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Welcome to Venture Valuation’s VC Deal Summary This month saw a major low point in venture capital backed financing for private European biotech firms. The three rather small financing rounds this month in Europe mark a 12 month low in European financing. The poor showing by Europe brought the total venture capital investment down by over USD 100 M from last month. On the other hand, deals in Israel and Japan contributed to a seven month high in venture capital financing of USD 31 M in the Rest of the World as reported on Biotechgate. Also for the first time in the last 7 months the Rest of the World has surpassed Europe in financing. Meanwhile, across the pond, the US dropped from last month but still had a strong showing; 9 new VC financing deals of private biotech therapeutic companies worth USD 135 M. Read about Anaeropharma in Japan, Avraham in Israel and the USD 176 M in VC funding in this months VC deal summary. March 2012: 2012: Financial highlights of the life sciences industry Financing rounds C3 Jian Closes USD 30 M Financing C3 Jian, Inc. (Los Angeles, CA. USA), a private company focused on providing improved oral healthcare, announced that it has closed its most recent equity financing, raising total proceeds of USD 30 M. The Company expects to use the proceeds to advance its lead product, C16G2, a peptide drug targeting dental caries, into human clinical trials in the United States. The Company is planning to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration in April. Proceeds from the financing will also be used to support production development and scale-up, GMP manufacturing, as well as final development and clinical testing of a hand held diagnostic product related to C16G2. The Company will also continue to invest in its pipeline of new proprietary peptide product candidates based on its platform technology. C3 Jian is the worldwide exclusive licensee of patents covering a cell signaling platform technology from The Regents of the University of California. Dr. Wenyuan Shi, a professor at the University of California, Los Angeles School of Dentistry and C3 Jian's co-Founder, is one of the inventors of the technology. C3 Jian has used the platform to identify a variety of drug leads, including peptides that have the potential to re-mineralize teeth, in addition to promoting nail and hair growth. The Company maintains a significant portfolio of intellectual property with over 70 patents issued and pending worldwide. (Source: Yahoo Finance) 1 INCJ Determined on up to JPY 2.2 B FollowFollow- on Investment Innovation Network Corporation of Japan has determined on a follow-on investment of up to JPY 2.2 B in Anaeropharma. Innovation Network Corporation of Japan has made its initial investment of JPY 700 M in November 2010. (Source: Company website) Yissum, Pontifax, and Clal Biotechnology Industries Invest USD 9 M in Avraham Pharmaceuticals to Pursue a Ph IIb Clinical Trial of Ladostigil, a Novel Drug for Treatment of Alzheimer's Disease Yissum Research Development Company Ltd., the technology transfer arm of the Hebrew University of Jerusalem, announced that it has participated in a USD.9 M financing of Avraham Pharmaceuticals Ltd. (Jerusalem, Israel), together with Pontifax, Clal Biotechnology Industries, Professor Marta WeinstockRosin and others. Yissum has also announced that, together with the Technion Research and Development Foundation (TRDF), the technology transfer arm of the Technion Israel Institute of Technology, it will exclusively license to Avraham the commercial rights of Ladostigil, a novel cholinesterase, brain-selective monoamine oxidase inhibitor and neuroprotective agent for treatment of Alzheimer's disease and other neurodegenerative diseases. The drug has proven to be safe and well tolerated in Phase I/IIa clinical trials. As part of an advanced product development program, Avraham will use the newly invested capital to complete an additional 52-week Phase II proof-of-concept efficacy trial in patients with Alzheimer’s disease. (Source: Company website) ConforMIS Reaches Funding Milestone with USD 89 M in Series E Financing Surpassing all previous fundraising rounds, privately-held medical-device company ConforMIS, Inc. (Burlington, MA. USA) announced that it has raised USD 89 M in a Series E round of funding, with additional funds beyond this amount committed upon meeting certain milestones. The company, which more than doubled its revenues in 2011, will use the funds to support ongoing sales and marketing expansion, R&D investment into new product lines, and build out of manufacturing infrastructure. The investments originated from private-equity funds in the U.S., Europe, Asia and the Middle East. Principal investors in the round include AGC Equity Partners and Axel Johnson, Inc., along with Government Investment Funds