After initially tapping taspoglutide as the latest in a string of likely blockbusters-to-be from Roche, analysts are turning sour on the drug’s prospects after gaining a close look at the side effect data presented by researchers over the weekend.

The once highly touted diabetes drug prospect was put through the ringer earlier in the month when Roche said that it needed to amend trials to watch for side effects like vomiting and nausea, delaying any app for up to 18 months. But a look at the data presented over the weekend at the American Diabetes Association meeting left analysts doubtful that the drug can ever gain marketing approval.

“The full data presentation suggest that taspoglutide’s side-effect profile may be worse,” said Annie Cheng, an analyst for Bryan, Garnier. Cheng, once bullish about the therapy’s blockbuster potential, reduced her estimate on the likelihood of an FDA approval from 60 percent to only 10 percent. That’s also bad news for Ipsen, which licensed the drug to Roche.

“We rate the possibility that Roche hands the drug back to Ipsen at around 50 percent,” noted Morgan Stanley, according to a report from Dow Jones. “Roche’s sub-optimal development for taspoglutde raises questions about the integrity of the development programs for their other large phase III programs.”

Source: FierceBiotech

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Roche has delayed development of its potential blockbuster type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects, including skin reactions and digestive symptoms. Heart and respiratory events were also observed in some patients. Roche will use the additional time to identify patients who are sensitive to the treatment and remove them from clinical trials. The Swiss drugmaker, which is developing the once-weekly injection in conjunction with French company Ipsen, had originally planned on filing for approval in 2011. A Jefferies industry analyst told Reuters that an approval may not come until 2014.

“A delay of 12 to 18 months is not good,” Andrew Weiss, an analyst at Bank Vontobel, told BusinessWeek. “It’s an important drug for Roche and they need it on the market to balance out the oncology franchise, which is starting to slow down.” Cancer blockbusters Rituxan, Herceptin and Avastin make up 50 percent of the drugmaker’s sales.

When positive results from a large Phase III trial were revealed earlier this year, analysts projected the drug could reach $2.8 billion a year in sales. But tolerability problems unveiled at a recent diabetes conference, in conjunction with this delay, have cause industry experts to adjust taspoglutide’s market potential to just $490 million in 2014. If approved taspoglutide will compete with Novo Nordisk’s Victoza, which is already on the market, and Amylin’s Bydureon.

Source: FierceBiotech

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Ipsen and Dicerna are combining their respective technologies as part of an exclusive collaboration to develop therapeutics in the field of oncology and endocrinology. The partnership will marry Ipsen’s peptide targeting vector platform with Dicerna’s Dicer Substrate siRNA (DsiRNA) technology for the cell-specific, intracellular delivery of DsiRNAs that silence specific disease-causing genes The firms hope their combined technologies will generate new DsiRNA-based therapies that demonstrate targeted delivery, high potency and extended duration of action.

“This is the second significant partnership with a major biopharmaceutical company that we have entered into in 2010, further validating our next generation Dicer Substrate Technology and our unique ability to generate a greater number of more potent gene silencing molecules,” claims James C. Jenson, Ph.D., Dicerna’s CEO and co-founder.

Dicerna is developing second-generation RNAi-based therapies and related drug delivery systems based on its Dicer Substrate Technology. The Dicer enzyme is a natural initiation point for the RNAi cascade that acts earlier in the pathway to prepare double-stranded RNA for processing, the firm explains. It claims that introducing sequence-specific RNA templates on which Dicer can act has resulted in the generation of a more potent and longer-lasting variant of RNA interference. The Dicer Substrate Technology™ can thus effectively be used to knock down the expression of a targeted gene in a manner that is both highly selective, specific, and more potent than other RNAi approaches, Dicerna states.

The company’s deal with Ipsen is its second major partnership in 2010. In January, Dicerna inked a research collaboration and license agreement with Kyowa Hakko Kirin focused on the research, development, and commercialization of drug delivery systems and DsiRNA pharmaceuticals in the cancer field.

Under terms of this deal, Dicerna received $4 million in cash up front, and could earn another $120 million in additional research funding, development, and commercial milestones for exclusive rights to one target in the field of oncology. The companies may also expand the scope of the collaboration by adding another 10 targets, and broadening the therapeutic focus of the partnership.

Source: GEN News

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In the lead-up to a new late-stage clinical trial ordered by the FDA, GTx has renegotiated its partnership with France’s Ipsen, inking a new deal for the bone loss drug toremifene that will deliver study-related milestones reaching up to $58 million in exchange for broader global marketing rights.

