|Threshold Pharma soars on FDA SPA. PDL resolves dispute. Tengion tanks on merger termination. After the bell: AVEO in $1.3 billion agreement|
|By Staff and Wire Reports|
|Wednesday, 16 February 2011 20:05|
After the bell Wednesday, AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced that they have entered into a worldwide agreement outside of Asia with Astellas Pharma Inc. (TSE:4503.to) to develop and commercialize tivozanib. The drug, AVEO's lead product candidate, is currently being investigated in a pivotal, global Phase 3 clinical trial called TIVO-1 comparing the efficacy and safety of tivozanib to sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC), as well as in additional clinical studies in other solid tumor types as a single agent and in combination with other anti-cancer agents. RCC is one of the most deadly forms of Kidney Cancer and is often resistant to chemotherapy.
AVEO will receive an up-front payment of $125 million and is eligible to earn milestone payments up to $1.3 billion.
Stated Tuan Ha-Ngoc, president and chief executive officer of AVEO, "......the agreement enables us to build out our North American commercial infrastructure to not only launch tivozanib, but also to support future products emerging from our growing oncology pipeline. We are excited to work with Astellas in our efforts to bring tivozanib to market and, based upon our mutual expectation of a favorable outcome in the TIVO-1 trial, we will be moving forward to accelerate and expand the clinical development of tivozanib beyond RCC prior to top-line TIVO-1 data."
Shares of AVEO were up $3.11 or 22% to $16.99 in extended trading.
Also after the bell, Allergan, Inc. (NYSE:AGN) announced that the FDA approved the expanded use of the LAP-BAND System, Allergan’s gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index of 30-40 and at least one obesity related comorbid condition.
Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) soared more than 57% today after the company announced that it has reached agreement with the FDA on a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma. This pivotal trial is expected to begin in the middle of 2011, and will enroll patients with metastatic or locally advanced unresectable soft tissue sarcoma who have not previously received chemotherapy outside the adjuvant or neoadjuvant setting. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone.
"With this SPA, we have reached agreement with the FDA on the key features of our Phase 3 trial design that will be necessary to support the registration of TH-302," said Stewart Kroll, Threshold's Vice President, Biostatistics and Clinical Operations. "The proposed trial is designed to confirm the encouraging results that we have previously reported in our ongoing Phase 1/2 trial of soft tissue sarcoma patients treated with TH-302 in combination with doxorubicin."
Shares of Threshold gained $1.00 to $2.75. More than 8 million shares traded hands.
Shares of PDL BioPharma, Inc. (Nasdaq:PDLI) fell today after the company announced that they have resolved all legal disputes with MedImmune, LLC, including those relating to MedImmune's product Synagis and PDL's patents known as the Queen et al. patents.
PDL has paid MedImmune $65 million on February 15, 2011 and will pay $27.5 million by February 10, 2012 for a total of $92.5 million. MedImmune has not paid royalties to PDL on sales of Synagis that occurred after September 30, 2009. No further payments will be owed by MedImmune to PDL under its license to the Queen et al. patents as a result of past or future Synagis sales. As part of the settlement agreement, MedImmune has agreed not to challenge or assist other parties in challenging the Queen et al. patents.
Shares of PDL dropped 41 cents or 7.5% to $5.03.
Shares of Tengion, Inc. (Nasdaq:TNGN), tanked today after the company announced that it has ended negotiations with a publicly traded company relating to the acquisition of Tengion through a stock-for-stock merger. The company stated that the potential suitor has terminated merger negotiations due to the recent increases in the trading price and volume of Tengion's common stock. Tengion says it has sufficient cash to fund its operations into April 2011 and if it cannot secure either sale or financing, then the company may have to wind down its operations to preserve the assests for the benefit of creditors and stcokholders.
Shares of Tengion fell $2.67 or 48% to $2.85.
Shares of Cyanotech Corporation (Nasdaq: CYAN), surged more than 39% today after the company announced that researchers at the University of California at Davis have determined that microalgae-based Hawaiian Spirulina Pacifica may improve immune function and ameliorate anemia in persons over 50. Results of the UC Davis study will be published in the March edition of the journal Cellular & Molecular Immunology, in a paper entitled, "The effects of Spirulina on anemia and immune function in senior citizens."
Cyanotech produces Hawaiian Spirulina Pacifica, along with other microalgae nutrition supplements, at its 90-acre facility in Kona, Hawaii using patented and proprietary technology. Spirulina Pacifica is a nutrient-rich, highly absorbable source of protein, mixed carotenoids and other phytonutrients, B-Vitamins, GLA and essential amino acids.
The stock closed at $3.65, up $1.03.
Cerus Corporation (NASDAQ:CERS) announced today that it has been granted orphan drug status for plasma prepared with the INTERCEPT Blood System for treatment of thrombotic thrombocytopenic purpura (TTP). TTP is a rare, life-threatening blood disorder that typically requires transfusion with large volumes of plasma. "This designation is a significant step toward making INTERCEPT plasma available to a very vulnerable U.S. patient population," commented Claes Glassell, Cerus' president and chief executive officer. "Patients with TTP are at heightened risk for transfusion transmitted disease given the considerable volumes of plasma used in therapeutic exchange procedures. We look forward to working with the FDA to determine their requirements for a TTP indication approval." Shares gained 16 cents or 4.7% to $3.54.
Amicus Therapeutics (Nasdaq:FOLD)today announced that additional positive data from the ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease will be presented at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada, February 16-18th, 2011.