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.
, which includes a database of 250 entries as of 7/9/09.
The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
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. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.
On 7/9/09, Rigel Pharma (NASDAQ:RIGL) announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.
On 7/9/09, GlaxoSmithKline (NYSE:GSK) announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE:MRK) Gardasil.
On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.
The market continues to slide on nerves and concerns about all kinds of developments that- for the most part- seem to indicate that advancing past this recession is a lot more difficult than most- including the U.S. government- expected. That's the bad news and there appears to be plenty more coming.
The good news is that while most of the market is flat, there is still lots of volatility and action to be had in the healthcare sector. These stocks move! Most other sectors are stagnant. Watching the movement in their stock prices is about as exciting as watching paint dry.The biomedical sector shows great resolve as the rest of the market falls apart and as the big pharmaceutical giants' pipelines dry up, that only makes things for the small caps and upstarts far more intriguing. There will be many fortunes made by investors and traders who recognize this and can act both astutely and sensibly.As I said yesterday, the biggest trades in the biotech sector have happened for us after digging for good intelligence. That means having up to date, reliable information about not only good up-and-coming companies, but also arming up with knowledge of important catalyst events- like upcoming FDA decisions and approvals- which undoubtedly have an impact on the prices of bio company shares. Look at the big boys here for guidance. Institutional investors pay big bucks (tens of thousands of dollars per year) for information like that. Until now, the vast majority of institutional investors had no way to access that information. As a news and information portal, we're actively attempting to change that. Soon, you'll see even more tools and information that will help lead the way.Things may be about to get even more interesting for the over all market, but if you're going to actively trade and invest in biotech stocks during this uncertain time you need to be smart and in order to be truly smart, you first need to be informed.Let's talk about a couple of small-cap companies I continue to keep an eye on based on the recent trading volume and chatter.First, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI). Even though the company was asked to provide more information to the FDA regarding their application for Zevalin as an initial treatment for non-Hodgkin's lymphoma, credible industry observers believe that the company should be feeling confident that the data it will submit will satisfy the the Complete Response letter's requirements. In addition, they feel that after seeing this type of scenario play out many times before, SPPI should expect a favorable regulatory decision. The drug is already approved as a treatment for non-Hodgkin's lymphoma patients who have relapsed. An approval would mean tremendous new revenue opportunities. In addition, the company has a second pending decision for approval by the FDA this October and that is very rare.Second, penny play BioElectronics Corporation (OTC:BIEL), rose a couple of cents since I told you about it. Look for it to continue to attract attention. The technology they use actually has it's roots in the work of Nikola Tesla, who is best known for many revolutionary contributions in the field of electricty and magnetism. It not only relieves pain, it also appears to show some healing propeties at the cellular level. Sounds like sci-fi, but studies apparently back up the claims. I'm in the process of tracking down a company spokesman and will try to dig for more information about the technology and this small company's future plans. The headline grabbing concerns posed by the FDA about possible restrictions of common painkillers and theliver damage they cause, this small bio play could continue upwards. Look for them to continue to put out their own good news as well.Here's a look at the last session's movers and shakers:
Gainers (% price change)
Last Trade
Change
Mkt Cap
Amgen, Inc.
AMGN
59.50
+7.27 (13.92%)
60.24B
Cambrex Corporation
CBM
4.18
+0.29 (7.46%)
122.15M
Tenet Healthcare Corp.
THC
3.05
+0.19 (6.64%)
1.46B
Capital Senior Living
CSU
4.32
+0.26 (6.40%)
116.00M
Transcend Services, Inc.
TRCR
16.91
+0.87 (5.42%)
143.42M
Losers (% price change)
Arena Pharmaceuticals
ARNA
3.96
-0.71 (-15.20%)
316.92M
Orexigen Therapeutics
OREX
5.34
-0.69 (-11.44%)
185.09M
Hemispherx BioPharma, Inc
HEB
2.00
-0.23 (-10.31%)
170.25M
Jazz Pharmaceuticals, Inc
JAZZ
3.78
-0.43 (-10.21%)
109.34M
3SBio Inc. (ADR)
SSRX
7.18
-0.81 (-10.14%)
154.46M
Most Actives (dollar volume)
Amgen, Inc.
AMGN
59.50
+7.27 (13.92%)
60.24B
Johnson & Johnson
JNJ
57.08
+0.85 (1.51%)
157.29B
Pfizer Inc.
PFE
14.61
+0.02 (0.14%)
98.59B
Merck & Co., Inc.
MRK
28.04
+0.42 (1.52%)
59.13B
Abbott Laboratories
ABT
46.31
+0.97 (2.14%)
71.57B
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).
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 for a possible FDA decision.
On 7/20/09, Labopharm (NASDAQ:DDSS) 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 7/20/09, Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK) announced that Benlysta (belimumab, formerly LymphoStat-B) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo groups. Assuming positive results in November 2009 from a second Phase 3 trial of Benlysta, the companies plan to submit marketing applications in the United States, Europe, and other regions during 1H10.
On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) 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.
On 7/20/09, Trinity Biotech (NASDAQ:TRIB) 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.
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