from Asia and the UAE. Since its founding in 2004, ConforMIS, the fastest growing orthopedic implant company, has built and brought to market the only full line of patient-specific implants and instruments for the treatment of knee osteoarthritis , a USD 7 B global market. In 2010, the company launched their second generation personalized partial knee solutions, the iUni G2 and iDuo G2. In 2011, ConforMIS received 510(k) clearance from the United States Food and Drug Administration to market the iTotal CR Knee Replacement System , the first and only patient specific total knee implant on the market. (Source: Company website) 2 Tranzyme Pharma Secures Additional USD 9.3 M Debt Financing Tranzyme Pharma (Durham, NC. USA) announced that it received an additional net USD 9.3 M in term loan proceeds through an amendment and restatement of its existing debt financing facility with Oxford Finance LLC and Horizon Technology Finance Corporation. After using a portion of the new proceeds to pay off a portion of the Company’s existing debt, the Company has USD 20 M in outstanding debt. The terms of the amended notes provide that the Company will pay interest only through February 2013. (Source: Company website) Celladon Corporation Completes USD 43 M Financing to Advance MYDICAR for the Treatment of Heart Failure Celladon Corporation (La Jolla, CA. USA), a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that it has completed a USD 43 M equity financing to advance its lead investigational product candidate MYDICAR for the treatment of heart failure. The financing was led by new investor Pfizer Venture Investments and also included new investors Lundbeckfond Ventures, Novartis Venture Funds, H&Q Healthcare/Life Sciences Investors, and GBS Venture Partners. All previous investors participated in this round including Enterprise Partners Venture Capital, Johnson & Johnson Development Corporation, and Venrock Associates. In conjunction with this financing, Celladon has added a new slate of directors to its board including Barbara Dalton, Ph.D., of Pfizer Venture Investments (Chair), Johan Kördel, Ph.D., Assoc. Prof., of Lundbeckfond Ventures, Lauren Silverman, Ph.D., of Novartis Venture Funds, Daniel Omstead, Ph.D., of Hambrecht & Quist Capital Management, and Josh Funder, D.Phil., of GBS Venture Partners. In addition, Andrew Senyei, M.D., of Enterprise Partners Venture Capital will continue to serve as a director. Celladon Corporation plans to advance the clinical development of MYDICAR in 2012. MYDICAR was recently granted Fast Track Status by the Food and Drug Administration in December, 2011 (Source: Company website) Apollo Endosurgery Announces USD 47.6 M Financing Apollo Endosurgery, Inc. (Austin, TX. USA), a company focused on the development of devices that advance therapeutic endoscopy to enable an entirely new generation of minimally invasive, scarless surgical procedures, announced a USD 47.6 M financing. New investors Novo A/S, Remeditex Ventures, and CPMG, Inc. joined existing investors PTV Sciences and H.I.G. BioVentures in this latest round of financing for the Austin-based medical device company. Proceeds from this financing will be used to support the commercial launch of the second generation OverStitch Endoscopic Suturing System and other Apollo Endosurgery flexible surgical tools that allow surgeons and interventional endoscopists to perform numerous procedures without making incisions into the patient’s skin. As part of the financing, Jack Nielsen of Novo A/S, John Creecy of Remeditex and Kent McGaughy of CPMG will join the Apollo Endosurgery Board of Directors. 3 Apollo Endosurgery’s OverStitch platform combines the flexibility of endoscopy with the precision of surgical suturing, allowing physicians to access, manipulate and suture internal tissue without making incisions through the skin. The platform therefore allows physicians to develop less invasive options for the patient. Apollo also recently announced the FDA clearance of its SuMO platform designed to help surgeons remove large, flat precancerous gastrointestinal lesions and polyps. In general, this new class of flexible surgery procedures may allow patients to benefit from reduced risk of infections and associated complications, no visible scarring and faster recovery times compared to those who undergo more traditional laparoscopic and open procedures. With the assistance of the Apollo Group, a world renowned flexible endoscopy "think tank" and other top surgeons and gastroenterologists across the globe, these devices are being used to create less invasive approaches to surgery for obesity, early-stage gastrointestinal cancers, and numerous other GI conditions. (Source: Company website) A uxogyn Completes USD 20 M in Series A Funding Auxogyn, Inc. (Menlo Park, CA. USA), a privately-held company focused on advancing women’s reproductive health, announced