Nektar Iherapeutics

Novartis pays $115M for Nektar pulmonary assets

John Carroll — Tue, 21 Oct 2008 10:52:51 -0400

Nektar Therapeutics has sold certain assets from its pulmonary business to Novartis for $115 million, leaving the company free to concentrate on developing new therapeutics. And Novartis says it will use the technology to advance new drugs for COPD, asthma and cystic fibrosis.

In the deal Novartis takes control of dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility capital lease obligations. The pact also transfers about 140 Nektar personnel to Novartis. And Nektar will transfer manufacturing and royalty rights to the Tobramycin inhalation powder program, which is already partnered with Novartis.

Nektar will retain its Bayer HealthCare-partnered program NKTR-061, scheduled to enter Phase III clinical trials by year-end, and royalties to Ciprofloxacin inhaled powder, also partnered with Bayer HealthCare. Likewise, Nektar will retain NKTR-063, scheduled to enter Phase II development in the U.S. early next year.

"This agreement will allow us to focus our efforts on the development of novel therapeutics using our PEGylation and conjugate chemistry-based drug development platforms," said Nektar CEO Howard W. Robin (photo). "The transaction also strengthens our balance sheet and significantly reduces expenses. It is a perfect example of our ability to monetize assets that had little future value for Nektar."

- check out the press release
- read the AP story

C&L: Somnus names executive team

Wed, 28 May 2008 06:59:52 -0400

Gary Cupit, PharmD, has been named CEO of Somnus Therapeutics. The rest of the executive team: Mary Osbakken, MD, PhD, chief medical officer; Christine Blumhardt, PharmD, chief regulatory officer; Linda Hogan, MS, MBA, chief business officer; Anne McCormick, MSW, director, clinical project management.

Altus Pharmaceuticals has appointed Georges Gemayel as CEO and member of the board of directors.

Amazon Biotech announced that Eliyahu BenTal Tolchinsky has been appointed as director and CEO.

NicOx said development chief Damian Marron will leave May 30 and will be replaced by Sanjiv Sharma, vice president of commercial affairs, and Gavin Spencer, senior director of business development. Marron will become CEO of another, unnamed biopharmaceutical company.

CyDex Pharmaceuticals announced that Theron E. Odlaug, Ph.D. has been appointed to the newly established position of president and chief operating officer.

Nektar Therapeutics named Bharatt Chowrira chief operating officer and head of the company's PEGylation Business Unit.

Nanobiotix it has appointed Elsa Borghi, MD, as medical director.

Adolor named Eliseo Oreste Salinas senior vice president of research and development and chief medical officer, effective June 2.

Schering-Plough Corporation announced that Janet M. Barth has been appointed vice president, investor relations. Endo Pharmaceuticals Holdings has named Blaine T. Davis vice president, investor relations and corporate communications. Ipsen has named Gerard Picot vice-president, global regulatory affairs.

Orchid Cellmark has named Jeffrey S. Boschwitz, Ph.D., vice president of North America marketing and sales.

Elan Corporation has named Patrick Kennedy and Donal O'Connor to the board of directors.

VentiRx Pharmaceuticals named Dr. Elliott Grossbard to its board of directors.

Struggling VaxGen put Paul De Stefano and Lori Rafield onto its board after three members quit.

A deluge of pre-ASCO data hits the market

Fri, 16 May 2008 06:59:57 -0400

As we mentioned earlier this week, data from almost 5,000 clinical studies was released last night in preparation for next week's ASCO meeting. And some of the most interesting data won't be released until the conference. In the meantime, here's a sampling of the trial results that are making waves today.

