Anadys Pharmaceuticals (Formerly Scriptgen Pharmaceuticals; to be acquired by Roche as of October 2011)
Steve Worland, PhD, President and CEO James L. Freddo, MD, SVP-Drug Development and CMO Kevin L. Eastwood, SVP-Corporate Development James Appleman, PhD, SVP-R&D and CSO
5871 Oberlin Drive, Suite 200
San Diego, CA 92121 USA
Tel: 858-530-3600 Fax: 858-527-1540
Email: keastwood@anadyspharma.com
Website: http://www.anadyspharma.com/
Special Report
In October 2011, Anadys Pharmaceuticals entered into a definitive agreement to be acquired by Roche. Under the terms of the merger agreement, Roche will commence an all cash tender offer for all outstanding shares of common stock of Anadys at $3.70 per share that represents a 256% premium over the closing price of $1.04 on October 14, 2011. The acquisition centers on Anadys' hepatitis C virus (HCV) compounds that provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance.
Profile
(Public (NASDAQ:ANDS)) Infection • Drug development
Anadys Pharmaceuticals is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of hepatitis, other serious infections, and cancer. The company has core expertise in toll-like receptor-based small molecule therapeutics and structure-based drug design coupled with medicinal chemistry. Anadys is the result of the unification of scientists, technologies, products and patents from Scriptgen Pharmaceuticals, the European Molecular Biology Laboratory (EMBL), and the Scripps Research Institute and the University of California San Diego.
In October 2011, Anadys Pharmaceuticals entered into a definitive agreement to be acquired by Roche. Under the terms of the merger agreement, Roche will commence an all cash tender offer for all outstanding shares of common stock of Anadys at $3.70 per share that represents a 256% premium over the closing price of $1.04 on October 14, 2011. The acquisition centers on Anadys' hepatitis C virus (HCV) compounds that provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance.
In October 2010, Anadys Pharmaceuticals priced its underwritten public offering of 13,888,889 shares of its common stock at $1.80 per share. The gross proceeds to Anadys from this offering were approximately $25.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Anadys has also granted the underwriter a 30-day option to purchase up to an aggregate of 2,083,333 additional shares of common stock to cover overallotments, if any. Lazard Capital Markets is acting as sole bookrunning manager in the offering.
In June 2009, Anadys Pharmaceuticals entered into definitive agreements with institutional investors to raise approximately $17.5 million in gross proceeds in a registered direct offering through the sale of shares of its common stock and warrants. Anadys estimates that net proceeds from the offering will be approximately $16.2 million, after deducting placement agent fees and estimated offering expenses (not including up to $100,000 of related expenses payable to the placement agent). Anadys has entered into subscription agreements with each of these investors pursuant to which it has agreed to sell a total of 8,358,000 units, each unit consisting of one share of common stock and one warrant to purchase 0.35 of a share of common stock (or a total of 2,925,300 shares), at a purchase price of $2.09375 per unit. The warrants will be exercisable six months after issuance at $2.75 per share and will expire 5 years from the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately. The closing of the transaction is scheduled to occur on June 9, 2009, subject to the satisfaction of customary closing conditions. All of the securities were offered pursuant to an effective shelf registration statement. Cowen and Company, a subsidiary of Cowen Group, acted as the exclusive placement agent for the transaction.
In June 2009, Anadys Pharmaceutical cut its work force by 40%, and ended the early stage HCV and anticancer drug programs for ANA773 to focus on ANA598, in midstage development for HCV.
In August 2007, Anadys Pharmaceuticals restructured its operations to focus on two key compounds with the highest commercial potential, ANA598 for hepatitis C and ANA773 for cancer. In connection with this restructuring, Anadys halted all work on early discovery projects, and reduced its workforce by one third.
In August 2005, Anadys Pharmaceuticals completed a public offering of 5.75 million common shares, including the underwriters’ full exercise of a 750,000 shares issue option, at $12.40 per share. The aggregate gross offering proceeds, including shares issued upon over-allotment option exercise, are $71.3 million, with net proceeds of approximately $66.7 million. Credit Suisse, First Boston, and SG Cowen & Co. acted as joint offering book runners with Piper Jaffray and Needham & Co. as co-managers.
