FDA related Press Releases

U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection

Mon, 13 Feb 2012 20:20:59 -0500

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada^® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.

The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists. Gilead submitted the Truvada for PrEP sNDA on December 15, 2011. The FDA has set a target review date for Truvada for PrEP under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012. The agency has also indicated that Truvada for PrEP will be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the U.S. National Institutes of Health and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.

Truvada is not currently indicated to reduce the risk of HIV infection.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the FDA may not approve Truvada for HIV-1 risk reduction, and any approval, if granted, may have significant limitations on its use. Additionally, even if approved, physicians may be reluctant to prescribe the product for HIV risk reduction, and payers may be reluctant to approve or provide reimbursement for the product for HIV risk reduction. As a result, there may not be significant use of Truvada as a risk reduction tool. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Truvada is available at www.Truvada.com.

Truvada is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

CONTACT:

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health AIDS Biotechnology Hospitals Pharmaceutical FDA

MEDIA:

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Regeneron Announces Presentation at the Leerink Swann 2012 Global Healthcare Conference

Mon, 13 Feb 2012 17:20:51 -0500

TARRYTOWN, N.Y., Feb. 13, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) will webcast its presentation at the Leerink Swann 2012 Global Healthcare Conference on Wednesday, February 15, 2012. The presentation is scheduled for 9:00 a.m. Eastern Time. The session may be accessed through the Company's web site, www.regeneron.com, on the 'Events and Presentations' page. An archived version of the presentation will be available for 30 days.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets two products in the United States, ARCALYST® (rilonacept) Injection For Subcutaneous Use and EYLEA® (aflibercept) Injection, and has filed regulatory applications with the U.S. Food and Drug Administration (FDA) for second indications for each of these products. A regulatory application has also been submitted to FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion. Phase 3 studies are in progress with EYLEA® in a third indication, with ZALTRAP® in a second indication, and with product candidate Sarilumab. Earlier-stage clinical programs are underway with nine additional product candidates. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.

Contact Information:

Manisha Narasimhan, Ph.D.	Peter Dworkin
Investor Relations	Corporate Communications
914-847-5126	914.847.7640
manisha.narasimhan@regeneron.com	peter.dworkin@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Columbia Laboratories Transfers NDA for Progesterone Vaginal Gel 8% to Watson Pharmaceuticals

Mon, 13 Feb 2012 07:20:45 -0500

LIVINGSTON, N.J. and PARSIPPANY, N.J., Feb.13, 2012 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that Columbia has transferred the new drug application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson.

Watson has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application as of February 10, 2012. The companies indicated that Watson is continuing to work with FDA in support of the review of the NDA.

The March 2010 Purchase and Collaboration Agreement between Columbia and Watson contemplates the transfer of the NDA. There are no incremental payments associated with the transfer, and Columbia maintains its financial interest in the product and its role in the companies' Joint Development Committee.

"We continue to enjoy a strong working relationship with Watson, and believe this is the appropriate time to transfer the NDA," said Frank Condella, President and CEO of Columbia Laboratories, Inc. "As a result of this action, shareholders and other stakeholders can be assured that Watson will provide the resources available, as a result of its position as a $4.6 billion global pharmaceutical industry leader, to support continued progress of this application."

The FDA is expected to take action on the NDA by February 26, 2012.

About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets. For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel), for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. Columbia's press releases and other company information are available online at http://www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," "intends," "believes," "expects," "anticipates," "potential," "could," "would," "should," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: success in obtaining timely approval, if any, of a new drug application (NDA) by the U.S. Food and Drug Administration (FDA) for progesterone vaginal gel 8% for the Preterm Birth indication; the timing and level of success of a future product launch, if any; successful development of a next-generation vaginal progesterone product; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations, including Medicaid; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's and Watson's reports filed with the SEC, including, but not limited to, their respective Annual Reports on Form 10-K for the year ended December 31, 2010 and Quarterly Reports on Form 10-Q for the period ended September 30, 2011. Neither Columbia nor Watson undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.

CRINONE® is a registered trademark of Watson Pharmaceuticals, Inc.

(Photo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )

Contacts
For Columbia Laboratories, Inc.	For Watson Pharmaceuticals, Inc.
Investors	Investors
Lawrence A. Gyenes	Patty Eisenhaur
SVP, Chief Financial Officer & Treasurer	VP, Investor Relations and Corp. Comm.
Columbia Laboratories, Inc.	(862) 261-8141
(973) 486-8860
--or--	Media
Seth Lewis	Charlie Mayr
VP, The Trout Group LLC	SVP, Corporate Affairs
(646) 378-2952	(862) 261-8483

Media
Amy Raskopf
President, Raskopf Communications, LLC
(917) 673-5775

SOURCE Watson Pharmaceuticals, Inc.; Columbia Laboratories, Inc.

