Inspire Pharmaceuticals

Inspire Pharma shares soar 75% on CF data

Fri, 06 Jun 2008 06:59:58 -0400

Shares of Durham, NC-based Inspire Pharmaceuticals took off this morning after researchers announced that a late-stage trial of its cystic fibrosis therapy produced promising results. Patients taking the drug experienced an improvement in lung function during the 24-week study. After hearing the news on denufosol, investors pushed up Inspire's shares by more than 75 percent.

"The data from this Phase 3 trial with denufosol are encouraging for the cystic fibrosis community because it brings us one step closer to a novel treatment that addresses the basic cystic fibrosis defect," Robert J. Beall, CEO of the Cystic Fibrosis Foundation.

- read the report in the Triangle Business Journal

Inspire abandons nasal spray after drug flunks trial

Wed, 23 Apr 2008 06:59:54 -0400

Disappointed by lackluster data, Inspire Pharmaceuticals has abandoned development of its epinastine nasal spray for the treatment of seasonal allergic rhinitis. Subjects treated with the nasal spray did not achieve better outcomes than those treated with placebo. In a statement, CEO Christy Shaffer said that the company won't devote any more resources to development of the spray, and that Inspire would focus on other programs. Those include a Phase III program for dry eye, another Phase III program for cystic fibrosis, and and Phase I glaucoma study.

- take a look at Inspire's release

C&L: Ellis joins Atrolyn Biosciences as CEO

Wed, 12 Mar 2008 07:59:52 -0400

M. Nixon Ellis, Ph.D. has joined Argolyn Bioscience as president and CEO and George Koszalka, Ph.D. has become the company's chief development officer.

TOPIGEN Pharmaceuticals announced that Paul Wotton, Ph.D., has resigned from his role as president, CEO and Director, and Patricia Lamothe has resigned from her role as chief financial officer.

Orexigen Therapeutics has named Carol Baum vice president of commercialization.

ProtoKinetix has appointed Randy Anderson as its vice president of government affairs.

MonoGen has named John Witkowski as vice president of operations.

Mary Anderson has been appointed as XOMA's new vice president, business development.

Znomics has appointed Stephane Berghmans director of drug discovery.

Vitro Biopharma announced that Dr. Tinalyn Kupfer has joined Vitro's scientific team.

SpectraCell Laboratories has added Dr. Wei Sun, PhD, MD to its scientific staff as manager of R&D.

Febit Holdings has named Michelle Lyles, Ph.D., to the newly created position of vice president, marketing and sales.

Elusys Therapeutics has named Robert Gundel, Ph.D., M.B.A., as vice president of research.

David Brand has been named to NeurAxon board of directors.

Inspire Pharmaceuticals said that William R. Ringo, Jr. will resign from the board of directors.

Gert Caspritz has resigned as a director of EpiCept.

The Board of Alchemia Limited has named Carlo Montagner to the position of non executive director.

Oxford BioMedica announced that Dr. Alexander Lewis will join the board on 3 April 2008 as a non-executive director and member of the remuneration and audit committees.

Nastech Pharmaceutical has appointed a Scientific Advisory Board for MDRNA, its wholly-owned subsidiary for the development of RNAi technology and therapeutics. It includes Roger Kornberg, Ph.D.; Carl Novina, M.D., Ph.D.; and James Rothman, Ph.D.

Inspire bails on $89M allergy pact

Mon, 14 Jan 2008 06:59:58 -0500

A little more than a year after agreeing to pay up to $89 million to license the promising allergy pill bilastine from FAES Farma, Durham, NC-based Inspire Pharmaceuticals is dumping the pact and refocusing on other programs in the pipeline. Inspire and FAES has amended the deal last summer after the FDA announced that further studies would be needed for approval.

"We have made a strategic business decision to terminate the bilastine agreement and focus our resources and capital investments on our other late stage development programs and commercial activities," Inspire CEO Christy L. Shaffer said in a prepared statement.

- and check out the release
- read the report from the News & Observer

Related Articles:
FAES inks $89M licensing deal on allergy drug. Report
Inspire licenses anti-infective for $13M upfront. Report

Inspire gets $75M injection from Warburg Pincus

Wed, 18 Jul 2007 06:59:54 -0400

Warburg Pincus is buying $75 million worth of Inspire Pharmaceuticals' stock. The private equity group paid a five percent premium for the shares, which immediately pushed up the value of the company's stock by 14 percent. For Inspire, the fresh injection of capital will help fund late-stage studies while launching the newly-approved AzaSite for bacterial conjunctivitis.

