|Kite Pharma Announces Exclusive License with the National Institutes of Health for T Cell Receptor; RXi Pharma Announces Positive Results with Novel Self-Delivering RNAi Platform|
|By Mary Davila|
|Tuesday, 20 October 2015 19:01|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 20, 2015.
Kite Pharma, Inc. (NASDAQ: KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the Company has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T Cell Receptor (TCR)-based product candidates directed against MAGE A3 and A3/A6 antigens for the treatment of tumors expressing MAGE, which include lung, pancreatic, gastric, and breast cancers, among others.
The National Cancer Institute (NCI), with Dr. Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery at the NCI and a special advisor to Kite, as principal investigator, is currently conducting two Phase 1-2a clinical trials of TCR-based product candidates targeting the MAGE antigens under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI. Pursuant to the terms of the license agreement, NIH will receive from Kite an upfront payment and certain clinical, regulatory, and sales milestone payments, as well as royalties on net sales of products covered by the license.
"We are pleased to announce this license with NIH, which further expands our therapeutic pipeline programs to treat diverse solid tumors," stated Arie Belldegrun, M.D., FACS, Kite's President and Chief Executive Officer. "We believe that our broad portfolio of TCR product candidates, including those targeting MAGE antigens, holds great promise in addressing the significant unmet needs of patients."
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) granted orphan drug designation for the Company's activin inhibitor, STM 434, for ovarian cancer. "Ovarian cancer is an aggressive tumor type with a significant unmet need for patients,” said Isaac Ciechanover, M.D., President and Chief Executive Officer of Atara Bio. “The receipt of an orphan drug designation for STM 434 is another important milestone for Atara Bio and the progress of our molecularly targeted programs.” Orphan drug designation is granted by the FDA OOPD to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The OOPD provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. The orphan drug designation also would entitle Atara Bio to a seven-year period of marketing exclusivity in the United States for STM 434 if it receives FDA approval for the treatment of ovarian cancer.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced its recognition as a leader in interoperability in the KLAS report, “EMR Interoperability 2015: Are We Lifting Together?” The report, released today, surveyed more than 240 providers across inpatient and ambulatory settings. According to the KLAS report, “no vendor is viewed more favorably regarding interoperability” than athenahealth. The report states, “Compared to other EMR vendors, athenahealth ranks very well in every measured category. Those connecting with or through athenahealth feel strongly that the vendor’s interoperability platform is simple to set up and maintain. Perhaps more impressive is the vote of confidence about the positive impact these connections are having or will have on patient care.” In the report, athenahealth was recognized for the following: Ranked as the easiest vendor to connect to; Recognized as the best-value connection for improving patient care; Noted for easy set-up and limited maintenance due to its unique cloud-based model which integrates the entire health care ecosystem—including practices, hospitals, labs, imaging systems, and public health agencies—onto a single-instance national health information platform; Praised for delivering both simple and complex connections with low integration costs. “Care organizations should be freed to focus on care delivery. No one person or team at any care organization should be responsible for optimizing technology with extra modules or investments to enable interoperability. That is the job of the technologists serving this industry,” said Jonathan Bush, chairman and CEO, athenahealth. “athenahealth is proud to be recognized for the connectivity we bring to our customers, but we still have a long way to go. We are committed to making meaningful information sharing inherent in health care regardless of the IT systems in place. Information must follow the patient and inform the provider across the care continuum. We will continue to innovate and remain transparent on this very important issue.”
BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced the initiation of a strategic big data collaboration with Pronutria Biosciences to identify diseases characterized by high unmet need for therapies and nutritional products that are amenable to Pronutria's novel technology platform. Pronutria is a biotechnology company pioneering a new class of products to mediate amino acid biology. Through this partnership, Pronutria will utilize BioXcel's first-in-class Big Data Innovation Lab (BDI-Lab) to develop biologics that leverage its novel platform and amino acid-based approach. BDI-Lab is an integrated product discovery engine which applies big data algorithms, recursive mapping and network pharmacology to build associations and neural networks for deciphering novel treatment options for rare diseases with no current standard of care. "With a proprietary platform of over 1 billion protein and fragment sequences to identify disease specific product candidates, we are unlocking the regenerative potential of homeostatic amino acid biology to transform the lives of patients and their families," said Dr. Peter Mueller, President of R&D and Chief Scientific Officer at Pronutria Biosciences. "By combining the potential of our proprietary platform with BioXcel's unique big data analytics and discovery capabilities, we will be able to enrich our pipeline with transformative products for relevant therapeutic and nutritional modalities."
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that recent Company research has produced data to expand the potential clinical indications for PRO 140 for autoimmune diseases. Accordingly, the Company recently filed with the FDA a new IND (Investigational New Drug) application and a full protocol for a Phase 2 clinical trial. Furthermore, CytoDyn intends to file for Orphan Drug Designation for a Graft versus Host Disease ("GvHD") indication for patients requiring bone marrow transplants in the near future. CytoDyn currently is in a Phase 3 trial with its lead product candidate, PRO 140, for the treatment of HIV and, if successful, anticipates approval in the first half of 2017. The Company has selected a transplantation indication called GvHD as its first non-HIV clinical indication. The CCR5 receptor, the target for PRO 140, is an important mediator of GvHD, especially in the organ damage that is the usual cause of death. The only approved CCR5 inhibitor, Maraviroc, is currently in a Phase 2 study in GvHD and results are expected in 2016. The Company believes that PRO 140 has significant advantages over Maraviroc in more favorable dosing and pharmacokinetics, less toxicity and side effects, and no direct stimulation (agonist activity) of the CCR5 receptor. CytoDyn also believes if the data is positive, it intends to file for breakthrough designation for this indication.
Endologix, Inc. (NASDAQ:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today details relating to the release of its third quarter 2015 financial results, which will take place on Monday, October 26, 2015 after the close of the market. Endologix will hold a conference call on Monday, October 26, 2015 at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results. The dial-in numbers are (877) 407-0789 for domestic callers and (201) 689-8562 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.endologix.com. After the live webcast, a replay of the webcast will remain available online from the investor relations page of Endologix's website, www.endologix.com, through October 26, 2016. In addition, a transcript will be posted to website and a telephonic replay of the call will be available until November 2, 2015. The replay dial-in numbers are (877) 870-5176 for domestic callers and (858) 384-5517 for international callers. Please use the replay pin number 13622012.
EXL (NASDAQ:EXLS), a leading business process solutions company, today announced its inclusion in the “Winner’s Circle” in the HfS Blueprint Report: Healthcare Payer Operations, authored by Barbra McGann. The HfS 2015 Payer Operations Blueprint covers sourcing for claims management, member management, provider data management, and health and care management, as well as analytics and enabling technology platforms. It is intended to complement the firm’s 2015 Population Health and Care Management Report, which also featured EXL in the “winner’s circle.” “The healthcare industry is being ‘shaken, not stirred’ by new ways and means of defining, delivering, and managing health and care,” McGann said. “We see healthcare organizations increasingly looking for the people and the partners to help them put together a solution with the best capabilities to drive results. To increase the value of the sourcing model, EXL is building competitive strength in healthcare business services through analytics with new operational frameworks, clinicians and cross-industry experience.” “We are pleased to be ranked in the winner’s circle of this important HfS Blueprint report,” said Rembert de Villa, Executive Vice President and Healthcare Business Head, EXL. “Furthermore, our top ranking in ‘innovation’ validates our continued commitment, vision and investment in our healthcare go-to-market strategy. Our integrated solutions help our clients better know their customers, engage members to drive behavioral change, involve and align providers, and measure process and outcomes every day.”
Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced the enrollment of the first patient in a Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone. The most common treatments for rosacea are topical therapies such as metronidazole and azelaic acid, as well as the oral antibiotics minocycline and doxycycline. "There is a huge demand for new safe and effective topical treatments," said Dov Tamarkin, Chief Executive Officer of Foamix Pharmaceuticals. "FMX103 has the same active ingredient, minocycline, as our lead candidate, FMX101, for acne. Based on the positive clinical data we have generated in acne and the dermatological similarities between rosacea lesions and inflammatory acne lesions, we believe FMX103 can be a safe and effective topical treatment for rosacea. FMX103 has the potential to offer significant advantages over the current standard of care."
Global Future City Holding Inc. (OTCQB:FTCY) announces its plans to deploy and operate a multi-level marketing program through its wholly owned subsidiary GX Life Global, Inc. GX-Life Global is a multi-level marketing company offering a diverse line of products presently in the following categories: beauty, energy, nutrition, and tea. In the beauty category, GX-Life Global has developed a line of high-end moisturizers, serums, and creams designed to protect the skin and combat the signs of aging. In the energy category, GX-Life Global offers two uniquely formulated F.I.T.T. Energy® one-ounce energy gel packs and a high antioxidant berry one ounce gel pack that contains the equivalent of 75–110 glasses of resveratrol in a single serving. In the tea category, GX-Life Global offers single-serve sachets of Authentea® organic tea extract and Herbalsoul® herbal tea extract, in addition to various tea wares. In the nutrition category, GX-Life Global offers a range of nutraceutical and diet products, including a multivitamin, probiotic, digestive enzyme, joint reliever, detoxifier, calcium supplement, and organic "superfood" powder. In addition, GX-Life Global provides its members with the opportunity to purchase all-inclusive travel packages with first-class air transportation and luxury hotel accommodations. Relatedly, GX-Life Global offers its members a selection of plastic surgery medical tourism packages that entitle the purchaser to a specified number of hours of invasive and/or non-invasive plastic surgery at an outpatient clinic in Newport Beach, California. GX-Life Global also provides its members with the opportunity to purchase fine art at a discounted price.
Greatbatch, Inc. (NYSE:GB) today announced that its wholly-owned subsidiary Greatbatch Ltd. had priced its previously announced private offering of $360 million aggregate principal amount of senior notes due 2023 at an issue price of 100%. The notes will have a coupon of 9.125% and will mature on November 1, 2023. The sale of the notes is expected to close on October 27, 2015, subject to customary closing conditions. Greatbatch intends to use the net proceeds from the notes as part of the financing for its previously announced acquisition of Lake Region Medical Holdings, Inc. The Lake Region acquisition is currently expected to close in late October. If the offering of the notes closes prior to the closing of the Lake Region acquisition, the gross proceeds from the offering (together with an additional amount representing interest payable on the notes through the date that is five business days after February 23, 2016) will be deposited into an escrow account until closing of the acquisition. If the closing of the Lake Region acquisition does not occur on or prior to February 23, 2016, or Greatbatch determines not to pursue the acquisition or the acquisition agreement is terminated, the notes will be subject to a special mandatory redemption at a redemption price equal to 100% of the initial issue price of the notes, plus accrued and unpaid interest to, but not including, the special mandatory redemption date. Upon consummation of the acquisition, Greatbatch, Inc. and certain of its U.S. subsidiaries (including certain U.S. subsidiaries acquired in connection with the Lake Region acquisition) will guarantee the notes.
ICU Medical, Inc., (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its third quarter 2015 earnings release conference call. The Company will release its third quarter 2015 results at approximately 4:00 p.m. EST (1:00 p.m. PST) and will be conducting a conference call concerning those results at 4:30 p.m. EST (1:30 p.m. PST) on Thursday, November 5, 2015. The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 63829289. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay by dialing (855) 859-2056, (404) 537-3406 international.