Insmed Incorporated Provides Update on Clinical Program for ARIKACE®

Fri, 10 Feb 2012 09:21:06 -0500

MONMOUTH JUNCTION, N.J., Feb. 10, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the Company is proceeding with a phase 2 clinical trial of ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease, as well as the previously planned European registration phase 3 clinical study of ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections. Simultaneously, Insmed continues its discussions with the U.S. Food and Drug Administration (FDA) regarding the clinical hold previously placed on the ARIKACE clinical study in CF patients with Pa lung infections.

"I am pleased to announce that we are moving forward with the ARIKACE clinical development program in NTM in the U.S., and with the European CF program," said Timothy Whitten, President and CEO of Insmed. "We look forward to continuing our dialogue with FDA regarding the CF clinical program in the U.S., and continue to believe that ARIKACE has the potential to be an important treatment option for CF and NTM patients."

The phase 2 clinical trial for ARIKACE in NTM patients will consist of a randomized, placebo-controlled study of approximately 100 adult patients with recalcitrant NTM lung disease. Patients who are NTM culture positive will continue with their antibiotic treatment regimen, and receive additionally, either ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), or placebo once daily. The primary efficacy endpoint will be change in mycobacterial density from baseline to the end of 84 days of treatment. At the conclusion of the randomized portion of the study, eligible patients will receive ARIKACE 560 mg once daily for an additional 84 days in an open-label design, primarily to measure longer-term safety and efficacy. The clinical trial design was previously agreed upon by Insmed and FDA. The Company expects to begin enrolling patients in the phase 2 clinical trial in mid-2012.

The European study in CF patients with Pa lung infections will be a randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System, to TOBI®(1) (inhaled tobramycin solution), which is a marketed inhaled antibiotic that is delivered twice daily. The Company anticipates that the study will be conducted in approximately 300 patients. The primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months). A key secondary endpoint will be time to pulmonary exacerbation. The study design was previously agreed upon by Insmed and the European Medicines Agency. Eligible patients will have the option to participate in a longer term open-label safety study. The Company expects to begin enrolling patients in the phase 3 European clinical study in the second quarter of 2012.

About Insmed

Insmed Incorporated is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, and has a proprietary protein platform aimed at niche markets with high unmet medical need. Insmed's primary focus is on the development of inhaled antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. For more information, please visit http://www.insmed.com.

About eFlow® Technology and PARI Pharma

ARIKACE is delivered by an investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE. The optimized device uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. eFlow® Technology is not an ultrasonic nebulizer technology, and it is not a general purpose electronic aerosol generator nebulizer technology. Combined with its quiet mode of operation, small size, light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. PARI Pharma focuses on the development of aerosol delivery devices and inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Online at www.paripharma.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to our financial position, results of operations, the status and the results of preclinical studies and clinical trials and preclinical and clinical data described herein, the timing of responses to information and data requests from FDA, the development of our products, and the business strategies, plans and objectives of management, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. Our results may be affected by such factors as the receipt and timing of FDA and other regulatory reviews and approvals, if at all, competitive developments affecting our product development, delays in product development or clinical trials, and patent disputes involving currently developing products. The risks and uncertainties include, without limitation, we may experience unexpected regulatory actions, delays or requests, our future clinical trials may not be successful, we may be unsuccessful in developing our product candidates or receiving necessary regulatory approvals, we may experience delays in our product development or clinical trials, our product candidates may not prove to be commercially successful, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2010 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2011. Investors are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

(1) TOBI® is a Registered Trademark of Novartis Pharmaceuticals Corporation

Investor Relations Contact:
Brian Ritchie – FTI Consulting
212-850-5683
brian.ritchie@fticonsulting.com

Media Contact:
Irma Gomez-Dib – FTI Consulting
212-850-5761
irma.gomez-dib@fticonsulting.com

SOURCE Insmed Incorporated

FDA issues draft guidance on biosimilar product development

Jennifer Levin — Fri, 10 Feb 2012 07:42:36 -0500

FDA issues draft guidance on biosimilar product development

Feb. 9, 2012

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”

The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway -- under section 351(k) -- for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product.

Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials.

A biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency.

Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.

