Biotech investors should take note that some of their favorite stocks may soon be listed as part of index for the first time. On Friday, the NASDAQ OMX Group, Inc. announced their semi-annual re-ranking of the NASDAQ Biotechnology Index (Nasdaq:NBI) , which will become effective with the market open on Monday, November 23, 2009.

The re-ranking will result in the following eight securities being added to the Index:

{tiny;SPPI;3}Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI). Prior to this news, this company had no index memberships. SPPI is a commercial-stage biotechnology company with a focus on oncology, develops and commercializes a portfolio of drug products. Its marketed products include ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin's Lymphoma (NHL); and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma. The company is also developing apaziquone for the treatment of non-muscle invasive bladder cancer. Its phase II products include Ozarelix, a drug being investigated for benign prostatic hypertrophy (BPH), a non-cancerous enlargement of the prostate, and hormone dependent prostate cancer; and Ortataxel, a third-generation taxane. In addition, it has exclusive worldwide rights to Renazorb and Renalan and related compounds.

 

{tiny;PARD;3}Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), together with its subsidiary, NeoRx Manufacturing Group, Inc., focuses on the development and commercialization of oncology products for people with cancer. Its lead platform product candidate, Picoplatin, is a platinum-based cancer therapy that is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Picoplatin is being studied in various cancer indications, combinations, and formulations. Poniard Pharmaceuticals is conducting a phase III clinical trial of intravenous picoplatin in small cell lung cancer; two phase II clinical trials in metastatic colorectal and castration-resistant (hormone refractory) prostate cancers; and a clinical trial of oral picoplatin in solid tumors.

 

{tiny;CSKI;3}China Sky One Medical, Inc. (Nasdaq:CSKI). Through its subsidiaries, the company engages in the development, manufacture, marketing, and sale of over-the-counter, branded nutritional supplements, and over-the-counter plant and herb based pharmaceutical and medicinal products primarily in China. The company?s products include sumei slim patch to foster weight loss and prevent weight gain; pain killer patch used for the treatment of various ailments, including fever, headache, dysentery, diarrhea, and stiffness and pain in the neck caused by hypertension; anti-hypertension patch that improves circulation and reduces blood pressure; and dysmenorrheal patch for pain relief from dysmenorrheal in a woman?s critical days, and for regulating pain and catamenia.

 

{tiny;HITK;3}Hi-Tech Pharmacal Co., Inc. (Nasdaq:HITK), develops, manufactures, markets, and sells generic, prescription, over-the-counter (OTC), and nutritional products in liquid and semisolid dosage forms in the United States. It produces a range of products for various disease states, including asthma, bronchial disorders, dermatological disorders, allergies, pain, stomach, oral care, neurological disorders, glaucoma, and other conditions. The company?s generic pharmaceutical products include oral solutions and suspensions, topical creams and ointments, and nasal sprays. Hi-Tech Pharmacal Co. also manufactures and sells liquid ophthalmic, otic, and inhalation products, as well as cough and cold products and prescription vitamins. It markets a line of branded products that include OTC, nutritional lines, and prescription products primarily for people with diabetes.

 

{tiny;VICL;3}Vical Incorporated (Nasdaq:VICL), engages in the research and development of biopharmaceutical products based on its DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. It develops DNA-based vaccines and therapeutics for the prevention/treatment of infectious diseases, cardiovascular diseases, and cancer, including Allovectin-7 cancer immunotherapeutic, a Phase III clinical trial product for the treatment of metastatic melanoma; Therapeutic vaccine for cytomegalovirus, a Phase II clinical trial product to prevent viral reactivation and disease after transplant; Prophylactic vaccine for H5N1 pandemic influenza virus, which completed its Phase I clinical trial to protect against infection, disease, and/or viral shedding; Prophylactic vaccine for cytomegalovirus, a preclinical status product, which prevents infection before and during pregnancy to preclude fetal transmission; and Therapeutic vaccine for herpes simplex type 2 virus, a research status product that prevents recurring flare-ups.

