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Jul 19
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MediGene sells full European rights for Eligard to Astellas for EUR 25 million and ongoing royalties

By Press Release
Press Release.

 

MediGene sells full European rights for Eligard to Astellas for EUR 25 million and ongoing royalties

Astellas to make one-off payments totaling EUR 25 million
•  MediGene to remain entitled to royalties
•  No further costs to MediGene
•  Sale price reflects the full NPV of all future Eligard® revenues while allowing MediGene to benefit from continued Eligard® growth
•  Analyst and press conference call and webcast tomorrow, July 20, at 11 a.m. (CEST)

Martinsried/Munich – MediGene AG (Frankfurt, Prime Standard, MDG, TecDAX) announces the sale of full European marketing and distribution rights to Eligard® (leuprolide acetate, for the treatment of hormone-dependent prostate cancer) to Astellas Pharma Europe Ltd. (London, “Astellas”), previously MediGene’s European marketing partner for Eligard®. MediGene acquired these rights from TOLMAR Therapeutics Inc. (formerly Atrix Laboratories Inc.) in 2001. In return for the Eligard® license, MediGene will receive EUR 25 million in cash from Astellas as well as royalties on future product sales. For MediGene, all future costs, obligations and risks associated with the supply of Eligard® to Astellas, as well all future procurement costs and license payments to TOLMAR, will cease within the next months.

This agreement will strengthen MediGene’s financial situation and provide the opportunity for MediGene to profit from future growth of Eligard® sales. This would not be possible under the former deal structure since MediGene’s net margin decreased once net sales by Astellas exceeded a certain threshold, capping royalty receipts.

MediGene will now receive a low single-digit royalty on net sales of Eligard® generated by Astellas in Europe. In 2009, MediGene’s net participation in Eligard® sales by Astellas totalled about 6%. In future, MediGene will receive about one third of this margin on Eligard® in-market sales. According to the contract, Astellas will pay EUR 25 million in three tranches as the steps of transfer of the rights are concluded over the next six to twelve months (EUR 5 million upon signature, EUR 15 million anticipated within six to eight months, EUR 5 million anticipated within six to twelve months).

Arnd Christ, MediGene’s CFO, commented: “This is an excellent deal for MediGene, both in financial and strategic terms. It not only reflects the full NPV of all future Eligard® revenues according to the previous deal structure, but also provides us with significant and non-dilutive financing in a very tough capital markets environment. Furthermore, the structure of the deal allows MediGene to continue to benefit from the increasing revenue from Eligard® which was not possible under the previous structure. The significant improvement of our balance sheet and the simplification of the Eligard® deal structure allow us to fund growth opportunities and thus strengthening the future pipeline of the company.”

“We are delighted to have reached this agreement with MediGene which confirms our strong commitment to meeting the needs of patients in the fields of urology and oncology,” added Masao
Yoshida, President and CEO of Astellas Pharma Europe Ltd. “We have a strong track record in urology and look forward to continuing applying our proven expertise to all aspects of the marketing and distribution of this important treatment throughout Europe.”

Analyst and press conference call and webcast: An analyst and press conference call in English will take place tomorrow, July 20, at 11 a.m. (CEST), and will be webcast live. The webcast and synchronized presentation slides can be accessed at www.medigene.com. A recording of the live presentation will also be available thereafter.

About Astellas: Astellas Pharma Europe Ltd. is a subsidiary of Astellas Pharma Inc. which is located in Tokyo, Japan. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. For more information on Astellas Pharma Europe Ltd., please visit the website at http://www.astellas.eu.

This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the forward-looking statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® is a registered trademark of MediGene AG. Eligard® is a registered trademark of Tolmar Therapeutics, Inc. These trademarks may be owned or licensed in select locations only.

– ends –

MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG, TecDAX) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market which are distributed by partner companies. It has several drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs with focus on oncology.

Contact MediGene AG
Email: investor@medigene.com
Fax: ++49 – 89 – 85 65 – 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 – 89 – 85 65 – 3324
Dr. Georg Dönges, Investor Relations, Tel.: ++49 – 89 – 85 65 – 2946

Jun 15
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Micromet’s Blinatumomab Induces Durable Remissions in Patients with Relapsed Non-Hodgkin’s Lymphoma

By Micromet, Press Release
Press Release.

