Pozen

ALSO NOTED: Acadia reports positive psychosis data; Alcon drug gets approval; FDA green lights migraine drug; and much more...

Wed, 16 Apr 2008 06:59:50 -0400

> Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. Report

> The UK's Acadia Pharmaceuticals has reported positive data from a mid-stage study of pimavanserin for the treatment of psychosis in patients with Parkinson's disease. Patients experienced a benefit for psychosis without impacting motor function. Release

> Alcon's hay fever drug Patanase has been approved by the FDA, and analysts expect it will compete well against MedPointe's antihistamine Astelin. Release

> The FDA has approved a new combination migraine therapy developed by Pozen and GlaxoSmithKline. Treximate combines sumatriptan, the active ingredient in GSK's painkiller Imitrex, with naproxen sodium. Release

> Zelos Therapeutics and Aegis Therapeutics have inked a deal to collaborate on the development of an intranasal spray formulation of the proprietary parathyroid hormone analog ZT-031 (Ostabolin-C(TM), cyclic PTH-(1-31). Release

> StemCells issued a release claiming that the US patent office had upheld two of its patents in a dispute with NeuralStem. And NeuralStem fired back a release saying that StemCells got it all wrong. Release | Report

> Genentech is upping its stock buyback program by $2 billion. Report

> A research team has combined a nanoparticle platform used in imaging growing blood vessels and combined it with the fungal drug fumagillin to create a new weapon to fight the growth of tumors. Report

> A dozen new Biomedical Research Units created under the U.K.'s National Institute for Health Research will receive more than €56 million to fund translational work on ailments that include obesity and heart disease. Report

> Merck wrote its own articles on Vioxx research and then paid prestigious doctors to append their bylines, according to a new JAMA report. Report

> According to a study by Verispan, 47 percent of docs thought they got as much info from e-promotions as face-to-face detailing by reps, and 21 percent thought it was better than the real, live thing. Report

> The FDA believes Baxter International's recalled heparin was tainted "by virtue of economic fraud," Commissioner Andrew von Eschenbach told a Senate panel yesterday. Report

And Finally... A new advance in cloning could lead to designer babies. Report

AstraZeneca, Pozen start Phase III combo drug trial

Fri, 07 Sep 2007 06:59:55 -0400

AstraZeneca and Pozen are starting Phase III trial of PN400, an experimental drug for arthritis pain that combines AstraZeneca's heartburn drug Nexium with the anti-inflammatory drug naproxen. In addition, the companies have amended their original licensing agreement for the drug. AstraZeneca will now pay Pozen up to $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment, which includes recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones, and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved. Pozen and AstraZeneca hope to file an NDA by the first half of 2009.

The new pact is good news for Pozen, which just last month was dealt yet another FDA delay for its migraine drug Trexima. For its part, AstraZeneca is facing a generic threat from Ranbaxy, which wants to produce a generic version of Nexium.

- see this press release for more
- read this article

Related Articles:
Pozen shares soar on rich pain med deal. Report
Drug combos not a sure thing. Report
AstraZeneca faces new patent fight over Nexium. Report
Pozen shares sink on latest Trexima delay. Report

Pozen shares sink on latest Trexima delay

Thu, 02 Aug 2007 06:59:58 -0400

Pozen stock took a painful dive this morning after GlaxoSmithKline announced that their two-in-one migraine drug Trexima would be delayed yet again--this time to satisfy FDA demands for more information on evidence of genotoxicity seen in a preclinical study. That genotoxicity was seen in Trexima, but was not apparent when the two compounds used in Trexima were studied alone. That was bitter news for investors, who were hoping that the second approvable letter from the FDA--the first arrived more than a year ago--would be the charm. They drove down Pozen's value by close to half. Researchers say they'll shoot for an early meeting with the FDA to better determine how to proceed.

- check out the release
- here's the AP report on Pozen

related Articles:
FDA buoys Pozen, accepts of amended response. Report
Pozen files NDA for new migraine treatment. Report
Pozen shares sink on new demand for data. Report
Pozen shares soar on rich pain med deal. Report

ALSO NOTED: FDA deadline looms for Trexima; Manhattan Pharma discontinues program; and much more...