 

{tiny;SIGA;3}SIGA Technologies, Inc. (Nasdaq:SIGA) is a biotechnology company, engages in the discovery, development, and commercialization of anti-infectives, antibiotics, and vaccines for the prevention and treatment of serious infectious diseases. The company focus on products for use in defense against biological warfare agents, such as smallpox, arenaviruses (hemorrhagic fevers), and other category A viral agents. Its lead product, ST-246, is an orally administered anti-viral drug that targets orthopox viruses. The company?s product candidates also include ST-294 and ST-193, which demonstrates antiviral activity in cell culture assays against arenavirus pathogens; and ST-669, a broad spectrum antiviral candidate, for various viruses in the Poxviridae, Filoviridae, Bunyaviridae, Arenaviridae, Flaviviridae, Togaviridae, Retroviridae, and Picornaviridae families. In addition, it also has four drug series in the pre-clinical development stage, including ST-610 and ST-148 for dengue virus of the genus Flavivirus.

 

{tiny;TRGT;3}Targacept, Inc. (Nasdaq:TRGT), is a biopharmaceutical company, engages in the design, discovery, and development of neuronal nicotinic receptor (NNR) Therapeutics for the treatment of diseases and disorders of the central nervous system. It markets Inversine, which is for the management of moderately severe to severe hypertension and uncomplicated cases of malignant hypertension. The company?s clinical stage product candidates include TC-5214 in Phase 2b clinical trial that modulates the activity of various NNR subtypes, including multiple forms of the a4ß2 NNR; AZD3480 (TC-1734), a small molecule, which modulates the activity of the a4ß2 NNR and completed two Phase 2b clinical trials; and TC-5619, a small molecule for cognitive dysfunction in schizophrenia or conditions characterized by cognitive impairment that completed a Phase 1 single and multiple rising dose clinical trial. It also has clinical stage product candidates, such as TC-2216, a product candidate for depression and anxiety disorders that completed a Phase 1 single rising dose clinical trial; and AZD1446 (TC-6683), a small molecule in Phase 1 clinical development that modulates the activity of the a4ß2 NNR.

 

{tiny;VNDA;3}Vanda Pharmaceuticals Inc. (Nasdaq:VNDA), is the Rockville, Maryland based biopharmaceutical company, engages in the development and commercialization of clinical-stage drug candidates for central nervous system disorders. Its product portfolio includes Iloperidone (oral), a compound for the treatment of schizophrenia completed Phase III clinical trial; and Tasimelteon, which completed Phase III clinical trials for transient insomnia and chronic primary insomnia. The company?s products also comprise Iloperidone (Injectible) for the treatment of schizophrenia and Tasimelteon for the treatment of depression, which are in the Phase II initiation status. The company was founded in 2002.

All of the companies are either classified as biotechnology or pharmaceutical companies and they all meet other Index eligibility criteria including minimum requirements for market value, average daily share volume and seasoning as a public company.

What does this mean? Well, investors should expect that this will end up being a net positive for the stocks involved. It may even affect the stock prices in a positive, albeit small way, relatively speaking.

At the end of the day, would you rather your favorite company be making the exclusive list or being taken off of it?

Well, just know that Matrixx Initiatives, Inc (Nasdaq:MTXX) is being removed from the Index.

According to NASDAQ OMX Group, the Biotechnology Index is the basis for the iShares Nasdaq Biotechnology Index(SM) Fund (IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the NASDAQ Biotechnology Index and the iShares Nasdaq Biotechnology Index Fund trade on various exchanges.

"Progress in public health depends on innovation. Some of the greatest strides forward for health have followed the development and introduction of new medicines and vaccines," said WHO Director-General Margaret Chan said. Veronica Garcia, New Mexico's Secretary of Education, talks about a seminar she and other officials attended on H1N1, the swine flu.