 

Durable responses ranging up to 30 months observed

 

BETHESDA, Md., – Micromet, Inc. (Nasdaq: MITI) today announced the presentation of updated results from a Phase 1 trial of the Company’s lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin’s lymphoma (NHL). A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing. Blinatumomab is the first in a new class of agents called BiTE(R) antibodies, designed to harness the body’s T cells to kill cancer cells.

The findings were presented on June 12, 2010 in an oral presentation (abstract # 0559) at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

“Blinatumomab continues to demonstrate a long duration of response in heavily pre-treated non-Hodgkin’s lymphoma patients,”

said Professor Ralph Bargou, Division of Hematology and Oncology, Department of Internal Medicine II, Wuerzburg University Hospital, and the study’s principal investigator.

“Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types.”

Phase 1 Study Design
This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin’s lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.

Patients initially received blinatumomab at dose levels ranging from 0.5 to 90 micrograms per meter squared per day over a four or eight week cycle. Based on findings in the ongoing study, a new dosing schedule was designed to mitigate the occurrence of neurological adverse events observed at the onset of treatment. Recently enrolled patients received a “step-dose approach” including a lower starting dose (5 or 15 micrograms per meter squared per day) of blinatumomab for one week, with subsequent escalation up to the target dose of 60 micrograms per meter squared per day.

Updated Phase 1 Results
The analysis presented at EHA included 52 patients, mainly with diagnoses of follicular lymphoma (FL) (42%) and mantle cell lymphoma (MCL) (42%). The majority of enrolled patients received three or more prior lines of chemotherapy. Of eight evaluable FL and MCL patients treated with constant dosing at a dose level of 60 micrograms per meter squared per day, 100% (8 of 8) achieved an objective response. The median response duration is 21 months. Three patients currently have ongoing responses ranging from 24 up to 30 months.

Among patients treated using constant dosing, the most common clinical adverse events were pyrexia, headache and fatigue. The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant cause of treatment discontinuation was neurologic events. These were observed in a sub-group of patients with an identified prognostic factor. All events resolved without sequelae following treatment discontinuation.

Data presented on six patients with an identified risk factor for neurologic events who were treated with blinatumomab using a “step-dose approach” indicates that the new treatment schedule appears to mitigate neurological events and maintain clinical activity. There was no occurrence of grade 3 or higher neurological events and five objective responses were achieved among the six patients treated.

“Our goal is to safely and effectively treat indolent and mantle cell lymphomas using a uniform treatment schedule irrespective of patient characteristics,”

said Jan Fagerberg, M.D., Ph.D., Micromet’s SVP, Chief Medical Officer.

“We look forward to continuing to advance enrollment in the on-going study using the adapted treatment schedule and broadening the eligible patient population to include other non-Hodgkin’s lymphoma subtypes.”

Conference Call and Webcast
Micromet management will host a conference call on Tuesday, June 15 at 8:30 AM EDT to review the data presented at EHA. To participate in the conference call, please dial 866-770-7120 (domestic) or 617-213-8065 (international) and reference the access code 28465583.

A replay of the call will be available from 11:30 AM ET on June 15, 2010 until midnight on June 22, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 87529369. The archived webcast will be available for 30 days in the Investor Relations section of the Micromet website at www.micromet-inc.com.

About Blinatumomab
Blinatumomab (MT103) is a novel, next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin’s lymphomas. Micromet received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the Food and Drug Association for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia, indolent B cell lymphoma, hairy cell leukemia and prolymphocytic leukemia.

About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) technology, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com

Safe Harbor
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the development of blinatumomab and its use in the treatment of cancer. You are urged to consider statements that include the words “ongoing,” “may,” “will,” “believes,” “potential,” “expects,” “plans,” “anticipates,” “intends,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that our preclinical data is not confirmed in clinical trials with our product candidates. This factor and others are more fully discussed in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

SOURCE Micromet, Inc.

Jun 04
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Amsterdam Molecular Therapeutics reports Positive New Clinical Data from Glybera Study

By Press Release
Press Release.

 

Amsterdam, The Netherlands, June 4, 2010 – Amsterdam Molecular Therapeutics (Euronext: AMT) a world leader in gene therapy, today reports new data showing that it’s lead product Glybera results in break-down of chylomicrons in lipoprotein lipase deficient (LPLD) patients.  The data will be presented on June 5 at the Second International Symposium on Chylomicrons in Disease, Sint Franciscus Gasthuis, Rotterdam, The Netherlands.