In June 2005, Anadys entered into the exclusive collaboration with Novartis to develop and commercialize ANA975 for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infections. In addition to the $20 million upfront payment, Anadys is eligible to receive up to $550 million in regulatory and commercial milestone payments based on the successful development and commercialization of ANA975. A $10 million payment is due following a successful IND submission, which Anadys expects to file with the FDA this summer. The agreement also includes potential royalty payments for sales outside the USA and a 35% USA copromotion option for Anadys.
In April 2004, the underwriters of Anadys Pharmaceuticals initial public offering have exercised their over-allotment option to purchase an additional 743,950 shares of common stock. Net company proceeds were approximately $4.8 million. This brings the total proceeds of the IPO, before offering expenses and after deducting underwriting discounts and commissions, to $45,530,615.
In March 2004, Anadys Pharmaceuticals priced its initial public offering of 6.25 million common shares at $7.00 per share.
In July 2002, Anadys raised $38.3 million through a private placement of Series C preferred stock. The round was led by Care Capital with a strong syndicate of existing and new investors, including: Advent International, Atlas Ventures, Chinese Development Investment Bank, Coastview Capital, HBM BioVentures, International BioMedicine Holdings (advised by Global BioMedical Partners), Lotus Biosciences, SG Asset Management, SG Capital Partners, Sete S.A., Venrock Associates and others. SG Cowen acted as the placement agent with Bear Stearns as a co-manager.
In December 2001, Anadys completed a private placement of $21.2 million. SG Capital Partners led the equity round. Other investors included Advent International, Atlas Ventures, International Biomedicine Partners, Lombard Odier & Cie, Pacific Rim Ventures, Sete, Sofinov, and Venrock Associates.
Current as of October 18, 2011
Company focus: Diagnostics
Foundation Medicine
Alexis Borisy, Chairman Michael J. Pellini, MD, President and CEO Kevin Krenitsky, MD, COO Gary Palmer, MD, SVP-Medical Affairs and Commercial Development Maureen T. Cronin, PhD, SVP-Research and Product Development Gary Cohen, VP-Bioethics, Law and Policy Jeffrey Ross, MD, Interim Head of Pathology and Molecular Diagnostics
One Kendall Square, Suite B3501
Cambridge, MA 02139 USA
Tel: (617) 418-2200 Fax: (617) 418-2201
Website: http://www.foundationmedicine.com/
Special Report
In October 2011, Foundation Medicine closed an expanded Series A financing, bringing the total raised in the round to $33.5 million. In addition to founding investor Third Rock Ventures, this financing includes new investors Kleiner Perkins Caufield & Byers (KPCB) and Google Ventures. Foundation Medicine has developed a comprehensive cancer diagnostic test that analyzes routine clinical specimens of formalin fixed, paraffin-embedded (FFPE) tumor tissue for molecular alterations in more than 200 cancer-related genes.
Profile
(Private) Diagnostics
Foundation Medicine, launched in 2010 by Eric Lander, PhD, Matthew Meyerson, MD, PhD, Todd Golub, MD, and Levi Garraway, MD, PhD, from the Broad Institute, the Dana Farber Cancer Institute, Harvard Medical School and the Massachusetts Institute of Technology (MIT), develops comprehensive tests to help physicians personalize cancer treatment for their patients. The company focuses on developing clinical laboratory tests that capture the relevant genomic and other molecular information in an individual patient’s cancer and connect this data with relevant clinical information to determine the appropriate treatment for individual patients. The company aims to bridge the gap between the available technology and the day-to-day practice of clinical oncology, to systematically obtain tumor information and efficiently interpret the specific molecular alterations associated with each patient’s disease.
In October 2011, Foundation Medicine closed an expanded Series A financing, bringing the total raised in the round to $33.5 million. In addition to founding investor Third Rock Ventures, this financing includes new investors Kleiner Perkins Caufield & Byers (KPCB) and Google Ventures.
In April 2010, Foundation Medicine raised $25 million in Series A funding led by Third Rock Ventures.