Kidney cancer patients taking Novartis' RAD001 (everolimus) had progression of their disease delayed by a year, a significantly better result than in those taking placebo. Release
Amgen's brain tumor drug AMG-102 may only work on a subset of patients. The data is from a small Phase II study of the drug. On a better note, Amgen said denosumab cut the risk of bone fractures in cancer patients, outperforming Novartis' Zometa in an early stage trial. Release
A Phase III trial of Avastin for early-stage colon cancer will be available sooner than previously thought, said Genentech, because of faster data collection and more patients with the disease. Data will be available in 2008--a full year earlier than previously planned. Release
BioVex said data from a Phase II trial of OncoVEX demonstrated an impressive rate and durability of response in patients with advanced metastatic melanoma. Release
Nektar Therapeutics announced results form a Phase I study of NKTR-102. The data shows significant anti-tumor activity in patients with refractory solid tumors. Release

Inhaled insulin lung cancer warning riles investors

Wed, 09 Apr 2008 06:59:58 -0400

The inhaled insulin field got blitzed again today after Nektar Therapeutics and Pfizer reported an increased number of lung cancer cases among patients taking the therapy during clinical trials. Nektar swiftly dumped its effort to find a new marketing partner--Pfizer had already announced its plans to pull out--and saw its stock plunge 30 percent. Even harder hit was Mannkind, which is developing its own inhaled insulin. Its stock went into free fall, losing 60 percent of its value as investors applied some dour logic from Nektar's failure to the whole area of drug development. Looking over trial data, researchers noted that six of 4,740 patients taking Exubera developed lung cancer compared to one in the control arm. Those figures were too small to reach a statistically valid conclusion whether the drug caused the cancer, and all patients were known smokers and therefore already in a high risk category. A warning on the cancer risk will be put on Exubera labels.

The cancer warning creates yet another black eye for the prospects of inhaled insulin. Once upon a time inhaled insulin was seen as a likely garden of blockbuster therapies. But that has turned around fast, as major drug developers wash their hands of pacts and go on to other programs. Exubera was once thought to be worth more than $2 billion a year, but sales have fallen far, far short of that mark.

"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Joe Feczko, MD, Pfizer's chief medical officer.

- see Nektar's release
- read the report in the Wall Street Journal

Related Articles:
Pfizer gives Nektar $135M for Exubera settlement
Pfizer kills off Exubera, hunts for deals
Exubera becoming a big disappointment for Pfizer
UK: Exubera not worth the price.
MannKind bets the farm on inhaled insulin

ALSO NOTED: Osiris inks $224M contract; Baxter and Nektar to collaborate;and much more...

Mon, 07 Jan 2008 06:59:50 -0500

> Osiris Therapeutics has inked a deal with the U.S. Defense Department to supply a potential $224 million worth of Prochymal for use in treating military personnel exposed to radiation. Release

> Osiris also regained all worldwide rights to Prochymal. Release

> Baxter International and Nektar Therapeutics are teaming up to investigate new therapies for a rare form of hemophilia. Report

> BrainStorm Cell Therapeutics has expanded its collaboration with Rutgers University aimed at curing spinal cord injuries through adult stem cell research. Release

> Jazz Pharmaceuticals has received orphan drug designation for an experimental epilepsy therapy. Report

> Waltham, MA-based Magen BioSciences has acquired the rights to dermatology compounds from Eli Lilly. Report

> Making a living off pharmaceutical companies suddenly isn't so lucrative: IMS Health, the market research company responsible for so much of the hard data on drug sales, is laying off about 10 percent of its work force. Report

> Celgene announced that it expects fiscal 2007 profits to double to $1.05 per share, as sales of its cancer drug Revlimid skyrocket. Report

> As if Amgen didn't have enough to worry about with its anemia drugs under fire. The company is defending itself against charges of bull-whipping sales reps into marketing drugs off label and violating patients' privacy. Report

And Finally... A pharma nightmare with an English accent: The UK government wants to slash prices for prescription drugs by 10 percent. Report

ALSO NOTED: FDA says no to Indevus; Nektar gets sweetened deal with Baxter; Akela pulls public offering; and much more...

Thu, 20 Dec 2007 06:59:50 -0500

> Indevus Pharmaceuticals says that the FDA has turned thumbs down on its new therapy for bladder cancer, a move that trimmed its stock value. Valstar was pulled from the market five years ago after an unstable ingredient was found in its original formulation. Indevus says that issue has been fixed, but regulators rejected its marketing application due to chemistry and manufacturing concerns. Deficiencies had been noted at a third-party manufacturing facility slated to make the drug. The company says it can sort out those problems in months and plans a new application with a request for a new inspection of the unnamed facility. Indevus obtained Valstar when it bought out Valera Pharmaceuticals earlier this year. Release