Tue, 10 Jul 2007 00:01:30 -0400

> An August 1 FDA action date for Pozen's migraine drug Trexima is looming, and the analysts are paying close attention as the decision deadline nears. Report

> Manhattan Pharmaceuticals says it will discontinue its Oleoyl-estrone program for obesity after seeing disappointing Phase IIa data. Release

> Theravance says its mid-stage study of the antibiotic TD-1792 met its primary endpoint of noninferiority to vancomycin. Release

> Germany's MediGene grabbed the headlines at a conference in Switzerland recently with new efficacy data from a Phase I/II trial of a genetically engineered herpes virus designed to kill cancer cells. Report

> Aveo Pharmaceuticals says it's developed a better mouse model for cancer tumors that will give it a big advantage in the race to develop new cancer therapies. But Aveo says this is one advance that they intend to keep in-house for use solely with their own discovery programs. Report

> The amazingly hot field of synthetic biology has now spawned an engineered virus that attacks bacteria. Report

And Finally… Despite company losses, Maryland CEOs are enjoying a big payday. Report

New combos of old drugs may be boon to biotech

Tue, 03 Jul 2007 00:01:36 -0400

New York Times scribe Andrew Pollack takes a careful look at the current trend of making new drugs out of combinations of old therapies. Despite reporting one trial failure last week, CombinatoRx is out in the lead on this one. Researchers at the company are systematically running through the possible combinations of 2,000 generic drugs. But Pozen, Orexigen and other biotechs have combinatorial programs in place as well.

- read the article from The New York Times

Related Articles:
FDA buoys Pozen, accepts of amended response. Report
Orexigen Therapeutics files $86 million IPO. Report

Pozen shares sink on new demand for data

Tue, 12 Dec 2006 19:01:38 -0500

Shares of Pozen sank about 10 percent this morning after it announced that the FDA had asked for more data on the migraine drug Trexima--a combination of sumatriptan and naproxen sodium--before it can be approved. The Trexima application had already been found wanting last June. This new warning came after the agency found the company's response insufficient. Pozen says it will submit more information by the end of the year, but adds that it feels the data already demonstrates the drug's superiority to sumatriptan.

- check out the company's press release
- here's the report on Pozen from TheStreet.com

Related Articles:
Pozen shares soar on rich pain med deal. Report
Pozen loses latest bid for FDA approval of MT100. Report
Pozen files NDA for new migraine treatment. Report

ALSO NOTED: Nucryst drug fails trial; Dr. Bugg to retire from Biocryst; Pozen shares jump; and much more...

Wed, 20 Sep 2006 20:01:30 -0400

> Nucryst Pharmaceuticals announced that a mid-stage trial of its topical cream for dermatitis did not achieve its goal, according to a preliminary review of the data. The company plans to continue to study other uses of the drug. Report

> Chutes & Ladders: BioCryst Pharmaceuticals announced that Charles E. Bugg, Ph.D., the company's chairman, CEO and co-founder, has informed the board that he intends to retire in 2007. Dr. Bugg will retain his current duties as CEO until a replacement has taken office. Release

> Shares of Pozen jumped after the company announced it had received a previously announced up-front payment for a collaboration deal with AstraZeneca. Report

> Swiss authorities have approved Novartis' Sebivo for chronic hepatitis B. Report

> The makers of the Ortho Evra patch are adding a new warning about non-fatal blood clots associated with the patch. Report

And Finally... A massive new study of top research centers is dominated by U.S. universities. Article

DEALS: AstraZeneca, Pozen in $375M licensing deal

Wed, 02 Aug 2006 20:01:32 -0400

DEALS
WHO	WITH	WHAT	SCOOP
AstraZeneca	Pozen	$375M licensing deal	The companies will co-develop remedies for chronic pain utilizing Pozen's technology. Pozen gets $40 million up front and up to $335 million in additional milestone payments.
Amgen	Predix	$307M licensing deal	Amgen will pay an initial $20 million for Predix's autoimmune disease treatment and up to an additional $287.5 million in milestone payments.
Nextar	Affymax	$17.6M licensing agreement	Nektar is providing Affymax with technology to develop Hematide. The deal was previously undisclosed.
YM BioSciences	Daiichi Pharmaceutical	$14.5M licensing deal	YM BioSciences has licensed developing and marketing rights for nimotuzumab for an up-front payment of $14.5 million plus additional milestone payments.
Archemix	Nuvelo	collaboration	Archemix and Nuvelo have expanded their collaboration. Archemix will be responsible for research and Nuvelo will be responsible for development and commercialization.
Enzon	Santaris	collaboration	Enzon will develop and commercialize a series of RNA antagonists based on Santaris technology.
Avalon	ChemDiv	collaboration	The companies are collaborating for the discovery and development of small molecule oncology therapeutics.
Eli Lilly	Alcon	collaboration	The companies signed a long-term agreement to co-promote ruboxistaurin mesylat.
Biovail	Athpharma	partnership	The companies are ending their development partnership for four cardiovascular drugs.
Dainippon Sumitomo	Bristol-Myers K.K.	partnership	Bristol-Myers will license to Dainippon the development rights of irbesartan. Dainippon will grant Bristol-Myers with co-marketing rights of miriplatin hydrate.
Receptor BioLogix	Aphton	acquisition	Receptor BioLogix has acquired the cancer vaccine Insegia and related assets from Aphton in a Chapter 11 sale.
Cambridge Antibody Technology	Enzon	acquisition	Cambridge acquired the license to CAT-5001 from Enzon.
Iconix	Merck KGaA	services agreement	Iconix will compare several of Merck's compounds to similar products to gain insight into the safety of new drug candidates in the early stages of pre-clinical development.

