On February 23, 2015, Dendreon completed the Sale Transaction. With the closing of the Sale Transaction, the Debtors have completed the disposition of substantially all of their assets, including all PROVENGE assets and all assets related to the Debtors’ enteric coated D-3263 hydrochloride product candidate (Filing, Dendreon, FEB 19, 2015, View Source [SID:1234502221]).
On February 19, 2015, as previously disclosed, the Debtors, Valeant Pharmaceuticals International, Inc. ("Valeant") and Drone Acquisition Sub Inc., a wholly-owned direct subsidiary of Valeant (the "Purchaser"), entered into a second amended and restated acquisition agreement (the "Acquisition Agreement") pursuant to which the Purchaser agreed to acquire substantially all of the assets and certain liabilities of the Debtors (the "Sale Transaction") for an aggregate purchase price of $495 million (which includes the purchase of $80 million in cash, for an effective increase of $15 million over the previously agreed purchase price for the purchase of certain additional assets of the Debtors), comprised of a cash payment of $445.5 million payable at closing and $49.5 million payable in common shares of Valeant to be issued to the Company on the date of effectiveness of a plan of liquidation or reorganization in the Chapter 11 Cases and subsequently distributed to creditors in accordance with such plan and the terms of the Acquisition Agreement. As previously disclosed, on February 20, 2015, the Bankruptcy Court approved an order authorizing the Sale Transaction with the Purchaser pursuant to the Acquisition Agreement (the "Sale Order").

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Merrimack Pharmaceuticals Announces Initiation of a Phase 2 Biomarker-Selected Clinical Trial of MM-121 in Patients with Heregulin Positive Non-Small Cell Lung Cancer

On February 19, 2015 Merrimack Pharmaceuticals reported the initiation of a global, open-label, biomarker-selected, randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody targeting ErbB3, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer (Press release Merrimack, FEB 19, 2015, View Source [SID:1234501755]).

“This marks the first MM-121 trial we’ve initiated where only patients with a high heregulin biomarker profile will be enrolled into the study. It builds on our learnings from the previous MM-121 Phase 2 clinical trials we completed across lung, ovarian and breast cancers where we saw a clear trend of patients in those studies with this biomarker profile benefitting from combining MM-121 with standard therapies,” said Akos Czibere, MD, PhD, MM-121 Global Development Lead at Merrimack. “This study is a significant step toward preparing a registration trial of MM-121 in non-small cell lung cancer, and further supports Merrimack’s systems biology approach and its impact on drug discovery and development. We look forward to applying our clinical biomarker findings to future studies with MM-121 and ultimately improving outcomes in patients who no longer respond to standard-of-care therapies.”

MM-121 is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, MM-121 is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner. Merrimack is pursuing this study based on encouraging results from a broad MM-121 Phase 2 program which identified high heregulin levels as a potential prognostic factor of poor response to standard-of-care therapy across multiple cancers. The results also showed that patients with heregulin-high tumors experienced a longer time to progression when they received a combination of MM-121 with their standard-of-care therapy as compared to patients who received the standard therapy alone. Across the three different standard-of-care combination regimens, a consistent safety profile demonstrated a modest yet tolerable increase in adverse events.

As part of this trial, Merrimack expects to enroll approximately 120 heregulin positive patients that will be randomized (2:1) to receive either MM-121 plus the investigator’s choice of docetaxel or pemetrexed, or the investigator’s choice of docetaxel or pemetrexed alone. Eligible patients for the trial must have failed prior treatment with no more than two lines of therapy for locally advanced or metastatic disease. The primary endpoint of the trial is progression free survival (PFS). Secondary endpoints include overall survival, objective response rate, safety and tolerability. Merrimack plans to conduct the trial at sites in the United States, Canada and Europe. Initial trial sites located at the Horizon Oncology Center in Lafayette, Indiana and Northwestern Medicine Developmental Therapeutics Institute in Chicago, Illinois are now open to screen patients in the United States.

Genmab Enters Commercial DuoBody Technology Agreement with BioNovion in the Field of Immuno-Oncology

On February 19, 2015 Genmab reported it has entered a co-development and commercialization agreement with BioNovion to evaluate a number of DuoBody product candidates targeting immune checkpoints (Press release Genmab, FEB 19, 2015, View Source [SID:1234501754]). Genmab and BioNovion will contribute panels of antibodies for the creation of bispecific antibody products using Genmab’s DuoBody platform technology. If the companies jointly select a product candidate for clinical development, development costs will be shared equally, with each party retaining a 50% share of the product rights. If one of the companies decides not to move a therapeutic candidate forward, the other company is entitled to continue developing the product at predefined licensing terms. The agreement also includes terms which allow the parties to opt out of joint development at key points in each product’s clinical development.

This commercial agreement follows a July 2014 research collaboration between Genmab and BioNovion.

“We are pleased to expand our research collaboration with BioNovion into a full commercial agreement, and utilize our robust and versatile DuoBody technology to create unique differentiated cancer therapeutics in the promising field of immuno-oncology,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

8-K – Current report

On February 19, 2015 Kite Pharma reported that it has entered into a lease agreement for a commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport (Filing 8-K , Kite Pharma, FEB 19, 2015, View Source [SID:1234501710]). Kite also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will not only support the planned clinical trials of Kite’s product candidates, but also will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.

“We are committed to the rapid advancement of KTE-C19, which has the potential to address the significant, unmet needs of patients with aggressive, refractory B cell lymphomas and leukemias,” said Arie Belldegrun, M.D., FACS, Kite Pharma’s President and Chief Executive Officer. “We are initiating pivotal studies for KTE-C19 in multiple indications and believe our new facilities will help ensure the timely completion of these studies as well as our commercial launch. We also expect the facilities to support clinical trials and potential commercialization of our other eACT based product candidates, including both chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates.”

The Santa Monica facility has approximately 18,000 square feet and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to utilize its contract manufacturer to support clinical trials of eACT based product candidates.

The El Segundo facility has approximately 44,500 square feet, and, under the lease agreement, Kite has an expansion option for an additional 17,000 square feet until July 1, 2017. Kite was represented in the negotiation of the lease by Andrew Riley and Jeff Pion of CBRE. Kite anticipates the El Segundo facility will be operational to support the planned commercial launch of KTE-C19 in 2017.

Commenting on the new leases, Cynthia Butitta, Kite’s Chief Operating Officer and Chief Financial Officer, said, “Securing these manufacturing facilities fits strategically with our expansion and is an exciting and necessary step as we advance multiple clinical trials and prepare for commercialization of our product candidates.”

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

NPS Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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