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NeuroVive Picks Up Biotica Polyketide Assets
Biotica, which was spun out from Cambridge University in 1996, had long been a pioneer in this area, and it had further consolidated the available technology in this space by acquiring assets from New York-based Bristol-Myers Squibb Co., which the latter firm had picked up in its 2008 takeover of Kosan Biosciences, of Hayward, Calif...NeuroStat has completed a Phase I trial and is being readied for a Phase IIa trial to prevent traumatic brain injury The deal does not include Biotica's rapamycin -
Aeterna Zentaris Slides on Perifosine Miss in Myeloma
Analysts had speculated last year that the Quebec City-based firm might terminate the study in relapsed or refractory multiple myeloma after perifosine failed to improve overall survival in colorectal cancer – a finding that cost Aeterna Zentaris its 2002 partnership with New York-based Keryx Biopharmaceuticals Inc -
Pharma: Clinic Roundup
Pfizer Inc., of New York, said the REMINDER trial of Inspra (eplerenone) showed statistically significant risk reductions in the primary composite efficacy endpoint, defined as time to first event of cardiovascular mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) BioWorld Today | Tuesday, March 12, 2013
Other News To Note
Celtic Therapeutics Management LLLP, of New York, changed its name to Auven Therapeutics Management LLLP to overcome confusion related to other Celtic entities...Retrophin Inc., of New York, reported data from a series of in vitro and in vivo experiments showing that RE-024 rescued the phenotype of pantothenate kinase-associated neurodegeneration (PKAN), demonstrating successful replacement therapy proof of concept
Clinic Roundup
Ziopharm Oncology Inc., of New York, initiated a randomized, open-label Phase II study of Ad-RTS IL-12 (previously ZIN ATI-001) in combination with palifosfamide in nonresectable recurrent or metastatic breast cancer
Pharma Clinical & FDA Action Update: February 2013
everolimus To prevent organ rejection in liver transplant patients FDA approved it 2/20/13 Novo Nordisk A/S (Bagsvaerd, Denmark) Tresiba and Ryzodeg Insulin degludec and insulin degludec/insulin aspart Diabetes Received a complete response letter from the FDA on its NDAs 2/13/13 Pfizer Inc. (New York) Lyrica Pregabalin capsules CV Refractory partial onset seizures in epilepsy Phase III data showed it was as effective as levetiracetam 2/22/13 Sanofi Pasteur (Lyon, France) Hexyon/Hexacima 6-in-1
Phase II Clinical Trials Update: February 2013
company is terminating development 2/1/13 Adynxx Inc. (San Francisco) AYX1 A small synthetic, dsDNA molecule that blocks EGR1 function by mimicking the genomic sequence EGR1 normally binds To prevent postsurgical pain First patient was dosed in a Phase II trial 2/26/13 BrainStorm Cell Therapeutics Inc. (New York) NurOwn Stem cell therapy Amyotrophic lateral sclerosis Began treating its first patient in a Phase IIa trial 2/5/13 Phytopharm plc (Godmanchester, UK) Cogane Product based on Asian
Phase I Clinical Trials Update: February 2013
New York) ITI-214 Phosphodiesterase 1 inhibitor Schizophrenia Completed a Phase I trial, showing it was safe and well tolerated 2/20/13 Neurovance Inc. (Cambridge, Mass.) EB-1020 Sustained-release formulation Adult attention deficit hyperactivity disorder Started a Phase I trial 2/22/13 GASTROINTESTINAL Avaxia Biologics Inc. (Lexington, Mass.) AVX-470 Its oral anti-TNF antibody Ulcerative colitis First patient was dosed in a Phase Ib study 2/26/13 INFECTION Integrated BioTherapeutics Inc
Other News To Note
China Botanic Pharmaceutical Inc., of Harbin, China, said that on March 1, the company received notice from the staff of the New York Stock Exchange that the plan of compliance previously submitted to the exchange had been accepted with a compliance date of May 1
Clinic Roundup
Ziopharm Oncology Inc., of New York, said an investigator-sponsored multicenter single-arm Phase II trial of palifosfamide (ZIO-201) has started in recurrent metastatic germ cell tumors
Appointments and Advancements
Intercept Pharmaceuticals Inc., of New York, appointed Daniel Regan chief commercial officer
Biotech IPOs: Are They Poised For a Major Surge This Year?
The biotech IPOs that have priced in 2013 include antibody drug developer KaloBios Pharmaceuticals Inc., which priced a slightly upsized offering of 8.75 million shares at $8 apiece for gross proceeds of $70 million and Stemline Therapeutics Inc., of New York, which closed its IPO of 3.8 million shares, including the exercise in full of the overallotment option covering 497,647 shares, at a price of $10 per share
Adcoms Recommend Higher Standards for Calcitonin Drugs
Rather than withdraw calcitonin drugs, they urged the FDA to require new labeling, including a warning of a possible cancer risk and a definition of "short-term use." "If we take this away, I think a lot of our patients would be in worse shape," Richard Bockman, head of endocrine service at the Hospital for Special Surgery in New York, said as he voted to allow continued marketing
Pharma: Clinic Roundup
Pfizer Inc., of New York, said results from a Phase III study demonstrated immunogenicity, tolerability and safety of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) in adults infected with HIV
Appointments and Advancements
NeoStem Inc., of New York, added Stephen W. Potter to its board
Medivir, Gilead Oral Drug Pair Strong in HCV, Early Phase IIa
Among them is New York-based Bristol-Myers Squibb Co. (BMS), which has tested it with the NS5A replication complex inhibitor daclatasvir with satisfying early stage results that could provide BMS with an important competitive edge, Levine-Wilkinson said
Other News To Note
Ventrus Biosciences Inc., of New York, reported results from a study investigating the quality of compounded topical 2 percent diltiazem hydrochloride formulations for anal fissures
Public Financing Of Biotechnology: February 2013
BMO Capital Markets Baird $75 N/A Ventrus Biosciences Inc. (New York; VTUS)6 2/10/12 2/4/13 6.67S and 0.22S of Series A $2.50 and $25 18.73 William Blair $22.2 $46.825 Total: $269.06M Number of follow-on offerings in February: 8 Average value of February follow-ons: $33.63M Number of follow-on offerings in 2013: 23 Total raised in follow-ons in 2013: $2,465.86M Average value of follow-ons in 2013: $107.2M Notes: # Unless otherwise indicated, shares are traded on the Nasdaq exchange
Other Financings Of Public Biotechnology Companies: February 2013
the company will receive proceeds of $8M 2/7/13 BrainStorm Cell Therapeutics Inc. (New York) Common stock purchase agreement 0.833S $0.25 BrainStorm raised $250,000 through an agreement with an individual private investor, selling 833,334 common shares at $0.30 per share with a 32-month warrant to purchase up to 0.833 shares of common stock at $0.50 per share 2/12/13 Celsion Corp. (Lawrenceville, N.J.) Registered direct offering 12.1S $15 Celsion received $15M in commitments from institutional
Venture Capital And Other Investments In Private Biotechnology Companies: February 2013
New York $10 Retrophin raised $10M by issuing 3.3M shares and warrants for 1.5M shares
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