Author: [email protected]

ProStrakan enters into agreement to buy Archimedes

On July 11, 2014 ProStrakan Group plc("ProStrakan") a subsidiary of global specialty pharmaceutical company, Kyowa Hakko Kirin Co.,Ltd. ("KHK"), reported that it has entered into an agreement with Novo A/S, a private limited liability company fully owned by the Novo Nordisk Foundation,to purchase the entire share capital of Archimedes Pharma Limited ("Archimedes") for a consideration of £230 millionin cash (Press release, ProStrakan, JUL 11, 2014, View Source [SID1234572119]). Archimedes is a fast growing European-based specialty pharmaceutical company providing novel and advanced treatments within the therapeutic areas of pain, oncology and critical care. Its largest product is PecFent, a fentanyl nasal spray used in the management of breakthrough cancer pain in patients who are already receiving maintenance opioid therapy for chronic cancer pain. The product was developed using Archimedes’ proprietary drug delivery technology platform,which is protected by several patents. Archimedes also has a diversified product portfolio of both promoted and non-promoted pharmaceutical products marketed to healthcare professionals across Europe. It has a strong European footprint with commercial operations in the UK, France, Germany and Spain. Archimedes is based in Reading, UK, and has a development facility in Nottingham, UK. In 2013, Archimedes recorded revenues of £41million, growing33% from the previousyear.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ProStrakan’s acquisition of Archimedes furthers KHK’s strategic vision of becoming a global specialty pharmaceutical company. The acquisition of Archimedes also delivers several strategic benefits to ProStrakan. The transaction significantly expands ProStrakan’s critical mass in Europe by growing its businesses in four of the largest European markets: UK, France, Germany and Spain. In each of these countries Archimedes has sales and marketing infrastructure which will complement ProStrakan’s current operations. In 2013, ProStrakan generated revenues of £155million, growing 20% from the previous year. Archimedes brings a strong product portfolio of high growth brands which expands ProStrakan’s offering in the core therapeutic areas of oncology and oncology supportive care. These brands are expected to be a key driver of growth for ProStrakan over the next several years. In addition, the enhancement of the infrastructure and portfolio broadens the reach of ProStrakan,helping it to position itself for the launch of several exciting new products currently being developed by ProStrakan’s parent company, KHK. One of these products, KW-0761, is a novel antibody being developed for haematology indications such as adult T-cell leukaemia/lymphoma. Dr Tom Stratford, Chief Executive Officer of ProStrakan, said :"The acquisition of Archimedes represents a rare opportunity to enhance the scale of our successful European operations by adding a strong portfolio of high value medicines as well as further strengthening our teams in major European markets. "Since joining KHK three years ago, ProStrakan has grown from strength to strength, culminating in the delivery of a positive profit contribution for the KHK group in 2013. The acquisition of Archimedes is a further step in KHK’s strategy of becoming a global specialty pharmaceutical company, as it significantly expands its presence in Europe."

Closing of the transaction is subject to anti-trust approvals in Germany .Lazard is acting as exclusive financial advisor to KHK and ProStrakan, and Wragge Lawrence Graham & Co. is acting as legal counsel to KHK and ProStrakan

Bristol-Myers Squibb Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo® (nivolumab), an Investigational PD-1 Immune Checkpoint Inhibitor, for Previously Treated Advanced Melanoma

On July 10, 2014 Bristol-Myers Squibb reported that it, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo (nivolumab) for previously treated advanced melanoma (Press release Bristol-Myers Squibb, JUL 10, 2014, View Source [SID:1234500639]). This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer," said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb.

The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen.

Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trade name for nivolumab.

Regeneus secures exclusive worldwide rights for new therapeutic human cancer vaccine

On July 8, 2014 Regeneus (ASX: RGS) reported that it has signed today an agreement with Northern Sydney Local Health District (NSLHD) for the exclusive worldwide rights to develop and commercialise a new personalised therapeutic human cancer vaccine. The technology was developed at the Bill Walsh Translational Cancer Research Laboratory which is part of the Kolling Institute of Medical Research at Royal North Shore Hospital in Sydney.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have secured the rights for human applications of the cancer vaccine technology following preclinical efficacy data and promising safety data generated from the treatment of a variety of dogs with a wide range of cancer types," said Professor Graham Vesey, CEO of Regeneus.* Regeneus holds the exclusive worldwide commercialisation rights of the vaccine technology for veterinary applications.

The production of the cancer vaccine for an individual patient requires a patient tumour sample obtained either by complete surgical removal or by small biopsy. This approach is a truly personalised therapeutic cancer immunotherapy.