Pozen shares soar on rich pain med deal

Tue, 01 Aug 2006 20:01:39 -0400

Shares of Pozen shot up 30 percent this morning when the company announced that it has signed a rich deal to develop a pain medication with AstraZeneca that will combine therapies from each company. Pozen gets $40 million up front, $160 million in potential milestone payments and $175 million for hitting sales targets along with royalties. The deal will pair the nonsteroidal anti-inflammatory drug naproxen with esomeprazole magnesium, the active ingredient in Nexium. The combinational product is intended to prevent the ulcers that sometimes occur as a side effect of nonsteroidal anti-inflammatories. Pozen will be responsible for filings with the FDA and AstraZeneca will seek regulatory approvals in the rest of the world.

- here's the MarketWatch report on Pozen

ALSO NOTED: Occulogix files IDE; North Carolina in running for plant; and much more...

Sun, 11 Jun 2006 20:00:50 -0400

> Canada's Occulogix says it will file an application for an Investigational Device Exemption with the FDA for its RHEO system to treat dry age-related macular degeneration. Occulogix says it met with representatives of the FDA last week and that they asked for a new study of the RHEO System. Report

> Holly Springs, NC has been excited by reports that it is in the running for a major biopharmaceutical facility that will generate up to 400 jobs. Report

> Shares of Pozen climbed in overnight trading, recovering some of the losses triggered by an FDA request last week for more data on its migraine drug Trexima. Report

> Citing "compelling" data, Bayer HealthCare will proceed with a late-stage study of antithrombosis drug BAY 59-7939 in two chronic indications. Release

> Sunesis has snared a $4.25 million milestone payment from Merck. Release

> Ceragenix is touting preclinical results for a lead compound that demonstrates signs of inhibiting bladder cancer growth. Release

> Avigen is planning to launch a Phase IIa trial of AV411 for neuropathic pain. Release

And Finally…The mentally ill suffer from diabetes at twice the rate of the general population. Article

FDA decision on Trexima may trigger new studies

Thu, 08 Jun 2006 20:01:37 -0400

The FDA has issued an approvable letter to POZEN and GlaxoSmithKline for Trexima as an acute therapy for migraines. But the drug developer says the agency's request for more safety data may require more studies of the drug. Researchers are seeking a meeting with the FDA to clarify their request. Trexima is a combination of sumatriptan 85 mg, as the succinate salt, formulated with RT Technology and naproxen sodium 500 mg in a single tablet. It is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

- here's the release on Trexima

SPOTLIGHT: FDA greenlights Pozen Phase III

Thu, 20 Apr 2006 20:01:33 -0400

The FDA has given Pozen a green light for its Phase III trial of PN 2000 for arthritis. The Chapel Hill, NC-based drug developer says it should begin the pivotal trial in the next few months. Pozen was dealt a significant blow last summer when the FDA rejected its MT 100 for migraines. Report

ALSO NOTED: Pozen wins UK approval; Genosis raises funds; Eisai transfers drug rights;and much more...

Sun, 27 Nov 2005 19:00:50 -0500

> Pozen of Chapel Hill, NC, has received approval from UK regulators for MT 100, a migraine drug. It's the first regulatory approval received by the drug developer. Report

> The UK's Genosis has raised ₤7 million through a stock placement. Report

> Japan's Eisai has transferred sales rights to the antibiotic Rulid to Sanofi-Aventis. Report

And Finally… International Congress Biotechnology 2005 in Havana is touting Cuba's work in the biotech field. Report

C&L: David R. Smith appointed CFO of Galapagos

Tue, 08 Nov 2005 19:01:32 -0500

Galapagos has appointed David R. Smith as CFO beginning February 1, 2006. He joins Galapagos from AstraZeneca, where he was Marketing Company CFO.

Arrow International named Kenneth E. Imler as senior vice president of regulatory affairs and quality assurance. Before joining Arrow, Imler served as a principal consultant for Quintiles Consulting.