Technology
Foundation Medicine focuses on developing clinical laboratory tests using next generation sequencing and other advanced technologies to broadly analyze the relevant tumor genomic and other molecular information present in individual patients’ tumors. The company has developed a comprehensive cancer diagnostic test that analyzes routine clinical specimens of formalin fixed, paraffin-embedded (FFPE) tumor tissue for molecular alterations in more than 200 cancer-related genes. The test will be optimized for clinical grade analysis of tumor tissues, overcoming multiple complexities such as purity, ploidy and clonality inherent to tumor genomes. The company is working to translate this capability into clinically relevant tests for pathologists and oncologists. Test results will be reported through a secure, interactive website linking genomic data to a structured knowledge base of relevant, publicly available scientific and medical information. By combining genomic data and scientific and medical information in an easy-to-use format, Foundation Medicine’s test results can serve as a helpful decision-support tool for physicians to recommend cancer treatment approaches tailored to each patient’s molecular subtype. In addition, this approach would identify patients with malignancies harboring specific genetic alterations who are often very difficult to recruit for clinical trials. The company has entered into collaborations with Novartis and Celgene. The company has CLIA approval to use its test which is expected to cost between $3,500 and $4,500.
In January 2011, Foundation Medicine entered into a strategic pilot collaboration with Novartis to develop, enhance and optimize Foundation Medicine’s cancer genome panel test for Novartis’ needs. If the pilot phase is successful, Novartis and Foundation Medicine will evaluate opportunities to collaborate on the production and commercialization of the test. Financial details of the agreement were not disclosed.
In October 2011, Kylin Therapeutics received a notice of allowance from the USPTO for a second patent that broadly covers new therapeutic RNA technology, as well as expanded areas regarding Kylin's proprietary nanoparticle packaging RNA (pRNA) technology platform. This new intellectual property covers multivalent RNA structures broadly encompassing: tissue targeting, aptamer binding, receptor-mediated endocytosis, and RNA interference.
Profile
(Private) Drug development • Enabling technology
Kylin Therapeutics was founded in late 2006, based on technology developed by Dr. Peixuan Guo at Purdue University. Formed through a joint effort between IN-vivo Ventures and North Carolina-based Golden Pine Ventures, Kylin Therapeutics acquired an exclusive license to an RNAi delivery method known as pRNA from Purdue in 2007. The company employs pRNA treat cancer and other diseases.
In July 2009, Kylin Therapeutics received a $100,000 Phase I Small Business (SBIR) Innovation Research grant from the National Institutes of Health (NIH).
In January 2009, Kylin received a $1.2 million grant from Indiana's 21st Century Research and Technology Fund.
In March 2008, Kylin raised a Series A-1 round of financing of approximately $1.2 million from private investors.
In September 2007, Kylin signed a collaboration agreement with Fort Dodge Animal Health, a division of Wyeth to develop novel RNAi therapeutics for the treatment of cancer in companion animals. Under the terms of the 3-year contract, Kylin will receive research funding, milestone payments and royalties on commercialized products. Kylin will retain rights to the therapies for human use.
Technology
Kylin Therapeutic employs an RNA nanoparticle technology platform referred to as packaging RNA (pRNA), inspired by the highly evolved design of a molecular motor found in the phi29 bacteriophage, to exploit the potential of oligonucleotides for treatment of many common diseases. The goal is to use RNA building blocks to create therapeutic nanotechnologies to address unmet medical needs. This platform may combine into one nanoparticle all possible RNA functionalities including receptor antagonism/activation, cell targeting/delivery and gene knockdown through mechanisms like RNA interference (RNAi). pRNA exists in individual subunits, consisting of only RNA, that self-assemble under ambient conditions into dimers, trimers, quatramers, and hexamers. RNA-based therapeutic modalities including aptamers, ribozymes, and therapeutic RNA, incorporated into individual subunits of pRNA, maintain both structure and function when incorporated into the pRNA system. pRNA complexes can be used to deliver RNA-based therapeutics specifically into diseased cells. Targeting molecules such as small molecules like folate, peptides, protein-binding aptamers, and monoclonal antibodies (MAb) can be easily incorporated into individual pRNA subunits. Once incorporated, pRNA is efficiently taken up by diseased cells via the targeting mechanism. After the diseased cells take up the nanoparticle, therapeutic RNA are cleaved, released and silence the genes that are causing the disease. Targeting mechanisms and gene silencing capabilities can be tailored to match the appropriate diseased tissue making the potential for the pRNA nanotechnology platform nearly endless.
