Posts Tagged ‘pharmaceutical stocks’

Anika Therapeutics Inc. (ANIK) Buzz Stock of the Day

Wednesday, August 19th, 2009

Shares of Anika Therapeutics, Inc. (NASDAQ: ANIK) rose nearly 74 percent on Thursday after the drug maker received approval from Health Canada for its osteoarthritis of the knee treatment, MONOVISC™. The product will be distributed in Canada by Anika’s distribution partner, Helix BioPharma Corp.

“Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish MONOVISC as the premier single-injection product on the market worldwide,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer in a statement.

The single injection viscosupplement drug has been available in the European Union since early 2008 and is currently being evaluated by the U.S. Food and Drug Administration.

The company has steadily made progress toward U.S. approval of the knee drug, and is expected to submit additional clinical data to the FDA before the end of the year. The company filed a modular premarket approval (PMA) application with the FDA for MONOVISC, which allows for submission of clinical data on an ongoing basis rather than all at once. Anika had previously presented an initial module of trial data for MONOVISC™.

MONOVISC™ is currently undergoing a retreatment study, which focuses on the safety of the drug and the benefits of repeat injections.

Anika also received a boost on Thursday as news broke that a U.S. advisory panel recommended that regulators reject a similar injection treatment for knee pain submitted by rival companies Q-Med AB and Smith & Nephew.

The panel decision could have long-term advantages for Anika if MONOVISC™ gets FDA approval. The drug would be the second single injection product on the market with the other being Genzyme Corporation’s drug, Synvisc-One™.

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

Tuesday, August 18th, 2009

Shares of Oculus Innovatie Sciences (NASDAQ: OCLS) were up as much as 21 percent from the previous day’s closing price on Tuesday after the company announced the commercial launch of its wound care product in the United States.

The Petaluma-based company’s Microcyn® wound care gel, which received FDA 510(k) clearance in May of this year, has demonstrated rapid activity against a broad spectrum of infections and has also demonstrated wound healing in chronic and acute wounds in clinical investigational studies. It has been commercialized outside of the United States for the treatment of infected wounds.

“We’re excited to make these products commercially available so quickly after receiving our FDA clearance in May,” said Oculus founder and CEO, Hoji Alimi in a statement. “As well, we are also sampling our new Microcyn hydrogel formulations to U.S. physicians and are preparing to initiate a study of this proprietary hydrogel against other wound gels. We believe this data will provide the evidence necessary for a successful hard launch of the product into the medical community in early 2010.”

The onslaught of the swine flu epidemic in Mexico bolstered first quarter unit sales of the company’s 240-milliliter bottles of the Microcyn hydrogel, which was sold mostly to pharmacies in Mexico.

First quarter unit sales increased 100 percent over the prior year to a monthly average of 57,000 units, up from 35,000 in the fourth quarter of fiscal 2009, and 28,000 in the same quarter last year. Unit sales to hospitals increased 101 percent, partially offset by lower selling prices. Normal unit sales of the 240 mL bottles in the first quarter represent about 38,000 to 40,000 units per month, while the units over that reflect one-time purchases related to the swine flu concerns during the quarter.

Oculus cut its first quarter net loss to $3.5 million, or $0.18 per share, from a net loss of $5.2 million, or $0.33 per share reported in the same period last year. Total revenue for the quarter was $1.8 million, up 52 percent from $1.2 million last year. A 56 percent increase in product revenue, a 37 percent increase in service revenue, and a 40 percent reduction in operating expenses were a few highlights of the quarter over the same period last year.

“In our last earnings call, we provided guidance regarding two objectives to achieve cash breakeven by March 2010 and to achieve annual revenue of $45-to-$60 million by fiscal year 2013 with operating profitability of 20 percent,” said Alimi. “We are reconfirming these targets.”

Oculus is currently sampling the new professional Microcyn Skin & Wound HydroGel formulation to U.S. medical professionals. The OTC version of the HydroGel product will be available to consumers beginning October 2009.

Oculus Innovative Sciences, Inc. was first featured as a Buzz Stock of the Day in late May, when the company received marketing clearance from the FDA for Microcyn. Shares spiked from $1.80 to $4.49 that day..

Transcept Pharmaceuticals Inc. (TSPT) – Buzz Stock of the Day

Monday, August 3rd, 2009

Shares of Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT) jumped $3.75 or 64.7 percent to $9.55 in morning trading on Monday, after the company announced a licensing deal for its insomnia treatment with Purdue Pharmaceuticals for up to $145 million, and royalty payments.

“This agreement is a transforming event for Transcept,” said Glenn A. Oclassen, President and CEO of Transcept Pharmaceuticals in a statement.

[–quote–]

Under the terms of the agreement, Purdue was granted the exclusive rights to sell Intermezzo in the U.S. and is able to negotiate for its approval in Mexico and Canada. Transcept Pharmaceuticals retains the rights to the drug in all other countries and has the option to co-promote Intermezzo to psychiatrists in the U.S.

The agreement states that Purdue will pay Transcept $25 million upfront, and up to $30 million more based on approval timing by the FDA. Additionally, Transcept could receive as much as $90 million more based on future benchmarks related to intellectual property and sales milestones.

The deal also includes royalties of greater than 10 percent and as much as about 25 percent for the Richmond, Calif.-based Transcept. If Transcept exercises the psychiatric co-promotion option, it will receive an additional double-digit royalty on those sales. Transcept can begin co-promotion as soon as one year after launch.

“We are excited to be working with Transcept towards the launch of this potential new entry into the prescription sleep aid market,” said Purdue’s President and CEO John H. Stewart. “This agreement is part of Purdue’s plan to diversify our product portfolio and broaden our commercial focus into therapeutic areas that complement our leadership position in pain.”

The active ingredient in Intermezzo is zolpidem, the same active ingredient in other insomnia sleep aids, such as Ambien. However, Intermezzo only has about one-third-to-one-quarter zolpidem as other insomnia treatments.

“We believe that Intermezzo has the potential to occupy an important position in the substantial worldwide market for prescription sleep aids, and that our U.S. partnership with Purdue is a key step toward the commercial success of Intermezzo.”