Novo Nordisk has appointed Christopher Porter as director of government affairs in the US. Prior to joining Novo Nordisk, Porter was the original co-staff director of the Congressional Diabetes Caucus.

Emilio A. Emini, Ph.D., was appointed executive vice president, vaccines research and development, Wyeth Pharmaceuticals. Emini joins Wyeth from the International AIDS Vaccine Initiative, where he was senior vice president for vaccine development.

Metabolon announced the addition of Dr. Michael Milburn as its chief scientific officer. Milburn was most recently senior vice president of research and corporate development at Sirtris Pharmaceuticals.

Arnold A. Pinkston has joined Beckman Coulter as senior vice president, general counsel and secretary. Previously, Pinkston was with Eli Lilly and served as deputy general counsel with responsibilities for the legal affairs of Lilly USA.

MDS has appointed Kenneth Horton As executive vice president, corporate development and general counsel. Horton joins MDS from PerkinElmer, where he held the role of vice president, acquisitions, ventures and general counsel for the Life and Analytical Sciences business unit.

Pozen has named Dr. Elly Savaluny vice president of biostatistics and data management.

Amarin announces appointment of Tom Maher as general counsel. Maher is currently a partner and head of the Life Sciences Group at Matheson Ormsby Prentice.

Sangamo BioSciences has appointed Dr. Philip Gregory as vice president of research. Dr. Gregory has served as Sangamo's senior director, research since July 2003.

CardioGenesis announced the addition of Gary S. Allen, M.D., to its board of directors.

Myrtle Potter, former Genentech president, has been appointed to the board of directors of FoxHollow Technologies.

Global Alliance for TB Drug Development has appointed Mark Kessel to its board of directors.

Friend G. Choate has been named to Escalon Medical's board of directors.

SPOTLIGHT: Pozen to pocket $20M

Tue, 11 Oct 2005 20:01:33 -0400

Pozen has gained a $20 million milestone payment with the FDA's acceptance of an application for GSK's Trexima for migraine. Article

Pozen files NDA for new migraine treatment

Sun, 07 Aug 2005 20:01:39 -0400

Just days after abandoning the experimental migraine treatment MT100 in the face of two rejections from the FDA, Pozen has filed an NDA for Trexima -- a new migraine therapy it's been developing with GlaxoSmithKline. If the FDA accepts the NDA, says Pozen, it will reap a $20 million milestone payment from GSK. Pozen, based in Chapel Hill, North Carolina, earned $15 million when Trexima entered a Phase III trial last year. An FDA expert committee rejected MT100 a week ago.

"We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA," said Marshall Reese, executive vice president of product development at Pozen. "This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline and Pozen."

- read this story from LocalTechWire for more

Pozen loses latest bid for FDA approval of MT100

Thu, 04 Aug 2005 20:01:39 -0400

Pozen lost another round with the FDA in its quest to gain approval for the migraine drug MT100. A special agency committee decided that the clinical data for the drug does not warrant exposing patients to tardive dyskinesia, involuntary movements of the tongue and mouth. The FDA issued a nonapprovable letter for MT100 more than a year ago, which at the time caused an immediate sell-off of Pozen stock that cut its $17 price in half. The company's CEO maintained that Pozen hadn't lost any ground on the drug, noting the earlier rejection. But investors weren't as confident. Pozen stock slipped 5 percent yesterday, closing at $7.97.

- read this story from Localtechwire for more

ALSO NOTED: Par drops Advancis partnership; Diovan gets new indication; Pozen makes case for MT-100; and much more...

Wed, 03 Aug 2005 20:00:50 -0400

> Par Pharmaceutical has pulled out of its development partnership with Advancis, saving itself a scheduled $4.75 million payment. The news follows Advancis' announcement that it would slash its staff following the failure of Amoxicillin PULSYS in Phase III trials. Story

> The FDA has approved a new indication for Novartis' bestselling Diovan, adding its use to improve survival after a heart attack. Story

> Pozen will make its case for MT-100 to the FDA today, arguing that patients taking the drug will suffer little risk of involuntary facial movements. The agency had rejected the drug last year, concerned that its effectiveness was in doubt and that patients might be at risk of a permanent movement disorder. Report

> The Texas Vioxx trial turned emotional with testimony from a daughter who believes the drug was instrumental in her father's death. Article

> One analyst cut his rating on Amylin triggering a slip in a variety of biotech stocks this morning. Story

> Zeltia is planning significant new investments in its PharmaMar unit. Story

> Nymox is touting interim data on its Phase II trial of NX-1207 for benign prostatic hyperplasia. Release

And Finally... Wounded soldiers are bringing back a drug-resistant bacteria from Iraq. Feature