) is reporting some interesting findings confirmed by the American Veterinary Medical Association (AVMA) that a household cat in Iowa developed signs of respiratory infection caused by H1N1 influenza virus. The AVMA report adds cats to the growing list of animals, including ferrets, hogs (most recently in Indiana and Taiwan) and turkeys reported to be infected by H1N1 influenza virus.

{tiny;AMAR;3}Dr. Joseph Cummins, President & CEO, ABI, said, "Any possible H1N1 mutations that worsen the virus' effect on humans could limit the effectiveness of vaccines or other prophylactic measures. Fortunately, oral or intranasal interferon alpha has been reported by scientists in France, Italy, Germany, Taiwan and the USA to be safe and beneficial in controlling viral diseases in cats, hogs, ferrets and poultry, regardless of mutations occurring."

A Phase 2 clinical trial of ABI's low-dose oral interferon is ongoing in Australia in 200 healthy human volunteers exposed to the H1N1 influenza virus and other respiratory viruses during the local influenza season.

Dr. Manfred Beilharz, one of the principal investigators in Australia, said, "Our study was conducted based on human results published in Russia and Bulgaria. Our study is expected to validate results of human clinical trials published years ago, which reported that low-dose interferon given orally or intranasally is safe and effective against influenza virus."

Results of this important Australian study are expected within a month.

{tiny;REGN;1}Sanofi-Aventis the Paris health-care giant, and Regeneron Pharmaceuticals Inc.(Nasdaq:REGN) the Tarrytown, N.Y., biopharmaceutical producer, have expanded their effort to discover and market therapeutic monoclonal antibodies. Within the deal, Sanofi-Aventis will boost its funding commitment to $160 million a year from $100 million beginning in 2010. The funding commitment will now extend through 2017 and given that the venture had been set to expire at the end of 2012 this is good news for Regeneron, whcih will gap shares up this morning. The companies aim to bring as many as five antibodies into clinical development each year, they said in a statement late on Tuesday. The two companies have advanced four antibodies into clinical development and have filed for a fifth.

{tiny;NEXM;3}Nexmed is getting a nice cash infusion.  NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on the NexACT® drug delivery technology, today announced that it raised $750,000 in gross proceeds from the issuance of new convertible notes due December 31, 2011, which are secured by a mortgage on NexMed’s facility in East Windsor, New Jersey.

The Notes were purchased by two investors, including The Tail Wind Fund Ltd., a long term investor in NexMed and are convertible into shares of NexMed common stock at $2 per share with a coupon rate of 7% per annum.

NexMed’s pipeline includes a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a P 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis.

{tiny;ALTH;3}Look for shares of Allos Therapeutics, Inc. (Nasdaq: ALTH) to rise as we head closer to an announced presentation of abstracts from studies of FOLOTYN™ (pralatrexate injection) were accepted for presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) to be held at the Ernest N. Morial Convention Center in New Orleans, La., from December 5-8, 2009.

Four poster presentations will summarize new analyses of data and updated efficacy results from the Company’s pivotal PROPEL study, which served as the basis for U.S. Food and Drug Administration’s accelerated approval of FOLOTYN™ on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. A complete schedule of the presentations can be found here.

 

