SuperGen

SuperGen shares slide on late-stage Dacogen failure

John Carroll — Tue, 01 Jul 2008 12:19:37 -0400

Shares of SuperGen took a dive this morning after the company revealed that Dacogen failed a late-stage trial for the bone marrow disease MDS. Researchers say the drug failed to improve the median survival rate of patients when compared to a group receiving best standard of care. A total of 233 patients volunteered for the trial.

Dacogen is partnered with MGI Pharma, which is now owned by Japan's Eisai. Analysts say Dacogen's failure is a plus for Celgene's Vidaza, which is being relaunched this fall. Dacogen was approved in 2006.

- check out SuperGen's release
- read the AP report

C&L: Kish new president at RHEI

Tue, 10 Oct 2006 20:01:32 -0400

RHEI Pharmaceuticals, which is focused on introducing approved and late clinical-stage proprietary drugs from the U.S. into China, announced today that Timothy M. Kish has joined the company as president and CFO.

Charles P. Slacik has resigned as CFO of Watson Pharmaceuticals to become senior vice president and chief financial officer of Beckman Coulter.

Robert J. Darretta is retiring as chief financial officer and vice chairman of the board in early 2007 after 38 years at the company.

Cardax Pharmaceuticals has appointed Fredric Pashkow, MD as executive vice president and chief medical officer.

Transave has hired Renu Gupta, M.D. as executive vice president of development and chief medical officer.

SuperGen announced that chief operating officer Edward Jacobs will leave the company at year-end.

Pharmos Corporation has named S. Colin Neill as senior vice president, chief financial officer, secretary and treasurer.

GenVec has hired Mark O. Thornton, MD, MPH, PhD as senior vice president, clinical development.

VioQuest Pharmaceuticals has named Lawrence Akinsanmi, M.D., Ph.D., to the role of vice president of clinical operations and regulatory affairs.

Array BioPharma has appointed April H. Teitelbaum, MD, MS, FACP, to the newly created position of vice president of clinical development--oncology.

Diatos SA has named Dr. Jamal Gasmi chief medical officer and Dr. James Cowburn as chief sales and marketing officer.

BioQuest LLC announced that Karen Skillen has joined the firm as managing director of its biopharmaceutical practice.

Penwest Pharmaceuticals announced that Amy O'Donnell, M.D. has joined the company as senior director, clinical development.

The life sciences venture firm Alta Partners announced that Alison de Bord has been promoted to director.

Progenitor Cell Therapy announced that Robert Hamm and Professor K.K. Jain have both agreed to join its board of managers.

The appointment of Maria Borelius as the Minister of Trade for Sweden has led to her resignation from the board of Active Biotech.

Joseph P. Cooper has joined Bioenvision's board of directors.

Rigel Pharmaceuticals has appointed Gary Lyons, an existing board member, to the audit committee.

Stem Cell Sciences has named David A. Dodd a non-executive director.

Affymax has named Daniel K. Spiegelman to its board of directors.

NovaVision named John F. Sasen, Sr. to its board of directors.

Peter O'Callaghan, senior vice president at QLT, and Dr. Simon Pimstone, CEO at Xenon Pharmaceuticals, were elected to BC Biotech's board of directors.

NanoBio has named Ronald M. Cresswell, Ph.D., Hon. D. Sc., F.R.S.E., to its board of directors.

J&J unit gains Dacogen rights in $80M deal

Wed, 05 Jul 2006 20:01:36 -0400

A unit of Johnson & Johnson has inked an $80 million licensing pact for MGI Pharma's Dacogen, which was approved by the FDA last May for patients with myelodysplastic syndromes. MGI will split a $10 million up-front fee from Cilag with SuperGen, which developed the therapy and sold the rights to MGI in 2004. Milestone payments of up to $47 million will also be split and MGI will get $25 million in research money over the next three years. Cilag in turn gets development and marketing rights outside of North America. Dacogen is the subject of several mid- and late-stage trials in the U.S. and Europe for different types of leukemia.