the close of the final tranche of its Series A financing, bringing the total funding to USD 20 M. The initial tranche was placed in May 2010, and investors in the round include Kleiner Perkins Caufield and Byers, TPG Biotech and Merck Serono Ventures. (Source : Company website) Velomedix Closes New Financing, Strengthens Leadership Team Velomedix, Inc. (Menlo Park, CA. USA), a development stage medical device company advancing the clinical field of Therapeutic Hypothermia, announced the closing of USD 10.2 M in Series B financing and the appointment of medical device veteran Jeffrey Gold as the company’s Chief Executive Officer and Michael Moore as the Vice-President of Operations. Velomedix is accelerating the paradigm shift in the management of patients suffering from cardiac arrest and, potentially, those suffering from acute myocardial infarction (AMI or heart attack) and stroke. The company’s initial clinical trial, CAMARO, enrolled cardiac arrest patients at multiple sites in the European Union (EU). The clinical results demonstrated unprecedented positive neurologic outcomes in patients surviving cardiac arrest, as compared to clinical data published in peer-reviewed papers. Proceeds from the company’s recent financing will be used to initiate a post-CE Mark trial in support of EU commercialization and obtain U.S. Food and Drug Administration approval for a clinical study in the United States. Concurrent with the closing of its Series B financing, Velomedix’s Board of Directors appointed Mr. Gold as the company’s President & CEO on a permanent basis. Previously Mr. Gold was the Interim CEO of Velomedix and a Venture Partner of Longitude Capital. As Interim CEO, Mr. Gold played a critical role in strengthening Velomedix’s position in the emerging Therapeutic Hypothermia market. (Source: BusinessWire website) 4 Applied Proteomics Appoints Appoi nts Peter Klemm as CEO Following Series B Financing of USD 22.5 M Applied Proteomics Inc. (San Diego, CA. USA), powering the proteome to transform diagnostics, announced the appointment of veteran diagnostic developer, Peter Klemm, Ph.D., as chief executive officer. Applied Proteomics also announced the move of the corporate headquarters to San Diego. Prior to the move, Applied Proteomics secured a USD 22.5 M Series B financing from Domain Associates, Vulcan Capital and returning angel investors. In conjunction with the financing, James C. Blair, Ph.D. founding partner at Domain, joined the Company’s board of directors. The financing will support the creation of new diagnostics based on Applied Proteomics’ proprietary proteomic platform solution to significantly improve medical care and therapeutic development. Through technological innovation and novel approaches, Applied Proteomics has solved the proteomics problem by rapidly collecting, processing, and analyzing data and identifying actionable medical information. With unique mass spectrometry-- based systems control and computational expertise, Applied Proteomics’ proteomics platform solution can accurately, reproducibly, and efficiently take “snapshots” of a patient’s proteome and provide a physiological picture of the proteins actually expressed in the body. Because proteins perform most cellular functions and are the targets of most drugs and therapies, they are the most powerful source of information to know the health status of the patient. Applied Proteomics is advancing the application of proteomics to the development of diagnostics, companion diagnostics, and personalized medicine applications to power better medical decisions and care. (Source: Company website) Altheos raises Additional USD12.5 M to close Series A at USD 32.5 M Altheos, Inc. (San Francisco, CA. USA), announced the dosing of the first patient in a Phase IIa clinical trial of its lead investigational candidate, ATS907, a Rho kinase-selective inhibitor in development as a next-generation eye drop for the reduction of elevated intraocular pressure in primary open angle glaucoma and ocular hypertension. ATS907 is one of a series of ROCK inhibitor compounds licensed from Asahi Kasei Pharma. Altheos also announced the company raised an additional USD 12.5 M in its Series A financing, bringing the total to USD 32.5 M. The round, which will be tranched as the company reaches specified milestones, was provided by existing investors Bay City Capital, Novo A/S, Canaan Partners, and additional investors. The first-in-human study is a randomized, controlled, investigator masked, dose-ranging, safety and efficacy study in subjects with primary open angle glaucoma and/or ocular hypertension. The study uses a two-stage adaptive design and is intended to evaluate a number of different doses of ATS907 ophthalmic formulation and to provide preliminary information on safety, tolerability and efficacy (reduction in intraocular pressure) following 28 days of