InterMune Inc. (ITMN), currently conducting a study of its hepatitis C drug, said it would discontinue studying a high level dose amid fears of liver damage.

Investors lifted the markets to a modestly higher close with the Dow rising 30 points to 10,437 after analysts provided upbeat prospects for Microsoft and Exxon Mobil. Nasdaq gained 5 points to 2203.

Drug stocks dip in early action Tuesday, while shares of Alkermes gain on positive news about two of its substance-abuse therapies.

Visit StreetInsider.com at http://www.streetinsider.com/news.php?st=p&id=5118135 for the full story.

Today’s tickers: CVS, LIZ, ITMN, MA, V, RF, KG, HW, WSM, AEP & NTAP

CVS - CVS Caremark Corp. – Shares of the pharmacy retail chain are up 1.5% to $31.11 perhaps due, in part, to the ‘buy’ rating it received at UBS today. Optimistic options activity took place in the December contract as one investor initiated a bullish risk reversal. It appears the trader sold 4,400 puts at the December 31 strike for an average premium of 94 cents apiece in order to finance the purchase of the same number of calls at the higher December 32 strike for 63 cents each. The investor pockets a 31 cent credit on the trade, which he retains in full as long as shares remain above $31.00 through expiration. Additional profits accumulate if CVS’s shares rally above $32.00.

LIZ - Liz Claiborne, Inc. – A 15,000-lot covered call in the January 2011 contract on Liz Claiborne today suggests shares are likely to recover, albeit at a glacial pace. Shares of the apparel and accessories retailer suffered a 5% decline to $4.55 during the trading session. One investor effectively purchased shares of the underlying stock for $3.30 apiece by selling 15,000 calls at the January 2011 5.0 strike for a premium of 1.25 each. Thus, the trader stands ready to accrue gains of 51% if shares of LIZ appreciate to $5.00 by expiration. The long-term positioning of the covered call play provides several advantages to the investor. One advantage is that the call options do not expire for another 13 months, which leaves ample time for LIZ’s shares to appreciate up to the strike price of $5.00. The 15,000-lot call transaction represents nearly 50% of the total existing open interest on LIZ of 31,502 contracts. Note that shares last traded above $5.00 yesterday at approximately 10:35 am (EDT).

ITMN - InterMune, Inc. – A bull call spread on the biotechnology company today suggests shares could rally significantly by expiration in April 2010. Bullish options activity on the stock belies the more than 3% decline in ITMN’s shares during the session to $10.94. The call spread involved the purchase of 3,750 calls at the April 15 strike for an average premium of 2.25 each, marked against the sale of the same number of calls at the higher April 25 strike for 75 cents apiece. The net cost of the transaction amounts to 1.50 per contract. The optimistic investor is positioned…

(CVS) - CVS Caremark Corp. - Shares of the pharmacy retail chain are up 1.5% to $31.11 perhaps due, in part, to the ‘buy’ rating it received at UBS today. Optimistic options activity took place in the December contract as one investor initiated a bullish risk reversal. It appears the trader ...

Here are some interesting stock filings that took place at the close of the market on Friday. The filings will likely have an effect on stock prices for the following companies:

BioMed Realty Trust, Inc. (NYSE:BMR) BioMed Realty Trust files mixed securities shelf under form S-3ASR InterMune, Inc. (NASDAQ:ITMN) filed $200M mixed securities shelf Cadence Pharmaceuticals, Inc.(NASDAQ:CADX) filed $100M mixed securities shelf. WuXi PharmaTech, Inc (NYSE:WX) registered to sell 10.43M American Depository Shares for holders

The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. The trial sponsor is Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052. XOMA will provide XOMA 052 drug product for the trial.

{tiny;XOMA;3}As many as 3 million Americans may have Type 1 diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the patient's own immune system destroys the patient's beta cells in their pancreas that normally control blood sugar level. Patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump every day for the rest of their lives. And even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

In addition, XOMA announced the grant of its first European Patent related to the XOMA 052 program. Granted by the European Patent Office, the patent covers XOMA's interleukin-1 beta (IL-1 beta) antibody XOMA 052, as well as nucleic acids, expression vectors and production cell lines for the manufacture of XOMA 052. The patent provides exclusivity in Europe into 2026.

 

{tiny;ITMN;3}InterMune, Inc. (Nasdaq: ITMN) has announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.

"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."

 

{tiny;DARA;3}DARA BioSciences, Inc. (Nasdaq:DARA) has announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 12/112,213 entitled "Methods for Decreasing or Preventing Pain Using Spicamycin Derivatives." When issued, the patent will allow protection through 2021. DARA BioSciences has exclusive licenses with Massachusetts General Hospital and Kirin Pharmaceuticals of Japan for the treatment of pain with Spicamycin derivatives.

Earlier this year, the company successfully completed a clinical proof-of-concept study for the treatment of neuropathic pain in patients with advanced cancer using KRN5500. The results of this Phase 2 study will be presented as a poster, "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain Intensity in Patients with Cancer" at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain to be held in San Francisco, November 19-21, 2009. Sharon M. Weinstein, MD, a leading investigator in the study, will present the poster.

 

{tiny;GNVC;3}GenVec, Inc. (Nasdaq: GNVC) has announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TNFerade(TM) for the treatment of pancreatic cancer.

"Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits," stated Dr. Paul Fischer, GenVec's President and CEO.