For its part, Ipsen will receive either co-promotion rights in the U.S. or double digit royalties, along with a lengthy list of new countries to add to its European marketing rights. Ipsen is also off the hook for milestones related to a European approval. The $58 million in milestones is tied to the “initiation, enrollment and progression” of the second Phase III clinical trial.

“Once the agreement is reached with the FDA on a final study protocol required for marketing approval, we will initiate the second phase III clinical trial later this year with toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy,” says GTx CEO Mitchell Steiner.

Shares of GTXI tumbled badly last November when the word got out that the FDA was demanding a new Phase III trial. The developer then cancelled bonuses and axed more than a quarter of its workforce.

Source: FierceBiotech

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GTx could earn another €42 million (about $56.89 million) in milestone payments from Ipsen as part of the companies’ expanded partnership for GTx’ selective estrogen receptor modulator, toremifene. The amended deal relates to development and commercialization of toremifene 80 mg for the reduction of fractures in advanced prostate cancer patients on androgen-deprivation therapy and toremifene 20 mg for the prevention of prostate cancer in high-risk patients with high-grade prostatic intraepithelial neoplasia (HGPIN).

The reworked deal also gives Ipsen first right of negotiation (under specific conditions) to the oral LH inhibitor, GTx-758, in its licensed toremifene territories. GTx-758 is currently in Phase II development for the first-line treatment of men with advanced prostate cancer.

GTx submitted an initial toremifene NDA for the fracture-reduction indication in 2008. In October 2009, FDA’s complete response letter requested a second Phase III trial. GTx anticipates starting this study later this year once an agreement has been reached with the FDA on a final study protocol required for marketing approval.

GTx and Ipsen signed their original toremifene collaboration back in 2006, with GTx paying $30 million up front. Terms of the expanded agreement provide for Ipsen to pay GTx up to €42 million on the initiation, enrollment, and progression of a second toremifene 80 mg Phase III trial. In return, Ipsen gets the right to either co-promote toremifene 80 mg in the U.S. or to receive double-digit royalties on net sales of the drug in the U.S.

The French firm also receives additional licensed territories for marketing toremifene products outside Europe, including Australia and certain countries in North Africa, the Middle East, and Asia (excluding Japan). Ipsen will in addition be relieved from previous contractual obligations relating to the payment of potential milestones tied to European approval of toremifene 80 mg.

“This new agreement with GTx gives us expanded market reach and rights for toremifene,” state Stéphane Thiroloix, evp corporate development at Ipsen. “It will strengthen Ipsen’s franchise in hormone-dependent cancers and broaden our drug range in the oncology area.”

Source: GEN News

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Ipsen is to provide Inspiration Biopharmaceuticals with up to $259 million in funding as part of the companies’ strategic partnership to develop Inspiration’s hemophilia products. The deal will also see Ipsen pay $85 million up front for a 20% stake in Inspiration.

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Additionally, Ipsen will grant Inspiration an exclusive, worldwide sublicense to the recombinant porcine factor VIII product OBI-1, in exchange for $50 million in convertible notes and a 27.5% royalty on future OBI-1 sales.

The successful development of OBI-1 and Inspirations lead candidate could earn Inspiration another $174 million in clinical and regulatory milestones. For each milestone payment, Ipsen would receive a note convertible into Inspiration equity. The company states that assuming all milestones payments are made and the notes are converted into Inspiration equity, it could feasibly take on a 47% ownership of Inspiration’s equity on a fully diluted basis. Upon certain triggering events, Ipsen would also have the ability to acquire full control of Inspiration.

Ipsen’s OBI-1 is in development for the treatment of patients with acquired hemophilia and hemophilia A who have developed an inhibitory immune reaction to human forms of factor VIII. Inspiration’s lead in-house hemophila product is a recombinant factor IX called IB1001 (rFIX) for hemophilia B. Both OBI-1 and IB1001 are expected to start Phase III trials this year.

Inspiration also has earlier-stage candidates focused on both intravenous and noninvasive dosage forms of factor IX (hemophilia B), factor VIII (hemophilia A), and factor VIIa (hemophilia A&B). It is using its recombinant protein-manufacturing technologies to develop new, more efficacious, and cost-effective hemophila products. The company’s portfolio

As a result of the alliance, global private equity firm Celtic Pharma, has converted both its direct interest in Inspiration’s IB1001 product and its equity interest in the company into a new class of preferred shares in Inspiration. Celtic says that this will give it a significant interest in the new enterprise.

“OBI-1 makes sense to us as a strategic fit in our portfolio of products,” comments John Taylor, co-founder and chairman of Inspiration. “Not only does it add a valuable late-stage product to our pipeline, but it will benefit from our existing development infrastructure and future specialty sales force.”