> Nektar Therapeutics has sweetened its deal with Baxter International to develop improved therapies for hemophilia. Under a pact extension, Nektar will be able to earn up to $44 million in upfront fees and milestones for its work on pegylated forms of hemophilia drugs. The new collaboration is an extension of a deal the two companies forged in 2005. Release

> Akela Pharma has become the latest biotech victim of a chilly market environment, abandoning its U.S. public offering as it explores alternative financing sources. Release

> Ligand Pharmaceuticals picked up a million-dollar milestone on Glaxo's submission of an NDA for Promacta. Release

> Vertex Pharmaceuticals is pondering the idea of consolidating its scattered operations in Cambridge into an office tower on the South Boston Waterfront. Report

> Novavax announced favorable interim results from a Phase I/IIa human clinical trial of its non-adjuvanted pandemic influenza virus-like particle vaccine candidate. Release

> Forbes Medi-Tech is asking shareholders to approve a reorganization that will allow it to undertake new financing options. Release

> Akers Biosciences chairman David Wilbraham has converted fees into 61,017 shares in the company. Report

> There's nothing like a whistleblower lawsuit to get a company riled. A former Pfizer exec has accused the company of using continuing medical education as stealth marketing for its cholesterol drug Lipitor. Report

> A copycat of Wyeth's Effexor XR could cut $500M off the company's sales. Report

> Now here's an op-ed Big Pharma can unite behind. In the Baltimore Sun, journalist and patient Naomi Wax assails the FDA for calling generic drugs exactly equivalent to their brand-name counterparts. Report

And Finally… Scientists have advanced a new nanotech process to engineer replacement blood vessels. Release

C&L: Somaxon names interim CEO

Wed, 12 Dec 2007 06:59:52 -0500

Somaxon Pharmaceuticals' current non-executive chairman of the board, David F. Hale, has been appointed executive chairman and will become interim CEO effective January 1, 2008. Kenneth M. Cohen has resigned as president and CEO, effective December 31, 2007.

David Stout, GlaxoSmithKline's president of pharmaceuticals, plans to leave the company in February while Chris Viehbacher, president of the U.S. pharmaceuticals division, will join the board at the end of January.

Nektar Therapeutics promoted John Nicholson to chief financial officer, replacing Tim Harkness.

Ceregene has promoted Raymond T. Bartus, Ph.D., to the position of executive vice president of clinical and preclinical R&D and chief operating officer.

ClinPhone has appointed Vincent Renz as chief operating officer.

Quintiles Transnational announced the appointment of John Goodacre as executive vice president and general counsel.

US Oncology named Glen Laschober as the company's new executive vice president and chief operating officer.

Dr. David Stoffel has been named partner at Radius Ventures. Anthera Pharmaceuticals has named Christopher P. Lowe vice president of administration and chief financial officer.

Dendreon Corporation has promoted Mark Frohlich, M.D. to the position of senior vice president of clinical affairs and chief medical officer.

SpectraScience announced that Jim Dorst has joined the company as its vice president of finance and chief financial officer.

Parexel International named Charles Stevens as vice president and general manager of health policy and strategic reimbursement services.

Novis Pharmaceuticals named Lisa Lopez as vice president of human resources.

MacroChem has appointed David Luci as general counsel and vice president of corporate development.

Commonwealth Biotechnologies has named Mark Hober vice president, business development and marketing

Febit has added David Mahoney to the newly created position of director of global intellectual property and U.S. legal affairs.

InNexus Biotechnology announced that Judith James, M.D., Ph.D., has joined its Scientific Advisory Board.

F-star has established a Scientific Advisory Board and appointed three scientists to it: Professor Sir Ravinder Maini, Imperial College, London, UK; Professor Anthony Rees, MIP Technologies AB, Lund, Sweden; and Professor Sir Gregory Winter, MRC Laboratory of Molecular Biology, Cambridge, UK.

Professor Alain Fischer will join the Cellectis' Scientific Advisory Board while Alain Godard board as an independent member.

Hershey Center for Applied Research announced that Alan J. Snyder, Ph.D., has been appointed to the board.

Affymax has appointed Keith Leonard and Christi van Heek to the company's board of directors.

