22.03.2013 - French Ipsen and its insolvent partner Inspiration Biopharmaceuticals Inc announced the closing of the sale of OBI-1 to Baxter International Inc.
The transaction, which strengthens Baxter as global leader in haemophilia, was announced at the end of January. Under the terms of the agreement, Ipsen and Inspiration will sell their rights on OBI-1 together with Ipsen's manufacturing plant in Millford. Recombinant porcine factor VIII under development for the treatment of congenital hemophilia A with inhibitors and acquired haemophilia A, as well as Ipsen's manufacturing facility for OBI-1 in Milford, Massachusetts are in the deal. The Ipsen employees working on the development and manufacturing of OBI-1 will be offered employment by Baxter. Baxter will pay US$50m upfront, and up to US$135m in milestones as well as net sales payments up to 17.5%. The recombinant porcine factor VIII is currently in a pivotal trial for the treatment of individuals with acquired haemophilia A.
25.04.2012 Even after the takeover of German-American Micromet Inc. by Amgen, Bite antibody technology remains interesting for other pharma partners.
Berlin/Martinsried – Bayer HealthCare has agreed to extend its collaboration with Amgen Research GmbH, as the former Micromet site in Munich is called today. Bayer and its partner will develop another new Bispecific T cell Engager antibody against an undisclosed target expressed in multiple tumours. The German pharma had forged a first option, collaboration and license agreement with Micromet in January 2009 to discover and develop a novel BiTE antibody targeting PSMA (prostate specific membrane antigen) for the treatment of patients with prostate cancer. Amgen acquired Micromet in March this year for US-$1.2bn and promised to keep the German site as its largest research centre outside the US. Under the terms of the present agreement, Bayer will collaborate with Amgen Research from the research phase through to the completion of Phase I clinical trials, upon which Bayer will assume full control of further development and commercialisation of the product candidate. The cooperation also includes evaluation of BiTE antibodies with an extended serum half-life. Financial details of the collaboration were not disclosed. Meanwhile, the development of the initial BiTE antibody resulting from the 2009 collaboration progresses according to plan and the initiation of the clinical Phase I trial could start as early as in the second half of 2012.
26.04.2012 Novartis has gained EU marketing approval for the first targeted therapy to treat Cushing’s disease, a rare endocrine disorder.
Basel – Swiss pharma major Novartis has got the green light from the European Commission to market Signifor (pasiretoid) as treatment for Cushing disease, a debilitating endocrine disorder caused by the over-expression of cortisol. Data from a Phase III trial on 162 patients with the disease showed that subcutaneous injection of the somatostatin analogue twice daily normalised the level of cortisol in the urine („urinary-free cortisol, UFC“) by 47,9% after six months of treatment (N Engl J Med. 2012 Mar 8;366(10):914-24). Clinical symptoms such as high blood pressure, high BMI and cholesterol levels and overweight in the two dosage groups (2 x 600µg and 2x 900 µg) significantly improved after administration of the orphan drug. About 250,000 people in the EU suffer from the disease. In two thirds of them, the disorder is caused by so-called pituitary tumours that release the corticoid hormone ACTH which then triggers cholesterol over-expression. Signifor is approved for adult patients with inoperable pituitary tumours. It reduces ACTH levels by targeting the somatostatin receptor 5 with 40-fold higher affinity as any other somatostatin analogue. In January 2012 the European Medicines Agency in London had recommended approval of Signifor as first-in-class treatment for Cushing’s disease.
27.04.2012 Zeltia Group has received €19m from its partner Johnson & Johnson. Progress with the cancer drug Yondelis triggered the milestone payment.
Madrid – Zeltia’s oncology subsidiary PharmaMar S.A. has received a second €19m milestone payment from Yondelis (trabectedin) ex-Europe partner Janssen, a Johnson & Johnson company. This follows the December 2011 receipt of €19m paid on agreement of a new US development plan. In late December 2011, PharmaMar reached the agreement with J&J subsidiary Janssen to push forward the development of Yondelis (trabectedin) in the US, with studies using the anti-tumour drug for the treatment of recurrent ovarian cancer and L-sarcoma.