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.Akorn, Inc. (NASDAQ:AKRX) a specialty pharmaceutical company, reported financial results for the third quarter ended September 30, 2009.Allos Therapeutics, Inc. (NASDAQ:ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics announced management will present at two upcoming conferences: the Lazard Capital Markets 6th Annual Healthcare Conference and the Windhover Therapeutic Area Partnerships event, where the Company’s Pralatrexate for Peripheral T-cell Lymphoma project was named as one of Windhover’s Top 10 interesting oncology projects.ArQule, Inc. (Nasdaq:ARQL) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009 at 5:10 p.m. eastern time.Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced researchers are scheduled to present data relating to Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 51st Annual Meeting of the American Society of Hematology (ASH), to be held December 5 – 8, 2009 at the Ernst N. Morial Convention Center in New Orleans.Biogen Idec Inc. (NASDAQ:BIIB) announced its presentation at the Lazard Capital Markets 6th Annual Healthcare Conference will be webcast live, via the internet, on Tuesday, November 17, 2009 at 10:55a.m. EST.Elan Corporation, plc (NYSE:ELN) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference, on Tuesday, November 17, 2009 at; 9:55 a.m. Eastern Time and 2:55 p.m. GMT.Genoptix, Inc. (Nasdaq:GXDX), a specialized laboratory services provider, announced the Company's participation at the Lazard Capital ManaGement 6th Annual Healthcare Conference at The St. Regis Hotel in New York City on November 17-18, 2009.Impax Laboratories, Inc. (NASDAQ:IPXL) announced the Company will present at the Credit Suisse 18th Annual Healthcare Conference on Friday, November 13th, at 10:00 a.m. Mountain Standard time.ImmunoGen, Inc. (Nasdaq:IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced several ImmunoGen poster presentations will be made at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics to be held in Boston, MA, on November 15-19, 2009.The positive mix lift expected as farmers choose to upgrade to next-generation technologies allows Monsanto Company (NYSE:MON) to reconfirm its commitment to double its 2007 gross profit in 2012, Monsanto President and CEO Hugh Grant will tell investors.Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, announced Gerald T. Proehl, president and chief executive officer, will make a presentation at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009, at 10:55 a.m. Eastern time (7:55 a.m. Pacific time) at the St. Regis Hotel in New York City.S3 Investment Company, Inc. (OTC:SIVC) announced the company's wholly owned Redwood Capital subsidiary has received payment valued at over $500,000 in the form of cash and stock from the recent closing of a client equity offering.Sigma-Aldrich® (Nasdaq:SIAL) announced it has entered into an exclusive worldwide distribution agreement with Stemgent, Inc. to offer Stemgent's portfolio of lentivirus-based delivery systems for the generation of induced pluripotent stem (iPS) cells.Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab.Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) announced holders of its 4.75% Convertible Senior Subordinated Notes due 2013 have agreed to exchange approximately $109.0 million in aggregate principal amount of those notes and accrued interest for approximately 4.8 million shares of the Company’s common stock, which is approximately 140,000 shares more than the number of shares into which the notes were convertible under their original terms.

On 6/10/09, Access announced that the Company received issue notifications from the United States Patent and Trademark Office for two US patents (numbers 7,544,348 and 7,547,433) for MuGard and related product line extensions. MuGard is a polymer solution which provides a protective coating for the oral cavity when swirled gently around the mouth that could be expanded into related markets, including dental applications, oral surgery, and other related medical interventions requiring protection of the oral mucosa. The product is formulated as a ready-to-use viscous liquid which is easy to use and carries the added benefit of preventing the incidence of mucositis.

Up to 40% of all patients receiving chemotherapy and/or radiation therapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. In patients receiving radiation therapy for head and neck cancer, 42% of patients using MuGard Rinse did not develop significant mucositis, as compared to just 9% in a historical control group. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops.

In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece (launched in late June), and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea with expected commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement becomes established in each region.

Commercial partner estimates for MuGard include global annual peak sales potential of $350 million with a scaled royalty rate of 20-25% for Access, which translates into royalties of $70M or about 1.5X the Company's current fully-diluted market cap. Access has already announced marketing agreements with SpePharm for the EU, Milestone for the U.S., JCOM in Korea, and RHEI for China and other Southeast Asian countries.

On 7/7/09, Access announced new preclinical data demonstrating that thiarabine shows remarkable efficacy in the prevention and treatment of rheumatoid arthritis (RA). In a well-established animal model for RA, an exceptional restoration of joint structure was observed in the studies, which were conducted at Wayne State University School of Medicine and at Southern Research Institute.

Thiarabine is the Company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Once again, ACCP is working with the leader in this field - in this case, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment centre in the U.S. for leukaemia and lymphoma). The Company is currently finalizing clinical trial protocols based on previously gathered data to evaluate the drug in a variety of leukemia and lymphoma subtypes.