Regeneus will fund a first-in-man trial (safety study) scheduled to commence in the first quarter of 2015 and further research at the Bill Walsh Cancer Research Lab to support the trial. Leading oncologists Professor Stephen Clarke and Associate Professor Nick Pavlakis, from the University of Sydney’s Northern Clinical School at the Kolling Institute, will be the investigators on the trial. "Following the positive results we have seen in canines, this has been an encouraging prelude to undertaking a human clinical trial. It’s exciting to see world-class innovative cancer research done at the Kolling Institute translated into the clinic as a potential new therapeutic cancer vaccine," Professor Clarke said. The trial design and target tumour type will be finalised prior to seeking ethics approval.

"The therapeutic vaccine has the potential to target a wide range of hard-to-treat cancers with a single product. As the vaccine uses the patient’s own tumour cells and can be prepared under the supervision of the treating clinician, the local regulatory environment for biological therapies in Australia may allow for an accelerated clinical pathway for the autologous cancer vaccine removing the need for expensive and time consuming phase III trials" said Professor Vesey.

Under the Licence Agreement, Regeneus is responsible for the clinical and commercial development of the cancer vaccine for human applications and will pay royalties to NSLHD on the commercial use of the product.

Over the last few years there has been an increased focus on therapeutic vaccines with the US Food and Drug Administration approving the first therapeutic vaccine for cancer in 2010. There is a growing pipeline of therapeutic vaccines for an array of chronic conditions including cancer. The market for therapeutic vaccines is projected to grow at 55% per year reaching $13billion in revenues by 2018.**

*Cancer Immunology Research, a peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), published this trial data in February 2014.

**Oliver Wynan’s MedTRACK analysis, 2012.

Incyte Achieves $25 Million Milestone for Approval of Jakavi® (ruxolitinib) in Japan

On July 8, 2014 Incyte reported that it has earned a $25 million milestone payment from Novartis in connection with the approval of Jakavi (ruxolitinib) in Japan for the treatment of patients with myelofibrosis (Press release Incyte, JUL 8, 2014, View Source [SID:1234500622]). Incyte will record this amount as contract revenue in the third quarter. Under the Incyte-Novartis Collaboration and License Agreement, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi (ruxolitinib).

“We are very pleased with the progress that Novartis is making in the global roll-out of Jakavi,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “The recent approval of Jakavi in Japan is further evidence of that progress.”

Novartis also continues to make progress in obtaining formal pricing and reimbursement approval for a third major European country and expects this to occur in the second half of 2014. Once achieved, Incyte will earn an additional $60 million milestone payment.

Austrian Biotech Company “APEIRON” Announces Start of its First Clinical Trial for Neuroblastoma Patients in Japan

On July 7, 2014 APEIRON Biologics reported that a phase I clinical trial with its neuroblastoma immunotherapy APN311 has received all necessary approvals to start recruiting patients. The trial will be locally conducted by Nagoya University Hospital and is part of a long-term collaboration to make this therapy available to patients suffering from this severe type of children’s cancer (Press release, Apeiron Biologics, JUL 7, 2014, View Source [SID:1234502247])r. In Japan, it won a grant by the Japanese government as an Investigator-initiated clinical trial that utilizes collaboration between the Department of Pediatrics and the Center for Advanced Medicine and Clinical Research (CAMCR) at Nagoya University Hospital. "This is a great achievement for us as we have supported this joint effort from the very beginning. Two years ago the ground was prepared when the Austrian Embassy – Commercial Section in Tokyo hosted a scientific meeting for Japanese pediatric oncologists to learn about this innovative therapy of pediatric neuroblastoma developed by Apeiron ", says Dr. Martin Glatz, Commercial Counsellor of the Austrian Embassy. "The meeting two years ago was part of a focus program aiming to bring more Austrian medical research and biotech companies to the Japanese market. The market has seen tremendous changes recently with companies exploring new opportunities and the government addressing regulatory issues," he added. Hans Loibner, PhD, CEO of Apeiron, commented, "We are very happy and proud to be rewarded with this milestone achievement after all the effort that was invested. I would like to particularly thank the physicians from Nagoya University, Dr. Seiji Kojima and Dr. Yoshiyuki Takahashi, as well as Dr. Masaaki Mizuno, Dr. Katsuyoshi Kato and Dr. Shinobu Shimizu at CAMCR, as we owe it to their dedication and tireless work that this trial can now start. We are confident that Japanese patients will benefit from the introduction of APN311 to Japan and look forward to making the next steps towards approval of this promising antibody therapy of neuroblastoma by the Japanese regulatory authorities."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!