-1, is being developed to treat short stature and associated metabolic disorders. Insmed's growth hormone product, SomatoKine, also is awaiting FDA approval.
Vivential Biotech Inc., of Toronto, said its board ratified two interim bridge loans for $900,000 and $2 million obtained on July 26 and Aug. 3, respectively, from Leslie Dan, the company's chairman, and an entity controlled by him. In addition, the board approved and authorized the company to obtain an additional interim bridge loan of $400,000 from Dan to fund ongoing operations. All of the loans are unsecured, have an interest rate of 4.5 percent and are repayable on demand.