December 24, 2013

Madison Dearborn Partners to Acquire Ikaria

Existing Shareholders, Including New Mountain Capital and Company Management, will Receive Minority Positions; Transaction Values Ikaria at Approximately $1.6 Billion
PDF Download

read more »

November 14, 2013

Evolva and IFF to end collaboration on second ingredient

Evolva Holding SA (SIX: EVE) announces that its collaboration with International Flavors & Fragrances Inc. (IFF), announced in May 2012 and targeted at an undisclosed flavouring ingredient, will be discontinued in early 2014. Evolva is considering continuing work on the ingredient on its own account. The two parties are discussing potential additional collaboration areas.
PDF Download - English Version
PDF Download - German Version

read more »

October 28, 2013

Symetis Announces a Symbolic Milestone: the 1000th Patient implanted with ACURATE TA™

• SAVI 2 Registry to further support Symetis TA franchise
• Valve-in-valve clinical study to extent ACURATE TATM label

Symetis Inc., a privately-­‐owned Swiss company focused on transcatheter aortic valve implantation (TAVI) systems announced today that it has achieved a symbolic milestone: the implantation of the 1000th  ACURATE TA™ transaortic valve.
PDF Download

read more »

October 07, 2013

Evolva to license EV-077 to Serodus

Evolva Holding SA (SIX: EVE) and Serodus ASA (Oslo, Norway) today announced that they have signed a binding term sheet for the clinical development of EV-077, Evolva’s compound targeted at diabetic nephropathy (progressive kidney disease caused by diabetes). The parties aim to sign a full license agreement no later than 31 December 2013 allowing Serodus to initiate the next clinical study on EV-077 in the second quarter of 2014.
PDF Download - English Version
PDF Download - German Version

read more »

September 30, 2013

FDA Grants Orphan Drug Designation to Omeros' OMS824 for Huntington's Disease

Omeros Corporation (NASDAQ: OMER) announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. As previously reported, Phase 1 clinical results in healthy subjects demonstrated that OMS824 is well tolerated and suggest that it has a better clinical therapeutic index or "safety factor" than other PDE10 inhibitors in development. Omeros plans to begin a Phase 2 clinical trial evaluating OMS824 in patients with Huntington's disease later this year. A Phase 2 clinical trial of the drug is already underway in patients with schizophrenia.
PDF Download

read more »

September 26, 2013

Biotie: Selincro enters the market in Italy

Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has brought Selincro on the market in Italy. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone payment of EUR 2 million related to the market entry. Lundbeck will continue the rollout of Selincro in additional European markets through 2013 and into 2014.
PDF Download

read more »

September 24, 2013

Biotie Completes Planned Portfolio Review

Biotie Therapies Corp., a specialized drug development company focused on neurodegenerative and psychiatric disorders, today announces the outcome of its planned portfolio review following its success earlier in the year with the approval and launch of Selincro® in Europe by H. Lundbeck A/S ("Lundbeck") and the exercise by UCB S.A. ("UCB") of its license for tozadenant (SYN115), for which Biotie received a USD 20 million milestone.
PDF Download

read more »

September 24, 2013

Evolva’s antibiotic GC-072 (EV-035 series) selected for contract negotiations for preclinical funding by US DTRA

The US Defense Threat Reduction Agency (DTRA) has announced that it has selected Evolva to enter into contract negotiations regarding possible preclinical funding for Evolva’s antibiotic compound GC-072 (the lead compound in Evolva’s EV-035 series) under the Transformational Medical Technologies Initiative (TMTI). The size of the award could be up to USD 14.7 million.
PDF Download - English Version
PDF Download - Germand Version

read more »

September 19, 2013

Omeros Reports Initiation of Phase 2 Clinical Trial with OMS824 -- PDE10 Inhibitor Administered to Patients with Schizophrenia --

Omeros Corporation (NASDAQ:OMER) today announced initiation of enrollment in a Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor. The trial will evaluate the compound's tolerability, safety, pharmacokinetics, potential interactions with concomitant antipsychotic medications, and a battery of cognitive tests in patients with stable schizophrenia.
PDF Download

read more »