administration. Altheos expects to initiate the second stage of this trial, a comparison of ATS907 and latanoprost (a prostaglandin analogue), closely following completion of the first stage. The expanded Series A round will enable completion of a robust Phase II clinical program. (Source: Company website) 5 Innavirvax Lands USD 4.9 M in Series B Funding Round InnaVirVax (Evry, France), a biopharmaceutical company dedicated to the development of therapeutic and diagnostic solutions in pathologies associated with immune dysregulation, announced the closing of a USD 4.9 M Series B round of funding. This round has been led by Pradeyrol Développement and private equity funds Fa Dièse and FRCI (Fonds Régional de Co-Investissement d’Ile-de-France). Historical InnaVirVax’s investors CapDecisif 2 and G1J Ile-de-France also participated in the round. This funding allows the company to pursue its development, and especially to conduct the Phase I/IIa clinical trials of VAC-3S immunotherapy, which will be carried out in two clinical centers of the Assistance Publique – Hôpitaux de Paris, namely the Pitié Salpêtrière and Cochin Hospitals. Moreover, InnaVirVax will also be able to develop other research projects relying on the same scientific background such as the comprehension of immune dysregulations during severe pathologies. (Source: Company website) Cayenne Medical Closes USD 10 M Capital Raise Cayenne Medical, Inc. (Scottsdale, AZ. USA), a private sports medicine device company, announced the closing of a USD 10 M equity financing, with new investor Fletcher Spaght Ventures joining existing investors Split Rock Partners, MB Venture Partners and Investor Growth Capital. The proceeds will be used to enhance the company’s sales and distribution and to support expansion of its portfolio of sports medicine orthopedic solutions. Cayenne Medical currently markets products that address previously unmet clinical needs in knee ligament reconstruction and meniscal repair, including the AperFix II System, the CrossFix II System and the iFix System. This month the company is also launching the Quattro Shoulder System for rotator cuff and labral repairs. (Source: Fierce Medical Devices website) Mnemosyne Pharmaceuticals Inc. Completes USD 5.4 M Series A Round to Support Drug Discovery Programs Mnemosyne Pharmaceuticals, Inc. Providence, RI. USA), an emerging biotechnology company focused on the discovery and development of small molecule drugs to treat neuropsychiatric disorders, has secured USD 5.4 M in a Series A financing. The round was led by Access BridgeGap Ventures and also included existing investor Slater Technology Fund. Proceeds from the financing will support the company’s drug discovery programs, and the identification of lead product candidates for treatment of schizophrenia and other neuropsychiatric disorders. Mnemosyne was founded in 2010 and previously raised seed funding from Slater Technology Fund and private investors. The company’s founding scientists have extensive experience in N-Methyl-DAspartate (NMDA) receptor pharmacology and drug discovery for neuropsychiatric disorders. Mnemosyne is developing a new class of molecules, Subunit Selective NMDA Receptor Modulators (SNRMs) for the neuropsychiatry market. The NMDA receptor is widely recognized as the master switch for learning and memory, and a large body of preclinical and clinical research supports targeting this receptor to treat a broad range of neuropsychiatric diseases and cognitive dysfunction. Learning and memory disorders represent a major unmet medical need in neuropsychiatry. Together, these disorders encompass a significant 6 portion of the broader USD 80 B mental health market. There is strong evidence indicating that a principal underlying cause of schizophrenia is defective NMDA receptor function. Mnemosyne believes that by potentiating a specific NMDA subunit, the company’s SNRM product candidates will provide therapeutic benefit for cognition, and also impact the positive and negative symptoms of schizophrenia. (Source: Company website) BARDA Awards Contract Worth up to USD 67 M for the Development of a Novel Tetraphase Antibiotic Tetraphase Pharmaceuticals, Inc. (Watertown, MA. USA), a clinical-stage life science company developing a portfolio of potent new antibiotics designed to be effective against dangerous, drugresistant bacteria, including multidrug-resistant (MDR) gram-negative pathogens, announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract worth up to USD 67 M for the development of TP-434, a potent new antibiotic effective against multidrugresistant gram-negative pathogens and the lead product candidate in Tetraphase’s clinical pipeline. Tetraphase will be working on this contract with Buffalo, NY-based CUBRC, Inc. The BARDA contract includes pre-clinical efficacy and toxicology studies; clinical studies; manufacturing activities; and