- check out the release
- read the AP report

Related Articles:
Inspire wins feds approval of eye infection therapy. Report
Inspire licenses anti-infective for $13M upfront. Report
Side effects prompt Inspire to shutter trial. Report
Inspire shares plunge after FDA finds data insufficient. Report

DEALS: Abbott buys Kos in $3.7B deal

Wed, 08 Nov 2006 19:01:32 -0500

Abbott buys Kos in $3.7B deal

DEALS
WHO	WITH	WHAT	SCOOP
Abbott Laboratories	Kos Pharmaceuticals	$3.7B buyout	Kos makes Niaspan and Advicor, which boost "good" cholesterol, and is in late-stage development of Simcor.
Merck	Sirna Therapeutics	$1.1B buyout	Sirna's lead drug candidate, Sirna-027, is being developed as a treatment for wet, age-related macular degeneration.
Allergan	Groupe Corneal Laboratoires	$216M buyout	Allergan, which makes Botox, plans to separate the French companies' aesthetic and ophthalmic business with an eye to selling the ophthalmic division.
Wyeth	Ablynx	$212M licensing deals	Ablynx has agreed to license its Nanobodies technology to Wyeth.
Lonza	Genentech	$150M purchase	Switzerland's Lonza has struck a deal to buy a manufacturing plant in Spain from Genentech.
Inspire Pharmaceuticals	FAES Farma	$89M licensing deal	Inspire Pharmaceuticals gains U.S. and Canadian licensing rights to bilastine.
Wyeth	Inovio Biomedical	$64.5M deal	Wyeth will use Inovio Biomedical's DNA delivery technology for certain DNA vaccines in development.
Roche	InterMune	$60M deal	Roche has signed a deal to develop InterMune's experimental therapy for hepatitis C.
Biomira	ProlX Pharmaceuticals	$23.9 buyout	The acquisition will give Biomira control of Stimuvax, a synthetic MUC1 peptide vaccine now in Phase III, and PX-12, a thioredoxin inhibitor which is headed into Phase II.
Cephalon	Ambit	$18 deal	Cephalon is gaining access to Ambit's proprietary KinomeScan technology.
Merck	J. David Gladstone Institutes	$3.25M collaboration and licensing pact	The groups have signed a collaboration and licensing pact for the research and development of drugs to treat neurodegenerative diseases.

FAES inks $89M licensing deal on allergy drug

Tue, 31 Oct 2006 19:01:36 -0500

Inspire Pharmaceuticals has agreed to pay Spain's FAES Farma $7 million up front and up to $82 million in milestone payments for the U.S. and Canadian licensing rights to bilastine. The drug is currently in Phase III for allergic rhinitis, a seasonal allergic reaction that includes runny nose. Faes will also receive royalties on sales.

"Based on the clinical profile to date, we believe that the oral formulations of bilastine, if approved by regulatory authorities, could generate more than $200 million dollars in peak sales in the $3 billion annual oral antihistamine market in the United States," said Inspire CEO Christy L. Shaffer.

- read the AP report on the deal

Related Articles:
Side effects prompt Inspire to shutter trial. Report
Inspire shares plunge after FDA finds data insufficient. Report

ALSO NOTED: Wyeth bullish on late-stage drug; Zeltia forms research arm; and much more...

Wed, 04 Oct 2006 20:01:30 -0400

> Wyeth is bullishly forecasting potential annual sales of the experimental drug bazedoxifene after analyzing late-stage data for osteoporosis and vasomotor symptoms of menopause. Report

> Wyeth has inked a $195 million licensing pact with the UK's Biotica for novel rapamycin analogs. Report

> Spain's Zeltia is creating a separate arm to pursue work in RNAi. The new unit, Sylentis, will explore gene silencing in ophthalmology and digestive systems. Release

> A subsidiary of Zeltia says that its independent data monitoring committee has approved a Phase III clinical trial of Yondelis for ovarian cancer. Report

> Roche has released new data demonstrating the effectiveness of Fuzeon in treatment-experienced HIV patients. Report

> The FDA has fast-tracked Agennix's talactoferrin alfa for cancer/diabetic foot ulcers. Report