The following three guidance documents provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency. FDA is seeking public comment on these draft guidance documents:

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product:
The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application, called a “351(k)” application, to the FDA. This draft guidance describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product:
The draft guidance provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes the importance of extensive analytical, physico-chemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009:
The draft guidance provides answers to common questions from people interested in developing biosimilar products. The question and answer format addresses questions that may arise in the early stages of product development, such as how to request meetings with the FDA, addressing differences in formulation from the reference product, how to request exclusivity, and other topics.

FDA will seek public comment on the guidance documents and instructions on how to submit comments will be announced in an upcoming Federal Register notice. In finalizing the guidance documents, the agency will consider the information received from the public.

For more information

• FDA: Biosimilars

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for Linacl

Wed, 08 Feb 2012 19:20:58 -0500

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an advisory committee meeting in connection with the its review of the New Drug Application (NDA) for linaclotide proposed for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). On August 9, 2011, Ironwood, along with its partner Forest Laboratories, announced that they submitted the NDA for linaclotide to the FDA. Under the FDA’s Prescription Drug User Fee Act (PDUFA), the companies anticipate action by the FDA in June 2012, approximately 10 months from the submission date.

Ironwood and Forest submitted the NDA for linaclotide for the treatment of IBS-C and CC based upon efficacy and safety results from a Phase 3 program comprising four double-blind placebo-controlled trials and two open-label long term safety studies. A total of more than 2,800 patients received a once-daily dose of either linaclotide or placebo across the four clinical trials: two trials in patients with IBS-C and two trials in patients with CC. Additionally, over 3,200 patients have enrolled in ongoing open-label safety trials and more than 2,000 of those patients have received linaclotide for at least 12 months.

About Linaclotide

Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. Linaclotide is an orally delivered peptide that acts locally in the gut with no measurable systemic exposure at therapeutic doses and is intended for once-daily administration. An issued composition of matter patent for linaclotide provides protection to 2025 in the United States. Ironwood and Forest plan to co-promote linaclotide in the U.S. Ironwood has out-licensed linaclotide to Almirall for European development and commercialization, and to Astellas Pharma Inc. for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand.

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS-C is a chronic functional gastrointestinal disorder characterized by abdominal pain, abdominal discomfort, and bloating associated with altered bowel habits, and as many as 11 million people in the U.S. suffer from it. IBS-C can have a negative impact on daily living. There are currently few available therapies to treat this disorder.

About Chronic Constipation (CC)

As many as 34 million Americans suffer from symptoms associated with CC and 8.5 million patients have sought treatment. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and fewer than three bowel movements per week, as well as abdominal discomfort and bloating. There is a high rate of dissatisfaction with currently available treatments for CC.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. Linaclotide, Ironwood’s GC-C agonist, is an investigational drug for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The efficacy portion of linaclotide’s development program has been completed and supports the recently submitted NDA for both indications, as well as the MAA submission in Europe for the IBS-C indication. Ironwood also has a growing pipeline of additional drug candidates in earlier stages of development. Ironwood is located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the possibility that the advisory committee meeting gets rescheduled to a later date, the potential the FDA convenes an advisory committee that does not recommend approval of linaclotide or that recommends modifications to the proposed label for linaclotide, the risk that the FDA issues a complete response letter for linaclotide, the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, and the timely development and launch of new products, as well as the risk factors listed from time to time in Ironwood's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other SEC filings. Ironwood undertakes no obligation to update these forward-looking statements to reflect events or circumstances occurring after this press release. These forward-looking statements speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

CONTACT:

Ironwood Pharmaceuticals, Inc.
Susan Brady, 617-621-8304
Corporate Communications
sbrady@ironwoodpharma.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical FDA

MEDIA:

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Neuralstem President and CEO to Present at BIO CEO & Investor Conference 2012

Wed, 08 Feb 2012 10:21:21 -0500

Live Webcast to Air on Monday, February 13, at 3:00 p.m. EST

ROCKVILLE, Md., Feb. 8, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announces that President and CEO Richard Garr will present at the 14th Annual BIO CEO & Investor Conference 2012 in New York City on Monday, February 13, at 3:00 p.m. EST. Garr will present a business overview, and an update on the company's ongoing clinical trials in both its cell therapy and pharmaceutical divisions.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)

The webcast will be available in real-time at http://www.veracast.com/webcasts/bio/ceoinvestor2012/43114242.cfm, and again beginning one hour after the conclusion of the live event, and archived for 90 days. The webcast link will also be posted on the Investor Center home page on Neuralstem's website: www.neuralstem.com.

