SurModics, Inc. announced yesterday that it has signed an exclusive agreement with the Roche Group and Genentech for the licensing of its proprietary drug delivery system. This agreement will also establish a development process whereby a new, sustained-delivery formulation for the highly successful Lucentis® (ranibizumab) injection will be commercialized and brought to market using SurModics’ technology, logistics and expertise.

This incredibly lucrative agreement includes an initial, up-front licensing fee of $3.5 million, and an estimated $200 million in payments if development of the Lucentis formulation and other products is successful. In addition, the agreement indicates that SurModics will be used to develop and manufacture the drug. With the potential to develop other drugs in the future via this agreement, SurModics will also obtain certain undisclosed royalties on sales of developed products.

Lucentis is the only FDA-approved treatment for neovascular (wet) age-related macular degeneration (ARMD), a degenerative condition of the central retina,

Hospira (HSP) recently obtained approval for its anti-infective Azithromycin injection from the U.S. Food and Drug Administration (FDA). Azithromycin is a generic variant of Pfizer's (PFE) Zithromax and is ADD-Vantage system compatible.

ADD-Vantage is an advanced drug delivery system that does not need a needle and syringe to mix the drug with the solution. This lowers the risk of accidental needle pricks, improves workflow and prevents waste due to stability and shelf-life elements. Hospira is the first company to offer Azithromycin in an advanced drug delivery system. U.S. sales of generic and name-brand Azithromycin injection amounted to nearly $40 million in 2008.

Hospira's specialty injectable pharmaceuticals (SIP) portfolio comprises of nearly 200 generic injectable drugs across multiple therapeutic areas including anesthesia, anti-infectives, analgesics, cardiovascular and oncology. SIP accounted for 50% of the total revenues of the company in 2008. We expect SIP to continue to drive

Below are companies with market caps under $250 million from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases.

BioMimetic Therapeutics [BMTI: 9.07, -0.52 (-5.42%)]: On 6/17/09, BMTI announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft

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

Vyteris, Inc., developer of the first FDA-approved active transdermal drug delivery system and a leader in active transdermal drug delivery technology, announced today that it has entered into an agreement with Zealand Pharma A/S, a Denmark-based biopharmaceutical company focused on discovering and developing innovative peptide-based drugs, to apply its technology to the controlled transdermal delivery of Zealand Pharma’s peptide optimization technology.

“This strategic partnership with Zealand Pharma, a recognized leader in peptide drug development, marks another milestone in the active roll-out of our patented smart patch transdermal technology for the delivery of high-value, therapeutic peptides,” commented Dr. Haro Hartounian, president and chief executive officer of Vyteris, Inc.

“Needle-free, tightly controlled delivery of peptides via active, transdermal patches is an innovative and patient-friendly route of administration which can lead to increased safety and compliance. Our ongoing female infertility project with Ferring Pharmaceuticals, Inc. has now entered clinical phase II, and we hope