- read the AP report on the development pact

DEALS: J&J buys Pfizer's OTC division for $16.6B

Wed, 05 Jul 2006 20:01:32 -0400

J&J buys Pfizer's OTC division for $16.6B

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Johnson & Johnson	$16.6B sale	Pfizer has sold its OTC division to J&J for $16.6 billion in cash.
Siemens	Bayer Healthcare	$5.3B buyout	Siemens has purchased the diagnostics division of Bayer Healthcare. The move is expected to help Bayer complete the acquisition of Schering.
Barr Pharmaceuticals	Pliva	$2.2B buyout	Barr Pharmaceuticals beat out Actavis Group when generic drug maker Pliva announced that it accepted Barr's $2.2 billion buyout offer.
Johnson & Johnson	Vertex	Collaboration deal	The companies will collaborate to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments.
Takeda	Affymax	$535M deal	Takeda will pay Affymax up to $535 million for the worldwide rights--excluding Japan--to Hematide, a therapy for anemia in cancer and kidney disease patients.
Sanofi-Aventis	Taiho	$360M deal	The deal is for most of the global rights to Taiho's S-1 cancer therapy for colorectal, head and neck cancer
Johnson & Johnson	Metabolex	Licensing deal	Johnson & Johnson is buying into Metabolex's program for diabetes and other metabolic conditions with a new collaboration pact that provides a $40 million equity stake and up to $508 million in milestones.
Mayne Pharma	SuperGen	Licensing deal	Mayne has bought North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments.
Skyepharma	Mundipharma International Holdings	$5M licensing deal	Skyepharma bought back European rights to DepoBupivacaine for its experimental pain drug DepoBupivacaine.
Eli Lilly	Inpharmatica	Licensing deal	Eli Lilly has licensed Admensa Interactive, Inpharmatica's suite of predictive drug absorption, distribution, metabolism and excretion (ADME) models and compound prioritization tools.

Mayne inks $34M deal to buy SuperGen products

Wed, 21 Jun 2006 20:01:36 -0400

Mayne Pharma is buying the North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments. Mayne also says it is in talks to buy the cancer therapy mitmycin for the U.S. from SuperGen. "The addition of Nipent fits our strategy perfectly, building on our core oncology capability, particularly in the important US market," Mayne chief executive Dr Thierry Soursac said.

- read the report on the buyout from The Age

ALSO NOTED: SuperGen gains $20M milestone; Cubist wins FDA OK; and much more...

Thu, 25 May 2006 20:00:50 -0400

> MGI Pharma's move to begin marketing Dacogen as a blood cell disease therapy triggered a $20 million milestone payment to SuperGen. Report

> Cubist Pharmaceuticals scored a big win with the FDA's approval late yesterday for expanding the use of Cubicin to include bloodstream infections. Cubist has made expanded approval a key strategy and expects to net millions of additional revenue as it begins a wider marketing program. Report

> Drug makers are drawing heavy fire from consumer advocates who say that private deals worth tens of millions of dollars are keeping generic drug manufacturers away from their markets. In one case involving Bristol-Myers and Sanofi-Aventis, 10 lawsuits have been filed that tackle a deal that delays a generic competitor to Plavix for years. And regulators may be starting to pay close attention to these generic drug pacts. Report

> NovaDel Pharma says that the FDA has accepted its submission on its NDA for NitroMist as a complete response. Report

> Biopure announced that an FDA advisory committee will meet in two months to discuss a clinical trial of its blood-loss therapy, Hemopure. Report

> Highland Clan announced a reverse takeover of Raptor Pharmaceutical and a $5 million financing. Release

> Agile Therapeutics has completed a $12 million equity financing. Release

> Chutes & Ladders: MultiCell Technologies has hired Stephen M. Chang, Ph.D., as its new CEO. Release

And Finally… Researchers have tracked down the missing viral link in chimps that triggered the AIDS pandemic. Report

FDA approves Dacogen for MDS

Tue, 02 May 2006 20:01:37 -0400

Shares of MGI Pharma took a positive bounce on the news that the FDA had approved its blood cell therapy Dacogen. Dacogen is designed to treat myelodysplastic syndromes (MDS), a disease category that is characterized by poorly functioning blood cells. Phase III data suggest that about one in five patients respond to the drug, which will be launched in the second quarter. SuperGen developed Dacogen and now stands to benefit from its sale.