The BIO CEO & Investor Conference 2012 will be held at the Waldorf=Astoria in New York City, February 13-14. For more information, see: http://www.bio.org/events/conferences/14th-annual-bio-ceo-investor-conference. Now in its 14th year, the BIO CEO & Investor Conference is billed as the largest independent investor conference focused on publicly traded biotechnology companies.

Neuralstem's President and CEO Richard Garr is also scheduled to present at the 6th Annual BIO-Europe Spring Conference 2012, March 19-21, in Amsterdam, Holland. Please see http://www.ebdgroup.com/bes/index.php for more information.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and Huntington's disease. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

SOURCE Neuralstem, Inc.

Medtronic Stent Resulted in 90% Freedom from Reinterventions in Narrowed Leg Arteries at 12 Months in International Study

Wed, 08 Feb 2012 08:21:21 -0500

New Clinical Data Presented for First Time at Medical Meetings in U.S. and Europe Show Durable Vessel Patency in Treating Atherosclerotic Lesions of Superficial Femoral Artery

MINNEAPOLIS--(BUSINESS WIRE)-- Consistent with its commitment to developing better treatments for peripheral arterial disease (PAD), Medtronic Inc. (NYSE:MDT) today announced the one-year results of an international study of the Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA). The device is investigational in the United States.

As presented for the first time at ISET and LINC in January, the Complete SE SFA study demonstrated a primary patency rate of 73.1 percent, a major adverse event rate of 11.0 percent and a target lesion revascularization (TLR) rate of 9.4 percent at 12 months of patient follow-up. The TLR rate, a patient-centric measure of symptom-driven reintervention, means that more than 90 percent of study subjects at the one-year time-point had not required another procedure to treat the target lesion.

The Complete SE SFA study was a prospective, single-arm trial that enrolled 196 subjects (with a total of 213 lesions) at 28 sites in the United States and Europe.

Approved by the U.S. Food and Drug Administration (FDA) under an investigational device exemption (IDE), the study evaluated the safety and efficacy of the Complete SE stent in treating lesions of the SFA, including the proximal popliteal artery (PPA), with the primary endpoints assessed at 12 months: major adverse events for safety and primary patency for efficacy. All study subjects were determined to have symptomatic, ischemic PAD involving the SFA/PPA.

The principal investigators of the study are Dr. John Laird of UC Davis Medical Center in the United States and Prof. Dr. Dierk Scheinert of the University of Leipzig Heart Center in Germany.

“The strong performance of the Complete SE vascular stent in this rigorously conducted clinical trial is encouraging,” said Dr. Laird, who presented the results at this year’s International Symposium on Endovascular Therapy (ISET) in Miami and the Leipzig Interventional Course (LINC) in Germany. “The investigators found the device easy to use in treating SFA lesions of varying complexity, which is indicative of clinical practice.”

Study subjects showed statistically significant improvements in all measures of clinical and functional effectiveness, such as Rutherford Category, mean ABI/TBI, and Walking Assessment. These improvements were achieved despite the enrollment of patients with moderately or severely calcified lesions (91.0%), diabetes (45.4%), and a Rutherford Category rating of 3 or higher (66.8%) at baseline.

More than 80 percent of study subjects had achieved a Rutherford Category value of 0 or 1, the favorable end of the 0–6 scale, at 30 days, and that benefit persisted through six months and one year of follow-up. Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ABI/TBI scores at six and 12 months, with more than 60 percent of study subjects improving by at least 0.15 over the follow-up period. On Walking Assessment measures, impairment improved by 36.8 percent, distance by 32.4 percent, speed by 21.8 percent and stair climbing by 23.3 percent.

The Complete SE stent, which is commercially approved by the FDA for use in the iliac arteries, is Medtronic’s flagship self-expanding peripheral vascular stent, known for its innovative delivery system that enables exceptional deployment accuracy. Medtronic also plans to seek FDA approval for the SFA indication.

“Our commitment to building the clinical evidence to advance peripheral interventional therapies takes many forms,” said Tony Semedo, vice president and general manager of the Endovascular Therapies business at Medtronic. “The Complete SE SFA study is a prime example. We are also devoting significant resources to building a strong clinical foundation for the use of drug-eluting balloon technology to treat atherosclerosis in the lower extremities.”

The superficial femoral artery (SFA) runs under the skin of the upper leg and carries blood to the lower extremities, from the thigh to the toes. In patients whose SFA narrows (usually due to the accumulation along the inner wall of the artery of fatty deposits called plaque), the flow of oxygenated blood to the lower extremities becomes restricted, with consequences ranging from leg pain while walking (claudication) to limb loss (amputation).

