In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...Operating expenses for the quarter increased to $128.1 million compared to $66.8 million for the first quarter of 2012, with Jazz citing high cost of product sales due to a change in product mix and lower gross margin due to inclusion of products from the EUSA Pharma acquisition...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation

Valeant Pharmaceuticals International Inc., of Laval, Quebec, has provided additional information related to the proposal to continue Valeant into British Columbia under the British Columbia Business Corporations Act...The continuance will be presented for shareholder approval at the company's annual meeting of shareholders on May 21

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

Valeant has granted Actavis the exclusive right to co-promote Zovirax cream to obstetricians and gynecologists in the U.S., and Actavis has granted Valeant the exclusive right to co-promote Actavis Specialty Brands' Cordran Tape (flurandrenolide) product in the U.S...and, Kayexalate is prescribed to remove dangerously high levels of potassium in the blood

Another $13 million to $15 million in equipment, integration service and testing will be provided by Agila...Cardiome Pharma Corp., of Vancouver, British Columbia, said Institutional Shareholder Services Inc...The compounds are thought to have relevance for Parkinson's disease

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch...Medigene's partner, Nordic Pharma Group, of Paris, is planning to launch Veregen in the Czech Republic, Poland, Hungary and Slovakia this year, upon conclusion of the reimbursable price-fixing procedure by the responsible authority...The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology

With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or is metastatic and no longer responding to Gleevec (imatinib, Novartis AG) and Sutent (sunitinib, Pfizer Inc.), two other FDA-approved drugs to treat GIST...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

The merger is expected to close as soon as practicable...It also licensed rights to an oral calcitonin tablet to Tarsa Therapeutics Inc., of Philadelphia, which is developing it for postmenopausal osteoporosis

Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7.1 showed promising safety and tolerability in heavily pretreated solid tumors...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals

In addition to active involvement in the development of the monoclonal antibody, AET BioTech will provide additional investment in the biosimilar based on committed long-term financing and will oversee future commercialization of the product...IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...Medgenics Inc., of Misgav, Israel, said it presented preliminary data

Results of a Mini-Sentinel assessment of Pradaxa (dabigatran etexilate mesylate, Boehringer Ingelheim GmbH) bleeding rate were not higher than those associated with new use of warfarin, according to the FDA...The agency investigated actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin using insurance claims and administrative data...Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need

IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...Medgenics Inc., of Misgav, Israel, said it presented preliminary data at the American Society of Nephrology's annual meeting from its ongoing Phase IIa trial in Israel with Epodure Biopumps to treat anemia in patients on dialysis with end-stage renal disease, by sustained delivery of erythropoietin...Ventrus has

and Acetylon Pharmaceuticals Inc., among others. (See BioWorld Today, Feb. 10, 2012, Sept. 17, 2012, and Sept. 24, 2012.) The company isn't worried, however, and in a flash note following the acquisition of pracinostat, Roth Capital Partners analyst Joseph Pantginis described the compound as a "positive expansion of MEI Pharma's pipeline...The company also received $25.0 million from the sale of common stock in a private placement to strategic partner AstraZeneca plc, of London, that closed

Forest Laboratories Inc., of New York, said preliminary results from its annual meeting indicate that shareholders have selected nine of the company's 10 director nominees and one of billionaire investor Carl Icahn's four nominees, Pierre Legault, to its board...Renaissance Pharma Inc., of Newtown, Pa., acquired the U.S...and New American Therapeutics Inc., of Cranford, N.J. Renaissance established a new subsidiary, Prestium Pharma, to commercialize the prescription antiviral indicated for the

In other news from Forest, shareholder Carl Icahn and the company are continuing their battle over the leadership and direction of the firm in advance of an Aug. 15 annual meeting

The news helped drive up the company's share value, which vaulted 114 percent in the second quarter. (See BioWorld Today, May 21, 2012.) One of the winners from the recent annual meeting of the American Association for Cancer Research was Pharmacyclics Inc...Impressive data presented at the annual meeting of the American Society of Hematology also showed its ability to fight chronic lymphocytic leukemia. (See BioWorld Today, Dec. 13, 2011.) For the quarter, Pharmacyclics' shares jumped 97 percent