> The FDA has approved Berlex's birth control pill Yaz for a new indication: premenstrual dysphoric disorder. Report

> MedImmune has taken its quest to sue Genentech in a patent violation case directly to the Supreme Court. Report

> Inspire Pharmaceuticals says it is continuing talks with the FDA over Prolacria for dry-eye. The agency said earlier this year that it had insufficient data on the drug's efficacy for an approval. Article

And Finally... Can the FDA regulate nanotech effectively? A former FDA official doesn't think so. Article

Side effects prompt Inspire to shutter trial

Mon, 07 Aug 2006 20:01:37 -0400

Inspire Pharmaceuticals announced that it shuttered a mid-stage drug trial on the recommendation of its data monitoring committee after seeing data on a "range of bleeding complications among volunteers. There were no deaths reported among the 160 participants in the trial, who were taking the experimental INS50589 Antiplatelet after undergoing coronary artery bypass graft surgery utilizing a cardiopulmonary bypass pump. The company said it would undertake a thorough review of what happened in the trial, but added it was likely that Inspire would reallocate its resources to its other drug candidates.

- here's the AP report on Inspire's trial

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: LAB International plans spinoff; Merck backs off Vioxx analysis; and much more...

Tue, 30 May 2006 20:00:50 -0400

> LAB International plans to spin off its contract research organization through an IPO. Report

> Merck has backed off its assertion that its analysis of a statistical test demonstrated that Vioxx caused damage only after 18 months of regular use. That has been a core part of its defense against an avalanche of lawsuits over Vioxx. Article

> Adolor says the FDA has accepted its response to the agency's approvable letter for Entereg. Report

> The FDA and the EMEA have agreed to joint briefing meetings on the submission of genomic data. Report

> Millennium Pharmaceuticals announced that preliminary results for its monoclonal antibody MLN1202 for atherosclerosis met its primary endpoint in a Phase II trial. Report

> In a head-to-head study, Teva says that a comparison of Copaxone and Biogen Idec's Avonex shows that Copaxone continues to work after patients no longer respond to Avonex. Israel's Teva said that Copaxone reduce annual relapse rates by an additional 57 percent over Avonex, adding that neurologic disability did not deteriorate in 86 percent of patients. Copaxone was originally approved by the FDA 10 years ago. Release

> Regeneron Pharmaceuticals says the FDA has given fast track status to its chronic inflammation therapy. Report

> Cubist Pharmaceuticals plans to sell $275 million in notes to retire debt and help commercialize Cubicin. Report

> Japan's Toyama has filed an application to market its garenoxacin antibiotic, T-3811, in Japan. Report

> Inspire Pharmaceuticals plans to file an INDA for its experimental seasonal allergic rhinitis. Report

> Bio-Bridge Science announced it has finished construction of a research and manufacturing facility in Beijing. Release

> DiscoveRx Corporation announced its new strategic vision to focus on expanding its development of a series of innovative biochemical and cell based assays. Release

And Finally… A new survey suggests that the rate of new HIV infections has begun to fall. Article

ALSO NOTED: Pharmaxis launches Phase III Bronchitol trial; TeGenero offers trial settlement; and much more...

Tue, 18 Apr 2006 20:00:50 -0400

> Australia's Pharmaxis has begun a Phase III trial of Bronchitol, its experimental therapy for bronchiectasis. Results are expected by the mid-part of next year. Report

> Chembio Diagnostics has received an approvable letter for its rapid HIV test and expects formal approval in the "very near future." Report

> TeGenero is offering £5,000 to six men who suffered organ failure at the beginning of a Phase I trial, provided they agree not to sue. Lawyers for several of the men said that TeGenero wants the men to agree to binding arbitration to arrive at a fair compensation figure. Article

> TriPath Imaging has received approval for a new breast cancer test. Report

> SCOLR Pharma plans to raise $11.8 million in a stock offering. Report

> The UK's Lectus Therapeutics has acquired the assets of NeuroServe, an electrophysiology company which tests compounds on ion channels for pharmaceutical and biotech clients. Release

> Isis Pharmaceuticals has licensed its HIV therapy--Isis 5320--to Imquest. Report

> Predix Pharmaceuticals of Lexington, MA, which recently announced a definitive agreement to merge with EPIX Pharmaceuticals, announced that it has completed a Phase Ib clinical trial to study the pharmacodynamics and tolerability of PRX-08066 in 15 adults. Release

> Inspire Pharmaceuticals has received a $1.25 million milestone from Santen Pharmaceutical. Release

> China's Aida Pharmaceuticals has agreed to purchase the remaining outstanding shares of Shanghai Qiaer Bio-Technology Co. for $495,650. Release

And Finally… New studies discount the possibility that mercury in fillings can harm children. Article

ALSO NOTED: Investors back Sequenom; Inspire meets with FDA; and much more...