"This approval is a significant milestone for SuperGen. Over the course of more than seven years, SuperGen developed Dacogen by working with scientists, clinicians, patient advocacy groups, and regulatory agencies to get this product approved for patients with MDS," said James S. Manuso, Ph.D., president and CEO of SuperGen.

- here's the AP report on the FDA approval

SuperGen's Orathecin disappoints in Phase II trial

Tue, 25 Apr 2006 20:01:38 -0400

SuperGen says a Phase II trial of Orathecin plus gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy failed to demonstrate sufficient gains in median survival rates to warrant its advance into a Phase III study. One-year survival statistics were "encouraging," says the company, and Orathecin demonstrated the same safety profile as seen in Phase I.

"We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need and realize its commercial value for our stockholders," said James S. Manuso, SuperGen's CEO.

- here's the release for more information

DEALS: Angiotech follows a combinational route

Wed, 01 Feb 2006 19:01:32 -0500

Angiotech follows a combinational route.

DEALS
WHO	WITH	WHAT	SCOOP
Angiotech Pharmaceuticals	American Medical Instruments	$785 million cash buyout	The deal expands Angiotech's drug development business with combinational devices and gives it a bigger sales force in the bargain.
SuperGen	Montigen	$18M buyout	Montigen's assets include its R&D team, a proprietary drug discovery technology platform and optimization process, and preclinical compounds targeting aurora-A kinase and members of the tyrosine kinase receptor family.
GeoVax	Dauphin Technology	Merger	Emory University emerges as the largest shareholder in venture aimed at developing an AIDS vaccine.
Par Pharmaceutical	FineTech Laboratories	Divestiture	FineTech has been transferred to Arie L. Gutman, Ph.D., president and CEO of FineTech.
Clearview	BioMachines	Acquisition of majority control	The deal is a vote of confidence in BioMachines' future in diagnostics.
AngioGenex	eClic	Reverse merger	The merger allows AngioGenex to go public.

SuperGen inks deal to buy Montigen

Thu, 26 Jan 2006 19:01:36 -0500

SuperGen has inked a deal to acquire Salt Lake City-based Montigen for $18 million in cash and stock. Montigen shareholders will also be eligible to earn up to $22 million more based on established regulatory milestones. Montigen has late-stage compounds in its pre-clinical portfolio. These include inhibitors of aurora-A kinase and products which target the tyrosinekinase receptor family. The compounds have shown pre-clinical activity in solid tumors of several cancer types.

- read this article from the UPI

ALSO NOTED: Chlorogen raises $6M in VC; Antisense receives approval to restart Phase IIa trial; and much more...

Thu, 19 Jan 2006 19:00:50 -0500

> Chlorogen has raised $6 million series B funding. The company will use the investment to finance development of its lead product candidates, which include protein-based therapies for gynecological cancers. Release

> Antisense Therapeutics has received approval from the Ethics Committee of the University of Essen in Germany to restart the Phase IIa trial of its antisense compound, ATL1102, for patients with relapsing-remitting multiple sclerosis. Release

> The FDA is questioning whether GlaxoSmithKline's Xenical can be sold safely over the counter. Report

> Takeda has begun Phase II clinical studies of ATL-962, a treatment for obesity and related diseases. Release

> SuperGen has withdrawn its marketing application for Orathecin from the European Medicines Agency (EMEA). Orathecin is an investigational drug for the treatment of pancreatic cancer. Release

And Finally... Isn't it nice to know your cell phone won't give you brain cancer? Article

ALSO NOTED: FDA panel recommends Zostavax; Serono pleads guilty; Wistar Institute sells royalties;and much more...