Under the terms of the agreement, PharmaMar received a first €19m milestone payment at the end of 2011. On top of the actual €19m payment further €60m of milestones may fall due in 2013/2015, in addition to the economics agreed at the time of the original license. The PharmaMar mother company is approaching additional key pipeline catalysts, with an interim analysis of the ADMYRE study of Aplidin in relapsed/refractory multiple myeloma expected soon. An interim analysis of the Phase II PM01183 trial in resistant ovarian cancer and results of a Phase II study of Nypta (tideglusib) in Alzheimer’s disease, are both due at the end of the year. Yondelis is already marketed for the treatment of advanced soft tissue sarcoma and ovarian cancer in Europe, Russia and South Korea. Yondelis sales growth to €80m (+12%) in 2011 was hampered by supply issues with Doxil, with which it is administered in ovarian cancer. However Yolendis sales declined in Q1/2012 compared to the first quarter in 2011.
30.04.2012 The acquisition of Genzyme shows its benefits: Sanofi reported strong
sales and earnings growth in the first quarter of 2012.
Paris – The French drug maker reported a net profit of €1.8bn, up from €1.2bn in the first quarter of 2011. The better earnings, however, were not enough to change the company's gloomy outlook for the coming year. The executives warned that earnings in the rest of the year would be hit by the loss of US market exclusivity of its blood thinner Plavix (clopidogrel) in May, and blood pressure drug Avapro (irbesartan) at the end of March. Net sales rose more than 9% to €8.5bn, with revenue at the flagship pharmaceutical division, increasing 8.8% at constant exchange rates, to €7.32bn.
Genzyme contributed €841m. Sanofi benefited from growth in emerging markets (+9.9% to €2.6bn), with Brazil, Russia, Indian and China together contributing €917m. Sanofi's diabetes franchise also increased by 14.4% to €1.3bn. The contribution of Lantus (insulin glargine) is €1.1bn (+17.2%), which means it is the company's top-selling drug. Sanofi's oncology business grew by 12.8% to €741m, with Eloxatin (oxaliplatin) generating €321m in the US.
Sanofi's CEO Chris Viehbacher emphasised that the patent loss of former key products like Plavix and Avapro had been something the French multinational had long foreseen. According to Viehbacher, the company is now entering the final phase of its patent cliff. He said that Sanofi had built six "growth platforms" to replace sales lost to generic competition and generate sustainable growth. He noted that these new products would not be dependent on patents to the same extent. Growth platform businesses include Genzyme developments – including rare disease products like Cerezyme and Fabrazyme, plus the late-stage multiple sclerosis products Aubagio (teriflunomide) and Lemtrada (alemtuzumab). Other growth platforms are diabetes, vaccines, consumer health care, animal health, new products and emerging markets.
02.05.2012 Results from a NIH study confirm that treating wet AMD with unlicensed Avastin (bevacizumab) leads to more adverse effects than Novartis’ Lucentis.
Basel - Novartis AG has highlighted results from a head-to-head study comparing safety and efficacy of the VEGF antibody fragment Lucentis (ranibizumab) with the full VEGF antibody Avastin (bevazizumab) in wet AMD therapy. According to the NIH-funded CATT study (Comparison of Age-related macular degeneration Treatment Trials), Lucentis showed superior safety when compared to Avastin, which has been not approved as treatment for wet AMD but has been broadly used off label by ophtalmologists due primarily to a 50fold lower price.
According to Novartis, which has licensed marketing rights from Roche for Lucentis, two year data from 1107 patients confirm 30% higher risk of serious systemic adverse events with unlicensed bevacizumab versus Lucentis. Additionally, the Swiss pharma major pointed to reports of arteriothrombotic events, systemic haemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death, which were more frequent in bevacizumab treated patients. These events have been previously associated with systemic anti-VEGF treatment.