Glybera is a gene therapy product that induces functional lipoprotein activity. New data from an ongoing Canadian clinical study indicate that a single administration of Glybera in LPLD patients results in a remarkable improvement in the ability to break down the chylomicrons that transport dietary fat (triglycerides).  Lipoprotein-lipase-deficient (LPLD) patients are incapable of clearing chylomicrons which are responsible for causing significant morbidity and mortality.

“The long-term improvement in chylomicron handling following Glybera administration is very impressive”

said Dr. André Carpentier, co-investigator from the University of Sherbrooke, Quebec, Canada, who designed and analyzed the chylomicron sub-study.

“These data are important, because the major complications observed in LPLD patients, including pancreatitis, are a consequence of chylomicron overload. They also constitute evidence for a long term clinically relevant lipoprotein lipase activity induced by Glybera”

noted the principal investigator, Prof. Daniel Gaudet, from the University of Montreal, and ECOGENE-21 clinical study center, Chicoutimi, Quebec, Canada.

These new data provide a basis for explaining the mechanism of action of Glybera in LPLD patients, and in general for continued pharmacologic activity after one time gene therapy.

About  LPLD
LPLD is a seriously debilitating, and potentially lethal, orphan disease, for which no approved therapy exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent LPL activity in patients. LPL activity is needed in order to break down Chylomicrons, large fat-carrying particles that are formed in the gut and enter the circulation after each meal.  When such particles are not adequately broken down they accumulate in the blood, they may obstruct small blood vessels, which in turn can lead to pancreatitis.  Recurrent pancreatitis in LPLD patients can result in difficult-to-treat diabetes.

For further information
Jörn Aldag
Chief Executive Officer
Tel +31 (0) 20 566 7394
j.aldag@amtbiopharma.com

Jun 01
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Advent Sells Respivert to J&J for Significant Cash Return

By Press Release, Respivert
Press Release.

 

Advent Venture Partners was instrumental in the development of RespiVert, a true example of a classic venture investment and a case study of Advent‘s ability to find strong innovation at the early stage and develop it to a strong and early exit.

 

Advent backed an exceptional Founding team at Respivert,  helped refine the business plan, assembled an international venture capital syndicate, and placed Rudi Pauwels (former Advent Venture Partner and current CEO of portfolio company Biocartis) as chairman of the board. Advent has remained the largest shareholder of the company throughout.

The sale of RespiVert represents a further validation of Advent’s strategic approach to portfolio building, which is designed to produce earlier cash returns to our LPs than typically associated with venture funds. RespiVert is the third profitable exit from the Life Science element of the APEF IV portfolio following successful exits for Thiakis and Algeta. Each of these three companies received a single round of finance and in each case an exit has been achieved within four years of the initial investment.

 

Press Release

Centocor Ortho Biotech Inc. Acquires Respivert Ltd, Strengthens Pulmonary Focus

 

Acquisition Bolsters Pulmonary Portfolio and Capabilities, Accessing Promising Pipeline of First-in-Class Compounds and Renowned Team of Respiratory Scientists

Horsham, Pa., June 1, 2010 – Centocor Ortho Biotech Inc. today announced that it has acquired RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases.  The company’s lead compounds, RV-568 and RV-1088, narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities, are progressing into clinical development as potential first-in-class treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).  The clinical development of RV-568 and RV-1088 will be led by RespiVert in collaboration with scientists at Centocor Research and Development, Inc.  The company is not disclosing financial terms.

“The RespiVert compounds offer the potential for a new class of medicines for patients with severe lung disease that are insensitive to inhaled corticosteroids,”

said Susan Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Centocor Research and Development, Inc.

“The addition of RespiVert’s expert scientific team and discovery platforms for inhaled medicines strengthens our capabilities and further builds our pipeline of novel oral and biologic therapies for serious pulmonary diseases.”

With the acquisition of RespiVert, Centocor Ortho Biotech gains a portfolio of first-in-class, early-stage inhaled treatments for serious lung diseases.  RespiVert will continue to maintain its research and discovery presence in London from the Imperial BioIncubator, which is based at the campus of Imperial College London.  RespiVert employees will continue to lead ongoing research and drug discovery efforts.

Dr. Garth Rapeport, Chief Executive Officer of RespiVert, who is remaining with RespiVert following the acquisition, said,

“We believe that our focused discovery efforts in pulmonary disease offer a unique opportunity to bring completely new treatment options to patients who suffer from severe, chronic respiratory diseases including Chronic Obstructive Pulmonary Disease, severe asthma and Cystic Fibrosis.”

