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Jan 26
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Amgen to Acquire Micromet

By Micromet, Press Release
Press Release.

 

Acquisition Includes a Novel Cancer Treatment in Clinical Trials for Hematologic Malignancies

Micromet’s Proprietary BiTE® Platform has Potential to Improve Treatment in Multiple Tumor Types

All-Cash Transaction Values Micromet at $1.16 Billion

THOUSAND OAKS, Calif., and ROCKVILLE, Md., Jan. 26, 2012 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Micromet, Inc. (NASDAQ:MITI) today announced that the companies have entered into a definitive merger agreement under which Amgen will acquire Micromet, a biotechnology company founded in Germany with its research and development (R&D) center in Munich and headquarters in Rockville, Md., for $11 per share in cash. The transaction, which values Micromet at approximately $1.16 billion, was unanimously approved by both the Amgen and Micromet Boards of Directors.

The acquisition includes blinatumomab, a Bispecific T cell Engager (BiTE) antibody in Phase 2 clinical development for acute lymphoblastic leukemia (ALL). Blinatumomab is also in clinical development for the treatment of non-Hodgkin’s lymphoma (NHL), and could have applications in other hematologic malignancies.

“The acquisition of Micromet is an opportunity to acquire an innovative oncology asset with global rights and a validated technology platform with broad potential clinical applications,”

said Kevin Sharer, chairman and CEO at Amgen.

“Blinatumomab will serve as an important complement to our oncology pipeline and is representative of our corporate strategy, which is focused on developing and successfully commercializing therapeutics to treat patients with grievous illness.”

Amgen will gain the following as a result of the acquisition:

■Blinatumomab, a BiTE antibody that has demonstrated encouraging single-agent activity in both adult and pediatric patients with ALL as well as adult patients with NHL, and is currently under investigation in five trials:
■Two Phase 2 trials for adult patients with relapsed/refractory ALL
■Phase 1/2 trial for pediatric patients with relapsed/refractory ALL
■Phase 2 trial for adult ALL patients with minimal residual disease (MRD)
■Phase 1 trial for adult patients with relapsed/refractory NHL
■Proprietary BiTE antibody technology which provides an innovative, validated platform for future clinical research
■Potential milestone and royalty payments from existing licensees of BiTE and other technologies
■Unencumbered rights to solitomab, a BiTE antibody in Phase 1 for patients with advanced solid tumors
■Micromet’s Munich site, which will operate as an Amgen R&D center of excellence
“We believe that this transaction represents an attractive opportunity for Micromet, its stockholders and cancer patients,” said Christian Itin, Ph.D., Micromet’s president and CEO. “Amgen’s extensive resources and experience in the development and commercialization of biologics promise to speed blinatumomab’s path to market, expand its development across a broader range of B-cell malignancies and maximize the full potential of our novel BiTE technology.”

Terms of the Transaction

Under the terms of the merger agreement, a subsidiary of Amgen Inc. will commence a tender offer to acquire all of the outstanding shares of Micromet’s common stock at a price of $11 per share in cash. Following the purchase of shares through the tender offer, Amgen will complete the transaction by acquiring all remaining shares not acquired in the offer through a merger at the same price as the tender offer. The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Micromet shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act and other customary conditions. The tender offer is not subject to a financing condition. The transaction is expected to close in the first quarter.

Amgen is advised by Moelis & Company LLC and Sullivan & Cromwell LLP. Goldman, Sachs & Co. and Cooley LLP are acting as financial and legal advisors, respectively, to Micromet.

Amgen will discuss the transaction as part of its fourth quarter earnings conference call today with the investment community at 2:00 p.m. Pacific Standard Time.  The previously scheduled conference call will primarily address Amgen’s fourth quarter and full year financial results.  Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. The conference call, including the question and answer session, is expected to last approximately one hour.

The webcast of the conference call, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.

About Micromet, Inc.
Micromet is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Micromet is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. Micromet’s lead product candidate blinatumomab is currently the subject of a European trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and Sanofi.

About Blinatumomab

Blinatumomab is a Bispecific T cell Engager (BiTE antibody) designed to direct a patient’s cytotoxic T cells to eliminate cancer cells that express CD19. CD19 is a protein expressed on the surface of B-lymphocytes including acute lymphoblastic leukemias and non-Hodgkin’s lymphomas.  Data on blinatumomab demonstrating a high complete remission rate in adult patients with relapsed/refractory B-precursor ALL was recently reported at the American Society of Hematology (ASH) Annual Meeting, held in December 2011.

About BiTE Technology

BiTE antibodies are designed to direct the body’s cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately killing the tumor cells.

Amgen Forward-Looking Statement

This news release contains forward-looking statements that are based on Amgen’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described.  All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about the planned completion of the tender offer and the merger, estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results.  Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.  Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business.  Unless otherwise noted, Amgen is providing this information as of Jan. 26, 2012 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects.  Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.  Further, preclinical results do not guarantee safe and effective performance of product candidates in humans.  The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models.  The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.  Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market.  Amgen’s business may be impacted by government investigations, litigation and products liability claims.  Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement.  Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products.  In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products.  Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products.  In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for its products or product candidates.  Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products.  Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates.  Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations.

The scientific information discussed in this news release related to product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.  Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated.  Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

Additional Information

The tender offer described in this communication (the “Offer”) has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Micromet, Inc. (“Micromet”) or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (“SEC”). The offer to purchase shares of Micromet common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Armstrong Acquisition Corp., a wholly owned subsidiary of Amgen formed for the purpose of making the Offer, and Amgen, and the solicitation/recommendation statement will be filed with the SEC by Micromet.  Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to Georgeson Inc., the information agent for the Offer, at (888) 877-5360 (toll free).

Micromet Safe Harbor Statement

Statements in this announcement that relate to future results and events are forward-looking statements based on Micromet’s current expectations regarding the tender offer and transactions contemplated by the merger agreement. Actual results and events in future periods may differ materially from those expressed or implied by these forward-looking statements because of a number of risks, uncertainties and other factors. There can be no assurances that a transaction will be consummated. Other risks, uncertainties and assumptions include the possibility that expected benefits may not materialize as expected; that the transaction may not be timely completed, if at all; that, prior to the completion of the transaction, if at all, Micromet may not satisfy one or more closing conditions; that the merger agreement may be terminated; and the impact of the current economic environment; risks related to Micromet’s ongoing development activities and clinical trials; and other risks that are described in Micromet’s most recent Form 10-Q for the quarter ended Sept. 30, 2011. Micromet undertakes no obligation to update these forward-looking statements except to the extent otherwise required by law.