"The apparent differential safety risk between the two medicines may be due to differences in the molecules and their commercial formulation“, said Tim Wright, Global Head of Development, Novartis Pharma. Previously published retrospective Medicare analyses compared the safety of unlicensed ocular bevacizumab and Lucentis for treating wet AMD. The primary analysis from the Curtis study showed that unlicensed bevacizumab and Lucentis were not associated with increased risks of death, heart attack, bleeding or stroke compared with photodynamic therapy or pegaptanib. A secondary analysis in the Curtis et al study, which included approximately 40,000 patients, showed a significantly higher risk of mortality (16%) and stroke (28%) with unlicensed intravitreal bevacizumab than with Lucentis. Gower et al. assessed 77,886 Medicare beneficiaries with wet AMD over 10 months. In this study patients treated with unlicensed intravitreal bevacizumab experienced an 11% significantly increased risk of death and a 57% significantly increased risk of haemorrhagic stroke compared to patients treated with Lucentis. The risk of ocular inflammation was 80% higher with unlicensed intravitreal bevacizumab than with Lucentis.
03.05.2012 Denmark’s Novo Nordisk has exclusively licensed Caisson's heparosan-based drug delivery to develop compounds of its drug pipeline.
Oklahoma City/Austin/Baegsvard – With the exclusive license deal, Novo Nordisk has secured a key platform to extend the life cycle of its existing drugs by simply attaching them to bio-inert sugar polymers, which cannot be degraded extra-cellularly. Under the terms of the agreement, Caisson Biotech LLC, a wholly owned subsidiary of Heparinex, L.L.C, will receive an undisclosed upfront payment from the Danish drugmaker plus fees for contract research and manufacturing. In addition, Caisson will be eligible to receive milestone payments upon achievement of certain predefined clinical, regulatory and commercial targets, plus royalties on the global sales of the therapeutic products developed under the agreement, representing a total deal value of more than $100m.
Caisson’s drug delivery technology, who was invented by the firm’s CSO Dr. Paul DeAngelis at the University of Oklahoma, utilises heparosan, a naturally occurring sugar polymer that is stable and inert in the bloodstream, but is biodegradable inside cells for the purpose of cloaking, enlarging and/or protecting drug cargo. Heparosan can be customised with respect to polymer size and conjugation chemistry, thus increasing product half-life, reducing immunogenicity, and increasing stability.
In contrast to PEGylation, heparosanylation shows no toxicity. Additionally, Caisson Biotech claims higher and faster water solubility, longer excretion half life and its larger flexibility concerning usage to different drug types and delivery systems.
04.05.2012 Newly founded Iteos Therapeutics SA closed its Series A financing round, worth €9m, for the development of immunmodulators for cancer therapy.
Louvain-La-Neuve – Belgian Iteos Therapeutics SA is a joint spin-off of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute at the Université Catholique de Louvain. The company raised €3m from LICR, Hunza Ventures SCA, Life Science Research Partners, Vives Louvain Technology Fund and several business angels. Additionally, it received a non-dilutive €6m grant from Belgian Walloon Government in December 2011.
The field of cancer immunotherapy has come to the fore in the last two years with the approval of drugs and vaccines that harness the power of the immune system to treat cancer patients more safely, efficiently and effectively. However, therapeutic uses of these treatments can be limited, as the tumours often develop mechanisms that enable them to escape the immune system.
Iteos strives to develop small-molecule immunomodulators that can increase the efficacy of cancer immunotherapy, as well as leverage the spontaneous anti-tumour immune response. "Effective immunotherapy treatments enable the body's immune system to re-engage in destroying tumour cells, thereby potentially creating better patient outcomes with fewer side effects when compared to conventional cancer treatments", said Iteos’ co-founder Benoît Van den Eynde. He announced that the new company will try to reach a proof of concept in humans by completing a Phase I/IIa study for the first compound programme and to submit an Investigational New Drug application for a second candidate within four years.