Mon, 27 Mar 2006 19:00:50 -0500

> A group of investors have agreed to buy $30 million of Sequenom stock. The money will be used as working capital for Sequenom, which makes biotech research equipment. Report

> Inspire Pharmaceuticals met with the FDA to discuss its approvable letter for its dry eye clinical program for diquafosol. Release

> Optimer Pharmaceuticals has launched Phase III trials of OPT-99 for bacterial gastroenteritis. Release

> YM BioSciences says its partner, Oncoscience, has been cleared by German regulators to initiate a Phase III trial of nimotuzumab in combination with radiation in children with inoperable pontine (brain stem) glioma. Release

> BioFocus, a unit of Galapagos, has inked a deal to supply chemical compounds to Roche for the next three years. Report

> Immunicon has extended its R&D agreement with Pfizer for detecting antigens on tumor cells. Release

> BG Medicine will conduct a joint biomarker program for muscle toxicity with Mitsubishi Pharma. Release

> The FDA has added six months of market exclusivity to Cephalon's Provigil. Release

And Finally… British doctor Jeremy Farrar has more first hand experience dealing with bird flu cases than anyone else, and he believes fears of a pandemic are at least somewhat overblown. Article

ALSO NOTED: Inspire licenses antihistamine;Antisoma wins orphan drug status; and much more...

Tue, 21 Feb 2006 19:00:50 -0500

> Inspire Pharmaceuticals has paid Boehringer Ingelheim $2.5 million up front to license an antihistamine to treat nasal allergies. Boehringer retains marketing rights outside of the U.S. and Canada. Report

> The University of Liverpool is contributing funds toward the creation of a new research center to focus on zoonosis, diseases like bird flu that start in animals and migrate to humans. Article

> France and The Netherlands have received EU permission to begin vaccinating bird flocks against the avian flu virus. Report

> Shares of the UK's Antisoma were on the rise after the company announced it had received EU orphan drug status for its aptamer drug AS1411 for the treatment of renal and pancreatic cancers. Report

> Shares of Antares Pharma of Exton, PA jumped after the biotech announced plans for a Phase III trial of its gel therapy for overactive bladder. Report

> India's Lupin is ending a deal with Cornerstone Biopharma for the distribution of its antibiotic Suprax in the U.S. Report

> CuraGen has released new data from its failed trial for velafermin as a treatment for cancer-related mouth sores. Report

> Rigel Pharmaceuticals of South San Francisco is planning new trials of R788 following the positive early results of a Phase I trial. Release

> The FDA has approved less restrictive labeling for Tasmar. Release

And Finally… A retired doctor from Austin filed suit against GlaxoSmithKline, saying that he lost $14 million in Las Vegas after doses of Requip and Mirapex turned him into a compulsive gambler. Article

ALSO NOTED: Warner Chilcott contraceptive approved; Inspire inks deal with Boehringer;and much more...

Mon, 20 Feb 2006 19:00:50 -0500

> The FDA approved Warner Chilcott's 24-day contraceptive Loestrin(R) 24 Fe. This is the first 24-day contraceptive to hit the U.S. market. Warner Chilcott focuses on dermatology and women's health. "This FDA approval is a significant step forward for Warner Chilcott as we continue to sharpen our therapeutic focus on women's health and expand our product portfolio in this area," said Roger Boissonneault, CEO. Report

> Inspire Pharmaceuticals has inked a licensing deal with Boehringer Ingelheim to develop a new therapy for rhinitis. Report

> Shares of Merck were on the rise this morning as investors bid up the stock after the company won its first federal trial regarding Vioxx. Report

> Iceland's deCODE Genetics has reported the successful conclusion of a Phase I trial of DG041 for peripheral artery disease. Release