Contacts
Amgen, Thousand Oaks
Mary Klem, 805-447-6979 (media)
Arvind Sood, 805-447-1060 (investors)

Micromet
Jennifer Neiman, 240-235-0246 (media and investors)
Andrew Cole/Lesley Bogdanow
Sard Verbinnen & Co.
212-687-8080

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

(Logo: http://photos.prnewswire.com/prnh/20120124/LA41366LOGO)

SOURCE Amgen

Jan 25
Love0

CN Creative Raises Series A Funding to Develop First Medically Approved Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

By CN Creative, Press Release
Press Release.

 

—Financing Led by Advent Life Sciences—

—Intends to File for UK MHRA Approval of Its Nicadex™ Inhaler Nicotine Replacement Therapy in 2012 with Regulatory Filings in the US and Globally Thereafter—

—CNC Combining Its Broad Expertise in Smoking Cessation and Electronic Cigarette Technology to Offer Smokers New Medical Options to Reduce Harm and Help Them Quit—

MANCHESTER, UK, January 25, 2012 – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today announced it has raised a Series A financing round led by Advent Life Sciences.  The financing raised £2 million, equivalent to approximately US $3.1 million.  CNC intends to use the investment to continue and finalise development of its Nicadex™ electronic inhaler nicotine replacement therapy (NRT) product for use as part of medically supervised smoking cessation programmes.

Despite large-scale public health efforts, about 20% of adults in the UK and the US continue to smoke.  Smoking remains the most common cause of preventable death in the Western world and generates enormous costs for healthcare systems worldwide.  Two-thirds of smokers report that they would like to quit, and about three-quarters of current smokers say they have tried to stop, but smoking is a powerfully addictive habit that can make quitting very difficult or almost impossible.  Fewer than 10% of smokers are estimated to achieve success when trying to stop smoking on their own.  In addition, studies show that currently available NRT products help only a small proportion of smokers to stop smoking permanently.

“CN Creative provides innovative approaches to reduce the harm caused by smoking, by helping smokers quit whenever possible or reduce their consumption of cigarettes when total abstinence is not achievable,”

said David Newns, a co-founder and Company Director of CN Creative.

“We believe our Nicadex electronic inhaler NRT, which will deliver pharmaceutical-grade nicotine using advanced electronic vaporisation technology, has the potential to help significant numbers of smokers stop entirely or significantly reduce their exposure to harmful tobacco smoke.”

Nicadex is similar in concept to the electronic cigarettes currently marketed to adult consumers by CN Creative and others, but with several key differences.

First, Nicadex will be tested in clinical trials and then submitted for regulatory review under the process used for other prescription NRT products, initially through the UK Medicines and Healthcare products Regulatory Agency (MHRA) and then through the US Food and Drug Administration (FDA) and other regulatory agencies.

Second, CNC intends to market the Nicadex electronic inhaler as a medically supervised NRT designed to reduce the harm caused by smoking and to help smokers quit as part of a comprehensive smoking cessation programme.

Third, the Nicadex electronic inhaler has been specially engineered and will be manufactured in the UK under the same stringent standards used for regulated medical products, and the pharmaceutical-grade nicotine solution it uses is being produced by CNC in its own UK-based cGMP facilities approved for the manufacture of prescription drugs.

“The support from our colleagues at Advent Life Sciences will enable CNC to undertake the clinical trials and medical regulatory review needed to confirm the safety and efficacy of Nicadex and to prepare for commercialisation.  We expect to file for regulatory approval of the Nicadex electronic inhaler in the UK later this year,”

added CN Creative co-founder and Company Director Chris Lord.

Nicadex is a hand-held device that delivers purified nicotine to the user through the vaporisation of a pharmaceutical-grade solution of nicotine.  A rechargeable lithium battery powers the vaporiser that instantly turns the nicotine solution into a vapour that is inhaled by the user.  Many users report that the sensation of using the Nicadex device is similar to smoking, but the vapour contains no smoke and none of the carbon monoxide, tar or thousands of toxic impurities that make smoking tobacco products so damaging to health.  In addition, since there is no smoke, there are no smoke by-products that can cause “second-hand” harm to others.

“Decades of smoking cessation initiatives have had a positive impact on public health but millions continue to smoke and new approaches are urgently needed,”

noted long-time smoking cessation and public health advocate Dr. Chris Steele.

“I am encouraged by the potential of the innovative Nicadex electronic inhaler being developed by CNC, which provides a smoke-free, tobacco-free nicotine replacement product in a format that is highly acceptable to smokers.  If approved, Nicadex could be a valuable addition to our smoking cessation toolkit, immediately reducing the harm caused by smoking and enabling many smokers to proceed over time to full cessation.  CNC’s emphasis on clinical testing, regulatory review, medical supervision and supportive services is encouraging, and I look forward to seeing the results of the clinical trials the company will be conducting this year.”

A distinctive element of CNC’s strategy is its recognition of the value of harm reduction.  As noted in the influential 2010 UK government report, A Smokefree Future,

“The tar and the carbon monoxide in smoked tobacco are the primary causes of smoking-related disease and death. …  Nicotine (in the doses obtained from smoked and smokeless tobacco) is not a significant contributor to disease.”

The report proposes that harm reduction measures should be an important element of smoking cessation programmes, noting that

“this strategy … opens more routes to quitting, which, we believe, will help thousands more smokers to quit successfully.  The new routes will encourage smokers to … manage their nicotine addiction using a safer alternative product … and dramatically reduce the harmful effects to their health, and the harmful effects to those around them. …”

Similarly, after a comprehensive review of the medical and scientific literature, the American Association of Public Health Physicians (AAPHP) became the first medical organisation in the US officially to endorse tobacco harm reduction as a viable strategy to reduce the death toll related to cigarette smoking.  It advocates in its white paper, The Case for Harm Reduction, that inveterate smokers – who are unable or unwilling to abstain from nicotine and tobacco – should be encouraged to switch to lower-risk smokeless tobacco products.

Dale R. Pfost, PhD, a General Partner at Advent Life Sciences and the newly appointed Chairman of CN Creative commented, “CNC’s strategy of applying their smoking cessation expertise and the technology innovations first deployed in their Intellicig® electronic cigarettes to provide smokers with an advanced electronic inhaler nicotine replacement therapy is a potential game changer.  We believe that Nicadex will significantly increase smokers’ chances of ending or reducing their reliance on smoking, while also reducing the well-documented health risks caused by smoking tobacco.  With this investment in CN Creative, we aim to continue our track record of investing in innovative life science companies with the potential to become best-in-class in their fields.”