Companies with Certified Existing Treatments for Swine Flu

Gilead Sciences, Inc. (NASDAQ:GILD) /Roche Holding Ltd. (OTC:RHHBY) Product: Tamiflu (oseltamivir)GlaxoSmithKline plc (NYSE:GSK) /Biota Holdings Ltd.(ASX:BTA)Product: Relenza (zanamivir)Baxter International Inc. (NYSE: BAX) Product: A(H1N1) vaccine using its Vero cell culture technologyNovartis AG (NYSE:NVS)Product: Influenza A(H1N1) vaccine using Cell-based manufacturing technology

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

Companies with Adjuvantsfor Swine Flu VaccinesHemispherx Biopharma (AMEX:HEB)Product: AmpligenAntigenics, Inc. (NASDAQ:AGEN) Product: QS-21 StimulonOther Technologies Which Combat H1N1Oculus Innovative Sciences, Inc. (NASDAQ:OCLS)Microcyn® Technology platform

Chan, who last month declared a full pandemic underway from the H1N1 virus, said that patents can help ensure that companies develop medicines to "stay ahead of the development of drug resistance" in diseases like malaria and tuberculosis.

The discovery of isolated H1N1 infections that resist the anti-viral Tamiflu, made by Roche and Gilead, and the global scramble to secure flu vaccines have shown the importance of robust research and development, Chan said.

"Innovation is needed to keep pace with the emergence of new diseases, including pandemic influenza caused by the new H1N1 virus," she told a meeting on intellectual property and health, a contentious issue that has divided rich and poor nations.

In the speech, Chan said most drug access problems faced by developing countries could be remedied by tinkering with the existing patent system, which "operates as a stimulus for research and development for new products."

In May, at the WHO's annual assembly, rich and poor nations failed to reach consensus on how they should share virus samples of H1N1 and other flu strains with companies that use the biological material to make vaccines.

Indonesia has been especially vocal against this, arguing that developing countries would not be able to afford patented jabs made from their specimens.

PROBLEMS WITH PATENTS

Chan said those talks on "one of the most difficult, and divisive, issues ever negotiated by WHO" had identified problems with patents but said that the existing intellectual property regime did not need to be fully dismantled in pursuit of equity.

"R&D can indeed be needs-driven as well as profit driven," the former Hong Kong health director said. "International agreements that govern the global trading system can indeed be shaped in ways that favor health needs of the poor."

Chan described the global vaccine making capacity as "finite and woefully inadequate for a world of 6.8 billion people, nearly all of whom are susceptible to infection by this entirely new and highly contagious virus."

While acknowledging that "the lion's share of these limited vaccines will go to wealthy countries," she said the shortfall was "the result of limited global manufacturing capacity. It is not, in essence, a result of intellectual property issues."

The WHO has recommended that health workers, pregnant women and children should get priority access to H1N1 vaccines, and noted that every country worldwide will need them.

Chan said the ideal H1N1 shot would protect against seasonal strains as well as a range of candidate pandemic viruses.

"This innovation has not come about yet," she said. "This would be the best and most rational insurance policy for increasing supplies and encouraging more equitable access."

Top flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, Schering Plough's Nobilon, GlaxoSmithKline, Solvay and AstraZeneca's MedImmune.

(Editing by Dominic Evans)

A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.

With shares of Human Genome Sciences (NASDAQ:HGSI) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. Click here for more info at the FDA website regarding the regulatory approval process for medical devices.

On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

On 5/29/09, Theratechnologies (TSE:TH) (PINK:THTCF) ($2.00) filed a New Drug Application (NDA) with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is expected to occur in late 1Q10.

On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron, which is already approved by the Agency.

On 7/14/09, Genta (OTC:GETA) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta's recently completed Phase 3 trial of Genasense in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication.

On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe.

On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.

On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.

This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010.

Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). The stock price for JAV has increased by about 24% in the last five trading days and the volume was over 2X its average on 7/20/09.

In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.

Hemispherx Biopharma (AMEX:HEB) ($2.49): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09. On 5/26/09, HEB announced that the FDA advised the Company that it may require up to 1-2 additional weeks to take action beyond the original PDUFA action date of 5/25/09. Click here for an exclusive interview of HEB's CEO, Dr. William A. Carter, which was posted at BioMedReports.com on 6/12/09.