associated regulatory activities to position the broad-spectrum antibiotic TP-434 as a potential empiric countermeasure for the treatment of inhalational disease caused by Bacillus anthracis, Francisella tularensis and Yersinia pestis. In parallel, TP-434 is being developed as a potential therapeutic agent for serious hospital infections, including those caused by multidrugresistant aerobic and/or anaerobic gram-negative and gram-positive pathogens. The contract includes a 12-month base period with committed funding of USD 11.5 M and subsequent option periods that, if completed, would bring the total value of the award to approximately USD 67 M. (Source: Tetraphase Pharmaceuticals’ Company website) Diabetes Drug Company Lumena Raising up to USD 2 M to Reach Clinical Trials Diabetes drug development company Lumena Pharmaceuticals aims to harness a benefit that diabetics receive from gastric bypass surgery and deliver it to those patients in the form of a pill. Lumena Pharmaceuticals (Durham, NC. USA), plans to start clinical trials on its experimental drug this year. To get there, Lumena has raised USD 500,000 in a round that could go up to USD 2 M with funding so far coming largely from Durham venture capital firm Pappas Ventures. That something else is the diversion of bile. While bile is a means for the body to process fats, it also acts as a signaling agent. In normal gastrointestinal function, most of the bile is recirculated. But gastric bypass surgery also bypasses that mechanism, Grey said. The bile in the GI tract triggers receptors that release glucagon-like peptide 1, or GLP-1, a hormone that helps regulate blood sugar. Lumena was founded in January. The technology, however, comes from a scientist who used to work at Amylin Pharmaceuticals), a San Diego, California biotechnology company that develops diabetes and obesity treatments. The scientist’s discovery came after he left the company and Grey said that Amylin has no claims on its technology. But one of the Lumena’s board members is Ted Greene, founder and former CEO of Amylin. (Source: Medcitynews website) 7 Satori Pharmaceuticals Raises USD 15 M in New Funding Satori Pharmaceuticals (Cambridge, MA. USA), a developer of life changing therapeutics for Alzheimer’s disease (AD), announced that it has raised an additional USD 15 M in financing. Current investors InterWest Partners, New Enterprise Associates Inc. (NEA) and Prospect Venture Partners co-led the round. Prior to this round, Satori had raised a total of USD 25 M in financing which has allowed the Company to select a group of lead compounds poised for clinical development. Today, the Company also announced that Donald Hayden was elected as Chairman of the Board of Directors and that Dr. David Schnell, of Prospect Ventures and Stephen Muniz of PureTech Ventures were appointed as new members of Satori’s Board. (Source: company website) 8 Mergers & acquisitions Alexion Completes Acquisition of Enobia Pharma Corp. Alexion Pharmaceuticals, Inc. (Cheshire, CT. USA) announced that the Company has completed its previously announced acquisition of 100% of the capital stock of Enobia Pharma Corp., a private biopharmaceutical company focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders. Goldman, Sachs & Co. acted as financial advisor to Alexion. Ropes and Gray LLP acted as lead legal counsel to Alexion and Cassels Brock & Blackwell LLP acted as Canadian legal counsel to Alexion. (Source: Alexion’s Company website) Biogen Idec To Acquire Stromedix Biogen Idec (Weston, MA. USA), and Stromedix, Inc. (Cambridge, MA. USA), announced that they have entered into a definitive agreement under which Biogen Idec will acquire Stromedix Inc., a privately held biotechnology company focused on innovative therapies for fibrosis and organ failure. Under the terms of the agreement, Biogen Idec will make an upfront cash payment of USD 75 M and additional contingent value payments of up to USD 487.5 M based on the achievement of certain development and approval milestones across multiple indications. Stromedix’s lead candidate, STX-100, is a novel humanized monoclonal antibody that selectively disrupts the TGF-beta pathway, which plays a central role in fibrotic disease. STX-100 exhibited significant anti-fibrotic activity in preclinical animal models of fibrotic disease and demonstrated an attractive safety and tolerability profile in a Phase I trial. Stromedix has also identified a series of clinical biomarkers that reflects the biological activity of STX-100. STX-100 is entering a Phase II trial in patients with idiopathic pulmonary fibrosis (IPF), a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung. More than 200,000 patients in the United States and Europe have IPF, and there is no FDA-approved treatment for the disease at this time. STX-100 has potential in several additional fibrotic indications given its