September 12, 2013

Omeros Reports Additional Positive Results from OMS824 Program

Omeros Corporation (NASDAQ: OMER) today announced positive data from the Company's Phase 1 clinical trial evaluating the pharmacokinetics of OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program, further supporting that OMS824 can achieve superior target engagement with lesser side effects compared to other PDE10 inhibitors in development. With these data and the previously announced encouraging results from the OMS824 positron emission tomography (PET) clinical trial, Omeros is advancing OMS824 into Phase 2 clinical programs. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia.
PDF Download

read more »

September 10, 2013

Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency

Omeros Corporation (NASDAQ: OMER) today announced that it recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery in the European Union (EU). Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery® product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.
PDF Download

read more »

September 09, 2013

Cargill and Evolva move into pilot scale ahead of schedule for fermentation-based steviol glycosides

Cargill and Evolva Holding SA (SIX: EVE) announced today that their development program for fermentation-based steviol glycosides is moving into pilot scale ahead of schedule, potentially making it available for commercialization sooner than expected. Earlier this year, Cargill and Evolva entered into an agreement to jointly develop and commercialize fermentation-based steviol glycosides. Steviol glycosides are the compounds responsible for the sweet taste of stevia plant leaves.
PDF Download - English Version
PDF Download - German Version

read more »

August 12, 2013

Symetis announces successful, first time implantation of its ACURATE TA™ and ACURATE TF™ TAVI systems in Japan

 Procedures performed at Osaka University Hospital
 Four patients successfully treated in initial feasibility study
 Results to support PMDA filing

Symetis Inc., a privately-owned Swiss company focused on transcatheter aortic valve implantation (TAVI) systems, announced that its ACURATE TA™ and ACURATE TF™ TAVI systems were used to successfully treat patients at the Department of Cardiovascular Surgery of the Osaka University Graduate School of Medicine. These procedures were performed as part of a feasibility study being conducted under the leadership of Professor Yoshiki Sawa. 
PDF Download
 

read more »

August 08, 2013

Japanese authorities rule Evolva’s resveratrol to be regulated as a food and nutritional supplement

Evolva Holding SA (SIX: EVE) announced today that, following Evolva’s request, the Japanese Ministry of Health, Labor and Welfare has issued a notice that resveratrol should be classified into the Non-drug material group. This opens the way to using Evolva’s natural, fermentation-derived resveratrol in food and as a nutritional supplement in Japan, provided it complies with the food sanitation act and other general safety assessments. This decision significantly facilitates the approval process for the product in Japan. Evolva’s resveratrol already has self-affirmed GRAS (Generally Regarded As Safe) status in the US and is European Novel Foods approved.
PDF Download - English Version
PDF Download - German Version

read more »

August 01, 2013

Omeros Submits New Drug Application to U.S. FDA for OMS302

Omeros Corporation (NASDAQ: OMER) announced that the company recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery. Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery™ product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.
PDF Download

read more »

July 02, 2013

European Medicines Agency Approves Positive Opinion on Omeros' Pediatric Investigation Plan for OMS302

Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) approved a positive opinion issued by the European Pediatrics Committee (PDCO) agreeing to the Company's Pediatric Investigation Plan (PIP) for OMS302. EMA's approval of PDCO's positive opinion is a prerequisite for submission of the OMS302 Marketing Authorization Application (MAA) and, on completion of the post-marketing pediatric study, leads to an additional six months of patent exclusivity for OMS302 in Europe. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
PDF Download

read more »

June 13, 2013

Omeros Obtains Regulatory Approval to Initiate Phase 1 Clinical Trial for Lead Antibody in MASP-2 Program

