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U.S. FDA grants Breakthrough Therapy Designation for Roche's investigational cancer immunotherapy MPDL3280A (anti-PDL1) in non-small cell lung cancer

On February 2, 2015 Roche reported that it has received a second Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti-PDL1) (Press release Hoffmann-La Roche , FEB 1, 2015, View Source [SID:1234501442]). The designation was granted for the treatment of people with PD-L1-positive (Programmed Death-Ligand 1) non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumour).

“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,’’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to personalised healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines. ”

This breakthrough therapy designation is based on early results of MPDL3280A in people whose NSCLC was characterised as PD-L1-positive by an investigational test being developed by Roche. All studies of MPDL3280A are prospectively evaluating PD-L1 expression. Some studies will evaluate the medicine regardless of a tumor’s PD-L1 status; other studies are evaluating the medicine only in people whose tumors are characterized as PD-L1 positive.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The FDA granted the first Breakthrough Therapy Designation for MPDL3280A in metastatic bladder cancer in 2014. Ongoing pivotal studies of MPDL3280A include lung and bladder cancer, and we plan to initiate Phase III studies in additional tumor types this year.

Stemline Therapeutics Announces SL-701 Granted Orphan Drug Designation for the Treatment of Glioma

On January 30, 2015 Stemline Therapeutics reported that SL-701 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of glioma (Press release Stemline Therapeutics, JAN 30, 2015, View Source [SID:1234501432]).

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SL-701 is an enhanced immunotherapy designed to activate the immune system to kill malignant gliomas, which are aggressive malignancies of the brain that arise in both adults and children. A multicenter Phase 2 clinical trial is currently evaluating the antitumor activity of SL-701 in adult patients with second-line glioblastoma multiforme (GBM), a particularly aggressive type of glioma. An earlier version of the therapy demonstrated clinical activity, including durable complete responses (CRs) and partial responses (PRs) as well as prolonged disease stabilizations and an overall survival signal, in both adults and children with malignant glioma.

"We are pleased with the FDA’s decision to grant Orphan Drug designation to SL-701 as it provides Stemline with a number of benefits through development and commercialization of this novel therapy," noted Eric K. Rowinsky, M.D., Stemline’s Chief Medical Officer and Head of Research and Development. He continued, "GBM is a highly aggressive disease with few effective treatment options and remains a major unmet need. Instead of targeting a single component of the cancer, SL-701 is designed to activate and direct the immune system against multiple targets overexpressed on glioma cells. We are very pleased about the high level of interest in the study from patients and clinicians alike."

OSE Pharma appoints Simbec-Orion to conduct its Tedopi® Phase III international clinical trial in advanced lung cancer patients

On January 29, 2015 OSE Pharma reported that they have entered into a collaboration agreement to conduct the upcoming Tedopi Phase III pivotal trial in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy (Press release, OSE Pharma, JAN 29, 2015, View Source [SID:1234502959]).

The protocol of this pivotal Phase III trial, which will treat advanced invasive (stage IIIb) or metastatic (stage IV) NSCLC patients who express the HLA-A2 receptor (approximately 45% of the NSCLC population), has been recently approved both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency’s (EMA). Simbec-Orion will manage this multi-centre, multi-country study involving up to 70 sites and 500 patients in the United States and Europe.

Simbec-Orion has started the feasibility study for the planned study with international clinical experts and patient enrolment is planned for the second half of 2015. Simbec-Orion will be responsible for site selection, patient enrolment, clinical monitoring, data management, statistical analysis and regulatory affairs.

Simbec-Orion has been selected because of its expertise in oncology and rare diseases offering medical and operational strengths, flexibility, commercial insight and a shared commitment to patients. As part of the collaboration agreement, Simbec-Orion has accepted warrants giving right to equity as part of payment for a portion of its fees. OSE Pharma and Simbec-Orion believe that this will closely align both parties’ interests.

"We are delighted to be collaborating with OSE Pharma in this pivotal step prior to registration of OSE Pharma’s Tedopi," said Ronald Openshaw, Chief Executive Officer of Simbec-Orion. "We have combined the development expertise of OSE Pharma with our broad clinical know-how to create a true strategic partnership."

"After an extensive global review of potential clinical research organisations, we selected Simbec-Orion as a strategic partner for our Phase III programme. This partnership provides clinical development support for Tedopi and will help us accelerate in the race for registration of immunotherapies", said Dominique Costantini CEO of OSE Pharma.