The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation provides potential financial and regulatory incentives including study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Lannett Company, Inc. (NYSE:LCI), a manufacturer of generic pharmaceuticals, announced the company will release its fiscal 2010 first-quarter financial results on Monday, November 9, 2009.

Catalyst Health Solutions, Inc. (NASDAQ:CHSI), a pharmacy benefit management company, announced its financial results for the third quarter ended September 30, 2009.

SuperGen, Inc. (Nasdaq:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced Mohammad Azab, M.D., Chief Medical Officer, will present at the Merriman Curhan Ford 6th Annual Investor Summit on Tuesday November 10, 2009 in New York.

Unigene Laboratories, Inc. (OTC:UGNE) will release financial results for the quarter ended September 30, 2009, after the market closes on Monday, November 9, 2009.

Emisphere Technologies, Inc. (OTC:EMIS) announced management will host a conference call to discuss the Company’s financial and operational results for the third quarter ended September 30, 2009 on Monday, November 9, 2009 at 10:00 AM EST.

BioClinica™, Inc. (NASDAQ:BIOC), a global provider of clinical trial services, announced its financial results for the quarter and nine months ended September 30, 2009.

Universal Detection Technology (OTC:UNDT), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats, announced it is expanding its product catalogue to include a consumer-ready kit for the detection of black mold.

Emdeon® (NYSE:EM), a leading provider of healthcare revenue and payment cycle management solutions, announced its eRx Network® will provide real-time electronic billing solutions to retail pharmacies for the nation's top 25 medical payers in light of the dramatic increase in H1N1 vaccinations being administered by pharmacies.

Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its senior vice president and chief financial officer, Chris Menard, and senior vice president of integration and product strategy, Martin Young, will present at the 18th Annual Credit Suisse Healthcare Conference at the Arizona Biltmore Hotel in Phoenix, Arizona.

Medidata Solutions (NASDAQ:MDSO), a leading global provider of hosted clinical development solutions, announced a multi-year contract extension with Shire plc (NASDAQ:SHPGY) for use of Medidata Grants Manager™ and CRO Contractor™ benchmarking and analysis tools for investigator site and contract research organization (CRO) trial budget planning and forecasting.

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), reported financial results for the quarter ended September 30, 2009, and provided details on further developments.

AcuMedSpa Holdings, Inc. (OTC:AMSZ) is pleased to announce that it has reached an agreement with Santa Barbara Medical Innovations (SBMI) to become a preferred provider of the popular Zerona protocol which is a proven, non-invasive cold laser solution for unwanted body fat as well as for body slimming and contouring. Zerona has been featured in dozens of magazines and on TV shows such as "Rachael Ray," "Extra" and "The Doctors."

Advanced Life Sciences Holdings, Inc. (OTC:ADLS), announced it will host a conference call and webcast discussing the Company's 2009 third quarter results on Tuesday, November 10, 2009 at 10:00 a.m. (EST).

InterMune, Inc. (Nasdaq:ITMN) announced it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Javelin Pharmaceuticals, Inc. (NYSE:JAV) announced its CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, will host a conference call to discuss the Company's quarterly results for the period ending September 30, 2009.

Lannett Company, Inc. (NYSE:LCI), a manufacturer of generic pharmaceuticals, announced the company will release its fiscal 2010 first-quarter financial results on Monday, November 9, 2009.

Unilife Medical Solutions Limited (OTC:UNIFF) (Unilife Australia) entered into a Merger Implementation Agreement with Unilife Corporation (Unilife USA) to facilitate the proposed redomiciliation of the Unilife group in the United States of America (Proposed Transaction).

Aeolus Pharmaceuticals, Inc. (OTC:AOLS) reported researchers from National Jewish Health and McGill University have completed a series of preliminary studies demonstrating that AEOL 10150 protects lungs from chlorine gas exposure in mice.

Pro-Pharmaceuticals, Inc. (OTC:PRWP) announced it has closed a $310,000 tranche of a private placement of up to $6.0 million with 10X Fund, L.P., which is purchasing unregistered Series B convertible preferred stock and warrants.

Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., announced data from a Phase 2 clinical trial of Hematide™ showing that Hematide increased hemoglobin and reduced or eliminated the need for blood transfusion in most patients with erythropoietin-induced pure red cell aplasia (PRCA).

Alkermes, Inc. (NASDAQ:ALKS) announced its corporate presentation will be webcast live by Credit Suisse on Wednesday, November 11, 2009, at 5:00 p.m MT (7:00 p.m. ET) from the Arizona Biltmore Hotel in Phoenix, Arizona.

Flamel Technologies (Nasdaq:FLML) expects to release its financial results for the third quarter of 2009 the morning of November 16th, before the market opening.

Neurogen Corporation (NASDAQ:NRGN), a drug development company, announced it will release its third quarter 2009 financial results on Friday, November 6, 2009 before the opening of the U.S. financial markets.

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, reported financial and operating results for the quarter ended September 30, 2009.

Genta Incorporated (OTC:GETA) announced the Company will release its third quarter 2009 financial results on Monday, November 16, 2009.

Gilead Sciences, Inc. (Nasdaq:GILD) announced its corporate presentation will be webcast from the 18th Annual Credit Suisse Healthcare Conference in Phoenix.

SurModics, Inc. (Nasdaq:SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, reported financial results for the fourth quarter and fiscal year ended September 30, 2009.