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Adeona's reaZin, A Better Preventative than Cure?

chemistfrog@gmail.com (Chemistfrog) — Fri, 01 Jul 2011 23:01:18 GMT

Adeona Pharmaceuticals (AMEX: AEN) and its reaZin® prescription medical food for the management of Alzheimer’s disease and mild cognitive impairment has finally come full circle. After some promising interim data in 2010, the final data was presented at the 63^rd Annual Meeting of the American Academy of Neurology on April 14, 2011 in Honolulu, Hawaii. The data indicated that the clinical study met the primary outcome of increasing serum zinc and decreasing serum free copper. Per the presentation, secondary outcomes of mental status as measured by three standardized cognitive tests all favored the treatment group versus the placebo group. The secondary outcomes in this trial were the most important factors for the targeted indication, but the statement “favored the treatment group versus the placebo group” didn’t give the full story with only a weak correlation in the biotech world. For this trial, a statistically significant (P < 0.05) was the sought after correlation, and none of the three measurements of mental status change met the desired endpoint. The secondary data were as follows:

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), an average net improvement of 0.41 points in favor of the treatment group versus placebo (p < 0.36)

Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB), an average net improvement of 0.38 points in favor of the treatment group versus placebo (p < 0.10)
Mini Mental State Examination (MMSE), an average net improvement of 0.19 points in favor of the treatment group versus placebo (p < 0.42)

Although the secondary data were somewhat disappointing, the company still indicated that it would stick with the indication and follow through with marketing the reaZin medical food for the dietary management of Alzheimer’s disease and mild cognitive impairment. On April 20^th they announced that they had executed an agreement with TG United, Inc. of Brooksville, Florida, to provide commercial-scale manufacturing capabilities for reaZin®. With the weaker secondary data set, Adeona did find a sub-set of patients that were over 70 years old that mostly met the (P < 0.05) criteria of significance and intends to conduct another Alzheimer's disease clinical study to evaluate its proprietary zinc-based tablet in patients age 70 and over. The data for this subset were as follows:

ADAS-Cog - Alzheimer's Disease Assessment Scale - Cognitive Subscale p-value: 0.037
CDR-SOB - Clinical Dementia Rating Scale - Sum of Boxes p-value: 0.032
MMSE - Mini Mental State Examination p-value: 0.067

The data from this subset was impressive enough that Adeona is preparing a larger clinical study protocol to evaluate patients diagnosed with mild to moderate Alzheimer's disease who are age 70 and over. It is anticipated that the clinical study will enroll over 100 patients and that the evaluation period will be at least 12 months. They intend to develop reaZin® for this subset as a drug (as opposed to only making reaZin® available as a prescription medical food) and to conduct the study under an Investigational New Drug (IND) application to be filed with the FDA.

The author applauds Adeona’s tenacity for the use of reaZin® in combating Alzheimer’s disease and hopes for the best for the company and its target group. Alzheimer’s is relentless and is a sad disease to watch progress with little current hope of cure and only a little more hope of slowing its progression. There is another approach that Adeona hasn’t mentioned anywhere per the author’s research that he hopes will be investigated. In the research that Adeona and its team of experts that have been developing reaZin® have undertaken, much work has been done to cure and slow the progression of Alzheimer’s disease and mild cognitive impairment. They have accomplished much for the purpose of their own marketing of reaZin® and for the medical community and patients in general. However, in many studies the beta amyloid plaque and the damage its buildup causes to the neurons in the brain is the central focus of attacking the disease. Some of this damage, even if the plaque if removed or redissolved and removed by the patient’s body, may be irreparable. Not stating that there is no cure after a certain level of progression but rather the author hopes that Adeona, with the approach it has chosen to undertake in attacking the disease, may need to refine its approach with an additional means of trying to prevent rather than only trying to cure the disease.

The author’s proposal to Adeona Pharmaceuticals is that it considers a trial on patients with a predisposition to developing the disease based on genetics or based on very early detection of the disease. Particularly exciting is the recent story in the NY Times about a study led by Belgian and US researchers on the very early detection of Alzheimer’s. The study found certain biomarkers in spinal fluid that provided a “signature” that was able to identify 94 percent of a group of patients that had developed Alzheimer’s whose disease had been confirmed by autopsies. The study was also able to identify every patient (patient size not disclosed) with mild cognitive impairment who would go on to develop Alzheimer’s disease within five years. This type of early detection or even prediction, if legitimate, would be a radical development in the treatment and prevention of Alzheimer’s. It would enable companies with novel preventatives or cures to have a new approach and new group of individuals to include in their future trials. This could be key for a company taking an approach, like Adeona, that does not focus on the beta amyloid plaque removal. According to the Fisher Center for Alzheimer’s Research Foundation website, there are over 100 clinical trials being conducted on Alzheimer’s and dementia. If Adeona or one of these other biotechs, pharmaceuticals or universities has the silver bullet already in its arsenal, a means of predicting Alzheimer’s disease at its very earliest stages or even before may be the key target the silver bullet should be aimed at. Take heed, Adeona Pharmaceuticals and its investors, there are millions of patients and families watching and waiting.