Currently iTeos, which is a semi-virtual company, has initially received exclusive rights to its three targets from the LICR and has an option to receive rights to future targets discovered by LICR.
07.05.2012 Healthcare cost watchdogs are not convinced by GSK’s Lupus drug Benlysta: British NICE and German IQWiG have recommended against the drug.
Cologne/London – “No additional benefit documented” – With these harsh words the German Institute for Quality and Efficiency in Health Care (IQWiG) rebuffed GSK’s Lupus antibody belimumab (Benlysta). Under the new, tougher German reimbursement regime, the Institute evaluates newly approved drugs for their additional medical benefit and issues a draft benefit assessment. That decision could mean a large, forced discount to Benlysta's price on the German market.
Although Benlysta is the first new treatment for lupus for decades, it has been slow to take off so far. Negative assessments as form NICE and IQWiG won’t help to improve the situation. GSK, Britain's biggest drugmaker, said on Thursday that the judgment from IQWiG was "completely inexplicable from a medical point of view and disregards genuine progress in therapy".
„Their case for a higher bid seems to be based on the market potential of Benlysta, but the arguing has begun over how realistic those hopes are“, stated Drug discovery Chemist Derek Lowe. Besides Benlysta, HGS might bank on albiglutide (Diabetes) and darapladib (Artheroslcerosis), which are currently undergoing Phase III trials, which could bring significant revenues if approved.
08.05.2012 Satisfied investors again hand out money to UK-biotech Oxford Nanopore. Almost all of the newly raised €39m comes from existing funders.
Oxford – British next generation sequencing specialist Oxford Nanopore Technologies Ltd has announced that its recent fundraising round has been successful. All in all, €39.0m (£31.4m) will lubricate the biotech’s plans to boost its operational standing. CEO Gordon Sanghera wants to spend the money on different fronts: „This round of funding will support a range of corporate development activities including the development of our commercial infrastructure and the expansion of our manufacturing function. We will also continue to maintain our leadership position in nanopore innovation through maintenance and expansion of our broad intellectual property portfolio."
Almost all the money comes from existing investors via private placements of ordinary shares. Oxford Nanopore summed up that the total amount raised in the company’s life since its inception as a University of Oxford spin-off in 2005 is about €130.2m. The up-and-coming high-tech shack has developed a rapid and cheap new sequencing technology based on nanopores to directly and electronically detect and analyse single molecules. Since the first public demonstration of the technology in mid-February friends and foes alike early await its direct to customer commercialisation in the manifestations of the GridION platform and the MinION device in the second half of 2012. Currently, competitors such as Roche/IBM are just in research stage.
09.05.2012 Austrian biotech company Intercell AG has signed a €25m financing deal with Swiss investor BB BiotechAG.
Vienna – The vaccine maker also said it is in talks with other investors concerning a private stock placement that could total €15m. The investment, through a fully owned subsidiary of BB Biotech AG, consists of a €20m secured loan and a commitment to invest €5m as part of a proposed private share placement. Intercell’s CEO, Thomas Lingelbach, stated: “Following the successful strategic resetting in 2011, this financing marks an important step in the renewal of Intercell as a notable biotech vaccine company. With growing sales from our first product on the market, a diversified pipeline and technology base and a disciplined financial strategy, we are now very well positioned for the next development phase of our company.”
Intercell is trying to get back on track after several product setbacks sparked worries about its pipeline prospects. After a setback in the development of a traveller’s diarrhoea vaccine last year, the new focus of the company is on vaccines preventing nosocomial infections. The secured six-year loan carries a variable interest rate. Intercell will pay BB Biotech royalties on sales revenues from its product Ixiaro, a vaccine for Japanese encephalitis. The €5m equity investment will see BB Biotech subscribe for nearly 2 million Intercell shares for about 2.55 € per share as part of the private placement. According to Intercell, existing shareholders will not get subscription rights for the placement