In October 2011, Kylin Therapeutics received a notice of allowance from the USPTO for a second patent that broadly covers new therapeutic RNA technology, as well as expanded areas regarding Kylin's proprietary nanoparticle packaging RNA (pRNA) technology platform. This new intellectual property covers multivalent RNA structures broadly encompassing: tissue targeting, aptamer binding, receptor-mediated endocytosis, and RNA interference.
In November 2010, Kylin Therapeutics was granted $244,479.25 under the Qualifying Therapeutic Discovery Project (QTDP) program to advance the company’s pRNA nanoparticle cancer treatment research.
In February 2010, the USPTO issued Kylin Therapeutics a patent that broadly covers a number of functionalities for the packaging RNA (pRNA) nanotechnology platform including receptor binding, ribozyme activity, and RNA interference (RNAi). The patent's principal author is Peixuan Guo, who invented and developed the pRNA technology when he was a professor of molecular virology and biomedical engineering and faculty scholar at Purdue University. He is now an endowed professor and director of the Nanomedicine Bionanotechnology Center at the University of Cincinnati. This patent has also been granted in in Europe and Australia.
Current as of October 04, 2011
Company focus: Drug Delivery
Aura Biosciences
Elisabet de los Pinos, PhD, Founder and CEO Andrew Schiermeier, PhD, CBO Peter Elliott, PhD, CSO Zahra Shahrokh, PhD, SVP-Development Rhonda Kines, PhD, Director-Research
85 Bolton Street
Cambridge, MA 02140 USA
Tel: 617 401-3360 Fax: 617 401 3762
Website: http://www.aurabiosciences.com
Profile
(Private) Drug delivery • Drug development
Aura Biosciences, established in November 2008, is developing Nanosmart technology, a new generation of nano-delivered chemotherapy designed to improve the efficacy and reduce the toxicity of these agents. Nanosmart particles encapsulate the drug and use tumor-specific markers to target it to cancer cells, releasing their payload only once inside the tumor. Nanosmart chemotherapy is expected to provide better results with fewer side effects, allowing many more patients to benefit from these vital treatments.
In August 2011, Aura Biosciences raised $2.95 million in its second funding round. Among its investors are OXO Capital and Lealtad.
In September 2010, Aura Biosciences completed a debt offering of $1.43 million to 18 private investors.
In January 2009, Aura Biosciences secured a $3.7 million initial capital from private, mostly European, investors.
Technology
The Nanosmart technology enhances drug delivery by encapsulating therapies within protein nanoparticles engineered for precise targeting, immune system evasion, and efficient cellular uptake. With a uniform structure and reproducible distribution of surface targeting molecules, Nanosmart proteins also offer scalable manufacturing. Nanosmart technology creates hollow protein nanoparticles 20 nmm² to 30 nmm² in size on the surface of which targeting agents are displayed in a highly reproducible manner to interact with tumor specific receptors and become internalized through receptor-mediated endocytosis. The proteins self degrade through natural pathways. Aura Biosciences is also applying its Nanosmart platform to solve delivery challenges associate with the clinical use of RNA interference (RNAi) by creating nanoparticles that are optimized to mediate specific and targeted cell entry, allowing small interfering RNA (siRNA) to be delivered in vivo. Nucleic acids are highly charged, they do not cross cell membranes by free diffusion, and their hydrophilic, anionic backbones further reduce their uptake by cells. Aura secured scientific collaborations to create and optimize its Nanosmart platform through agreements with both the German Cancer Research Center (Heidelberg, Germany) and Queen Mary´s University (London, UK). Aura Biosciences is applying its Nanosmart platform to create nanoparticles that are optimized to mediate specific and targeted cell entry, allowing small interfering RNA (siRNA) to be delivered in vivo.
In November 2010, Aura Biosciences was granted $244,000 under the Qualified Therapeutic Discovery Project (QTDP) program to support the further development of a topical self-administered treatment for cervical and anal dysplasia.