Elan Corporation, plc (ADR) EPS Growth for next year hanged about 157.10% - NYSE:ELN

zeeshan@brilliantinnovators.com (Tapebeat Staff) — Thu, 07 Apr 2011 14:03:04 GMT

Elan Corporation, plc (ADR) (NYSE:ELN) recently traded higher than its average volume. ELN was opened at $7.15 increased +0.44 points or +6.15%. ELN transacted shares during the day were over 14.80 million shares however it has an average volume of 3.20 million shares.

ELN has a gross margin of 50.13% as compared to operating margin of -16.38% and its profit margin remained -27.76% for the last 12 months. The company has earnings of $-324.70 million and made $1.17 billion revenue for the last 12 month. Its quarter to quarter earnings per share (EPS) remained -14.13%.

The company has 586.70 million of outstanding shares and 469.80 million shares were floated in the market. According to the most recent quarter its current ratio was 1.91 that represents company’s ability to meet its current financial obligations.

The price moved ahead of 14.97% from the mean of 20 days, 14.48% from 50 and went up 33.40% from 200 days average price. Company’s performance for the week was 10.64%, 16.59% for month and yearly performance remained 1.34%.

Elan Corporation, plc operates as a neuroscience-based biotechnology company primarily in Ireland and the United States. It operates in two segments, BioNeurology and Elan Drug Technologies (EDT). The BioNeurology segment engages in the research, development, and commercial activities primarily in the areas of Alzheimers disease, Parkinsons disease, multiple sclerosis (MS), Crohns disease, and severe chronic pain. Its offers Tysabri to treat relapsing forms of MS; Prialt, a non-opioid and intrathecal analgesic for the treatment of severe chronic pain, principally neuropathic pain; Azactam, a monobactam to treat pneumonia, post-surgical infections, and septicemia; and Maxipime, an injectable cephalosporin antibiotic used to treat patients with serious and/or life-threatening infections. This segment in collaboration with Biogen Idec, Inc., develops and markets Tysabri for the treatment for Crohns disease. It also develops beta amyloid immunotherapies for the treatment of Alzheimers disease through collaboration with Wyeth. In addition, this segment develops ELND005, a novel therapeutic agent, which is in Phase II clinical study to treat Alzheimers disease; ELND006, a small molecule gamma secretase inhibitor is in Phase I clinical studies for the treatment of Alzheimers disease; and Beta secretase, a precursor to plaque development in the brain. Further, BioNeurology segment has collaboration agreement with PharmatrophiX to develop small molecule ligands for growth factor receptors relevant to neurological disorders. The EDT segment offers pharmaceutical products using its proprietary drug technologies. It also provides formulation development services and contract manufacturing services that include analytical development, clinical trial manufacturing, scale-up, product registration support, and supply chain management. Elan Corporation sells its products primarily to drug wholesalers. The company was founded in 1969 and is headquartered in Dublin, Ireland.

Advanced Battery Technologies, Inc. generated Return on Assets of 19.06% with no Debt in most recent quarter - NASDAQ:ABAT

zeeshan@brilliantinnovators.com (Tapebeat Staff) — Fri, 01 Apr 2011 13:06:11 GMT

Advanced Battery Technologies, Inc. (NASDAQ:ABAT) recently traded higher than its average volume. ABAT was opened at $1.58 dropped -0.07 points or -3.48%. ABAT transacted shares during the day were over 16.32 million shares however it has an average volume of 1.64 million shares.

ABAT has a gross margin of 47.25% as compared to operating margin of 38.97% and its profit margin remained 37.81% for the last 12 months. The company has earnings of $36.73 million and made $97.13 million revenue for the last 12 month. Its quarter to quarter earnings per share (EPS) remained -60.25% while earning per share for the next 5-years is expected to grow at 0.40%.

The company has 68.90 million of outstanding shares and 67.31 million shares were floated in the market. According to the most recent quarter its current ratio was 18.21 that represents company’s ability to meet its current financial obligations.

The price moved down of -46.51% from the mean of 20 days, -47.82% from 50 and went down -47.55% from 200 days average price. Company’s performance for the week was -47.43%, -47.71% for month and yearly performance remained -48.54%.

Advanced Battery Technologies, Inc., through its subsidiaries, engages in the design, manufacture, and marketing of rechargeable polymer lithium-ion (PLI) batteries in the United States, Europe, and Asia. The companys rechargeable PLI batteries are used in consumer products, such as portable computers, personal digital assistants, and cellular telephones. It also develops and manufactures various types of electric vehicles, including electric bicycles, electric scooters, and electric sports utility vehicles. Advanced Battery Technologies, Inc. was founded in 1984 and is based in New York, New York.