Kaasim Mahmood, a Partner at Advent Life Sciences who is joining the CN Creative Board of Directors, added,

“We believe CNC’s products have great clinical and commercial potential, and we are delighted to provide the CNC team with financial and strategic support as they embark on the clinical studies and regulatory review process central to the success of this exciting new approach.”

About CN Creative
Headquartered in the Bioscience Incubator at Manchester University in the UK, CN Creative provides innovative and sustainable solutions to global problems arising from smoking and smoking-related illnesses.  It has developed a distinctive portfolio of products and services focused on smoking cessation and harm reduction, including user-friendly nicotine delivery systems and patient-focused smoking cessation and support services.  CNC’s diverse products include QuitDirect, an NHS-accredited supplier of comprehensive smoking cessation services, the Intellicig® electronic cigarette, ECOpure proprietary high purity nicotine preparations and NRT Direct, which provides traditional nicotine replacement therapy products and patient support services to publicly and privately sponsored smoking cessation programmes.  CNC’s Nicadex™ electronic inhaler nicotine replacement therapy product is in clinical development for use as part of medically supervised smoking cessation programmes.  For more information, visit www.cncbio.co.uk.

About Advent Life Sciences
Advent Life Sciences is the dedicated Life Sciences Fund at Advent Venture Partners, one of Europe’s best-established growth and venture capital firms.  Advent Life Sciences invests predominantly in early-stage and growth equity life sciences companies in the UK, Europe and the US.  It will back companies that have a first- or best-in-class approach in a range of sectors within the life sciences, including new drug discovery, enabling technologies, med-tech and diagnostics.

The Advent Life Sciences team is a leader in European life sciences capital.  Its investments include  PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases acquired by Johnson & Johnson; EUSA Pharma, a rapidly growing transatlantic specialty pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (OSE: ALGETA), an oncology company developing treatments for bone metastases and disseminated tumours.  For more information see www.adventventures.com.

For more information, please contact:

CN Creative
Media
Barbara Lindheim or Jennifer Anderson, BioCom Partners:
blindheim@biocompartners.com, +1 212 584-2276 ext. 201
janderson@biocompartners.com, +1 212 584-2276 ext. 202
Corporate
David Newns
david.newns@cncbio.com +44 (0) 7834 767 367

Advent Life Sciences
Sophie Kreifman, Grayling:
sophie.kreifman@grayling.com; +44 20 7592 7924

Jan 20
Love0

Avila Announces FDA Allowance of Partner Clovis Oncology’s IND Application

By Avila, Press Release
Press Release.

 

Avila Announces FDA Allowance of Partner Clovis Oncology’s IND Application for CO-1686,
an Oral EGFR Mutant-Selective Inhibitor

Triggers $4 Million Milestone Payment to Avila

BEDFORD, Mass.–(BUSINESS WIRE)– Avila Therapeutics™, Inc. a biotechnology company
developing targeted covalent drugs that treat diseases through protein silencing, announced
that it has achieved the first milestone in its Epidermal Growth Factor Receptor (EGFR) Mutant
-Selective Inhibitor (EMSI) alliance with Clovis Oncology triggering a $4 million milestone payment
to Avila.

The U.S. Food and Drug Administration (FDA) has allowed an investigational new drug (IND)
application to begin clinical investigation of CO-1686, a novel, oral, targeted covalent inhibitor of
epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). Initial
Phase I/II studies with CO-1686 are expected to commence in the U.S. and Europe during the
second quarter of 2012 and in Asia during the third quarter of 2012. CO-1686 is the second
covalent drug to advance to clinical development from Avila’s proprietary Avilomics™ platform,
along with Avila’s proprietary drug candidate AVL-292, a Bruton’s Tyrosine Kinase (Btk) inhibitor
in Phase Ib clinical development for the treatment of B-cell cancers.

“We are pleased with the tremendous progress that our partners at Clovis have made in
advancing CO-1686 into development, particularly in NSCLC, a disease for which novel
treatments are so sorely needed,”

said Katrine S. Bosley, CEO of Avila Therapeutics.

“With this achievement we have now successfully created two clinical development candidates using our targeted covalent drug platform. This further demonstrates our ability to design and develop innovative medicines using Avilomics.”

EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian
patients and approximately 30 to 35 percent in East Asian patients. These patients experience
significant tumor response to erlotinib (Tarceva®) and gefitinib (Iressa®), which are first-
generation EGFR inhibitors. However, most patients ultimately progress on erlotinib and gefitinib
therapy, with approximately 50 percent of patients developing acquired resistance from a second,
or “gatekeeper” mutation, T790M. CO-1686 was designed and developed to selectively target
both the initial activating EGFR mutations as well as the T790M mutation, while sparing wild-type,
or “normal” EGFR. Because CO-1686 spares wild-type EGFR, it has the potential to cause a
lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR
inhibitors.

Because CO-1686 inhibits the initial activating mutations of EGFR as well as T790M mutations, it
also has the potential to effectively treat first-line NSCLC patients. CO-1686 may prevent the
T790M resistance from occurring, which could result in responses of greater duration and,
because it does not inhibit wild-type EGFR, it may possess a more tolerable side-effect profile.
CO-1686 is a targeted covalent, or permanent, inhibitor of EGFR mutations. As a covalent drug,
CO-1686 forms a durable bond with its target mutations in a highly directed and controlled
manner. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor
shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth
inhibition at a variety of doses.

About the Avila Alliance with Clovis Oncology

Avila and Clovis Oncology entered into a partnership for the worldwide development and
commercialization of an EGFR Mutant-Selective Inhibitor (EMSI) in May 2010. Under the terms of
the agreement, the two companies collaborated on the preclinical development of the EMSI
program and Clovis Oncology is fully responsible for worldwide development and
commercialization, including development of companion diagnostics to prospectively identify
patients with clinically-arising resistance mutations of the EGFR. Avila is eligible to receive
development, regulatory and sales-based milestone payments, with a total potential value of $209
million, as well as tiered royalties on potential future product sales.

About Avila Therapeutics™, Inc.

Avila Therapeutics is a clinical-stage biotechnology company focused on the design and
development of targeted covalent drugs to achieve best-in class outcomes. This approach, called
“protein silencing”, cannot be achieved through traditional chemistry techniques. The company’s
product pipeline has been built using its proprietary Avilomics™ platform and is currently focused
on cancer, viral infection and autoimmune disease. Avila’s most advanced product candidate,
AVL-292, a potential treatment for cancer and autoimmune diseases, is currently in Phase 1
clinical testing. Avila is funded by leading venture capital firms: Abingworth, Advent Venture
Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners. For additional
information, please visit http://www.avilatx.com.