On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today 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, and the Company's share price has increased by about 58% in the past month.

On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09. Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission. Shares of SOMX have increased by about 239% over the past three months and the Company raised $6 million in a private placement in early July - providing adequate liquidity through 2Q10.

On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) ($1.39) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.

On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) 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. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. CTIC 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.

Nuvo Research (PINK:NRIFF) (TSE:NRI) ($0.36) has a pending NDA re-submission for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10 million and is also eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA.

Advanced Life Sciences (OTC:ADLS) ($0.46): Cethromycin NDA (a once-daily antibiotic for the treatment of community acquired pneumonia - CAP) with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed Pharma announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed's New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).

The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date during 4Q09 for a possible FDA decision.

On 7/8/09, Transdel Pharma (OTC:TDLP) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.

On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in 4Q08. Vical expects the trial to be completed during 4Q09 with final data available during 1H10.

On 11/14/08, Nephros (OTC:NEPH) ($1.25) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.

Disclosure: No positions.

, the world leader in flu shots, will commence within days, company officials said on Tuesday.

Companies with Certified Existing Treatments for Swine Flu

Gilead Sciences, Inc. (NASDAQ:GILD) Roche Holding Ltd. (OTC:RHHBY) Product: Tamiflu (oseltamivir)GlaxoSmithKline plc (NYSE:GSK) /Biota Holdings Ltd.(ASX:BTA)Product: Relenza (zanamivir)Baxter International Inc. (NYSE: BAX) Product: A(H1N1) vaccine using its Vero cell culture technologyNovartis AG (NYSE:NVS)Product: Influenza A(H1N1) vaccine using Cell-based manufacturing technology

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

Companies with Adjuvantsfor Swine Flu VaccinesHemispherx Biopharma (AMEX:HEB)Product: AmpligenAntigenics, Inc. (NASDAQ:AGEN) Product: QS-21 StimulonOther Technologies Which Combat H1N1Oculus Innovative Sciences, Inc. (NASDAQ:OCLS)Microcyn® Technology platform

The launch of clinical trials is a key part of a widening programme of work being undertaken by big pharmaceutical companies as they prepare for mass vaccination from next month.

GlaxoSmithKline , the other "big three" flu vaccine supplier, said it would initiate clinical studies later this month.

H1N1 swine flu, which first surfaced in Mexico in April and was declared a pandemic by the World Health Organisation (WHO) in June, has infected millions and killed an unknown number.

The WHO stopped counting at 800 confirmed deaths, since not every patient can possibly be tested.

Healthcare officials are relying on a vaccine to contain the spread of disease, providing a potential sales windfall for those companies that are able to deliver quickly and in large volume.

Australia's CSL has so far been the fastest commercial operator, after starting its first clinical trials in Australia two weeks ago. Now others are catching up.

"We started a little over a week ago," Novartis spokesman Eric Althoff said by telephone from Basel.

Benoit Rungeard, product communications director for Sanofi Pasteur, the vaccines division of the French drugmaker, told Reuters his company would start "in the coming days or next week".

Althoff said Swiss-based Novartis was conducting its clinical trials in a number of countries, including the United States, Britain and Germany, and was testing both single and booster, or repeat, doses of vaccines.

Novartis, in common with other manufacturers, will also compare vaccines with and without adjuvants -- ingredients that boost the immune system response.

AstraZeneca, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around Aug. 17.

As well as racing against the clock, vaccine companies are also working flat out to maximise their production capacity.

Initially, all the manufacturers except MedImmune -- which uses a different process -- struggled with low yields when making swine flu vaccine, with most companies only getting about 30 percent of the usual yield of seasonal flu strains.

But that is starting to improve.

"We are higher than that (30 percent)," Sanofi's Rungeard said.

"During the production campaign the yield increases because we learn how to better use it -- at the beginning it is not same as at the end," he added. Regulators in Europe and the United States plan to fast-track approval of swine flu vaccines to ensure they are available for the start of the northern hemisphere winter.