"Although pricing was an important consideration in our evaluation process, Simbec-Orion’s understanding of our mission was crucial and weighed heavily in our final decision. We are very pleased to have this team involved in such an important aspect of OSE Pharma’s future. We believe this Phase III study conducted with Simbec-Orion is an important step to validate the results of earlier studies and demonstrate the risk/benefit ratio of Tedopi alone.

"We believe that the combinatorial approach of Tedopi with other immune-oncology therapies on which we are also currently working will enable to deliver synergies and increase the duration of patients’ response."

About OSE Pharma

OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi that directs the body’s immune system to generate a specific cytotoxic T response to prevent cancer cell growth.

OSE Pharma’s lead product, OSE-2101, Tedopi combines 10 "neo-epitopes" directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.

OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.

Tedopi targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi contains ten optimized epitopes, or "neo- epitopes", designed on the binding of HLA-A2 and TCR,. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape..

Dendreon Reaches Agreement For Valeant To Serve As "Stalking Horse Bidder" In Court-Supervised Sales Process

On January 29, 2015 Dendreon reported that it has reached an agreement with Valeant Pharmaceuticals International pursuant to which, subject to bankruptcy court approval, Valeant will serve as the "stalking horse" bidder in conjunction with a court-supervised sales process (Press release Dendreon, JAN 29, 2015, View Source [SID:1234501440]).

Under the terms of the agreement, Valeant would acquire the world-wide rights of PROVENGE (sipuleucel-T) and certain other Dendreon assets for $296 million, subject to higher and better bids.

Valeant is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics.

"We are pleased to reach this agreement with Valeant and to move forward with the court-supervised sales process," said W. Thomas Amick, president and chief executive officer of Dendreon. "We are confident that this process will result in a strong new owner for PROVENGE, and that patients will continue to receive treatments with no disruption moving forward. We thank our employees for their continued hard work, dedication and commitment to serving our physicians and their patients."

The Company also announced that it would be extending the bid deadline for interested parties to submit qualified bids to participate in an auction for the Company’s assets from January 29, 2015 at 5:00 p.m. Eastern Time to February 10, 2015 at 5:00 p.m. Eastern Time. Assuming additional qualified bids are submitted, an auction would be held on February 12, 2015.

The full terms of the agreement will be filed with the Securities and Exchange Commission. Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Skadden, Arps, Slate, Meagher & Flom LLP is serving as the Company’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.

Weil, Gotshal & Manges LLP acted as legal advisor to Valeant.

Valeant Selected As Lead Bidder To Acquire Dendreon And Its Leading Immunotherapy Treatment, PROVENGE® (sipuleucel-T)

On January 29, 2015 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) reported that it has entered into a "stalking horse" asset purchase agreement to acquire certain assets of Dendreon Corporation ("Dendreon") for $296 million in cash (Press release Valeant, JAN 29, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Selected-As-Lead-Bidder-To-Acquire-Dendreon-And-Its-Leading-Immunotherapy-Treatment-PROVENGE-sipuleucel-T/default.aspx [SID:1234501430]).

Pursuant to the terms of the agreement, Valeant will acquire the world-wide rights to Dendreon’s PROVENGE (sipuleucel-T) product and certain other Dendreon assets. PROVENGE (sipuleucel-T) is an immunotherapy treatment designed to treat men with advanced prostate cancer by taking the body’s own immune cells and reprograming them to attack advanced prostate cancer. The product was approved by the U.S. Food and Drug Administration (FDA) in April 2010 and realized revenues of approximately $300 million in 2014. PROVENGE was approved by the European Medicines Agency in 2013.

Dendreon has been a debtor pursuant to chapter 11 of the U.S. Bankruptcy Code since November of 2014. The asset purchase agreement constitutes a "stalking horse bid" in a sale process being conducted under Section 363 of the U.S. Bankruptcy Code. As the "stalking horse bidder," Valeant will be entitled to a break-up fee and expense reimbursement if it ultimately does not prevail as the successful bidder at a subsequent auction for Dendreon’s assets. Valeant’s role as a stalking horse bidder, and the sale itself, are subject to approval by the Bankruptcy Court. In addition, completion of the transaction remains subject to higher or better offers at such auction and customary closing conditions.

"We believe that oncology has similar characteristics to our current therapeutic portfolios, such as strong growth, high durability, strong patient and physician loyalty, and a terrific reimbursement regime," stated J. Michael Pearson, chairman and chief executive officer. "We have not previously found an economic way to enter this market, but with the unique dynamics of this situation, we believe that this transaction will create significant shareholder value."

Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Weil, Gotshal & Manges LLP is serving as Valeant’s legal advisor. Skadden, Arps, Slate, Meagher & Flom LLP is serving as Dendreon’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.