Jan 20
Love0

Advent Life Sciences Invests in Acutus Medical and Acutus Medical Expands Senior Management Team

By Advent Life Sciences, Press Release
Press Release.

 

20th January 2012, London: – Advent Life Sciences announced it has invested $2.2 million in Acutus Medical, a medical technology company based in San Diego and Zurich, as part of a Series A of $5.4 million which includes previously announced participation by Index Ventures and the company founders.  Acutus is developing an electrophysiological mapping system to optimize the treatment of cardiac arrhythmias and will use the initial funding to develop prototypes of its novel system.

Acutus Medical, founded in 2011, is developing technology to allow significantly improved mapping of the cardiac space. This will enable instantaneous and precise visualization of areas of the heart to be ablated in patients with cardiac arrhythmias such as atrial fibrillation and ventricular tachycardia. The advanced technology is being developed in the US and Europe. The Acutus system is being designed to provide unprecedented accuracy for the real-time guidance necessary to determine the location for ablating sources of arrhythmias.

Shahzad Malik, general partner at Advent Life Sciences and new Board member at Acutus Medical, said,

“We are delighted to invest in Acutus Medical and this investment underlines our commitment to investing in first-in-class and best-in-class life sciences opportunities.  The treatment of atrial fibrillation using medical devices is an area with substantial growth potential and we believe Acutus has the ability to significantly expand the market while improving outcomes based on more accurate electrophysiological mapping. ”

With this investment, Acutus Medical also announced it has recruited Graydon Beatty as its Chief Technology Officer. Graydon was previously an inventor of the EnSite Technology and founder of Endocardial Solutions, Inc., incorporated in 1992, which produced integrated advanced mapping and navigation systems for the location and improved treatment of cardiac arrhythmias.

Endocardial Solutions was acquired by St. Jude Medical, Inc. in 2005 where Graydon continued to contribute to product development.  Acutus President, Randy Werneth said, “With Graydon, we add a world-leading expert to our team of highly experienced and successful developers of advanced cardiac mapping and imaging systems. With his exceptional previous achievements and perfect fit with our team and our tasks we believe we are poised to produce a breakthrough in cardiac mapping systems.”

About Acutus Medical:
Acutus Medical is a medical technology company committed to developing an innovative breakthrough platform technology of safe, cost effective and clinically advanced tools for the minimally invasive diagnostic mapping of complex cardiac arrhythmias such as atrial fibrillation and ventricular tachycardia. The Company’s technology is being developed in the US and Europe and is expected to achieve CE marking within two years.  The company is located in San Diego, California and Zurich, Switzerland and is privately funded with lead investors, Index Ventures and Advent Ventures.

www.acutusmedical.com

About AdventLife Sciences:
Advent Life Sciences is the dedicated Life Sciences Fund at Advent Venture Partners, one of Europe’s best established growth and venture capital firms.  Advent Life Sciences invests predominantly in early-stage and growth equity life sciences companies in the UK, Europe and the US.  It will back companies that have a first- or best-in-class approach in a range of sectors within the life sciences, including new drug discovery, enabling technologies, med-tech and diagnostics.

The Advent Life Sciences team is a leader in European life sciences venture capital.  Its investments include:  PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; EUSA Pharma, a rapidly growing transatlantic speciality pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (OSE: ALGETA), an oncology company developing treatments for bone metastases and disseminated tumours.

www.adventventures.com

For more information contact:

Acutus Medical
Randy Werneth, CEO
Email: randy.werneth@acutusmedical.com

Advent Venture Partners (London)
Josephine Defty
Ph: +44 (0) 20 7932 2116
Email: Josephine@adventventures.com

Jan 19
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Advent Life Sciences Fund I welcomes additional investor

By Advent Life Sciences, Press Release
Press Release.

 

Présentation de deux projets de fonds d’investissement dans l’avenir de l’économie Luxembourgeoise

 

A l’issue d’une réunion conjointe de la commission parlementaire des Finances et du Budget et de la commission parlementaire de l’Economie, du Commerce extérieur et de l’Economie solidaire, le ministre des Finances, Luc Frieden, et le ministre de l’Économie et du Commerce extérieur, Jeannot Krecké, ont présenté deux projets de fonds d’investissement dans l’avenir de l’économie luxembourgeoise.

1.    Fonds Life Sciences

Le plan d’action « technologies de la santé » établi et présenté en 2007 prévoit la mise en place d’un outil de financement approprié. La décision du gouvernement d’investir à travers la Société Nationale de Crédit et d’Investissement (SNCI) dans un fonds capital à risque spécialisé dans le domaine des sciences biomédicales s’inscrit dans ce contexte.

Afin de s’assurer que l’investissement substantiel consenti par le gouvernement en matière de recherche biomédicale (en 2008 : 140 millions € étalés sur cinq ans) puisse sortir ses effets également d’un point de vue économique, le gouvernement a décidé de placer une somme à travers la SNCI dans un fonds d’investissement existant ayant fait ses preuves.

Suite à une procédure de sélection, c’est le groupe Advent Venture Partners de Londres qui a finalement été retenu. Advent Venture Partners a été créé en 1988 et le fonds Advent Life Sciences Fund I (ALSF I) dans lequel la SNCI investira une vingtaine de millions d’euro est le cinquième fonds mis en place par Advent. C’est leur premier fonds dédié exclusivement aux technologies biomédicales – les quatre autres fonds avaient deux axes d’investissement: les technologies de l’information et de la communication ainsi que les technologies de la santé. C’est un fonds d’investissement britannique libellé en livres sterling ayant une durée de vie de 10 ans pouvant être étendue deux fois d’une année. Par ailleurs, Le Fonds Européen d’Investissement (FEI) compte parmi les actionnaires d’ALSF I.

ALSF I a commencé à investir en février 2011 – à ce jour trois investissements sont réalisés. Le fonds vise une quinzaine d’investissements dont une dizaine environ sera consacré à la création de jeunes entreprises, et le reste au financement de projets. 70% des investissements seront réalisés en Europe.

Pour Raj Parekh, General Partner, Advent Life Sciences,

“cette initiative du gouvernement luxembourgeois dans le domaine des technologies de la santé est exceptionnelle aussi bien pour sa vision et que pour sa conception, et permet d’accélérer le développement du Luxembourg afin de devenir un acteur important dans les biotechnologies. C’est un privilège pour Advent Life Sciences d’avoir été choisi par le gouvernement et ses partenaires afin de les soutenir dans cette initiative importante.”