 

About Asthma, COPD, and CF
Severe or uncontrolled asthma is associated with significant morbidity, resulting in missed work and school days, and substantial limitation of activity, adversely impacting quality of life in asthmatics.  Severe asthma represents a particular societal burden, with sources suggesting that half of the total cost of asthma in the United States is attributable to severe disease.  Asthma is the cause of over 4,000 deaths each year in the U.S. and over 12,000 in Europe.

COPD is an umbrella term for a group of lung diseases which include chronic bronchitis, emphysema and small airways disease.  COPD is a serious, chronic disorder characterized by a slowly progressive decline in lung function with symptoms such as chronic cough and dyspnoea significantly impacting quality of life.  COPD is estimated to cause 130,000 deaths per year in the U.S.

CF is an inherited life-threatening disease involving a genetic mutation that disrupts the cystic fibrosis transmembrane regulator (CFTR) protein, resulting in poorly hydrated, thickened mucous secretions in the lungs and digestive tract.  Due to these changes, the lungs of individuals with cystic fibrosis are colonized and infected by bacteria from an early age.  This leads to progressive and severe lung inflammation which is difficult to treat.

About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology.  The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc.  Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options.  Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.  For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com.  Centocor Ortho Biotech Inc. and Centocor Research and Development Inc. are wholly-owned subsidiaries of Johnson & Johnson.

About RespiVert
RespiVert is a small molecule drug discovery company working towards the identification of new treatments for patients with Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF) and severe asthma.  The more severe forms of these diseases are poorly responsive to existing therapies such as inhaled corticosteroids and new disease modifying treatments are urgently required.

RespiVert has been financed by Advent Venture Partners, Fidelity Biosciences, Imperial Innovations and SV Life Sciences.

Forward-looking statements
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.  These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech Inc.’s and/or Johnson & Johnson’s expectations and projections.  Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

May 11
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Cellnovo and Home Diagnostics, Inc. form Strategic Alliance

By Cellnovo, Press Release
Press Release.

 

Technology integration and expansion of distribution platform drive partnership

LONDON, UK AND FORT LAUDERDALE, FLORIDA, USA – Building on a shared vision to simplify diabetes management worldwide, Cellnovo, a London-based medical device company, and Home Diagnostics, Inc., a leader in diabetes products, today announced a strategic alliance that involves integrating technologies and developing distribution opportunities for Cellnovo’s insulin patch pumps.

The partnership allows both companies to accelerate their growth and has the potential to transform the pump industry.  The first phase of the agreement calls for the inclusion of Home Diagnostics TRUE™ blood glucose technology in the Cellnovo wireless mobile handset.  The companies will also begin exploring ways to leverage Home Diagnostics’ distribution network to expand Cellnovo’s presence in the United States and other countries.

“We are extremely excited about our partnership with Home Diagnostics,”

said Bill McKeon, Chief Executive Officer of Cellnovo.

“On a technical level, it will provide our customers with the most advanced blood glucose monitoring technology available today within our mobile handset.  From a business perspective, it provides an extensive distribution network that includes 45,000 points of distribution, leading insurance companies and major product order suppliers.”

The Home Diagnostics blood glucose unit will operate as a built-in meter within the Cellnovo handset, enabling patients to monitor their blood sugar using touchscreen controls and TRUEresult™ and TRUEtest™ Test Strips.  Like all information in the handset, the glucose readings will be automatically stored and sent wirelessly to physicians, clinicians and family members.

“Our agreement with Cellnovo allows us to leverage the emerging opportunities in the insulin pump market through the most innovative pump system in the industry,”

said Joseph H. Capper, Home Diagnostics’ President.

“We look forward to helping Cellnovo bring the convenience, ease-of-use and wireless capabilities of their visionary product to diabetes patients throughout the U.S. and beyond.”

The Cellnovo pump, which is available in three models, is the industry’s smallest patch pump and the first to offer wireless, touchscreen operation.  With the integration of the Home Diagnostics blood glucose meter, patients can monitor their glucose levels using the same handset that records their insulin use, daily meals and activity levels, making diabetes management easier and more accurate.

“The combination of Home Diagnostics’ leadership technology and its significant distribution channels positions us to not only drive new advancements in health care, but to also bring greater freedom and convenience to diabetes patients worldwide”,

said McKeon.