Biovail Corporation announced that industry veteran Lloyd M. Segal, CEO of Thallion Pharmaceuticals, has been appointed to its board.

Ambrilia Biopharma has named Jean-Paul St-Pierre, M.D., to the board.

Diamyd Medical has proposed a slate of directors for election. They are: Lars Jonsson, founder and majority owner of Stellar Holding; Christer Hagglund, majority owner of Proffice AB; Sam Lingren; and Anders Essen-Moller, founder of Diamyd Medical.

Oscient Pharmaceuticals has appointed John R. Leone, a Partner at Paul Capital Healthcare to its board of directors.

Michael Kurman, M.D., an independent consultant to the pharmaceutical, biotechnology and health care industries, will be joining Thallion Pharmaceuticals as a new board member. Dr. Sylvie Gregoire has resigned from Thallion's board.

Insmed has named Dennis "Denny" Lanfear to its board of directors.

Donald J. Santel has been named to the board of directors of Arete Therapeutics.

Pfizer gives Nektar $135M for Exubera settlement

Tue, 13 Nov 2007 06:59:55 -0500

Nektar Therapeutics got a consolation prize of $135 million from Pfizer--and a fresh shot at signing a new partner--to calm any upset feelings about Pfizer's abandonment of Exubera, a once mighty prospect in the world of inhalable diabetes therapies. In return, both parties are absolved of any further obligations for Exubera or the next-generation version of the therapy that Nektar has in Phase I. And if Nektar lines up a new partner, Pfizer has agreed to hand over any rights it has in the two products.

- check out Pfizer's release
- here's the report on Nektar from RTT News

Related Articles:
Pfizer kills off Exubera, hunts for deals. Report
Exubera becoming a big disappointment for Pfizer. Report
UK: Exubera not worth the price. Report
FDA approves Pfizer's inhaled insulin. Report

Pearl Therapeutics finds $15.5M in first VC round

Thu, 06 Sep 2007 06:59:54 -0400

Upstart Pearl Therapeutics, which is developing therapies for respiratory disorders, has raised $15.5 million in its first round. The Redwood City, CA-based biotech's round was co-led by New Leaf Ventures and Clarus Ventures with 5AM Ventures as a major participant. Pearl has in-licensed a suite of particle technologies from Nektar Therapeutics. The biotech was co-founded by two former members of Nektar's corporate and product development organizations.

- check out the release

ALSO: San Diego-based Cyntellect has completed a $3 million second closing on its Series D round. This closing follows the initial Series D closing of $15.1 million. Release

C&L: Worland tapped for Anadys post

Wed, 29 Aug 2007 06:59:52 -0400

Steve Worland has been promoted to the position of president and CEO of Anadys Pharmaceuticals.

Depomed Chairman, President and CEO John Fara is retiring. Executive Vice President and COO Carl Pelzel will take over those offices.

eBioscience Corporation announced the appointment of Todd R. Nelson, Ph.D., to CEO.

Hana Biosciences has named its chief medical officer to be president and CEO. Hana said Steven Deitcher, M.D., formerly executive vice president of development, will also join the company's board.

Nucryst Pharmaceuticals has appointed Thomas Gardner as chairman, president and CEO. Gardner replaces Barry Heck as chairman and Scott Gillis as president and CEO.

Neuro-Hitech announced that Dr. Gary Shearman has been named president and CEO.

Emisphere Technologies has named Michael R. Garone as CFO.

Nektar Therapeutics announced the appointment of Tim Harkness as senior vice president and CFO.

Prestwick Pharmaceuticals has added Robert S. Radie to its senior management team as executive vice president and chief business officer.

OMRIX Biopharmaceuticals has named Ana I. Stancic, as executive vice president, CFO.

IDM Pharma announced that Jeffrey W. Sherman, M.D., F.A.C.P. has been appointed as the company's chief medical officer and senior vice president of research and development.

Magellan Biosciences announced that Steven E. Diamond, PhD, has joined the company as chief scientific officer.

Vernalis says that Dr John Hutchison, development director, will be leaving the company to join another company in the life sciences sector.

ProBioGen announced that Dr Klaus Stünkel will take over the position of vice president business development licensing.

Ventaira Pharmaceuticals has appointed Lex Adjei, Ph.D. as vice president, research and development.