At the moment swine flu is rated only a "moderate" pandemic by WHO standards but it could worsen as temperatures cool, making conditions better for the virus. (Editing by Greg Mahlich)

The new virus, which emerged in March, has been declared an international pandemic and the World Health Organization predicts a third of the global population will eventually become infected.

Companies with Certified Existing Treatments for Swine Flu

Gilead Sciences, Inc. (NASDAQ:GILD) Roche Holding Ltd. (OTC:RHHBY) Product: Tamiflu (oseltamivir)GlaxoSmithKline plc (NYSE:GSK) /Biota Holdings Ltd.(ASX:BTA)Product: Relenza (zanamivir)Baxter International Inc. (NYSE: BAX) Product: A(H1N1) vaccine using its Vero cell culture technologyNovartis AG (NYSE:NVS)Product: Influenza A(H1N1) vaccine using Cell-based manufacturing technology

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

Companies with Adjuvantsfor Swine Flu VaccinesHemispherx Biopharma (AMEX:HEB)Product: AmpligenAntigenics, Inc. (NASDAQ:AGEN) Product: QS-21 StimulonOther Technologies Which Combat H1N1Oculus Innovative Sciences, Inc. (NASDAQ:OCLS)Microcyn® Technology platform Although most cases are mild to moderate, H1N1 appears to be about as deadly as the more common seasonal flu, which kills some 10,000 people a year in Japan and up to 500,000 globally.Following are key facts about the new flu in Japan, which could become one of the first challenges for the winners of an Aug. 30 national election. -- Japan had confirmed some 5,000 cases of the H1N1 flu as of late July, when it changed its method of tracking the outbreak. Three have died so far, with the first fatality confirmed last Saturday [ID:nT291073].-- The government now monitors group contagion and hospitalised cases. In the week of Aug. 12-18, 86 patients were hospitalised because of the H1N1 flu, with more than 70 percent of them aged below 20.-- Japan's National Institute of Infectious Diseases said on Friday that the new flu has reached epidemic proportions in Japan after the number of flu patients reported by about 5,000 core medical institutions rose above 1.00 per facility, which is Japan's yardstick for the start of a flu epidemic. The benchmark often rises above 1.00 with seasonal flu.-- Japan last month confirmed its first case of a genetic mutation of the H1N1 flu virus that shows resistance to antiviral flu drug, Tamiflu, made by Switzerland's Roche AG (ROG.VX) [ID:nSP527393]. But the two main antiviral drugs, Tamiflu and GlaxoSmithkline's (GSK.L) Relenza, have helped most patients.-- With the flu spreading at a faster rate than expected in the summer, Japan wants to delay the spread before the autumn weather sets in, worsening the situation. But it has warned that the new flu could spread more quickly once students return to school after summer holidays in September.VACCINE-- Japan wants to be ready to provide enough H1N1 flu vaccine to treat 53 million people, nearly half the country's population. But Japanese makers, which are allocating some resources away from the production of vaccines for seasonal flu, are only expected to be able to produce enough vaccine to treat 13-17 million people, far fewer than they had originally targeted. The government is considering importing vaccine to fill the gap, although some analysts said Japan should also provide vaccine to developing countries to help the poor with the disease.-- The H1N1 flu vaccine is expected to be ready for mass vaccinations around the end of October, although the government has not yet prioritised who will be vaccinated first. A panel of experts is meeting this month to discuss this and other issues such as possible side effects of the vaccine. The government will make a final decision taking into account the panel's recommendations.-- There are four makers that produce both seasonal and H1N1 flu vaccines for the Japanese market: Denka Seiken Co., Ltd, the Research Foundation for Microbial Diseases of Osaka University, Kaketsuken (The Chemo-Sero-Therapeutic Research Institute) and the Kitasato Institute.OTHER STEPS-- The government has urged the public to wash their hands and gargle. It has also said that those with flu symptoms should wear masks and avoid going outside, but there are no plans to limit public gatherings.-- The government is stockpiling antiviral drugs and planning to distribute a list of serious cases of the disease to medical institutions. (Reporting by Yoko Nishikawa; Editing by Joseph Radford for Reuters)