Posts Tagged ‘biotech’

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Buzz Stocks of the Day – Aeterna Zentaris (AEZS), Keryx Biopharmaceuticals (KERX)

Monday, June 1st, 2009


Shares of Canadian biotech firm, Aeterna Zentaris, Inc. (Nasdaq: AEZS) were up as much as 35 percent in mid day trading today after its partner, Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced positive Phase 2 data from its cancer treatment perifosine (KRX-0401), an Akt-inhibitor compound that is used as a treatment for colon and kidney cancer.

Perifosene is in-licensed by Keryx from Aeterna Zentaris.

The data was presented over the weekend at the American Society of Clinical Oncology Annual Meeting. The poster #4081 entitled, “Randomized Phase 2 study of perifosine in combination with capecitabine versus capecitabine alone in patients with second- or third-line metastatic colon cancer”, showed that perifosine combined with capecitabine, more than doubled time to progression versus capecitabine plus placebo with a statistically significant p-value. In addition, perifosine plus capecitabine more than doubled the Overall Response Rate and almost doubled the Clinical Benefit Rate versus capecitabine plus placebo.

Aeterna Zentaris’ annual revenues during the last years have been in the range of $35 million to $40 million, coming from sales of marketed products, license agreements and services.

In March 2009, the company signed a collaboration agreement with leading pharmaceutical company, Sanofi-Aventis (NYSE: SNY) for the commercialization of the company’s lead compound, cetrorelix, which is used in treating benign prostatic hyperplasia (BPH), a benign enlargement of the prostate.

“The agreement provided us with an upfront payment of $30 million, bringing the total of our non-dilutive funding over the last 18 months to roughly $100 million,” said Aeterna Zentaris CEO, Juergen Engel Ph.D, in a recent interview.

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Buzz Stock of the Day – Oculus Innovative Sciences (OCLS)

Wednesday, May 27th, 2009

Shares of Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) were up more than 135 percent at mid-day on the Nasdaq.

The Petaluma-based company said U.S. health regulators approved its Microcyn skin and wound gel as both a prescription and over-the-counter formulation, sending shares up 70 percent before the bell.

The gel is intended to treat wounds such as leg ulcers, pressure ulcers, diabetic ulcers and mechanically or surgically debrided wounds.

“We understand the critical role that reimbursement plays in the successful commercialization of a medical product, and in that this is our first reimbursable product, we plan to aggressively market to the U.S. healthcare community,” said Oculus’ founder and CEO Hoji Alimi. “At the same time, we are taking all steps necessary to secure regulatory approvals outside North America so as to begin generating international sales through our existing distribution channels worldwide.”

Oculus, in partnership with its North American contract sales organization, Advocos, will market and sell the Microcyn® Skin and Wound Gel to the North American medical community as well as consumers beginning in June 2009.

Earlier this month, Oculus announced that its manufacturing facility in Mexico was working around the clock to meet the sudden product demand for Microdacyn™, a broad-spectrum antiseptic and sterilant approved by the Mexican Ministry of Health. Microdacyn has not been reviewed for similar indications by U.S. or European regulatory authorities nor has any regulatory body approved this technology for a specific swine flu indication. The Microcyn Technology is manufactured and marketed as Microdacyn™ in Mexico and is available through physicians and pharmacies as a non-toxic topical antimicrobial (antiseptic).

Regardless of the type of virus, it’s believed that Microdacyn’s mechanism of virus inactivation involves destruction of the proteins on the viral surface responsible for initial infection. Following destruction of these proteins, the viruses are no longer capable of causing any harm, according to a recent news release. Microdacyn has not been reviewed for similar indications by U.S. or European regulatory authorities nor has any regulatory body approved this technology for a specific swine flu indication.

Shares of Oculus were trading at $2.05 before the bell. They closed at $1.20 Tuesday on Nasdaq.

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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 – Sharps Compliance (SMED)

Wednesday, April 29th, 2009

Our Buzz Stock of the Day — Sharps Compliance Corp. (OTCBB: SCOM) — provides medical waste disposal solutions for the healthcare industry and U.S. consumers. The Houston-based company’s flagship product, the Sharps Disposal by Mail System, is used to dispose of medical waste including hypodermic needles, lancets and other medical devices and objects used to puncture or lacerate the skin.

Sharps Compliance Corp. reported a sharp increase in Q3 profits, thanks in large part to a recently announced $40 million contract with an agency of the U.S. Government Customer billings. Revenue for the third quarter increased to $6 million, from $2.9 million a year earlier. Revenue for the nine-month period ended March 31, 2009 increased 35 percent to $13.6 million, compared to the same period last year.

“Our third quarter results reflect the success of our full-service medical waste management solutions and the business model that we have developed as we execute our first large scale government contract,” said the company’s chairman and CEO, Dr. Burton J. Kunik. “We have created a convenient, cost-effective and safe method to properly dispose of medical and pharmaceutical waste in locations outside of the hospital setting to include homes, alternative care facilities, retail clinics, industrial and commercial facilities and emergency management programs.”

Gross margin for the quarter was 59.2 percent, compared to 49 percent a year earlier. Operating income, or profit realized from the company’s operations, was $2 million or 33.2 percent of revenue for the quarter, compared with an operating loss of $100,000 for same period a year ago.

As of March 31st, Sharps Compliance Corp. had $3.6 million in working capital, up from $1.9 million at June 30, 2008. Total assets increased to $11.8 million, from $5.7 million at june30, 2008.

There is a growing interest for the company’s RXTakeAway(TM) line of products, according to a recent earnings release.

“We believe our new line of products address a very serious disposal issue in the country that is currently harming our environment and placing our children at risk,” said Kunik. “Our existing solutions and infrastructure are uniquely positioned to facilitate the proper and cost-effective disposal of unused medications in the consumer / community markets.”

The company has a very small float — only 5.6 million shares, and has outperformed the S&P 500 over the past 52-weeks. Sharps has quarterly earnings growth (yoy) of 317 percent, and earned about $1.6 million, on revenue of $13.3 million (ttm).

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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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