> Corgentech announced that pivotal Phase 3 trial results from the second of two Phase 3 trials. The results demonstrated that children undergoing medical procedures requiring venipunctures and intravenous line placements treated with ALGRX3268 experienced significantly superior pain relief in just one to three minutes versus those receiving placebo. Release

> Memory Pharmaceuticals of Montvale, NJ released positive Phase I cognitive data for MEM 3454. Release

> Germany's Schwarz Pharma has received EMEA approval to market its Neupro Parkinson's disease treatment in 25 EU countries. Report

> Cerimon Pharmaceuticals of South San Francisco has licensed the worldwide rights to Novartis Pharma's Simulect for inflammatory bowel disease. Release

> Neurochem's safety review board has given its fourth recommendation to continue a late-stage trial of Alzhemed for Alzheimer's. Report

> Following discussions with the FDA, Synthetic Blood International says it will start a Phase II sickle cell anemia trial in the second quarter. Release

And Finally… Researchers are trying to determine if stem cells could hold the key to curing cancer. Article

Inspire halts Phase II clinical trials

Thu, 19 Jan 2006 19:01:35 -0500

Inspire Pharmaceuticals has halted two Phase II clinical trials of denufosol tetrasodium intravitreal injection in patients with macular edema after the treatment was shown to have no statistically significant effect in either reduction of retinal thickness or improvement in visual acuity in patients. The company does not plan to conduct any other studies of denufosol for the treatment of retinal disease.

- read this press release for more

Inspire shares plunge after FDA finds data insufficient

Thu, 01 Dec 2005 19:01:39 -0500

Shares of Inspire Pharmaceuticals lost one-third of their value in premarket trading after it was announced that the FDA found their data for the dry eye therapy diquafosol tetrasodium insufficient to warrant an approval. The agency outlined steps needed to gain a green light for diquafosol tetrasodium and urged a meeting to plan a way forward for the company. Inspire has been waiting for more than two years for approval of the drug. Allergan, which sells the dry eye treatment Restasis, had been working with Inspire to bring the new drug to market.

The FDA's letter stated that "[t]he submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product."

- read this AP report for more information

ALSO NOTED: European panel recommends Exubera; genOway takes over IngenKO; Regeneration Technologies recalls tissue; and much m

Thu, 13 Oct 2005 20:00:50 -0400

> Pfizer and Nektar Therapeutics announced that a European advisory panel has recommended approval of Exubera inhalable insulin. An FDA expert panel has already endorsed the therapy. Report

> France's genOway has taken over the commercial activities of Australia's IngenKO. Report

> Regeneration Technologies of Alachua, FL, has issued a recall of donor tissues after questions were raised about donor documentation. Release

> Chutes & Ladders: Canada's ConjuChem has named Mark Perrin as its new president and CEO. Release

> Inspire Pharmaceuticals says that new data submitted to the FDA warrants a Phase III trial of denufosol for cystic fibrosis. Release

> Nabi Biopharmaceuticals has completed a $20 million bulk vaccine manufacturing plant in Boca Raton, FL. Release

> DOR BioPharma has issued a pipeline update. Release

> Curis has received $1.25 million in additional funding from Genentech. Report

And Finally... Researchers say in this week's BMJ that an analysis of drugs approved over the last year shows that the promise of cheaper and better drugs using biotechnologies has not been met. Article

ALSO NOTED: Inspire files amended NDA; Genetic variations influence Coumadin use; Immunomedics begins Phase III;and much more..

Wed, 01 Jun 2005 20:00:50 -0400

> Inspire Pharmaceuticals is taking another shot at gaining approval for its experimental treatment for dry eye, filing an amended NDA for a drug that has failed two Phase III trials. Story

> Newly discovered genetic variations play a role in determining the right dose of the anti-clotting drug Coumadin. Article

> Immunomedics of Morris Plains, New Jersey, has begun dosing patients in a Phase III trial of its lead drug -- epratuzumab -- for lupus. Release

> Teva Pharmaceutical has received final FDA approval for a generic version of Abbott's antibiotic Biaxin Tablets. Story

> Neurion Pharmaceuticals has won a $500,000 grant from the National Institute of Mental Health. Release

> Chiron and the Multiple Myeloma Research Consortium announced the initiation of a Phase I clinical trial of CHIR-258 in multiple myeloma. Release

And Finally... A variety of cash-strapped states are considering new "botaxes," adding levies on cosmetic procedures. Story