Omeros Corporation (NASDAQ: OMER) today announced that it has obtained regulatory clearance to start the Phase 1 clinical trial evaluating OMS721, the Company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program. The first clinical trial with OMS721 will be conducted in Europe and will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered subcutaneously in healthy subjects. Omeros plans to follow this study with a clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome (aHUS), a rare but life-threatening form of thrombotic microangiopathy (TMA). Enrollment in the initial clinical trial is scheduled to begin next month.
PDF Download

read more »

June 04, 2013

Biotie purchases option to acquire Neurelis, Inc

Biotie Therapies Corp. ("Biotie") today announced that it has obtained an exclusive option to acquire Neurelis, Inc. ("Neurelis"), a private specialty pharmaceutical company based in San Diego, CA, focused on developing products for epilepsy and other disorders of the central nervous system ("CNS").
PDF Download

read more »

May 31, 2013

Omeros Reports Positive Results from OMS824 Positron Emission Tomography Clinical Trial

Omeros Corporation (NASDAQ: OMER) today announced positive results from its Phase 1 clinical program evaluating OMS824, the lead compound from its phosphodiesterase 10 (PDE10) program. This study measured the extent to which OMS824 binds to PDE10 in the basal ganglia, a region of the brain that has been linked to a wide range of diseases that affect cognition. The results show that the selected dose of OMS824 achieved approximately 50 percent occupancy of PDE10 without triggering the extrapyramidal symptoms (loss of muscle control, e.g., muscle rigidity, tremors, or involuntary muscle movements) reported as side effects with other PDE10 inhibitors that achieved similar or significantly lower occupancy levels. OMS824 is Omeros' proprietary compound that selectively inhibits PDE10, and the Company plans to advance into Phase 2 clinical trials in Huntington's disease and schizophrenia later this year.
PDF Download

read more »

May 28, 2013

Omeros Files Clinical Trial Application for Lead Antibody in MASP-2 Program -- Phase 1 Clinical Trial Expected to Begin Early Next Quarter

Omeros Corporation (NASDAQ: OMER) today announced that it has filed a Clinical Trial Application (CTA) with European regulators to initiate clinical trials evaluating OMS721, the Company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program. The lead indication for OMS721 will be atypical hemolytic uremic syndrome (aHUS), a rare but life-threatening form of thrombotic microangiopathy (TMA). Assuming positive regulatory review of its CTA, Omeros plans to initiate a Phase 1 clinical trial evaluating OMS721 early next quarter.
PDF Download

read more »

May 23, 2013

Omeros - Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease

Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA.
PDF Download

read more »

May 16, 2013

RuiYi and Genor Biopharma Collaborate on Development in China of RYI-008, a Novel Therapeutic for Autoimmune Diseases and Cancer

RuiYi Inc. announced today that it has entered into an exclusive license and collaborative development agreement with Genor Biopharma for the development of RYI-008 in China. RYI-008 is a novel anti-IL-6 monoclonal antibody with a unique pharmacologic profile that has the potential to define a new paradigm in the treatment of disease.
PDF Download

read more »

May 14, 2013

CMC Biologics and RuiYi Enter into an Agreement for Development of a Novel Anti-IL-6 Monoclonal Antibody

CMC Biologics today announced the execution of an agreement with RuiYi Inc. to develop a cell line for RYI-008, a novel anti-IL-6 monoclonal antibody. CMC Biologics’ proprietary CHEF1® high-productivity expression plasmid will be utilized for the cell line development to optimize cell growth, and consistent, high-level protein expression in a rapid time frame. Specific terms of the agreement were not disclosed.
PDF Download

read more »

May 10, 2013

Omeros Announces $16.2 Million Registered Direct Offering of Common Stock

Omeros Corporation (NASDAQ: OMER) today announced that it has agreed to sell 3,903,004 shares of its common stock at a price of $4.14 per share, a two percent premium over the closing price on May 8, 2013, for gross proceeds of $16.2 million. The shares were offered and are expected to be sold to RA Capital Management and other investors in a registered direct offering conducted without an underwriter or placement agent. The net proceeds from the offering, after deducting estimated offering expenses, will be approximately $16.1 million. The offering is expected to close on or about May 14, 2013.
PDF Download

read more »