FDA Panel Votes in Favor of Orexigen's Contrave (OREX)

staff@tapebeat.com (TapeBeat Staff) — Tue, 07 Dec 2010 22:15:58 GMT

In the most anticipated news, the Food and Drug Administration panel has recommended that the agency approve Orexigen Therapeutics Inc.'s weight loss drug Contrave.

On Tuesday, December 7, 2010, the FDA panel voted in favor 13 to 7 for an approval of Contrave, and 11 to 8 that more studies should be conducted on heart risks. The panel noted safety concerns on the drug but believe that benefits will outweigh the risks.

The FDA is not required to follow the advice of the FDA Panel, but sometimes does.

Biodel's Stock Plunges Heavy as Company Receives CRL for Linjeta (BIOD)

approval@tapebeat.com (TapeBeat Staff) — Mon, 01 Nov 2010 21:28:16 GMT

Biodel, Inc. (NASDAQ:BIOD) has received a CRL from the FDA regarding the new drug application for Linjeta. The stock have plunged more than 41% or a drop of $1.50 and closed at $2.13. The volume of the shares trading was 13x above average.

Many have expected a CRL for Linjeta but apparently, it was one of the harshest and the worst case scenario that has happened. For a full press release, click here. As to make it short to the point: “The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration.”

Clarity on Linjeta from FDA May Give Shares a Boost (BIOD)

approval@tapebeat.com (TapeBeat Staff) — Wed, 27 Oct 2010 22:26:53 GMT

Starting from the beginning of the week, the price of Biodel (NASDAQ:BIOD) shares have fallen for the second day in a row, as a majority of investors are eagerly waiting for the response from the FDA, which has a scheduled PDUFA on October 30th, 2010. The closing price of a share was at $3.57 with a loss of 0.18 cents or 4.80%.

According to two seperate polls conducted by TheStreet.com and currently conducting by BioRunUp.com, majority of investors are leaning toward a "Light CRL", meaning FDA would provide a path to eventually approval with additional studies. However, "Heavy CRL" would mean that a new trial would be required. Other scenarios that might occur is that either FDA would approve Linjeta for Type II diabetics only or perhaps grant full approval, which is unlikely.

{module 146} Additionally, after a close look at the chart and volume of Biodel shares, a selling occured for the past six days straight. The short term investors and the day traders seem to close their positions as the response date is approaching. Some believe that the CRL is already priced in and a "Light CRL" would only boost Biodel price per share.· It will certainly be a surprise if BIOD would get an approval but we do stay optimistic that it would get approved in the near future or a surprise buy-out of the company might occur.

Results of Synergistic Collaboration of Merck/Ariad Pharma Nearing (ARIA, MRK)

chemistfrog@gmail.com (Stephen Ramey) — Fri, 15 Oct 2010 02:08:26 GMT

Ariad Pharmaceuticals (NASDAQ: ARIA) captured Merck’s (NYSE: MRK) attention enough with its cancer drug, ridaforolimus, in July 2007 to forge a partnership to help Ariad through several clinical trials for multiple cancer indications. More recently, preliminary results of the phase III were impressive enough to give Ariad enough leverage to modify the agreement in May to a much more favorable position for Ariad.

Earnings Season Unofficially Kicks off with a Bang, Alcoa Inc (NYSE: AA)

traderjoe247@gmail.com (TB Staff) — Thu, 07 Oct 2010 20:57:41 GMT

Alcoa Inc (NYSE:AA) unofficially kicked off the third-quarter earnings season on a high note reporting a profit that comfortably beat the Wall Street’s expectations. It also raised its growth forecast for global aluminum demand this year to 13 percent from 12 percent which underscores that the global recovery though slow is intact.

Micron Technology Earnings Fall Short of Consensus Estimates (NASDAQ: MU)

traderjoe247@gmail.com (TapeBeat Staff) — Thu, 07 Oct 2010 20:34:14 GMT

Micron Technology (NASDAQ: MU) reported sales for its fiscal fourth quarter 2010 of $2.5 billion, up from $2.3 billion in the third quarter of fiscal 2010, and $1.3 billion for the fourth quarter of fiscal 2009, but below the Street consensus at $2.66 billion.

OFIRMEV’s Europe Track Record, A Good Omen for US Market, Cadence Pharmaceuticals (CADX)

traderjoe247@gmail.com (Venkat Nukala) — Wed, 06 Oct 2010 02:59:00 GMT

Cadence Pharmaceuticals Inc’s (NASDAQ: CADX) drug OFIRMEV™ is currently under review at FDA with a new Prescription Drug User Fee Act(PDUFA) action date or FDA approval decision date of November 4, 2010. OFIRMEV™ is an intravenous formulation of acetaminophen that is currently marketed in Europe and approved in many other parts of the world for the treatment of acute pain and fever. OFIRMEV™ received a complete response letter from FDA in February 2010. Cadence stated that "In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA's facility inspection of Cadence's third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval. "