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces receipt of authorization from the Ministry of Health in Argentina to market and distribute NexoBrid® for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Tuteur S.A., MediWound's exclusive distribution partner in Argentina, intends to launch NexoBrid in Argentina in the next quarter. This regulatory approval builds upon NexoBrid marketing authorization from the European Medicines Agency (EMA) for the same indication and validates MediWound strategy to use the EMA approved registration file for seeking approval in emerging markets. "We are delighted NexoBrid will soon be available to treat patients in Argentina, who are afflicted with severe burns and who are mainly treated at a few specialized burn centers. This approval is in line with our strategy to expand the reach of NexoBrid to emerging markets with a focus in Latin America, Asia Pacific and CIS. We look forward to additional marketing approvals in these regions in the coming quarters while we seek to further expand our distribution channels to other markets through our on-going business development efforts. Tuteur has more than 40 years of experience in marketing pharmaceutical products in Argentina and has intimate knowledge of this market. We will work closely with Tuteur to further advance burn care in Argentina by assimilating NexoBrid as an effective and minimally invasive treatment modality," stated Gal Cohen, President and Chief Executive Officer of MediWound.
Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced it has executed an amended and restated license agreement with Arthrex, Inc., through which Arthrex has exercised its right to assume responsibility for the manufacture and supply of the Company's Angel® Concentrated Platelet Rich Plasma System (Angel), an option granted and contemplated in the original license agreement. Additionally, Nuo is retaining the underlying patents to Angel while transferring the as-defined product registration rights and obligations. Under the amended agreement, Arthrex will now have the exclusive license for Angel in all worldwide non-surgical aesthetics markets, with the exception of the UK and Ireland, which remain non-exclusive. In addition, the amendment grants Arthrex permission to market Angel on a non-exclusive basis for wound care applications outside the U.S. The term of the agreement has also been extended to 2024, upon which the last Angel-related patent expires. Additionally, Arthrex has paid the Company a $775,000 advance against discounted second half 2015 royalties. This amount will be subject to a true-up payment in February 2016. Based on the extended term of the agreement plus certain escalating minimum royalties in the years 2018 through 2021, Nuo anticipates the gross royalty stream from Arthrex during the remaining nine-year term of the amended license agreement will be in excess of $20 million. Including the advance payment, Nuo cash on hand as of October 19, 2015 was approximately $4.1 million.
Rand Capital Corporation (NASDAQ:RAND), a business development company that makes venture capital investments in companies with emerging product, service or technology concepts, announced that one of the largest holdings in its portfolio, Rheonix, Inc. (www.rheonix.com), recently completed a $28.6 million Series B equity raise. Rand co-led the offering with Cayuga Venture Fund, which is based in Ithaca, New York. Cayuga Venture Fund focuses its investments in start-up technology companies, many with a connection to Cornell University. Rand also partnered with past co-investors, including Advantage Capital Partners and Gefinor Capital, to complete this equity offering. Earlier in 2015, Rand had provided convertible bridge financing to support Rheonix during the fundraising process, and its $680,000 bridge notes were converted to equity upon completion of the Series B offering. Rheonix develops fully automated microfluidic-based molecular assays. Most recently, Rheonix was granted a patent for the Rheonix CARD® cartridge, which enables assays to be performed on the company's Rheonix Card and Encompass family of products. The fully enclosed Rheonix CARD® cartridge makes molecular testing simpler and easier to perform and at a fraction of the cost of other options while also eliminating the potential for contamination, reducing user error, and streamlining workflow. Rand has invested a total of $2.8 million in Rheonix since 2009, representing one of Rand's five largest holdings at 8.9% of its net assets as of June 30, 2015.
SeaSpine Holdings Corporation (Nasdaq:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the appointment of Patrick Keran to the newly created position of General Counsel, effective October 12, 2015. Mr. Keran has over 15 years of legal and operational experience, primarily with respect to capital raising, corporate governance and FDA-regulated entities. For the past eight years, Mr. Keran has held progressively senior positions at Mast Therapeutics, a clinical-stage drug development company, most recently as President and Chief Operating Officer, where he oversaw multiple acquisitions and raised close to $250 million. "I am excited to join the leadership team of SeaSpine and to contribute to the innovation that will drive growth," said Mr. Keran. "I'm looking forward to the opportunity to simplify our operations and approach to the market to make it easier for our surgeon customers and distributors to do business with us." Mr. Keran will be part of the senior leadership team, reporting directly to Keith Valentine, President and Chief Executive Officer.
Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the signing of additional preferred provider organization (PPO) agreements. Under the terms of the agreements, the Signal Genetics MyPRS® assay will be offered through additional PPO networks including the Stratose, USA Managed Care Organization, and Evolutions Healthcare Systems PPO networks. These new agreements will provide coverage to over 21 million patients across the United States. Tamara A. Seymour, Chief Financial Officer, commented, "We are pleased to continue the expansion of our partnerships with provider networks, as the signing of these agreements will further enhance and simplify our reimbursement process. With strong partnerships and a streamlined reimbursement procedure, we expect to see additional revenue recovery from these initiatives. In addition, these recent agreements demonstrate our ability to continue to execute our growth strategy. Together with the PPO agreement we announced earlier this year and our other payor relationships with Medicare and Blue Cross Blue Shield of Arkansas, the covered lives within our universe has increased to over 93 million patients in the United States."
SmallCapVoice.com, Inc. (SCV) and Terra Tech Corp. (OTCQX:TRTC), a vertically integrated cannabis-focused agriculture company, today announced that Derek Peterson, CEO of Terra Tech, was featured in an audio interview on SmallCapVoice.com. Derek Peterson, CEO of Terra Tech (OTCQX:TRTC) called in to SmallCapVoice.com to discuss recent Company news and developments, as well as the outlook for the Company and industry. Topics covered in the interview include; IVXX market penetration, California legalization, a Nevada update, and much more. “If you look at where we were a couple years ago versus where we are today, Terra Tech has changed and progressed quite drastically,” said Derek Peterson. “We have a gigantic farming division on the east coast, we’re in 1,800 major retailers, and we have eight permits in Nevada, which I think is going to be one of the top markets in the country. Additionally, we have strong distribution of the IVXX brand throughout California, as well as the potential legalization of recreational of cannabis in both the California and Nevada markets in the near future.” An audio recording of the interview can be accessed by clicking on the following link: http://bit.ly/1LSQsS3.
Sun BioPharma, Inc., (OTCPink:SNBP), a biopharmaceutical company developing therapies for the treatment of pancreatic diseases, announced today that the Company will present pre-clinical data in three abstracts on its lead development candidate, SBP-101, at the 2015 American Pancreatic Association (APA) annual meeting being held November 4-7, 2015 in San Diego, CA. "We are excited to present three abstracts featuring pre-clinical data from our lead drug candidate SBP-101, a first-in-class proprietary polyamine compound designed to exert a therapeutic effect in a mechanism specific to the pancreas," stated David Kaysen, President and CEO of Sun BioPharma. "This data formed the basis for the Investigational New Drug (IND) approval that was recently granted by the United States Food & Drug Administration (FDA) and drove the development of the Phase I clinical study expected to initiate in Australia by the end of the year, and in the U.S. in the first half of 2016."
Vodis Pharmaceuticals Inc. (CSE:VP) (FSE:1JV) is pleased to provide an operational update and announce plans to maximize production for the tenant at its Bellingham, Washington based production facility. In addition, the Company is pleased to announce that it has entered into negotiations with another licensed producer to initiate production in the second building situated on its Bellingham property. The Company has initiated the second phase build-out of its premises at the Bellingham production facility to improve the production capacity for Vodis' tenant, Our Church International LLC ("OCI"). Otto Folprecht, Vodis' Chief Executive Officer commented, "The objective of this work program is to maximize the production capacity available to OCI under the Tier II license that has been granted by the Washington State Liquor and Cannabis Board." In addition to working to enhance OCI's production capacity, Vodis has entered into negotiations with another licensed producer to initiate production in the second building located at the Company's Bellingham property. Otto Folprecht commented: "The second building on our Washington property is ideally suited for a Tier I license holder and the Company plans to retrofit this building as soon as negotiations are finalized."