Jean-Luc Bélingard, chairman and CEO of Ipsen, adds, “Inspiration has both strong development experience and a broad pipeline that will provide the opportunity for new growth on our way to building a new, multiproduct global franchise for Ipsen in hematology. Subject to the products in development being approved by the relevant regulatory authorities and upon successful commercialization, we believe Inspiration’s portfolio including OBI-1 could exceed sales of $1 billion in the next 10 years.”

Source: GEN News

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Roche rolled out data from a pair of Phase III trials of its experimental diabetes drug taspoglutide, saying that researchers have nailed down its superiority to Merck’s blockbuster Januvia. The pharma giant also reported that the Type 2 diabetes drug bested a placebo and proved to be well tolerated among patients, but left a sour taste among analysts who wanted to learn more about its side effects.

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Roche licensed the drug, which is injected once a week, from France’s Ipsen. The latest data comes from the second and third of eight planned late-stage trials, as Roche collects a stack of data for regulators in the U.S.Europe.

Analysts appeared happy to see that the drug beat out Januvia–which earned $1.4 billion in 2008–but were left hungering for more insight on the drug’s side effects. New diabetes drugs like Byetta have had trouble gaining a significant foothold in the market due to frequently reported incidents of nausea and vomiting–the two most common side effects of the Roche drug. Bank Sarasin analyst David Kaegi told Dow Jones that the data reported by Roche today shed “little light” on the side effect issue. Analysts will be watching for that at an upcoming diabetes conference in 2010.

Source: FierceBiotech

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Debiopharm and its European licensee, Ipsen, confirmed French regulatory clearance for the six-monthly sustained-release formulation of the LHRH agonist, Decapeptyl®, for locally advanced and metastatic prostate cancer. Ipsen says that it expects to launch the drug in France during the first quarter of 2010.

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The six-monthly formulation was approved in October via the European decentralized registration procedure in nine countries: Germany (the reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain, and The Netherlands. Regulatory submissions in Portugal, the U.K., Ireland, Italy, Romania, and Lithuania have been filed as national line extensions to existing approvals for other Decapeptyl formulations.

The therapy is already available in monthly and quarterly sustained-release formulations as well as a daily formulation. It is sanctioned in various markets including the U.S. for the treatment of advanced prostate cancer as well as for indications in endometriosis, precocious puberty, IVF, and uterine fibroids. Debiopharm says worldwide sales by its licensees are over $400 million.

Source: GEN News

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Ipsen (Euronext:IPN), an innovation-driven global specialty pharmaceutical Group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced today the signature of an agreement under which Debiopharm is granted an exclusive worldwide license to develop and commercialise Ipsen’s first-in-class inhibitor of the CDC25 phosphatase enzyme (now Debio 0931), for the treatment of various human cancers.

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CDC25 is a key enzyme involved in the regulation of cell cycle. Its over-expression is associated with the progression of cancer. By blocking the cell cycle and thus interrupting tumour growth, Debio 0931 represents a promising novel target for cancer therapies. This preclinical candidate will now be the subject of a full development program under the responsibility of Debiopharm.

Under the terms of the agreement Debiopharm will be exclusively responsible for the development of Debio 0931, with Ipsen having an option to re-acquire development and commercialisation rights post completion of Phase II clinical trials. Ipsen will receive an upfront payment and be eligible for milestone payments and royalties.

Jean-Luc Bélingard, Ipsen’s Chairman and Chief Executive Officer said: “We are delighted that Ipsen’s CDC-25 inhibitor will be progressed toward clinical development by Debiopharm, a company with a strong track record in oncology. Debiopharm is our long-standing partner with whom we have had a very fruitful partnership in other areas of oncology for more than 20 years and we feel confident that the full potential of CDC-25 will be maximised, thanks to Debiopharm’s strong expertise in oncology development.”

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Rolland-Yves Mauvernay, President and Founder of Debiopharm Group added: “We are extremely pleased to enter into another alliance with Ipsen. This collaboration is an opportunity to grow our pipeline in oncology, our area of expertise. We believe that Debio 0931 may have applications in the treatment of various types of cancer which will increase the quality of life of many cancer patients.”

Source: Ipsen Group

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The filing of the new Decapeptyl® 1 6-month formulation is in accordance with Ipsen’s regulatory timeline.
PARIS– Ipsen (Euronext: FR0010259150; Paris: IPN) today announced the start of the filing process in Europe of the 6-month sustained release formulation of Decapeptyl®, a luteinizing hormone releasing hormone agonist (LHRHa) developed by Debiopharm for the Read the full story

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