selective mechanism of action. In addition to STX-100, Stromedix has a preclinical compound that may have utility for the treatment of injury due to inflammation. (Source: Biogen Idec’s Company website) 9 Deals Avanir Pharmaceuticals Pharmac euticals And Concert Pharmaceuticals Announce License Agreement To Develop And Commercialize DeuteriumDeuterium-Modified Dextromethorphan For Disorders Of The Nervous System Avanir Pharmaceuticals, Inc. (Aliso Viejo, CA. USA) and Concert Pharmaceuticals, Inc. (Lexington, MA. USA) announced that they have entered into an exclusive license agreement that provides Avanir worldwide rights to develop and commercialize Concert’s deuterium-modified dextromethorphan (dDM) for the potential treatment of neurological and psychiatric disorders. The agreement includes the rights to multiple deuterium-modified dextromethorphan compounds. Under the terms of the agreement, Concert will receive an upfront payment and is eligible to receive additional milestone payments upon achievement of certain predefined clinical, regulatory and commercial targets as well as tiered royalties on worldwide sales of products containing d-DM. Avanir will have overall responsibility for research, development and commercialization of d-DM. Concert will provide manufacturing support for investigational new drug enabling studies. (Source: Concert’s Company website) Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. enter a collaboration agreement for XIAFLEX in Canada, Australia, Brazil and Mexico Auxilium Pharmaceuticals, Inc. (Malvern, PA. USA) and Actelion Ltd. (Allschwil/Basel, Switzerland) announced that they have entered into a long-term partnership for the development, supply and commercialization of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren’s contracture and Peyronie’s disease. Under the terms of the agreement, Actelion will receive exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in these countries. XIAFLEX has been approved by the U.S. Food and Drug Administration and the European Medicines Agency as a treatment for Dupuytren’s contracture, and is also in development in Japan. In addition, XIAFLEX has been accepted for review by Health Canada for the treatment of Dupuytren’s contracture in Canada and regulatory action is expected in the second half of 2012. Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren’s contracture in Australia, Brazil and Mexico over the next 12 months. XIAFLEX is also being evaluated in a global Phase III development program for Peyronie’s disease with top-line data expected in late second quarter 2012. Under the terms of the agreement, Actelion will pay Auxilium USD 10 M upfront and will also make up to USD 16 M in potential regulatory, pricing and reimbursement milestone payments and USD 42.5 M in potential sales milestone payments. Auxilium will also receive increasing tiered double-digit royalties based on sales of XIAFLEX in Actelion’ territories and will supply product to Actelion at a predetermined cost. Auxilium will remain primarily responsible for the global development of XIAFLEX in Peyronie’s disease and will be responsible for all clinical and commercial drug manufacturing and supply. Actelion will be 10 responsible for clinical development activities and associated costs corresponding to any additional trials required for specific territories. (Source: Actelion’s Company website) Shire and Sangamo Collaborate to Develop Therapeutics for the Treatment of Hemophilia and Other Monogenic Diseases Shire plc (Dublin, Ireland), the global specialty biopharmaceutical company, and Sangamo BioSciences, Inc. (Richmond, CA. USA), a leader in genome-editing technology, announced that they have entered into a collaboration and license agreement to develop therapeutics for hemophilia and other monogenic diseases based on Sangamo’s zinc finger DNA-binding protein (ZFP) technology. Shire will receive exclusive world-wide rights to ZFP Therapeutics designed to target four genes (for blood clotting Factors VII, VIII, IX and X) which will be used to investigate curative therapies for hemophilia A and B. Shire also receives the right to designate three additional gene targets. Sangamo is responsible for all activities through submission of Investigational New Drug (IND) Applications and European Clinical Trial Applications (CTA) for each product and Shire will reimburse Sangamo for its internal and external research program-related costs. Shire is responsible for clinical development and commercialization of products arising from the alliance. Shire will pay Sangamo USD 13 M upfront followed by research, regulatory, development and commercial milestone payments, and royalties on product sales. Sangamo’s ZFP Therapeutic approach utilizes its proprietary ZFP nuclease (ZFN) and ZFP transcription factor (ZFP TF) technology. ZFPs can be engineered to recognize any specific