– Ends –

About Cellnovo
Cellnovo Limited is an innovative medical device company based in London, UK.  Cellnovo has developed and produced the world’s first wireless touchscreen insulin patch pump system for diabetes management.  With its novel technology platform, Cellnovo is committed to providing freedom and ease-of-use to people living with diabetes and to providing the healthcare professional a means to better manage a patient’s disease.  Cellnovo’s technology platform benefits all constituencies – the patient, the provider and the payer – by enabling efficient insulin delivery and management, while also providing industry first mobile-enabled connectivity and real-time event tracking. Cellnovo lead investors are Advent Venture Partners and Heathcare Ventures.

About Home Diagnostics
Based in Fort Lauderdale, Florida, Home Diagnostics, Inc. is a leading developer, manufacturer and marketer of diabetes management products.  Home Diagnostics offers a portfolio of high-quality blood glucose monitoring products and systems available throughout the world.  Home Diagnostics is the exclusive co-brand supplier of blood glucose monitoring systems for leading pharmacies including CVS, Rite Aid and Walgreens, as well as distributors such as AmerisourceBergen, Cardinal Health, McKesson, Invacare and Liberty Medical.  For more information, please visit www.homediagnostics.com.

May 10
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SEP, the Pan-European Specialty Urology Company, acquires Mitem

By Press Release, SEP
Press Release.

 

Speciality European Pharma Limited (SEP), the pan European urology focused specialty pharmaceutical company, is pleased to announce its acquisition of the product Mitem® from Curasan AG.  Mitem is currently sold in Germany.  SEP takes over German distribution rights and plans to introduce the product into other European markets once Marketing Authorisations are granted.

Mitem is an injectable mitomycin product used either on its own or in combination with other therapies in the treatment of a range of cancers.  Most notably Mitem is given intravesically (into the bladder) for the treatment of bladder cancer.

Commenting on the acquisition, Geoff McMillan, Chief Executive Officer of SEP, said:

“This acquisition further enhances SEP’s product offerings to the urologist and is another milestone in the Company’s development as a pan European urology company.  It is the Company’s fourth specialist urology product, the others being Plenaxis® for the treatment of prostate cancer and Regurin® and Regurin® XL each for the treatment of overactive bladder.”

– Ends –

About Mitem
Mitem is a powdered form of mitomycin, a cytotoxic medicine used in the treatment of a variety of cancers, including bladder cancer. Mitomycin products have been on the market for many years and in Germany, the largest European market for mitomycin products, they represent the standard treatment for patients with low risk bladder cancer.  Intravesical therapy with Mitem is frequently used as adjuvant treatment in patients with superficial bladder cancer.  Compared with surgery alone, surgery plus intravesical mitomycin has been shown to cause tumour regression and to reduce the rate of short-term tumour recurrence.

About Speciality European Pharma
Founded in April 2006, SEP is a privately owned speciality pharmaceutical company.  Its mission is to become the leading Urologist focused Specialty pharmaceutical business in Europe.

SEP owns worldwide rights to Plenaxis®, the world’s first approved GnRH blocker for the treatment of prostate cancer.  Plenaxis gives a rapid and sustained decline in testosterone levels, which gives quick and sustained control of prostate cancer and its symptoms.  Plenaxis was launched in Germany in February 2008.

SEP has distribution rights in the UK and the Republic of Ireland for two products, Regurin® and Regurin® XL, respectively twice daily and once daily treatments for overactive bladder.

SEP has distribution rights in France and Italy for Haemopressin®, a product for the treatment of bleeding oesophageal varices.  This product is delivered to clinicians in a hospital setting.

SEP has established its own commercial operations in the UK, Germany, France and Italy and will market its products in other regions and territories through relationships with expert partners.

Apr 12
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Biocartis raises €30 million in Series B’ financing round

By Biocartis, Press Release
Press Release.

 

Lausanne, Switzerland – Biocartis SA, a biotech company active in the field of personalized medicine and focused on fast, multiplexed and fully integrated molecular diagnostics based on its proprietary micro-technology and sample preparation platforms, today announced the successful closing of a Series B equity financing round. The Company raised EUR 30 million (~ USD 41.3 million) from its current shareholder base of leading life science investors and two new strategic investors from the pharmaceutical/diagnostic industry.

The new investors are the Debiopharm GroupTM (Debiopharm) (Lausanne, Switzerland) and Johnson & Johnson Development Corporation (JJDC), each thus obtaining a minority stake in Biocartis.