 

Les objectifs poursuivis par le gouvernement avec cet investissement sont multiples:

(a)    Participer à des investissements dans des projets porteurs et rémunérateurs, quelle que soit leur localisation géographique. Cette ouverture doit permettre:

•   d’intégrer le réseau des fonds en capital à risque et, partant, de faire connaître le Luxembourg;

•   d’investir dans des sociétés stratégiquement intéressantes pour l’effort de recherche consenti au niveau national.

(b)    Investir dans l’une ou l’autre société pouvant être implantée au Luxembourg dans un but de diversification économique.

(c)    Essaimer  l’un ou l’autre projet de valorisation issu de l’effort de recherche luxembourgeois si l’opportunité se présente

(d)    Assister  à la mise en place d’un dispositif de transfert de technologie en étroite coopération avec le gouvernement et les autres acteurs du terrain

(e)    Assurer un transfert de savoir vers les acteurs luxembourgeois et accroître la visibilité du Luxembourg en matière de sciences de la vie. A cet effet, Advent s’est notamment engagé à:

•    Assurer une présence au Luxembourg
•    Former l’un ou l’autre analyste  de l’administration gouvernementale
•    Organiser des réunions et conférences spécialisées au Luxembourg.

Au sujet d’Advent Life Sciences:

Advent Life Sciences est le fonds dédié aux sciences de la vie au sein d’Advent Venture Partners(www.adventventures.com), une des entreprises en capital risque les plus connues en Europe. Advent Life Sciences investit principalement dans des jeunes entreprises du secteur des technologies et sciences de la santé au Royaume-Uni, en Europe et aux Etats-Unis. Le fonds soutient des entreprises classées parmi les meilleures dans plusieurs domaines relatifs aux sciences de la vie, dont la découverte de nouvelles molécules, les technologies habilitantes, les technologies médicales et le diagnostic.

L’équipe d’Advent Life Sciences est leader en Europe en matière de capital risque dans le domaine des sciences de la vie. Parmi ses investissements, on trouve: PowderMed, une société ayant développé un vaccin thérapeutique ADN vendue à Pfizer; Thiakis, une société ayant développé un traitement contre l’obésité acquise par Wyeth Pharmaceuticals; Respivert, une société active dans le domaine des maladies respiratoires qui a été achetée par Johnson & Johnson; EUSA Pharma, une société pharmaceutique transatlantique active dans plusieurs segments dont le traitement du cancer en stade terminal et les antidouleurs; et, Algeta (OSE: ALGETA),une société active dans l’oncologie qui développe des traitements contre les métastases osseuses et les tumeurs disséminées.

2.    Luxembourg Future Fund

A la demande du Gouvernement, la SNCI, ensemble avec le Fonds Européen d’Investissement (FEI), mettra en place un Luxembourg Future Fund.

Ce fonds aura comme objet de soutenir la diversification et le développement durables de l’économie luxembourgeoise en contribuant à attirer au Luxembourg, directement ou indirectement, des activités entrepreneuriales en phase de démarrage/développement/croissance ou des activités contribuant à l’innovation.

Luxembourg Future Fund sera géré par le FEI qui y participera également en tant qu’investisseur minoritaire. Le FEI est spécialisé dans le financement à risque des PME en Europe et est majoritairement détenu  par la Banque Européenne d’Investissement. Avec actuellement plus que 12 milliards d’euros sous gestion, le FEI dispose d’une grande expérience et d’une excellente réputation  dans le domaine du capital à risque pour les PME.

Taille et investisseurs du Luxembourg Future Fund

La taille visée du fonds s’élèvera à quelque 150 millions d’euros. Le FEI participera en tant qu’investisseur avec 30 millions d’euros. La SNCI prend une participation à hauteur de 120 millions d’euros.

Gestionnaire du Luxembourg Future Fund

Le FEI sera chargé de la gestion du fonds. Il recourra aux compétences internes de ses départements en vue de la sélection, de l’analyse et du suivi des dossiers investis. Luxembourg Future Fund devra fonctionner suivant les règles de gouvernance du FEI.

Ce fonds pourra pleinement profiter non-seulement des structures et du savoir-faire du FEI pour la mise en place et la gestion, mais aussi de son expérience et de sa réputation pour le choix des projets à investir, le cas échéant aussi avec des co-investisseurs.

Stratégie d’investissement du Luxembourg Future Fund et nouvel instrument de diversification et de développement durables de l’économie luxembourgeoise

Deux grands principes cumulatifs de gestion régiraient le Fonds Luxembourgeois :

i.    Rentabilité financière : Le fonds sera géré et investira selon des critères strictement commerciaux avec des objectifs de performance financière bien définis à l’avance et en accord avec le profil de risque du fonds.

ii.    Retombées pour l’économie luxembourgeoise : Les investissements du fonds devront avoir une dimension permettant de s’attendre à avoir un impact en termes de diversification et de développement durables de l’économie luxembourgeoise.

Le Luxembourg Future Fund réalisera des investissements directs et indirects, ces derniers via une activité fond de fonds, dans des PME innovantes en phase de démarrage, de développement ou de croissance, actives dans les secteurs technologiques les plus variés (ICT, Cleantech et autres, à l’exclusion, directe et indirecte, du secteur des Technologies de la Santé/Life sciences) et contribuera indirectement au développement d’un écosystème en capital-risque au Luxembourg.

Les investissements seront réalisés dans des conditions pari-passu avec les co- investisseurs potentiels des projets investis tout en respectant les critères de rentabilité financière du fonds.

L’environnement luxembourgeois existant, avec ses  infrastructures (ICT, logistique) et son cadre fiscal (loi sur la propriété intellectuelle) viendra soutenir les efforts entrepris dans ce contexte pour favoriser le développement économique et la diversification du Luxembourg.

Les domaines d’investissement du Fonds Luxembourgeois

Luxembourg Future Fund investira soit directement soit indirectement à travers des fonds de fonds à capital risque, le cas échéant avec d’autres co-investisseurs.

Un nouvel instrument de diversification et de développement durables

II est entendu que le mode de fonctionnement est tel que l’Etat et la SNCI ou d’autres vont pouvoir contribuer au deal-flow en signalant au gestionnaire des projets potentiellement éligibles. Partant, Luxembourg Future Fund constituera un nouvel instrument complémentaire et d’importance de la politique de diversification et de développement durables de l’économie luxembourgeoise.

Le Luxembourg Future Fund devra décider d’une liste en principe négative des investissements ne remplissant pas les critères de responsabilité éthique, sociale ou environnementale.