DNA sequence within a gene, and may be applicable to certain Shire therapeutic areas, including hematology and lysosomal storage disorders. (Source: Shire’s Company website) Merck and Threshold Announce Global Agreement to CoCo- Develop and Commercialize Phase III HypoxiaHypoxia-Targeted Drug THTH - 302 Merck KGaA (Darmstadt, Germany) announced that a global agreement was signed with Threshold Pharmaceuticals, Inc., (San Francisco, CA. USA) to co-develop and commercialize TH-302, Threshold’s small molecule hypoxia-targeted drug. TH-302 is currently being investigated in a global Phase III clinical trial in patients with soft tissue sarcoma, a randomized Phase II trial in patients with advanced pancreatic cancer from which top-line results are expected in February, as well as additional clinical studies in other solid tumors and hematological malignancies. Under the terms of the agreement, Merck will receive co-development rights, exclusive global commercialization rights and will provide Threshold an option to co-commercialize the therapeutic in the United States. In exchange, Threshold will receive an upfront payment of EUR 19 M and could receive up to EUR 26.5 M in additional development milestones during 2012. Threshold is also eligible to receive a EUR 15 M milestone payment based on positive results from its randomized Phase II trial in pancreatic cancer. In the United States, Threshold will have primary responsibility for development of TH-302 in the soft tissue sarcoma indication. Threshold and Merck will jointly develop TH-302 in all other cancer indications being pursued. Merck will pay 70% of worldwide development costs for TH-302. Subject to 11 FDA approval in the United States, Merck will initially be responsible for commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales. Under the royalty-bearing portion of the agreement, Threshold retains the option to co-promote TH-302 in the United States. Additionally, Threshold retains the option to co-commercialize TH-302 allowing the company to participate in up to 50% of the profits in the United States, based on certain revenue tiers. Outside of the United States, Merck will be solely responsible for the commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales in these territories. TH-302 is a hypoxia-targeted drug that is thought to be activated under tumor hypoxic conditions, a hallmark for many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic. (Source: Merck’s Company website) Enanta Enters Into Strategic Collaboration to Advance Ns5a Inhibitor Candidate For HCV Enanta Pharmaceuticals, Inc. (Watertown, MA. USA), a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced that it has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. Enanta has received IND approval for EDP-239 from the FDA. NS5A, a clinically validated target, is a non-structural viral protein that is essential to viral replication. Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development. Enanta’s NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts. EDP-239, Enanta’s lead candidate targeting NS5A was most recently recognized on Windhover’s list of the “Top Most Interesting Infectious Disease Projects to Watch”. Under the terms of the agreement, Enanta will receive an upfront payment of USD 34 M and is eligible to receive up to USD 406 Million if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains co-detail rights in the United States. Novartis will be responsible for all costs associated with the development, manufacture and commercialization of EDP-239 and will fund Enanta’s drug discovery efforts on certain additional compounds targeting NS5A. (Source: Enanta’s website) 12 February 2012 Financing rounds Summary from Biotechgate Company name Sector Anaeropharma Science, Inc. eSight Corporation Biotechnology - Therapeutics and Diagnostics Medical Technology 27.7 Type of Round Series B 2.0 Series A Celldex Therapeutics Ltd. YM BioSciences Inc. 40.4 On-Q-Ity Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology / R&D Services Amyris, Inc. Biotechnology - other 83.7 Receptos Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - other 10.8 30.0 Pharmalink AB C3 Jian, Inc. Satori Pharmaceuticals Inc. Collegium Pharmaceutical, Inc. BioAmber Inc. Vascular Magnetics, Inc. Integrated Diagnostics Ceres, Inc. ADOCIA Alexza Pharmaceuticals, Inc. OpGen, Inc. Tetraphase Pharmaceuticals BioLineRx Mnemosyne Pharmaceuticals, Inc. Apnex Medical, Inc. Atossa Genetics, Inc. Avaxia Biologics, Inc. Amount Ownership Country Private / independent Private / independent Public Japan Other Financing stage Equity First stage Equity Start-up Post-IPO 80.5 Other Post-IPO Public Canada 5.3 Series C Series B Private / independent Private / independent Public Sweden 5.0 Equity Later stage nd Equity – 2 stage n/a Series B n/a USA Equity financing n/a Equity First stage Equity First