May 06, 2013

Biotie: Selincro launched in the United Kingdom

Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has launched Selincro in the United Kingdom. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone payment of EUR 2 million related to the UK launch. Biotie will potentially contribute to Lundbeck towards any required post approval commitment studies. These contributions are not expected to be significant in 2013.
PDF Download

read more »

May 03, 2013

Ambrx Initiates Collaboration with Bristol-Myers Squibb for Discovery, Development of Next-Generation Antibody Drug Conjugates

Ambrx today entered into a collaboration agreement with Bristol-Myers Squibb (NYSE: BMY) for the discovery and development of novel antibody drug conjugates using Ambrx's protein medicinal chemistry technology.
PDF Download

read more »

April 17, 2013

Omeros Files Orphan Drug Application for Treatment of Atypical Hemolytic Uremic Syndrome with OMS721

-- Orphan Drug Designation Could Provide Financial Incentives and Faster Regulatory Review --
Omeros Corporation (NASDAQ: OMER) today announced that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP 2) program, for use in the treatment of atypical hemolytic uremic syndrome (aHUS). As Omeros previously announced, based on positive preclinical data in thrombotic microangiopathy (TMA), the first indication planned for OMS721 clinical trials is aHUS, a rare but life-threatening form of TMA. Orphan drug designation is granted to treatments that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients per year. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity.
PDF Download

read more »

April 10, 2013

Omeros Announces that GPR17 Antagonists Improve Function in Model of Multiple Sclerosis

Omeros Corporation (NASDAQ: OMER) today announced positive data in the most commonly used model for studying the clinical and pathological features of multiple sclerosis (MS), further advancing its development program of GPR17-targeting compounds for the treatment of MS. Compounds previously discovered by Omeros that inhibit GPR17, an orphan G protein-coupled receptor (GPCR) unlocked by Omeros, significantly improved function from experimental autoimmune encephalomyelitis (EAE) in mice. Using its proprietary high-throughput Cellular Redistribution Assay (CRA), Omeros believes that it alone has identified compounds that functionally interact with GPR17 and has patents pending that are broadly directed to any such compounds active at the receptor.
PDF Download

read more »

April 09, 2013

Evolva reports financial results for 2012

Evolva Holding SA (SIX: EVE) today announced its financial results for the period 1 January to 31 December 2011. The annual report is available on Evolva’s website.
Jørgen Hansen to succeed Jutta Heim as CSO – Jutta Heim nominated to join Board
PDF Download Press Release in English
PDF Download Press Release in German
PDF Download Annual Report in English
PDF Download Annual Report  - Summary in German
PDF Download Presentation

read more »

April 04, 2013

Astellas and Ambrx Initiate Collaboration for Discovery and Development of Next-Generation Antibody Drug Conjugates for Oncology

Astellas Pharma Inc. (Tokyo: 4503, “Astellas”) today entered into a collaboration with Ambrx Inc. (“Ambrx”) for the discovery and development of novel antibody drug conjugates (“ADCs”).
PDF Download

read more »

March 27, 2013

Evolva completes CHF 31.3 million fundraising

Evolva Holding SA (SIX: EVE, “Evolva”) today reports the completion of the capital increase that was announced on 6 March 2013. The offering that was fully subscribed by existing shareholders and new investors, provides Evolva with gross proceeds of CHF 31.3 million before transaction costs.
PDF Download - English Version
PDF Download - German Version

read more »

March 20, 2013

Evolva raises CHF 31.3 million in oversubscribed share issue

Evolva Holding SA (SIX: EVE, “Evolva”) today announced that its offering (announced on 6 March 2013) was fully subscribed by existing and new shareholders. The offering provides Evolva with gross proceeds of CHF 31.3 million before transaction costs.
PDF Download - English Version
PDF Download - German Version

read more »