Structure légale du Luxembourg Future Fund

Le FEI a une préférence pour un fonds fermé sous la forme d’un Fonds d’Investissement Spécialisé – SIF SICAV S.A. Il s’agit d’une structure de fonds qui doit obtenir l’agrément de la CSSF et qui fonctionne sous la surveillance de cette dernière.

Durée du fonds

Il est proposé que le fonds en question ait une durée de 15 ans qui peut être prolongée de maximum deux ans. Les investissements se feront sur les 5 premières années avec la possibilité d’augmenter la période d’investissement d’un an, sans toutefois exclure des réinvestissements ultérieurs des revenus générés par la cession d’actifs. Les parties devront s’engager à temps utile à discuter d’un fonds successeur (principe d’un fonds « evergreen »).

Gouvernance et reporting

Dans le cas d’une SICAV S.A., le Luxembourg Future Fund fonctionnera avec un Conseil d’administration, qui se composera de trois membres (deux membres seront désignés par la SNCI et un membre par le FEI) et une assemblée des actionnaires disposant des droits leur réservés par la loi et les statuts. Le Conseil sera informé des investissements du fond. Il lui incombera notamment d’assurer que tous les documents officiels requis soient préparés et transmis aux autorités de contrôles compétentes et que les assemblées des actionnaires soient préparées et tenues selon les règles de l’art.

Dans le cadre de la stratégie d’investissement arrêtée par les actionnaires, le FEI, en tant que gestionnaire du fonds, disposera d’un pouvoir de gestion indépendant (sélection, analyse et suivi des dossiers investis) qui lui sera délégué par le Conseil d’administration du Luxembourg Future Fund. Le FEI produira des rapports trimestriels sur le développement des investissements réalisés.

Un comité d’investissement sera créé (deux membres seront désignés par la SNCI et un membre par le FEI), qui disposera d’un droit de refus en ce qui concerne les décisions définitives d’investissement du fonds, identifiées et proposées par le gestionnaire, notamment afin de vérifier le respect de la condition concernant les retombées luxembourgeoises. Il est prévu que le comité d’investissement disposera aussi d’un droit de regard au niveau du suivi des projets et des désinvestissements.

Closing et démarrage des activités

Bien que le closing du fonds soit prévu pour le 1er semestre 2012, il est proposé que d’autres investisseurs stratégiques, qui adhèreraient aux objectifs et à la stratégie d’investissement du Luxembourg Future Fund et seraient prêts à s’engager pour une participation substantielle d’au moins 50 millions d’euros, pourraient rejoindre le fonds pendant les 12 mois suivant le closing. Chaque nouvel investisseur devrait être approuvé par les deux investisseurs fondateurs (FEI et SNCI). Il est prévu que la SNCI reste, dans
toutes les circonstances, majoritaire au niveau des droits de vote et du capital social.

Communiqué par le ministère des Finances et par le ministère de l’Économie et du Commerce extérieur

Jan 04
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Cornerstone Therapeutics Acquires Cardiokine

By Cardiokine, Press Release
Press Release.

 

January 04, 2012 07:30 ET

Cornerstone Therapeutics Acquires Cardiokine

CARY, NC–(Marketwire – Jan 4, 2012) – Cornerstone Therapeutics (NASDAQ: CRTX)

•Cornerstone acquires worldwide rights to investigational therapy for hyponatremia
•Hyponatremia is one of the most common metabolic conditions affecting up to 6 million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually
•New Drug Application for lixivaptan filed Dec. 29, 2011; FDA approval expected in Q1 2013
•Expected launch of the product in the U.S. hospital market in 2013

Cornerstone Therapeutics (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital and respiratory markets, today announced that it has acquired Cardiokine Inc., a specialty pharmaceutical company focused on developing hospital products for cardiovascular indications. The merger was effective Dec. 30, 2011.

Under the terms of the agreement, Cornerstone will acquire all outstanding shares of Cardiokine which is located in Philadelphia. Cardiokine recently completed a series of phase III clinical trials for its lead compound, lixivaptan for treatment of hyponatremia, and filed a New Drug Application (NDA) with the FDA on Dec. 29, 2011. Lixivaptan is an orally active, selective vasopressin 2 receptor antagonist and has the potential to address a large unmet medical need as current treatment options have significant limitations that have impeded adoption by many hospitals.

“We are very excited about adding a hospital product to complement Curosurf, our neonatal lung surfactant. This is the first of several deals we hope to complete as we continue to execute the strategic plan that we initiated in 2011,”

said Craig A. Collard, Cornerstone’s Chief Executive Officer.

“The hyponatremia market is expected to grow significantly in the coming years and currently has limited treatment alternatives. The acquisition of Cardiokine allows Cornerstone to expand our pipeline into a new area of treatment and creates the potential to use our hospital specialty expertise to help meet the needs of patients with hyponatremia.”

Mr. Collard continued,

“Consistent with our stated strategic intent, we expect this transaction to be accretive within the first full year following launch. Additionally, we will continue the ex-U.S. licensing discussions initiated by Cardiokine, which present the opportunity for incremental revenue.”

“The clinical trials of lixivaptan were conducted in addition to current standard care in patients with hyponatremia associated with heart failure and the syndrome of inappropriate hormone secretion (SIADH), and comprise the largest placebo-controlled dataset to date in these populations,”

said Cesare Orlandi, MD, former Cardiokine Chief Medical Officer, who will continue his work on lixivaptan as a consultant to Cornerstone.

About Hyponatremia
Hyponatremia is a metabolic condition that occurs when there is not enough sodium (salt) in the blood. It is the most common electrolyte disorder among hospitalized patients affecting up to six million people in the U.S. and is often diagnosed in patients with heart failure. In the U.S. alone, there are five million heart failure patients, and each year one fourth of them develop hyponatremia. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis, and syndrome of inappropriate hormone secretion (SIADH).

About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing products for the respiratory, hospital and related specialty markets. Key elements of the Company’s strategy are to focus on identifying therapeutic niches within respiratory, hospital and related specialty markets to leverage existing business and create new opportunities; promote the Company’s current products to high prescribing physicians through the Company’s respiratory sales force and to hospital-based healthcare professionals through the Company’s hospital sales force; license or acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance the Company’s development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through the Company’s wholly owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including statements regarding the progress and timing of our product development programs and related trials, our strategy and our future operations and opportunities, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of preclinical studies and clinical trials with respect to our products under development, our ability to satisfy FDA and other regulatory requirements, our ability to enter into strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all, and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 3, 2011 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release, and these statements should not be relied upon as representing our views as of any other date and do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise.