stage nd Equity – 2 stage st Equity – 1 stage st Equity – 1 stage IPO IPO Private / independent Private / independent Private / independent Private / independent Private / independent Private / independent Private / independent Public Public Post-IPO Public USA Equity Later stage n/a USA Post-IPO Private / independent Private / independent Public Equity Start-up Equity Later stage IPO Equity Start-up Private / independent Private / independent Public Private / independent USA 15.5 22.5 Series B 30.0 Series C Medical Technology 7.0 Series A Biotechnology / R&D Services 30.0 Series A Biotechnology - other Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology / R&D Services 65.0 33.5 Other Other 3.5 Series C Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Medical Technology 11.5 15.0 development contract Other 5.4 Series A 20.0 Series C Medical Technology Biotechnology - Therapeutics and Diagnostics 6.0 4.1 Other Series A 22.0 Canada USA USA USA USA USA USA USA USA USA USA France USA Israel USA USA USA 13 Cayenne Medical, Inc. Medical Technology 10.0 Other DFine, Inc. Medical Technology 25.0 Series E InnaVirVax SA Biotechnology - Therapeutics and Diagnostics Biotechnology / R&D Services 4.9 Series B 8.0 Series B Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Medical Technology 60.5 Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Medical Technology Courtagen Life Sciences, Inc. Exelixis Inc. Altheos, Inc. Ironwood Pharmaceuticals, Inc. Cempra Pharmaceuticals Velomedix, Inc. MannKind Corporation Applied Proteomics, Inc. Radius Health Avraham Pharmaceuticals Ardea Biosciences Apollo Endosurgery, Inc. Transgenomic, Inc. USA Private / independent Public USA USA France USA USA Series A 79.2 Other Equity – 2 stage Post-IPO 47.7 Other IPO Public USA 10.2 Series B n/a USA 86.3 Post-IPO 22.5 Follow-on financing Series B Private / independent Public USA 86.2 Other IPO Private / independent Public 3.0 Series B Equity First stage IPO Private / independent Public Israel n/a USA Post-IPO Private / independent Public Equity Start-up Equity Start-up nd Equity – 2 stage Post-IPO Private / independent Private / independent Private / independent Public USA Equity Start-up Debt financing Equity First stage n/a Private / independent Public USA Private / independent Private / independent Norway 166.2 Other 47.6 22.0 Auxogyn, Inc. Biotechnology / R&D Services 20.0 Private Placement Series A Insero Health Biotechnology - other 1.1 Series A Nuclea Biotechnologies Inc. Response Genetics, Inc. Stemgent Biotechnology / R&D Services 9.8 Series B Biotechnology / R&D Services 7.8 Biotechnology / R&D Services 6.3 Other Tranzyme Pharma Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics Biotechnology - Therapeutics and Diagnostics 9.3 Debt Financing Series A Lumena Pharmaceuticals nd Private / independent Private / independent Private / independent Private / independent Public 12.5 Biotechnology / R&D Services Targovax AS Equity First stage Equity Later stage Equity First stage Equity First stage Post-IPO 0.4 0.5 n/a USA USA USA USA USA USA USA USA USA USA 14 Therapeutic BIoTech Financing – Last 13 Months1 Financing Worldwide (in USD millions) Biotechnology - Therapeutics and Diagnostics Private/independent Companies Year 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2012 2012 Month Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Totals US Europe Rest of World 208 123 61 24 160 114 46 0 567 418 136 13 415 284 126 5 479 396 40 43 512 416 35 61 266 221 26 19 385 201 156 28 441 386 55 0 660 503 154 3 220 168 41 11 280 174 95 11 176 135 11 31 Grand Total 4770 3538 982 250 Source Biotechgate 15 Biotech Financing Biotech Therapeutic Financing Rounds 25 700 600 500 15 400 300 10 200 5 100 0 Feb 11 Mar 11 Apr 11 May 11 Jun 11 Jul 11 Aug 11 Sep 11 Oct 11 Nov 11 Dec 11 Jan 12 Feb 12 Deal Value EU 61 46 136 126 40 35 26 156 55 154 41 95 11 Deal Value US 123 114 418 284 396 416 221 201 386 503 168 174 135 Total Deals US 7 10 12 12 14 18 15 11 13 21 15 9 9 Total Deals EU 5 7 5 9 6 5 4 10 9 6 2 8 3 0 Copyright © 2012 Venture Valuation VV Ltd. All rights reserved. This report is provided for information purposes only. All information regarding financing rounds, deal summaries and merger and acquisition transactions was obtained from company websites or industry newsletters including Fiercebiotech, OnBioVC, and SECA. The above information can also be accessed on the Biotechgate website. All graphical information was provided via Biotechgate. While the information contained herein has been obtained from sources deemed reliable, Venture Valuation VV Ltd makes no guarantees that it is accurate, complete, timely, or sequential. For more information about Biotech companies, including deal, licensing and financing round details, please visit the Biotechgate website at www.biotechgate.com 16 Total Value in Million USD Number of Financing Rounds 20