As a therapeutic treatment of established disease, thiarabine demonstrated a highly significant, dose-dependent amelioration of arthritis. Thiarabine treatment resulted in a broad inhibition of disease pathology, with reduction of both inflammatory and erosive disease parameters, as well as protection from loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a significant reduction in disease incidence and severity at 20 mg/kg/day.

In a therapeutic study comparing thiarabine to methotrexate, a commonly used clinical drug for RA treatment, high resolution 3-D images from an X-ray microtomograph were used along with histological scoring to evaluate joint and bone destruction. Thiarabine demonstrated statistically significant anti-arthritic efficacy comparable to that of methotrexate President & CEO Jeffrey B. Davis, stated, "Our current development focus for thiarabine is for the treatment of hematological cancers, but we believe these new RA data provide compelling evidence that thiarabine should be developed for rheumatoid arthritis as well."

In early June, ACCP announced that new thiarabine preclinical data will be published in the journal "Cancer Chemotherapy and Pharmacology" which demonstrates that thiarabine combined with clofarabine provides much greater anti-tumor activity than achieved by either agent used alone (e.g. in one colorectal cancer model, 66% of mice were cured of their tumors). The publication is based on work conducted by the Company's collaborators at the Southern Research Institute, and the paper is entitled "Enhancement of the in vivo antitumor activity of clofarabine by 1-beta-D-[4-thio-arabinofuranosyl]-cytosine" (thiarabine).

Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These studies will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials with data expected around mid-2010 to serve as the basis for partnership discussions for further development and commercialization. The IND for thiarabine has been transferred to Access and the Company is awaiting FDA clearance of study protocol and drug recertification before initiating RA trials, in addition to seeking co-development partners for the drug across all therapeutic indications.

ProLindac is a very promising, next-generation platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells because they reside at a low pH (acidic).

Pharmacology studies conducted outside of living, human tissue (ex-vivo) within comparable environments (e.g. acidic or low pH) to the tumors being treated by ProLindac have demonstrated that about half (50-60%) of the platinum is released over a period of 96 hours (four days) from a single administration. Thus, a single dose of ProLindac not only delivers over 10X the platinum dose in a targeted manner to cancer cells, but also mimics a four-day continuous infusion as the drug persists at the tumor site.

ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5 billion in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. Access also employs Esteban Cvitkovic as their director of oncology R&D - who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin. Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending.

Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy. Access previously announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.

Access has scaled-up its manufacturing in order to begin the next phase of clinical development for Prolindac and the Company plans to conduct several combination Phase 2 trials during 2H09 in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners. Access is currently in discussion with potential North American and European partners for co-development of ProLindac while the Company is working with its existing partners in Asia to design and manage new clinical trials for the compound.

Access also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's (OTC:RHHBY) Avastin. Angiolix targets a specific portion of a protein called lactadherin that is only expressed on solid tumors. Angiolix has a dual mechanism of action, which includes (1) inhibiting angiogenesis (blood vessel proliferation which feeds tumor growth) via the lactadherin target and (2) inducing a process known as apoptosis or programmed cell death in cancer cells which are dividing and growing in an unregulated manner. Unlike Avastin, Angiolix has an anti-proliferative effect on cancer cells when used by itself in addition to when it is used in combination with other chemo drugs.

Finally, Access has demonstrated promising results for a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections of widely used drugs such as insulin, hGH, and EPO. This drug delivery technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in 1,000 to 1,000,000-fold increases in absorption through the gut of large molecule drugs typically administered by injection.

Access anticipates an expense of about $2 million and about 12-15 months to get an IND filed to initiate clinical trials in humans for the nano-polymer drug delivery system; although this timeline could be shortened if such trials were conducted outside of the U.S. (e.g. India). A long-acting, basal insulin product (similar to the activity profile of Lantus insulin) is the most advanced in terms of achieving oral bioavailability of about 80-90% after initially achieving results in the 30-40% range. hGH, which is about 3X larger than insulin on a molecular basis, is currently in the 30-40% bioavailability range in preclinical animal models.

In mid-June, Access announced that the Company has signed evaluation agreements with two bio-pharmaceutical companies for its Cobalamin Oral Drug Delivery Technology. Under the terms of the agreements, both companies plan to evaluate the Company's oral insulin product in preclinical, animal models before entering licensing discussions. Access previously announced an agreement with a large pharmaceutical company to evaluate the oral delivery of hGH.