Dec 30
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Amsterdam Molecular Therapeutics Announces 2.5 Million Equity Raise

By Press Release
Press Release.

 

Amsterdam, The Netherlands – December 30, 2011 – Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the Company has raised € 2.5 million in new equity by means of a private placement to three of its existing shareholders: Forbion Capital Partners, Gilde Healthcare Partners and Advent Venture Partners.

Under the terms of the transaction, AMT has agreed to issue 7,352,938 new shares at a price of € 0.34 per share, being the closing price on December 29, 2011, when the shares were placed. The proceeds of this issue will provide additional flexibility to further explore its strategic options to secure the financial stability of the Company. The proceeds do not eliminate the Company’s negative equity position, which will continue after completion of the equity raising, which is expected to take place on or around January 4, 2012, and the Company’s financial prospects remain as described in the announcement of December 15, 2011.

As a result of the private placement, the Company’s issued share capital will amount to 31,051,454 shares.

Pursuant to the Financial Supervision Act (Wet op het financieel toezicht) there is no obligation to publish a prospectus approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiele Markten) in relation to the equity raising or the admission of the new shares to trading on NYSE Euronext in Amsterdam. The Netherlands Authority for the Financial Markets does not supervise the equity raising or the admission of the new shares to trading on NYSE Euronext in Amsterdam.

About Amsterdam Molecular Therapeutics
AMT is a world leader in the development of human gene based therapies. AMT has a product pipeline of several gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows AMT to pursue its strategy of focusing on this sector of the industry.  AMT was founded in 1998 and is based in Amsterdam. Further information can be found at www.amtbiopharma.com.

For further enquiries:
Jörn Aldag
CEO
AMT
Tel : +31 20 566 7394
j.aldag@amtbiopharma.com

Nov 18
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FDA approves Erwinaze to treat a form of leukemia

By EUSA Pharma, Press Release
Press Release.

 

The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.

Erwinaze is injected directly into the muscle three times a week and works by breaking down one of the body’s protein building blocks (the amino acid, asparagine) that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.

“The approval of Erwinaze underscores the FDA’s commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints”

said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Erwinaze was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions.

In the trial to support efficacy, the main outcome (endpoint) was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.

Side effects associated with Erwinaze treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia).

Prior to Erwinaze’s approval there were two asparagine specific enzyme products – Elspar (asparaginase injection) and Oncaspar (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.

Erwinaze has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.

Erwinaze is manufactured by EUSA Pharma Inc. of Langhorne, Pa.

Nov 18
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EUSA Pharma Announces FDA Approval Of Orphan Drug ERWINAZE™ For Treatment Of Acute Lymphoblastic Leukemia

By EUSA Pharma, Press Release
Press Release.

 

Langhorne, PA and Oxford, UK – 18 November 2011 – EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE™ (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. ERWINAZE will be available to patients throughout the United States immediately.

ALL is the most common form of childhood cancer, with approximately 2,900 patients under the age of 20 diagnosed in the USA each year [1]. It is also one of the most curable forms of cancer,with remission rates in treated children of over 95% and 75 – 85% surviving at least five years without recurrence of leukemia [1]. Treatment involves a number of stages and drugs, and typically includes asparaginase as an essential component of current protocols. ERWINAZE isindicated as an integral part of a multi-agent regimen for the treatment of ALL patients who develop hypersensitivity to current products derived from E. coli, and is therefore the first and only approved treatment option available for patients with hypersensitivity to standard-of-care treatment with pegaspargase. An estimated 15 – 20% of ALL patients develop hypersensitivity to E. coliderived asparaginase, representing approximately 450 – 600 children in the United States eachyear [2].

“Treatment with asparaginase is a vital and life-saving therapy for thousands of patients, mostly children, with acute lymphoblastic leukemia each year. Unfortunately, a number of these patients develop hypersensitivity to asparaginases derived from E. coli, including pegaspargase, and are unable to complete the recommended course of treatment. The approval of ERWINAZE is an important advance because it is the only treatment option that can enable these patients to continue and complete their full course of therapy,”

said Stephen E Sallan MD, Chief of Staff,Dana-Farber Cancer Institute and Professor of Pediatrics, Harvard Medical School.

“Today’s approval of ERWINAZE highlights EUSA’s ongoing commitment to the oncology field, and the treatment of patients affected by orphan diseases. We are grateful to our partners at the UK Health Protection Agency, our investigators and employees, and to the Food and Drug Administration for their dedication to this effort and for helping us make ERWINAZE available to the hundreds of patients who can benefit from it each year,”

said Dr Tim Corn, EUSA Pharma’s Chief Medical Officer.

Commenting on the news, Bryan Morton, President and Chief Executive Officer of EUSA Pharma, said, “The approval of ERWINAZE marks a major milestone for EUSA, and represents the culmination of many years of work. Launching ERWINAZE to sit alongside our existing portfolio of specialty products is also a major strategic milestone for the company, as this is the first treatment EUSA has developed internally. This achievement represents a transformation for the company, signaling our transition into a specialty development as well as commercialization organization.”

The ERWINAZE approval is based on the results of clinical studies in 630 ALL patients. In the pivotal efficacy study conducted in 58 subjects, 100% of evaluable patients achieved the asparaginase activity primary endpoint.

EUSA will offer a patient assistance program to help expand access to ERWINAZE for patients who lack health insurance or meet certain other criteria. For further information about ERWINAZE and full prescribing information visit www.erwinaze.com.

About ERWINAZE

ERWINAZE is an asparaginase enzyme that depletes the level of asparagine in the bloodstream.

Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria,and approximately 15 – 20% of patients develop hypersensitivity to modern products derived from Escherichia coli, preventing their continued treatment [2]. ERWINAZE, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments. ERWINAZE was originally discovered by the UK Health Protection Agency, and the assays for the US Biologics License Application were conducted by AIBioTech, Richmond, Virginia.

Selected Important Risk Information
Contraindications: History of serious hypersensitivity reactions, including anaphylaxis, to Erwinaze; History of serious pancreatitis, thrombosis or hemorrhagic events with prior Lasparaginase therapy.

Warnings and Precautions: Discontinue Erwinaze if serious hypersensitivity reactions, includinganaphylaxis, or severe or hemorrhagic pancreatitis occur. Warnings include: monitor glucose(intolerance may not be reversible; insulin may be needed for hyperglycemia); thrombosis and hemorrhage: discontinue until resolved. Do not use in lactating women and use in pregnant women only if clearly needed.