This financing round was also underwritten by Aescap, Biocartis’ original lead-investor (The Netherlands), Biovest (Belgium), Advent Venture Partners (United Kingdom), several Biocartis employees and Benaruca, the family investment vehicle of Biocartis’ co-founder Rudi Pauwels.

Biocartis has developed and licensed a series of new technologies to build a broadly applicable new diagnostics platform for low to highly multiplexed detection, quantification, and amplification of molecular-based biomarkers, including nucleic acids, proteins, and small molecules. Following its recent acquisition of the Philips’ technology for rapid and fully automated DNA/RNA molecular diagnostic testing, Biocartis will use the proceeds of this round to accelerate its plans to finalize the development and validation of the first version of its proprietary new platform.

“Debiopharm recognized some time ago that companion diagnostics would play an increasingly important role in personalized medicine and the cost-effectiveness of healthcare in general”

said Thierry Mauvernay, executive vice-president of Debiopharm Group, who added:

“we are extremely happy to have started a new financial partnership with a dynamic start up company that has all the necessary strengths and management know-how to become a leading player in the field of in-vitro-diagnostics. Its potential combined with the various disruptive technologies it has created and licensed is perfectly in line with Debiopharm’s own efforts at the frontline of innovation in life-sciences at large”.

Dr. Pietro Scalfaro, from Debiopharm has joined the board of directors of Biocartis, now chaired by Dinko Valerio from Aescap. Dr. Scalfaro holds an MD with a specialty in pediatric intensive care medicine and led several drug development projects at Debiopharm before focusing on the development of their companion diagnostics strategy within a newly created business unit.

Rudi Pauwels, founder of Biocartis, Director and CEO, commented

“This successful financing, within weeks after closing the acquisition of the Philips technology, is yet another important step in our plans to bring a novel and cost-effective diagnostic solution to the healthcare community. There is a global need to turn the many scientific advances in the understanding of the molecular basis of diseases and treatments into routine daily clinical practice. The commitment and support of the Biocartis Board members, shareholders and employees have been instrumental in Biocartis’ rapid progress on this mission. I am particularly pleased that two new investors have now joined Biocartis. Our vision is of a future for medicine whereby the classical isolated elements of diagnostics and pharmaceuticals become more aligned and increasingly part of a much more integrated solution designed to optimize the outcome for the individual patient. Biocartis plans to actively work together with pharmaceutical, diagnostic and biomarker groups who can and would like to contribute to the practical realization of these goals.”

 

About Biocartis
Biocartis is a privately owned biotech company that 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). Biocartis engages in the development of a novel diagnostics technology platform for low to highly multiplexed detection of molecular-based biomarkers. The Company is focused on the delivery of a versatile and compact molecular diagnostic platform whose ease of use and operational characteristics will lower the entry barrier to molecular diagnostic testing. Biocartis is based at the EPFL Science Park in Lausanne, Switzerland and at the High Tech Campus in Eindhoven, The Netherlands.

About Debiopharm – www.debiopharm.com
Debiopharm is a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and which has embarked in the field of companion diagnostics with a view to progressing in the area of personalized medicine.

About Aescap Venture – www.aescap.com
Aescap Venture is a venture capital company investing in private medical companies in Europe. Aescap’s Partners have a proven track record of success and the skills to coach entrepreneurs in accelerating the growth of their companies.

About Biovest – Rudi Mariën
Rudi Mariën was co-founder, reference shareholder and Chairman of Innogenetics, and has been the founder, shareholder and Managing Director of several clinical reference laboratories.

About Advent Venture Partners
Advent Venture Partners is a long established European Venture Capital firm with a strong record of building successful companies.

For further information, please contact:
Rudi Pauwels
CEO
Phone: +41 21 693 90 51
Fax: +41 21 560 42 91

Mar 30
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The Leukemia & Lymphoma Society and Avila Therapeutics Enter Partnership to Accelerate Development of AVL-292 For Patients with Cell B Malignancies

By Avila, Press Release
Press Release.

 

White Plains, NY and Waltham, Mass. – The Leukemia & Lymphoma Society (LLS) and Avila Therapeutics, Inc., today announced they have established a collaboration to support development of one of Avila’s lead product candidates, AVL-292, for treatment of adults with B cell cancers.

Through the partnership, LLS will provide up to $3.2 million to support Avila’s clinical development of AVL-292. Avila anticipates the drug entering clinical trials in 2010.