Thu, 15 Dec 2005 19:00:50 -0500

> An expert FDA panel has recommended Merck's Zostavax for people 60 or over. The vaccine is designed to prevent shingles. Report

> Switzerland's Serono has pled guilty to criminal charges that it paid kickbacks to doctors in order to boost falling sales of its drugs and formally agreed to pay $704 million to settle criminal fines and civil claims. Prosecutors said that Serono made illegal payments to doctors and provided trips to France in exchange for their prescribing Serostim. Report

> The Wistar Institute has sold some of its anticipated royalties in the experimental drug Rotateq to Paul Capital Partners for $45 million. Report

> CollaGenex Pharmaceuticals has struck a deal to pay up to $6.75 million for SansRosa Pharmaceutical Development. Report

> Ortec International will buy the privately held Hapto Biotech. Release

> Halozyme has initiated a clinical trial of Hylenex. Release

> OSI Pharmaceuticals has priced a private placement of $100 million in senior notes. Release

> ImaRx has completed a private placement of $15 million in shares. Release

> MGI Pharma and SuperGen say that the FDA has accepted their resubmission in response to the agency's approvable letter for Dacogen. Release

> Invitrogen and genOway have inked a co-marketing agreement around RNAi-related services. Release

> Corgentech and AlgoRx have formally completed their merger. Release

And Finally… New research published in The Lancet predicts that the number of dementia cases will double every 20 years. Currently, 24.3 million people are believed to suffer from dementia. Report

ALSO NOTED: Amgen selects manufacturing site; Discovery Labs inks collaboration deal;and much more...

Sun, 11 Dec 2005 19:00:50 -0500

> Amgen has reportedly selected a site in Ireland for a $1.54 billion manufacturing plant. Release

> Discovery Labs and Chrysalis Technologies are partnering to develop and commercialize aerosolized surfactant replacement therapies for treating respiratory conditions. Article

> Alexion Pharmaceuticals has announced three year cumulative data for patients given eculizumab. Release

> TransGene has released positive Phase I/II data for an experimental therapy for skin cancer. Release

> Ambit Biosciences has expanded its collaboration with Bristol-Myers Squibb. Release

> Vanda Pharmaceuticals has initiated a Phase III clinical study of iloperidone, an antipsychotic agent in development for schizophrenia and related disorders. Release

> Amgen, Supergen and MGI Pharma all used the weekend meeting of the American Society of Hematology to tout their clinical trial data for experimental therapies. Article

> Germany's Schering AG says it will lay off between 65 and 125 workers at its Jenapharm unit as part of a cost-cutting program. Jenapharm's research activities will be integrated into Schering's Berlin operations. Report

> In a Phase II study of patients with advanced indolent non-Hodgkin's lymphoma who were previously exposed to multiple courses of therapy, 74 percent responded to Cephalon's Trenda (bendamustine HCl), including 35 percent with a complete response. Release

And Finally… Health officials are warning that a rapid HIV test is delivering too many false positives. Article

SPOTLIGHT: Developers pull European Dacogen application

Mon, 14 Nov 2005 19:01:33 -0500

MGI Pharma and SuperGen have pulled their European application for Dacogen injection saying they will need to provide more clinical data. But the companies added that the decision won't have an impact on their US application and have submitted their response to the FDA's approvable letter. Release

SuperGen, MGI predict delay in European OK for Dacogen

Wed, 26 Oct 2005 20:01:37 -0400

SuperGen and collaborator MGI Pharma said that a recent meeting with European regulators has led them to believe that they may have to delay the launch of Dacogen on the continent so they can provide more data on the treatment. The FDA issued an approvable letter for Dacogen September 1, indicating that the drug developers needed to provide more information on the drug before it achieved final marketing approval. SuperGen and MGI Pharma have been seeking regulatory approval to market Dacogen as a treatment for myelodysplastic syndromes, in which the body loses its ability to manufacture healthy new blood cells.

- read this article from MarketWatch for more

C&L: Dr. Egberts to take helm at NovaDel

Tue, 27 Sep 2005 20:01:32 -0400

NovaDel Pharma has appointed Dr. Jan H. Egberts to the position of COO and to succeed Dr. Gary Shangold as president and CEO of NovaDel, effective December 23, 2005. Dr. Egberts joins NovaDel from Dynogen Pharmaceuticals, where he was the COO.

Pluristem Life Systems has appointed Zami Aberman as CEO. Shai Meretzki will resume his position as chief technology officer. Aberman operated within high-tech global companies in the fields of Automatic Optical Inspection, network security, Video over IP, software, chip design and robotic markets.