Aaron D. Berg has been named vice president of marketing at Oscient Pharmaceuticals and Mark A. Glickman has been named vice president of sales.

PharmaNet Development Group has appointed Bengt Danielsson to the position of vice president, PharmaNet Consulting.

BrainStorm Cell Therapeutics has retained the services of the Director of Cell and Gene Therapies of the Biologics Consulting Group, Dr. Andra E. Miller, as consultant to handle the company's FDA interactions.

LifeCycle Pharma announced that Francesca DeMartino has been named director, investor relations and corporate communications.

Immtech Pharmaceuticals announced that David Fleet has joined the company's board of directors.

EyeGate Pharma has named Paul G. Chaney as a member of the board.

CV Technologies said that Maurice (Ted) Bilyea of Toronto has accepted an invitation to join its board of directors.

ZARS Pharma announced that Nicholas L. Teti, Jr. has joined the company's board of directors.

Celgene has elected Ernest Mario, Ph.D. to the company's board.

Biodel has added Ralf Rosskamp, M.D., to its Scientific Advisory Board.

DEALS: Pfizer, Icagen ink development pact

Thu, 16 Aug 2007 06:59:52 -0400

Pfizer, Icagen ink development pact

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Icagen	Development pact	Icagen stands to pocket up to $359 million in milestones for successful programs that target three sodium ion channels as a mechanism for controlling pain.
Sonic	Bioscientia	$256.4M buyout	Bioscientia has been acquired by Sonic Healthcare, which valued the company at €190 million.
Nektar Therapeutics	Bayer Healthcare	$225M licensing deal	Nektar Therapeutics is getting $50 million up front in a $175 million licensing deal for the successful development of a new therapy for severe pneumonia.
Archemix	Ophthotech	Licensing deal	Archemix granted Ophthotech worldwide rights to all ophthalmic uses of Archemix's proprietary aptamers targeting the C5 component of the complement cascade.

Nektar scores $175M pact for pneumonia therapy

Mon, 06 Aug 2007 06:59:57 -0400

Nektar Therapeutics is getting $50 million up front in a $175 million licensing deal with Bayer Healthcare for the successful development of a new therapy for severe pneumonia. Nektar will deploy its pulmonary technology to deliver aminoglycoside antibiotic NKTR-061. The pact includes a rich co-promotion deal for the U.S. market along with a royalty split on sales outside the U.S.

- see this release
- read the AFX report on the deal

Related Articles:
Nektar settles university patent fight. Report
Nektar gains fast track for lung infection drug. Report

C&L: Stonehouse tapped to run Biocryst

Tue, 09 Jan 2007 19:01:32 -0500

BioCryst Pharmaceuticals announced that Jon P. Stonehouse, has been appointed CEO and a member of the company's board of directors. Stonehouse succeeds Charles E. Bugg, Ph.D., founder and former CEO who previously announced his intention to retire in 2007. In his new role, Dr. Bugg will become non-executive chairman of BioCryst.

Vincent F. Simmon, Ph.D., has joined Xytis as president, CEO and member of the board of directors. Dr. Simmon had been COO of Merrimack Pharmaceuticals previously served as the president and CEO of Cortex Pharmaceuticals.

Nektar Therapeutics has named Howard W. Robin as the company's new president and CEO. Robin will replace acting president and CEO Robert Chess who will remain chairman.

Panacos Pharmaceuticals announced that Alan W. Dunton, M.D. has joined the company as CEO.

Capnia has appointed Joseph J. Vallner, Ph.D., as president and CEO. Dr. Vallner joins Capnia from Cell Genesys where he served as president and COO.

Access Pharmaceuticals announced that Stephen R. Seiler has joined the company to serve as president and CEO and has been named a member of the board. Rosemary Mazanet, MD, PhD, former acting CEO of Access, has been appointed vice-chairman of the board and David P. Luci, C.P.A., has agreed to serve as audit committee chairman.

Aerovance has named Mark L. Perry, currently the company's executive chairman, as president and CEO.

Covance has promoted Luis Gutierrez to the new role of president of Covance Commercialization Services.