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

ABOUT MEDTRONIC

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology –– alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

CONTACT:

Medtronic Inc.
Joseph McGrath, 707-591-7367
Public Relations
Jeff Warren, 763-505-2696
Investor Relations

KEYWORDS: United Kingdom United States Europe North America Minnesota

INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Medical Devices

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Idenix Announces Removal of the Partial Clinical Hold on HCV Nucleotide Inhibitor, IDX184

Fri, 03 Feb 2012 09:21:04 -0500

CAMBRIDGE, Mass., Feb. 3, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the partial clinical hold on IDX184 has been removed and that the Company's 12-week phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV) may continue. IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection is a pan-genotypic oral nucleotide polymerase inhibitor, and has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies. Recently announced interim phase IIb data demonstrated favorable antiviral activity and no serious adverse events.

"After review of the interim safety and antiviral activity results from the IDX184 phase IIb clinical trial, the FDA removed the partial clinical hold and has allowed us to continue enrollment of this study," Ron Renaud, President and Chief Executive Officer of Idenix, commented. "Importantly, this allows us to expand the phase IIb program and evaluate IDX184 in interferon-free combination regimens with other direct-acting antivirals. We are working toward beginning all-oral combination trials as quickly as possible."

About IDX184 Phase IIb Study

In July 2011, Idenix initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Study objectives include safety and tolerability, and antiviral activity endpoints. The FDA has agreed to truncate the study from 100 patients, as in the original protocol, to a total of 60 patients, and to expand the enrollment criteria.

About IDX184 Partial Clinical Hold

A clinical hold originally was issued in September 2010 as a result of three cases of elevated liver function tests observed during a drug-drug interaction study in healthy volunteers of the combination of IDX184 and IDX320, an investigational HCV protease inhibitor. Idenix reviewed available data and conducted additional preclinical studies. With the help of independent experts and an external safety committee, the Company concluded that the observed toxicity was likely caused by IDX320 and submitted all data to the FDA. At the beginning of 2011, the FDA removed a full clinical hold on IDX184, and the program was placed on partial clinical hold allowing the Company to initiate the 12-week phase IIb study for IDX184 in July 2011. In January 2012, Idenix submitted interim phase IIb data for the first 31 patients to the FDA, along with a recommendation from the independent Data Safety Monitoring Board to continue the study, and requested removal of the partial clinical hold on IDX184. The partial clinical hold has now been removed allowing the initiation of dosing of an additional 30 patients in the ongoing phase IIb clinical trial and the initiation of a broad phase IIb program with IDX184 in the coming months.

About IDX184

IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

Forward-Looking Statements

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C; the likelihood and success of any future clinical trials involving our drug candidates; and expectations with respect to funding of operations and future cash balances. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the Company's dependence on its collaboration with Novartis Pharma AG; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2011, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors)

SOURCE Idenix Pharmaceuticals, Inc.

OptiNose Files Investigational New Drug Application to use Sumatriptan Delivered with its Novel Drug Delivery Technology

Thu, 02 Feb 2012 15:20:55 -0500

YARDLEY, Pa.--(BUSINESS WIRE)-- OptiNose Inc. announces the filing of an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) in December, 2011. The FDA has completed its review and has notified OptiNose that the studies under this IND may proceed. The Company will initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.

“This filing signals an important milestone in our quest to deliver improved relief to patients who suffer from migraine headaches, “said Peter Miller, Chief Executive Officer (CEO) of OptiNose. “Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology and the significant impact it could have on patients with this debilitating condition.”

About OptiNose Inc.

OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform the static nasal drug delivery market. Founded in 2000, OptiNose’s devices are designed to deliver intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. The technology has been tested in a number of clinical trials assessing both clinical efficacy and safety.

About Bi-directional Nasal Delivery Technology

OptiNose’s bidirectional nasal delivery technology significantly improves delivery to the targeted sites deep into the nose. While exhaling into the device, the soft palate automatically closes off the nasal cavity completely. The breath enters one nostril through a sealing nozzle and triggers the release of drug particles into the airflow. This action causes the narrow nasal passages to expand and carry these particles beyond the nasal valve to targeted sites. After delivering drug particles to the targeted sites, the air flow then exits the nasal cavity through the other nasal passage in the opposite direction.

CONTACT:

OptiNose Inc.
Dan Zacchei, 212-446-1882
dzacchei@sloanepr.com

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical FDA

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