Common Adverse Reactions 1%: Serious hypersensitivity including anaphylaxis, pancreatitis, and abnormal transaminases, coagulation abnormalities (thrombosis, hemorrhage), nausea, vomiting, and hyperglycemia.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the US, a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of 10 specialist hospital products,which are sold in over 80 countries globally*. These include Erwinase®/Erwinaze™ and Kidrolase®for the treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp® G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.

Nov 17
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Biocartis completes EUR 71 million (USD 100 million) Series C Fund Raising

By Biocartis, Press Release
Press Release.

 

Lausanne (Switzerland) – November 17, 2011. Biocartis, a company developing and commercializing compact molecular diagnostic (MDx) systems designed to drive the widespread adoption of personalized medicine and other applications including the improved diagnosis of infectious disease, announced today the completion of EUR 71 million (USD 100 million) Series C equity fund raising backed by existing investors, new investors and industrial collaborators and partners. Investors in the round were Debiopharm Group™, Philips, Johnson & Johnson Development Corporation (JJDC), the Wellcome Trust, Korys (investment holding of the Colruyt family), Valiance, Biovest, the family office of Dr Paul Janssen, IHL SA (Luc Verelst), PMV, New Rhein Healthcare, certain members of the Biocartis senior management team and the family office of founder Rudi Pauwels (Benaruca).

Rudi Pauwels, the founder and CEO of Biocartis, commenting on today’s announcement said,

“Completing one of the largest life science fundraisings this year, against the background of the current turbulent financial background, is testament to the quality of Biocartis’ technology, its team and the attractive market opportunity for a transformational molecular diagnostics platform which can change the face of global healthcare. We have succeeded in attracting a broad and diverse group of investors who have recognized our potential and the progress we have made towards our goal of becoming a fully integrated global diagnostics company commercializing molecular diagnostics systems that will make personalized medicine an everyday reality.”

Biocartis’ first system, codenamed Apollo, is expected to be launched in 2013. Apollo takes its inspiration from the consumer electronics industry, being designed for everyday use by a broad range of customers in a wide range of settings. The Apollo system has been established in close collaboration with Philips Corporate Technologies, which is the key development partner of the platform. Apollo is a compact, scalable, core system that allows multiple assays to be performed anywhere, anytime, simply, rapidly and without the need for a specialist laboratory environment and trained technicians. Apollo can deliver results as accurate as those generated in a specialized clinical laboratory setting in as little as one hour from sample preparation to read out.

Apollo is highly versatile with regard to sample types and assay types and can analyze multiple disease parameters in one assay. Apollo has also been designed to be easily integrated into healthcare IT systems and to benefit from lower capital requirements and running costs.

Biocartis is using a collaborative business model to help drive the build-up of the shared installed base of its Apollo system once launched and to broaden the menu of infectious disease and personalized medicine assays required to meet the needs of the growing MDx market. Biocartis’ key collaborators include bioMerieux and Janssen Pharmaceutica (J&J). Biocartis’ aim is to rapidly create a widely adopted platform that is accessible to both the Company and other developers of new MDx assays.

Rudi Pauwels further commented,

“Today’s financing is a key step in enabling Biocartis to deliver its broader vision for diagnostics, to enhance each patient’s quality of life by offering better treatments based on better and more personalized diagnostics. With the backing of our investors, the drive and experience of the Biocartis team and the support of collaborators I am confident we can achieve this ambitious and important goal.”

Following the fundraising, the Biocartis Board will be enlarged. Current Board members, Rudi Pauwels (Benaruca), Rudi Mariën (Biovest), Domenico (Dinko) Valerio (Aescap), Pietro Scalfaro (Debiopharm), Greg Parekh (New Rhein), Jean Deleforge (bioMerieux) will be joined by new Board members, Vincent Vliebergh (Korys), Alex Dittmair (Valiance), Christine Deuschel (Debiopharm) and Staf Van Reet (J&J). Current Board members Ruth Devenyns (KBC Private Equity) and Shahzad Malik (Advent Venture Partners) will stand down having greatly contributed to the Company’s development to this stage.

The Series C financing round was led by Biocartis’ senior management and Peter Verhaeghe, managing partner at VVGB in Brussels, Belgium.

About Biocartis (www.biocartis.com)

Biocartis aims to transform the global diagnostics market by making personalized medicine an everyday reality. The challenge Biocartis addresses is to enable the broadest possible access to new technologies that will allow individual diagnoses to be made quickly based on a systematic analysis of the wealth of rapidly emerging biomarkers rather than solely on physiological symptoms as they are today. Ending the ‘one drug fits all’ paradigm will empower physicians to make better diagnoses based on better information and help tackle efficacy failings and increasing healthcare costs. Biocartis intends to become a fully integrated provider of novel, broadly applicable molecular diagnostics and immunodiagnostics solutions (instruments, analytical techniques, chemistries, sample preparation and other innovative tools) with high-value clinical assay menus. These solutions are designed to be compatible with deployment in a wide variety of health care settings, providing rapid, high-quality care close to the patient. Biocartis’ vision is shared by its current collaborators which include bioMerieux and Janssen Pharmaceutica (J&J).

Biocartis is currently developing two innovative systems that share a common user interface and design philosophy:

– Apollo, a system designed for the MDx market, comprising an instrument, communication console and single use, disposable cartridges. This system can detect and quantify multiple DNA- or RNA-based biomarkers in a wide variety of patient sample types with truly minimal user intervention.
– A second system that has been built around disposable, microfluidic cartridges with digitally encoded micro carriers for the rapid and sensitive detection of a broad range and number of biomarkers. The first product from this technology will focus on protein-based biomarkers and will allow Biocartis to enter the immunoassay market.

Biocartis was founded in 2007 by Dr. Rudi Pauwels (Co-founder of Tibotec, Virco and Galapagos Genomics), Prof. Philippe Renaud (Prof. at EPFL), and Nader Donzel (Co-founder of Scitec laboratory Automation). The company has raised more than 100 million euro in equity funding. Biocartis SA is based at the EPFL’s Innovation Square in Lausanne, Switzerland; it has a fully owned Belgian subsidiary in Mechelen and a Dutch subsidiary at the High Tech Campus in Eindhoven.

Contacts
Rudi Pauwels, CEO
Tel: +41 21 69 39 051
pr@biocartis.com
Hilde Windels, CFO
Tel: +32 15 632 663
pr@biocartis.com
Citigate Dewe Rogerson
David Dible/Chris Gardner
Tel : +44 (0) 20 7638 9571
david.dible@citigatedr.co.uk/chris.gardner@citigatedr.co.