HealthSport Inc. is the preeminent formulator and developer of edible, multi-layer film strips that deliver over-the-counter drug, nutritional and dietary supplement actives through buccal (between the cheek and gum) and sublingual absorption as well as oral ingestion. The company’s proprietary edible film strip technology has five patents pending and is believed to be superior to competitors’ film strips already on the market.

The company announced today that its strategic manufacturing partner, SMI Manufacturing, has agreed to invest $10 million into HealthSport. The investment is expected to accelerate the company’s growth and strengthen its alliances with large pharmaceutical companies to provide this breakthrough, next-generation drug delivery technology.

HealthSport will use the funds in a multitude of ways – as working capital, to provide funds for research & development, and to enhance the company’s current manufacturing plant. In exchange for the $10 million, SMI will receive a 55% stake in HealthSport.

HealthSport’s drug delivery

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On Tuesday, SurModics Inc. (SRDX) announced that it licensed its drug delivery technology to Roche (RHHBY) and its wholly owned subsidiary, Genentech. Drug delivery technologies create and support site specific drug delivery polymers and coating technologies for use in drug/device combination products in chosen markets.    Under the terms of the agreement, SurModics is entitled to an up-front payment of $3.5 million. Furthermore, the deal could be worth up to $200 million in delayed payments if multiple products are successfully developed. SurModics will also receive royalties on product sales. SurModics will receive payments for its development services. Under the terms of the agreement, Roche and Genentech have the right to obtain manufacturing services from SurModics.   The transaction provides Roche and Genentech complete access to the biodegradable microparticles developed by SurModics. They intend to use the products in a long-lasting version of their optical drug Lucentis ...

On early Tuesday morning, SurModics announced their new licensing deal with Roche. SurModics Inc. said that they have licensed their drug delivery technology to Roche and Roche’s Genentech unit for a deal that could be worth around US$ 200 million. The news about the new licensing deal by SurModics gave a great boost to the shares of SurModics and they started climbing in the morning trading itself.  The shares were around $5.97, or 24.6 percent, to $30.24 in the morning trade, but it quickly moved up and halted at $29.04. SurModics shares have normally traded between $15.96 to $30.75 in the previous years.

Roche is based in Switzerland and is one of the world’s biggest drugmakers. However, it has been acquired by a San Francisco biotechnology company called Genentech in 2008.

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Alexza Pharmaceuticals, Inc. announced a private placement equity offering of 8.1 million shares of common stock to several qualified institutional investors. The company will receive $2.4325 per share, or approximately $19.1 million in net proceeds.

Alexza Pharmaceuticals also issued 7.3 million warrants as part of the deal. The warrants entitle the holder to purchase 0.9 shares of common stock at $2.77 per share. The warrants expire in seven years.

Alexza Pharmaceuticals is developing a proprietary drug delivery technology called the Staccato® system. This technology vaporizes unformulated pharmaceutical drugs into an aerosol form that allows rapid systemic delivery through lung inhalation.

Alexza Pharmaceuticals has completed Phase 3 trials for using this technology to deliver Loxapine for use in treating schizophrenic or bipolar disorder patients. The company plans a new drug application submission in 2010.

Staccato® is also being tested for use in other areas, including the treatment

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AlphaRx, Inc. is a specialty pharmaceutical company that applies proprietary drug delivery technologies to reformulate FDA approved drugs to achieve improved efficacy and patient compliance. AlphaRx’s main goal is to become prominent in the development of effective medicines and drug delivery.

By having an acceptable delivery method, they can in turn improve the effectiveness of existing pharmaceuticals and new chemical entities that have exhibited poor absorption due to poor solubility. Several major pharmaceutical products with combined worldwide sales of over $10 billion have been identified as potential candidates for their proprietary drug delivery systems.

The utmost care is given to the creation of these carriers. Its components are FDA classified as GRAS (generally regarded as safe), thus cutting down on approval times and costs. The effectiveness of these carriers can be seen not only in their flexibility, but also in their ability to be modified for application

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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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BioDelivery Sciences International

(NASDAQ:BDSI)

Continuing with the trend of pre-FDA decision BioPharma companies, StocksHaven Investments takes a closer look at BDSI which hopes it’s product Onsolis will strive past approval and make its way onto shelves world-wide.

About BDSI: BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is utilizing licensed and owned drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, significant new formulations of proven therapeutics. Utilizing its drug delivery technologies, the Company is developing formulations of pharmaceuticals aimed at acute (short term) conditions occurring in patients, mostly notably in the areas of pain and fungal infections.

Onsolis: BDSI®’s first application of the lead BEMA™ technology is Onsolis™ (fentanyl buccal soluble film). Onsolis™ utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer

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Emisphere [EMIS: 0.00, N/A (N/A)] is an emerging bio-pharma company specializing in the development of a drug delivery technology platform for the oral administration of therapeutic compounds which are either poorly absorbed or must be given through alternative routes such as injections.

On 6/1/09, EMIS announced that Novartis [NVS: 41.95, +1.66 (+4.12%)] and Nordic Bioscience have completed recruitment for the planned second multi-center Phase 3 study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere’s proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a FDA regulatory approval filing in the U.S., includes more than 900 patients between the ages of 51-80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is

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The cancer biotech space has attracted the interest of investors, traders, and diversified healthcare giants this year with Johnson & Johnson [JNJ: 55.50, +0.34 (+0.62%)] announcing a $1B cash tender offer for Cougar Biotech [CGRB: 42.87, -0.12 (-0.28%)] last week and Roche’s [ROG: 17.67, +0.61 (+3.58%)] [RHHBY: 0.00, N/A (N/A)] mega-deal to acquire full control of Genentech earlier this year. In addition, positive clinical trial results for Dendreon’s [DNDN: 23.2099, +0.5399 (+2.38%)] Provenge and stock price turnarounds from the brink of zero at Cell Therapeutics [CTIC: 1.60, +0.17 (+11.89%)] have fueled interest in the small and micro-cap cancer bio-pharma space among investors and traders looking for the next big trade.

Access Pharma [ACCP: 0.00, N/A (N/A)] is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to

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NexMed, Inc., a New Jersey based pharmaceutical and medical technology company, will receive $3.5 million from Swiss pharmaceutical giant Novaris, for fulfilling patent and enrollment milestones as part of a product agreement originally signed in 2005. NexMed announced today that they have received a Notice of Allowance from the patent office for its patent application entitled “Antifungal Nail Coat and Method of Use”. A Notice of Allowance indicates that all the basic steps of a patent application process are completed.

The patent is for a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis, a fungal infection of fingernails or toenails. NexACT is the company’s transdermal drug delivery technology. Under the agreement, development, production, and commercialization of the new product will be handled by Novaris.

NexMed CFO, Mark Westgate, commented, “In addition to the $2 million patent milestone, NexMed will also receive $1.5 million from Novartis for

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