Assay Designs has appointed Gustavo Salem as president and CEO. Prior to joining Assay Designs, Salem held a variety of positions at Bio-Rad Laboratories in Hercules, California, including Division Manager of Protein Separations and Business Unit Manager for Biomaterials.

Genizon BioSciences has named Claude Lambert, CA, MBA, as vice-president and CFO and Dr. Renno Schuurmans as vice-president, business development, Europe.

Alastair McEwan has joined Cornerstone BioPharma as CFO. He has substantial experience in fund raising activities at all levels and has participated in two successful IPOs, most recently while at Inveresk Research Group, where he served as a member of the Group Executive Board and president of the Global Clinical division.

Questcor Pharmaceuticals named George Stuart as vice president of finance and CFO. Stuart joins Questcor from Xcel Pharmaceuticals, where he was vice president of finance, CFO and treasurer.

Oncolytics Biotech has named Karl Mettinger, MD, PhD, as chief medical officer. Prior to joining Oncolytics, he was senior vice president and chief medical officer with SuperGen.

Depomed has promoted Carl Pelzel to executive vice president and COO. Pelzel joined Depomed in June 2005 as vice president, marketing and commercial development.

IsoTis OrthoBiologics has appointed Kathryn (Kathe) E. Liljestrand as vice president marketing.

Pharmasset has appointed Lynn Hill as vice president, alliance & project management and Darryl Cleary, as vice president, manufacturing.

FoldRx has appointed Christoph Adams, PhD, as the company's first chief business officer. Dr. Adams comes to FoldRx having held senior-level management positions at Ciba-Geigy, Transkaryotic Therapies, and most recently ViaCell.

Tony Alvarez has been appointed to the newly created position of vice president, Commercial Operations, Schering-Plough in Japan. He joined Schering-Plough in 2003 as vice president, Global Business Planning and Services, following a career with Pharmacia.

AVANIR Pharmaceuticals has elected Craig A. Wheeler to the board of directors to fill a vacancy resulting from the resignation of Dennis J. Carlo, PhD.

Peter G. Schultz, PhD, has joined Nanosphere's board of directors.

Neil MacAllister has joined INC Research's board of directors.

Feds ask for more data on Dacogen

Thu, 01 Sep 2005 20:01:39 -0400

Shares of MGI Pharma and SuperGen slid this morning after they announced that the FDA issued an "approvable" letter for Dacogen -- their new treatment for bone marrow disorders -- but would need more data before the agency could give it a green light. MGI Pharma bought the treatment from SuperGen last year, leaving SuperGen with a 30 percent royalty deal. The FDA's letter, though, did state that the drug could be approved after an analysis to determine how many patients currently in a trial received a blood transfusion. That data could be delivered in the fourth quarter.

"We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during the fourth quarter," stated Lonnie Moulder, president and CEO of MGI Pharma. "The MGI Pharma commercial organization is prepared to launch Dacogen injection upon final FDA approval."

- read this story from MarketWatch for more

ALSO NOTED: OxiGene touts data; Caraco wins FDA nod; SuperGen cited for leukemia ads; and much more...

Mon, 22 Aug 2005 20:00:50 -0400

> OxiGene is touting new clinical data for its lead vascular disruption agent. Release

> Detroit-based Caraco Pharmaceutical Laboratories has received the FDA's approval of an ANDA for Zolpidem Tartrate, 5mg and 10mg tablets. Release

> Dublin, California-based SuperGen has been cited by the FDA for what it calls misleading ads about SuperGen's Nipent leukemia drug. Story

> India's Biocon will collaborate with Nobex on a new oral peptide therapy for cardiovascular disease. Report

> A federal judge has dismissed a class-action suit against Saddle River, New Jersey-based PDI. Release

> The FDA has cleared a new pharmacogenetic test from Third Wave Technologies of Madison, Wisconsin. Release

And Finally… The Washington Post examines the 40-year career of Robert Webster, who's pioneering work on avian flu continues to play a key role in fighting against an outbreak of a global pandemic. Article