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Acorda Therapeutics, Inc. (Nasdaq: ACOR) Buzz Stock of the Day

Thursday, October 15th, 2009

Shares of Acorda Therapeutics, Inc. (Nasdaq: ACOR) skyrocketed 50 percent in morning trading Thursday to a high of $26 from Wednesday’s closing price of $16.74 after analysts said a U.S. Food and Drug Administration (FDA) panel review of the company’s multiple sclerosis drug paved the way for approval by next year. Acorda Therapeutics Inc. topped the list of Biggest Percentage Price Gainers among common stocks on the Nasdaq Stock Market.

An Advisory Committee panel announced today that they would stand behind Acorda’s drug candidate Fampridine-SR, a multiple sclerosis drug geared to help mobility in patients. The announcement today came in sharp contrast to a more negative review by FDA staff a few days earlier that sent the company’s shares down sharply, analysts said.

“In my view, the briefing documents were a total red herring to investors, most of whom sold positions heavily,” said Hapoalim Securities analyst Raghuram Selvaraju. “This morning, what you’re seeing is the about-face that I would have expected.”

The FDA will decide on October 22 whether the drug will be approved. An unaffiliated panel of experts voted 12-1 in favor of the drug, and concluded that fampridine was both safe and effective, but recommended it not be used in patients with known seizure problems. Additionally, the experts recommended lower doses be studied in clinical trials, which could be done after FDA approval. Some analysts predicted approval could be delayed until early 2010 to prepare a program to manage fampridine’s risks.

Ron Cohen, M.D., Acorda Therapeutics President and CEO said in a statement Thursday, “We are pleased with the outcome of today’s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS.”

Analyst Raghuram Selvaraju projects annual sales of fampridine reaching $900 million by 2017, putting it near the $1 billion threshold for a drug to be deemed a blockbuster. The 50 percent surge in share prices Thursday launched Acorda Therapeutics to a market value of nearly $1 billion, which combined with the earnings potential of fampridine, makes Acorda a possible acquisition candidate.

Aside from Biogen Idec (BIIB.O), which holds fampridine rights outside the United States, analysts predict other pharmaceutical companies with multiple sclerosis programs might be interested in acquiring Acorda, including: Teva Pharmaceutical Industries (TEVA.TA), Novartis (NOVN.VX), Merck KGaA (MRCG.DE) and Sanofi Aventis (SASY.PA), which is developing a drug that is similar to fampridine, but further behind in development.

Selvaraju continues, “I think they’re an extremely eminent takeover target, I think any company that either has a foothold in the MS space or wants to have one should be very interested in this company.”

Acorda Therapeutics does not comment on speculation regarding possible acquisitions.

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Labopharm, Inc. (Nasdaq: DDSS) Buzz Stock of the Day

Wednesday, October 7th, 2009

Shares of Labopharm, Inc.(NASDAQ: DDSS) surged 50 percent in trading Wednesday after the company announced that the manufacturer of the active ingredient in Labopharm’s novel anti-depression medication had been given the green light from the US Food and Drug Administration (FDA) to reopen its manufacturing facility, which had been closed following FDA inspection in June and July of this year.

In a letter received by Labopharm, the FDA states that Angelini, the manufacturer of the active pharmaceutical ingredient (API) for Labopharm’s novel trazodone formulation, has sufficiently addressed all the deficiencies cited during inspections in June and July. The letter also states that the FDA now classifies the manufacturing facility as acceptable.

The letter received today from the FDA comes after another received by the Company on July 17, 2009, in which the FDA informed the Labopharma that it’s new drug application for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility, although it was stated that the deficiencies were not efficacy or safety issues.

Trazodone, Labopharma’s second product, is a psychoactive compound with anti-depressant and sedative properties that also encompasses the Company’s proprietary controlled-release technologies. Trazodone is currently awaiting FDA approval.

Labopharm Inc. is an emerging biopharmaceutical company that specializes in improving and optimizing existing small-capsule drugs using proprietary time-release technologies. The Company’s first product, a once-daily time-release treatment for chronic pain is sold in 17 countries worldwide in major markets such as US, Canada, and Europe.

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CEL-SCI Corporation (AMEX: CVM) Buzz Stock of the Day

Monday, September 21st, 2009

Shares of CEL-SCI Corporation (AMEX: CVM) jumped more than 24 percent in morning trading Monday after the company announced plans to move forward with two highly-anticipated drug trials.

In addition to recent FDA approval to go ahead with clinical trials of CEL-SCI’s novel LEAPS-H1N1 flu medication, the company has also raised the capital necessary to go forward with Phase III clinical trials of its flagship cancer treatment, Multikine, which analysts believe could become a standard of care for cancer treatment.

The company announced last week that a definitive agreement had been reached to raise nearly $20 million, which was expected to close on or before Monday.

The agreement states that CEL-SCI will sell 14,285,715 shares of common stock at a price of $1.40 per share for a gross profit of approximately $19 million. Additionally, investors will also receive warrants to purchase 4.7 million shares of CEL-SCI’s common stock at $1.50 per share that can be exercised any time after the transaction closing within a two-year time period.