B cells are an important component of the body’s immune system. B cells can become cancerous, leading to diseases such as non-Hodgkin lymphoma. Approximately 85 percent of non-Hodgkin lymphomas originate from B cells. AVL-292 is a targeted covalent drug designed to bind specifically to the protein target Bruton’s Tyrosine Kinase (Btk). Btk plays a critical role in B cell development and activation, and it is believed the inhibition of Btk will provide benefits in treating B cell cancers.

Taking an active role in accelerating development of novel therapies for patients, LLS has committed substantial, multi-year funding to support this collaboration as part of its Therapy Acceleration Program (TAP). TAP is LLS’s bold initiative designed to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers. By partnering directly with biotechnology companies, LLS is taking a results-oriented approach to more quickly identify potential breakthrough therapies and advance them along the FDA drug approval pathway.

“Avila, with its targeted covalent approach to Btk, hopes to develop, and ultimately deliver to patients, a cancer treatment with optimal efficacy and safety. We believe AVL-292 is a therapeutic candidate with significant opportunity to benefit the patients that we serve, and that Avila is an excellent partner for the LLS. Together the LLS and Avila hope to change the standard of care and improve the quality of life for patients suffering from blood cancer,”

said Louis DeGennaro, Ph.D., LLS’s chief mission officer.

“We are very honored that The Leukemia & Lymphoma Society recognizes the potential of AVL-292 and is making this substantial investment with Avila, which will significantly enhance the drug’s development,”

says Katrine Bosley, Avila’s chiefexecutive officer.

“In pursuing their mission, LLS is combining scientific advancement with connecting to doctors and patients – that ‘translational thinking’ helps companies like Avila cross the bridge from research into development much more effectively forpeople battling blood cancers.”

 

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and theirfamilies. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9a.m. to 6 p.m. ET. www.lls.org.

About Avila Therapeutics™, Inc.
Avila focuses on design and development of targeted covalent drugs to achieve best-inclass outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Mar 24
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MediGene reports additional phase II results of EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer

By Press Release
Press Release.

 

Clinical trial objective achieved – data confirm positive efficacy trend of EndoTAGTM-1 combination therapy

 

Martinsried/Munich, June 24, 2010. The biotechnology company, MediGene AG (Frankfurt, Prime Standard, MDG, TecDAX) announces additional phase II clinical trial results of the drug candidate EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer. The extensive data analysis of the three-arm trial conducted in 140 patients confirms a positive efficacy trend of EndoTAGTM-1 in combination with paclitaxel for the treatment of this difficult to treat type of cancer. The objective of the trial was achieved, and the initial conclusion of the preliminary data published on May 6, 2010 was verified.

The primary endpoint was achieved with EndoTAGTM-1 combination therapy. In addition, the analysis of the secondary endpoints (median progression-free survival, non-progression rate, safety, and tolerability) shows further positive results for EndoTAGTM-1 combination therapy.

Trial design
The trial recruited 140 patients diagnosed with triple receptor-negative breast cancer. These patients were randomized into three treatment groups, receiving either EndoTAGTM-1 in combination with the cytotoxic drug, paclitaxel (55 patients), or EndoTAGTM-1 monotherapy (57 patients). The third group (28 patients) was treated with paclitaxel alone. The patients treated with combination therapy received 22 mg/m2 EndoTAGTM-1 plus 70 mg/m2 paclitaxel once per week. EndoTAGTM-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers across several European countries and India. According to the trial protocol, the trial results are based on centralized data analysis. The patient numbers whose data were eligible for the central analysis are shown in the following results.

Trial results
The trial objective of evaluating efficacy of EndoTAGTM-1 was achieved by the combination therapy with Paclitaxel.

Primary endpoint: The primary endpoint was a progression-free survival rate of the patients treated with either EndoTAGTM-1 monotherapy or EndoTAGTM-1 plus paclitaxel combination of at least 30% after 16 weeks of treatment. At the same time, the 95% confidence interval, which provides information about the potential error rate, also had to be above 30%. The group of patients treated with EndoTAGTM-1 and paclitaxel combination therapy showed a progression-free survival rate of 59% (26 of 44 patients). The group treated with EndoTAGTM-1 monotherapy achieved a rate of 34% (13/38). For the group treated with paclitaxel monotherapy, this rate was 48% (12/25). Regarding the set confidence interval, the primary trial endpoint was met by the EndoTAGTM-1 combination therapy arm only.