Dr. Michael Morrissey, formerly executive vice president of discovery at Exelixis, has been promoted to president of research and development. Lupe Rivera has been promoted to senior vice president of human resources and communication. Dr. Jeffrey Latts, formerly executive vice president of development, has decided to retire.

The Biotechnology Industry Organization has hired Sandra J. P. Dennis as BIO's new deputy general counsel for healthcare regulatory affairs.

Thomas Ichim has joined Medistem Laboratories as its chief of scientific development.

Cerimon Pharmaceuticals has named Daniel Levitt, M.D., Ph.D., executive vice president of research and development.

Ambit Biosciences has named Wendell Wierenga, Ph.D., as executive vice president of research and development.

NovaCardia, has named John E. Crawford as CFO.

Aptuit has appointed Peter J. Adamski as CFO.

ForteBio has named William A. Albright, Jr. as the company's CFO.

PharmAthene has named Christopher C. Camut as vice president and CFO.

ChemoCentryx has named Juan Jaen, Ph.D., to the position of senior vice president, drug discovery.

Idenix Pharmaceuticals has named Douglas Mayers, M.D. to the position of executive vice president and chief medical officer.

China Aoxing Pharmaceutical Company has named Hui (David) Shao, Ph.D., MBA, as senior vice president of finance.

INC Research has named Hans J. Moebius, M.D., Ph.D., as senior vice president of its central nervous system business for Europe.

Pozen named Gilda M. Thomas as senior vice president and general counsel.

Auriga Laboratories has appointed Jae Yu as its vice president of finance.

Takeda Pharmaceuticals North America has named Laurene Bentel vice president of human resources and administration.

Panacea Pharmaceuticals has named Pamela Harris, MD, as vice president medical and clinical affairs.

Hana Biosciences has promoted Gavin S. Choy, Pharm.D. and Alex Tkachenko, Ph.D. In their new roles, Dr. Choy will be responsible for all clinical operations as vice president, clinical operations, while Dr. Tkachenko gains added responsibility overseeing Hana's business development as vice president, corporate development and strategic planning.

Agile Therapeutics has made several appointments: Dr. Gary Shangold, M.D., has been engaged by the company as a senior scientific advisor; Greg Arnold, I.E., has joined the company as vice president of manufacturing and scale up; Bob Conway, M.E., has joined the team as vice president of operations.

Tikvah Therapeutics has named Lou Barbato, M.D., as vice president of clinical research and development and chief medical officer.

Progenics Pharmaceuticals has named Walter M. Capone to the newly created position of vice president, commercial development and operations. Additionally, Nicole S. Williams has been appointed to the company's board of directors.

Urigen has appointed Dennis H. Giesing, PhD to serve as the company's director of product development.

Avalon Pharmaceuticals has formed a clinical advisory board with Brian J. Druker, M.D.; Beverly Mitchell, M.D.; Carmen Allegra, M.D.; Kenneth C. Anderson, M.D.; Otis Brawley, M.D.; Edward A. Sausville, M.D. and Chris H. Takimoto, M.D.

CytoDyn has appointed Shan Lu, MD, PhD, to its scientific advisory board.

Acorda Therapeutics has elected Barry Greene, COO of Alnylam Pharmaceuticals, to its board of directors.

Bradley Pharmaceuticals has elected Leonard S. Jacob, M.D., Ph.D., as its non-executive chairman of the board.

Celgene announced that James J. Loughlin has been elected to the board of directors.

William D. Anderson, former president of Bell Canada Enterprises Ventures, will be joining MDS's board of directors.

David P. Meeker, M.D., president of the LSD Therapeutics business unit of Genzyme Corporation, has been named to the board of Penwest Pharmaceuticals.

David Mann of Spring Mill Venture Partners has joined BioStorage Technologies' board of directors.

ALSO NOTED: Dynavax shares slump on inconclusive trial; iCo licenses rights to CAT-213; and much more...

