Posts Tagged ‘pharmaceuticals’

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Buzz Stock of the Day – Vanda Pharmaceuticals (VNDA)

Thursday, May 7th, 2009


Shares of our Buzz Stock of the Day — Vanda Pharmaceuticals, Inc. (Nasdaq: VNDA) — were up as much as 800 percent today on news that the drug maker’s atypical antipsychotic drug, Fanapt was approved by the Food and Drug Administration.

The FDA rejected the drug in July 2008. The letter issued by the FDA at that time raised concerns about the efficacy of Fanapt and urged Vanda to conduct a new clinical trial and collect additional safety data.


Vanda instead chose to resubmit the drug to the FDA last November with additional data from its existing clinical trials. Most investors considered this strategy a long shot. Many analysts either dropped coverage of VNDA or downgraded the stock, and shares of VNDA dropped well below $1, which valued the company at less than its cash on hand.

The FDA’s approval of the drug was based on two studies in which Fanapt performed better than placebo, but the drug doesn’t stack up as well against existing schizophrenia treatments, including Johnson & Johnson’s Risperdal and Pfizer’s Geodon, according to a recent article.

Also benefitting from today’s news was Titan Pharmaceuticals (Pink Sheets: TTNP), which is entitled to receive royalties on global net sales of Fanapt equal to 8% on annual net sales up to $200 million, and 10 percent on annual net sales above $200 million. Shares of TTNP were up as much as 1400 percent at mid-day trading today.

Global sales from the class of atypical antipsychotics exceeded U.S. $20 billion in 2007.

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Buzz Stock of the Day – Hemispherx Biopharma (HEB)

Monday, April 27th, 2009

Shares of niche makers of antiviral products were up on Monday following news that we could be facing a global pandemic of the swine flu virus.

Our Buzz Stock of the Day — Hemispherx Biopharma, Inc. (AMEX: HEB) — was up more than 43 percent at 2:15 p.m. EST.

The Philadelphia-based company’s flagship products include Alferon N Injection(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(r) and Oragens.

Hemispherx just announced that it received notice of an Annual Report prepared by a director of the National Institute of Infectious Diseases (NIID) to the governing organization of the Japanese Ministry of Health that reported a series of successful preclinical studies in new pandemic vaccines that rely critically on Ampligen, the company’s experimental RNA nucleic acid being developed for globally important immune system disorders.

Hemispherx’s Japanese partner, Biken Corp., recently completed a series of preclinical tests on Ampligen that were necessary to complete a new product registration in Japan.

The Company also recently completed enrollment of a Phase II flu prevention clinic study in Australia.

Shares of HEB are up about 100% over the past 3 months.

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Buzz Stock of the Day – China Sky One Medical (CSKI)

Thursday, April 16th, 2009

Business is booming for our buzz stock of the day, China Sky One Medical, Inc. (Nasdaq: CSKI).

The company, which manufactures over-the-counter drugs in China, reported record results for the fourth quarter and 12 months ended December 13, 2008.

Operating income for the year increased 91.6 percent to $35.7 million, and revenues increased 86.2 percent to $91.8 million.

The company started trading on the Nasdaq Global Market on September 16, 2008, and recently completed several key acquisitions, and recently received SFDA final approval for 19 drugs.

China Sky One expects full-year 2009 revenue to increase 40 percent to between $128 million and $130 million, and net profit margin to increase to $38 million to $39 million.

For the trailing 12 month period, China Sky One earned about $5.60 a share on revenue of $78.5 million. The company has about $51 million of cash, and generated $21 million of levered free cash flow.

We like CSKI because the company has continued to demonstrate growth in tough economic times, made some key acquisitions that could be accretive in the very near future, and has hefty 40.3 percent operating margins. The company also has a low P/E ration (8.58) compared to the industry average of 9.39.

“We are confident about the prospects for our business in 2009 and will continue to focus on increasing market share by both strengthening and further refining our successful sales and distribution network, building and enhancing our brand image, and making strategic acquisitions that continue to support our growth,” said Yan-Qing Liu, Chairman and CEO of China Sky One Medical, Inc.

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Buzz Stock of the Day – Antigenics (AGEN)

Tuesday, April 14th, 2009

Last month, cancer vaccine developer, Antigenics, Inc. (Nasdaq: AGEN) announced that its personalized cancer treatment, Oncophage(R) was granted a positive recommendation by the Committee for Orphan Medical Products (COMP) of the Europen Medicines Agency (EMEA) for orphan drug designation for the treatment of giloma, a life-threatening cancer that starts in the brain or spine.

Results from a Phase 1, 12 patient investigator-sponsored study, showed that the overall median survival was approximately ten and a half months, with four patients surviving beyond 12 months and one patient surviving almost two and a half years.

This compares with survival based on historical experiences in a similar patient population, which is in the range of six and a half months. The company is currently enrolling patients for the Phase 2 portion of the study, which is ongoing and has enrolled about two-third of its target patients, according to Antigenics’ chairman and CEO, Garo Armen, PhD.

Oncophage is already approved as an adjuvant treatment for early stage kidney cancer in Russia, where the company is still seeking commercial partners and government reimbursement. Russia has only recently launched proprietary products from western companies, and there are additional uncertainties including the company securing the necessary partnerships and government funds to successfully launch the product.

Antigenics’ bread and butter is its licensing revenue from QS-21, an adjuvant that’s used in various vaccines. Antigenics’ licensees include GlaxoSmithKline and Elan. There are currently 16 vaccines that cover a number of indications including non-smal cell lung cancer, malaria, HIV, melanoma, and influenza that use QS-21. GSK’s malaria vaccine, which uses the adjuvant, should enter a phase 3 study across Africa in the “very near term,” according to Armen.

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