March 06, 2013

Evolva to raise up to CHF 31.3 million

Evolva Holding SA (SIX: EVE, “Evolva” or the “Company”) today announces the start of its capital increase. Evolva will raise up to CHF 31.3 million by means of a rights issue to existing shareholders. The new shares will be priced at CHF 0.60 per share. Due to the high level of demand from international institutional investors, the Company has decided to increase the size of the financing from the previously indicated level of CHF 10-20 million to the currently expected CHF 31.3 million.
PDF Download - English Version
PDF Download - German Version

read more »

March 06, 2013

Evolva And Cargill In Deal To Co-develop Steviol Glycosides

Evolva Holding SA (SIX: EVE) today announced that it has entered into an agreement with Cargill to jointly develop and commercialize fermentation-derived steviol glycosides. Cargill will be responsible for commercialization and has agreed to make a CHF 5 million (approximately USD 5.3 million) equity investment in Evolva. Additionally, Evolva stands to receive up to USD 7.5 million in milestone payments and has the right to a 45% participation in the final business. If Evolva decides not to exercise this option it will receive royalty payments from global sales of the codeveloped steviol glycoside products; these royalties will scale from mid-single digit to low double-digit percentages as a function of sales volume and other parameters.
PDF Download - English Version
PDF Download - German Version

read more »

February 07, 2013

Omeros Announces Toxicology Study Data from MASP-2 Inhibitor

Omeros Corporation (NASDAQ: OMER) today announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin associated serine protease-2 (MASP-2) program. Based on the data from these nonhuman primate studies, OMS721 is expected to be delivered subcutaneously to patients at a convenient dosing schedule of weekly, bi-monthly or even less frequently. Omeros is now analyzing additional data and expects to submit, in the second quarter of this year, an Investigational New Drug (IND) Application or Clinical Trial Application (CTA) to the applicable regulatory body to initiate clinical trials evaluating OMS721.
PDF Download

read more »

February 05, 2013

IFF and EVOLVA enter pre-production phase for Natural Vanillin for global food and flavour markets

International Flavors & Fragrances Inc. (NYSE: IFF), a leading global creator of flavors and fragrances for consumer products and Evolva Holding SA, Reinach, Switzerland (SIX: EVE), a biosynthesis technology expert, today announced that they have entered into pre-production phase to develop and scale-up, via a third party, natural vanillin for commercial application through a cost-effective, natural and sustainable route. The two companies are working to confirm scalability and yield targets through a yeast-based fermentation route during the pre-manufacturing phase.
PDF Download English Version
PDF Download German Version

read more »

January 29, 2013

Evolva reaches milestone in BASF collaboration

Evolva Holding SA (SIX: EVE) today announced that it has achieved a key milestone in its collaboration with BASF (announced in March 2011). The collaboration involves joint research on the design of novel and optimised biosynthetic routes for a natural product with crop protection potential.
PDF Download English Version
PDF Download German Version

read more »

January 22, 2013

Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial -- Market Launch Expected First Half of 2014 --

Omeros Corporation (NASDAQ: OMER) today announced the successful completion of the 90-day safety database lock in the second of the Company's two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery. In November 2012, Omeros announced that OMS302 met the co-primary efficacy endpoints in this second pivotal Phase 3 clinical trial by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period.
PDF Download

read more »

January 17, 2013

Evolva in collaboration with Ajinomoto Co

Evolva Holding SA (SIX: EVE) today announced that it has entered into a collaboration agreement with Ajinomoto Co. Inc., Japan, for the joint development of novel
fermentation production routes for a natural functional ingredient for application in Personal Care. Ajinomoto Co is a world leader in the area of amino acids.
PDF Download English Version
PDF Download German Version

read more »

January 16, 2013

Omeros Identifies Small Molecules for Class B GPCR

Omeros Corporation (NASDAQ: OMER) today announced that its proprietary Cellular Redistribution Assay (CRA) technology, which to date has successfully "unlocked" 46 of the 80 total Class A orphan G Protein-Coupled Receptors (GPCRs) for drug development, has identified small molecules that interact with a Class B GPCR.
PDF Download

read more »