Sun, 07 Jan 2007 19:01:30 -0500

> The big loser among biotech companies this morning is Dynavax Technologies, which saw its shares slump 26 percent after it announced that it was unable to determine the effectiveness of its ragweed allergy therapy in a clinical trial. The culprit: The absence of ragweed allergies among the volunteers. Release

> Canada's iCo Therapeutics has licensed the rights to develop CAT-213, an antibody currently being studied for allergic conjunctivitis, from Cambridge Antibody Technology. AstraZeneca bought CAT last year. CAT-213 has been advanced through Phase II. Report

> ProEthic Pharmaceuticals of Montgomery, AL says it will file an NDA for its migraine drug therapy, PRO-513, in the early part of this year after reporting that a late-stage study hit its primary endpoints for relieving pain in comparison to a placebo. Release

> Chutes & Ladders: Howard Robin, the former president and CEO of the recently bought out Sirna Therapeutics, has been named president and CEO of Nektar Therapeutics. He replaces acting CEO Howard Chess. Report

> Authorities in Vietnam are racing to contain a recent outbreak of avian flu in birds. Report

> Pierre Fabre has acquired the OTC business of UCB in France, Benelux, Switzerland and Greece. Release

> Savient Pharmaceuticals is laying off the 19 people in its Oxandrin weight gain therapy after releasing a generic version of the drug. Release

> Provectus Pharmaceuticals' anti-cancer agent, PV-10, has received orphan drug designation by the FDA. Release

> Scientists have discovered a new source of stems cells and have used them to create muscle, bone, fat, blood vessel, nerve and liver cells in the laboratory. These stem cells, taken from the amniotic fluid that surrounds developing embryos, could put to rest the controversy that's surrounded stem cell research. Release

And Finally... A White House adviser says that any repeat of a 1918 flu pandemic is likely to spur many more deaths than the 62 million recently forecast. Article

ALSO NOTED: Serono inks pact with Syntonix; Sanofi mentioned as possible BMS suitor; and much more...

Sun, 17 Sep 2006 20:01:30 -0400

> Serono has signed a development and commercialization pact with Syntonix Pharmaceuticals for its FSH:Fc candidates to treat infertility. Syntonix gains a collaboration fee and will stand to earn up to $54 million in milestones if Serono exercises its option in the deal. Report

> You can add the name of Sanofi-Aventis to the growing list of potential suitors for Bristol-Myers Squibb. Article

> GlaxoSmithKline has filed for U.S. approval of Tykerb in combination with Xeloda for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have received prior therapy. Release

> Tenby Pharma, a shell company, has acquired Sirion Therapeutics and arranged $25 million in financing. Report

> Opexa Therapeutics is reporting positive data for its Phase I/II trial of the MS drug Tovaxin. The drug developer has also announced the launching of its 150-patient Phase IIb Tovaxin trial. Release

> The European Commission has granted orphan medicinal status to Nektar Therapeutics' Amphotericin B Inhalation Powder. Release

> Schering has granted an exclusive worldwide license to Bausch & Lomb to develop and market a selective glucocorticoid receptor agonist for the non-systemic treatment of eye disorders. Release

> The World Bank estimates that a bird flu pandemic could cost between $1 trillion and $2 trillion, or about three percent of global GNP. Report

> Chutes & Ladders: Targanta Therapeutics has named Mark Leuchtenberger as the company's new president and CEO. Release

And Finally… New research indicates that 40 percent of the people who get botoxed become addicted to the cosmetic procedure that paralyzes facial muscles. Report

ALSO NOTED: Nektar closes UK site; Martines resigns from NSP; and much more...

Wed, 26 Jul 2006 20:00:50 -0400

> Nektar Therapeutics has closed a site in the U.K. that employs 35 workers. Report

> Chutes & Ladders: Sergio Martines has resigned as a director, president and CEO of NSP Pharma. Release

> Inspire Pharmaceuticals has launched a Phase III clinical trial to evaluate its drug candidate, denufosol tetrasodium Inhalation Solution, in patients with mild cystic fibrosis lung disease. Release

> Pfizer has won conditional marketing approval from the EU for Sutent as a therapy against a type of advanced kidney cancer. Report

> UCB has submitted an NDA for the approval of Xyzal (levocetirizine dihydrochloride), a new prescription antihistamine for treatment of allergy symptoms. Release

> Glaxo is seeking marketing approval in the U.S. and Europe for a new medicine to treat the symptoms of seasonal allergic rhinitis and perennial allergic rhinitis. Release

And Finally… Researchers say they've found a second DNA code which may help illuminate how cells activate genes. Article

ALSO NOTED: TransPharma raises $18M; Biogen Idec, Elan re-release Tysabri; and much more...