CEL-SCI will use the funds to move forward with human clinical trials for LEAPS-H1N1 flu treatment, a drug designed to treat the white-blood cells of already-infected patients. The FDA’s approval of trials for CEL-SCI’s H1N1 flu treatment has pushed CEL-SCI shares to some of the most heavily traded in the biotech market.

“Everybody’s focus is on vaccines and they’re having all kinds of problems with the vaccines, but there has to be someone working to help these patients who have a high likelihood of death,” said CEL-SCI’s CEO Geert Kersten. “That’s how we got to that. With LEAPS, we can control in advance and determine, almost by design, how the immune system will process the epitope and therefore we know what kind of immune response we will get — whether cellular or humoral. By doing that, you can — we feel — have significant impact on these people’s chances of survival.”

CEL-SCI is also expected to start long-awaited and highly-anticipated Phase III trials of Multikine, the company’s advanced head and neck cancer treatment. The first of its kind, Multikine is a multi-targeted approach cancer immunotherapy that specifically targets and kills cancer cells, and activates the body’s immune system to attack cancer cells. Multikine is a cancer immunotherapy that incorporates both active and passive immune activity.

CEL-SCI Corp. is based in Vienna, Virginia and develops novel immune-based therapies that utilize the body’s own immune defense system to fight disease. These therapies are effective and non-toxic to the body’s normal cells and organ systems, unlike traditional cancer therapies such as chemotherapy, radiation and surgery, which are most often highly toxic or damaging.

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The Medicines Co. (MDCO)– Buzz Stock of the Day

Wednesday, September 2nd, 2009

Shares of The Medicines Co.(NASDAQ: MDCO) was up as much 35 percent on Wednesday morning after the company announced the issuance of a new patent for a safer version of Angiomax, the Company’s anti-clotting drug for patients undergoing coronary angioplasty.

The newly issued patent, No. 7,582,727 (‘727 patent) updates the current patent covering Angiomax, after the company preformed further clinical studies to improve the drug. The ‘727 refers to an improved and safer version of Angiomax.

The new patent has been presented to the U.S. Food and Drug Administration (FDA) for immediate listing in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” generally referred to as the Orange Book. The drug’s current U.S. patent No. 5,196,404 (‘404 patent), expires on March 23, 2010 and specifically relates to the composition of the chemical bivalirudin. Furthermore, The Medicines Company has been granted pediatric exclusivity through September 23, 2010.

In clinical trials, Angiomax showed absolute reduction of 1.7 percent in cardiac mortality and improved overall survival in patients who had suffered the most severe heart attack and received angioplasty. The study, which is called the Horizons-AMI, showed that Angiomax reduced cardiac-related death by 43 percent, improved overall survival by 27 percent and reduced major bleeding complications by 39 percent, compared to the standard of care.

“These results underscore our goal: to bring to doctors critical care medicines that change clinical practice for the better,” said the Company’s President and Chief Operating Officer, John Kelley.

The data also supports results from previous studies that showed an association between reduced major bleeding in angioplasty patients and greater long-term survival.

“The bottom line is that in this population of heart attack patients undergoing PCI, Angiomax saves lives, and the degree of that benefit is striking,” said Kelley.

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Icagen (ICGN)– Buzz Stock of the Day

Tuesday, September 1st, 2009

Shares of biopharmaceutical company Icagen, Inc.(NASDAQ: ICGN) were up as much as 65 percent from Monday’s close in morning trading on Tuesday, after the company announced favorable results from a late-stage clinical trial of Senicapoc, a potential new treatment for asthma.


“We are pleased with the results of this study, and believe that they justify further evaluation of Senicapoc as a novel approach to the treatment of asthma,” said Seth Hetherington, M.D., Senior Vice President of Clinical and Regulatory Affairs for Icagen.

A total of 34 patients with asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom and 31 of them were evaluable for the study goals.

In the study, patients who received Senicapoc demonstrated an improvement in all measures of late asthmatic response (LAR), while those who received only dummy drugs had no improvements, the company said in a statement.

A secondary goal of the study was to gauge the fraction of exhaled nitric oxide, a measure of airway inflammation that is generally at an elevated level in asthmatic patients. The study found that senicapoc reduced exhaled nitric acid by 24 percent compared to study participants who received the placebo.

“We believe that the combination of the reduction in LAR among the Senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of Senicapoc, a selective blocker of the KCa3.1 channel,” said Dr. Hetherington.

The North Carolina-based Icogen is currently evaluating strategic options concerning the future of the company, including a possible partnership or the sale of the company.
“We have received interest from several companies to partner us in this program and we will certainly pursue discussions as appropriate,” Chief Financial Officer Richard Katz said in a statement.

Icagen is also developing four proof-of-concept studies in the areas of asthma, epilepsy and pain, but do not plan to pursue the programs any further than the concept phase without additional capital that could come in a variety of forms.

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