Access trades at a fully diluted market cap of about $40 million at the closing price of $1.84 on 7/13/09, which includes 11.3 million shares outstanding and 10.6 million shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance). At the end of 1Q09, Access also had a convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. Access should have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through at least 2H10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments from additional partnerships and MuGard royalties.

During 2H09, the Company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail - topical econazole and Pexiganan - a novel topical anti-infective) for an additional source of non-dilutive funding. If MuGard reaches just $20 million in global sales at a 20% royalty rate, this would generate positive operating cash flow during 2010. Between non-dilutive funding, partnerships, and MuGard royalties; the fully diluted share count should stay below 25 million at the time Access achieves positive operating cash flow so that existing shareholders will not be diluted into oblivion. Access is also in the process of obtaining an AMEX listing for its shares for greater visibility and liquidity compared to the OTCBB trading.

A video presentation for MuGard is available at YouTube, in addition to more information and links at the Company's newsroom website. Please visit the research section of BioMedReports.com to view or download PDF stock research reports for Access written by Griffin Securities from April 2009 with a 12-month price target of $7.50 (which equates to a fully diluted market cap of about $164 million) and Dawson James from July 2009 with a $4 price target (3X estimated 2011 revenue), in addition to the Company's most recent corporate presentation. Access also has a proactive management team which holds a large financial stake in the Company and has established a social media presence on Facebook, Twitter, and LinkedIn.

The list below (Data Sources: Yahoo! Finance, SEC Filings as of 7/12/09) includes a valuation comparison, upcoming catalysts, and pipeline comments for several other small and micro-cap cancer biotechs, including Aeterna Zentaris (NASDAQ:AEZS), Allos Therapeutics (NASDAQ:ALTH), Cell Therapeutics (NASDAQ:CTIC), GTx Inc. (NASDAQ:GTXI), Lixte Biotech (OTC:LIXT), Spectrum Pharma (NASDAQ:SPPI), SuperGen (NASDAQ:SUPG), and YM BioSciences (AMEX:YMI).

Company Ticker Price Market Cap

Aeterna Zentaris AEZS $1.74                     $93 million

initial cetrorelix Phase 3 results 3Q09, NDA filing 2010

Allos Therapeutics ALTH $7.60                     $679 million

pending FDA decision late 3Q09 for pralatrexate (priority review)

Cell Therapeutics CTIC $1.35                     $624 million

possible 4Q09 regulatory decisions for pixantrone (US-FDA) and Opaxio (EU-EMEA)

GTx Inc. GTXI $7.84                     $286 million

toremifene 80mg pending NDA 4Q09, toremifene 20mg Phase 3 results 3Q09

Lixte Biotech LIXT.OB $0.61                     $18 million

preclinical cancer drug discovery pending patent applications, IND filings

Spectrum Pharma SPPI $5.08                     $168 million

possible 3Q09 FDA rulings to expand label of Zevalin & Fusilev, EOquin - Phase 3

SuperGen SUPG $2.03                     $120 million

Eisai 1Q10 sNDA to expand label of Dacogen + early stage cancer pipeline, CLIMB drug discovery platform

YM BioSciences YMI $0.55                     $30 million

pending Phase 3 trials AeroLEF, nimotuzumab multiple Phase 2/3 trials, $40 million cash and zero debt

Disclosure: Long ACCP.

Analysts speculated that those two companies, which have similar specialties to Medarex, could be the next to be acquired.

The $2.4 billion deal for antibody technology specialist Medarex, announced late on Wednesday, marked the latest in a string of windfalls for biotech investors this year.

The industry has also seen a wave of out-sized share price gains in 2009 on the back of positive clinical data and deals.

Regeneron was up 9 percent at $19.60 in afternoon trading, while Seattle Genetics was 6.9 percent higher at $9.97.

Like Medarex, both of those companies specialize in monoclonal antibodies. Shares of ImmunoGen (Nasdaq:IMGN) another monoclonal antibody specialist, were up 3.9 percent.

