The sizzling initial public offering (IPO) market gained two more biopharma contestants with a third moving carefully toward it, as Prosensa Therapeutics BV filed an F-1 registration statement, Evoke Pharma Inc. filed an S-1 and Oculus Innovative Sciences Inc. disclosed that subsidiary Ruthigen Inc. submitted a confidential draft registration statement to the SEC. Prosensa is seeking to raise up to $60 million and a listing on Nasdaq under the symbol "RNA." Evoke, a specialty pharma developing

LONDON – Two of Europe's longest-standing public biotechs are leaving the stage following clinical trial failures, with Agennix AG going into liquidation and Phytopharm plc announcing a reverse merger. Agennix has been looking for a path forward since the bust in August 2012, when it reported negative results for the 742-patient Fortis-M Phase III trial of lead product Talactoferrin alfa in treating advanced non-small-cell lung cancer. The result was unequivocal, with median overall survival of

Alkermes plc, of Dublin, Ireland, reported Phase I data showing that ALKS 3831, a drug candidate for treating schizophrenia, produced significantly less weight gain in subjects compared to olanzapine. ALKS 3831 combines olanzapine with the company's opioid modulator, ALKS 33, to treat schizophrenia without the associated weight gain usually seen with olanzapine treatment. Data showed the drug also was found to be safe and well tolerated. Those results were presented at the New Clinical Drug

Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported data from the EXPEDITE study at the First European Congress on Intrapartum Care in Amsterdam, the Netherlands, which demonstrated that use of a controlled-release misoprostol vaginal insert significantly reduced time (21.5 hours vs. 32.8 hours) to vaginal delivery compared to a dinoprostone vaginal insert. Misoprostol is a synthetic prostaglandin E1 analogue used for labor induction. The EXPEDITE study compared the efficacy and

Addex Therapeutics SA, of Geneva, is evaluating steps to reduce its operating costs and work force to conserve cash while ADX71149, its mGluR2 positive allosteric modulator, is being developed through a partnership with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. The compound is in clinical development, funded by Janssen, for schizophrenia and anxious depression. In accordance with Swiss law, Addex has initiated a consultation process to determine its

At a time when a majority of biotech companies are partnering up with big pharma for Phase III trials, Ophthotech Corp., of Princeton, N.J., is building a war chest to go it alone. The company raised $175 million to support a global Phase III program for Fovista, an antiplatelet-derived growth factor (anti-PDGF) agent, in combination with anti-VEGF therapy for age-related macular degeneration (AMD). The $175 million breaks down into $125 million from Novo A/S, in exchange for royalties on

Revamping Medicare Part D, for some people, would be the health care equivalent of remaking Gone with the Wind. Some classics just shouldn't be messed with, they reason. When it comes to government programs, Part D, which covers prescription drug costs, is a classic. The long-running blockbuster hit boasts 90 percent participation and a 94 percent approval rating. And its costs continue to come in at 45 percent under budget. But despite its successful run of nearly a decade, Part D could be in

LONDON – Following an 18-month hiatus, ImmuPharma plc can now proceed with Phase III development of its lupus treatment, Lupuzor, after agreeing to a £50 million (US$75.7 million) loan to finance the trial. The product has been stalled since October 2011 when ImmuPharma took back rights following the acquisition of its partner Cephalon Inc. by Teva Pharmaceutical Industries Ltd. At that point, the London-based company expected it would rapidly find another partner and said it would not do any

GlaxoSmithKline plc, of London, and the Biomedical Advanced Research and Development Authority (BARDA) agreed to a collaboration that will support the development of several antibiotics to fight antibiotic resistance and bioterrorism. The public-private agreement calls for the Department of Health and Human Services to provide $40 million for the initial 18-month agreement and up to $200 million if the agreement is renewed over five years. The agreement will be governed by a BARDA-GSK joint

Adherex Technologies Inc., of Research Triangle Park, N.C, said it received feedback from the FDA at an end-of-Phase II meeting, during which the company proposed a small pivotal single-arm study to testing eniluracil/5-FU/leucovorin in metastatic breast cancer patients, based on data from patients who had rapid disease progression on Xeloda (capecitabine, Roche AG). The agency, however, strongly recommended that Adherex consider other larger clinical trial design alternatives. Adherex said, in

SHANGHAI, China – Chipscreen Biosciences Ltd., of Shenzhen, China, reported encouraging Phase II trial results for its Chidamide (formerly HBI-8000) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who had failed at least one prior systemic therapy. Unlike currently available treatments which are delivered intravenously, Chidamide is an oral agent and is particularly effective against the most aggressive subtype of PTCL that's far more common in Chinese patients than

BioWorld's offices were closed Monday, May 27, in observance of the Memorial Day holiday in the U.S. No issues were published that day.

Flu pandemics are a sure thing. But what is not a sure thing at all is which viral strain will be the one to cause the next pandemic. The most recent potential candidate is the H7N9 strain that first reared its head earlier this year. To date, there have been around 130 confirmed infections and 30 deaths from the new strain. Like H5N1, the even more lethal strain of influenza that is still sporadically rearing its head, the number of cases has been small. But the worry is what will happen if

Novo Nordisk A/S, of Bagsvaerd, Denmark, reported top-line results from a 56-week Phase IIIa trial testing the potential of GLP-1 drug liraglutide to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as prediabetes, hypertension and dyslipidemia. From a mean baseline weight of 106 kg and a body mass index (BMI) of 38 kg/m2, the average weight loss for those treated with liraglutide 3 mg was 8 percent vs. 2.6 percent for the placebo

The decision by Merck & Co. Inc. to end its Phase III program with preladenant based on three studies that failed to show efficacy in Parkinson's disease put the spotlight on adenosine A2A receptor antagonists as a class, which has been explored by a handful of other companies, some of them with work still under way. Merck, of Whitehouse Station, N.J., said last week that the company is "taking steps to discontinue" the extension phases of the studies and will abandon bids for regulatory

Seaside Therapeutics Inc. reluctantly terminated an open-label extension study of STX209 (arbaclofen), for Fragile X syndrome, due to resource limitations. The company said the decision was not related to any safety issues with the drug, and expressed regret that the termination of the trial would be "disruptive and disappointing for many families." STX209 did not meet its primary endpoint of reducing social withdrawal in the recently completed Phase III trial, but the Cambridge, Mass.-based

Elan Corp. plc, of Dublin, Ireland, priced its offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021 by its wholly owned subsidiaries, Elan Finance public limited co. and Elan Finance Corp. Net proceeds of the offering, set to close May 31, will be deposited into escrow pending the closing of Elan's previously announced royalty participation transaction with South San Francisco-based Theravance Inc. Earlier this month, Elan offered $1 billion in cash to buy a