Sun, 23 Jul 2006 20:00:50 -0400

> TransPharma Medical, which is developing a new drug delivery technology, has raised $18 million in financing. Report

> Biogen Idec and Elan have re-released Tysabri for MS in the United States. Report

> Researchers are exploring the effectiveness of a combination of cancer-drug mitoxantrone and copaxone to treat aggressive MS. Release

> Biovail and Athpharma have terminated a development pact for four cardiovascular drugs. Report

> Barr Pharmaceuticals says it is confident that it can meet any requirements the FTC may have as a condition for buying Pliva. Report

> Nektar Therapeutics announced that it received $17.6 million from Affymax for a previously undisclosed licensing deal. Report

And Finally… Scientists at the Max Planck Institute for Evolutionary Anthropology plan to crack the genetic code of Neanderthals in order to better understand why they became extinct while modern man thrived. Article (WSJ sub. req.)

Nektar settles university patent fight

Thu, 06 Jul 2006 20:01:37 -0400

Nektar Therapeutics has agreed to settle a patent suit filed by the University of Alabama in Huntsville for $25 million. The dispute centered on the work of Milton Harris, who started a company Nektar bought five years ago for $197 million. Harris had worked at the university and the university claimed ownership of Harris' patents. In the agreement, Nektar and Harris jointly paid $15 million to the university while Nektar agreed to pay $1 million a year for 10 years. In return, the university is dropping its claims to the PEGylation patent portfolio.

- here's the AP report on the settlement

ALSO NOTED: Nektar gains fast track for lung infection drug; Vertex reports positive hep C data; and much more...

Sun, 21 May 2006 20:00:50 -0400

> Nektar Therapeutics was given a fast-track designation for its lung infection prevention drug. Report

> Vertex announced that all 12 patients in a mid-stage trial of its VX-950 hepatitis C therapy showed no detectable signs of the virus after 28 days of therapy. Report

> ViroPharma announced that HCV-796, in development with Wyeth, cut levels of the hepatitis C virus by 97 percent in a small Phase I trial. Report

> CombinatoRx has released positive data for its mid-stage trial of Crx-102 for patients with periodontitis. Report

> Cell Genesys reports that an early-stage trial demonstrated that its experimental therapy, CG-0070, was safe and may have anti-tumor activity. Report

> A new study presented at the scientific meeting of the American Psychiatric Association has identified five predictors of bipolar disease. Researchers concluded that significant risk factors of bipolar disorder among patients already diagnosed with major depression were anxiety, feelings of people being unfriendly, family history of bipolar disorder, a recent diagnosis of depression and legal problems. Release

> Repros Therapeutics provided an update for its ongoing clinical studies. Release

> Consumer groups are asking the FDA to do a better job at policing nanotechnology. Report

> Alexza Pharmaceuticals has launched a Phase I trial of an experimental pain therapy. Release

And Finally… The search for an HIV vaccine has moved overseas amid a storm of controversy. Article

ALSO NOTED: Eisai files sNDA for Alzheimer's; Nektar gains orphan status; and much more...

Mon, 13 Feb 2006 19:00:50 -0500

> The FDA has accepted Eisai's supplemental NDA for Aricept as a treatment for severe Alzheimer's. Release

> The FDA has granted Nektar Therapeutics orphan drug status for an inhaler treatment used to prevent infections in the lungs of patients with suppressed immune systems. Report

> Chelsea Therapeutics has completed a private placement, raising $21.5 million. Release

> EU health officials are urging calm as the H5N1 virus continues to spread. Slovenia is testing for the virus in dead birds and Nigeria is now testing what may be the first human cases found in Africa. Article

> Immtech International has licensed a new class of anti-infectives--including one for malaria--from Tulane University. Report

> India's Orchid Chemicals has received regulatory approval for its generic version of Merck's Mefoxin. Report

> Researchers say that estrogen therapy may not help women in their 60s but could be helpful in their 50s. Article

> Denmark's Genmab has licensed angiogenesis targets discovered by Bionomics. Release

And Finally… A patient discusses the hallucinations that can be caused by drugs for Parkinson's. Article