"In the wake of the Medarex acquisition, I see Regeneron as one of the last remaining companies with a true (monoclonal antibody) platform that is still stand alone," ThinkEquity analyst Jason Kolbert said.

Just as Medarex had struck partnership deals, Kolbert said Regeneron has ties to large companies such as Bayer and Sanofi-Aventis.

"They have a great balance sheet, great partnerships with pharma giants," Kolbert said. "It's got all of the same ingredients that a Medarex has."

Regeneron and Seattle Genetics are the most likely next candidates to be acquired, said Mark Monane, an analyst at Needham & Co.

Monane said other characteristics that define likely biotech takeout targets included companies with hematology and oncology products, medicines in late-stage development and existing partnerships with other companies.

Monane said that other companies that could be put in play, although somewhat less likely, include Alexion Pharmaceuticals (Nasdaq:ALXN), Allos Therapeutics (Nasdaq:ALTH), AMAG Pharmaceuticals (Nasdaq:AMAG), ArQule (Nasdaq:ARQL), Celldex Therapeutics (Nasdaq:CLDX),  Dendreon (Nasdaq:DNDN) and Poniard Pharmaceuticals (Nasdaq:PARD).

Dendreon shares rose 6.6 percent to $24.57 after a source told Reuters the biotech company hired JPMorgan Chase as an adviser to help it find an international licensing partner for its prostate cancer vaccine Provenge.

Many other large drugmakers are scrambling to buy promising biotechnology companies to fill their late-stage pipelines as they confront generic competition to big-selling products.

Indeed, Bristol-Myers CEO James Cornelius said the company remains financially able to pursue more deals even with the Medarex deal.

Earlier this month, Johnson & Johnson (NYSE:JNJ) completed its $930 million purchase of Cougar Biotechnology Inc, just days after agreeing to pay $1 billion for an 18 percent stake in Irish drugmaker Elan Corp (NYSE:ELN) and to acquire a major stake in Elan's portfolio of experimental treatments for Alzheimer's disease.

Several biotech companies have seen their shares soar this year after surprising investors with positive clinical data or regulatory approvals.

Just this week, Human Genome Sciences (Nasdaq:HGSI) shares jumped more than 200 percent after the company announced positive data for its experimental lupus drug.

Dendreon and MAP Pharmaceuticals (Nasdaq:MAPP) are among the other companies with positive surprises this year.

(Reporting by Lewis Krauskopf and Bill Berkrot; Editing by Ted Kerr and Richard Chang)

Eli Lilly (NYSE:LLY) expects to report results from a third Phase 3 Clinical Trial are expected in late 2009 for arzoxifene to increase bone mineral density in post-menopausal women. Arzoxifene has been shown to reduce bone turnover/breakdown and is also being studied to reduce the risk of breast cancer. The drug significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo. The third Phase 3 trial, GENERATIONS, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density, with results expected in late 2009.

On 4/21/09, Alkermes (NASDAQ:ALKS) announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.

On 4/29/09, Rockwell Medical (NASDAQ:RMTI) announced the completion of patient enrollment in the Phase 2b study of SFP, which is a six-month, dose-ranging study in about 130 hemodialysis patients to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be completed by the end of September and data should be released about 60 days later, which should occur in late November or early December. The Phase 3 clinical trial for SFP should begin sometime during 4Q09-1Q10 and RMTI has guided for adequate cash flow and liquidity to reach this point without the need for raising cash. Click here to view or download my PDF stock profile report for RMTI from late April 2009.

On 5/7/09, Avanir Pharma (NASDAQ:AVNR) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.

On 5/11/09, Acadia Pharma (NASDAQ:ACAD) provided the following update along with its quarterly financial results: Enrollment was completed in the Company's first pivotal Phase 3 trial of pimavanserin in patients with Parkinson's disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.