Secondary endpoints: Median progression-free survival time during the trial was 4.2 months in the EndoTAGTM-1 combination therapy arm (52 patients), 3.4 months in the EndoTAGTM-1 monotherapy arm (48), and 3.7 months in the paclitaxel monotherapy arm (25). The rate of patients whose tumors had not progressed further (clinical benefit rate) in treatment week 16 was 59% in the EndoTAGTM-1 combination therapy arm (26/44 patients), 34% in the EndoTAGTM-1 monotherapy arm (13/38), and 50% in the paclitaxel monotherapy arm (12/24). In 76% of the patients in the EndoTAGTM-1 combination therapy arm (38/50), the tumor was either stable or regressive at a certain point in time during the treatment period (best overall response). The corresponding rate was 58% for the EndoTAGTM-1 monotherapy arm (26/45), and 58% for the paclitaxel monotherapy arm (14/24). Safety and tolerability profile of EndoTAGTM-1 was confirmed during the trial. The combination of EndoTAGTM-1 with paclitaxel did not lead to additional toxicity.

Professor Dr. Ahmad Awada, Head of the Medical Oncology Clinic, Department of Medicine, Institut Jules Bordet, Brussels, and principal investigator of the trial, commented:

“These are promising results for a disease that is as difficult to treat as triple receptor-negative breast cancer. Since the trial demonstrated a clinical benefit combining EndoTAGTM-1 with paclitaxel, I am confident that this therapy may represent a novel treatment option in the future.”

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented:

“Following the positive phase II clinical results obtained in pancreatic cancer indication, this trial conducted in another very difficult to treat type of cancer also shows clear indication of efficacy of EndoTAGTM-1. The data represent further clinical evidence of the therapeutic principle (proof-of-concept) of EndoTAGTM-1 combination therapies for indications with high medical need.”

 

About triple receptor-negative breast cancer: According to recent estimates by the American Cancer Society, approximately 193,000 newly diagnosed cases of breast cancer and 41,000 deaths associated with it occurred in the USA in 2009. Breast cancer is by far the most common type of cancer in women, accounting for 27% of cancer diagnoses. Malignant breast tumors that do not possess estrogen, progesterone or HER2 receptors are called “triple receptor-negative” breast cancer. About 15% of all breast cancers belong to this subgroup.1 Patients suffering from this type of breast cancer have a significantly poorer prognosis, and there are very few treatments available since conventional anti-hormonal treatments or treatments targeting HER2 are not appropriate. In case of recurrence following initial surgery, the only remaining treatment option is chemotherapy, and this also provides only a limited number of suitable therapeutics for this type of cancer.

About EndoTAG™-1: EndoTAGTM-1 represents an innovative therapeutic approach that unfolds its effect by both a targeted antivascular (against newly formed tumor blood vessels), and an anti-tumoral (directed against the tumor) mechanism. The drug candidate attaches itself selectively to newly developed, negatively charged tumor blood vessels, thus attacking only these blood vessels and not those in healthy tissue. Concurrently, EndoTAGTM-1 prevents the formation of new vessels, which is expected to suppress further tumor growth. EndoTAGTM-1 is a combination of positively charged liposomes with the therapeutic substance paclitaxel embedded therein.

EndoTAGTM-1 is MediGene’s first product candidate derived from the EndoTAGTM platform technology. MediGene obtained positive results with EndoTAGTM-1 in a controlled phase II clinical trial in pancreatic cancer. In Europe and the USA, EndoTAGTM-1 has been granted orphan drug designation which provides both cost and timeline benefits in the drug development process.

Analyst conference call and webcast: An analyst conference call in English will take place today at 2.30 p.m. (CEST), and will be webcast live. The webcast and synchronized presentation slides can be accessed at www.medigene.com. A recording of the live presentation will also be available thereafter.

1 Source: Cleator S, Heller W, Coombes R Ch. Triple-negative breast cancer: therapeutic options. Lancet Oncol 2007; 8:235-44

This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene, EndoTAGTM, and EndoTAGTM-1 are trademarks of MediGene AG. These trademarks may be owned or licensed in select locations only.

MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG, TecDax) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market which are distributed by partner companies. It has several drug candidates in clinical development, and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs with emphasis on oncology.

Contact MediGene AG
E-mail: investor@medigene.com
Fax: ++49 – 89 – 85 65 – 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 – 89 – 85 65 – 3324
Dr. Georg Dönges, Investor Relations, Tel.: ++49 – 89 – 85 65 – 2946