On 5/11/09, GTx Inc. (NASDAQ:GTXI) reported quarterly results and stated that is conducting a pivotal Phase 3 clinical trial evaluating Acapodene (toremifene) 20 mg for the prevention of prostate cancer in men with high-grade pre-cancerous prostate lesions (high-grade PIN). The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTXI anticipates reporting data for this Phase 3 study in late summer 2009 and will file a NDA with the FDA in late 2009 based upon a positive trial outcome. GTXI also has a pending NDA for toremifene 80 mg (standard 10-month review with FDA decision expected in late October) seeking approval for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

On 5/28/09, Poniard Pharma (NASDAQ:PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin. Overall survival data are expected 2H09 for this trial.

On 6/1/09, Raptor Pharma (RPTP.OB) announced that it has dosed the first patient in its Phase 2b clinical trial, conducted in collaboration with the University of California, San Diego ("UCSD"), to evaluate Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") capsules in nephropathic cystinosis ("cystinosis"), a rare genetic lysosomal storage disease. Under Raptor's open Investigational New Drug application ("IND"), UCSD is performing the Raptor-sponsored trial at its General Clinical Research Center. The Phase 2b clinical trial will enroll up to six cystinosis patients with a history of good compliance using the currently available immediate-release form of cysteamine bitartrate, the only drug cleared for marketing by the FDA and European Medicines Agency ("EMEA") to treat cystinosis. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Data from the study are expected during 3Q09.

On 6/15/09, pSivida Corp. (NASDAQ:PSDV) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010.

On 6/15/09, Aeterna Zentaris (NASDAQ:AEZS) reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010.

On 6/17/09, BioMimetic Therapeutics (NASDAQ:BMTI) announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data during 4Q09. On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. The Company expects to release top line data from the trial during 2H09.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoza in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending. The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending.

Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 in favor of the drug's cardiovascular safety profile.

On 7/6/09, Protalix BioTherapeutics (AMEX:PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease.

The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.

On 7/7/09, Cell Therapeutics (NASDAQ:CTIC) announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.

On 6/24/09, CTIC announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. The Company is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.

On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.

Bristol-Myers (NYSE:BMY) and AstraZeneca (NYSE:AZN) have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.

United Therapeutics (NASDAQ:UTHR) announced on 4/28/09 that the FDA has extended the PDUFA action date for the Company's pending Tyvaso (inhaled treprostinil) NDA. The new PDUFA date is 7/30/09 and UTHR expected the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.

On 6/16/09, a FDA Advisory Panel ruled that Savient Pharma's (NASDAQ:SVNT) experimental gout drug is safe and effective for certain patients with the disorder. SVNT is seeking FDA approval for the infused drug (Krystexxa) for those who have the painful type of arthritis, but fail to improve with first-line treatments or cannot tolerate other treatments. The FDA's panel of outside experts (in a 14-1 vote) ruled that the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems and allergic reactions. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.

On 3/12/09, Endo Pharma's (NASDAQ:ENDP) majority-owned subsidiary Indevus Pharma announced that the FDA accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting 9/2/09 as the PDUFA action date for a possible decision on the NDA. Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL. The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. On 7/20/09, SPPI announced that the FDA accepted the Company's CRL resubmission for filing as a Class 1 (60-day) review with a new PDUFA action date of 9/7/09 (which falls on Labor Day, so a decision is more likely to be announced on Tuesday 9/8).

The FDA accepted Spectrum Pharma's supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009. The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

On 4/24/09, the FDA accepted as complete for review Theravance's (NASDAQ:THRX) response to the Agency's February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of cSSSI.

On 4/6/09, the FDA Accepted Theravance's NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).

Allos Therapeutics (NASDAQ:ALTH) filed a NDA on 3/25/09 with the FDA for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.

Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.

On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.

On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency.

GlaxoSmithKline (NYSE:GSK) and XenoPort (NASDAQ:XNPT) have a pending NDA for Solzira (gabapentin enacarbil) seeking approval for the treatment of moderate to severe restless leg syndrome with an early November PDUFA action date for a possible FDA decision.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.

On 6/19/09, BioElectronics (BIEL.PK) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II.

The Company will conduct a conference call on 7/28/09 to discuss the results of a recently completed clinical study and to discuss the status of current FDA filings and additional FDA filings expected to occur over the coming weeks, including one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.

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